Institutionalization of Intellectual Property Management: Case Studies from Four Agricultural Research Institutions in Developing Countries

CAS-IP National Partners Initiative (NPI) Institutionalization of Intellectual Property Management: Case Studies from four Agricultural Research Institutions in Developing Countries - A Compilation of Four Working Papers Intellectual Property Management Regime in the Indian National Agricultural Research Systems (R. Kalpana Sastry, India) Establishment of a Plant Breeders’ Rights System in Tanzania: Achievements and Challenges (Patrick Ngwediagi, Tanzania) A review of the Nigerian System of Intellectual Property (Victor M. Ibigbami and Christopher U. Orji, Nigeria) Establishing a Technology Transfer Office in a developing country academic institution: Experience of Moi University (Antony S. Mbayaki, Kenya) CAS-IP C/O Bioversity International Via dei Tre Denari, 472a 00057 Maccarese (Rome) Italy Tel.: (39) 066118.1 - Fax: (39) 0661979661 www.cas-ip.org

The individual case studies and the compilation are licensed under the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-sa/3.0 or send a letter to Creative Commons, 171 Second Street, Suite 300, San Francisco, California, 94105, USA. Recommended citation for the compilation: CAS-IP NPI. 2009. Institutionalization of Intellectual Property Management: Case Studies from four Agricultural Research Institutions in Developing Countries. CAS-IP, Rome, Italy. Recommended citation for individual case studies: R.Kalpana Sastry. 2009. Intellectual Property Management Regime in the Indian National Agricultural Research Systems. In: CAS-IP NPI. 2009. Institutionalization of Intellectual Property Management: Case Studies from four Agricultural Research Institutions in Developing Countries. CAS-IP, Rome, Italy. Patrick Ngwediagi. 2009. Establishment of a Plant Breeders’ Rights System in Tanzania: Achievements and Challenges. In: CAS-IP NPI. 2009. Institutionalization of Intellectual Property Management: Case Studies from four Agricultural Research Institutions in Developing Countries. CAS-IP, Rome, Italy. Victor M.Ibigbami, Christopher U.Orji. 2009. A Review of the Nigerian System of Intellectual Property. In: CAS-IP NPI. 2009. Institutionalization of Intellectual Property Management: Case Studies from four Agricultural Research Institutions in Developing Countries. CAS-IP, Rome, Italy. Antony S.Mbayaki. 2009. Establishing a Technology Transfer Office in a Developing Country Academic Institution: Experience of Moi University. In: CAS-IP NPI. 2009. Institutionalization of Intellectual Property Management: Case Studies from four Agricultural Research Institutions in Developing Countries. CAS-IP, Rome, Italy. The CAS-IP National Partners Initiative (CAS-IP NPI) and the publication of the working papers have received funding from the Dutch Ministry of Foreign Affairs (Cultural Co- operation, Education & Research Department) under grant agreement DCO/OC-354/07 For more information please contact: CAS-IP C/O Bioversity International Via dei Tre Denari, 472a 00057 Maccarese (Rome) Italy Tel.: (39) 066118.1 - Fax: (39) 0661979661 http://www.cas-ip.org CAS-IP is a system office unit of the CGIAR b

Institutionalization of Intellectual Property Management: Case Studies from four Agricultural Research Institutions in Developing Countries - A Compilation of Four Working Papers written by: R.Kalpana Sastry National Academy of Agricultural Research Manangement, Hyderabad-50040. Andhra Pradesh. INDIA Patrick Ngwediagi Registrar of Plant Breeders’ Rights, Ministry of Agriculture Food Security and Cooperatives, Dar Es Salaam, TANZANIA Victor M. Ibigbami National Biotechnology Development Agency (NABDA) 16, Dunukofia Street, Area 11, Garki, P.M.B.5118 Wuse, Abuja, NIGERIA Christopher U. Orji National Biotechnology Development Agency (NABDA) 16, Dunukofia Street, Area 11, Garki, P.M.B.5118 Wuse ,Abuja, NIGERIA Antony S. Mbayaki Technology Transfer Manager, Moi University, Eldoret, KENYA.PO Box 3900-30100 Studies conducted in 2008. Online publication of working papers: April 2009. c

About Authors Kalpana Sastry received her undergraduate degree from the University of Delhi in Botany and her Masters from Indian Agricultural Research Institute, New Delhi in the area of Mycology and Plant Pathology. She completed her PhD in the same subject and joined the Agricultural Research Service, ICAR, New Delhi in 1984. She is presently working as a Principal Scientist at National Academy of Agricultural Research Management, Hyderabad, India. Her work focuses on agricultural innovations, intellectual property management systems and in research centring policy issues in this area for the national agricultural system in India. In addition, she is part of team for facilitating IP portfolios for stakeholders like farmers, traders’ organizations and scientists. Patent Facility services through her team have been rendered to several scientists and farmers in National Agricultural Research System of India. She is recognized faculty on IP and WTO issues in Agriculture at national and international fora. As a Fulbright Senior Research Scholar at Cornell University, during 2008, she worked on “Policy and strategy options for nanotechnology in agricultural and food systemsquot; against the background of environmental, social and intellectual property implications. This study aimed to facilitate internalization of such technologies in agricultural research and innovation systems. Early results gained in this study are now being extended further to assess the use of this emerging technology into Indian agriculture systems. Patrick Ngwediagi graduated from Wonsan Agricultural University in DPR Korea where he received his first degree in Agronomy in 1987. He obtained his Masters degree in the subject of Seed Technology from the University of Edinburgh, Scotland, United Kingdom in 1992. He has also undertaken short and medium term training on seed science and technology, plant breeding and plant variety protection. Since 2005 Mr. Ngwediagi has been the Registrar of Plant Breeders’ Rights of the Ministry of Agriculture Food Security and Cooperatives in Tanzania. His main responsibility is to grant plant breeders’ rights and to oversee the implementation of the country’s Plant Breeders’ Rights Act of 2003. Between 1993 and January 2005 he worked as the Research Coordinator and Head of the National Vegetable Seed Programme at the Horticultural Research Institute-Tengeru where he led a team of experts to develop a number of now most popular vegetable varieties and established a formal vegetable seed production system using those varieties and other local varieties. Between 1998 and 2005 while heading the Vegetable Seed Programme Mr. Ngwediagi trained many framers on how to produce quality declared seed (QDS) on their own farms for their own use as well as selling to neighbouring farmers. He is a member of the National Variety Release Committee and National Seed Committee which is the highest organ that advises the government on matters related to development of the seed industry. Victor M. Ibigbami received a B. Sc. in Soil Science and an M. Sc. in Soil and Water Conservation both from the University of Ibadan, Nigeria. He also attended numerous short courses including one on Biodiversity, Biotechnology and Law jointly organized by Global Biodiversity Institute and International Institute of Tropical Agriculture (IITA), Ibadan, Nigeria. After a short career as a lecturer he moved to become a policy maker in the Ministry of Science and Technology of Nigeria. He is now Director, Agricultural Biotechnology and Bioresources Department, National Biotechnology Development Agency (NABDA), Abuja, Nigeria. In this capacity he is also responsible for formulating policies on Intellectual Property in biotechnology and related issues for the institution and the country. Christopher U. Orji received a bachelor’s degree in Animal Science and a Master of Business Administration (MBA) from the University of Nigeria, Nsukka. His working career started in Nigeria’s World Bank sponsored Agricultural Development Project (ADP) where he served as an extension officer. He is presently working in the Agricultural Biotechnology Department of the National Biotechnology Development Agency where his responsibilities include formulating institutional and national Intellectual Property Policies in biotechnology and agriculture to meet the WTO expectations. d

Mbayaki Antony obtained his BSc. Degree in Electrical Engineering in 1991 from the University of Nairobi in Kenya. He worked in the private sector shortly as a maintenance engineer before joining the public service as a patent examiner with Kenya Industrial Property Institute (KIPI) for over 11 years where he was also mandated with creation of intellectual property awareness in the country as the Assistant Education and Outreach Coordinator. He joined Moi University in 2004 to establish an Intellectual property management office on secondment from KIPI becoming a pioneer Technology Transfer Manager in public universities and R&D institutions in Kenya. He has experience in patent and other Intellectual Property drafting and prosecution. He has co-authored several documents for World Intellectual Property Organisation (WIPO) and East African Regional Programme and Research Network for Biotechnology, Biosafety and Biotechnology Policy Development (BIOEARN), a project supported by the Swedish International Development Agency (SIDA). e

Preface The National Partners Initiative (NPI) of CAS-IP is an innovative project which was started in May 2007. Over the last two years, it has brought together approximately 40 Intellectual Property (IP) and technology transfer (TT) practitioners, working together, across many countries and regions, in a sustained manner to improve their individual skills and institutional capacities. The NPI has resulted in the recognition and confidence that developing country IP professionals effectively serve the needs of agricultural institutions engaged in research and development activities and enhance the livelihoods of rural economies both in their local environment and at the international level. 1. The Activities of NPI Initiative During the last two years, the NPI project has focused on activities relating to skill development of the partners and sharing of practical experiences through interaction, training workshops and mutual discussions on topics such as project proposal writing, authorship, communication skills and developing technical skills encompassing the theme of IP/TT management. In an effort to document practices and experiences as a mechanism to enhance the skills of the NPI members and the level of IP/TT practice in institutions, the project has started an initiative of giving opportunities for case studies projects in individual countries. We believe that these case studies will help to create a platform for discussion of issues confronting researchers and other stakeholders in balancing the needs of IP regimes in their domestic environments and in confronting challenges in emerging markets at the global level. The broad objectives of the case studies are to understand evolving processes, challenges being encountered in institutionalization processes of IP regime in public funded research organizations or academic institutions through the case study approach 2. Case Study Approach During 2008, case studies from four national partners located in India, Tanzania, Kenya and Nigeria were sponsored by the CGIAR-CAS-IP NPI Project. These cases were selected as they proposed to look at IP management strategies being developed in the national environments. In 2009, following this initial set, a second sponsorship has been granted to five more NPI partners representing Costa Rica, Indonesia, Malaysia, Burkina Faso and Peru. By the end of three years, NPI members aim to share country experiences from twelve developing countries in the areas surrounding IP policy making, policy implementation and use of IPRs by researchers for leveraging more benefits to the stakeholders, people, institutions and countries. The principal objective of the four studies from the first year was to describe and evaluate the attempts being made in strengthening IP management at the institutional level and to understand the implementation and enforcement initiatives. The results of the case studies have been prepared as four working papers in the present compilation for year 2008. The four working papers are on the following topics: Intellectual Property Management Regime in the Indian National Agricultural Research Systems (R. Kalpana Sastry, India) Establishment of a Plant Breeders’Rights System in Tanzania: Achievements and Challenges (Patrick Ngwediagi, Tanzania) A review of the Nigerian System of Intellectual Property (Victor M. Ibigbami and Christopher U. Orji, Nigeria) Establishing a technology transfer Office in a developing country academic institution: Experience of Moi University (Antony S. Mbayaki, Kenya) f

2.1 Intellectual Property Management Regime in the Indian National Agricultural Research Systems This case study presents an overview of the changing environment for public research organizations in the Indian Agricultural Research System with respect to intellectual property management. In its commitment to cater to its broader societal objectives, the system has been challenged with growing sovereignty and restrictions on the sharing of germplasm, privatization of knowledge, and pressures to reduce demands on public finances through the commercialization of research products. Starting with a review of the relevant legal and policy documents to understand the background of the obligations at national and at the international level, followed by a brief review of the role and functions played by some statutory agencies in India, the implications for the National Agricultural Research System were studied. Against the realization of need for IP policy for the large system, the provisions and governance model of the new IP policy of the national agricultural organization like the Indian Council of Agricultural Research (ICAR) was analyzed. Then the implementation of guidelines now in place for two constituent institutes Project Directorate of Poultry (PDP) and Directorate of Rice Research (DRR), animal- based and crop-based institutes respectively, were studied in detail from the IP policy perspective. The study highlights on the implementation of guidelines, structural adjustments in decision making activities in IP management at institutes and at understanding the specific issues of IP management relevant to the research mandate of these institutes. 2.2 Establishment of Plant Breeders’ Rights System in Tanzania: Achievements and Challenges The study is on establishment of plant breeders’ rights system in Tanzania: achievements and challenges seeks to review appropriateness of the current plant breeders’ rights system in Tanzania and its contribution to an effective sui generis system, and attempts to formulate an appropriate model in line with the TRIPS Agreement. The results indicate a need for a benchmark review of process of activities to be useful towards the creation and operationalization of a sui generis system. The involvement of the stakeholders in this exercise in Tanzania proved to be very useful exercise and should be continued as many other developing countries develop models to suit the needs in their niche areas. The findings suggest a strong need of such actions to enable policy makers take prudent decisions while complying with the TRIPs agreement. Issues of benefit sharing and access to biological resources especially in PVP context need to evolve if the IP protection systems are to bring the needed changes for the stakeholders. 2.3 A Review of the Nigerian System of Intellectual Property Nigeria is taking steps to comply with the new IP regime ushered in by the WTO TRIPS and supported by African Union (AU). The issues such as Plant Variety Protection (PVP) and patent for microorganisms are technological in nature and the country should exercise the sui generis option provided in the TRIPS agreement to develop suitable laws. It is necessary that such laws may have instruments to be able to be used beyond the country’s existing IP framework like through the aegis of AU Model Law. This study also points to the need to amend the National Crop Varieties and Livestock Breeds Registration and Release Committee Decree 33 of 1987 in Nigeria to provide space for Plant Variety Protection (PVP), Animal Breeders Rights, and Farmers’ Rights. The Committee is currently administered by the National Centre for Genetic Resources and Biotechnology (NACGRAB) in the Ministry of Science and Technology and institutional mechanism should be put in place. Analysis of two grants relating to biotechnological related inventions and consequent efforts for licensing the technology indicate the need for regulation of such inventions in terms of best practices methods. Providing strong legal mechanisms for biotechnological inventions through National Biotechnology Law may lead to g

institutionalizing the norms for biosafety through institutions like National Biotechnology Development Agency (NABDA). This will help regulate research on microorganisms in terms of IP creation, benefit sharing and on biopharmaceuticals and nutraceuticals which the patent law presently does not address. It is envisaged that such measures would lead to increased investment in technology development and the resulting products can better the lives of the people of Nigeria. 2.4 Establishing a Technology Transfer Office in an Academic Institution in a Developing Country: Experience of Moi University The study relates to the experience of Moi University (in Eldoret Kenya) on the establishment of the first technology transfer office in a university or public research institution in Kenya. This study indicates the efforts of the policy makers leading to the establishment of the office at the institutional level. Nuances in the process of establishment, the challenges that faced and continue to open up, the manner of countering and overcoming have been discussed. The success and the roadblocks during the process serve as vital lessons for several other organizations that are now in the process of establishing Technology Transfer Office (TTO) in academic institutions especially in Africa. The study indicates that the benefits accrued through such offices placed in institutions of higher learning are enormous. If technology transfer has to be disseminated to reach to end users in a climate of ‘win-win’ situation, it is necessary to institutionalize the technology transfer in all institutes. Since the provisions in law have to be actualized and enforced, TTOs will have a major role in overseeing that potential and actual through sound IP management reach all stakeholders. 3. Recommendations 3.1 Designing Institutionalization of IP Regimes In the four case studies, the policies being developed in representing institutions are based on following criteria. These are to: (a) understand the need for compliance with international obligations in the national administration and enforcement of IPRs (b) attempt to ‘balance’ incentives for IP rights holders with access for the users of subject matter covered by IPRs (c) recognize the emerging levels of domestic creation of intellectual property in these countries (d) rationalize the flow of benefits IPRs through adoption of “holistic” approaches, and (e) develop relevant institutions for managing the assets and address the institutionalization of IP policies. The four case studies clearly indicated that such initial attempts have been started, both at the national and institutional levels to achieve these objectives. 3.2 Institutional Challenges in Developing Countries The four case studies examine current levels of institutional capacity for addressing the challenges related to: (a) formulation of policy and legislation on IP; and (b) administration and enforcement of IPRs at the national level in line with international obligations. In all these four studies, the lack of IP expertise in the institutions emerges as a major challenge. This in turn results in a serious shortage of a professional approach to issues of IP management in research institutions. It is essential to learn from these h

experiences that development of institutional capacity for policy coordination across government and participatory processes for IP policymaking and enforcement (with active participation of all stakeholders) is therefore, vital. While levels of awareness creation may vary in each of four studies, it is important to understand that this issue needs to be strengthened. These efforts will ensure a continuum after the policy development step to actual institutionalization of the policy. Implementation through regulations, creating new institutional arrangements and modernization of office operating procedures are indeed necessary to nurture the IP climate for which trained manpower are essential. 3.3 Maximizing the Process for Benefits of IP policy The case studies indicate means to exploit the maximum possible benefits in terms of cost reduction and administrative efficiency from existing regional and international co-operation mechanisms. The institutions in three countries within the African region, would benefit through membership of ARIPO or OAPI and extend the lessons from these initial experiences. More work on policy research and analysis on intellectual property subjects in the national interest (eg protection of plant varieties; traditional knowledge and folklore; technology transfer etc) within academic organizations, policy think-thank institutes and other stakeholder organizations in civil society needs to be undertaken to catalyze the processes of intellectual property policy and legislative development and enhance the economies of the developing countries. Similarly, it is important that studies to understand the challenges of IP management may need to be undertaken at institutional level for all sectors of agricultural systems viz fisheries, engineering, veterinary, horticulture etc., This sub – sectorial studies would be essential especially for the large NARS sector like that in India. Such in-depth analyses will make decision making for corrective measures more scientific based and more rational. Concurrently, these will ensure that policies developed are successfully implemented at the institutional, organizational and country levels. Later these can be transferred at the transnational levels in SAARC, ASEAN and other related groups. 3.4 Facilitating Platforms for Maximizing the Process for Benefits of IP policy All the four case studies under discussion here reflect that IP policy and governance is evolving in the respective countries. The studies indicate that the process is constantly changing due to global and national debates and institutions need to be aware of this. Hence there needs to be a platform to discuss these. Since the pace of IP regime differs in each country against the background of common issues, platforms of discussions and opinion sharing would be vital and necessary to implement the governance models. For instance, the experience of Farmers Rights so vital to developing countries and has been much debated in all platforms. The perspectives from India and Tanzania need to be understood and other countries should evolve taking gains from these experiences. Similarly, issues of transfer of technology as reflected in the experience of Nigeria evoking major change in the domestic laws are pointers for several countries in the African region who do not have a system in place as yet. Keeping the institutional environment in developing countries, the case of Moi University reflects the need for change in mindsets of people engaged in technology transfer process in innovation life cycle processes. ***** i

Intellectual Property Management Regime in the Indian National Agricultural Research Systems A Case Study Under NAARM-CAS-IP NPI Collaboration Project R.Kalpana Sastry Principal Scientist NAARM Email: kalpanas.regulagedda@gmail.com kalpana@naarm.ernet.in National Academy of Agricultural Research Management Indian Council of Agricultural Research Rajendranagar,Hyderabad 500407, Andhra Pradesh, India Phone 091+40+24581300 & 24581444 Fax 091+40+24015912 & 091+40+24015926 E-Mail:naarm.hyd@naarm.ernet.in

Contents Executive Summary Acronyms Chapter I Introduction 8 1.1 Background 1.2 Goal of the Study 1.3 Purpose of the Study 1.4 Evaluation Process 1.5 Outline of the Report Chapter 2 Intellectual Property Rights and Agricultural R&D 10 Scenario 2.1 Research and Development Scenario in India 2.2 Impacts of Global Changes 2.3 Impact on Agriculture R&D Chapter 3 Review of Relevant Legal and Policy Documents 13 3.1 Global Context 3.2 Indian Context 3.3 Summary of Provisions under Various Acts for IPs in India Chapter 4 ICAR System 29 4.1 The Indian Council of Agricultural Research (ICAR) 4.2 Partners and Mode of Functioning 4.3 New Role 4.4 Need for Institutionalization of IP Policy 4.5 ICAR Guidelines for Intellectual Property Management and Technology Transfer / Commercialization Chapter 5 Project Directorate on Poultry (PDP) 40 5.1 Background 5.2 Genesis of PDP 5.3 Mandate 5.4 Governance Model of PDP 5.5 Research Activities 5.6 Consultancy, Patents, Commercialization of Technology 5.7 IP Activities 5.8 IP Check list Intellectual Property Management Regime in the Indian National Agricultural Research Systems 2

Chapter 6 Directorate of Rice Research (DRR) 49 6.1 Background 6.2 Genesis of DRR 6.3 Mandate 6.4 Governance Model of DRR 6.5 Research Activities 6.6 Activities under IP and Commercialization of Technology 6.7 IP Check list Chapter 7 Conclusion 58 Annexure i-ix 59 Intellectual Property Management Regime in the Indian National Agricultural Research Systems 3

Executive Summary This case study presents an overview of the changing environment for public research organizations in the Indian Agricultural Research System with respect to intellectual property management. The National Agricultural Research System (NARS) in India continues to fulfil its commitment to cater to its broader societal objectives. However, the dimensions of dealing with growing sovereignty and restrictions on the sharing of germplasm, privatization of knowledge, and pressures to reduce demands on public finances through the commercialization of research products are new challenges to the system. A review of the relevant legal and policy documents was done to understand the background of the obligations at national and at the international level. This was followed by a brief review of the role and functions played by some statutory agencies in India that are actively involved in IP facilitation. Later the National Agricultural Research System was studied with an intention to understand the complexities and magnitude vis-a-vis the IP policy. Then the provisions and governance model of the new IP policy of the ICAR was analyzed. Thus, the principles and strategies for intellectual property management as adapted from the Laws in India through the ICAR guidelines on IP and Technology Management are outlined. Against this background, two constituent institutes of ICAR, namely, Project Directorate of Poultry (PDP) and Directorate of Rice Research (DRR), animal- based and crop-based institutes respectively, were studied in detail from the IP policy perspective. The study highlights on the implementation of guidelines, structural adjustments in decision-making activities in IP management at institutes and at understanding the specific issues of IP management relevant to the research mandate of these institutes. Intellectual Property Management Regime in the Indian National Agricultural Research Systems 4

Acronyms ADG Assistant Director General AICCIP All India Coordinated Crop Improvement Project AICRIP All India Coordinated Rice Improvement Project AICRP All India Coordinated Research/Network Projects AIMS Agriculturally Important Microbes AnGR Animal Genetic Resources ATMC Agro-Technology Management Centre AVT Advance Varietal Trial BARC Bhabha Atomic Research Centre CARI Central Avian Research Institute CAS Central Advisory Service CBD Convention on Biological Diversity CDFD Centre for DNA Finger Printing and Diagnostics CGIAR Consultative Group on International Agricultural Research CGPDT The Controller General of Patents Designs and Trademarks CIMMYT Centro Internacional de Mejoramiento de Maíz y Trigo CITES Convention on Trade in Endangered Species CODEX Codex Alimentarius CP Cartagena Protocol on Biosafety CSCS Central Sub-Committee on Crop Standards CSIR Council of Scientific & Industrial Research CTMC Central Technology Management Committee DARE Department of Agriculture Research and Education DBT Department of Biotechnology DNA Double helix Nucleic Acid DRR Directorate of Rice Research DST Department of Science and Technology DUS Distinctness, Uniformity and Stability ENV Extent Notified Rice Varieties FAO Food and Agriculture Organization FV Farmers' Variety GADVASU Guru Angad Dev Veterinary and Animal Sciences University GATT General Agreement on Trade and Tariffs GDP Gross domestic product GI Geographical Indications GIR Geographical Indications Registry GMO Genetically Modified Organisms GPA Global Plan of Action GURT Genetic Use Restriction Technology IARI Indian Agricultural Research Institute IC Integrated Circuit ICAR Indian Council of Agricultural Research ICRISAT International Crops Research Institute for Semi-Arid Tropics ICT Information and Communication Technology IET Initial Evaluation Trial IFPRI International Food Policy Research Institute IP Intellectual Property IPAB Intellectual Property Appellate Board IPC International Patent Classification IPPC International Plant Protection Convention Intellectual Property Management Regime in the Indian National Agricultural Research Systems 5

IPR Intellectual Property Rights IRC Institute Research Council IRRI International Rice Research Institute ITMC Institute Technology Management Committee ITMU Institute Technology Management Units ITPGRFA International Treaty on Plant Genetic Resources for Food And Agriculture IVRI Indian Veterinary Research Institute IVT Initial Varietal Trial KAU Kerala Agricultural University KTKA Kerala Traditional Knowledge Authority KVAFSU Karnataka Veterinary, Animal and Fisheries Sciences University KVK Krishi Vigyan Kendras LMO Living Modified Organisms MDG Millennium Development Goals MHRD Ministry of Human Resource Development MoCI Ministry of Commerce and Industry MoCIT Ministry of Communications and Information Technology MoEF Ministry of Environment and Forests MOU Memorandum Of Understanding MTA Material Transfer Agreement NAARM National Academy of Agricultural Research Management NAIP National Agricultural Innovation Project NARO National Agricultural Research Organization NARS National Agricultural Research Systems NBA National Biodiversity Authority NBAGR National Bureau of Animal Genetic Resources NBFGR National Bureau of Fish Genetic Resources NBPGR National Bureau of Plant Genetic Resources NDUS New Distinctness, Uniformity and Stability NEH North Eastern Hill region NIIPM National Institute of Intellectual Property Management NPA National Policy on Agriculture NPI National Partner Initiative NRSA National Remote Sensing Agency NRV Notification and Release of Varieties PCT Patent Co-operation Treaty PDP Project Directorate of Poultry PGRFA Plant Genetic Resources for Food and Agriculture PIS Patent Information System PPV &FR Protection of Plant Varieties and Farmers Rights PVP Plant Variety Protection QRT Quinquennial Review Team QTL Quantitative Trait Locus SAU State Agricultural Universities SBB State Bio-diversity Board SCIP Supervisory Council on Intellectual Property SICLD Semiconductor Integrated Circuits Layout-Design SICLDR Semiconductor Integrated Circuits Layout-Design Registry SKUAST Sher-e-Kashmir University of Agricultural Sciences and Technology of Kashmir SPS Sanitary and Phyto-Sanitary Measures Intellectual Property Management Regime in the Indian National Agricultural Research Systems 6

SRC Staff Research Council SVRC State Variety Release Committee SVVU Sri Venkateswara Veterinary University TRIPS Trade Related Intellectual Property Rights TQ Technical Questionnaire UGC University Grants Commission UPOV International Union for the Protection of Plant Varieties USA United States of America USC Unites States Code USPTO United States Patent and Trademark Organization VIC Variety Identification Committee WCT WIPO Copyrights Treaty WIPO World Intellectual Property Organization WPPT WIPO Performances and Phonograms Treaty WTO World Trade Organization ZITMC Zonal Institute Technology Management Committee OIE International Office of Epizootics Intellectual Property Management Regime in the Indian National Agricultural Research Systems 7

1 Introduction 1.1 Background The National Academy of Agricultural Research Management (NAARM), a constituent of Indian Council of Agricultural Research and also part of National Partner Initiative (NPI) of Central Advisory System/Intellectual Property (CAS/IP) was invited by CAS/IP to undertake a case study in order to understand the system and document the lessons learnt, the challenges present and the experiences gained in the process of operationalising the Intellectual Property (IP) management guidelines in the Indian NARS. Accepting this invitation NAARM undertook the assignment with an aim at understanding and explores modalities to improve the effectiveness of the IP management and technology transfer guidelines in agriculture based public sector institutions in India. 1.2 Goal of the Study The goal of the study is to contribute to improving the newly established policy framework and guidelines for the systematic management of IP assets and technology transfer in National Agricultural Research System (NARS) in India. 1.3 Purpose of the Study The study aims at understanding and also explores modalities to improve the effectiveness of the IP management and technology transfer guidelines in agriculture based public sector institutions in India 1.4 Evaluation Process The study involved collection and reviewing of existing literatures and documents related to establishment and operationalization of the ICAR guidelines for IP management and technology transfer /commercialization in Indian NARS. Detailed information relevant to the objectives set was elicited through: 1.4.1 Information Collection • Identifying the technology from two institutes in NARS for building a IP portfolio • Review of relevant, legal and policy documents through secondary sources. • Administration of questionnaire survey (Annexures i to iv). • Interviews and discussions with IP practitioners, officials of the statutory bodies, academicians, seed producers, farmers/group of farmers to obtain their views on the need and implementation of IP guidelines. • Participation and discussions in ICAR Training-cum-Workshop on IP and Technology Management held at various institutes between June to December 2008. • Visit both the constituent-institutes identified for the study and interact with concerned sections. • Critical analysis and synthesis of the collected information. This synthesis was then discussed again with the concerned departments in the two institutes and a consolidated checklist prepared. 1.4.2 Information Analysis Based on the final discussions, a strategy for operationalising IP policy for these two institutes was prepared. Intellectual Property Management Regime in the Indian National Agricultural Research Systems 8

1.5 Outline of the Report The report starts with a brief introduction to the IPR regime in India and its relevance to agricultural systems. A review of the relevant legal and policy documents was done to understand the background of the obligations at national and at the international level. This was followed by a brief review of the role and functions played by some statutory agencies in India that are actively involved in IP facilitation. In the fourth chapter, the National Agricultural Research System was studied with an intention to understand the complexities and magnitude vis-a-vis the IP policy. Then the provisions and governance model of the new IP policy of the ICAR was analysed. Two constituent institutes, namely Project Directorate of Poultry (PDP) and Directorate of Rice Research (DRR), animal- based and crop-based institutes respectively were studied in detail from the IP policy perspective. Most of the discussion has been focussed on the implementation of guidelines, structural adjustments in decision-making activities in IP management at institutes and at understanding the specific issues of IP management at these institutes. Intellectual Property Management Regime in the Indian National Agricultural Research Systems 9

2. Intellectual Property Rights and Agricultural R&D Scenario “An inventor had no special advantage from his own invention. The patent system changed this; secured to the inventor, for a limited time, the exclusive use of his invention; and thereby added the fuel of interest to the fire of genius, in the discovery and production of new and useful things.”- Abraham Lincoln, Second lecture on discoveries and inventions. February 11, 1859 Intellectual Property Rights (IPRs) can play a significant role in achieving the United Nations Millennium Development Goals (MDGs), as they affect agricultural and rural development in developing countries. The main impact of IPRs is through their relationship with the transfer of traditional and modern agricultural technologies, and making IPRs support rather than hinder sustainable development. However, developing countries like India have a less homogeneous agro-socio-economic environment in which farmers operate. While it is now accepted that IPRs can help stimulate economic growth and reduce poverty, there are still inherent fears on a more negative impact of these in Indian Agriculture. The functioning of IPR systems raises genuine concerns especially in the changing models of agricultural research, which are now emerging in partnership mode with multiple agencies. All systems including the public sector systems may incur considerable costs, time and money, and need to ensure conducting research without infringing upon others’ IP rights, or defending their own IP rights against other users. This raises questions as to whether the substantial costs involved in IP litigation are a necessary price to pay for the incentives offered by the IP system, or whether ways can be found to reduce them. How does this proliferation of Intellectual Properties (IPs) affect competition and research? The concerns about the impact of IP are now becoming important for research outcome auditing. The importance of intellectual property protection to develop the scientific and technological capacity of developing countries and benefits derived from the enhanced level of growth has now become a matter of common understanding. IP systems management is strong determinant of economic growth of a nation as it helps 1 entrepreneurs recover costs of their innovative expenses . 2.1 Research and Development Scenario in India Since independence, India has tried to effectively use science and technology for its advancement as major economy in the world. The ushering of “Green Revolution” to support the country’s efforts for increasing food productivity has been to due timely interventions based on scientific acumen and technology. Despite these successes, newer challenges like declining and degenerating natural resources, increasing population, and emphasis on quality food, nutrition, healthcare and access to better livelihoods are surmounting. There is a growing need to be able to meet these through adoption of newer technologies including biotechnological approaches. 2.2 Impacts of Global Changes Several changes at global level after advent of WTO, has started to build technology- led enterprises with knowledge, as an asset fetching remunerations. Research today is poised to come out of its sheltered existence to a more open era and help institutions face competition. The agricultural research requires pursuit of excellence through innovation, technology development, evaluation and refinement. While the IPR system can provide pursuit for effective competition, there is bound to be some parallax. Issues like public good versus private right; food and nutrition security versus industrial agriculture; public disclosure of 1 Laik, Kaushik.2005.Role of Intellectual Property in Economic Growth. Journal of Intellectual Property Rights.Vol.10, November.2005.pp465-473. Intellectual Property Management Regime in the Indian National Agricultural Research Systems 10

information/specification for seeking IPR versus holding back the know-how for better bargain in licensing contracts are conflicting zones of operation. This is more challenging in public research systems in agriculture. Until 1989 India refused to enter into detailed negotiations on standards. But the threat of unilateral retaliatory trade sanctions played a role in changing the stand of many developing countries on this matter 2 .Thus, India has amended all the relevant legislations for the various forms of intellectual property as per the mandatory requirements of World Trade Organization (WTO) by January 1, 2000 3 . The time frame for implementation was 2005 and the necessary rules for process of implementing the acts have now been completed. 2.3 Impact on Agriculture R&D With the framing, enacting and operationalization of all these legislations, and India becoming compliant with TRIPS, the onus is now on the research systems including those in agriculture to use these provisions in their research programs and build strong IP instruments where required. On the same plane, the issues towards defence of indigenous innovation and the recognition of the contribution of our biodiversity are also interwoven in IP building for researches based on agro-biodiversity. Articles 8 and 15 of the Convention on Biodiversity (CBD) center on the theme of the sovereign rights of states over their natural resources. Article 8(j) 4 is particularly important because it recognizes the rights of indigenous farming communities in India and their traditional knowledge and practices. Article 15 of the CBD, regarding access to genetic resources, is also important for providing a framework for regulating access to genetic resources and their use by foreign organizations and corporations. As per TRIPS, the issue of ownership is to be determined by national law, by creating an institutional framework and helping safeguarding the rights of local people. It would make it mandatory for such corporations to share their profits with the indigenous communities. 2.3.1 The Last Ten Years Notwithstanding these challenges, a decade after India launched it’s innovate-and patent campaign, there are signs of early success 5 . The Science and Technology Policy of the Government of India was announced in 2003 and aims at establishing an intellectual property regime which maximized the incentives for the generation and protection of IP by all types of innovators 6 . Similarly the predominantly publicly funded agricultural research system in India needs a IP policy framework 7 and the National Agricultural Research System (NARS) is in the process of developing IPR management strategies for effective transfer of IP protected technologies 8 . The Protection and Utilisation of Public Funded Intellectual Property 2 For example, China, Brazil, India, Taiwan and Thailand were quot;investigatedquot; under the `Special 301' section of the US Trade Acts, and many other countries (e.g. Argentina, Andean Group countries) were repeatedly threatened with trade sanctions in order to obtain changes in their IPR regimes. USA, in fact lodged a complaint with DSB at WTO in 1996 on non-compliance by India that was upheld even after an appeal. 3 Kalpana Sastry. 2007. Mechanisms of Protection of Agricultural Innovations in India. DESIDOC Bulletin of Information Technology .27(6): 3-11. 4 This article enunciates three rights. First, it acknowledges farmers’ traditional rights over their biological resources. Second, it stipulates that wider application of farmers’ knowledge, innovations and practices is subject to their approval and involvement. Third, it calls for the equitable sharing of ensuing benefits. All three rights, needed to be embodied in a national legislation, and can provide ownership and protection of local resources. India ratified as a party to CBD in 1994. 5 The purchasing of patent for Indian designed software that eliminates noise from complex digital data by a US company and that of a pomegranate deseeder invented by college drop out by a fruit growers of California and Turkey indicate early successes of the regime which is slowly evolving. See: Ganapati Mudhur. 2006. India’s 10-year patent drive. Technology Review. September/October.2006 pp18-19. 6 The Science and Technology Policy, 2003, Govt. of India clearly states the intellectual property rights have to be viewed as an effective policy instrument that will be relevant to wide ranging socio- economic technological and political concepts. 7 Rao,N.H. and R.Kalpana Sastry.2004. Towards a Policy for Management of Intellectual Property in Public Agricultural Research Systems in India. Journal of Intellectual Property Rights Vol. 9.May 2004 pp 242-259. 8 The Director General, Indian Council of Agricultural Research (ICAR) had constituted a committee in November 2005 for developing the organization’s IPR guidelines. These have now been developed and implemented in national agriculture research institutions under ICAR since October, 2007. Intellectual Property Management Regime in the Indian National Agricultural Research Systems 11

Bill 2008, introduced by Science and Technology Ministry in December 2008,in Rajya Sabha 9 aims to develop a framework for protection and utilisation of intellectual property created out of public funded research and development. Currently the national government controls the rights to IP developed at academic or research institutions with the support of public funds. The bill proposes that the inventing institution be assigned these rights. This is based on the provisions of the Bayh-Dole Act does in the United States of America (USA) 10 and seeks to provide for a funding agreement between the government and the recipient before release of grant for research and development. Besides seeking to bar public disclosure, publication and exhibition of the public funded intellectual property, the Bill lists duties of the recipient who retains the titles. Against such a background of paradigm shifts in national research scenario, it becomes imperative to monitor the initiatives for catalysing the changes in positive manner and take corrective steps in a timely manner. The present study is an attempt in this direction. 9 Upper House of the Indian Parliament 10 The Hindu Business Line. 2008. Bill for protecting IPR in public funded research in RS. Monday, December 15, 2008. Intellectual Property Management Regime in the Indian National Agricultural Research Systems 12

3. Review of Relevant Legal and Policy Documents “A country without a patent office and good patent laws is just a crab and can't travel any way but sideways and backwards.”- Mark Twain in his book, A Connecticut Yankee in King Arthur's Court (1889) 3.1 Global Context Over last few decades, several agreements at various international fora have been negotiated and adopted in order to enhance and better the livelihoods and help nations achieve the targets set in Millennium Development Goals. Some of these are of direct relevance to sustainable agriculture, enhanced trade and ensuring better environment. These include Convention of Biological Diversity (CBD), 1992; Convention on Trade in Endangered Species, 1973 (CITES); International Plant Protection Convention (IPPC), 1997; International Union for the Protection of Plant Varieties (UPOV), 1978 and 1991; Cartagena Protocol on Biosafety, 2000; Trade Related Intellectual Property Rights, 1994 (TRIPs); and The International Treaty on Plant Genetic Resources for Food And Agriculture, 2001 (ITPGRFA) 11 . These international conventions /treaties/agreements have comprehensive provisions for conservation and sustainable use of, and access to genetic resources and for sharing of benefits derived from their use. Concurrently, new emerging regimes in protection mechanisms for innovations at the global levels are impacting the access, transfer, and use of biological and /genetic resources for furthering the research and developmental activities in all fields of agriculture (Table 3.1). Table 3.1. International Treaties/Conventions affecting Agriculture Innovation Systems Treaty / Agreements/ Convention Objectives 1. Convention on International Trade Ensure international trade in specimens of in Endangered Species of Wild wild animals and plants under strict Fauna & Flora (CITES), 1975 regulation and not endanger their further http://www.cites.org/ survival 2. International Convention for the Grant and protect breeders rights protection of new varieties of plants (UPOV), 1978; 1991 http://www.upov.int/index.html 3. Convention on Biological Diversity Conservation of Biological Diversity (CBD), 1992 Sustainable use of its components (biological resources) http://www.biodiv.org/default.shtml Fair and equitable sharing of benefits arising out of utilization of genetic resources 4. FAO-CGIAR Agreement, 1994 Designated germplasm held in trust in CG centers 5. Agreement on Trade-Related To promote effective and adequate protection Aspects of Intellectual Property of IPR Rights (TRIPs) , 1995 To ensure IPR themselves do not become http://www.wto.org/English/docs_e/l barriers to legitimate trade egal_e/legal_e.htm 6. Global Plan of Action Developed State of World’s PGFRA (GPA), 1996 20 priority areas under four groups Adopted by 150 countries 11 Cooper,H.D. and N.Murthi Anishetty. 2004. International Treaties relevant to the management of Plant Genetic Resources. Encyclopedia of Plant and Crop Science Marcel Dekker . Intellectual Property Management Regime in the Indian National Agricultural Research Systems 13

Treaty / Agreements/ Convention Objectives http://www.fao.org/ag/ AGP/AGPS/GpaEN/gpatoc.htm 7. Cartagena Protocol, (CP), 2000 Safe transfer, handling and use of living http://www.biodiv.org/biosafety/defa modified organisms (LMOs) resulting from ult.aspx modern biotechnology that may have adverse effects on conservation and sustainable use of biological diversity taking also into account risks to human health, and specifically focusing on transboundary movements 8. International Treaty on Plant Conservation and sustainable use of plant Genetic Resources for Food & genetic resources for Food and Agriculture Agriculture of FAO (ITPGRFA) 2001 (PGRFA http://www.fao.org/ag/cgrfa/itpgr.ht Fair and equitable sharing of the benefits m arising out of their use in harmony with CBD for sustainable agriculture and food security 9. Agreements on Sanitary and Phyto- Provides basic rights to the member countries Sanitary Measures (SPS) namely sovereign right, scientifically http://www.wto.org/English/tratop_e/ justifiable, to protect the health and safety of sps_e/sps_e.htm their citizens, animals, plants and the environment in which they live as defined Allows justified discrimination in contrary to non-discrimination of other agreements These measures in any case would constitute a disguised restriction on international trade Provides harmonization the members to have standards based on international guidelines where ever they exist in compliance to Codex Alimentarius (CODEX), International Office of Epizootics (OIE) and International Plant Protection Convention (IPPC) which should be subjected to periodic review, but however, members. 3.2 Indian Context All these agreements have thus led India to put in place the commensurate and compliant mechanisms and instruments. Some of the legal instruments passed by the Indian Parliament as part of compliance to the TRIPS include The Patents Act, 1970 (39 of 1970), The Patents (Amendment) Act, 1999 (17 of 1999), The Patents (Amendment) Act 2002 (38 of 2002), The Patents (Amendment) Act 2005 (15 of 2005), The Geographical Indications of Goods (Registration & Protection) Act, 1999 and The Protection of Plant Varieties and Farmers Rights Act, 2001 (PPV FR Act) (53 of 2001). Apart from these, the Government of India also enacted an umbrella legislation called the Biological Diversity Act, 2002 (No.18 of 2003). Proper application and effective enforcement of these laws is the next challenge. Various ministerial departments under the Government of India are responsible for the administration of these Acts (Table 2). At present, there is no specific IPR Act to provide protection for undisclosed information (trade secret). The Indian Contract Act of 1872 and common law have provisions covering this. The Ministry of Law and Justice is the nodal agency for this purpose. In October, 2007, the Department of Science and Technology, Govt of India released draft 12 version of the proposed National Innovation Act 2008 . This is to provide legislative framework 12 The Preamble of National Innovation Act states as “An Act to facilitate public, private or public- private partnership initiatives for building an Innovation support system to encourage Innovation, evolve a National Integrated Science and Technology Plan and codify and consolidate the law of confidentiality in aid of protecting Confidential Information, trade secrets and Innovation” Indian Innovation Act: trade and confidentiality. Kamakhya Srivastava. October 8, 2008. Posted at: http://www.cafezine.com/depts/ article.asp?id=21215&deptid=6 Intellectual Property Management Regime in the Indian National Agricultural Research Systems 14

to protect trade secrets in India considering opportunities for trading in innovations. In addition, the biodiversity-IPR related matters are covered under the Biological Diversity Act, 2002 by the Table 3.2 Broad Institutional Mechanism of the Indian IPR Regime S. IP Legislation Administration Authority Nodal Agency No. 1. Patent The Patents Act, The Controller General of 1970 Patents Designs and Trademarks (CGPDT)/Controller of Patents Department of 2. Design The Design Act, The CGPD/Registrar of Industrial Policy 2000 Designs & Promotion 3. Trade Mark The Trade Marks The CGPDT/Registrar of (DIPP), Ministry Act, 1999 Trademarks of Commerce 4. Geographical The Geographical The CGPDT/Registrar of and Industry Indication Indications Geographical Indications (MoCI) (Registration and Protection) Act, 1999 5. Copyright The Copyright Act, Director and Registrar of Department of 1957 Copyright Secondary and Higher Education, Ministry of Human Resource Development (MHRD) 6. Integrated The Semiconductor Registrar, Semiconductor Department of Circuit Design Integrated Circuits Integrated Circuits Layout- Information Layout-Design Act, Design Registry Technology, 2000 Ministry of Communication s and Information Technology (MoCIT) 7. Plant varieties The Protection of Protection of Plant Varieties Department of Plant Varieties and and Farmers’ Rights Agriculture and Farmers’ Rights (PPV&FR) Authority/Registry Cooperation, Act, 2001 Ministry of Agriculture 8. Undisclosed The Contract Act, Civil courts Ministry of Law information 1872; Common and Justice (Civil) Law 9. Biodiversity The Biological National Biodiversity Authority Ministry of Diversity Act, 2002 (NBA) Environment and Forests (MoEF) 10. Traditional None Secretary of the concerned MoHRD; MoCI knowledge Ministry(ies) Source: Kochhar, Sudhir 2008 13 . 13 Kochhar, Sudhir 2008. Institution and capacity building for the evolution of IPR regime in India: Protection of Plant Varieties and Farmers Rights. Journal of Intellectual Property Rights. Vol. 13, January 2008,pp.51-56 Intellectual Property Management Regime in the Indian National Agricultural Research Systems 15

National Biodiversity Authority wherein the Ministry of Environment and Forests is the nodal agency. On the issues of traditional knowledge, two ministries of the central government, namely, the Ministry of Commerce and Industry and the Ministry of Human Resource Development, act as the nodal agencies for different matters. 3.3 Summary of Provisions under Various Acts for IPs in India 3.3.1 Copyright India has one of the most modern copyright protection laws in the world. The earlier 1994 amendment to the Copyright Act of 1957 had provided protection to all original literary, dramatic, musical and artistic works, cinematography, films and sound recordings. Through the amendment in 1999, to the Copyright Act of 1957 to make it fully compatible with the provisions of the TRIPS Agreement, a provision was made bring sectors such as satellite broadcasting, computer software and digital technology under Indian copyright protection. The Copyright Act is now in full conformity with the TRIPS obligations 14 . It is called the Copyright (Amendment) Act, 1999 and came into force on January 15, 2000. The Indian law facilitates copyright protection to the creators of original works of authorship for: literary works (including computer programs, tables and compilations including computer databases which may be expressed in words, codes, schemes or in any other form, including a machine readable medium); dramatic, musical and artistic works and cinematographic films and sound recordings. However, a copyright law does not protect facts, ideas, systems, or methods of operation; although it may protect the way these things are express. A copyright protects the rights of authors, i.e. creators of intellectual property in the form of literary, musical, dramatic and artistic works and cinematograph films and sound recordings. The author is the first owner of copyright in a work. Under the Act, the author is the person who creates the work in the case of a literary or dramatic work; or composer in the case of a musical work; or the producer in the case of a cinematograph film; or the producer in case of sound recording or the photographer in the case of photograph; or the person who uses the work to be created in the case of a computer generated work. In the case of a work made in the course of the author’s employment under a contract of service or apprenticeship, the employer shall, in the absence of any agreement to the contrary, be the first owner of the copyright therein. In addition, there are moral rights of an author also. The author of a work has the right to claim authorship of the work and to restrain or claim damages in respect of any distortion, mutilation, modification or other acts in relation to the said work which is done before the expiry of the term of copyright if such distortion, mutilation, modification or other act would be prejudicial to his honour or reputation. Moral rights are available to the authors even after the economic rights are assigned. For performances, the Act entails rights of performers too. Legally, a copyright can be assignable. The owner of the copyright in an existing work or the prospective owner of the copyright in a future work may assign to any person the copyright either wholly or partially and either generally or subject to limitations and either for the whole term of the copyright of any part thereof. The term of copyright in India is the lifetime of a creator and 60 years after his/her death. In the case of original literary, dramatic, musical and artistic works, the 60-year period is counted from the year following the death of the author. In the case of cinematograph films, sound recordings, photographs, posthumous publications, anonymous and pseudonymous publications, works of government and works of international organizations, 14 The Indian Copyright Act today is compliant with most international conventions and treaties in the field of copyrights. India is a member of the Berne Convention of 1886 (as modified at Paris in 1971), the Universal Copyright Convention of 1951 and the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement of 1995. Though India is not a member of the Rome Convention of 1961, the Copyright Act, 1957 is fully compliant with the Rome Convention provisions. Two new treaties, collectively termed as Internet Treaties, were negotiated in 1996 under the auspices of the World Intellectual Property Organization (WIPO). These treaties are called the ‘WIPO Copyrights Treaty (WCT)’ and the ‘WIPO Performances and Phonograms Treaty (WPPT)’. These treaties were negotiated essentially to provide for protection of the rights of copyright holders, performers and producers of phonograms in the Internet and digital era. India is not a member of these treaties as yet. Further reference: http://copyright.gov.in/ Intellectual Property Management Regime in the Indian National Agricultural Research Systems 16

the 60-year period is counted from the date of publication. The term of rights for performers is 25 years. The permission of copyright owners is not required for use of the work in specified cases under the act. The Act has specified the instances where permission is not required viz., for the purpose of research or private study; for criticism or review; in act of reporting current events; or in connection with judicial proceedings. Performance by an amateur club or society if the performance is given to a non-paying audience or making the sound recordings of literary, dramatic or musical works under certain conditions are also permitted. Administration of copyright can be taken in collective manner. Very often, the management and protection of copyright in works are undertaken by a society of owners of such works. Since these societies, have basic organizational facilities and strength, they are able to keep a constant vigil over the uses of the work and are able to monitor the collection of royalty for such use. Since India is a member in international conventions, these societies can have reciprocal arrangements with similar societies in other countries and can collect royalty from any use of such work. It is in the interest of copyright owners to join a collective administration/organization to ensure better protection to the copyright in their works and for reaping optimum economic benefits from their creations. Copyright of works of the countries of nationals of countries who are members of the Berne Convention for the Protection of Literary and Artistic Works, Universal Copyright Convention and TRIPS Agreement are protected in India through the International Copyright Order. The same is extended to Indian nationals in those countries. In India, acquisition of copyrights is automatic and it does not require any formality. However, the certificate of registration of copyright and the entries made therein serve as prima facie evidence in a court of law with reference to disputes relating to ownership of 15 copyright. Hence, in case of any infringement/disputes it is essential to register. A copyright owner can take legal action against any person who infringes the copyright in the work. The copyright owner is entitled to remedies by way of injunctions, damages and accounts. Copyright infringement is a criminal offence. Any person who knowingly infringes or abets the infringement of the copyright in any work commits a criminal offence under Section 63 of the Copyright Act. The minimum punishment for infringement of copyright is imprisonment for six months with a minimum fine of Rs 50,000/-. In the case of a second and subsequent conviction, the minimum punishment is imprisonment for one year and a fine of rupees one lakh. 16 As per the Indian Act, infringement is a cognizable offence . Any police officer, not below the rank of a sub-inspector, may, if he is satisfied that an offence in respect of the infringement of copyright in any work has been, is being, or is likely to be committed, can seize without warrant, all the copies of the work and all plates used for the purpose of making infringing copies of the work, wherever found. All copies and plates so seized shall, as soon as practicable, are to be produced before a magistrate. The National Copyright Office 17 was established under the provision of the Copyright Act, 1957 18 . The office provides registration 15 Making infringing copies for sale or hire or selling or letting them for hire; permitting any place for the performance of works in public where such performance constitutes infringement of copyright; distributing infringing copies for the purpose of trade or to such an extent so as to affect prejudicially the interests of the owner of copyright; public exhibition of infringing copies by way of trade and import of infringing copies into India. 16 Section 12 of the Copyright Act also lays down the powers of the Copyright Board and deems it to be a civil court for the purposes of Sections 345 and 346 of the Code of Criminal Procedure, 1973 and also that all the proceedings of the Board would be deemed to be judicial proceedings within the meaning of Sections 193 and 228 of the Indian Penal Code 17 Section 11 of the Copyright Act requires the Central Government to constitute a Copyright Board headed by a Chairman with not less than two and not more than 14 other members. Registrar of Copyrights is to be Secretary of the Copyright Board 18 The Section 9 of the Copyright Act requires for establishment of an office to be called the Copyright Office for the purpose of the Act. The Copyright Office is to be under the immediate control of a Intellectual Property Management Regime in the Indian National Agricultural Research Systems 17

facilities for all types of works indicated in the Act and is headed by a Registrar of Copyrights 19 . 3.3.2 Industrial Design This is one of the categories of IP where the design system focuses on the aesthetic feature of an article derived from its visual appearance. A design refers to the features of shape, configuration, pattern, ornament or composition of lines or colors, applied to any article, in two or three-dimensional (or both) forms. The IP does not include any mode or principle of construction or anything, which is mere mechanical device. It also does not include any trade mark or any artistic work. Any person or the legal representation or the assignee can apply separately or jointly for the registration of a design. The term “person” also includes firm, partnership and a body corporate besides individuals. In India, the governance and administration of this IP is through the Designs Act, 2000. The International Classification of Industrial Designs as per the Locarno Agreement has also been introduced into Design Rules, 2001 under the Indian legislation conform to international trends in design administration. Essential requirement for registration is that the design should be new or original, distinguishable from known design/ a combination of known designs and be applied to an article and should appeal to the eye. A design should not comprise or contain scandalous obscene matter or not be disclosed to the public any where by publication in 20 tangible from or by use or in any other way prior to the filing date .The registration of a design confers upon the registered proprietor the exclusive right to apply a design to the article in the class in which the design has been registered. A registered proprietor of the design is entitled to legal protection of his intellectual property. Registration initially confers this right for ten years from the date of registration and is renewable for a further period of five years. However, if the fee for extension is not paid for the further period of registration within the period of initial registration, this right will cease. There is provision for the restoration is filed within one year from the date of cessation in the prescribed manner. Registration of the design is done only after undertaking a substantive examination is carried out where the novelty and/or originality are checked before the acceptance of the application (Fig. 1). Once the design is registered, it is entered into the design register and notified and published in 21 official gazette and a design registration certificate is issued . 3.3.3 Patent A patent is a legal grant in respect of any invention in goods giving exclusive right for a limited period of time granted by the Government to the patentee, subject to his full disclosure of the invention. It is one of most popular and a strong form of IP, which focuses on an invention, which is any new and useful art, process, method or manner of manufacture, machine, apparatus or other article, and any substance produced by manufacture. An invention also includes any new and useful improvement in any of them. In India, the governance and administration of this IP is presently through The Patents Act, 1970 (39 of 1970) and the subsequent amendments made to it in a phased manner in 1999, 2002 and 2005, [The Patents (Amendment) Act 1999 (17 of 1999; The Patents (Amendment) Act 2002 (38 of 2002) The Patents (Amendment) Act 2005 (15 of 2005)] and their Rules to comply with the obligations by India to TRIPS agreement 22 . An invention must have certain essential characteristics to be suitable for grant of a patent. These include novelty, non-obviousness and capability of industrial application. Registrar of Copyrights to be appointed by the Central Government, who would act under the superintendence and directions of the Central Government. 19 Registrar of Copyrights;New Delhi.India 20 Some items not considered for registration under this Act include: Book jackets, calendars, certificates, forms, dressmaking patterns, greeting cards, leaflets, maps and plans cards, post cards, stamps, transfers, medals; labels, tokens, cards, cartoons; any principle or mode of construction of any article Buildings and structures; parts of articles not manufactured and sold separately; mere mechanical contrivance or workshop alterations of components of an assembly; mere change in size of article; flags, emblems or signs of any country . 21 At: http://www.ipindia.nic.in 22 http://www.patentoffice.nic.in/ipr/patent/patents.htm. Intellectual Property Management Regime in the Indian National Agricultural Research Systems 18

Provision for grant of utility patents under the Indian Act is not there. Further, The Patent Act, 1970 and subsequent amendments in 2002 and 2005 specify some areas 23 that are not allowed for patenting even after meeting the essential requirements of a patent. Application for patents can be made by any person claiming to be the true and first inventor of the invention or by his assignee or legal representative 24 . An application for patent can be made by any of these persons either alone or jointly with any other person. Two or more companies as assignees may also make an application jointly. An application for the patent has to be filed in the respective patent office where the territorial jurisdiction. This application is a techno-legal document, which fully and particularly describes the invention and the best method of performing it. Immediately on receiving the application, the patent office accords an application number to it, and starts the procedure for examination. The procedure comprises of several stages including examination for patentability, opposition, scope for hearing for or against opposition, etc. The grant of a patent confers upon the patentee the exclusive right to it and entitlement of a legal protection to his intellectual property. This right is for period of 20 years from the date of application and has to be maintained for same period by payment of maintenance fees. However, if the fee is not paid this right will cease. And the invention will be in public domain. Granting of patent is done only after undertaking a substantive examination process where the patentability is checked before the acceptance of the application. Once the patent is accepted it is entered into the register and sealed through notification in official gazette and a patent grant certificate is issued. For inventions based or using biological materials, there are specific requirements as per Section 10 of the Act, which 25 are mandatory to be followed before the application is made to the Patent Office . Some of the special provisions provided towards instruments of patentability relating to inventions based on biological resources or traditional knowledge under the Indian Patent Act (amended), 2005 are tabulated in Table 3.3. Table 3.3. Provisions relating to Traditional Knowledge, Genetic Resources and Benefit Sharing under Patents (Amendment) Act, 2005 Provisions Not patentable inventions include ‘an invention which in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components’ [Sec. 3(p)] If the patent application mentions a biological material, the applicant is required to ‘disclose the source and geographical origin of the biological material in the specification, when used in the invention’ [Sec. 10(4)(d)(D)] Grant of a patent may be opposed or revoked, among others, on the following grounds: o ‘that the complete specification does not disclose or wrongly mentions the source or origin of biological material used for the invention [Sec. 25(j) and 64(p)] o ‘that the invention so far as claimed in any claim of the complete specification is o anticipated having regard to the knowledge, oral or otherwise, available within o any local or indigenous community in India or elsewhere (Sec. 25(k) and 23 Chapter II; Section 3 (a) to (p) of Indian Patent Act,1970 define the inventions not patentable. Section 4 and 5 define inventions relating to atomic energy not patentable and inventions where only methods or processes of manufacture patentable. 24 Section 6, Indian Patent Act, 1970. 25 Requirement for biological materials (in Section 10 of the IPA, 1970; The specification to be accompanied by an abstract to provide technical information on the invention; The deposit of the material shall be made not later than the date of the patent application in India; All the available characteristics of the material required for it to be correctly identified or indicated are included in the specification along with name, address of the depository institution and the date and number of the deposit of the material at the institution (as per the Budapest Treaty of which India is a signatory). Access to the material is available in the depository institution only after the date of the application for patent in India or if a priority is claimed after the date of the priority; applicants are to disclose source and geographical origin of the biological material in the specification, when used in an invention. Intellectual Property Management Regime in the Indian National Agricultural Research Systems 19

64(q)] These provisions have been made with a premise to afford the legal space to several inventions based on rich heritage of the land. The patent system in India is administered under the superintendence of the Controller General of Patents, Designs, Trademarks and Geographical Indications 26 . The Office of the Controller General, functions under the Department of Industrial Policy and Promotion, Ministry of Commerce and Industry. Controller General’s office is in Mumbai. There are four patent offices in India with the Head Office at Kolkata and other Patent Offices at Delhi, Mumbai and Chennai. 3.3.4 Geographical Indications (GI) Geographical Indications of Goods 27 are defined as that aspect of industrial property which refers to the geographical indication referring to a country or to a place situated therein as being the country or place of origin of that product. Typically, such a name conveys an assurance of quality and distinctiveness which is essentially attributable to the fact of its origin in that defined geographical locality, region or country. It is essentially a sign used on goods with a specific geographical origin possessing qualities or a reputation stemming from that place of origin. Indications are which identify as goods originating in a territory, region or locality, where a given quality, reputation or other characteristic of the goods is essentially attributable to its geographical origin. It is a method of IP protection by a decree or by a register and can be a word or a mark. This protection gives right of exclusion to the owners in a competitive environment by preventing misuse by others. It also ensures quality and genuineness of products to the consumers and better market returns to the producers. Unlike other IPs, GI is a property owned by groups or community. It is recognition for products, which already exist with clear history and reputation and not created new. An association of persons or association of producers or any organization or Authority established by or under any law can register as owners of GI but not individuals. India, enacted the Geographical Indications of Goods (Registration & Protection) Act, 1999 and is in o force from 15th September 2003. The Act and the Rules provide for establishment of GI registry. As per the Act, “goods” means any agricultural, natural or manufactured goods or any goods of handicraft or of industry and includes food stuff; the “indication” includes any name, geographical or figurative representation or any combination of them conveying or suggesting the geographical origin of goods to which it applies. For these goods the owners or major stakeholders are the 28 29 30. producer , proprietor and authorized user Goods are classified in the Fourth Schedule of the Rules. There are 34 classes identified in The Act 31 . 26 The Office of the Controller General of Patents, Designs & Trade Marks (CGPDTM) is located at Mumbai. The Head Office of the Patent office is at Kolkata and its Branch offices are located at Chennai, New Delhi and Mumbai. The Offices of The Patent Information System (PIS) and National Institute of Intellectual Property Management (NIIPM) are at Nagpur. The Controller General supervises the working of the Patents Act, 1970, as amended, and also renders advice to the Government on matters relating to these subjects. At: http://www.patentoffice.nic.in/ 27 Under Articles 1 (2) and 10 of the Paris Convention for the Protection of Industrial Property, geographical indications are covered as an element of IPRs. They are also covered under Articles 22 to 24 of the Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement, which was part of the Agreements concluding the Uruguay Round of GATT negotiations. 28 Producer in relation to goods, means any person who If such goods are agricultural goods, produces the goods and includes the person who processes or packages such goods; If such goods are natural goods, exploits the goods; If such goods are handicraft or industrial goods, makes or manufactures the goods, and includes any person who trades or deals in such production, exploitation, making or manufacturing, as the case may be, of the goods 29 Registered proprietor: Means any association of persons or of producers or any organization for the time being entered in the register as proprietor of the geographical indication 30 Authorized user: Means the authorized user of a registered geographical indication 31 For details refer :Fourth Schedule of GI Act,1999 Intellectual Property Management Regime in the Indian National Agricultural Research Systems 20

3.3.5 Semiconductor Integrated Circuit (IC) Semiconductor Integrated Circuit (IC) means a product having transistors or other circuitry elements, which are inseparably formed on a semiconductor material or an insulating material or inside the semiconductor material and designed to perform an electronic circuitry function. To give effect to Section 6 in Part II of TRIPS, relating to Layout-design (topographics) of integrated circuits as intellectual property (IP), the Indian Parliament passed in September 2000, the Semi Conductor Integrated Circuits Layout-Design Act, 2000. The Semiconductor Integrated Circuits Layout-Design (SICLD) Act, 2000 is the governing Act for 'Lay out Designs of Integrated Circuits' in India. It defines 'layout design' means a layout of transistors and other circuitry elements including lead wires connecting such elements. The aim of the Act is to provide protection of Intellectual Property Right (IPR) in the area of Semiconductor Integrated Circuit Layout Designs and for matters connected therewith or incidental thereto. The Act and the Rules provide for establishment of semiconductor integrated circuits layout-design registry. The Semiconductor Integrated Circuits Layout- Design Registry (SICLDR) is the office where the applications on Layout-Designs of integrated circuits are filed for registration of created IP. This Registry has jurisdiction all over India. 32 The Department of Information Technology , Ministry of Information Technology is the implementing agency. The Registrar is empowered to determine the originality of the design 33 based on the information available with the office as also through the mechanism of advertisement of the application for registration of the layout-design and or any input received by the registry. The registration of a layout-design 34 shall be for a period of ten years from the date of filing an application for registration or from the date of first commercial exploitation anywhere in India or in any country, whichever is earlier. 3.3.6 Trade Mark It is an IP in form of a visual symbol and is often more popular as brand name. This may be a word signature, name, device, label, numerals or combination of colours on goods or services or other articles of commerce and which help to distinguish it from other similar goods or services originating from a different source. Thus this mark guarantees the identity of the origin of goods and services can stimulate further purchase by the purchasers. It identifies the actual physical origin of goods and services. The brand itself is the seal of authenticity. In India, as a consequence to TRIPS, major changes have taken place in the Trade and Merchandise Marks Act, 1958. The Trade Marks Act, 1999 is now in force since 15th September 2003 35 . Through the amendments, the definition of trademark stands enlarged. It now includes shape of goods, packaging and combination of colours, which can be adopted as a trademark. The Act also provides for registration of trademark for services in addition to goods 36 . A single Register of trademarks with simplified procedures for registration has been provided. It also provides for registration of collective marks owned by association of persons. All applications for registration of trade marks are received at the Head Office and its branches according to territorial jurisdiction. Applications are then examined mainly with regard to the distinctiveness, possibility of deceptiveness and conflicting trademarks. The 32 http://india.gov.in/outerwin.htm?id=http://www.mit.gov.in/ 33 A layout-design is prohibited from registration if: It is not original or it has been commercially exploited in India or in a convention country or is not inherently distinctive or those that are not capable of being distinguishable from any other registered layout-design 34 Semiconductor Integrated Circuits Layout-Design Registry , New Delhi. 35 The Trade Marks Registry was established in India in 1940 and presently it administers the Trade Marks Act, 1999 and the rules there under. It acts as a resource and information centre and is a facilitator in matters relating to trade marks in the country. 36 The objective of the Trade Marks Act, 1999 is to register trade marks applied for in the country and to provide for better protection of trade mark for goods and services and also to prevent fraudulent use of the mark. The main function of the Registry is to register trade marks which qualify for registration under the Act and Rules. Intellectual Property Management Regime in the Indian National Agricultural Research Systems 21

registrar on consideration of the application and any evidence of use or distinctiveness decides whether the application should be accepted for registration or not. If accepted, it is published in official gazette i.e Trade Marks Journal for opposition. Within a prescribed period any person can file an opposition following which hearing takes place. If it dismissed, the trademark is entered in the Register and certificate issued. The registrar’s decision can be put to appeal to the Intellectual Property Appellate Board. The Registry has its Head Office at Mumbai with four regional offices in other jurisdictions. 3.3.7 Protection of Plant Varieties Plant variety rights are a form of intellectual property protection granted to breeders of new varieties of plants. In a very general sense, a plant variety is a strain of a plant (or, more often, a crop) that is a pure breed. In other words, for a plant variety to be protected, it must produce the same type of plant in every generation, and should be distinct in appearance and distinguishable from others. Plant variety rights include, inter alia, royalty rights over a certain identified time period and restrictions on the propagation and subsequent use of seeds derived from such varieties. The protection of plant varieties around the world is guided by Article 27(3)(b) of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) 37 .The Article mandates states to protect plant varieties, while allowing them the flexibility to choose between a pure patent system, a unique protection system of its own kind, (sui generis), or a combination of the two. Given the TRIPs requirement and since the existing Indian Patent Act, 1970 excluded agriculture and horticultural methods of production from patentability; the Government of India has adopted the sui generis system for the protection of plant varieties India designed a sui generis legislation 38 . The sui generis PPV&FR Act of India has the convergence of provisions made under the TRIPS Agreement, the Convention for the Protection of New Varieties of Plants (UPOV 39 ), The International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) and the traditional/conventional privileges and rights already available to Indian farmers and farming communities in the civil society. However, this Act also has substantial deviation from the UPOV Acts of 1978 and 1991 and, hence, it could not serve, so far, as a relevant instrument of India’s accession to the UPOV Convention 40. The ITPGFRA entered into force in 2004 is a comprehensive treaty whose objectives are the conservation and sustainable use of plant genetic resources for food and agriculture (PGRFA) and the fair and equitable sharing of benefits derived from their use, in harmony with the CBD, for sustainable agriculture and food security. The core of the Treaty is a ‘multilateral system for access and benefit-sharing’ which for certain categories of PGRFA guarantees facilitated access in return 37 This sub-clause contains three conditions binding on sovereign states. States: may exclude from patentability plants, animals and essentially biological processes for the production of plants and animals ; must allow patents for micro-organisms and non-biological and microbiological processes for the production of plants or animals ;must provide protection for plant varieties, either by patents or by an effective sui generis [of its own kind] system or a combination. 38 The process of drafting the PPVFR took more than 10 years. Starting in late 1980’s, the first draft was produced by 1993 by Ministry of Agriculture, nodal Ministry throughout the development of the Bill. Based on the UPOV model, the penultimate draft was introduced in Lok Sabha (Lower House of Parliament)on December 12, 1999, and later was referred to 30-member Joint Parliamentary Committee (JPC) of both the Houses, for redrafting the Bill. This was which was due to inadequate provisions to protect the interests of the farmers, registration of extanct varieties and tribunals for speedy settlement of disputes etc. The JPC redrafted the Bill, thus incorporating a chapter on farmer’s rights, as per the IU, which is a unique feature. The original Bill authorized only the High Court to hear appeal against order of decisions of the authority or register. The new Bill recommended constitution of Tribunal for the purpose. Government of India 2001.The Protection of plant varieties and Farmers’ Rights Act 2001.Act No.52 of 2001 New Delhi: Akalank Publications. 39 Union for the Protection of New Varieties of Plants, commonly known as UPOV(based on its initials in French - Union Internationale pour la protection des oblentions vigetales) 40 Considerable debate has been generated on issue of India joining the UPOV. For India, protecting farmers’ rights may be a contentious issue when it decides to join UPOV. Article 37(3) of the UPOV 1991 convention clearly states that after December 31, 1995, all countries which wish to join UPOV must accede to the 1991 convention. http://www.agbioindia.org/archive.asp Intellectual Property Management Regime in the Indian National Agricultural Research Systems 22

for benefit-sharing. However, in respect of traditional knowledge, the key provision of the Treaty is its recognition of ‘farmers’ rights’ 41 . Thus the plant variety protection in India is governed by the ‘The Protection of Plant Varieties and Farmers’ Rights Act, 2001’ (PPV& FR Act) (53 of 2001). The PPV&FR Rules 2003 were published in the Gazette on September 12, 2003 and provide the manner and procedures for registration of Plant Varieties. The Act covers all categories of plants, except microorganisms 42 . There are two unique provisions of the sui generis legislation developed for the first time by India. These are: (i) protection of extant varieties, which include previously notified varieties under the seed law and other varieties of common knowledge/public domain, and (ii) farmers’ rights 43 , which are quite elaborate and recognize the farmers as conservers and providers of genetic resources, breeders of farmers/new varieties, and users/cultivators of the varieties protected under the law, having the right to use their farm-saved seed in a variety of ways, except as branded seed. Further, to affirm such privileges and rights to farmers 44 as the availability of farm saved seed for further propagation, sharing, exchanging or even selling except for as branded seed, the Indian legislature has imposed a ban on the grant of exclusive right over such new plant varieties under this Act as may carry the genetic use restriction technology (GURT) 45 . Apart from the breeders and others involved in developing new varieties, the Act recognizes farmers too. A farmer who has bred or developed a new variety shall be entitled for registration and other protection under PPV&FR Act, 2001 in the same manner as a breeder of a variety. Similarly, a farmer who is engaged in the conservation of genetic resources of land races and wild relatives of economic plants and their improvement through selection and preservation shall be entitled in the prescribed manner for recognition and reward from the Gene Fund provided that material so selected and preserved has been used as donors of genes in varieties registered under this Act. Farmer shall be entitled to save, use, sow, re-sow, exchange and share or sell his farm produce including seed of a variety protected under this act in the same manner as he was entitled before the coming into force of this Act provided that the farmer shall not be entitled to sell branded seed of a variety 46 protected under this Act . While plant variety present in wilderness cannot be registered, under PPV&FR Authority, any traditionally cultivated plant variety, which has undergone the process of domestication/improvement through human interventions, can be registered and 41 The International Treaty on Plant Genetic Resources for Food and Agriculture is aims to fight against hunger and poverty and essential for the achievement of Millennium Development Goals 1 and 7. No country is self-sufficient in plant genetic resources; all depend on genetic diversity in crops from other countries and regions. International cooperation and open exchange of genetic resources are therefore essential for food security. The fair sharing of benefits arising from the use of these resources has for the first time been practically implemented at the international level through the Treaty and its Standard Material Transfer Agreement. The International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) At: http://www.planttreaty.org/ 42 Cullet,Phillippe and Radhika Koduru.2003.Plant Variety Protection and Farmers Rights. Towards a broader understanding. 24 Delhi Law Review 2002(2003). Pages 41 –54. Also available at http://www.ielrc.org/content/a0304.pdf. 43 “This is the first time anywhere in the world the rights of farmers and breeders are given concurrent recognition.” Quoted from: Swaminathan.M.S.2001. September 15, 2001 “Down to Earth” Pages 48 to 50. 44 Section 2(k) quot;farmerquot; means any person who cultivates crops by cultivating the land himself; or cultivates crops by directly supervising the cultivation of land through any other person; or conserves and preserves, severally or jointly'. With any person any wild species or traditional varieties, or adds value to such wild species or traditional varieties through selection and identification of their useful properties. 45 Kochhar, Sudhir.2008. Institutions and capacity building for the evolution of IPR regime in India: Protection of Plant Varieties and Farmers, Rights. Journal of Intellectual Property Rights.Vol.13,January 2008,pp 51-56. 46 PPV&FR Act, 2001. Chapter VI.[Section 39 (1), (i) – iv)] Intellectual Property Management Regime in the Indian National Agricultural Research Systems 23

protected subjected to fulfillment of the eligible criteria 47 . The duration of protection of registered varieties varies for different crops considering their nature 48 . The Act has specified prerequisites for registration of a plant variety 49 .These include denomination assigned to such variety with an affidavit that variety does not contain any gene of gene sequences involving terminator technology to be attached. It is required that complete passport data of parental lines (geographical location in India; all information relating to the contribution if any, of any farmer (s), village, community institution or organization in breeding, evolving or developing the variety along with characteristics of variety with description for Novelty, Distinctiveness, Uniformity and Stability (NDUS). In addition the person 50 making application for registration shall disclose the use of genetic material conserved by any tribal or rural families for improvement of such variety 51 . In addition, the breeder shall be required to deposit the seed or propagating material including parental line seeds of registered variety to the Authority. An applicant has to submit a fixed amount of seed sample (breeder seed) with the seed quality test report. The seed samples received by the Authority will be properly tested for its purity and germination. A part of the seed sample will be sent to the test center for conduct of Distinctiveness, Uniformity and Stability (DUS) tests and a part of it will be kept by the Authority in the National Gene Bank to maintain the seed samples of the registered varieties for their entire period of protection. Any person seeking for the seed sample of a protected variety or a variety undergoing the DUS test procedure has to get permission from the Authority or the concerned breeder of the variety. Table 3.3 shows a tabulation of various provisions afforded towards protection of traditional knowledge base, genetic resources and on the issues of benefit sharing. Table 3.4. Provisions relating to Traditional Knowledge, Genetic Resources and Benefit Sharing under Protection of Plant Variety and Farmers’ Right Act, 2001 Provisions ‘benefit sharing, in relation to a variety, means such proportion of the benefit accruing to a breeder of such variety or such proportion of the benefit accruing to the breeder from an agent or a licensee of such variety, as the case may be, for which a claimant shall be entitled as determined by the Authority under Section 26 [Sec. 2(b)]; Every application for registration …shall contain a complete passport data of the parental lines from which the variety has been derived along with the geographical location in India from where the genetic material has been taken and all such information relating to the contribution, if any, of any farmer, village community, institution or organization in breeding, evolving or developing the variety’ [Section 18(e)]; ‘contain a declaration that the genetic material or parental material acquired for breeding, evolving or developing the variety has been lawfully acquired’ [Section 18(h)]; 47 As defined by Indian law, “variety” broadly means “a plant grouping except micro organism within a single botanical taxon of the lowest known rank, which can be… considered as a unit with regard to its suitability for being propagated, [and] which remains unchanged after such propagation, and includes propagating material of such variety, extant variety, transgenic variety, farmers’ variety and essentially derived variety”, Section 2(za), PVP Act. 48 Duration of protection for trees and vines-18 years For other crops -15 years For extant varieties- 15 years from the date of notification of that variety by the Central Government under Section 5 of the Seeds Act, 1966. [vide Section 24 of the Act]. 49 Vide Section 15 of PPV&FR Act, 2001. 50 Persons/Institutions eligible to apply are: Any person claiming to be the breeder f the variety; Any successor of the breeder of the variety; Any person being the assignee or the breeder of the variety in respect of the right to make such application; Any farmer or group of farmers or community of farmers claiming to be breeder of the variety. 51 Form I – for registration of new variety, extant variety and farmer’s variety and Form II – for essentially derived varieties (EDVs) and transgenic varieties Technical Questionnaire covering detailed information of the concerned variety. Along attached with the forms (I and II) – for Prescribed fee Intellectual Property Management Regime in the Indian National Agricultural Research Systems 24

On receipt of copy of the certificate of registration…the Authority shall publish such contents of the certificate and invite claims of benefit sharing to the variety registered under such certificate in the manner as may be prescribed [Section 26(1)](2) On invitation of the claims under sub-section (1), any person or group of persons or firm or governmental or nongovernmental organization shall submit its claim of benefit sharing to such variety in the prescribed form within such period, and accompanies with such fees, as may be prescribed [Section 26(2)]: the extant and nature of the use of genetic material of the claimant in the development of the variety relating to which the benefit sharing has been claimed. the commercial utility and demand in the market of the variety relating to which the benefit sharing has been claimed. The amount of benefit sharing to a variety determined under this section shall be deposited by the breeder of such variety in the manner referred to in clause (a) of sub-section 45 in the National Gene Fund. the amount of benefit sharing determined under this section shall, on a reference made by the Authority in the prescribed manner, be recoverable as an arrear of land revenue by the District Magistrate within whose local limits of jurisdiction the breeder liable for such benefit sharing resides. During the period between filing of application for registration and decision taken by Authority on application, the right holder shall enjoy provisional protection of his variety against any abusive act committed by any third party In case of any act of such abuse the right holder may bring it to the notice of Registrar PPV&FR who is entrusted with the powers to issue directions in such cases as per Section 24(5) of the Act, and also powers of a Civil Court to protect the interests of a breeder. As a result of grant of Plant Variety Protection (PVP) certificate, a title holder of a registered variety can exclusively use the variety on his own or through agents/licensees/inheritors/successors/assignees for the entire term of its protection, excluding others from unauthorized protection, sales, marketing, distribution, import or export of propagation material of the protected variety. Whereas, the registrar and the PPV&FR Authority shall administer the grant, maintenance, revocation, and cancellation of breeder’s right or any correction of entry in the register, if applicable, or the registration of agents/licensees of breeder for a particular registered variety, in terms of the restriction of breeders’ right, the PPV&FR Authority invites any claims for benefit sharing by publishing the particulars of the registered variety in Plant Variety Journal of India, gives opportunity to breeder to be heard, and decides on benefit sharing. The PPV&FR Authority is also allowed to admit cases, hear and decide on grant of compulsory license, if any, setting the term and conditions and limitations of compulsory license, and grant and quantum of remuneration to the breeder for the compulsory license. In case a breeder is aggrieved with any order or decision of the Authority or Registrar that affects his entitlement rights, he may make an appeal before the PVP Appellate Tribunal. Such appeals will be admitted and disposed of in respect of the following matters; (i) registration of varieties, (ii) registration of agents/licensees, (iii) revocation or modification of compulsory license, and (iv) payment of compensation made under the law. Further, if a breeder notices an infringement of his entitlement right, he may approach any Court (but not inferior to a District Court) in whose 52 jurisdiction any act of alleged infringement occurs . The Act has provisions for the registration of agents and licensees, and has also accorded rights to them 53 . Further, unless validity of registration is challenged, certificate issued by Registrar shall be the conclusive proof of entitlement of agents/licensees along with conditions/restrictions, if any as per Section 28(5) of the Act. The Act also provides that the registered agent/licensee not entitled 52 District Courts will admit such cases of alleged infringement under Section 65. 53 For example, to prevent infringement of Breeder’s Right, a registered agent may institute legal proceedings in his own name as per Section 28 (6) of the Act. However, he may have to do so only after giving information of infringement and 3 months’ time to the title holder to take proceedings to prevent it. In such proceedings, the breeder shall be added as defendant. He shall not be liable for any costs unless he enters an appearance and takes part in the proceedings as per Section 28 (7) of the Act. Intellectual Property Management Regime in the Indian National Agricultural Research Systems 25

to transfer the right any further as per Section 28(8) of the Act. The implementation of PPV&FR Act revolves round the core institutional mechanism provided by the PPV&FR Authority and the PPV&FR Registry, various enforcement provisions made in the Act, and also the provision for speedy legal remedies and recourse by the PVP Appellate Tribunal (Fig. 1). Fig. 1. Administration and Enforcement Structure of PPV&FRA Central Government PPV&FR Authority [Section 3(1)] Ministry of Agriculture Standing Committee/ Tribunal Registry Other (Section 54) [Section 12(1)] Committees [Section 5(1)] Court of Law Fig Source: Adapted from Trivedi, 2006 54 and Kochhar, 2008 55 . At present, the Act also provides that the existing Appellate Tribunal under the Trade Marks Act, 1999 would hold for the purpose of PPV&FR Act till the regular Appellate Tribunal is appointed separately. The PPV & FR Authority and Registrar haves the powers of a Civil Court 56 . Further, all appeals for the orders/decision of Authority/Registrar will be made to the PVP Appellate Tribunal 57. The Act provides that suits for the infringement of the breeder’s rights shall be filed as per Section 65 of the Act in a District Court, or a Superior Court, within the local limits of whose jurisdiction any act of infringement of breeder’s right is committed. This provision is clearly aimed at avoiding delay in the settlement of IPR related disputes, which is otherwise possible in lower courts due to long queues of pending cases. The PPV&FR Authority was created under the aegis of this Act, as the implementing Authority in this legislation, with central operations in Delhi 58 . The genera and species of the varieties for protection are notified through a Gazette notification. In May 2007, twelve species 54 Trivedi,RK.2006. Lecture in training program for agriculture officers of AP at NAARM, Hyderabad, during November 2006. 55 Kochhar, Sudhir 2008. Institutions and capacity building for the evolution of intellectual property rights regime in India:-conformity and enforcement issues. Protection of Plant Varieties and Farmers Rights. Journal of Intellectual Property Rights.Vol. 13, May 2008,pp.239-244. 56 Vide Section 11(a) of the Act and the orders passed by them are executable as a decree of a Civil Court as per Section 11(b) of the Act in all proceedings for the purposes of receiving evidence, administering oaths, enforcing the attendance of witnesses, compelling the discovery and production of documents, issuing commissions for the examination of witnesses, etc 57 vide Section 56 of the Act for the purposes of registration of variety, registration of agent/licensee, claim for benefit sharing, revocation/modification of compulsory license, and payment of compensation made as per Section 54 of the Act. 58 Protection of Plant Varieties and Farmers’ Rights Authority has been established and is located at NASC Complex, DPS Marg, Opp- Todapur, New Delhi-110 012. Intellectual Property Management Regime in the Indian National Agricultural Research Systems 26

of crops 59 were opened up for applications. Till Dec 1, 2008, about 970 applications had been received, of which 550 relate to extant varieties, 5 are for farmers' varieties, while the remainder are for new varieties 60 . Though the number of applications is fairly large, it is important to note that not all of them are not in acceptable format. For example, there are applications which are not accompanied by seed, which is required by law in some categories, which have been automatically treated as 'dropouts'. The largest number of applications have been for 'extant varieties’, which under the Act, may be of four types, those varieties that are already notified under the Seed Act, 1966;Farmers' Variety (FV) 61 'Variety of Common Knowledge', which are protected under the PPVF&R Act; or any other variety which is in the public domain. More than half of the applications (about 550) for registration received were of the extant variety category. Of these, the Extant Variety Recommendations Committee formed within the Authority has cleared almost half the cases for final approval. The Authority also publishes the monthly Plant Variety Journal 62 of India which serves as the Gazette for this Act. Twelve issues of the Plant Variety Journal of India, a priced publication of the PPV&FR Authority, have been already brought out until December 2008 63 to disseminate public knowledge related to the PPV&FR Act, and also to publish information on the status of the applications. The Authority is also contributing in developing capacity of trained manpower and for enhancing institutional capacity for the implementation of the plant variety protection and the farmers’ rights provided in the Act, the PPV&FR Authority has made collaborative arrangements with ICAR institutes like Indian Agricultural Research Institute (IARI) 64 to impart training for developing skills in the professionally qualified (PQ) persons, scientific manpower, farmers, NGOs, extension workers, and other public and private agencies. These trainings are organized for different durations, ranging from 3-5 days to 10 weeks. It also sponsors training in other institutes 65 and state agricultural universities for all engaged in this activity from public and private sector. 3.3.9 Space relating to Traditional Knowledge, Genetic Resources and Benefit Sharing in the other Laws In tune with societal needs in a country with rich traditional base, following the instances of alleged bio-piracy on issues related top biological resources in recent past, policy and lawmakers in India have provided various provisions in Indian Laws. This is done with a premise to develop instruments to enhance the profits to the concerned stakeholders on one hand and also to preserve the rights of people engaged in knowledge spheres of traditionally held domains in the society. The Biological Diversity Act, 2002 enacted in 2002 enables a statutory authority, National Biodiversity Authority (NBA),which oversees the 59 DUS test guidelines finalized for 14 notified crop species: Black gram, Bread wheat, Chickpea, Field pea, Green gram, Kidney bean, Lentil, Maize, Pearl millet, Pigeon pea, Rice, Sorghum, Cotton, Jute . vide Section 29(2) of the Act At: http://www.plantauthority.gov.in/index.htm 60 Sumathi Chandesekhran. 2008. At: http://spicyipindia.blogspot.com/2008/12/spicyip-interview-plant- variety.html 61 The definition of 'farmers' variety' is contentious and still in process. According to the Chairperson PPVFRA, “there lies here a potential project for institutions to document FVs, especially rice, which is an Indian variety and under threat from MNCs”. 62 Soft copies of the journal are also available on the official website of the Authority. At: http://www.plantauthority.gov.in/publications.htm 63 For instance, the ACCEPTED APPLICATION FOR REGISTRATION of an application is now in the latest issue of journal. In: Plant Variety Journal of India, Vol. 2, No.12. December 01, 2008/ At: http://www.plantauthority.gov.in/PDFile/PVJ_dec_2008.pdf 64 Premier agricultural research institute in India and a deemed-to-be-university for human resource development 65 NAARM has been partnering with Farm and Rural Science Foundation (FRSF), a non-profit organization for conducting training programs sponsored by the Authority during last two years, 2006- 08. Intellectual Property Management Regime in the Indian National Agricultural Research Systems 27

activities defined. Table 3.5 lists some of the provisions under law to use of biological resources and IPRs resulting from using them. Table 3.5. Provisions relating to Traditional Knowledge, Genetic Resources and Benefit Sharing under BD Act, 2002. Provisions under BD Act, 2002 The Act prohibits certain category of persons, especially foreigners, ‘without previous approval of the National Biodiversity Authority’ to, ‘obtain any biological resource occurring in India or knowledge associated thereto for research or for commercial utilization or for bio-survey and bio-utilization’ [Sec. 3(1)]. The Act prohibits the ‘transfer the results of any research relating to any biological resources occurring in, or obtained from, India for monetary consideration or otherwise’ to certain categories of persons, especially foreigners [Sec. 3(4)] The Act prohibits the application ‘for any intellectual property right, by whatever name called, in or outside India for any invention based on any research or information on a biological resource obtained from India without obtaining the previous approval of the National Biodiversity Authority before making such application’ [Sec. 6(1)]. ‘The National Biodiversity Authority may, while granting the approval under this section, impose benefit sharing fee or royalty or both or impose conditions including the sharing of financial benefits arising out of the commercial utilization of such rights’ [Sec. 6(2)]. o ‘The National Biodiversity Authority shall while granting approvals under section 19 or section 20 ensure that the terms and conditions subject to which approval is granted secures equitable sharing of benefits arising out of the use of accessed biological resources, their by-products, o innovations and practices associated with their use and applications and knowledge relating thereto in accordance with mutually agreed terms and conditions between the person applying o for such approval, local bodies concerned and the benefit claimers.’ [Sec. 21 (1)]. The National Biodiversity Authority shall, subject to any regulations made in this beha determine the benefit sharing which shall be given effect in all or any of the following mann namely(a) grant of joint ownership of intellectual property rights to the National Biodivers Authority, or where benefit claimers are identified, to such benefit claimers; (b) transfer technology;(c) location of production, research and development units in such areas wh will facilitate better living standards to the benefit claimers; (d) association of Ind scientists, benefit claimers and the local people with research and development in biologi resources and bio-survey and bio-utilization; (e) setting up of venture capital fund for aid the cause of benefit claimers; (f) payment of monetary compensation and non-moneta benefits to the benefit claimers as the National Biodiversity Authority may deem fit. Intellectual Property Management Regime in the Indian National Agricultural Research Systems 28

4. ICAR System “A policy is a temporary creed liable to be changed, but while it holds good it has got to be pursued with apostolic zeal.quot; - Mahatma Gandhi 4.1 The Indian Council of Agricultural Research (ICAR) The Indian Council of Agricultural Research (ICAR) is an autonomous organisation under the Department of Agricultural Research and Education, Ministry of Agriculture, Government of India. Formerly known as Imperial Council of Agricultural Research, it was established on 16 July, 1929 as a registered society under the Societies Registration Act, 1860 in pursuance of the report of the Royal Commission on Agriculture. The ICAR 66 is the apex body for planning, promoting, coordinating and undertaking research, coordinating, guiding and managing research and education in agriculture including horticulture, fisheries and animal sciences in the entire country. It is also the nodal agency of the National Agricultural Research System (NARS) comprising Central and State Agricultural Universities, Central Universities and affiliated colleges of agriculture, and other organizations (includes public and private, national and international agencies) dealing with agricultural research. The ICAR system consists of a network of institutions comprising 47 national institutes including 4 deemed to be universities and an academy of agricultural research management, 5 national bureaus, 12 project directorates, 31 national research centres, 91 All India Coordinated Research/Network Projects (AICRP) and 538 Farm Science Centres (Krishi Vigyan Kendras or KVKs). The AICRP programs are the main link between ICAR and State Agricultural Universities (SAUs). These were introduced to ensure complementarities in the research programmes of different institutions and provide a mechanism for joint evaluation of 67 new technologies by the scientists through multi-location testing . The number of centres under AICRPs is about 1300 of which 900 are based in universities and 200 in the ICAR institutes 68 . 4.2 Partners and Mode of Functioning Several other partners support the research activities of ICAR. These include 23 general universities, under the University Grants Commission (UGC), several scientific organisations such as Council of Scientific and Industrial Research (CSIR), Bhabha Atomic Research Centre (BARC), National Remote Sensing Agency (NRSA), other governmental agencies, and more than 100 private and voluntary agencies and about 105 scientific societies. All these form a part of the National Agricultural Research System (NARS). The total number of scientists exceeds 20,000 making the Indian NARS is one of the largest systems in the world 69 . It is well contended that the effective functioning of this system, in close association with education and extension systems, has contributed to the rapid growth of agriculture after India became independent in 1947 70 . Research programs are centring basic as well as applied issues, and on diverse problems facing production of crops, animals, fisheries, etc., with the objective of evolving new production technologies suited to different agro- climatic conditions. Using formal and informal arrangements with these agencies, ICAR continues to 71 : 66 Indian Council of Agricultural Research (ICAR), Krishi Bhawan, 1, Dr. Rajendra Prasad Road, New Delhi – 110 001; is a Registered Society, incorporated under the Societies Registration Act, 1860. 67 Raman, K.V. and Balaguru, T. 1990. National Agricultural Research System in India. Journal of Indian School of Political Economy 2(3): 449-474. 68 As quoted in Page 16. Source: ICAR Vision 2020. Vision Document 2020. 84 Pages. 69 The research system includes approximately 30,000 scientists and more than 100,000 supporting staff actively engaged in research related to agriculture. 70 Balaguru, T. and Raman, K.V. 1988. Agricultural Research System in India. In: Agricultural Research Systems and Management in the 21st Century, Raman, K.V. et al. (Eds), NAARM Alumni Association, Hyderabad 71 Supra at n. 3 Source: ICAR Vision 2020. Vision Document 2020 DARE/ICAR Annual Report 2007- 2008. http://www.icar.org.in/anrep/200708/AR200708.htm Intellectual Property Management Regime in the Indian National Agricultural Research Systems 29

(i) implement research mandates extending beyond the administrative boundaries of the States; (ii) pursue basic research not undertaken by most Agricultural Universities (iii) evaluate research results through multi - location testing (iv) develop manpower for Agricultural Universities and other agricultural institutions. This approach has helped it to play a pioneering role in ushering Green Revolution and subsequent developments in agriculture in India. Research and technology development programs have enabled the country to increase the production of food grains by 4 times, horticultural crops by 6 times, fish by 9 times (marine 5 times and inland 17 times), milk 6 times and eggs 27 times since 1950-51, thus making a visible impact on the national food and 72 nutritional security . 4.3 New Role With new changes in agriculture at the global levels, the ICAR is attempting to redefine its mission through the Vision plan 73, and is embarking on developing profess in the use of cutting-edge technologies 74 . In conjunction with ongoing programs, it now aims to look into problems relating to broader areas of rural development concerning agriculture, including post-harvest technology, by developing co-operative programmes with other organizations at national and international levels 75. The agriculture sector in India accounts for about 22% of its GDP, 15% of the total export earnings and employs about 56.7% of the country’s workforce.It plays a key role in ensuring national food security, and in the process, national security as well. For these reasons, agricultural development has a strong multiplier effect across the economy. There is increasing consensus that, in a globalizing economy, a long- term economic growth agenda for India is feasible only if it has agricultural development that raises rural incomes as its central concern. Rising economic growth rates and investments, and expanding global trade create opportunities for agricultural growth that can raise rural incomes, reduce poverty and provide for food and nutritional security. Making use of these opportunities requires a transition from the present producer- driven approach to agricultural development to a market-led agricultural development approach that enables producers to understand and respond appropriately to consumer needs and preferences. Piloting the agricultural transition, therefore, requires that special attention be given to reducing the vulnerability of the poor in the disadvantaged regions and ensuring their smooth integration into the economy. The National Policy on Agriculture (NPA), 76 the Tenth Five Year Plan , as well as the Eleventh Five Year Plan of the Government of 77 India , which is in force currently, all recognize the need for a market-led, but regionally- differentiated approach to agricultural development. The Policy and Plans also accord high priority to agricultural research for generation and transfer of agricultural technologies that 72 http://www.icar.org.in/ICARataglance.pdf 73 Source: ICAR Vision 2020. Vision Document 2020 74 “Keeping this in view, our priority areas would be eco-region specific technology generation and extension in continuation; systems perspective in research and education; enhancement of water productivity and nutrient-use efficiency; climate change and management of stresses; landuse systems for multi-functional agriculture; diagnostics, vaccines and delivery systems; valueadded product development, food safety and quality assurance; biosensors, biofuels, biomolecules, biofortification, biosafety, biosecurity, bioremediation, and biofertlization; IT-based decision support systems for technology transfer; human resource development in niche areas; and enabling mechanisms for enhancing R&D productivity. This calls for significant new initiatives in research and development and enhanced investments for technology generation relevant to different regions/situations”.- Dr Mangala .Rai, DG, ICAR. Quoted from : DARE/ICAR Annual Report At: 2007-2008 http://www.icar.org.in/anrep/200708/AR200708.htm 75 Section 5 of the Indian Patent Act 1970 only inventions which are methods or processes of manufacture were patentable; restricted patents from substances in India for use or capable of being used as food or as medicine or drug ….. . substances capable of being used as food/medicine/drugs were not allowed for patenting. This was prior to 1995. 76 At: http://planningcommission.nic.in/plans/planrel/fiveyr/welcome.html 77 Eleventh Five Year Plan.(2007–2012).Agriculture, Rural Development, Industry, Vol. III.Pages 537. At: http://planningcommission.nic.in/plans/planrel/fiveyr/11th/11_v3/11th_vol3.pdf Intellectual Property Management Regime in the Indian National Agricultural Research Systems 30

help to increase farm incomes and rural employment opportunities, as well as to ensuring sustainability of livelihoods in the less developed regions. Against this premise, the Govt of India has launched an innovative programme called the National Agricultural Innovation Project (NAIP) in 2006, with World Bank support, to bring about plurality of stakeholder involvement in agricultural R&D through consortia mode of operation 78 . This program is seen as the means to achieve the holistic approach to help India become more competitive in agriculture trade and also improve livelihoods of many in this sector. Along with this it is realised that trade liberalization has shifted economic incentives and improved technologies are now critical factors in a country’s ability to exploit its comparative and competitive advantages. Technological needs are changing toward more knowledge- and skill-intensive agriculture and more complex farming systems. Important changes in the technology for research itself, especially the new biotechnologies and informational technologies, are raising new issues in organizing national research systems, related to economies of size, international collaboration, and public-private linkages. 4.4 Need for Institutionalization of IP Policy Such paradigm shifts in agricultural systems though essential for broad vision of improving rural sectors are necessitating the reorientation of mechanisms and mode of agricultural research and innovation system all over the world including India. Historically, agricultural research was not concerned with IP issues (except to a limited extent for mechanical inventions) as living organisms (plants and animals) or the bioprocesses (like tissue culture), and inputs used to produce them like fertilizers, and pesticides were kept out of the purview of IP protection 79. It was only after 1995, when the WTO agreement on Trade Related Intellectual Property Rights (TRIPS) 80 made it mandatory for all member nations to provide for protection of IP arising from agricultural research. The agreement expanded the level, scope, extent and role of IP protection tremendously and forced the developing countries into its ambit, leading to fundamental changes in the nature and ownership of innovations and resources in agriculture 81 . The entry of new players and opening of markets in global arena has also brought new equations on owning of intellectual property and resultant difficulties in access for inputs in research. The role of intellectual property rights (IPRs) in international trade, the global economy and international relation has grown considerably, especially since the 1970s 82 (IPR-protected products, technologies and services are major exports and rights manifesting in form of licenses to use the patented processes, products, designs, trademarks or copyrights. All these developments necessitate legal protection mechanisms to be in place. A summary of legal provisions in IP laws in India was discussed in preceding chapter. ICAR is also bound by national laws and recognizes the evolving trends in IP jurisprudence 78 “The NAIP is to facilitate accelerated and sustainable transformation of Indian agriculture in support of poverty alleviation and income generation by collaborative development and application of agricultural innovation by the public research organizations in partnership with the farmer’s groups, the private sector, the civil society organizations and other stakeholders”. ICAR. 2006. National Agricultural Innovation Project. Project Implementation Unit, NAIP, New Delhi. Available at: http://www.naip.icar.org.in/ 79 Section 5 of the Indian Patent Act 1970 only inventions which are methods or processes of manufacture were patentable; restricted patents from substances in India for use or capable of being used as food or as medicine or drug substances capable of being used as food/medicine/drugs were not allowed for patenting. This was prior to 1995. 80 Available at: http://www.wto.org/english/tratop_e/TRIPS_e/TRIPS_e.htm#WhatAre 81 Juma, C.1999. Intellectual Property Rights and Globalization: Implications for Developing Countries. Science, Technology and Innovation Discussion Paper No.4, Center for International Development, Harvard University, Cambridge, MA, USA. 82 Dutfield, Graham. 1999. Intellectual Property Rights, Trade and Biodiversity: The Case of Seeds and Plant Varieties. Background Paper written for IUCN Project on the Convention on Biological Diversity and the International Regime. Inter-sessional Meeting on the Operations of Convention. Montreal, Canada, 28-30 June 1999.Pages 1-97. Intellectual Property Management Regime in the Indian National Agricultural Research Systems 31

and in developing its IP policy; it has imbibed these obligations too 83 . For organizations like ICAR which is part of a large NARS, it becomes more obligatory to place an institutional mechanism in place. Institutionalizing intellectual property management requires an effective policy 84 to guide decisions and internal processes related to the management of various forms of IP at all levels of hierarchy within the organization. For public systems, policy is driven by a vision of society’s future and guided by the basic principles of effectiveness, transparency, equity, consistency and comprehensiveness 85 . By this definition, a national agricultural policy 86 would include a set of principles, rules, guidelines or mechanisms to effectively plan and regulate production, processing and trade of agricultural products while providing for sustainable food security and rural employment to promote growth and equity. Likewise, a policy on intellectual property (IP) in agricultural research in public research systems includes a set of principles, rules, guidelines or mechanisms to guide decisions on managing intellectual property to promote more effective research and technology transfer, in a manner that is consistent with the role and objectives of the organization. It is contended that an effective IP policy not only supports efficient decision- making, but also provides the basis for institutionalizing related organizational systems, mechanisms and procedures to ensure both efficiency and accountability of decisions at all levels of hierarchy within the organization. Hence, in adjusting to the external forces and changing the management of IPR, a national agricultural research organization (NARO) must 87 take into account , a policy framework guiding its mission, objectives and programs, with its stakeholders, and its research scientists. Since management of intellectual property (IP) attached to agricultural research is a relatively new phenomenon, developing, implementing and managing such a dynamic system can present formidable challenges and complications. In the recent past, several agriculture research institutions including the CGIAR system have responded to these demands and initiated institutionalization of IP policy 88 . 4.5 ICAR Guidelines for Intellectual Property Management and Technology Transfer / Commercialization In the Indian NARS, the earlier approach to manage IPs was on case-to case approach taking cue from few documented rules and guidelines 89 . The process was more at the central headquarters and all its constituent institutes dependent on the central unit. Taking note of the new shifts and efforts at international institutes and realising the need for a more vibrant and viable system, the ICAR had initiated its efforts to devise such a policy for public agricultural research institutions. In doing so, it kept in mind its fundamental social mission to contribute to national growth and equity, consistent with the national economic and 83 “The management approach as described in the guidelines will conform to the national IPR laws and policies in force in the country. It will be in line with the legal framework required as per the TRIPS Agreement. The provisions of the Convention on Biological Diversity (CBD) and the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) will be recognized” Chapter 1. Page 14.In: ICAR. 2006. ICAR Guidelines for Intellectual Property Management and Technology Transfer/ Commercialization. Indian Council of Agricultural Research, New Delhi. October 2006. 84 Policy refers to a set of principles, rules, guidelines or mechanisms that guide stakeholders in planning and decision-making in organizations. 85 Norton R.D. 2004. Agricultural Development Policy: Concepts and Experiences, John Wiley and Sons,USA. 540 pages. 86 “The Government of India trust that this Statement of National Agriculture Policy will receive the fullest support of all sections of the people and lead to sustainable development of agriculture, create gainful employment on a self sustaining basis in rural areas, raise standards of living for the farming communities, preserve environment and serve as a vehicle for building a resurgent national economy” In: NATIONAL AGRICULTURE POLICY, Ministry of Agriculture, Department of Agriculture & Co- operation, Government of India. At:http://www.nls.ac.in/CEERA/ceerafeb04/html/documents/agri.htm 87 Managing Intellectual Property – Challenges and Responses for Agricultural Research Institutes. Pages 209-217 in G.J. Persley and M.M. Latin (eds.) Agricultural Biotechnology and the Poor: Proceedings of an International Conference. 21-22 October, 1999. CGIAR, Washington DC. 88 Egelyng, H. 2005. Evolution of capacity for institutionalized management of intellectual property at international agricultural research centers: A strategic case study. AgBioForum, 8(1), 7-17. Available on the World Wide Web: http://www.agbioforum.org. 89 “ICAR Rules and Guidelines for Training, Consultancy, Contract Research and Contract Services, 1997”, the “ICAR Guidelines for Filing Patent Applications, 2001” and the “Memorandum of Association: Rules and Bye-Laws of the Indian Council of Agricultural Research Society, 2000”. Intellectual Property Management Regime in the Indian National Agricultural Research Systems 32

agricultural policies 90 and the legal framework at the national and international fora. The entire process, spanning over two years, was through detailed review at in-house levels, through the discussions from practitioners of IP management in other fields 91 , at national 92 and international levels 93 . All these efforts culminated in the establishment of its current decentralized IPR domain since October 2, 2006. This set in the implementation of ‘ICAR Guidelines for Intellectual Property Management and Technology Transfer / Commercialization’ in all its institutes 94 .Besides providing the working guidelines for facilitation of IP management and technology transfer activities, ICAR has also delegated powers to all Directors of its institutes to execute protection, maintenance and transfer of the IP subsisting in the ICAR’s research results for the benefits of farmers and farm enterprises. Many state agricultural universities (SAUs) have also adopted the ICAR guidelines in spirit, either as such or by making suitable modifications to meet their specific needs 95 . 4.5.1 Institutional Arrangements The guidelines describe the institutional arrangement for IP management. A Central Technology Management Committee 96 (CTMC) at the ICAR headquarters is chaired by Director General, ICAR and is the apex decision-making body. All matters of policy concerning IPR portfolio management and technology transfer/ commercialization are decided by the CTMC. At the respective ICAR institutions, the Institute Technology Management Committee 97 (ITMC), chaired by the Director of the Institution, is the final decision making body for IP related matters/progress/concerns at that institute. Further, selected institutes at the zonal level have been designated as the Zonal Institute Technology Management Committee 98 (ZITMC). These committees take decisions for the IPR portfolio management and technology transfer/ commercialization of the ICAR institutions in the zone and also the inter-institutional matters in that zone. The ITMCs in that zone can seek advice from zonal committees regarding their IPR portfolio and technology transfer matters. These central, zonal and institute level committees will take steps to coordinate, harmonize and synergize with other relevant committees at the ICAR headquarters/institutions. In addition an Agro-Technology Management Centre (ATMC) has been established at ICAR headquarters for IP management and technology transfer/ commercialization. ATMC functions as the secretariat of CTMC at ICAR headquarters. At the level of ICAR institutions, Institute Technology Management Units (ITMUs) have been established since 2007. These units are responsible for IP protection/ management and technology transfer/ commercialization with internal capabilities as well as external legal and business experts wherever required. The ITMUs act as Secretariat for the respective ITMCs. Selected ITMUs 90 Rao,N.H.and R.Kalpana Sastry.20004.Towards a policy for Towards a Policy for Management of Intellectual Property in Public Agricultural Research Systems in India. Journal of Intellectual Property Rights Vol. 9.May 2004 pp 242-259. 91 CSIR Guidelines for technology Transfer and Utilization of Knowledge base. Council of Scientific and Industrial Research, New Delhi, January 2002.83p. 92 NAAS,2003.IPR in Agriculture. Policy Paper 19.National Academy of Agricultural Sciences. New Delhi. 93 Cornell Intellectual Property Hand Book. Cornell Research Foundation, Inc., Ithaca. 26p.+ Appendices. 94 ICAR. 2006. ICAR Guidelines for Intellectual Property Management and Technology Transfer/ Commercialization. Indian Council of Agricultural Research, New Delhi. October 2006..pages120 95 Three state agricultural universities have now initiated the process. At the State level, the Government of Kerala approved the Intellectual Property Rights Policy for Kerala, 2008. The policy envisages the setting up of a specialized governmental body called the Supervisory Council on Intellectual Property (SCIP) to oversee the activities of the proposed Kerala Traditional Knowledge Authority (KTKA) and State Bio-diversity Board (SBB) with regard to the protection of traditional knowledge, to provide overall supervision in matters relating to Intellectual Property Rights, and to follow up the recommendations of the KTKA with regard to prosecutions for the violation of knowledge-users' rights. Government Order G.O. (Ms) No.127/2008/Law Dated, 22/12/08.Government of Kerala. 96 Short title for Central IP Management and Technology Transfer/ Commercialization Committee 97 Short title for Institute IP Management and Technology Transfer/ Commercialization Committee 98 Short title for Zonal Institute IP Management and Technology Transfer/ Commercialization Committee Intellectual Property Management Regime in the Indian National Agricultural Research Systems 33

at national/central institutions in different zones are designated as Zonal Agro-Technology Management Centres (ZTMCs) (Fig. 6). 4.5.2 Issues of Governance of IP Policy Recognising the strong need to build capacity in manpower for an effective working of its IPR domain, the ICAR has scaled the previously existing component of IPR and a new scheme “Intellectual Property Management and Transfer/Commercialization of Agricultural Technology Scheme has been initiated to cater to budgetary needs for capacity building at the ITMUs, ZTMCs and ICAR headquarters 99 . The IPR &Policy Unit at ICAR headquarters under the guidance of CTMC is spearheading efforts on capacity building on IP management. NAARM is closely associated with this activity 100 . Since May 2007, a country wide campaign has been launched and 9 thematic programs have been conducted to about 300 participants across the ICAR institutes and SAUs. 4.5.3 Possible Types of IPs on Research Works in ICAR system Apart from the institutional arrangements, the guidelines also define boundaries for various IP generated in ICAR. While ownership revolves with solely with ICAR from research work conducted through the use of funds from it; Collaborative projects results are to be processed for IP ownership as per the agreements. The guidelines clearly indicate that the provisions of Sec 3 101 in Indian Patent Act are to be adhered to. Since the Act does explicitly specify that any method relating to the treatment of plants is patentable it can be interpreted that the Act allows an invention to be patented that is merely a method of making plants free of disease. Also, a process for improving the plant’s value or increasing the value of the plant’s products is patentable. The living entity of artificial origin such as microorganism, vaccines are considered patentable The biological material such as recombinant DNA, plasmids and processes of manufacturing thereof are patentable provided they are produced by substantive human intervention. In addition, the processes relating to microorganisms or producing chemical substances using such microorganisms are patentable. Patents are now permissible for “processes or methods of production of tangible and nonliving substances” like enzymes, hormones, and vaccines, processes using bioconversion, microorganisms, biologically active substances, biotechnology, microbiology, and/or chemical substances produced by using genetically 99 ICAR Training cum workshops on IP and technology management. September 2008.ICAR .KAB-I, Pusa, New Delhi. 100 ICAR. 2006. Chapter 12. Pages 66-69 supra at n.27. 101 As per Sec. 3 of the Patents Act, 1970 as amended in 2002 and 2005, the following are not inventions within the meaning of this Act, - (a) an invention which is frivolous or which claims anything obvious contrary to well established natural laws; (b) an Invention the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment; (c) the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substances occurring in nature; (d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.;(e) a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance; (f) the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way; (g) void, (h) a method of agriculture or horticulture; (i) any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products; (j) plants and animals in whole or arty part thereof other than microorganisms but including seeds, varieties and species and essentially biological :processes for production or propagation of plants and animals; (k) a mathematical or business method or a computer programme per se or algorithms; (l) literary, dramatic, musical or artistic work or any other aesthetic creation whatsoever including cinematographic works and televisions productions; (m)a mere scheme or rule or method of performing mental act or method of playing game; (n)a presentation of information; (o) topography of integrated circuits; (p) an invention which, in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components. Intellectual Property Management Regime in the Indian National Agricultural Research Systems 34

engineered organisms. While clones and new variety of plants are not patentable, the process / method of preparing genetically modified organisms are patentable subject matter. These provisions make several outputs from research under ICAR qualify for getting IP protection in form of patents, copyrights and designs. Various forms of research results may be patentable, protectable in any form of other IP or not protectable under law for projects in ICAR are listed in Table 4.1. Fig. 6. Three- Tier Mechanism for IP Management in ICAR System Director-General, ICAR Central Technology Management Committee (CTMC) Agricultural Technology Management Centre (ATMC)/IPR 5 Zonal Institute Management Centre Management Centre Management Centre Management Centre Management Centre Zonal Technology Zonal Technology Zonal Technology Technology Zonal Technology Zonal Technology Management (North-2) (North-1) (South) (East) (West) Committees (ZITMCs) one each with five ZTMCs 5 Zonal Institute Technology Management Committees (ZITMCs) one each with five ZTMCs 66 Institute 21 Institute Technology Management Centre Management Centre Management Centre Management Centre Technology Management Centre Management Technology Technology 22 Institute Technology Technology 16 Institute 16 Institute 20 Institute (North-1) (North-2) (South) Committees (East) West) (ITMCs) one each with ITMUs at all institutes of ICAR Intellectual Property Management Regime in the Indian National Agricultural Research Systems 35

Table 4.1 Types of IP 102 permitted on Results Generated in ICAR System S. IP Legislation Forms of Research Results No. • Microorganism based formulations, viz bio-control 1. Patent The Patents Act, 1970 and its agents, biofertilizers, specific dairy catalysts, etc., and amendments the processes for their use. • Various genetically engineered microorganisms for an array of specific uses, such as biodegraders, bio- stimulants, bio-protectants, etc., and the processes related to their application/use. • Novel dairy and horticultural products, bye-products, such as enzymes, and processes for their production and use • Plant based agro-chemicals, their purification and testing processes, and various formulations. • Diagnostic kits. • Agricultural machinery, implements, and laboratory equipment. • High value compounds from terrestrial, aquatic and living systems, such as animal rumen, Intenodal cavities of bamboos, etc. • Novel genes from microbial and higher biological systems; • Research tools of genetic engineering, such as gene primers, constructs, and gene transfer tools like gene gun, etc. • Information systems with software, etc. • Patentable part of know-how, for scaling up of research results or manufacture of prototypes/ commercial products • Microorganisms 103 • Processes leading to the development of Genetically Modified Organisms (GMO) 104 • Designs of any commercial value, developed in ICAR, 2. Design The Design Act, 2000/ Copyright may be protected as registered designs • Technologies involving considerations of shape (like Law, 1957 shape of moldboard plough), configuration (like hitched implements, mounted implements) and pattern (like straight type harrow or triangular hoe) or farm machine or any process equipment in prototype stage • Collective mark for ICAR emblem 3. Trade Mark The Trade Marks • Institutes to register their trademarks and use with the Act, 1999 collective ICAR mark • A collective intellectual property of the community 4. Geographical The • Is not in the ICAR’s IPR domain Indication Geographical • Assistance and advice being given as ‘technological Indications backstopping’ to concerned parties 105 for processing (Registration and Protection) Act, as agricultural GIs of specific national and regional 1999 interests • Institutional creations/ works, viz., publications, audio- 5. Copyright The Copyright Act, 1957 visuals, designs, computer programmes, databases, websites, cd-roms, software, multimedia product. • Rights on individual creations as allowed by the law permitted 102 Chapters 3,5 6 and 7. Supra at n. 27. 103 ICAR will not seek patent on a microorganism in the same form in which it is retrieved from its natural habitat. 104 Animal/ poultry breeds, fish strains, etc., cannot be protected in India as patents or variety protection. 105 The GI Act provides for the facilitator role by some other relevant bodies in the registration and protection of GIs Intellectual Property Management Regime in the Indian National Agricultural Research Systems 36

S. IP Legislation Forms of Research Results No. • ICAR varieties of field, horticultural and agro-forestry 6. Plant varieties The Protection of Plant Varieties crops, including the new, extant, essentially derived and Farmers’ varieties (EDV), and transgenic plant varieties Rights Act, 2001 protected as per the PPV&FR Act/ plant variety 106 protection (PVP) laws of other countries • A know-how available with ICAR, constitutes an 7. Undisclosed The Contract Act, information 1872; Common important, potentially useful property, irrespective of 107 (Civil) Law whether it is patentable or not • ICAR protects such know-how as trade secret • Execute the confidentiality agreements in case of usage by other parties • ICAR shall also disclose the traditional knowledge 8. Traditional None knowledge and related to the innovations made in its set up in all its other assets patent/ IPR applications to the best of its knowledge and information 108 • Recognizes that isolation of indigenous genes from plant and animal systems and their application for specific target traits has special significance and prospects • The bureaus for genetic resources (plants, animals, fish and agriculturally important microorganisms ) make efforts to register, document and index these knowledge items in public domain 109 The requirement for biological materials 110 including the deposit of the material at the institution (as per the Budapest Treaty of which India is a signatory) are other conditions needed to met and which the guidelines are indicated explicitly. However, the reference samples deposited at the Genetic Resources Bureaus of ICAR are encouraged. Though these are helpful for internal reference, against a premise that in case of any litigation, it is likely that the evidence in the form of ‘such duly characterized and documented referral sample that can be held valid at the discretion of a Court of Law’, the guidelines strongly encourage ICAR institutions to initiate processes towards deposits at National Bureaus for Genetic resources in ICAR system 111. Therefore, all ICAR institutions must take individual initiative of depositing a referral sample at the respective National Bureaus for Plants, Animals, Fish and Microorganisms Genetic Resources before filing a patent for any invention based on biological material. Procedures for registration for plant varieties as per the provisions of PPV&FR Act, 2001 have been clearly indicated in the guidelines in Chapter 7. As a policy, ICAR has prioritized action to apply for the registration and protection under the PPV&FR Act of its extant varieties of different crops which are already notified under the Seeds Act, 1966 but have not completed 15 years from the date of notification. The National Bureau of Plant 106 The types of plant varieties for legal protection include :All extant varieties of ICAR, i.e., the previously notified varieties under section 5 of the Seeds Act, 1966, which have not completed 15 years from date of their notification; New plant varieties identified for their worth (value for cultivation and use) in ICAR, which fulfill the essential criteria of distinctiveness, uniformity, and stability under the PPV&FR Act and ICAR plant varieties and transgenic plants, protectable as per corresponding PVP laws of other countries, in the form of PVP certificate, plant patent, etc. 107 Confidentiality agreement with the other party shall be entered into before any demonstration of the technology or its validation or scaling up is undertaken. 108 The Indian Patents Act and some other IPR Acts require a disclosure of traditional knowledge used in the invention/innovation. 109 This step is to discourage any patenting of the public domain traditional knowledge. 110 Section 10 of the IPA, 197 111 Five National Bureaus for Genetic Resources (one each for Plants, Animals, Fish and Agriculturally important microorganisms) are functioning in ICAR system. All these serve as repository for collections in various groups and are also used as referral agencies by National Biodiversity Authority established under the BD Act, 2002. Intellectual Property Management Regime in the Indian National Agricultural Research Systems 37

Genetic Resources (NBPGR 112 ) has been notified as the Nodal Institute to facilitate this action. All other ICAR institutions are to provide all the necessary information required under the PPV&FR Act/Rules for registration of extant varieties developed by them to NBPGR. This includes the particulars required for the National Register of Plant Varieties, such as the denomination of the variety, names of breeders involved in its development, pedigree details, salient features of identity vis-à-vis most similar varieties, zone(s) of adaptation, performance limits under specified situations particularly for DUS traits, etc. along with a referral seed sample. NBPGR verifies the database of extant varieties developed and maintained at the Bureau. It supplements the information with the molecular profile of the variety, if available. Authenticated seed samples of the variety are to be deposited in the active and base collections at the national gene bank at NBPGR. At the institutional level, process for applying is through the respective ITMU/ZTMC. The protocol for the process has been detailed and is in process in several institutes. 113 Since animal, poultry breeds, fish strains , etc., cannot be protected in India as patents or variety protection are not patentable in India as the laws do not permit and no sui generis system is available to animal breeds. However, it is well known that the farm animal genetic resources 114 have remained the back-bone of Indian agrarian economy through contributing milk, meat, egg, fibre, draught power and manure. India is one of the main centres of animal biodiversity, particularly for domesticated animals, such as buffalo, goat, sheep, cow, horse, camel etc. Improved breeds/ strains from indigenous animal biodiversity over several decades developed in ICAR system constitute valuable assets. With an objective to check their misuse or exploitation, ICAR is developing a system of their registration 115 and documentation, at the respective National Bureaus of Animal and Fish Genetic Resources for placing these assets through disclosure in the public domain thereby forestalling any unforeseen patenting in other countries. For instance an authentic national documentation system of valuable sovereign genetic resource with known characteristics, a mechanism for “Registration of Animal Germplasm” has been initiated at National Bureau of Animal Genetic Resources (NBAGR) 116 , This would provide protection to the valuable animal genetic diversity and facilitate its access for genetic improvement of animal breeds 117.at national level. Similar attempts are being done for fish 118 and agriculturally important microbes 119 . These mechanisms of protection are often termed as ‘soft protection’. But these must be viewed as attempts by the national system to pre-empt any unforeseen grant of patents on animals/fish including the improved breeds/strains and important microbial populations from India. The existing model existing system of plant germplasm registration at NBPGR is being extended to register and document the elite and new breeds/strains of animals/poultry fish and agriculturally important microbes developed in ICAR. As a policy, ICAR endeavours to monitor the registration and documentation activity in plants, animals and fish in public interest. To elucidate the attempts for operationalization the IP policy and guidelines, discussions with Policy Unit at the ICAR headquarters were made. A check list of 30 112 NBPGR is the nodal organization in India for exchange, quarantine, collection, conservation, evaluation and the systematic documentation of plant genetic resources. At:http://www.nbpgr.ernet.in/ 113 Sec.3( b)IPA,1970 114 As per FAO, Animal Genetic Resources (AnGR) refer to those animal species and the populations within each species that are used, or may be used, for production of food and agriculture 115 Special Feature. Registration of farm animal germplasm. Indian Journal of Animal Sciences 78(1):127-131.January 2008. 116 Identification, Evaluation, Characterization, Conservation and Utilization of Livestock and Poultry Genetic Resources 117 http://www.nbagr.ernet.in/GUIDELINES.htm 118 National Bureau of Fish Genetic Resources (NBFGR) was established for cataloguing and conserving aquatic bioresources of India, genotyping, registration of aquatic germplasm, gene banking and evaluation of endangered and exotic fish species At: http://www.nbfgr.res.in/index.htm 119 National Bureau of Agriculturally Important Microorganisms (AIMs) is the nodal Institute at national level for acquisition and management of indigenous and exotic microbial genetic resources for food and agriculture, and to carry out related research and human resource development, for sustainable growth of agriculture. At:http://www.nbaim.org/ Intellectual Property Management Regime in the Indian National Agricultural Research Systems 38

indicators 120 (Annexure v) for IP and technology commercialization was administered. Data collected indicates that initial attempts towards operationalizing have been made. Budgetary provisions with administrative sanctions 121 , creating the organisational bodies and training the personnel in these bodies 122 have been the main focus of the IPR Unit at ICAR headquarters since 2007. Three areas viz. like speedier process for extant varieties registration, faster decision making channels and stronger IP portfolio making at institutes were identified as areas that needed more attention and intervention needed. IP inventory and audit completed (for IP used in research, including plant genetic resources) to assess freedom to operate, mechanisms for valuation of IP in place and infringements are areas still to worked out. It is also encouraging to note that several outputs have processed for patents in India.PCT filings and few grants in other jurisdictions have also been initiated 123 . 120 Refer Annexure v for details 121 Administrative guidelines are included in the ICAR's IPR Guidelines, which are supported by a 5-year XI Plan budget sanction. In addition, ICAR's Rules and Guidelines on Professional Service Functions (Training, Consultancy, Contract Research and Contract Service) have been updated and aligned with ICAR's IPR Guidelines. These are, however, under consideration of a Committee constituted for the purpose 122 12 sensitization programs completed during 2007-08. Over 570 related scientists and staff of National Agricultural Research System, that includes not just ICAR but also Agricultural Universities, given exposure on all the dimensions of 'IPRs and Technology Transfer' 123 About 300 patents include both 'applied' and 'granted' from Indian Patent Office. 4 PCT applications, 2 granted in other countries Intellectual Property Management Regime in the Indian National Agricultural Research Systems 39

5. Project Directorate on Poultry (PDP) “The very essence of the creature is novelty and hence we have no standard by which to judge it”-. Carl R Rogers. The animal based research institute under ICAR studied is this case study was the Project Directorate on Poultry. The Project Directorate on Poultry (PDP) is a constituent of the Indian Council of Agricultural Research and is located in Hyderabad in Southern part of India. 5.1 Background In India the value of livestock output has grown by 6 percent per annum in real terms between 1985 and 1992 124 .The dairy and poultry industries have contributed the major share of this growth. In 1990, livestock accounted for about 32 % of the total value of agricultural output. The increasing demand for livestock products is driven by sustained economic growth and rising incomes. In addition, the income elasticity of demand for livestock products is high, estimated at around unity for certain wealth groups in rural areas 125 . Poultry is now one of the fastest growing segments of the agricultural sector in India today. While the production of agricultural crops has been rising at a rate of 1.5-2 % per annum, in case of eggs and broilers, the production has been rising at a rate of 8-10 % per annum 126 . The growth of the poultry sector in India has also been marked by an increase in the size of the poultry farm 127 .For example, in earlier years broiler farms used to produce a few hundred birds (200- 500 chicks) per cycle on an average. Nowadays, while units with less than 5,000 birds are becoming rare, units with 5,000 to 50,000 birds per week cycle are common indicating the increasing trends in poultry sector in India. 5.2 Genesis of PDP The history of the Directorate dates back to the IV Plan 128 period, when it had its origin in the form of All India Coordinated Research Project(AICRP) on Poultry Breeding 129 , an all India net work project launched by the ICAR with the objective of augmenting commercial poultry production and achieving self-sufficiency in the country. The coordinating unit of the project was located at the Poultry Research Division, Indian Veterinary Research Institute (IVRI), which monitored the AICRP centres located in different State Agricultural Universities (SAUs) and ICAR Institutes. The coordinating unit operated from IVRI till 1979, after which it functioned from the newly established Central Avian Research Institute. Considering the importance of the project in improving commercial large scale poultry production in the country, the coordinating unit was elevated to the status of Directorate on 1st March 1988 and established at Hyderabad and named as “Project Directorate on Poultry”. The activities of the Directorate were simultaneously expanded by introducing new AICRPs in 124 World Bank (1999) India Livestock Sector Review: Enhancing Growth and Development. The World Bank, Washington, D.C. and Allied Publishers, New Delhi. 125 Mehta Mehta, R., Nambiar, R.G., Delgado, C. and Subramanyam, S. (2003) Annex II: Livestock Industrialization Project: Phase II – Policy, Technical, and Environmental Determinants and Implications of the Scaling-Up of Broiler and Egg Production in India. IFPRI-FAO project on Livestock Industrialization, Trade and Social-Health-Environment impacts in Developing Countries. 126 Supra at n.2 127 Czech Conroy.2004. Livestock Sector Growth and Poverty, with particular reference to India.Natural Resources Institute.May 2004 128 The Government of India implements Five year plans. Each Five Year Plan addresses specific o problems which have emerged either because of new political and economic developments in the country and in the world, or as a consequence of progress already achieved. Fourth Plan Period was 1969 to 1974. At: http://planningcommission.nic.in/plans/planrel/fiveyr/default.html 129 All India Coordinated Research Project (AICRP) on Poultry in 1970 at Izatnagar, Uttar Pradesh. Subsequently the unit was elevated as a full-fledged Project Directorate during 1988 and shifted to Hyderabad. The objectives of the Directorate were to coordinate research at AICRP centers located across the country and conduct research on the development and improvement of chicken lines for commercial and rural poultry production Intellectual Property Management Regime in the Indian National Agricultural Research Systems 40

Poultry Nutrition and Housing and Management with centres located in selected SAUs, where the breeding units were already in existence. The research work in these three areas continued till March 1993, after which the nutrition and housing & management activities were discontinued and the breeding project continued. In addition to coordination of AICRP, the Directorate was given the task of developing suitable germplasm for rural poultry production, maintenance and improvement of elite broiler and layer purelines (for meat and egg), maintenance of random bred control populations, and the naked neck and dwarf gene lines for tropical poultry production. The primary focus of research was on breeding. 5.3 Mandate The Directorate formulated the Perspective Plan for a period of 25 years, called “Vision 2025”. Keeping in view the present needs of poultry farming in the country and the challenges ahead, the research agenda has been identified with the following programmes as the priority. • Development of germplasm for backyard/ free range farming for rural and tribal areas • Maintenance and evaluation of layer populations • Maintenance and evaluation of coloured broiler populations With an aim to realize its Vision of “enhancing productivity of chicken for household nutritional security, income and employment generation” and the Mission of “developing and propagating improved varieties of chicken for sustainable production under intensive and 130 extensive systems”, the mandate of the Directorate is: • To coordinate and monitor ICAR-sponsored network research programmes • To undertake applied research on genetics and breeding, and conservation of improved chicken germplasm with supportive research on nutrition, disease control and management. • To lay emphasis on development of chicken varieties for meeting the needs of rural/tribal and other under-privileged sections of the society. 5.4 Governance Model of PDP The governance model for the Directorate is headed by a Project Director who is guided and supported on an advisory role by the Management Committee and Research Advisory Committee. The research progress is monitored and reviewed by the Research Advisory Committee. The QRT has been constituted for evaluating the Directorate’s performance during 2001-2006. The financial, administrative and other relevant issues were monitored by the Institute Management Committee. The institute is publically funded through the ICAR and through grants from externally funded research projects with or no collaboration with other agencies. The collaborating agencies include SAUs, and network of AICRP centers or schemes of departments like Department of Biotechnology (DBT 131 ) and other universities. It also generates revenue of primarily through sale of germplasm to private firms and farmers. The institute has staff strength of 64 personnel with 9 scientists who are supported in their research activities by 14 technical staff personnel (Table 5.1). 130 Project Directorate on Poultry. Annual Report for 2007-08.Pages 81. 131 The setting up of a separate Department of Biotechnology (DBT), under the Ministry of Science and Technology in 1986 gave a new impetus to the development of the field of modern biology and biotechnology in India. In more than a decade of its existence, the department has promoted and accelerated the pace of development of biotechnology in the country. At:http://dbtindia.nic.in/uniquepage.asp?id_pk=4 Intellectual Property Management Regime in the Indian National Agricultural Research Systems 41

Table 5.1 Staff Position Grade Sanctioned In position Vacant Director - RMP 01 01 Nil Scientific 15 09 06 Technical 15 14 01 Administrative 13 10 03 Supporting 20 18 02 Total 64 52 12 Fig 7. Organanogram of PDP Project Directorate on Poultry Research Advisory Project Director Management Committee AICRIP Headquarters Research Central Administration Rural Poultry for Poultry at PDP Facilities Poultry Engg for Meat ICAR Population Farm Establishment SVVU, KVAFSU, Research Genetics & Hyderabad Bangalore Complex, Breeding Agartala Hatche Cash & Bills Molecular AAU, Genetics GADVASU, Anand Ludhiana Feed Purchases JNKVV, Nutrition & Unit & Stores Jabalpur Physiology CARI, CARI, Library Audit & Izatnagar Izatnagar Accounts Health ARIS Record & KAU, OUAT, Cell Dispatch Mannuthy Bhubaneswar Estate & Security Germplasm supply & Marketing The four research units at the Directorate are: Population Genetics & Breeding, Molecular Genetics, Nutrition and Physiology, and Health. There are nine scientists and thirteen technical personnel in position. In addition to the Directorate is responsible for coordination of coordinating unit under AICRP. There are 10 network centers under the AICRP on Poultry Breeding, located across the country in SAU's and ICAR institutes (Fig 7). Intellectual Property Management Regime in the Indian National Agricultural Research Systems 42

5.5 Research Activities The primary focus of research was on breeding with supportive research on nutrition, health cover and molecular genetics formed an integral component of the research agenda of the Institute. The four research units at PDP are mandated to carry out applied and technology generating research on chicken involving breeding, duly supported by nutrition and health cover with the emphasis on developing high yielding germplasm for rural and tribal farming. A repository for two random-bred control populations (one each for layer and broiler type of chicken) is also maintained along with a germplasm center to make available the improved strains and stocks to the user agencies. Further research efforts are underway for developing newer crosses that are tailor-made for adoptability under rural conditions. Attempts are also on to provide better nutrition and health cover packages for pure lines, parents and crosses. The molecular genetics tools also have been used in the breeding programmes as complementary to the conventional popular genetics. The Directorate coordinates and monitors the network project of All India Coordinated Project on Poultry Breeding, being implemented in a total of 10 centres located in different Agricultural/Veterinary Universities and ICAR institutes. The primary objective of the project is to develop high yielding stocks of broilers and layers for commercial farming and thereby make the country self-reliant. Besides, another component of rural poultry was added and 132 133 being implemented at Agartala and Jabalpur . In addition to coordination of AICRP, the Directorate is mandated to develop suitable germplasm for rural poultry production, maintenance and improvement of elite broiler and layer purelines (for meat and egg), maintenance of random bred control populations, and the naked neck and dwarf gene lines for tropical poultry production. These research programmes focus on research relevant to societal needs, and application-oriented research towards commercialization. These include the areas of poultry breeding, molecular genetics, applied nutrition, immunomodulation, disease diagnosis and health management etc. During last few years, research on nutrition, health cover and molecular genetics form an integral component of the research agenda of the Institute with funding from in-house sources and several external sponsors. A list of ongoing research projects underway is listed at Table 5.2. Table 5.2. List of On-going Research Projects 134 S.No. Title I. Institute sponsored projects A. Breeding 1. Development of germplasm for backyard/ free range farming for rural and tribal areas 2. Maintenance and evaluation of coloured broiler populations 3. Maintenance and evaluation of layer populations 4. Maintenance and evaluation of gene lines B. Molecular genetics 5. Molecular characterisation of layer and broiler germplasm 6. Candidate gene approach for QTL analysis pertaining to egg production traits in layer chicken C. Avian Nutrition & Physiology 7. Development of nutritional package of practices for rural poultry germplasm during nursery rearing 8. Nutrient requirements and feeding schedules of coloured broiler populations 9. Nutrient requirements and feeding schedule for parent lines of Vanaraja 10. Effect of supplemental organic Zn on coloured broiler breeders and their progeny 132 In State of Tripura, North-Eastern part of India 133 Central India 134 Supra at n. 7. Intellectual Property Management Regime in the Indian National Agricultural Research Systems 43

11. Effect of semen quality parameters on fertility in chicken 12. Collaborative project with CIMMYT on “Utilization of quality protein maize in poultry diets” D. Avian Health 13. Molecular identification, characterization and control of infectious neoplastic diseases 14. Disease surveillance, monitoring and control in poultry germplasm at PDP 15. Expression profiling and molecular characterisation of Toll-like receptors in chicken II. Collaborative projects* 16. Improvement of backyard poultry in Kashmir Valley (SKUAST, Srinagar) III. Ad-hoc schemes* (DBT) 17. Quantitative Trait Loci (QTL) identification in broilers *Funded through external agencies The concerted efforts made by AICRP centers resulted in the release of certain promising crosses for commercial exploitation. The potential of these crosses was evaluated in Random Sample Poultry Performance Tests and found them to be at par with most of the commercial crosses that are being marketed by the industry. The promising crosses released from AICRP centres are tabulated in Table 5.3. Table 5.3. Promising crosses Layer crosses Broiler crosses ILI-80 (CARI, Izatnagar B-77 (CARI, Izatnagar) ILM-90 (KAU, Mannuthy) IBL-80 (GADVASU, Ludhiana) ILR-90 (SVVU, Hyderabad) IBB-83 (KVAFSU, Bangalore IBI-91 (CARI, Izatnagar) 5.7 Consultancy, Patents, Commercialization of Technology The research at the Directorate has resulted in impacting the stakeholders. The Directorate paid special attention for evolving superior varieties over the existing native chicken breeds and developed exclusively for improving poultry production in rural and tribal areas. The two crosses, Vanaraja and Gramapriya 135 have been widely distributed across different parts of the country. These successes have led in the Directorate playing a pioneering role in popularizing the concept of rural poultry production. The, other crosses, Krishibro and Krishilayer developed for intensive commercial farming have been popular among the farmers. These crosses are distributed in substantial numbers to farmers and other user agencies in the form of hatching eggs, day-old chicks, parent chicks and grown up chicks (Table 5.4). Besides, a total of 8,464 embryonated eggs were supplied to Govt. agencies for vaccine production. There are still no attempts for patents or other IPs. 135 These two varieties have been extremely popular and supplied to user agencies in different parts of the country covering the southern, northern, eastern and northeastern states, including Jammu & Kashmir, Lakshadweep, the North East and Andaman & Nicobar Islands. Intellectual Property Management Regime in the Indian National Agricultural Research Systems 44

Table 5.4. Germplasm supplied during 2007-08 136 A. Hatching eggs No. Gramapriya 163043 Layer 8960 Vanaraja 39008 Krishibro 26703 Control broiler 1260 Total 238974 B. Day old chicks Gramapriya 15098 Gramapriya parents 7110 Layers 4303 54488 Vanaraja Vanaraja parents 6168 5675 Krishibro Total 92842 16853 C. Grownup birds 5.8 IP Activities Since 2006, the Directorate has initiated the implementation of IP policy of the ICAR. As part of its initiation, the ITMC and ITMC were formed in 2007. The constitution of these committees is as per the ICAR guidelines with, the ITMC being chaired by Director of the Institution. This is the highest decision making body relating to all issues of IP management and technology transfer/commercialization. The ITMC has the Director as its Chairman, with one member who is the Head of Division, two Technical Experts (Scientists of the institution) and one expert in IPR (Scientist from ICAR institutions in the zone). The Research Council of Institute is also represented by its Secretary. This is to keep a continuum with research activities of the institutes. As part of this study, the questionnaire administered to the scientists revealed that 137 inputs from this institute during formalizing of ICAR guidelines were meager . This is probably type of research done earlier which was more focused on the coordination of research activities in various AICRP centers. The Directorate initially was mandated to coordinate research at AICRP centers located across the country and conduct research on the development and improvement of chicken lines for commercial and rural poultry production. After the finalization of the Vision 2025 document and re-look at its mandate, focus on new and more areas of research is now emphasized. The scientists are now aware of new IP regime and have started tuning their research programmes towards the adherance of the guidelines. Most scientists agreed with the importance of IP but reflected the lack of awareness, knowledge and training. Only two scientists have attended awareness programs of ICAR. However, all felt the need of IP regime and the IP policy of ICAR with guidelines useful to strategize their research outputs. To the question on of public sector as a holder of IPR, it was opined that this sector should take lead role considering the clientele in India continues to be dependent on the NARS for augmenting better productivity levels. There will not be any problem if public sector becomes a major holder of IPR. Public sector should take lead role in implementing IP rights and should become major holder of IPRs in agriculture. To the query of identification of IPs from their respective projects, there was well documented response clearly indicating their interest and awareness. A summary of possible 136 The Directorate supplies these to several user agencies including Industry at nominal price 137 Responses to questionnaires tabulated and appended as Annexure v. Intellectual Property Management Regime in the Indian National Agricultural Research Systems 45

IPs being generated from the research being pursued by the scientists is tabulated in Table 5.5. It is interesting to note that only patents form major category wherein biotechnological tools, processes and value additions to formulations formed major areas. Though the policy ensures that ICAR scientists can generate other IPs like designs, copyrights or trademarks, the emphasis here was on patents. Table 5.5. List of Possible IPs as identified by the Scientists Category of IPs Type • Recycling of poultry house wastes as feed and fertilizer and different Poultry feeds, protocols, value added Patents poultry feeds, nutritional diets • Genetic marker for economic trait • Diagnostic kits • molecular markers, tools • New poultry semen extenders • Poultry semen freezing protocols. • Registration of coloured broiler male line (PB-1), Registration – Soft protection coloured female line (PB-2) Krishibro. • Registration of gene lines & Molecular characterization of layers and broilers Keeping the nature of the work at the Directorate and its mandate to cater to its stakeholders, promising lines and the fact that the law in India does not permit patents on animal breeds, the need to document the indigenous breeds and germplasm was voiced. This is in line with ICAR policy which clearly states that since there is no IPR enabling provision under the existing Indian law for elite animal/ genetic material in the public domain. The Directorate has now initiated the process for extending the existing system of plant germplasm registration at NBPGR to register and document the elite and new breeds/strains of animals/poultry and fish developed in ICAR, at the National Bureau of Animal Genetic Resources (NBAGR) 138 . It may be pointed that nearly 15 chicken breeds with identified home tracts and complete data have been registered by NBAGR since 2007 139 . The Directorate is also in the process of documenting the available materials in the institution and through the AICRP programmes it co-ordinates. Through a decision making process initiated through its ITMC 140 , it is now preparing the documentation for application registration of poultry breeds to NBAGR 141 . Discussions with the scientists revealed that the process of registration is a welcome step and the Directorate has large sources of breeds and elite lines needed to be registered. There is need for building a good database with details of all entries so that the application process with complete technical data needed for filing with NBAGR may be speeded up. 5.9 IP Check list An analysis of the indicators for institutionalization of IP policy at the Directorate indicates positive trends in the initiation of the process (Table 5.6). More steps for awareness creation at the institute, evolving a system from project initiation, building better portfolios need more attention. A transparent information IP management system though standard inventories, audit need to be in place to hasten the operationalization of the guidelines 138 Discussions with ADG(Animal Sciences) during his lecture at ICAR Training-cum-Workshop on IP and Technology Management , ICAR Training-cum-Workshop on IP and Technology Management, ICAR Res. Complex, for NEH region Barapani, Nov.19, 2008. Also refer: Special Feature. Registration of farm animal germplasm. Indian Journal of Animal Sciences 78(1):127-131.January 2008. 139 As in :http://www.nbagr.ernet.in/Accession%20number%20for%20Breeds.htm#registration 140 ITMC meeting on December 19,2008 at the Directorate. 141 A format of the application for registration is available at : http://www.nbagr.ernet.in/GUIDELINES.htm Intellectual Property Management Regime in the Indian National Agricultural Research Systems 46

Table 5.6: Check list of Indicators for Institutionalization of IP Management No Indicator Yes/No 1 Institutional vision and mission defined Yes 2 Guiding principles of IP policy listed Yes 3 IP management Unit constituted and staff trained 4 trained, others Needed 4 IP management budget allocated Yes 5 IP management general guidelines issued Yes 6 IP management guidelines for specific categories of IP issued Yes 7 IP management administrative guidelines issued Yes 8 IP inventory and audit completed (for IP used in research, including No genetic resources) to assess freedom to operate 9 Existing databases, software, websites, multimedia products, CD- No ROMs and publications protected by copyright 10 Copyright provisions clarified and its management regularized for Yes different categories 11 Existing germplasm, lines, breeds registered or documented in Initiated the process national repositories 12 IP portfolio of existing commercializable IP available No; in public domain 13 IP decision-making flowcharts available Yes 14 IP awareness/capacity building programmes initiated with Yes scientists/ faculty 15 IP/patent search facilities made accessible No 16 Proper research record books/registers designed to maintain Yes research records, and made available 17 IP disclosure forms designed for scientists to intimate ITMC about Yes new IP 18 Materials Transfer Agreements standardized Yes 19 Guidelines for use of third party IP in place Yes 20 Templates for confidentiality agreements (CAs) available Yes 21 Proforma and guidelines for MOUs for negotiating collaboration Yes with private sector standardized 22 Proforma and guidelines for MOUs/agreements for negotiating Yes collaboration with other national and international organizations 23 Mechanisms for valuation of IP in place Yes 24 Guidelines for sharing of incentives (between inventors and Yes organization) in place 25 IP policies, management guidelines and MTAs/MOUs/CAs made Yes available on line 26 Compliance by scientists and employees in routine use of MTAs, Yes CAs 27 Compliance by research managers in observing guidelines, MoUs, Yes and other agreements for collaborations with private sector and other organizations 28 IP matters coordination with other agencies –IP granting agencies/ Yes offices, legal firms 29 Procedures for protecting infringements against IP owned by the No institution 30 Capacity building initiatives Yes 31 No of technologies patented protected Registration of 9 breeds initiated 32 No. of technologies commercialized 3 Intellectual Property Management Regime in the Indian National Agricultural Research Systems 47

No Indicator Yes/No 33 Institutional earnings from royalties and commercialization 60 lakhs INR Adapted from Egelying 142 and NHRao 143 It is gratifying to note that there is trend of commercialization the technologies generated and the Directorate has well-earned reputation with its stakeholders in the transfer of its technologies. The templates for MOUs, agreements and other documents being in place, the Directorate can use a more professional and legalised system approach to transfer the research results and technologies and build better public-private partnerships. Since the initial processes of defining the vision and policy are already in place and with a positive support from the ICAR headquarters, the Directorate should be able to accelerate its efforts to utilize the IP policy too for achieving its mandate and bettering livelihoods of its stakeholders as well as build a strong IP portfolio. 142 Egelying, H. 2005. Evolution of capacity for institutionalized management of intellectual property at international agricultural research centers: a strategic case study, AgBioforum, Vol 8, No.1, pp 7-17 143 N.H.Rao. 2006. Intellectual Property Policy: Institutionalizing Intellectual Property Management in Public Agricultural Research Systems. Paper presented at Assam Agricultural University. March 2006. Intellectual Property Management Regime in the Indian National Agricultural Research Systems 48

6. Directorate of Rice Research (DRR) “Great discoveries and improvements invariably involve the cooperation of many minds. I may be given credit for having blazed the trail, but when I look at the subsequent developments I feel the credit is due to others rather to myself.” Alexander Graham Bell The crop- based research institute under ICAR studied is this case study was the Project Directorate of Rice Research (DRR). The Project Directorate is a constituent of the Indian Council of Agricultural Research and is located at Hyderabad, India. 6.1 Background Rice is major staple food and a way of life for several stakeholders in India. Globally, India ranks first in area 144 and second in production. At the country level, this crop is major crop and accounts for 37 percent of total area and 43 percent of total food grain production. The green revolution in India was partially due to phenomenal increase in rice production in the country. The NARS continues to focus on the green revolution technology model of breeding short-duration high yielding cultivars, irrigation and intensive use of fertilizers and other agro-chemicals. But the deceleration in growth rates in recent times is matter of concern and new solutions to break these barriers are being worked. Since the rice industry has an important socio-economic impact in India and the rice sector is a relatively important part of the national economy, research investments by the ICAR continue on its own or through new partnerships. 6.2 Genesis of DRR The Directorate of Rice Research (DRR), formerly All India coordinated Rice Improvement Project (AICRIP), was established by the Indian Council of Agricultural Research (ICAR) in 1965 with its national headquarters at Hyderabad to organize and coordinate multi-location testing of genetic lines and technologies for crop production and protection generated across the country. The Project was elevated to Directorate of Rice Research in 1985 with an added mandate of research in the thrust areas of irrigated rice. The All India Coordinated Crop Improvement Projects (AICCIP) are experiments in the realms of applied research established by ICAR first in Maize in 1957 closely followed by Wheat and Rice in mid-sixties. The All India Coordinated Rice Improvement Project (AICRIP) which began functioning since 1966 coordinates the multidisciplinary and multi-location testing of varietal, crop management and crop protection technologies across diverse ecosystems for increasing and stabilizing the rice production in India from DRR. The Directorate as the nodal agency has adopted unique model which facilitates joint programme planning and implementation of its multi-location testing programme, exchange of germplasm and breeding material, mechanism for transfer of technology and to conduct strategic research for irrigated ecology. More than 200 scientists from 46 funded and about 70 voluntary centres of State Agricultural Universities, State Departments of Agriculture and ICAR institutes carry out planned trial/experiments of Breeding, Entomology, Pathology, Agronomy, Soil Science and Plant Physiology disciplines. 6.3 Mandate The goal of the institute is to ensure food and nutritional security and augment the livelihoods of rice farmers in India. The Directorate achieves this goal by focussing on developing technologies to enhance rice productivity, resource and input use efficiency with the mandate as follows: 144 http://beta.irri.org/statistics/index.php?option=com_content&task=view&id=413&Itemid=192 Intellectual Property Management Regime in the Indian National Agricultural Research Systems 49

• To coordinate multi-location testing at national level to identify appropriate varietal and management technologies for all the rice ecosystems • To conduct strategic and applied research in the major thrust areas of irrigated rice aimed at enhancement of production, productivity and profitability and at preserving environmental quality • To initiate and coordinate research networks relating to problems of national and regional importance • To serve as major centres for exchange of research material and information to accelerate the pace of technology transfer through frontline demonstrations, training programmes and ICTs. • To develop linkages with national, international and private organizations for collaborative research programme • To provide consultancy services and undertake contractual research 6.4 Governance Model of DRR In order to fulfil the mandate effectively, DRR is headed by a Project Director and is organised into various departments/sections at its headquarters. These are Plant Breeding, Hybrid Rice, Biotechnology, Crop Production with Agronomy, Soil Science, Plant Physiology, Agricultural Engineering, Geographic Information System, Statistics; Crop Protection with Entomology, Plant Pathology, and Training/Transfer of Technology. The research programmes of DRR are supported by centralised facilities of farm, Administration, Accounts, Technical Cell and Library. The DRR has also been fulfilling its major mandate of AICRIP involving multilocation research by active participation of 196 scientific personnel in various disciplines in the 46 funded centers 145 . Table 6.1 Staff Position 146 Grade Sanctioned In position Vacant Director- RMP 01 01 Nil Scientific 61 45 01 Technical 55 53 02 Administrative 34 33 01 Supporting 42 29 13 Forty five scientists at the headquarters organise lead research in frontier areas of irrigated rice and transfer of technology through formal training programmes and on farm frontline demonstrations. This team of scientists is assisted by 54 technical, 31 administrative and 24 supporting staff (Table 6.1). 6.5 Research Activities The Directorate has been engaged on systematic research on rice combining the conventional methods with modern technologies. Starting with recombination breeding, mutation breeding, gene introgession development of hybrids and gene introgression through biotechnological tools has been initiated. With the advent of biotechnological innovations, marker aided selection for major genes conferring resistance to biotic stresses is being employed in improving rice varieties. Projects are proposed and discussed at the Institute Research Council (IRC), which is the approving body for the projects. More than 40 projects encompassing the various disciplines across conventional disciplines to cutting-edge technologies in biotechnology and molecular biology are now under progress 147 . 145 http://www.drricar.org/ 146 Directorate of Rice Research. 2007.Annual Report 2006-07.Directorate of Research.Rajendranagar.Hyderabad-500030,India. 147 Details in Annexure vi Intellectual Property Management Regime in the Indian National Agricultural Research Systems 50

Fig. 8. Organogram of DRR Project Director Research Advisory Institute Management Committee Committee Institute Administration & Service & AICRI Network Research Accounts Support Projects Council Project Monitoring & Farm, Workshop, Hybrid Rice Research Technical Cell, ARIS, Biotechnology Frontline Library, Hostel Sections GIS & Statistics Demonstrations Transfer of Technology Crop Crop Crop & Training Improvement Productio Protection Linkage with SAUs, Agronomy Genetics & Entomology other ICAR Institutions, Soil Science Plant Breeding Plant State Agriculture Plant Hybrid Rice Departments, DAC, Pathology Physiology CSIR, DBT, IRRI, Biotechnology UNDP/FAO Agril Engineering The Directorate has strong and wide network of linkages and collaboration with several organizations in India and abroad. Apart from AICRIP 148 , there are research projects under the hybrid network programmes with 12 centres. It is coordinating one network project and participating in three network programs. It also has other collaborations with universities like Delhi University, Centre for Cellular and Molecular Biology (CCMB), Centre for DNA Fingerprinting and Diagnostics (CDFD).These are public institution outside the ICAR-SAU system. At international level, it collaborates with Consultative Group on International Agricultural Research (CGIAR) institutions like International Rice Research Institute (IRRI) and International Crops Research Institute for Semi-Arid Tropics (ICRISAT). Several government agencies like Department of Science (DST), Department of Biotechnology (DBT), and ICAR system also fund the projects 149 . In addition, several scientists are recognised academic guides/supervisors for students who are affiliated to several universities in across the country. The research work is done using the facilities at the Directorate under the supervision of its scientists. While the lead research in various disciplines is done at the Directorate itself, the AICRIP projects account for co-ordinated research. An approximate 20,685 elite lines 148 Under AICRIP ,DRR has 46 centres affiliated to 22 SAUs; State departments and five ICAR institutes 149 Detailed list in Annexure viii Intellectual Property Management Regime in the Indian National Agricultural Research Systems 51

developed by different cooperating centers have been tested across the country with partnership of private sector extended in testing the material in the programme as per guidelines and payment of prescribed fee. Every year about 2000 experiments/trials are laid out in rice. The testing programme follows a three tier system involving one year of Initial Varietal Trial (IVT) i.e., which constitutes the first level of testing after assigning the Initial Evaluation Trial (IET) number to each one of the nominated entries developed by different cooperating centers and two years of Advance Varietal Trial (AVT - 1 and AVT - 2) in order to identify the elite lines with consistent high yield potential which is better than the best check in each of the experiments as specified, taking into consideration the duration limits of various rice growing areas, situations, seasons and prevailing cropping patterns. Simultaneously the elite breeding lines are screened at hot spot locations as well as under artificial conditions for generating information on their pest/disease resistance/tolerance, grain quality attributes and agronomic performance. Thus, the best performing breeding lines on three years of testing across the regions for a particular ecosystem are identified by the Variety Identification 150 and then approved for release and Committee (VIC) in the All India Rice Workshop notification by Central Sub-Committee on Crop Standards, Notification and Release of Varieties (CSCS&NRV) for commercial cultivation and the top location specific entries are released by the State Variety Release Committee (SVRC) for a particular state. This multilocation evaluation system, which has also become a model for international nurseries evaluated worldwide by the CGIAR institutions, has recorded outstanding merit 151 . This systematised approach has led to the testing and release of 836 varieties including 33 hybrids for all the ecosystems till 2007 152 . Among these 98 varieties including 10 hybrids were released through Central Sub Committee on Crop Standards, Notification and Release of Varieties (CSCS & NRV) while the State Variety Release Committee released 738 varieties and 23 hybrids. Of these varieties, 372 are for irrigated areas, 114 for rainfed uplands, 155 for rainfed low lands, 37 for semi deep and 14 for deep water situation, 44 for high altitudes, 31 for saline and alkaline areas, 1 for aerobic, 10 for boro and 49 aromatic long and short grain varieties were released. 26 export quality basmati rice varieties have also been released by the programme. DRR itself has developed 51 varieties and 2 hybrids for different ecologies 153 . Apart from this, several technologies across the disciplines of Biotechnology, Crop Production with Agronomy, Soil Science, Plant Physiology, Agricultural Engineering, Geographic Information System, Statistics; Crop Protection with Entomology, Plant Pathology have contributed to several technologies which have been success stories with its stakeholders 154 , 155. 6.6 Activities under IP and Commercialization of Technology 6.6.1 Before the Formulation of ICAR IP Policy DRR has been supporting IP linked activity for the ICAR even before the IP policy. Following the grant of patent to RiceTech Co. by the USPTO in 1997, the Government of India constituted a High–Level Task Force to examine the possibilities of filing for a re- examination. ICAR was also part of re-examination case and the scientists from DRR provided technical evidence 156 . 150 Workshop are held annually for reporting the results and planning trials for ensuing season 151 N.Shobha Rani,GSV Prasad,IV Subba Rao,I Sudharashan,Manish K Pandey,VR Babu, T Ram,G Padmavathi.KMularidharan,IC Pasulu and BC Viraktamath. 2008. High yielding rice varieties of India. Technical Bulletin No.33. Directorate of Rice Research, Rajendranagar, Hyderabad 5000030. India. 188pp. 152 Supra at n9. 153 As quoted in paper titled “Licensing of ICAR Plant Varieties/hybrids/inbred lines for commercial use by private seed agencies in rice”. In: Background Information for Group Meeting on High Volume Hybrids/Parental linesheld on September 29, 2008 at DRR, Hyderabad. 154 Several success stories of technologies generated at the Directorate have been eneumerated. Nearly 27 technical bulletins (2003 to 2007) are listed at http://www.drricar.org/. Few stories are uploaded at : http://www.drricar.org/sucstories.htm 155 N.Shobha Rani and L.V.Subba Rao .2004.Sustainable management of plant Biodiversity- a success story.Technical Bulletin.No 10. 156 DRR provided technical evidence and related technological documents as part of prior art evidence and also catalogues of availability of seed in DRR germplasm collection. Intellectual Property Management Regime in the Indian National Agricultural Research Systems 52

After the enactment of the PPV&FR Act, 2001, the National Guidelines and descriptors for DUS test in rice were prepared and published by DRR for the rice breeders of the AICRIP 157 , 158 . The final versions of the approved guidelines were published by the Protection of Plant Varieties and Farmers’ Rights (PPV&FR) Authority in 2007 159 . The ICAR has approved DRR as the nodal centre for DUS testing. Hence, the Directorate has the responsibility to conduct DUS testing for the PPV&FRA. As a preparation towards this role and to fulfil this responsibility, DRR has made major effort in collecting reference collections of varieties (RCV) and their characterization and digitalization. The RCVs are used against candidate varieties since the start of DUS testing in May 2007. 6.6.2 After the Implementation of ICAR IP Policy Since 2006, the Directorate has initiated the implementation of IP policy of the ICAR. As part of its initiation, the ITMC and ITMU were formed in 2007. The constitution of these committees is as per the ICAR guidelines. The ITMC is chaired by the Director, DRR. This is the highest decision making body relating to all issues of IP management and technology transfer/commercialization has nine scientists to take decisions on IP management. The questionnaire circulated to the scientists as part of this study, revealed that most of them felt that they did not play any role during the initial discussions in formulating the IP policy of ICAR. But they contend that IPRs are needed considering the fact that India is a rich agri-biodiversity centre with lot of land races along with associated traditional knowledge. Most of them have attended various training programs but still felt that there is scope for more exposure to remove confusion. In fact, such awareness they felt is necessary for all 160 stakeholders in rice value chain . The ITMC has conducted in-house awareness program during January 2008. Apprehensions that IPR may prove hindrance to the public sector organizations reaching to the needs of poor farmers continue to be there. However, the formulation of a policy and the implementation through guidelines was considered a step worth pursuing. Several forms of IP like patents for outputs from research using biotechnological tools were identified as possible IPs. (Table 6.2). In addition, trademarks and copyrights and registration of rice varieties were also considered as important IPs from the research. Table 6.2. List of Possible IPs as identified by the Scientists Category of IPs Type • Novel approaches for the management of pests, resistant germplasm, mass production and formulation techniques for bio control agents. • Bio fertilizers, bio-control agents • Plant growth promoters Patents • Useful enzymes • Novel genes from microorganisms for use in recombinant DNA technology • Gene sequences • Diagnostic kits • Molecular markers, tools • Seeds Trademarks • Bio-formulations 157 N Shobha Rani, LV Subba Rao, BC Viraktamath and B Mishra.2004.National Guidelines for the conduct of Distinctness, Uniformity and Stability-Rice, Oryza Sativa. 158 N Shobha Rani, LV Subba Rao and BC Viraktamath .2006.National Guidelines for the conduct of Distinctness, Uniformity and Stability-Rice, Oryza Sativa. 159 General Guidelines to the examination of DUS and the development of harmonized descriptions of plant varieties. SG/01/2007.20 February 2007.Available at : http://www.plantauthority.in/ 160 Details in Annexure ix Intellectual Property Management Regime in the Indian National Agricultural Research Systems 53

• Copyrights Publications • Databases • Digital information • Multimedia products • GIS related databases • Designs on tools, machinery • Registration Genetic stocks • Elite and unique lines of germplasm • Fixed breeding lines, segregating lines, • New varieties, hybrids • Multi-biotic resistance rice varieties • Rhizosphere microbial community • CMS lines, maintainers, restorers, parental lines • Transgenics • EDVs • Hybrids • Innovative strategies of marker-assisted breeding In case of DRR, crop variety is probably one of main outputs emanating from lead research at the head quarters and also through the coordinated research under AICRIP centers. All forms of plant varieties including new varieties, hybrids, parental lines of hybrids, warrant registration under the Indian Law. The scientists also have identified these as outputs expected from their research which may need some form of IP protection. Presumably, IP in agriculture being still a concept, the focus of most scientists was on filing for registration under the new Indian law and hence at the national level only. However, soft registration of genetic stocks / elite lines which are unique and have potential attributes of academic, scientific or commercial value are encouraged to be registered with NBPGR. In addition, the immediate focus of DRR is to process the registration of the extant notified varieties (ENVs). The Indian Plant Variety law is perhaps the only legislation which has given the option to institutions and others to register varieties under this category. ICAR 161 to utilise this option given by PPV&FR Authority 162 . As per the encourages its system PPV&FR Act, an extant variety is the variety available in India which is either (i) notified under section 5 of the Seeds Act, 1966 (54 of 1966) or (ii) a farmers’ variety or (iii) a variety about which there is common knowledge or (iv) any other variety which is in public domain. This option gives an opportunity to obtain legalised protection for several of varieties which are already in the public system and still continue to be catalytic in enhancing productivity levels of crops like rice. The process for ICAR institutions includes filing the filled in application from along with technical questionnaire (TQ).This along with a referral seed sample is sent to NBPGR which forwards to the PPV&FR Authority on behalf of ICAR. Rice crop being among first set of notified crops by the Authority, DRR has initiated the process. 123 ENVs have been sent to NBPGR with details of particulars required which were forwarded to PPV&FR Authority and it is expected that the final stage of registration will be completed in few months. About 70 more applications in rice are in pipeline. (Table 6.32) Table 6.3. Extant Notified Rice Varieties (ENVs) registration 163 Stage in process Number ENVs sent to PPV&FRA for registration 123 161 “Protection of all extant varieties of ICAR, which have not completed 15 years from the date of notification shall be taken up under the PPV&FR Act as a priority activity in a time-bound manner ”Page 35. ICAR. 2006. ICAR Guidelines for Intellectual Property Management and Technology Transfer/ Commercialization. Indian Council of Agricultural Research, New Delhi. 162 The deadline given by PPV&FR Authority is for three years starting May 2006. 163 Status as on 31st October, 2008 Intellectual Property Management Regime in the Indian National Agricultural Research Systems 54

ENVs ready for submission to PPV&FRA through 21 NBPGR ENVs under progress for filling 50 It is necessary to execute an extensive maintenance of seed of RCVs, example varieties, exotic varieties and candidate varieties. The scientists indicated that awareness on intricacies of process for DUS testing for rice breeders especially in AICRIP system needs to be strengthened through more capacity building programs if the filing process has to be hastened before the set deadline. Several varieties are part of large testing system spread all over the country. As pointed by the scientists, there seems to be a lack of clarity on the responsibility of testing agency (primary or secondary testing centre) in terms of filing the applications. Policy intervention on this could avoid duplication of filings which would save resources including time. Considering the quantum of research at DRR through collaboration in the centers or through external funded projects, there is an urgent need to put in place agreements with the collaborators and sponsoring agencies. There should be a systematized activity through the ITMC. Most members opined that that the ICAR guidelines have improved the awareness of the scientists in the area of IP management and provide a framework for drafting of MTAs for commercialization and transfer of technology generated. They visualize no major operational problems for implementation while institutionalizing the guidelines. With necessary support in terms of man power and infrastructure the systematization can be done even though the system is intricately complex and involves several trained personnel and agencies. However, as most scientists have major responsibilities in the lead and co-ordinated research programs of the Directorate, premier time allotment for these activities under ITMCs may be difficult especially when the research is oriented as season-bound field work. It may be necessary to have full time person overseeing this activity at DRR with guidance from the ITMC. The enormous work under plant variety registration and the added role of DRR as the DUS testing 164 center warrants a full time appointee , who may be well versed with the legal intricacies and technology transfer methods. 6.7 IP Check list An analysis of the indicators for institutionalization of IP policy at the Directorate indicates positive trends in the initiation of the process (Table 6.4). Table 6.4. Check list of Indicators for Institutionalization of IP Management No Indicator Yes/No 1 Institutional vision and mission defined Yes 2 Guiding principles of IP policy listed Yes 3 IP management centre constituted and staff trained Yes, Partially 4 IP management budget allocated Yes 5 IP management general guidelines issued Yes 6 IP management guidelines for specific categories of IP issued Yes 7 IP management administrative guidelines issued No 8 IP inventory and audit completed (for IP used in research, No including plant genetic resources) to assess freedom to operate 9 Existing databases, software , websites, multimedia products, No CD-ROMs and publications protected by copyright 10 Copyright provisions clarified and its management regularized No for different categories 11 Existing plant varieties protected as extant varieties In progress 12 IP portfolio of existing commercializable IP available To be initiated 13 IP decision-making flowcharts available Yes 14 IP awareness/capacity building programmes initiated with Yes; partially scientists/ faculty 164 ICAR has made budgetary and administrative provisions for this. Intellectual Property Management Regime in the Indian National Agricultural Research Systems 55

No Indicator Yes/No 15 IP/patent search facilities made accessible No 16 Proper research record books/registers designed to maintain Yes, Partially research records, and made available 17 IP disclosure forms designed for scientists to intimate ITMC No about new IP 18 Materials Transfer Agreements standardized Yes 19 Guidelines for use of third party IP in place Yes 20 Templates for confidentiality agreements (CAs) available Yes 21 Proforma and guidelines for MOUs for negotiating collaboration Yes, Partially with private sector standardized 22 Proforma and guidelines for MOUs/agreements for negotiating No collaboration with other national and international organizations 23 Mechanisms for valuation of IP in place No 24 Guidelines for sharing of incentives (between inventors and Yes organization) in place 25 IP policies, management guidelines and MTAs/MOUs/CAs made No;ICAR available on line guidelines are available 26 Compliance by scientists and employees in routine use of MTAs, Yes CAs 27 Compliance by research managers in observing guidelines, Yes MoUs, and other agreements for collaborations with private sector and other organizations 28 IP matters coordination with other agencies – ICAR, IP granting Yes agencies/ offices, legal firms 29 Procedures for protecting infringements against IP owned by the No institution 30 Capacity building initiatives Yes; 31 No of technologies patented/plant varieties protected Patents: nil; varieties: 123 32 No. of technologies commercialized 4 33 Institutional earnings from royalties and commercialization Not as yet * adapted from Egelying (2005 165 ) and NHRao, 2006 166 Intensifying awareness programs and capacity building in IP including DUS testing procedures, evolving a system for IP management from project initiation and building better portfolios need more attention. A transparent information IP management system though standard inventories and internal audit needs to be in place to hasten the operationalization of the guidelines. It is gratifying to note that there is trend for commercialization of the technologies generated and the Directorate has well-earned reputation with its stakeholders in the transfer of its technologies. Several products especially high value rice seed material from DRR need to be brand valued to garner more reputation with the stakeholders. The venturing of licensing with four companies and efforts for registration of varieties is welcome step and indicate the value being accorded for building up a strong IP portfolio. The high quality research being done with cutting-edge technologies in DRR necessitates an inventory of the tools used and the outputs being generated. With the templates for MOUs, agreements and other documents being in place, the Directorate can use a more professional and legalised system approach to transfer the research results and technologies and build better public-private partnerships in research collaborations and technology transfer. Against the background of defined vision and policy, the Directorate should be able to accelerate its 165 Egelying,H. 2005. Evolution of capacity for institutionalized management of intellectual property at international agricultural research centers: a strategic case study, AgBioforum, Vol 8, No.1, pp 7-17 166 Rao,N.H. 2006. Intellectual Property Policy: Institutionalizing Intellectual Property Management in Public Agricultural Research Systems. Paper presented at Assam Agricultural University. March 2006. Intellectual Property Management Regime in the Indian National Agricultural Research Systems 56

efforts to utilize the IP policy too for achieving major economic gains on one hand and balance its commitment to poor stakeholders of the major crop, the production of which plays a major role in food security and export earnings to India. Intellectual Property Management Regime in the Indian National Agricultural Research Systems 57

7. Conclusion “India has always believed in the middle path. It can be traced to the tendency in our cultural milieu to avoid extremes in any thought process. Intellectual property rights (IPR) management is no exception. We have tried to bring parity with international norms as required under WTO but have introduced specific variations to suit our conditions” -Anil K Gupta, 2008. IPRs are part of complex, multi-faceted area involving technical competence in strategic business planning, management and knowledge of techno-legal subjects. This is more challenging in sectors like agriculture. Considering the myriad of complexities in Indian agriculture system and increasingly multi-layered dimensions in the agri-value chain, IP management is a formidable challenge for all. Adopting a policy through in-house analysis and re-visiting the mandate, the Indian Council of Agricultural Research (ICAR) has set itself a road map to leverage the economic benefits of IPs arising out of its research and also address societal issues for its stakeholders predominantly in the rural sectors. An attempt to understand the three dimensions namely, laws governing Intellectual Property in India, the mandate and goals of public sector agricultural research institutions like Indian Council of Agricultural Research (ICAR) and the policy space afforded in governance of IP assets was done in this case study. The analysis indicates that for a the large National Agricultural Research System (NARS) in like the one in India, an effective policy with appropriate legal spaces would be the key to evolve appropriate and comprehensive IP management strategies. The case analysis presents the efforts being made by the huge system to systemize the policy and streamline the guidelines put in place. The in-depth study of two constituent institutes under ICAR indicates that instruments to realize the humanitarian, academic and commercial gains of various research products and outputs are in place and that the two institutes have initiated their IP management activities. While these initial efforts set an encouraging tone, capacity building on managing the IP assets among the scientists to help them address the techno-legal complexities is urgently needed to be addressed. Since the scientists are part of several research programmes through collaborations at national and international levels, it is essential to be continuously updated on the issues relating to Intellectual Property (IP) management. The study indicates a requirement to create an awareness of intricacies of these issues among all the multiple partners of the research system. It was also clear that a more professional IP management would be needed to be set in the institutes in future. Therefore, while the building the capabilities of manpower in the area of IP management would be a pre-requisite, it is critical to initiate a working mechanism and inculcate IP portfolio management as part of research agenda in these days of multi-sectoral and multi- collaborative approaches at the national and at global levels. An IP Integrated Management System can perhaps provide solution to systematize all facets of IP management at the organizational level and be a platform of information for taking long term decisions for sharing the assets. The attempts being initiated in NARS point towards this approach only and need to be sustained to leverage higher economic gains with societal benefits in the agrarian sector in India. Intellectual Property Management Regime in the Indian National Agricultural Research Systems 58

Annexure i Survey Questionnaires Survey Sheet for Experts 1. Please describe any role you have played in formulating/implementing/providing suggestions for IP Rights in India or internationally. 2. How important do you think IPR are in India and internationally and why? 3. What do you think should be included in types of IPs as related to your research area? 4. What do you see as the possible achievements of IPRs in agriculture in India? Has there been any change after the laws as per TRIPS have been implemented. 5. What are the main limitations of IP Rights in India? Are they barriers to stakeholders in your sector? 6. How do you think these limitations/barriers can be overcome? 7. What role do you see for the public sector in implementing IP rights in India? Do you see any problems if public sector also becomes a major holder of IPRs in agriculture (in research priorities or distribution of seeds to farmers)? 8. Do you think IP policy is needed for your organization? 9. How do you think that ICAR guidelines for Intellectual Property Management and technology transfer and commercialization seek to help the researchers and stakeholders in NARS? 10. Have you come across any achievements (success stories) in establishing IP Rights in India or any countries? How can any of these measures be translated in India and internationally to better implementation of ICAR guidelines on IP and technology commercialization? 11. How can the stakeholders be involved in this process of establishing IP regime both in India and internationally? 12. What are the suggestions you would like to give to operationalize the IP guidelines of ICAR? Intellectual Property Management Regime in the Indian National Agricultural Research Systems 59

Annexure ii Survey Questionnaires Survey Sheet for Experts at ICAR Headquarters 1. Please describe any role you have played in formulating/implementing/providing suggestions for IP Rights in India or internationally. 2. How important do you think IPR are in India and internationally and why? 3. What do you think should be included in types of IPs as related to the mandate of your organization? 4. What do you see as the possible achievements of IPRs in agriculture in India? Has there been any change after the laws as per TRIPS have been implemented. 5. What are the main limitations of IP Rights in India? Are they barriers to stakeholders in your sector? 6. How do you think these limitations/barriers can be overcome? 7. What role do you see for the public sector in implementing IP rights in India? 8. Do you see any problems if public sector also becomes a major holder of IPRs in agriculture (in research priorities or distribution of seeds to farmers)? 9. Do you think IP policy is needed for your organization? 10. How do you think that ICAR guidelines for Intellectual Property Management and technology transfer and commercialization seek to help the researchers and stakeholders in NARS? 11. Have you come across any achievements (success stories) in establishing IP Rights in India or any countries? How can any of these measures be translated in India and internationally to better implementation of ICAR guidelines on IP and technology commercialization? 12. How can the stakeholders be involved in this process of establishing IP regime both in India and internationally? 13. Can you list the major problems you are encountering during the process of operationalizing the guidelines of your organization, 14. How do you propose to overcome these? Intellectual Property Management Regime in the Indian National Agricultural Research Systems 60

Annexure iii Survey Questionnaires - 2 Survey Sheet for Experts-ITMU members 1. Please describe any role you have played in formulating/implementing/providing suggestions for IP Rights in India or internationally. 2. How important do you think IPR are in India and internationally and why? 3. What do you think should be included in types of IPs as related to your mandate of your institute? 4. What do you see as the possible achievements of IPRs in agriculture in India? Has there been any change after the laws as per TRIPS have been implemented. 5. What are the main limitations of IP Rights in India? Are they barriers to stakeholders in your sector? 6. How do you think these limitations/barriers can be overcome? 7. What role do you see for the public sector in implementing IP rights in India? Do you see any problems if public sector also becomes a major holder of IPRs in agriculture (in research priorities or distribution of seeds to farmers)? 8. Do you think IP policy is needed for your organization? 9. How do you think that ICAR guidelines for Intellectual Property Management and technology transfer and commercialization seek to help the researchers and stakeholders in NARS? 10. Please list any operational problems you face during the implementation of these guidelines in your organization. 11. How can the stakeholders be involved in this process of establishing IP regime both in India and internationally? 12. What are the suggestions you would like to give to operationalize the IP guidelines of ICAR? Intellectual Property Management Regime in the Indian National Agricultural Research Systems 61

Annexure iv Survey Questionnaire - 3 Survey Sheet for scientists 1. Please describe any role you have played in formulating/implementing/providing suggestions for IP Rights in India or internationally. 2. How important do you think IPR are in India and internationally and why? 3. Have you been part of awareness programmes on these issues and are you implementing some of issues on IP generation or practice in your research areas? 4. What do you think should be included in types of IPs as related to your research area? 5. Please list the projects you are handling with the tenure and your role (as PI or associate along with its funding source) and indicate possible types of IPs you could be planning to create in future. 6. What are the main limitations of IP Rights in India? Do you think they could be barriers to you or your stakeholders in your sector? 7. How do you think these limitations/barriers can be overcome? 8. What role do you see for the public sector in implementing IP rights in India? Do you see any problems if public sector also becomes a major holder of IPRs in agriculture (in research priorities or distribution of seeds to farmers)? 9. Do you think IP policy is needed for your organization? 10. How do you think that ICAR guidelines for Intellectual Property Management and technology transfer and commercialization seek to help the researchers and stakeholders in NARS? 11. Have you come across any achievements (success stories) in establishing IP Rights in India or any countries? 12. If yes, how can any of these measures be translated in India and internationally to better implementation of ICAR guidelines on IP and technology commercialization? 13. How can the stakeholders be involved in this process of establishing IP regime both in India and internationally? 14. What are the suggestions you would like to give to operationalize the IP guidelines of ICAR? Intellectual Property Management Regime in the Indian National Agricultural Research Systems 62

Annexure v Check list of indicators for IP and technology commercialisation No Indicator Y or N Remarks (if any) 1 Organizational vision and Y ICAR's Guidelines for IP Portfolio mission defined Management and Technology Transfer/Commercialization (hereinafter referred as ICAR's IPR Guidelines) have been implemented from Oct 2, 2006. 2 Guiding principles of IP policy Y In ICAR's IPR Guidelines. listed 3 IP management centres Y In ICAR's IPR Guidelines, which is constituted supported with 5-year XI Plan budget sanction. 4 IP management budget Y Through the 5-year XI Plan budget allocated sanction. 5 IP management general Y In ICAR's IPR Guidelines. guidelines issued 6 IP management guidelines for Y In ICAR's IPR Guidelines. specific categories of IP issued 7 IP management Y Administrative guidelines are included in administrative guidelines the ICAR's IPR Guidelines, which are issued supported by a 5-year XI Plan budget sanction. In addition, ICAR's Rules and Guidelines on Professional Service Functions (Training, Consultancy, Contract Research and Contract Service) have been updated and aligned with ICAR's IPR Guidelines. These are, however, under consideration of a Committee constituted for the purpose. 8 IP inventory and audit N To an extent, IP inventory and audit in completed (for IP used in terms of R&D programs and their review research, including plant is an established practice. However, genetic resources) to assess management of intellectual assets of all freedom to operate kinds, beginning with their stock-taking in the 95 Institutes of ICAR, is the next exercise through Zonal Technology Management Centres (ZTMCs). ZTMCs is the middle tier in ICAR's IPR Guidelines. 9 Existing databases, software , Y It is in the initial phase. But it will also websites, multimedia form a part in the exercise referred in products, CD-ROMs and Column 8. publications protected by copyright 10 Copyright provisions clarified Y Provisions clarified in ICAR's IPR and its management guidelines. regularized for different categories 11 Existing plant varieties Y&N Very good progress. But the process is protected as extant varieties linked with notification of new genera and species by Govt. of India. It is a continuing exercise. 12 IP portfolio of existing Y&N We are in the process of streamlining this commercializable IP available dimension. However, notwithstanding this Intellectual Property Management Regime in the Indian National Agricultural Research Systems 63

effort, such portfolios are generally available in each ICAR Institute. 13 IP decision-making flowcharts Y&N In our many sensitization workshops, we available have felt the need for still more work. This will be done. 14 IP awareness/capacity Y 12 sensitization programs completed in building programmes initiated the current year, 2009. Over 570 related with scientists/ faculty scientists and staff of National Agricultural Research System, that includes not just ICAR but also Agricultural Universities, given exposure on all the dimensions of 'IPRs and Technology Transfer'. 15 IP/patent search facilities Y&N In a few institutes. But budget provision made accessible given and approach clarified and communicated to each Institute. Intellectual Property Management Regime in the Indian National Agricultural Research Systems 64

Annexure vi Tabulation of Responses of Scientists to Questionnaire (PDP) Q.N. Question Synopsis 1 Please describe any role you have Scientists haven’t played any role in played in formulating/implementing/providing formulating/implementing/providing suggestions for IP Rights in India or suggestions for IP Rights in India or internationally. internationally. 2 How important do you think IPR are in Scientists opined that IPR issue are very India and internationally and why? important in India and internationally to protect rights in the novelty of the researches, protection of technology developed for commercial exploitation, to protect rich heritage of India and to enhance the quality of research as well to get due recognition for inventions. It is very important internationally under GATT and WTO regime. 3 What do you think should be included in Animal or poultry breeds are not included types of IPs as related to your mandate under IPR, whereas new varieties of your institute? developed from these breeds may be included in IPR. 4 What do you see as the possible IPRs have brought a change in Indian achievements of IPRs in agriculture in agriculture scenario. Recent guidelines and India? Has there been any change after laws for IP management have been done the laws as per TRIPS have been because of earlier fighting against patents implemented for Basmati rice, Neem and Turmeric by other countries. 5 What are the main limitations of IP Many barriers to stakeholders have been Rights in India? Are they barriers to reported in this sector. The main limitations stakeholders in your sector? of IP in India are lack of awareness, knowledge and training. The present form of IPRs should be modified as live genetic materials in the form of lines/strains cannot be patented. Patenting process should be made easy and faster. 6 How do you think these Through quick registration of the improved limitations/barriers can be overcome? lines/strains/varieties and by better awareness and training programmes, limitations/ barriers can be overcome. 7 What role do you see for the public There will not be any problem if public sector in implementing IP rights in sector becomes a major holder of IPR. India? Do you see any problems if Public sector should take lead role in public sector also becomes a major implementing IP rights and should become holder of IPRs in agriculture (in major holder of IPRs in agriculture. research priorities or distribution of seeds to farmers)? 8 Do you think IP policy is needed for Yes, IP policy is important for their your organization? organization but it should be under ICAR umbrella only. 9 How do you think that ICAR guidelines ICAR guidelines for Intellectual Property for Intellectual Property Management Management and technology transfer and Intellectual Property Management Regime in the Indian National Agricultural Research Systems 65

and technology transfer and commercialization is very useful but more commercialization seek to help the training programmes are needed. ICAR researchers and stakeholders in NARS? should have a separate extension and marketing section. 10 Please list any operational problems No operational problems reported in their you face during the implementation of organization. these guidelines in your organization. 11 How can the stakeholders be involved Stakeholders can be involved in the in this process of establishing IP regime process of establishing IP regime both in both in India and internationally? India and internationally to protect their rights. They can be provided with institute’s technical knowhow assistance with minimum or no investment, as they are rural / tribal poor. 12 What are the suggestions you would Suggestions to operationalize the IP like to give to operationalize the IP guidelines of ICAR are better awareness guidelines of ICAR? and training among scientific community, higher transparency and fast processing Intellectual Property Management Regime in the Indian National Agricultural Research Systems 66

Annexure vii Institute Research Projects 2008-09 (DRR) Code Project title Crop Improvement Breeding rice varieties with resistance to major pest and diseases. 1. GEY/BR-1 (CI/BR/1) Improvement of quality rices for higher productivity and export 2. GEY/BR-2 (CI/BR/2) Enhancing nutritional quality of rice through bio-fortification 3. GEY/BR-3 (CI/BR/3) Genetic enhancement of rice yield potential in irrigated ecosystem by 4. GEY/BR-6 developing New Plant Type (CI/BR/6) Breeding varieties for Boro 5. GEY-BR-9 (CI/BR/9) Breeding rice varieties for saline/alkaline soils 6. GEY/BR7 (CI/BR/7) Development and evaluation of three line hybrids with better grain 7. GEY/HY-1 quality and resistance to major pests and diseases. (CI/HY/1) Deployment of thermo-sensitive genic male sterility (TGMS) system 8. GEY/HY-2 for developing two line hybrids (CI/HY/2) Development and improvement of parental lines 9. GEY/HY-4 (CI/HY/4) Breeding for high yielding rice varieties and hybrids adapted to 10. GEY/HY-5 aerobic (non- flooded irrigated, condition (CI/HY/5) Introgression of yield contributing genes/alleles from wild species to 11. GEY/NP-1 rice using molecular markers (CI/BT/5) Genetic engineering resistance to biotic stresses 12. GER/BT-2 (CI/BT/2) Identification of genes for grain filling in rice 13. GEY/BT -3 (CI/BT/6) Application of biotechnological tools for understanding molecular 14.CI/BT/7 basis of yield heterosis and WA-CMS trait in rice Development of molecular markers for important quality traits in rice 15.CI/BT/8 Resource conservation technologies to sustain rice system 16.CP/AG/12 productivity Crop Production Studies on the effect of organo-inorganic P-sources on rice root 17. NP system attributes and P-uptake patterns for increase in nutrient-use CP/AG/9 efficiency and grain yield response of rice genotypes, under abiotic stress conditions Evaluation of the system of rice intensification (SRI) for its potential to 18. NP save water and sustaining rice productivity CP/AG/10 Management of sulphur nutrition in rice under rice based cropping 19. NP systems for improving / sustaining productivity CP/AG/11 Intellectual Property Management Regime in the Indian National Agricultural Research Systems 67

Code Project title Enhancing productivity of water in irrigated rice through integrated 20. CP/RUE-4 resource and crop management (CP/SS/6) Organic farming in Irrigated rice –influence on plant growth, 21. CP/RUE-3 productivity grain quality and soil health. (CP/SS/7) 22. NP Rhizosphere micriobial community composition and root exudation patterns as influenced by rice genotypes and soil types (CP/SS/8) Role of osmolytes in relation to stress adaptative mechanisms in rice 23. GEY/PHY-1 hybrids (CP/PP/6) Increasing the yield potential in irrigated rice : manipulating sources 24. (CP/PP/8) and sinks Impact of harvesting and threshing methods on the paddy output and 25. CP/MHY-3 head rice recovery (CP/ENG/4) Value addition by pelletizer using broken rice for starch based poultry 26. CP/MHY-4 field (CP/ENG/5) Development of information system for rice (RIS) 27. GIS1 GIS based RIS (CP/GIS/1) Expert Based Systems Crop Protection Host plant resistance (HPR) to insect pests 28. ENT/HPR/-1 (CPT/ENT/1) Chemical control of rice insect pests as a component of rice IPM 29. ENT-3 (CPT/ENT/3) Identification and functional analysis of genes related to gall midge 30. HPR/ENT-9 resistance in rice (CPT/ENT/9) Insect pest nutrient interactions with reference to plant hoppers 31. ENT-4 (CPT/ENT/10) Identification of new sources and mechanisms of resistance to rice 32. ENT-5 brown planthopper, Nilaparvata lugens and whitebacked planthopper, (CPT/ENT/11) Sogatella furcifera in rice Host plant resistance to yellow stem borer, (Scripophaga incertulus) 33. ENT-6 Walker in rice (CPT/ENT/6) Intellectual Property Management Regime in the Indian National Agricultural Research Systems 68

Annexure ix Tabulation of Responses of Scientists to Questionnaire (DRR) Q.N. Question Synopsis 1 Please describe any role you have They haven’t played any role in played in formulating/implementing/providing formulating/implementing/providing suggestions for IP Rights in India or suggestions for IP Rights in India or internationally. internationally 2 How important do you think IPR are in India is a rich agri-biodiversity centre with India and internationally and why? lot of land races along with traditional knowledge that needs to be protected in this era of globalization and commercialization. IPR helps in increasing our competitiveness in the international market as well. IPR benefit the people behind a novel product or process that have commercial importance. If India does not keep up with the pace of developed nations in this area we will lose out lot on our valuable research outputs and also on our rich Indigenous traditional knowledge. 3 Have you been part of awareness They have participated in many training programmes on these issues and are programmes organized by NAARM, IARI on you implementing some of issues on IP IP issue. generation or practice in your research areas. 4 What do you think should be included in Germplasm / donors registration specific for types of IPs as related to your research various biotic stresses, novel microbial pest area? control formulations, new crop management techniques for pest control, pesticide, new products and microbial are to be included in types of IPs as related to research area. 5 Please list the projects you are handling with the tenure and your role (as PI or associate along with its funding source) and indicate possible types of IPs you could be planning to create in future. 6 What are the main limitations of IP The main limitations of IPRs in India are Rights in India? Do you think they could lack of awareness and knowledge, illiteracy be barriers to you or your stakeholders among farmers, lack of comprehensive in your sector? patent database for free patent search, lengthy patent examination and expensive legal procedures, confusion among scientists working in public domain regarding patenting or making the technologies and products freely available to the farmers and other public agencies and obligations under RTI Act. 7 How do you think these By creating more awareness through limitations/barriers can be overcome? workshops/ training and also through distribution of printed material at all levels including stakeholders and developing clear policies and guidelines about IPR, formation of a comprehensive patent database, simplification of legal Intellectual Property Management Regime in the Indian National Agricultural Research Systems 69

procedures, In house lawyers to deal with patent issues 8 What role do you see for the public Public sector should play a pivotal role in sector in implementing IP rights in implementing IP rights in India. It should India? Do you see any problems if facilitate the process, help in identifying the public sector also becomes a major types of IPs and also in documenting them holder of IPRs in agriculture (in systematically. At present, there is research priorities or distribution of confusion among scientists working in seeds to farmers)? public domain regarding patenting or making the technologies and products freely available to the farmers and other public agencies and obligations under RTI Act. Few felt there will be a problem if public sector becomes a major holder of IPRs in agriculture as till now public sector developed varieties are freely distributed to farmers and other material was also shared freely with other organizations. But now, with IPR regime, one should also keep in mind the farmers rights and their needs. 9 Do you think IP policy is needed for Yes your organization? 10 How do you think that ICAR guidelines ICAR guidelines for IPM give an idea of for Intellectual Property Management types of IPs and also ownership details. and technology transfer and Guidelines are useful for patent filing and commercialization seek to help the commercialization of technologies. researchers and stakeholders in NARS? 11 Have you come across any They have come across many success achievements (success stories) in stories such as IPR issues of Basmati rice establishing IP Rights in India or any and turmeric. countries? 12 If yes, how can any of these measures For better implementation of ICAR guide be translated in India and internationally lines on IP and technology to better implementation of ICAR commercialization, the struggle faced by guidelines on IP and technology pioneers in patent filing in our system could commercialization? be avoided, and same models can be adopted to protect our IPR both in India and abroad 13 How can the stakeholders be involved By regular meetings of stakeholders at all in this process of establishing IP regime levels – regional, national and international. both in India and internationally? Creating database of traditional knowledge and products. Better partnerships between public sector and private sector organizations to share resources. 14 What are the suggestions you would Creating more awareness and IPs should like to give to operationalize the IP be identified at the time of formulation of guidelines of ICAR? project itself and process should also be initiated. Creation of committees at Institutional level and creating active core groups in each region or institute to monitor IP are some of the suggestions to operationalise the IP guidelines of ICAR. Intellectual Property Management Regime in the Indian National Agricultural Research Systems 70

Annexure x Tabulation of Responses of Scientists to Questionnaire (DRR) Q.N. Question Synopsis 1 Please describe any role you have They haven’t played any role in played in formulating/implementing/providing formulating/implementing/providing suggestions for IP Rights in India or suggestions for IP Rights in India or internationally. internationally 2 How important do you think IPR are India is a rich agri-biodiversity centre with lot in India and internationally and why? of land races along with traditional knowledge that needs to be protected in this era of globalization and commercialization. IPR helps in increasing our competitiveness in the international market as well. IPR benefit the people behind a novel product or process that have commercial importance. If India does not keep up with the pace of developed nations in this area we will lose out lot on our valuable research outputs and also on our rich Indigenous traditional knowledge. 3 Have you been part of awareness They have participated in many training programmes on these issues and programmes organized by NAARM, IARI on are you implementing some of IP issue. issues on IP generation or practice in your research areas. 4 What do you think should be Germplasm / donors registration specific for included in types of IPs as related to various biotic stresses, novel microbial pest your research area? control formulations, new crop management techniques for pest control, pesticide, new products and microbial are to be included in types of IPs as related to research area. 5 Please list the projects you are handling with the tenure and your role (as PI or associate along with its funding source) and indicate possible types of IPs you could be planning to create in future. 6 What are the main limitations of IP The main limitations of IPRs in India are lack Rights in India? Do you think they of awareness and knowledge, illiteracy could be barriers to you or your among farmers, lack of comprehensive patent stakeholders in your sector? database for free patent search, lengthy patent examination and expensive legal procedures, confusion among scientists working in public domain regarding patenting or making the technologies and products freely available to the farmers and other public agencies and obligations under RTI Act. 7 How do you think these By creating more awareness through limitations/barriers can be workshops/ training and also through overcome? distribution of printed material at all levels including stakeholders and developing clear policies and guidelines about IPR, formation of a comprehensive patent database, simplification of legal procedures, In house lawyers to deal with patent issues 8 What role do you see for the public Public sector should play a pivotal role in Intellectual Property Management Regime in the Indian National Agricultural Research Systems 71

sector in implementing IP rights in implementing IP rights in India. It should India? Do you see any problems if facilitate the process, help in identifying the public sector also becomes a major types of IPs and also in documenting them holder of IPRs in agriculture (in systematically. At present, there is confusion research priorities or distribution of among scientists working in public domain seeds to farmers)? regarding patenting or making the technologies and products freely available to the farmers and other public agencies and obligations under RTI Act. Few felt there will be a problem if public sector becomes a major holder of IPRs in agriculture as till now public sector developed varieties are freely distributed to farmers and other material was also shared freely with other organizations. But now, with IPR regime, one should also keep in mind the farmers rights and their needs. 9 Do you think IP policy is needed for Yes your organization? 10 How do you think that ICAR ICAR guidelines for IPM give an idea of types guidelines for Intellectual Property of IPs and also ownership details. Guidelines Management and technology are useful for patent filing and transfer and commercialization seek commercialization of technologies. to help the researchers and stakeholders in NARS? 11 Have you come across any They have come across many success achievements (success stories) in stories such as IPR issues of Basmati rice establishing IP Rights in India or any and turmeric. countries? 12 If yes, how can any of these For better implementation of ICAR guide lines measures be translated in India and on IP and technology commercialization, the internationally to better struggle faced by pioneers in patent filing in implementation of ICAR guidelines our system could be avoided, and same on IP and technology models can be adopted to protect our IPR commercialization? both in India and abroad 13 How can the stakeholders be By regular meetings of stakeholders at all involved in this process of levels – regional, national and international. establishing IP regime both in India Creating database of traditional knowledge and internationally? and products. Better partnerships between public sector and private sector organizations to share resources. 14 What are the suggestions you would Creating more awareness and IPs should be like to give to operationalize the IP identified at the time of formulation of project guidelines of ICAR? itself and process should also be initiated. Creation of committees at Institutional level and creating active core groups in each region or institute to monitor IP are some of the suggestions to operationalise the IP guidelines of ICAR. Intellectual Property Management Regime in the Indian National Agricultural Research Systems 72

Acknowledgments Grateful thanks to following people without whose help this study would not have possible: (a) Central Advisory Services on Intellectual Property (CAS-IP) of the Consultative Group on International Agricultural Research (CGIAR) for funding the study. (b) Director-General, ICAR for permitting the study. (c) Dr S.M.Ilyas, Director, NAARM, Dr N.H.Rao Joint Director and PI, LCB Project, NAIP, NAARM and Dr T.Balaguru, for advice right from the start, providing inspirational support and giving valuable technical advice all through the project. (d) Consultancy Proposal Committee (CPC) at NAARM for processing the project proposal. (e) Dr Victoria Henson-Apollonio (CAS-IP-Italy), Ms Karine Malgrand (NPI-France), for encouragement and editing. (f) Ms Irina Curca, Ms Kay Chapman and Mr Shawn Landers (CAS-IP-Italy for administrational support from CAS-IP. (g) Other National Partners Initiative members for encouragement and useful comments during the NPI meeting in Mombasa Kenya; January 2009. (h) IP Section at ICAR Headquarters, in particular, Dr S.Mauria, ADG (IPR) and Dr S.Kochhar, (Principal Scientist,[PB/IPR] ICAR) for help in the data collection and giving me the opportunities to interact at numerous workshops of ICAR on IPR during May 2008 to December 2008. (i) Dr B.C.Viraktamath, Project Director, DRR, Dr .Ms. N Shobha Rani, Principal Scientist & Head, Crop Improvement Section, DRR, Members of ITMU/ITMC and scientists at DRR for all their help and support for data. (j) Dr R.P.Sharma, Project Director, PDP; Dr M.N.Reddy, Senior Scientist, PDP; Members of ITMC/ITMC, PDP and scientists at PDP at PDP for ready help and support for data collection activities. (k) All the respondents representing various sectors of stakeholders for help in data collection. (l) Mr Suresh Kumar, CAO and his team in Administration and Accounts at NAARM; IC division of DARE, ICAR for support for project administration and processing the proposal. (m) Mr T.V.Ramadas, Ms H.Rashmi and Mr M.Hussian for their help during report preparation and proof reading. +++ Intellectual Property Management Regime in the Indian National Agricultural Research Systems 73

Establishment of Plant Breeders’ Rights System In Tanzania: Achievements and Challenges A Case Study Under the Ministry of Agriculture Food Security and Cooperatives, Tanzania -CAS-IP NPI Collaboration Project Patrick Ngwediagi Registrar of Plant Breeders’ Rights Ministry of Agriculture Food Security and Cooperatives Email: patrick.ngwediagi@kilimo.go.tz Ministry of Agriculture Food Security and Cooperatives P.O. Box 9192 DAR ES SALAAM,TANZANIA Tel: +255 22 286420 Fax: +255 22 2861403 Email: psk@kilimo.go.tz Website: http: //www.kilimo.go.tz

Contents Acronyms 2 1 Background and Justification for the Study 3 2 Materials and Methods 3 3 Meaning and Importance of Intellectual Property Rights 3 4 Plant Breeders' Rights, Farmers' Rights and Community 5 Rights Plant Breeders' Rights Farmers' Rights Community Rights 5 International Obligations for Tanzania 7 OAU Model Law TRIPS Agreements Convention on Biological Diversity (CBD) International Treaty on Plant Genetic Resources for Food and Agriculture (IT-PGRFA) UPOV Model and its Members 6 Establishment and Operationalization of Plant Breeders' 10 Rights System Need for a Plant Breeders' Rights System PBR Legislation Institutional Framework Plant Breeders Rights Development Fund Achievements and Challenges Participation of Stakeholders in the Administration of PBR Act Regional and International Collaboration 7 Lessons Learnt and Recommendations 20 8 References 21 22 Acknowledgements Establishment of Plant Breeders’ Rights System 1 In Tanzania: Achievements and Challenges

Acronyms ASARECA Association for Strengthening Agricultural Research in Eastern and Central Africa AU African Union AVRDC Asian Vegetable Research and Development Centre CAS-IP Central Advisory Services on Intellectual Property CBD Convention on Biological Diversity DUS Distinctness, Uniformity and Stability FAO Food and Agriculture Organization IPRs Intellectual Property Rights ISF International Seed Federation IT-PGRFA International Treaty on Plant Genetic Resources for Food and Agriculture MAFC Ministry of Agriculture Food Security and Cooperatives NPI National Partners Initiative OAU Organization of African Unity PBR Plant Breeders’ Rights/ Plant Breeder’s Right PBRA Plant Breeders’ Rights Act PBRO Plant Breeders’ Rights Office PVP Plant Variety Protection QDS Quality Declared Seed TRIPS Trade-Related Intellectual Property Rights UPOV International Union for the Protection of New Varieties of Plants WIPO World Intellectual Property Organization WTO World Trade Organization Establishment of Plant Breeders’ Rights System 2 In Tanzania: Achievements and Challenges

1. Background and Justification for the Study The Government of Tanzania has established a legal system for protection of plant breeders’ rights in order to put in place a mechanism for rewarding plant breeders and for the purpose of promoting plant breeding activities to stimulate and promote agricultural development. The system was put in place through enactment of the Plant Breeders’ Rights Act in 2002 which officially became operational in 2004 and based on the experiences and the outcome of implementing the system, there has been calls from stakeholders for the government to review the law governing the granting of plant breeders’ rights to make it more compliant to international systems of variety protection for the purpose of increasing local and foreign investment in plant breeding. In agreement with CAS-IP of Bioversity International, the Ministry of Agriculture Food Security and Cooperatives of Tanzania carried out a case study in 2008 in order to appraise the system and document experiences gained, lessons lent and challenges in the process of establishing and managing the Plant Breeders’ Rights Office in the country and make recommendations for improvement. The recommendations will also save as advice to other NPI member countries that are practicing or are in the process of putting in place similar system of plant variety protection. This study seeks to review appropriateness of the current plant breeders’ rights system in Tanzania and its contribution to an effective sui generis (“of its own kind”) system, and attempts to formulate an appropriate model in line with the TRIPS Agreement. The study prepares a benchmark review of activities undertaken in Tanzania thus far towards the creation and operationalization of a sui generis system (covering developments in legislation, institutions, as well as studies and analysis carried out by the government, private sector and other stakeholders). The study will also assess Tanzania’s compliance with the Agreement on Trade-Related Intellectual Property and other international legal frameworks for the protection of plant variety. The findings will facilitate an identification of the areas (legislative, analytical and institutional) where follow up for reform is required. The study will also examine how farmer s’ rights are handled. 2. Materials and Methods The study has reviewed and documented the whole process from what necessitated a decision on establishment of a plant variety protection system to development and implementation of the law, activities involved in the process of establishing the office and operationalization of the office including availability of necessary resources. In order to achieve the objectives of the case study, all existing literatures and documents on the establishment and operationalization of the plant breeders’ rights system in Tanzania were collected and reviewed. Opinions from major stakeholders of the system who included officials of the Ministry of Agriculture Food Security and Cooperatives and Plant Breeders’ Rights Office, plant breeders in the field, seed producers, academicians and farmers/farmer groups were collected though individual interviews or though discussions in workshops and meetings. During the process the stakeholders’ views regarding the efficiency of the system and suggestions for improvement were sought. The stakeholders meetings were also used to establish the level of their awareness on the importance and benefits of the plant variety protection system so that means of raising their awareness could be recommended. 3 The Concept and Importance of Intellectual Property Rights (IPRs) Intellectual property can be defined as that which is created by the human intellect (“ideas” or “thoughts”), often intangible unlike other forms of property. When the ideas or thoughts are converted to practice (for example, in appliances, drugs, books, new plant varieties etc), and the reduced-to-practice ideas are new (novel), they can be protected by government laws. These laws confer to the creator exclusive legal rights over the subject Establishment of Plant Breeders’ Rights System 3 In Tanzania: Achievements and Challenges

matter, which serve as a reward for their achievement and contribution to socio-economic progress as well as an incentive for further innovation. Types of intellectual property rights include: Industrial property: (patents, trade marks, special rights for integrated circuits, utility models, industrial designs, etc); and Literary and artistic property: (copyright, rights of performers, et. cetera). Plant variety protection (PBR): a sui generis system often excluded from lists of intellectual property categories 3.1 The Importance of IPRs to the Agricultural Sector In Tanzania, over 80 per cent of the population lives in rural areas and depends on agriculture for their livelihood. This sector contributes about 26.5 percent to the GDP and comprises 54 percent of the nation’s foreign exchange earnings 1 . Agricultural development is therefore crucial to both national economic development and poverty reduction, but specifically, it stimulates local rural economies and may curb rural to urban migration. Strong Intellectual Property Rights’ (IPRs) play a significant role in attracting investment in agriculture, and enhance market growth, access and diversification as they provide incentive to breeders by assuring them that their expenditure and development will be protected. Adequate plant variety protection encourages investment in the plant breeding sector and opens a country’s door to overseas varieties where the protection of law is guaranteed. More often than not, new plant varieties render higher yield and quality product, as well as a greater resistance to disease rendering them a crucial aspect of production. Through these varieties the benefits of plant variety protection therefore extend to farmers, producers and to the national economy. It is envisaged that Trade Marks, Patents and Plant Variety Protection will have some impact on the pace and direction of growth of the sector. Simply put, trademarks have an important role to play in the identification of agro-products, such as seeds, of a particular enterprise. They can also convey to customers an indication of the quality of the product. Patents and plant variety protection systems are likely to have greater influence on access to technology issues, such as seed of improved varieties. These latter two forms of protection share some commonalities: They create incentives for investment in the research and development of new plant varieties. Holders have the opportunity to exploit their inventions and therefore recoup their investment costs free from the competition of those who have not made such investments and who would, in the absence of patent or plant variety protection, benefit unfairly; The rights are territorially limited and therefore apply only within the state, or the group of states, in which they are granted; and They represent a balance between the public interest and the private interest of the holder. Despite these similarities between patents and plant variety protection laws, there are some principle differences between them. These are summarized in Table 1 below. 1 MAFC Budget Speech made to the National Parliament in July 2008 Establishment of Plant Breeders’ Rights System 4 In Tanzania: Achievements and Challenges

Table 1. A General Comparison of Patent And Plant Variety Protection Law Subject Patent Protection Plant Variety Protection Inventor Plant Breeder Holder of Protection Requires involvement of patent User friendly; breeder can Ease of making specialists/lawyers make the application. application (Industrial) invention Plant Variety Object of protection Required Required Documentary examination Not required Required Field examination Not required Required Plant material for testing a) Novelty a) Novelty Conditions for grant b) Industrial applicability b) Distinctness of rights c) Non-obviousness (inventive c) Uniformity step) d) Stability d) Enabling disclosure e) Appropriate denomination Determined by the claims of the Fixed by the national Determination of patent legislation (by UPOV scope of protection Convention in the case of UPOV member States) May require the authorization of Does not require authorization Use of a protected the patentee. of the right holder. variety for breeding further varieties 20 years from date of 25 yrs for trees and vines, 20 Term of protection application (as per TRIPS yrs for other plants, from date Agreement) of grant (1991 Convention) Source: Wachira F. & Ngwediagi. A review of PVP Laws in Eastern African countries of Kenya, Uganda, Tanzania and Rwanda, submitted to ASARECA in 2006 Patents are granted for inventions (there must be evidence of an inventive step); the patenting of plants has always carried misconceptions and ambiguities. In Tanzania Patent Act, 1987 does not allow the patenting of life forms (section 7) 2 . The same prohibition exists under the European Patent Convention. Therefore, plant breeders in Tanzania can only protect their new plant varieties through the plant variety protection legislation. 4. Plant Breeders’ Rights, Farmers Rights and Community Rights 4.1 Plant Breeders Rights Plant Breeders’ Rights (PBRs) are defined by UPOV 3 as an exclusive right over the commercial production and marketing of the reproductive or vegetative propagating material of the protected variety. The creation of this category of rights as an alternative to patents was intended to provide incentives for the seed industry. Therefore the primary motivation behind such rights is profit-making; these rights attract investment from the private sector and stimulate research and development of stronger and more productive plant varieties. The development of a new variety is usually a long and costly undertaking and therefore by allowing breeders to control commercialization of their variety, by enacting and implementing a plant breeders' rights legislation gives them a chance to recoup costs and profit from their breeding investment. This also motivates breeders to continue developing new varieties for the benefit of farmers and the society in general. 4.2 Farmers’ Rights 2 Tanzania Patent Act of 1987 3 UPOV Convention of 1991 Establishment of Plant Breeders’ Rights System 5 In Tanzania: Achievements and Challenges

In developing countries, seed supply requirements are met through exchanges between farmers, which operate alongside other more formal mechanisms. Farmers’ seed systems are largely based on traditional methods of selection between varieties as well as seed multiplication carried out on farms, but still involve modern varieties. Nevertheless there is no uniform interpretation of farmers’ rights in relation to IPRs on plant varieties. Farmers’ rights protection carries with it benefits such as the improvement of the livelihood of those farmers and their communities; environment conservation and the monitoring of resources; the prevention of rural migration; less dependence on foreign countries and the prevention of biopiracy by recognizing the contribution of local farmers. The major difference between farmers’ rights and IPRs is that while the latter offers exclusive rights, the former is geared towards compensation and benefit sharing. Also, farmers’ rights do not readily define the title holder or subject matter, while they are clearly established for IPRs. Finally, IPRs are also of a limited duration while farmers’ rights are unlimited Farmer’s rights are a counter-balance to PBRs in recognition of the farmer’s contribution to agricultural innovations, to promote the equitable sharing of genetic resources and in recognition of the importance of the conservation of such resources and traditional practices. The legal scope of these rights is still in debate. A whole spectrum of views has been put forward regarding the utility and place of farmers’ rights protection in the law. Some of these views include: There should be no relationship between farmers’ rights and IPRs; Farmers rights should be recognized in laws relating to plant breeders’ rights; A sui generis regime on farmers’ rights should be established separately from existing forms of IPRs and The existing definitions under plant breeders’ rights legislation should be extended to protect farmers varieties. Part V of the Model Law developed by the African Union outlines farmers’ rights which include the right to save, use, and exchange seed produced on farms, and to use protected varieties in the development of new farmer’s varieties. The importance of having a clear understanding of what should be regarded as farmers’ rights and their place in legal systems is less pronounced in developed countries but is relevant in the developing country context. Here, farmers are a primary source of seed supply through informal exchange arrangements. For example in Tanzania, 95 percent of seed management is carried out by farmers and the remaining 10 percent supplied by certified seeds sold on the market (these are generally much more expensive and are not 4 easily available to many farmers in remote areas) . The Plant Breeders Rights Act of 2002 recognizes this situation and therefore provides that farmers are privileges to save seeds of a protected variety as long as it is grown in their own holdings (farms). The Act also does not discriminate farmers in the definition of a breeder, meaning that a farmer can also develop and protect a new variety. However, the Act does not provide other forms of rights specifically for farmers but the government has initiated a process of enacting a law on access and use of plant genetic resources where all matters related to farmers rights will be captured. In order to solve the problem of seed availability and affordability to small scale farmers, the Tanzanian government has initiated an on-farm seed production system known as Quality Declared Seed (QDS) System 5 . The QDS system allows small scale farmers (growing not more than 5 acres of seed) to produce seed on their own farms and declared the quality of their own seed and sell to nearby farmers within an administrative area known as a ward. The national seed certification agency may once in a while inspect these farmers but their involvement does not exceed 10 percent. The system has been operational since the year 2000 and has now been legalized by the new Seed Act of 2003 6 . 4.3 Community Rights The sovereign rights of the state over its natural resources forms the basis of its negotiating position on the international plane and the right to develop policies appropriate for its national context. Community rights are those belonging to members of an identifiable 4 MAFC Report to the National Variety Release Committee, December 2008 5 QDS Programme Launch Report, 2002 6 Tanzania Seed Act of 2003 Establishment of Plant Breeders’ Rights System 6 In Tanzania: Achievements and Challenges

indigenous community, with each member entitled to use of the common property and any management issue pertaining to the property must have the consent of the entire community. A delineation of these rights is often difficult given that property rights are individualistic in nature, but this should not negate recognition of community rights which recognize their conservation role, to provide incentives and also to fulfill their human rights entitlements. Currently there is no specific law for the protection of community rights in Tanzania, and based on the current administrative structure in the country such law may be difficult to implement. As a way of strengthening national unity and cohesion, immediately after independence, Tanzania abolished village chiefdoms which existed along tribal boundaries and established new village boundaries and leadership that had little to do with tribal affiliations. It might therefore be difficult to distribute any benefits arising from the use of plant genetic resources which were obtained from areas originally belonging to a certain indigenous community. 5. International Obligations for Tanzania 5.1 OAU Model Law A Model Law which outlines its sui generis system has been developed by the AU, formally, OAU. The law deals with access to biological resources, benefit sharing and the rights of farmers and breeders over their knowledge and resources. It rejects the exclusive appropriation of any life form, including derivatives. Communities can prohibit access to resources only where it would be detrimental to their natural heritage; also, at least half of the benefits derived from access must be directed back to the community. This framework provides a comprehensive definition of farmers’ rights, including protection of their traditional knowledge relevant to plant and animal genetic resources, the right of equitable share of benefits arising from the use of plant and animal genetic resources, the right to participate in making decisions on matters related to the conservation, exchange, and sale of farm-saved seed or propagating material, and the right to use a commercial breeder’s variety to develop other varieties. It also provides that where food security or nutritional or health needs are adversely affected, governments are allowed, in the public interest, to restrict the realization of the rights of breeders. Breeders’ rights are modeled after the UPOV Conventions, although article 43 of the Model Law provides broad exemptions to breeders’ rights including noncommercial use rights, sale of the plant material for food or sale within the specific geographical location where the plant material originated, and also use as an initial source for 7 propagating another variety . Although the Organization unanimously approved the Model Law, very few members have enacted their PBR laws using the model law. This has brought the discussions on the need to revise the model law to meet the present needs of its member states. 5.2 TRIPS Agreement The World Trade Organization’s Trade-Related Intellectual Property Agreement 8 obliges its signatories to provide for such intellectual property protection in their laws, and sets out the minimum standards that must be contained therein. Plant variety protection is often excluded from lists of intellectual property categories. However, the adoption of the TRIPS Agreement has done more to encourage the legal protection of plant varieties than any other international agreement. As the Plant Variety Protection (PVP) debate has continued, a school of thought has evolved that considers it a form of industrial property right. The TRIPS Agreement does not require that a specific system be put into place to secure intellectual property rights for plant varieties. The Agreement mandates its signatories to provide patent protection for any invention in all fields of technology, provided that the inventions are “new, involve an inventive step and are capable of industrial application”. Such protection for plant varieties is covered by Article 27.3 (b) of the Agreement which partly states the protection is to be provided “...either by patents, or by an effective sui generis system or by any combination thereof”. This means that the range of options is unlimited, provided some requirements are met. This also means that WTO member states, including 7 http://www.grain.org/brl_files/oau-model-law-en.pdf 8 http://www.wto.org/english/tratop_E/TRIPS_e/trips_e.htm Establishment of Plant Breeders’ Rights System 7 In Tanzania: Achievements and Challenges

Tanzania are allowed to develop legislation that takes into account its unique features. Furthermore Article 27.3 (b) of the Agreement states that members may exclude from patentability “plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological processes. Thus, as presently written, the TRIPS Agreement would permit WTO members to decline to protect plant varieties using the patent method provided they protect such varieties with an effective sui generis plant variety protection system. There is no guidance or agreed formulation as to what constitutes ‘effective’, nor what a sui generis system should entail at minimum. The International Seed Federation (ISF) recommends that countries envisaging the development of such sui generis systems ensure that as a minimum they conform to the requirements of the 1991 Act of the UPOV Convention, Least Developing Countries (LDCs) such as Tanzania were given an extension until 1 July 2013 to set up the appropriate protection framework under the TRIPS Agreement. The TRIPS Agreement provides for a review of Article 27.3(b), which began in 1999. Among the topics discussed in the TRIPS Council are: How to apply the existing TRIPS provisions on whether or not to patent plants and animals, and whether they need to be modified. The meaning of effective protection for new plant varieties How to handle moral and ethical issues, for example, to what extent invented life forms should be eligible for protection. How to deal with the commercial use of traditional knowledge and genetic material by those other than the communities or countries where these originate, especially when these are the subject of patent applications. How to ensure that the TRIPS Agreement and the UN Convention on Biological Diversity (CBD) support each other. Most recently discussed are proposals on disclosing the source of biological material and associated traditional knowledge. The African group at WIPO has made a specific proposal on disclosure in patent applications of information on the origin of genetic resources and traditional knowledge on which invention is based. 5.3 Convention on Biological Diversity (CBD) The CBD 9 is the most recent and comprehensive instrument that balances the need for legal protection of intellectual property rights with that of the specific context of developing countries sustainable development agendas. The CBD preamble and its Article 8 recognize both the dependence of local communities on biological resources and the role that they have played in the evolution, conservation, and sustainability of such resources. The Convention calls for the equitable sharing of benefits arising from the use of their traditional knowledge, innovations and practices, relevant to the conservation of biodiversity and the sustainable use of its components. The CBD is not limited to plants but to all biological resources. The directives contained in the Convention have been included as an important element of the current TRIPS negotiations. Tanzania became a member of the CBD on 8th March 1996 and is therefore bound and affected by its impact on trade negotiations and potential future WTO amendments. The Convention offers an important setting for information sharing but also resources for technical assistance that Tanzania has been in the process of exploration since it became a member. Tanzania is also a member of the Cartagena protocol on Biosafety since September 2003. 5.4 International Treaty on Plant Genetic Resources for Food and Agriculture (IT-PGRFA) The International Undertaking on Plant Genetic Resources for Food and Agriculture 10 is a non-binding instrument which furthers the tenet that plant genetic resources are the common heritage of mankind. The treaty protects the material in gene banks and in farmers’ fields from being directly patented and encourages countries to protect farmer’s rights. Negotiations for a revision of some of the articles pertaining to farmer’s rights have caused some controversy as the draft provisions emphasize acknowledgment of the role of farmer’s 9 http://www.cbd.int/convention/ 10 http://www.planttreaty.org/ Establishment of Plant Breeders’ Rights System 8 In Tanzania: Achievements and Challenges

to agricultural management rather than their rights. The treaty focuses on aspects such as the protection of traditional knowledge and the equitable sharing of benefits arising from the exploitation of biological resources, proposing a multilateral system that facilitates access to genetic resources and sharing of benefits without any monopolies. The Treaty steers countries towards the recognition of the need to give farmers control over their knowledge for reasons of justice as well as to foster sustainable use and conservation of plant genetic resources. Nonetheless, it leaves member states free to decide on the most appropriate framework for them. Under Article 27, the Treaty is open for accession by all Members of FAO and any States that are not Members of FAO but are Members of the United Nations, or any of its specialized agencies or of the International Atomic Energy Agency. The Treaty entered into force the 29 th June 2004. Tanzania is a member of the treaty of which it acceded on 30 April, 2004 and has now initiated a process of enacting a law to domesticate it. 5.5 The UPOV Model and its Membership The International Union for the Protection of New Varieties of Plants 11 , known as “UPOV,” is an intergovernmental organization with headquarters in Geneva. The acronym UPOV is derived from the French name of the organization, Union Internationale pour la Protection des Obtentions Végétales. The mission of UPOV is to provide and promote an effective system of plant variety protection, with the aim of encouraging the development of new varieties of plants, for the benefit of the society. The purpose of the UPOV Convention is to ensure that the members of the Union acknowledge the achievements of breeders of new varieties of plants, by granting to them an intellectual property right, on the basis of a set of clearly defined principles. To be eligible for protection, varieties have to be (i) distinct from existing, commonly known varieties, (ii) sufficiently uniform, (iii) stable and (iv) new in the sense that they must not have been commercialized prior to certain dates established by reference to the date of the application for protection. The UPOV Convention sets out a minimum scope of protection and offers members the possibility of taking national or regional circumstances into account in their legislation. Like all intellectual property rights, plant breeders’ rights are granted for a limited period of time, which is twenty five years for trees and vine and twenty years for other plants respectively, at the end of which varieties protected by them pass into the public domain. The rights are also subject to controls, in the public interest, against any possible abuse. Under the 1991 UPOV Convention, a breeder is defined as the person who breeds, or discovers and develops, a variety. Therefore, protection is not limited to a breeder in the sense of someone who produces a variety as a result of crossing parent plants and selecting from the progeny. The term breeder also includes a person who discovers a mutation or a chance seedling and then by a process of selective propagation (development) converts that discovery into a cultivated variety. Discovery by itself is therefore not sufficient and the breeder must also have had an input of development. Many countries that have joined UPOV have reported increases in plant breeding activities with direct effects upon their agricultural and horticultural industries. They have reported increases in the range of varieties made available to farmers and growers as well as increased investments in agriculture. In Argentina for example, the number of PVP grants to foreign breeders, increased following the amendment of the national PVP law to comply with UPOV. The number of granted titles more than trebled in 10 years since the country became a UPOV member, that is, from 17 to 62 (355 percent). The increase in number of foreign titles was more evident in important agricultural crops (such as soybean, roses, strawberry and Lucerne), for which improved varieties are important for competitiveness in the global market. In China, farmers have greatly benefited from the introduction of a PVP system and in 11 http://www.upov.int/index_en.html Establishment of Plant Breeders’ Rights System 9 In Tanzania: Achievements and Challenges

particular with UPOV membership. They have seen the development of a number of new varieties of the most important agricultural crops such as maize, rice, wheat, soybean and oilseed rape. The number of PVP grants in China increased from 39 to 261, one year after joining UPOV. These examples demonstrate that with suitable PVP laws, returns from breeding activities can be potentially reinvested in crop improvement activities. This could contribute to the development and release of many more new varieties, particularly in Africa where most of the breeding activities are inadequately funded from public coffers. The UPOV plant variety protection system provides breeders with an incentive to properly maintain their varieties and ensure that authentic propagating material is available to users (including others breeders) to breed further varieties, thus serving as a genetic resource. Currently UPOV has 66 members and more than 18 applications for membership are being processed. In Africa there are four members (South Africa, Kenya, Morocco and Tunisia). Zimbabwe application is under consideration as well as collective application of 16 West African states under OAPI. 6. Establishment of and Operationalization of Plant Breeders’ Rights System 6.1 Need for a Plant Breeders’ Rights system The seed industry in Tanzania needs the active participation of private sector. The role of the private sector in agricultural development has been recognized in several government documents such as the Poverty Reduction Strategy (RSP) 12 , the Vision 2025 13 , and in particular, the Agricultural Development Policy of 1997 14 and the Agricultural Sector Development Strategy (ASDS) of 2001 15 . A well-functioning seed industry requires a suitable legal and institutional framework that could serve as a catalyst to seed trade under a free market economy, The objective or main purpose of the Tanzanian Plant Breeders’ Rights Act, as provided in its long title, is “to provide for the protection of new plant varieties in order to promote plant breeding activities that will stimulate, facilitate and improve agricultural research in the country, through the grant and regulations of plant breeder’s rights and the establishment of a plant breeder’s rights registry, which is entrusted with the obligations of granting plant breeders rights”. The government decided to put in place a plant variety protection framework after conducting a study to establish whether or not it was necessary. The study was conducted in 1995/96 with technical assistance from the United Nations’ Food and Agriculture Organization 16 (FAO). The study produced a number of recommendations after the FAO consultants had met and discussed with all stakeholders including government officials from relevant ministries, public and university plant breeders, seed companies and other stakeholders that it was right time for the country to introduce a legal framework to regulate granting of plant breeders’ rights. The study also recommended that the legal framework should establishment an independent PBR Office that will be based at the ministry responsible for agriculture. Most stakeholders had supported the idea of establishment of a plant variety protection system in Tanzania because they believed that it would contribute to increase in number of improved varieties as well as investment in agriculture sector in general. Following the revelation of the findings of the study, the government took sufficient time to discuss and finally accepted the recommendations and started the process of establishing the legal system for the protection of plant breeders’ rights. The process involved holding discussions with stakeholders on the formulation of a draft law before a bill was submitted to the National Assembly (Parliament) for final decision. The government and 12 Tanzania Poverty Reduction Strategy of 2001 13 Tanzania Development Vision 2025 of 2000 14 Agricultural Development Policy of 1997 15 Agricultural Sector Development Strategy (ASDS) of 2001 16 FAO 1996. Study on the need for a plant variety protection system in Tanzania Establishment of Plant Breeders’ Rights System 10 In Tanzania: Achievements and Challenges

stakeholders had expected that the system would confer the following advantages to Tanzania: To assist in providing sustainable compensation for long years of involvement in developing and testing new varieties; To provide an incentive to local (public and private) and international breeders to involve themselves fully in plant breeding in the country, therefore providing farmers with high quality varieties; To provide incentives for increased investments in seed production, horticulture and agriculture in general; To facilitate technology generation and transfer through shared breeding and licensing; It is important to note that before and after the Bill was submitted to the Parliament, no stakeholder including the non-governmental organizations had objected to the idea of introducing the plant variety protection system. To some extent this may have been attributed to the lack of sufficient knowledge on the impact of the system and lack of a proven example of any negative impact in African countries practicing the system. 6.2 PBR Legislation 6.2.1 PBR Act The Protection of New Plant Varieties (Plant Breeders’ Rights) Act No. 22 of 2002 17 is an Act to provide for the establishment of a registry of plant breeders’ rights; promotion of plant breeding and facilitation of agricultural advancements through the grant and regulation of plant breeders’ rights and for matters connected herewith. The Act was passed in the National Assembly on 7th November 2002 and the Minister responsible for agriculture declared 1st February 2004 as the official operational date of the Act. The Plant Breeders’ Rights Act of 2002 is a sui generis piece of legislation that provides for a voluntary system intended to enhance plant breeding activity in the public and private sectors. The Act adopts, to a large extent, major provisions of the UPOV Convention of 1991 although some differences are notable. As provided under UPOV Act, Section 14 of the Tanzanian PBRA requires that some specific conditions be met before a variety can be protected. Such variety must be: New; Distinct(clearly distinguishable from any other variety of common knowledge at the time of the application) ; Uniform; and Stable (unchanged after repeated propagation). The novelty condition (newness) is given in relation to commercialization of a particular variety in which the Act authorizes an allowance period for sale before application, that is, one year in the country of application, or, in any other country, six years for trees or vines, or four years for other plants. The applicant must also meet some administrative requirements such as filling in application forms and payment of prescribed fees. In addition the variety must have a suitable name (denomination) which must be used in the market place to avoid confusion and misidentification of varieties. The law does not allow for inclusion of any additional conditions for granting of PBR rights. The Plant Breeders’ Rights Act provides that the breeder of a protected variety shall have sole rights to: Sell Reproduce or multiply the propagating materials, Process Stock the variety Export and Collect royalties through licensing and assignment of his or her rights 17 http://www.agriculture.go.tz/Regulations.htm Establishment of Plant Breeders’ Rights System 11 In Tanzania: Achievements and Challenges

The PBR Act of 2002 gives exemption to the breeder’s right. As provided under UPOV 1991 Act, the PBR Act provides that the breeders’ rights do not cover private and noncommercial acts, experimental acts or those carried out for the purpose of breeding other varieties. Section 34 of the privileges farmers to save seeds of a protected variety harvested in their own holdings but unlike provisions of UPOV Convention of 1991, it does not require the authorities to put limit for farmers to as to how much should be saved on their own holdings. Under Section 35 of the statute, protection lasts 25 years for trees and vines, and 20 years for other crops. The rights holder can request to the Registrar for an extension upon expiry of the coverage period. The Act also details the procedures for objections to a grant of PBRs following publication of the notice for the filed application in the Official Gazette. In addition to fees paid at the application, the right holder is required pay a prescribed fees in order to maintain the right. The act allows applicants to appeal any decision of the Registrar before the Appeals Board The PBR Act does not clearly deal with the farmers and community rights save for section 57, which states simply that the Minister shall ensure that implementation of this Act shall not affect the fulfillment of government obligations pertaining to protection of farmers’ rights. The Act also establishes a Community Fund whereby part of the revenue paid to the Registry of Plant Breeders’ Rights is set aside for development activities of the arrears that contributed to the development of the protected varieties. The PBR Act privileges farmers to save seeds of a protected variety as long as it is used in their own holdings. The law protects public interests through provisions regulating compulsory licensing of a protected variety in case a right holder refuses to license it. 6.2.2 PBR Regulations Section 59 of the PBR Act empowers the Minister responsible for Agriculture to make regulations for effective implementation of the Act the task he accomplished in 2008 after following laid down procedures for this purpose. Although the regulations became operational five years after the Act came to force, the office of the Registrar was allowed to continue implementing the Act while the Regulations were being drafted. 6.3 Institutional framework Section 5 of the PBR Act establishes an independent plant variety protection office within the ministry responsible for agriculture known as the Plant Breeders’ Rights Registry which is responsible for administration of plant variety protection system. The independence of the arrangement is designed to provide a neutral and efficient body within the government structure to administrate PVP issues. The office falls under the Ministry of Agriculture Food Security and Cooperatives due to the fact that the Ministry is more placed to deal with plant variety matters than any other government Ministry. Section 4 of the Plant Breeders Rights empowers the Minister to appoint the Registrar who heads the Plant Breeders’ Rights Office. The main functions of the Registrar include: Granting of plant breeders rights Maintaining a register of plant breeders’ rights Maintaining a documentation centre for public scrutiny and access on plant breeders’ rights information Facilitation of transfer and PBR licensing, and Collaborates with national and international bodies on PBR matters Working as the Secretariat of the Plant Breeders’ Rights Fund. Section 10 of the PBR Act establishes the Plant Breeders Rights Advisory Committee comprising of members representing all major stakeholders of the plant breeders’ rights system including representatives of farmers and seed producers. Its major functions are: To advice the Minister on the enforcement of the Act; To receive Reports from the Registrar on the grant of PBR; To make expert consideration on the grant of PBR reports and tests leading to the grant; To advise the Registrar on the grant of PBR. Establishment of Plant Breeders’ Rights System 12 In Tanzania: Achievements and Challenges

In addition, section 48 of the Act establishes the Plant Breeders Rights Development Fund which is administered by the Plant Breeders Rights Advisory Committee. The main objective of the fund is to give grants to private and public breeders to enable them develop varieties that meet conditions for protection. 6.4 Plant Breeders Rights Development Fund The Plant Breeders Rights Development Fund became operational towards the end of 2007 after the Ministries responsible for agricultural matters and Finance agreed to establish the Fund as required by the Law. In addition to application fees that are paid to the Fund, the government has been contributing an average of US $ 55,000 annually as seed money. This amount is not sufficient to support the intended objective of supporting interested plant breeders to initiate or finalize on going plant breeding work. The Fund is currently processing 2 applications for grant to support plant breeding and related activities. The money has enabled the Fund to put in place a system that will be used to meet its intended goals. The funds have also been used to create awareness among beneficiaries as well as potential public and private donors who have promised to start contributing to the Fund in the near future. 6.5 Achievements and Challenges The PBR system in Tanzania effectively started in January 2005 when the PBR Office was established following appointment of the Registrar as required by law. The Law does not provide for the minimum qualifications that the candidate for the position of the Registrar must possess. Based on the qualifications possessed by the incumbent Registrar it is evident that the Minister used his powers to appoint some one who has sufficient knowledge in plant breeding and seed technology and who has some basic knowledge and experiences of legal matters. These qualifications and good connections with local and international players in the fields of plant breeding, seed technology and plant variety protection have greatly contributed to a good start and steady progress made by the PBR Office in Tanzania. Before a variety is protected as required by the PBR Act, the office conducts administrative and technical assessments. Administrative assessments include checking for correctness of application forms, verification for novelty of a particular variety and payment of application fees as shown table 2. Table 2. Prescribed Fees and related Charges S/No Type of Fees Amount (US$) 1. Application for a grant of PBR 200 2. Application for a Provisional Protection 300 3. For technical evaluation of a variety (DUS) 600 4. Annual maintenance fee 200 5. Purchase of a report from a testing authority in another 320 country 6. Replacement of lost or destroyed certificate 40 7. Claim of priority from a preceding application outside 20 Tanzania 8. For change of an approve denomination 80 9. Reinstatement of an abandoned application on petition 80 10. Surcharge for late payment 60 11. Application for a compulsory license 70 12. Application for extension of the period of a grant 100 13. Inspection of register and documents 40 14. Duplicate page of register or documents 0.50 15. Grant for Plant Breeders Rights certificate 240 As for technical assessments, the office works very closely with the Tanzania Official Seed Certification Institute (TOSCI) to carry out tests to establish if a variety in question is Establishment of Plant Breeders’ Rights System 13 In Tanzania: Achievements and Challenges

distinct, uniform and stable. The office has so far received 36 applications (table 3) from both public and private research institutions and granted twenty five (25) tittles. Table 3. Applications Received from Various Institutions 18 Applicant/Institution Public/Private Crop Species Number of Remarks applications Ministry of Agriculture Public Zea mays L. 5 All are locally (Maize) developed varieties 16 All are locally Anacardium developed occdentale L. varieties (Cashew) 2 All are locally Sesamum developed indicum L. varieties (Sesame) 1 Locally Phaseolus vulgaris L. developed (French Beans) variety 1 Locally Lycopersicon esculentum P. developed Mill variety (Tomato) Sub-Total 25 Sokoine University Semi-autonomous All are locally Phaseolus 2 of Agriculture vulgaris L. developed (French varieties Beans) Tanzania Coffee Private Locally Coffea 9 Research Institute developed arabica (TAcRI) (Coffee) varieties Total 36 Although the office has made some notable achievements in putting the system in place and making it operational, there are still a number of challenges that need be sorted out in order to achieve the intended objectives. The main challenge facing the system is how to increase number of local and foreign applications for plant breeders’ rights. Low number of local applications for PBR compared to number of officially released varieties (table 4) is attributed to lack of sufficient resources allocated to national research institutions for breeding work. There is also a lack of awareness on the importance and benefit of the PBR system among local breeders. To-date the office has not received any foreign application due to lack of truss among international breeders due to the fact that Tanzania is not yet a UPOV member. This matter has been discussed at length by government through the Ministry responsible for Agriculture and stakeholders though a number of forums and a decision has been reached that the country should join UPOV and in order to achieve this internal administrative and legal processes have already been initiated. The process involves amending the current Act to comply with provisions of the UPOV Convention of 1991. Tanzania intends to join UPOV for two main reasons. One is to increase investments in plant breeding and agriculture in general by raising trust among local and foreign breeders who believe in the effectiveness of UPOV system of plant variety protection. The other reason is the fact that Tanzania and other developing nations can only participate and influence international policy decisions on plant variety protection and utilization of plant genetic resources by becoming part of the system, otherwise in one way or the other, other countries will be making rules for Tanzania. 18 Till January 2009. Establishment of Plant Breeders’ Rights System 14 In Tanzania: Achievements and Challenges

Table 4. List of Officially Released Varieties of Selected Crops in year 2005- 2008 Species: Maize (Zea mays L.) Variety Year of Owner(s)/Maintainer Special attributes/Disease reaction release and seed source PAN 4 2004 Pannar (Pty) Ltd Good resistant to Cob rots, Leaf blight M-17 (Helminthrosporium turcicum), and Leaf Rust Good adaptability, stress tolerance, lodging resistance, and prolificacy PAN 4M- 2004 Pannar (Pty) Ltd Good resistant to Cob rots, Leaf blight 19 (Helminthrosporium turcicum), and Leaf Rust UH 6303 2004 ARI-Uyole Good resistant to Leaf blight (Helminthrosporium turcicum), and Grey Leaf Spot Longe 2004 Finca Seed Ltd Drought tolerant 6H Good poundability Early maturity TAN 2006 Tanseed International Good resistance to Maize streak virus, H611 Ltd Turcicum leaf blight, Cob rots, Grey leaf spot and Common rust Has twice level of essential amino acids: Lysine and Tryptophane than normal maize TAN 250 2006 Tanseed International Excellent resistance to Maize streak virus Ltd and Grey leaf spot, good resistance to Turcium leaf blight, Cob rot and Common rust TAN 254 2006 Tanseed International Good resistance to Maize streak virus, Ltd Turcicum leaf blight, Cob rots, Grey leaf spot and Common rust VUMILIA 2007 ARI Selian Very good resistant to Maize Sreak Virus K1 VUMILIA 2007 ARI Selian Good resistant to Maize Sreak Virus, cob H1 rots, leaf blight and rust WH 505 2007 Western Seed Co. Tolerant to Maize Streak Virus, Leaf blight, Ltd and rust WH 502 2007 Western Seed Co. Tolerant to Maize Streak Virus, Leaf blight, Ltd and rust WH 403 2007 Western Seed Co. Tolerant to Maize Streak Virus, Leaf blight, Ltd and rust Species: Paddy (Oryza sativa) Variety Year of Owners/Maintainer Special attributes releas and seed source e Kalalu 2006 SUA Resistant to Rice Yellow Mottle Virus and Rice blast Mwangaza 2006 SUA Resistant to Rice Yellow Mottle Virus and Rice blast Establishment of Plant Breeders’ Rights System 15 In Tanzania: Achievements and Challenges

Species: Wheat (Triticum aestivum.L) Variety Year of Owner(s)/Maintainer Special attributes/Disease reaction release and seed source Riziki –C2 2006 ARI Selian Moderate resistant to Stripe rust, Stem and Leaf rust RIZIKI – C1 2006 ARI Selian Moderate resistant to Stripe rust, Stem and Leaf rust Lumbesa 2006 ARI Selian Moderate resistant to Stripe rust, Stem and Leaf rust Species: Bean (Phaseolus vulgaris L.) Variety Year of Owner(s)/Maintainer Special attributes/ Disease reaction release and seed source Pesa 2006 SUA Moderate resistant and Angular Leaf Spot. Resistant to Bean Common Mosaic Virus and short to modern cooking time Mshindi 2006 SUA Moderate resistant to Angular Leaf Spot and Resistant to Bean Common Mosaic Virus Has short to modern cooking time Selian 05 2005 ARI Selian Resistant to Bean rust, Anthracnose, Mosaic Virus, and Halo blight SELIAN 06 2007 ARI Selian Resistant to Bean rust, Anthracnose, Mosaic Virus, and Halo blight CHEUPE 2007 ARI Selian Resistant to Bean rust, Anthracnose, Mosaic Virus, and Halo blight Species: Sesame (Sesamum indicum L.) Variety Year of Owner(s)/Mainta Special attributes/Disease rection release iner and seed source Lindi 02 2006 ARI Naliendele Tolerant to leaf spots, Cercoseptoria sesame, stem rot, and Fusarium spp. Susceptible to Flea beetles, (Alocyphe bimaculate) Good oil content: 55.61 % Species: Coffee (Coffea arabica) N 39-2 2005 TaCRI Resistant to Coffe Berry Diseases (Colletotrichum kahawae), Leaf rust (Hemileia vastatrix), Added advantage in bean size N 39-3 2005 TaCRI Resistant to Coffe Berry Diseases (Colletotrichum kahawae), Leaf rust (Hemileia vastatrix), Added advantage in bean size N 39-4 2005 TaCRI Resistant to Coffe Berry Diseases Establishment of Plant Breeders’ Rights System 16 In Tanzania: Achievements and Challenges

(Colletotrichum kahawae), Leaf rust (Hemileia vastatrix), Added advantage in bean size N 39-5 2005 TaCRI Resistant to Coffe Berry Diseases (Colletotrichum kahawae), Leaf rust (Hemileia vastatrix), Added advantage in bean size N 39-6 2005 TaCRI Resistant to Coffe Berry Diseases (Colletotrichum kahawae), Leaf rust (Hemileia vastatrix), Added advantage in bean size N 39-7 2005 TaCRI Resistant to Coffe Berry Diseases (Colletotrichum kahawae), Leaf rust (Hemileia vastatrix), Added advantage in bean size KP 423-1 2005 TaCRI Resistant to Coffe Berry Diseases (Colletotrichum kahawae), Leaf rust (Hemileia vastatrix), Added advantage in bean size KP 423-3 2005 TaCRI Resistant to Coffe Berry Diseases (Colletotrichum kahawae), Leaf rust (Hemileia vastatrix), Added advantage in bean size Species: Cashew (Anacardium occidentale L.) Variety Year of Ownner/Maintai Special alttributes/Disease reaction release nance and seed source AC 1 2006 ARI Naliendele Resistant to Powdery mildew, Anthracnose, and Die back AC 4 2006 ARI Naliendele Resistant to Powdery mildew, Anthracnose, and Die back AC 4/17 2006 ARI Naliendele Resistant to Powdery mildew, Anthracnose, and Die back AC 10 2006 ARI Naliendele Resistant to Powdery mildew, Anthracnose, and Die back AC 10/129 2006 ARI Naliendele Resistant to Powdery mildew, Anthracnose, and Die back AC 10/220 2006 ARI Naliendele Resistant to Powdery mildew, Anthracnose, and Die back AC 14 2006 ARI Naliendele Resistant to Powdery mildew, Anthracnose, and Die back AC 22 2006 ARI Naliendele Resistant to Powdery mildew, Anthracnose, and Die back AC 34 2006 ARI Naliendele Resistant to Powdery mildew, Anthracnose, and Die back AC 43 2006 ARI Naliendele Resistant to Powdery mildew, Anthracnose, and Die back AZA 2 2006 ARI Naliendele Resistant to Powdery mildew, Anthracnose, and Die back Establishment of Plant Breeders’ Rights System 17 In Tanzania: Achievements and Challenges

AZA 17 2006 ARI Naliendele Resistant to Powdery mildew, Anthracnose, and Die back AZA 17/79 2006 ARI Naliendele AZA 2006 ARI Naliendele Resistant to Powdery mildew, Anthracnose, 17/156 and Die back AZA 2006 ARI Naliendele Resistant to Powdery mildew, Anthracnose, 17/158 and Die back AC 4/285 2006 ARI Naliendele Resistant to Powdery mildew, Anthracnose, and Die back 6.6 Participation of Stakeholders in the Administration of PBR Act The Ministry of Agriculture Food Security and Cooperatives, through the Plant Breeders’ Rights Office, has continuously involved major stakeholders in running the office as well as in the process of improving operations of the office to implement the PBR Act. In the day to day administration of the PBR Act the stakeholders are involved through the PBR Advisory Committee which is composed of members representing various stakeholders. The Committee meets four times annually. Furthermore stakeholders are always involved before any major decision is made. Any matter that needs serious decisions is brought to the attention of the Committee where different opinions are discussed and conclusions submitted to the government for final decision. Between 2006 and 2008 the PBR Office has conducted three stakeholders’ workshops to discuss the implementations of the PBR Act. The participants to the workshops included representatives of relevant government ministries, representatives of Plant Breeders’ Association of Tanzania (PBAT), Tanzania Horticultural Association (TAHA) and Tanzania Seed Trade Association (TASTA). One of the most 19 important workshops was the one held in April 2007 to discuss report of an international study commissioned by TAHA in collaboration with the Ministry of Agriculture to assess stakeholder’s satisfaction with the processes of implementing the PBR Act. Another important workshop was organized by the PBR Office in November 2008 to discuss the issue of UPOV membership 20 . During this workshop, as it came out in other stakeholders’ workshops, it was agreed that there is a need for the country to join UPOV in order to fully realize the benefits of the plant variety protection system. The opinion has been presented to the government through the Ministry responsible for agriculture and the process has already been initiated to obtain Cabinet and Parliament approval to accede UPOV Convention of 1991 and also amend the Act to comply with the requirements of the Convention. Stakeholders were also involved during the process of developing an acceptable system for licensing of the protected public varieties to end users where draft ministerial policy paper and guidelines are now being improved through discussions with stakeholders. The policy paper is intended to put forward the procedure that will be followed to grant license to any applicant whishing to commercialize plant varieties developed and protected by government research institutions. The paper will also give formulae that will be used to charge royalties for such varieties. The ministerial guidelines will guide government institutions on how to use and share benefits arising from licensing of public varieties among institutions and individuals who contributed in one way or another in developing a particular variety. During the initial workshops and visits to meet individual stakeholders, it was observed that the level of awareness on the existence and provisions of the Plant Breeders’ Rights Act was very low among many stakeholders including local and foreign breeders and seed producers. However as the frequency of contacts between the officials of the Plant Breeders Rights Office and the stakeholders increased their awareness on the matter also went up. Stakeholders’ and general public awareness was also raised through distribution of PBR brochures and leaflets as well as through the media. It was however noted that more resources are needed to enable the office to prepare and disseminate different types of communication materials. As for foreign beneficiaries such as plant breeders, it has been leant that their awareness will be effectively raised when the country joins and follows the UPOV system of plant variety protection 19 Proceedings of the TAHA Stakeholders’ Workshop on PVP held in April in Arusha 20 Proceedings of the PBR Stakeholders’ Workshop on UPOV membership held in November 2008 in Kibaha Establishment of Plant Breeders’ Rights System 18 In Tanzania: Achievements and Challenges

6.7 Regional and International Collaboration The Plant Breeders Rights Office has established links with similar authorities in a number of countries which are implementing or are in the process of implementing plant variety protection regimes as well as international organizations related to intellectual property rights matters. As soon as the Office was established its officials were sent to Kenya and South Africa to get practical experiences from these countries which have been practicing the system for more than fifteen years. The officials and technicians of the Office have also attended courses on how to manage intellectual properties in Sweden and the Netherlands. In addition to bilateral links the office has also established useful links with international organization such as UPOV, CAS-IP and AVRDC World Vegetable Centre. The PBR Office has also been actively involved in the process of establishing a regional plant breeders’ rights system for the Southern Africa Development Community (SADC) which is made up of fourteen member states. A draft PBR protocol has been developed and is waiting for approval of the higher authority of the organization. The protocol is intended to establish a SADC Plant Breeders’ Rights Office that will be able to grant rights that that will be honoured in all member countries. This kind of arrangements has been very successfully practiced by European Union where as one PBR office grants a right that is honoured in all member states. The Office has also participated in the process of harmonizing seed policies and legislation in Eastern and Central African countries. Recently the office is coordinating efforts to expand these initiatives to include all 20 members’ states of African Regional Intellectual Property Organization (ARIPO). All these initiatives are aimed at reducing the cost of running a PBR system and increasing investments opportunities in the region. The Office has also used its experiences to assist other neighboring countries who are in the process of establishing legal and institutional frameworks for the protection of plant variety. A good example of this kind of cooperation is the recent assistance extended to Zambia by organizing a tour for officials of the Seed Control and Certification Institute which is designated to oversee implementation of the country’s PBR Act. In October 2008, expert from the Tanzanian PBR Office was also involved in developing draft Regulations for the operationalization of the Zambian PBR Act. The PBR Office has initiated contacts with PBR Authorities of a number of countries including Kenya, South Africa and the Netherlands to facilitate cooperation and exchange of DUS test results in the near future. 7. Lessons Learnt and Recommendations Based on the lessons lent from the findings of the study, the following recommendations are made for the benefit of the NPI countries that are practicing or intending to put in place a plant variety protection system: 1. A baseline study like the one conducted by the Ministry responsible for agriculture is necessary in order to decide whether or not there is a need for a plant variety protection system in a particular country 2. Internal consultations are necessary before a decision is to put in place a plant variety protection system 3. It is important to invest in physical infrastructure development and human resources through provision of short and long term trainings in order to build a credible plant variety protection system 4. In order for the country to benefit from the plant variety protection legal and institutional framework put up by a particular legislature, the authorities must continue to create awareness among stakeholders and the public in general 5. Although the Article 27 (3) (b) of the WTO’s TRIPS Agreement requires each country to put in place an effective sui generis system for the protection of plant varieties, each country must carefully study and choose an appropriate option that will produce maximum benefits. Countries should not just decide to put up a legal system just to meet TRIPS deadlines because putting up and running a plant variety protection system is a very expensive exercise. Establishment of Plant Breeders’ Rights System 19 In Tanzania: Achievements and Challenges

6. Regional collaboration may reduce the cost of putting up and running a plant variety protection system. 7. Furthermore wherever possible putting up and running a single plant variety protection office for a region is more cost effective and appropriate for increasing foreign direct investment in the region due to increased market size. 8. Since not all plant varieties meet conditions for protection, all research institutions should develop an IP policy that will give guidance on access and benefit sharing of innovations and are not coved under PVP legal regime. Establishment of Plant Breeders’ Rights System 20 In Tanzania: Achievements and Challenges

8. References African Model Law for the Protection of the Rights of Local Communities, Farmers and Breeders, and for the Regulation of Access to Biological Resources (2000) Erbisch, F. H. Basic Workbook in Intellectual Property Management, The Agricultural Biotechnology Support Project, Institute of International Agriculture, Michigan State University, (2005). FAO: Study on the need for a plant variety protection system in Tanzania (1996) International Union for the Protection of New Varieties of Plants (UPOV): UPOV Report on the Impact of Plant Variety Protection, Geneva, (2005). International Convention for the Protection of New Varieties of Plants: International Union for the Protection of New Varieties of Plants (UPOV), Geneva, (1991). Laurence R. Helfer, ‘Intellectual Property Rights in Plants Varieties: International Legal Regime and Policy Option for National Governments’, FAO (2004), at pg. 81. OAU, Organization of African Unity Model Law (2000) Philippe Cullet, ‘Food Security and Intellectual Property Rights in Developing Countries’, International Environmental Law Research Center Working Paper 2003-3. Philippe Cullet, ‘Plant Variety Protection in Africa: Towards Compliance with the TRIPS Agreement’, Journal of African Laws 45 1 (2001). Patricia Kameri-Mbote, ‘Community, Farmers’ and Breeders’ Rights in Africa: Towards a Framework for Sui Generis Legislation’, University of Nairobi Law Journal 2003. Philippe Cullet, ‘Plant Variety Protection in Africa: Towards Compliance with the TRIPS Agreement’, Journal of African Laws 45 1 (2001). South Centre, Trade Related Agenda, Development and Equity Working Papers: Options for the Implementation of Farmers’ Rights at the National Level (2000) World Bank, ‘Intellectual Property Rights: Designing Regimes to Support Plant Breeding in Developing Countries’, Agriculture and Rural Development Department, Report No. 35517- GLB (2006). United Republic of Tanzania, Protection of New Plant Varieties (Plant Breeders Rights) Act (2002) United Republic of Tanzania, Seeds Act (2003). Establishment of Plant Breeders’ Rights System 21 In Tanzania: Achievements and Challenges

Acknowledgements I wish to acknowledge the contributions of many players who in one way or another contributed to the successful completion of this report. In particular I would like to thank my employer, the Ministry of Agriculture Food Security and Cooperatives, for allowing me to take part in this collaborative study assignment and for availing important information used in this report. I also that CAS-IP for the financial and valuable moral support extended to me. I am also indebted to the NPI members who participated in the National Initiative Workshop held in January in Mombasa, Kenya for their suggestions which have been used to improve the study report. Establishment of Plant Breeders’ Rights System 22 In Tanzania: Achievements and Challenges

A Review of the Nigerian System of Intellectual Property A Case Study Under NABDA/CAS-IP NPI Collaboration Project Victor M. Ibigbami and Christopher U. Orji Intellectual Property Desk NABDA Email : orjiuchristopher@yahoo.com; viibigbami@yahoo.com National Biotechnology Development Agency (NABDA) (Federal Ministry of Science and Technology) 16 Dunukofia Street (Former CAC Building), Area 11, Garki, P. M. B. 5118 WUSE, ABUJA, NIGERIA. PHONE: 234-9-6715691-2, 234-3145473, Fax: 2345472 Email: nabdamails@yahoo.co.uk Website: www.nabda.gov.ng

Contents Executive Summary Acronyms Chapter 1 Introduction 7 1.1 Background 1.2 Materials and Methods 1.3 Purpose of the Study Chapter 2 Intellectual Property Laws And Administrative Framework 8 In Nigeria 2.1 IP administration in Nigeria 2.2 International IP Conventions relevant to Nigeria 2.3 World Trade Organization’s TRIPS and related Conventions 2.4 US Supreme Court Judgment on the patenting of microorganisms 2.5 Reform of Nigeria’s IP laws in conformity with TRIPS 17 Chapter 3 National Office For Technology Acquisition And Promotion (NOTAP) – Experience In Intellectual Property And Technology Transfer Management 3.1 NOTAP–Formation and mandate 3.2 Establishment of Intellectual Property and Technology Transfer Offices (IPTTOS) 3.3 Patent Information and Documentation Centre (PIDC 3.4 Functions of NOTAP on Patent 3.5 Patent Applications Filed and Granted 3.6 Developing Intellectual Property Culture in Nigeria 3.7 Promotion of Incentive/ Reward System Chapter 4 The Place of IP In Nigeria’s Research System 23 Agricultural research 4.1 4.2 The Bay-Dole Act (Small Business Patent Procedures Act) and IP in Nigeria 4.3 Policy Linkage of Nigerian R & D Institutions 4.4 National Biotechnology Development Agency (NABDA) 4.5 OBD-Plus Technology- a Nigerian Microbial Invention 4.6 Nigeria’s Draft National Biosafety Bill and the Cartagena Protocol 4.7 National Varietal Release Committee and the National Agricultural Seed Service (NSS) 4.8 Space and Information Technology Strategies A Review of the Nigerian System of Intellectual Property 1

30 Chapter 5 Case Study of A Licensed Nigeria Patent- Development of Nicosan / Hemoxin: A Drug For The Management of Sickle Cell Disease 5.1 Historical background 5.2 The birth of NICOSAN/HEMOXIN 5.3 About sickle cell disease 5.4 Hope for the Sicklers 5.5 Production and Marketing of NICOSAN by Xechem Pharmaceuticals Ltd 5.6 Intellectual Property issues arising from NICOSAN 5.7 Challenges in the Commercialization of NICOSAN Chapter 6 Lessons and Recommendations Of The Study 34 Chapter 7 Conclusion 37 38 Acknowledgements A Review of the Nigerian System of Intellectual Property 2

Executive Summary Intellectual Property (IP) in Nigeria can be traced back to the colonial era when the English Trademark Ordinance was introduced into the colonies even before the amalgamation of the then British Northern Nigeria and Southern Nigeria Protectorates to form what is today called Nigeria in 1914. Intellectual Property is administered in Nigeria under two main set ups- industrial property, which deals with trademarks, patents and industrial designs as well as copyright. The system of Trademark registration is governed by the Trademarks Act 1965 found in Cap 436 Laws of the Federation of Nigeria(LFN)1990. Patents and Designs registration on the other hand are governed by the Patents and Designs Act 1970, to be found in Cap 344, Laws of the Federation of Nigeria 1990. The Trademarks, Patents and Designs Laws are currently administered by the Commercial Law Department, Trademarks, Patents and Designs Registry, of the Federal Ministry of Commerce and Industry. Copyright on the other hand is protected in Nigeria by the Copyright Act and the Nigerian Copyright Commission (NCC), an agency under the supervision of the Federal Ministry of Justice, NCC is charged with the primary responsibility for all copyright matters. National and International developments have necessitated reforms in the intellectual property system of different countries of the world. The World Trade Organization’s TRIPS (Trade Related Aspect of Intellectual Property Right) Agreement of 1994, obliges members to provide intellectual property protection in its laws. TRIPS established minimum standards for the availability, scope, and use of seven forms of intellectual property: copyright, trademarks, geographical indications, industrial designs, patents including (Plant Variety Protection, PVP), layout designs for integrated circuits and undisclosed information (trade secrets). On living organisms, WTO allows countries to patent microorganisms but requires countries to use a sui generis( ie other, different) system to protect new plant and animal varieties or by the application of the two types of protection. As a WTO member, Nigeria is under obligation to reform its intellectual property laws in this direction though in line with AU Model Law which disapproves the patent of any life form. The mandatory requirement for amending the laws was January 1, 2000 while the time frame set for implementation was 2005 subject to extension. Recently in Nigeria (2006), there had been recommendations and steps taken for the different Intellectual Property schedules to be placed under one umbrella institutional framework for effective administration and management. To this extent there was a proposal to establish Nigerian Intellectual Property Organization (NIPO) by the Ministry of Science & Technology and NOTAP, to bring all the agencies under one umbrella similar to the WIPO system and ensure an effective and balanced development of the IP system in the country. The quest for a paradigm shift in the framework led to a move to secure the approval by the then President Olusegun Obasanjo of the Intellectual Property Commission of Nigeria (IPCON) under the aegis of the Federal Ministry of Justice, thus bringing the Nigerian Copyright Commission and the Registry of Trademark, Patents and Design together under one umbrella organization to be hosted by the Federal Ministry of Justice with the view that IP is a judicial matter. A draft national IP bill seeking to conform to WTO was prepared by a committee with members drawn from the stakeholder institution. The draft bill includes Plant Breeders Rights, Animal Breeders Rights and Farmers Rights. But there is the need to re-examine the proposed draft bill and the umbrella IP body it is seeking to create in view of experiences in other countries of the world and the expectations from the reform. This will enable Nigeria to benefit from the gains associated with the WTO’s TRIPS including associated increased investments and trade in agriculture and biotechnology. There is also the possibility of sanctions from the WTO if Nigeria continues to delay the reform process. The National Office for Technology Acquisition and Promotion (NOTAP), an agency under the aegis of the Federal Ministry of Science and Technology, established by Decree No. 70 of 1979 also plays important role in Intellectual Property and Technology Transfer (TT) Management in Nigeria. It does this by assisting researchers to patent their inventions free of charge, patent documentation, establishment of technology transfer offices in the universities and research institutes, awareness creation to increase the culture of patent in the country and assisting in licensing and commercialization. Records available at NOTAP shows that for the period 1998-2007(10years) the non-conventional (local) patents filed at the Trademarks, Patent and Designs Registry was 566 representing 11.7% of the total applications filed, while the conventional (foreign) patents filed was A Review of the Nigerian System of Intellectual Property 3

4,257 representing 88.3% of the total patents filed. For patents granted, non-conventional (local) has 318 applications granted representing 11.7% of the total granted, while the conventional (foreign) has 2,398 representing 88.3% of the total number of patents granted. Also considering the challenges and the objectives of establishing the Agricultural Research Council of Nigeria (ARCN), the Council has plans of setting up a central IP management body to be housed in its Legal Unit to coordinate intellectual property issues in the agricultural research institutes. This is because the council is aware that the public goods investments policy in agriculture is facing a bleak future for a number of reasons principal amongst which are: Increased emphasis on market mechanisms facing public funded organizations to respond to broad economic opportunities, and changes brought about by the introduction of intellectual property rights (IPR). The National Council on Science and Technology (NCST) and the newly formed Nigerian. Research and Development Coordinating Council (NRDCC) are important organs through which S&T policy issues affecting R&D such as Intellectual Property can be harmonized for the growth of R&D in Nigeria. A few recommendations have been offered. A study need to be carried out to determine which model of IP office the country should adopt- an umbrella body or a decentralized system of having the different IP registries in different ministries. This will enable the country overcome the present impasse in creating an umbrella agency. Irrespective of the outcome of the exercise, one clear observation under the new dispensation is that Plant Varieties Protection (PVP), Animal Breeders Rights, Farmers Rights and microorganisms are sui generis (unique, different), technological patents going by the WTO and extended by the AU Model Law which does not allow the patent of any life form. This implies that they are not to be administered within the existing IP frameworks is the trend in most other countries, and these are usually located within the technology system of the country for a balanced development. It is thus recommended that the National Crop Varieties and Livestock Breeds Registration and Release Committee Decree 33 of 1987 be amended to include Plant Variety Protection (PVP), Animal Breeders Rights, and Farmers Rights. The Committee is currently administered by the National Centre for Genetic Resources and Biotechnology (NACGRAB). Another recommendation is to enact a National Biotechnology Law. This will give a legal backing to the establishment of the National Biotechnology Development Agency (NABDA), regulate research on microorganisms in terms of IP, and regulate biotechnology research with respect to benefit sharing on biopharmaceuticals and nutraceuticals from bioresources. Alternatively, two separate laws on new plant varieties protection and to provide for a sui generis system for new microorganisms respectively should be enacted. Also the lessons offered by the licensing of NICOSAN- a drug developed by the National Institute of Pharmaceutical Research and Development (NIPRD) through a lead from traditional knowledge but licensed to Xechem International, an American company, could be useful in the exploitation of our rich genetic resources for disease control and wealth creation if harnessed. A Review of the Nigerian System of Intellectual Property 4

Acronyms AARD Agency for Agricultural Research and Development AU-STRC African Union Scientific, Technical and Research Commission ARCN Agricultural Research Council of Nigeria AU Africa Union BRELA Business Registration and Licensing Agency CAS-IP Central Advisory Service on Intellectual Property CHOP Children’s Hospital, Philadelphia CPB Cartagena Protocol on Biosafety CGIAR Consultative Group on International Agricultural Research CBD Convention on Biological Diversity CIPRO Companies and Intellectual Property Registration Office DTI Department of Trade and Industry EMBRAPA Brazil Agency for Agricultural Research, and Development FMST Federal Ministry of Science & Technology FDA Food and Drug Administration FGN Federal Government of Nigeria GI Geographical Indications ICANN Internet Corporation for Assigned Names and Numbers ICT Information and Communication Technology IP Intellectual Property IPCON Intellectual Property Commission of Nigeria IPR Intellectual Property Right IPS Intellectual Property System IPTTO Property and Technology Transfer Offices LFN Laws of the Federation of Nigeria MARDI Malaysia Agricultural Research and Development Institute NABDA National Biotechnology Development Agency NAFDAC National Agency for Food and Drug Administration and Control NASRDA National Space Research and Development Agency NARI National Agricultural Research Institutes NARS Nigeria Agricultural Research System NCC Nigerian Copyright Commission NCST National Council of Science and Technology NCST Nigerian Council on Science and Technology NGO Non-Governmental Organizations NHLBI-SCDR National, Heart Lung and Blood Institute, Sickle Cell Disease Lab Reference Laboratory NICTIB National Information and Communication Technology Infrastructure Backbone NIGCOMSAT Nigeria Communication Satellite NIPO Nigeria Intellectual Property Organization NIPRD National Institute of Pharmaceutical Research and Development NITDA National Information Technology Development Agency NJAES New Jersey Agricultural Experiment Station NNMDA Nigeria Natural Medicine Development Agency(NNMDA). NOIP National Office of Industrial Property. NOTAP National Office for Technology Acquisition and Promotion NPI National Partners Initiative NRDCC National Research and Development Coordinating Council A Review of the Nigerian System of Intellectual Property 5

NSS National Seed Service. NUC National Universities Commission OFAR On Farm Adaptive Research PBR Plant Breeders Rights PCT Patent Cooperation Treaty PDC Patent Information and Documentation Centre PIC Prior Informed Consent PROMETRA International Association for the Promotion of Traditional Medicine PVP Plant Variety Protection, R&D Research and Development RI Research Institute SACRO South African Companies Registration Office SAPTO South African Patents & Trade Marks Office SCD Sickle Cell Disease SHESTCO Sheda Science and Technology Complex S&T Science and Technology TMKP Traditional Medicine Knowledge and Practice TRIPS Trade Related Aspect of Intellectual Property Right TT Technology Transfer TTO Technology Transfer Offices UNIDO United Nations Industrial Organization. UPOV Union for the Protection of Plant Varieties VCU Virginia Commonwealth University WHO World Health Organization WIPO World Intellectual Property Organization A Review of the Nigerian System of Intellectual Property 6

1. Introduction 1.1 Background of the Study Intellectual property protection in Nigeria can be traced back to the colonial era, when the English Trademarks Ordinance was introduced into the colonies, even before the amalgamation of northern and southern protectorates to form what is now called Nigeria, in 1914. Intellectual Property is administered in Nigeria under two main set ups. Intellectual Property is administered in Nigeria under two main set ups- Industrial property, which deals with trademarks, patents and industrial designs as well as copyright The system of Trademark registration is governed by the Trademarks Act 1965 found in Cap 436 Laws of the Federation of Nigeria 1990. Patents and Designs registration on the other hand are governed by the Patents and Designs Act 1970, to be found in Cap 344, Laws of the Federation of Nigeria (LFN) 1990. The Trademarks, Patents and Designs Laws are currently administered by the Commercial Law Department, Trademarks, Patents and Designs Registry, of the Federal Ministry of Commerce and Industry. Copyright on the other hand is protected in Nigeria by the Copyright Act. One of the most salutary provisions of the Act is the establishment of a body charged with the responsibility of implementing and enforcing the law. Section 30 of the Act established the Nigerian Copyright Commission (NCC). An agency under the supervision of the Federal Ministry of Justice, NCC is charged with the primary responsibility for all copyright matters. National and International developments have necessitated reforms in the intellectual property system of different countries of the world. The World Trade Organization’s TRIPS (Trade Related Aspect of Intellectual Property Right Agreement of 1994, obliges members to provide intellectual Property protection in its laws. TRIPS established minimum standards for the availability, scope, and use of seven forms of intellectual property: copyright, trademarks, geographical indications, industrial designs, patents, layout designs for integrated circuits and undisclosed information (trade secrets). As a WTO member, Nigeria is under obligation to reform its intellectual property laws in this direction. WTO TRIPS has however provision for sui generis (unique, standalone) IP systems for which the AU Model Law endorsed by all African Heads of State, has given guidelines to African countries. National Biotechnology Development Agency (an agency in the Federal Ministry of Science and Technology ) is participating in the National Partners Initiative(NPI), a programme of the Central Advisory Service on Intellectual Property(CAS-IP) of the Consultative Group on International Agricultural Research(CGIAR) which is based in Rome, Italy. The aim of the NPI is developing an international network of intellectual Property (IP) experts involved in issues relating to management of IP in agriculture. CAS-IP NPI is doing this because it believes that IP management should be about ensuring that research outputs are accessible for use to benefit those who need them most- resource poor farmers. CAS-IP aims to enable access to, and the use of CGIAR products for the benefit of the poor through effective IP and technology transfer management. Twelve countries are participating in the NPI: Burkina Faso, India, Indonesia, Kenya, Malaysia, Nigeria, Peru, Philippines, Tanzania, and Thailand. The review of Nigeria’s IP policies, with a view to making recommendations for reform towards agricultural development in line with the objectives of the CAS-IP NPI and using the TRIPS and AU Model Law tools is a major objective of this paper. Issues discussed include Nigeria IP laws, and the framework for administration, the Copyright Notification System of the National Copyright Commission (NCC), the experience of the National Office for Technology Acquisition and Promotion (NOTAP) in promoting IP and TT and the role of the R & D system in promoting IP. The case study of NICOSAN - a drug for the management of Sickle Cell Disease as a licensed Nigerian patent was also discussed. 1.2 Objectives of the Study The study seeks to review the Nigerian system of Intellectual Property and Technology Transfer management viewed against the country’ s obligations as a WTO and AU member. It makes recommendations that will guide our policy makers as they try to reform our IP system to meet our A Review of the Nigerian System of Intellectual Property 7

national aspirations and as well conform with international standards. It tries to recommend legal and administrative framework needed for the reform. It is also hoped that Nigeria’s experiences in IP management when it is shared will offer a few lessons to other NPI participating countries either by avoiding Nigeria’s mistakes or in following Nigeria’s footsteps where it can make any positive contribution. 1.3 Materials and Methods To achieve the objectives of the study all available documents on the Nigerian system of intellectual property were reviewed. This was intended to review operations in the IP institutions. Some documents relating to Nigeria’s S & T policies as well as biotechnology policy were also reviewed. The institutions from which documents were reviewed include -Trademarks, Patents and Designs Registry, Nigerian Copyright Commission(NCC), Xechem Pharmaceuticals Ltd, Federal Ministry of Science and Technology, Federal Ministry of Commerce and Industry, Agricultural Research Council of Nigeria (ARCN), Sheda Science and Technology Complex, National Office for Technology Acquisition and Promotion(NOTAP), National Biotechnology Development Agency(NBDA), Nigeria Natural Medicine Development Agency (NNMDA) and National Centre for Genetic Resources and Biotechnology(NACGRAB). This study coincided with another study on the Compendium on Intellectual Property in the developing countries conducted by CAS-IP’s NPI. Questionnaires administered on the Nigerian system of IP for that purpose were also useful for this study. Interview from some officials of the major stakeholders of the system were also conducted including officials of National Agency for food and Drug Administration and Control (NAFDAC) and National Institute Pharmaceutical Research and Development. Websites of some relevant institutions were also visited including Africa Union (AU), WIPO, UPOV, Xechem International Inc. and Rutgers State University, New Jersey, USA. 2. Intellectual Property Laws and Administrative Framework In Nigeria 2.1 IP administration in Nigeria Intellectual property protection in Nigeria can be traced back to the colonial era, when the English trademarks ordinance was introduced into the colonies, even before the amalgamation of northern and southern protectorates to form what is now called Nigeria, in 1914. Intellectual Property is administered in Nigeria under two main set ups. i. Industrial property, which deals with trademarks, patents and industrial designs. The system of Trademark registration is governed by the Trademarks Act 1965 found in Cap 436 Laws of the Federation of Nigeria 1990. Patents and Designs registration on the other hand are governed by the Patents and Designs Act 1970, to be found in Cap 344, Laws of the Federation of Nigeria (LFN) 1990. The Trademarks, Patents and Designs Laws are currently administered by the Commercial Law Department, Trademarks, Patents and Designs Registry, of the Federal Ministry of Commerce and Industry1. The country has no legislation for Geographical Indications (GI). GI is administered as part of Trademarks under Section 43(1) of the Trademarks Act CAP 436(Certification Trademarks), Laws of the Federation of Nigeria (LFN) 19902. 1 Yauri Shafiu Adamu (Senior Asst. Registrar Trademarks, Patents and Designs Registry; Federal Ministry of Commerce and Industry, Old Secretariat, Area 1, Garki, Abuja) The System Of Intellectual Property Law And The Registration Framework In Nigeria: a paper contribution. 2 See http//: www.nigerianlaws.com A Review of the Nigerian System of Intellectual Property 8

A major drawback in the registry is inadequate funding which has not enabled it to re-tool sufficiently to meet international standard especially in the area of database management. This calls for a review of the status of the registry with a view to giving it some degree of autonomy. i. Copyright Copyright on the other hand is protected in Nigeria by the Copyright Act 3 . Nigeria is a member of the Berne Union 4 . Consequently, Nigeria is bound by the formality-free principle of copyright protection. Copyright protection in Nigeria is thus granted by the law automatically. Under the Nigerian Copyright law, beyond satisfying the basic requirement of originality and fixation in tangible medium from which it could be perceived or communicated, every copyright work is protected upon their creation with the import that copyright protection is automatic. There is no requirement of copyright registration under the Copyright Act. However, owing to the need to satisfy the constant yearning of right owners for a framework for establishing evidence of existence of works, especially unpublished materials, and pursuant to its statutory mandate to maintain a data bank of all authors and their works, the Nigerian Copyright Commission has introduced the Copyright Notification scheme, which allows authors of copyright works to notify the Commission of the creation and or existence of works, and all other information relating to the work. One of the most salutary provisions of the Act is the establishment of a body charged with the responsibility of implementing and enforcing the law. Section 30 of the Act established the Nigerian Copyright Commission (NCC). An agency of the Federal Ministry of Justice (earlier created under the Federal Ministry of Information), NCC is charged with the primary responsibility for all copyright matters. With the 1992 and 1999 amendments, the powers of the Commission have been expanded to cover enforcement of the law. Consequently, the Commission can appoint copyright inspectors who 5 are empowered to conduct investigation and prosecute copyright infringement cases . The inspectors have powers analogous to the powers of a police officer. The Commission is also empowered to make regulations prescribing conditions necessary for engaging in business involving the production, distribution or public exhibition of copyright works. 6 This power has served as a powerful tool in initiating some important rights management schemes, which are aimed at creating a favorable environment for the exercise of rights by authors and right owners 7 . The unfortunate byline is the low patronage of the scheme by authors and copyright owners. Between 2005 when the scheme was introduced in its present form and June 2008, the NCC received 995 applications only 8 . 3 Cap 68 Laws of the Federation of Nigeria 1990 as amended by Copyright (Amendment) Decree No.98 of 1992, and Copyright (Amendment) Decree No.42 of 1999. The Copyright Act was promulgated in 1988 as Copyright Decree No. 43 of 1988. 4 Nigeria became a member of Berne Union in 1993. 5 See Section 32A of the Act 6 Section 37 (4) of the Copyright Act. 7 Adewopo Adebambo; Framework for Copyright Registration: a Case Study of the Copyright Notification Scheme of the Nigerian Copyright Commission(NCC) , A paper submitted by the Director General, Nigerian Copyright Commission to the National Biotechnology Development Agency as part of the Case Study on the System of IP in Nigeria. 8 Data obtained from the Copyright Notification desk at NCC. Out of the 995 applications, literary works had 641, sound recordings 209, cinematograph film 115, artistic works 20, musical works 2, transfer of rights 8. A Review of the Nigerian System of Intellectual Property 9

Table 1: Applications received by Nigerian Copyright Commission Between 2005 and June 2008 TYPE OF COPYRIGHT NO. OF APPLICATIONS LITERARY WORKS 641 SOUND RECORDINGS 209 CINEMATOGRAPH FILM 115 ARTISTIC WORKS 20 MUSICAL WORKS 2 TRANSFER OF RIGHTS 8 TOTAL 995 20, 2, 8 115 209 641 This does not reflect the robust capacity of the creative industries today in Nigeria. For instance the Nigerian film industry often called Nollywood is ranked as one of the most vibrant in the world. The often cited reason for this low patronage is low level of awareness among authors. While such may A Review of the Nigerian System of Intellectual Property 10

hold true for some authors, especially the uneducated ones, we cannot say the same of the more enlightened sections of the creative industries. On a positive note however, the Copyright Notification is already beginning to prove its utility in cases of disputes. In a number of court cases, parties have been known to rely on the Copyright Notification Certificate to advance their claims. More so, some producers of works and prospective licensees now insist on documentary evidence of copyright ownership before accepting works for reproduction or signing any user license. The National Film and Video Censors Board has also prescribed as a condition for accepting a film for censorship and classification, the possession of a Copyright Notification Certificate issued by the NCC. These developments will hopefully strengthen the legal and administrative initiatives towards entrenching an effective rights management regime in the copyright industries. 2.2 International IP Conventions relevant to Nigeria The above IP laws are designed and tailored substantially along with international treaties and conventions on intellectual property. The following are international IP conventions that Nigeria has endorsed. i. The Universal Declaration of human rights (Article 27), which includes, the right to benefit from the protection of authorship of any scientific, literary, or artistic production. ii. The Paris Convention for the Protection of Industrial Property of 1883 was the first international agreement on the protection of intellectual property rights. It deals with only industrial property as other forms of Intellectual Property Rights (IPR) were considered non-industrial in nature. The convention conveys protection of trademarks, patents and industrial designs. iii. The Berne Convention of 1886 covers literary and artistic works. Nigeria became a member of the Berne Union in 1993. iv. The Rome convention of 1961 provides protection to producers of phonograms and broadcasting organization. v. The PCT, Patent Cooperation Treaty facilitate patent filing in different PCT member states, using a streamlined procedure. • Some important International IP Conventions that Nigeria has not endorsed include the following: i. Madrid System for the International Registration of Marks. The Madrid Protocol was adopted in June 1989 and entered into force in 1995. The protocol is one of two treaties comprising the Madrid System for international Registration of Trademarks. The first treaty, the 1891 Madrid Agreement provides for the registration of trademarks in several countries through the filing of one international trademark registration with WIPO. ii. Union for the Protection of Plant Varieties (UPOV) which will be discussed here later. 2.3 World Trade Organization’s TRIPS and related Issues. 2.3.1. World Trade Organization’s TRIPS The World Trade Organization’s TRIPS (Trade Related Aspects of Intellectual Property Rights) 9 Agreement of 1994 obliges members to provide IP protection in their laws. TRIPS establish minimum standards for the availability, scope, and use of seven forms of intellectual property: copyright, trademarks, geographical indications, industrial designs, patents (including Plant Variety Protection i.e. Plant Breeders Right), layout designs for integrated circuits and undisclosed information (trade secrets). TRIPS spelt out permissible limitations and exceptions in order to balance the interests of IP with interests in other areas, such as public health and economic development. TRIPS is unique among other IPR accords because membership in the WTO is a “package deal” meaning that WTO members are not free to pick and choose among agreements. They are 9 http//:www.wto.org A Review of the Nigerian System of Intellectual Property 11

subject to all the WTO’s multilateral agreements. However, it allowed countries to exclude from protection “plants and animals other than microorganisms”. It does require that countries provide for protection of plant varieties either by patents or by an effective sui generis (literally meaning of its own kind/genus or unique in its characteristics 10 or stand alone 11 ) system e.g. PVP or by applying both systems. The adoption of the Agreement also covered enforcement objectives that members are required to comply with and also provides for transitional period for compliance by members. The mandatory requirement for amending the laws was January 1, 2000 while the time frame set for implementation was 2005. The concerns of developing countries that TRIPS will not adequately compensate them as sources of genetic resources while they lack the capacity to compete in technologies that will generate patents is noteworthy. Indigenous communities also believe that all life forms and life creating processes are sacred and should not be subject to proprietary ownership. There are therefore calls for review of aspects of TRIPS. This has prompted the AU to develop a Model Law to guide member countries to develop national laws on some of the contentious areas. One major drawback of TRIPS is that it did not set definite guidelines nor was any mechanism put in place to assist countries in the reform of their laws. Implementation of the reform was left at the mercy of national bureaucrats who may be tempted to influence the process to the advantage of their institutions. 2.3.2 TRIPS and Biotechnology Inventions Under Article 27, TRIPS obliges patents for both processes and products, to be granted in all fields of technology. Article 27.3 (b), however allows the exclusion of plants and animals and essentially biological processes for their production from patent grant but obliges the protection of microorganisms and microbiological or non-biological processes for their production. In this regard issues like microbes, genes, gene sequences, genetic engineering and bioinformatics become very relevant as they are important processes of biotechnological inventions which are often carried out through genetic modification. However, there are a lot of microbiological discoveries that does not involve genetic modification. Another key concern of IP and biotechnology is the patenting of research tools or the grant of overly broad patents that could potentially block useful research 12 . TRIPS provide a way out under Article 30 on exceptions to patent rights and Article 31 on other use without the authorization of the patentee. Article 30 allows limited exclusions to the rights conferred by the patent “provided that such exceptions do not unreasonably conflict with a normal exploitation of a patent and do not unreasonably prejudice the legitimate interests of the patent owner”. Significantly under this provision interests of third parties such as non commercial users of patented product and process for research and experimental purposes would be permitted 13 . 2.3.3. Union for the Protection of Plant Varieties (UPOV) The purpose of this Convention Union pour la Protection des Obtentions Végétales (UPOV) or the International Union for the Protection of New Varieties of Plants signed in 1961 with its latest amendment in 1991 is to ensure that the members of the Union acknowledges the achievement of breeders of new plants by granting to them an intellectual property right on the basis of a set of clearly defined principles. Plant Variety Protection is a patent required under TRIPS but on a sui generis basis. Nigeria has no Plant Variety Protection Act. It is worthy of note that many UPOV member countries have reported increases in plant breeding activities with direct effect on their agricultural industries. 10 Dictionary.com quot;Word of the dayquot; 2001-06-14 [1] accessed 2007-10-14. In http://en.wikipedia.org/wiki/Sui_generis 11 http://en.wikipedia.org/wiki/Plant_breeders' right 12 Watal, J (2000) Intellectual Property and Biotechnology: trade interests of developing countries. Int. J. Biotechnology, Vol. 2, Nos 1/2/3, 2000. 13 Ibid A Review of the Nigerian System of Intellectual Property 12

United Kingdom combined the Plant Variety Protection and the Seed Act and enacted the Plant Variety and Seeds Act 1964 (UK). 14 The US on its part passed the Plant Variety Protection Act 1970 (US). This legislation provided protection to developers of novel, sexually reproduced plants. However, the United States originally acceded to the UPOV Convention on the basis of the Plant Patent Act of 1930 that provided for the patent of only asexually reproduced plants and did not bring the PVP Act into compliance with UPOV requirements until 1984 when the Commissioner of Plant Variety Protection promulgated rules to do so. Since the 1980s, the US Patent Office has granted patents on plants, including plant varieties: this provides a second way of protecting plant varieties in the USA. The landmark Supreme Court decision of Diamond v. Chakrabarty, 447 U.S. 303 (1980), suggested the possibility of securing utility patents on plants previously thought eligible solely for protection under the PVP Act. Two decades later, in the 2001 decision of J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc., 534 U.S. 124 (2001), the Court conclusively held that sexually reproduced plants eligible for protection under the PVPA are also eligible for utility patents. Like USA, Australia passed the Plant Variety Protection Act 1987 and the Plant Breeders Rights Act 1994. Australian patent law also permits the patenting of plant varieties. In total, 65 countries have signed the UPOV Convention and adopted plant breeders' rights legislation consistent with the requirements of the convention. 2.3.5 Convention on Biodiversity The Convention on Biological Diversity (CBD), which came into effect in 1993, reflects some issues of IP. The CBD which came into effect in 1993 was originally intended to preserve biological diversity, but its objectives also include the implementation of fair and equitable sharing of the benefits arising from the use of genetic resources. With regard to the handling of genetic resources, the CBD stipulates that each country has sovereign rights over its natural resources (Article 15, Paragraph 1), that access to genetic resources requires prior informed consent (PIC) of the contracting state providing the resources (Article 15, Paragraph 5), and that measures shall be taken with the aim of sharing in a fair and equitable way the results of research and development based on genetic resources, and the benefits arising from the commercial and other use of genetic resources, with the contracting state providing the genetic resources (Article 15, Paragraph 7). The link between IPR and CBD originated from the concept of ‘bioprospecting’ (in contrast to other forms of prospecting such as oil prospecting). In searching for new chemical entities or useful characteristics, some research based industries have found it profitable to screen natural resources such as soil samples, marine waters, insects, tropical plants and genes in developing countries. Some feel that, as compared to the conventional system of screening millions of synthesized chemicals, bioprospecting especially if further based on traditional knowledge, may even cut costs of pharmaceutical R&D. The link to IPRs arises from the fact that in many instances, the bioprospecting or their licenses are granted patent right over these products without any acknowledgement of the contribution of countries/regions of origin or of indigenous communities/individuals. Developing countries like Nigeria are demanding that when profits are reaped through bioprospecting, benefits and technologies developed should be shared with the original suppliers of genetic resources or traditional knowledge. This forms part of the objectives of the African Model Law in the aspect dealing with Community Rights. The recent licensing of the patent of NICOSAN-a drug for the management of Sickle Cell disease by an American Company is a good example. Originally discovered through indigenous knowledge the drug was developed in Nigeria by NIPRD using tropical herbs. The case study of NICOSAN is presented at a latter part of this study. The formation of drug based biotechnology companies in many countries of the world is on the basis of research results from genetic resources (bioresources) as illustrated with NICOSAN. 14 http://en.wikipedia.org/wiki/Plant_breeders' right A Review of the Nigerian System of Intellectual Property 13

As of January 2007, 190 countries have become parties to the Convention. The CBD recognizes the sovereign right of countries over their genetic resources. However, it does not provide any specific mechanisms of benefit sharing, so in actuality, although there are cases where benefit sharing has taken place as expected, for the most part there has continued to be conflict between developing countries like Nigeria as the holders of genetic resources and developed countries as the users of those resources. 2.3.4. African Model Legislation - for the Protection of the Rights of Local Communities, Farmers and Breeders, and for the Regulation of Access to Biological Resources. The African Model Legislation (also called the African Model Law) which took effect in 2000 deals with access to biological resources, benefit sharing and the right of breeders and farmers over their knowledge and resources. The law crafted under the sui generis option is intended to guide member countries to enact their Plant Variety Act/Plant Breeders Right, Animal Breeders Right and Farmers Rights in line with WTO TRIPS. It also includes guidelines on benefit sharing for individuals and local communities for genetic resources as provided by the Convention on Biodiversity (CBD) as well as guidelines on the patent of life forms which it does not approve on the ground that life is sacred and should not be subject to property ownership like patent. The implication of no patent for all life forms could be that only a sui generis system and not the existing IP mechanisms could be employed to patent all living organisms including microorganisms. A few African countries have already enacted the PBR such as Kenya. South Africa has operated PBR for over 15years as at 2008. Also Tanzania more recently enacted the PBR. All African Heads of State have signed AU Model Law but only very few have reviewed their IP laws in line with it. 2.4. U.S. Supreme Court judgment on the patenting of micro-organisms (1980) The United States Supreme Court judgment that permits the patenting of microorganisms is instructive to us in Nigeria particularly in respect of biotechnology. Tagged Diamond v Chakrabarty (1980), the judgment is based on the law that provides for the issuance of a patent to a person who invents or discovers quot;anyquot; new and useful quot;manufacturequot; or quot;composition of matter.quot; The respondent in 1972 filed a patent application relating to his invention of a human-made, genetically engineered bacterium of the genus Pseudomonas capable of breaking down crude oil (thus used for bioremediation of oil polluted soils), a property which is possessed by no naturally occurring bacteria to that level of efficiency. A patent examiner's rejection of the patent application's claims for the new bacteria was affirmed by their Patent Office Board of Appeals on the ground that living things are not patentable subject matter under that section of the law. The Court of Customs and Patent Appeals reversed the judgment, concluding that the fact that micro-organisms are alive is without legal significance for purposes of the patent law. This appeal court judgment was upheld by US Supreme court and forms the basis for patenting microorganisms in US 15 . Japan and Europe are following this model by patenting micro-organisms. WTO TRIPS provision on microorganisms also follows this model by allowing for the patent of microorganisms. The AU Model Law however rejects the patent of any living organism. If Nigeria should adopt the AU Model, then only a sui generis system that is different from the present patent law in Nigeria can be used to protect any existing but newly discovered microorganism, or a newly created microorganism which is often achieved by genetic engineering/modification technique. 2.5. Reform of Nigeria’s IP laws in conformity with TRIPS It is noteworthy that, the Nigerian IP legal framework seems to have been tailored towards what obtained in Britain/United Kingdom, which colonized Nigeria and established a system similar to what its home government had on ground. 15 http://supreme.justia.com/us/447/303/ A Review of the Nigerian System of Intellectual Property 14

But despite the country’s active participation in international conventions as outlined above and growing interest in IPR’s protection in the international scene, the colonial model had persisted without considerable variation. It is only recently that the nation’s legislation on IP is being reviewed in conformity with WTO/TRIPS obligation. Presently the country has no legislations on Geographical Indications, Plant Varieties Protection (Plant Breeders Right), Integrated Circuit Design, Undisclosed Information or Trade Secrets, Biodiversity and Traditional knowledge in various sectors. It also has not reviewed its existing patent law to provide for the patent of microorganisms and its processes of production. With respect to geographical indication (GI) which identify a good as originating in a locality where a given quality, reputation, or other characteristic geographic origin, some countries separately protect geographical indications for goods such as French cognac or Scotch whiskey. In the United States, geographical indications are protected together with collective marks as certification trade marks. They are treated as a subset of trademarks with the aim of preventing consumer confusion 16 and protect business interests . This is the system that Nigeria is practicing now and is not planning to create a separate law or registry for GI. Recently in Nigeria (2006), there had been recommendations and steps taken for the different Intellectual Property schedules to be placed under one umbrella institutional framework for effective administration and management. To this extent there was a proposal to establish Nigerian Intellectual Property Organization (NIPO) by the Ministry of Science & Technology and NOTAP, to bring all the agencies under one umbrella and ensure an effective and balanced development of the IP system in the country. The quest for a paradigm shift in the framework led to a move to secure the approval by the then President Olusegun Obasanjo of the Intellectual Property Commission of Nigeria (IPCON) under the aegis of the Federal Ministry of Justice, thus bringing the Nigerian Copyright Commission and the Registry of Trademark, Patents and Design together under one umbrella organization to be hosted by the Federal Ministry of Justice. A draft national IP bill was prepared by a committee with members drawn from the stakeholder institutions. The draft bill also includes some of the WTO requirements such as Plant Breeders Rights, Animal Breeders Rights and Farmers Rights. But the delay in addressing the issue of an umbrella body for IP administration in Nigeria has prevented the bill from making any significant progress. The effect is that Nigeria is not benefitting from the gains associated with the WTO’s TRIPS including associated increased investments in agriculture and allied industries from within and outside the country. Nigeria also faces the threat of sanctions from WTO as time elapses. A more detailed study showing which of the two modes of IP offices– centralized or distributed- that is more effective may, need to be carried out to determine which model that Nigeria should adopt. The result will help to guide the country in taking a quicker decision over the present impasse. But irrespective of the outcome of such a study a survey carried out in this study can serve as a guide. Historically, the different types of IP and their administrative frameworks had not developed collectively hence their location in different administrative set-ups in different countries. An internet survey of 191 countries shows that only 8 countries of the world have both their different offices for Copyright and Industrial Property under their Ministry of Justice. These countries are: Kazastan, Saint Kitts and Nevis, Samoa, Solomon Islands, Swaziland, Sweden, Uganda and the Holy 17 See (Vatican City) . In the South African Model, what they have is Companies and Intellectual Property Registration Office (CIPRO) in the Department of Trade and Industry (DTI).This was after a merger of two former directorates of the DTI: SACRO – South African Companies Registration Office and SAPTO – South African Patents & Trade Marks Office, from 1st March 2002 into a single Business Agency. Such a 16 Field Thomas G. What is Intellectual Property: file://E:IPRFocus on Intellectual Property, http://www.piercelaw.edu/tfield/tgf.htm.,19th March, 2007, p. 6 17 www.wipo.int/directory/en/urls.jsp A Review of the Nigerian System of Intellectual Property 15

merger within the same Ministry/Department would be easier than a merger cutting across different Ministries/Departments as Nigeria is trying to implement since Nigeria’s Ministries are averse to losing any of their agencies. It was observed that the Federal Ministry of Commerce and Industry in Nigeria is averse to losing the Trademarks, Patent and Designs Registry that has been under its administration since the amalgamation of Northern and Southern Nigeria into one country in 1914. In Tanzania both Copyright and Industrial Property is done by the Business Registration and Licensing Agency (BRELA) under the Ministry of Industry and Trade. Similarly, United States has both the Copyright Office and the Industrial Property Office in the Commerce Department. The example of India which has amended all the relevant legislations for the various forms of intellectual property with respect to the mandatory requirement of WTO is presented in table 2 below showing a distributed and not an umbrella system of IP offices. Besides, WTO’s TRIPS requirement for nations to make reforms to provide for different types of IP including the new technology patents does not recommend an umbrella IP office nor make it compulsory. About 65 countries under the membership of the Union for the Protection of Plant Varieties have got Plant Varieties Protection (PVP) law. Some other countries have got the law but are not yet members of UPOV. The European Union Office is called Community Plant Variety Protection Office distinct from the European Patent Office. The trend around the world is to have the Plant Variety Protection (PVP) as a separate office from the other IP offices, the reason being that it is a sui generis (different, other, unique) technology patent. In Kenya, Tanzania and India (see table 2 below), they are in the Ministry of Agriculture. Broad Institutional Mechanism of the Indian IPR Regime 18 Table 2.0 S/N IP Legislation Nodal Agency 1 Patent The Patent Act, 1970 Department of Industrial Policy & 2 Design The Design Act, 2000 Promotion(DIPP), Ministry of Commerce and Industry 3 Trademark The Trade Marks Act, 1999 4 Geographical The Geographical Indication Indications(Registration and Protection) Act, 1999 5 Copyright The Copyright Act, 1957 Department of Secondary and Higher Education, Ministry of Human Resource Development 6 Integrated Circuit The Semiconductor Department of Information Design Integrated Circuits Layout- Technology, Ministry of Design Act, 2000. Communications and Information Technology 7 Plant Varieties The Protection of Plant Department of Agriculture and Varieties and Farmers Cooperation, Ministry of Agriculture Rights Act, 2001 8 Undisclosed The Contract Act, 1872 Ministry of Law and Justice Information Common(law) Law 9 Biodiversity The Biological Diversity Act, Ministry of Environment and Forests 2002 10 Traditional None The concerned ministries Knowledge Ministry of Commerce and Industry, Ministry of Human Resources Development. 18 Kochar, Sudhir (2008). Institution and Capacity building for evolution of IPR regime in India: Protection of Plant Varieties and Farmers Rights. Journal of Intellectual Property Rights. Vol. 13, January 2008, pp. 51-56 A Review of the Nigerian System of Intellectual Property 16

Meanwhile the Nigerian Natural Medicine Development Agency (NNMDA) supervised by the Ministry of Science and Technology is said to be developing a legal framework for IP in Nigeria’s Traditional Medicine Knowledge and Practice (TMKP).The Convention on Biodiversity(CBD) has IP implications There are also emerging IP issues such as the Dormain name eg bbc.com, wsu.edu, unn.ed, nabda.ng etc which are used to occupy a cyberspace with some being more recognizable than others and are thus being protected from duplication. This goes to show that IP is very diverse and there may be difficulty accommodating everything under one roof. 3. National Office for Technology Acquisition and Promotion (NOTAP) – Experience In Intellectual Property 3.1 NOTAP–Formation and mandate The Federal Government initiated bold reforms of Nigeria’s Science, Technology and Innovation system and has assumed more direct and broader involvement in promotion at all levels the awareness of the importance of Intellectual Property Rights to enhance creativity and boost innovation in the fields of Information and Communication Technology (ICT), Space technology, Agriculture and Biotechnology, Medical and Pharmaceuticals, Industrial Production and Engineering Materials, Nuclear Energy, Sciences, Arts, Culture and literature, etc by establishing a conducive environment as well as creating a favourable legal framework for the management, protection and enforcement of Intellectual Property. The National Office for Technology Acquisition and Promotion (NOTAP), a parastatal under the aegis of the Federal Ministry of Science and Technology was established by Decree No. 70, 1979 as National Office of Industrial Property (NOIP). The name was changed to National Office for Technology Acquisition and Promotion (NOTAP) in 1992 to ensure that the new name adequately reflect its entire functions as contained in Decree No. 70 of 1979 and also to remove any ambiguity or misconception that may arise in relation to the activities of the agency and that of the Intellectual 19 Property Registry . NOTAP is mandated to carry out the following activities • Registration and Monitoring of foreign technology transfer agreements. • Promotion of Intellectual Property Rights and Innovation Systems. • Provision of technology information to SMEs, researchers, inventors, etc. from the Patent Information and Documentation Centre (PIDC) located in NOTAP, etc. • Commercialization of indigenous R&D results and inventions • Research Industry Linkages/Technology Database Development • Extension of Technology Advisory Services to researchers and entrepreneurs • Preparation of industrial Project Profiles In boosting innovation NOTAP promotes Intellectual Property Rights (IPRs) using the Intellectual Property System (IPS)- in particular, the patent system which has accumulated pool of technological information to spur inventiveness and creativity. Intellectual property system guarantees the holder of a patent or copyright, for example, the exclusive rights to the exploitation of the invention over a given period of time (20 years) in the case of patents and ensures that no one else would copy, adopt or use the innovation or invention without authorization from the holder, usually granted after payment of a royalty or through outright purchase or under a specific agreement. Today, virtually all innovations 19 Araba Funke (Mrs.), Director, Technology Acquisition, Documentation and Information (TADI ): Measures taken by the government to promote intellectual property system in Nigeria – Experience of the National Office for Technology Acquisition and Promotion (NOTAP)a paper contribution. National Office for Technology Acquisition & Promotion (NOTAP), Abuja, Nigeria, 2008. A Review of the Nigerian System of Intellectual Property 17

are patented as soon as they are developed. Thus it is imperative that all research results and inventions in Nigeria be patented. Furthermore, the intellectual property system encourages the creation of public pool of information of new technologies by virtue of disclosure and thus has become a tool for boosting innovation, as well as planning R&D and acquisition of technology. Boosting innovation in Nigeria is thus intimately linked to: • boosting patent awareness among researchers/inventors, • increasing the number of patents secured, and • active commercialization of patents to create industries, employment, wealth and enhanced national competitiveness. 3.2. Establishment of Intellectual Property and Technology Transfer Offices (IPTTOs) NOTAP has established twenty-three (23) Intellectual Property and Technology Transfer Offices (IPTTOs) in some Nigerian Universities, Research Institutes and Polytechnics with the aim of ensuring that R&D activities are demand-driven, thereby facilitating their being exploited commercially and transformed into a marketable product or system. Each IPTTO has been adequately equipped to provide the requisite support structures for the research community where it is located and various capacity building programmes were carried out in collaboration with World Intellectual Property Organist ion (WIPO), Geneva. Figure 1: Location of existing IPTTOs in Nigeria 3.3. Patent Information and Documentation Centre (PIDC) A Review of the Nigerian System of Intellectual Property 18

The Patent Information Documentation Centre (PIDC) is a computerized data bank in NOTAP and it provides access to patent information available globally through internet. The Centre was established with the technical assistance of World Intellectual Property Organization (WIPO), Geneva and this facility is established to assist end–users in Nigeria to focus on new research activities that are demand-driven and of market value. In addition, end-users are assisted to source global technology information via the Internet. The PIDC offers opportunities for the dissemination and distribution of information and performs searches on the state of the art in various fields of technology and assists researchers with necessary technical information to avoid re-inventing the wheel. More specifically, the following are the benefits of information from patent documents:- 3.4. Functions of NOTAP on Patent By virtue of the functions of NOTAP as embodied in its enabling Decree No. 70 of 1979, NOTAP has sustained the promotion of patent culture (which had been abysmally low in Nigeria among researchers, scientists, inventors, etc) and has demonstrated that patents are vital means of promoting and developing indigenous technologies and innovations. Thus, local inventors and researchers are assisted by NOTAP to patent their R&D results and inventions, with NOTAP paying all fees charged at the Trademark and Patent Registry. In rendering this service, NOTAP adopts the following procedure: • provision of search of the invention in patent documents in NOTAP’s Patent Information and Documentation Centre (PIDC) and other technological database to establish the novelty of the invention which is one of the major criteria of patentability, • assistance in appropriately completing the patent application forms, assistance in the preparation of patent application forms, • assistance in preparation of patent specifications consisting of title of invention abstract, background of the invention, detailed description of the invention including drawings, claims, • filling of the applications for patents and payment of the processing fees at the Trademark, Patent and Design Registry. In case of application for foreign patent grant, the application is submitted in line with the Patent Corporation Treaty (PCT). This activity strengthens the grant of patents from the Nigerian Patent and Trademark Registry which does not conduct any examination whatsoever before the grant of patents. • assistance in scouting for licenses for the commercialization of the indigenous inventions, • assistance in negotiation and drafting of the licensing agreement for the transfer of patented indigenous technologies by the inventors to the entrepreneurs. NOTAP offers these services principally on patents to clients that approach it. In this capacity NOTAP operates partially as a patent agent. 3.5 Patent Applications Filed and Granted NOTAP commenced processing the patent for public and private sectors in 1999 and a total of 233 innovations/inventions have been submitted to NOTAP for processing. After evaluation, 86 applications were filed at the Patent Registry, and 61 were granted patent rights. One hundred and forty seven (147) applications are pending because these applications have not met the prerequisites for patenting. This has spurred many researchers and inventors to recognizing the importance of patenting before publication disclosure. See Table I and Pie Chart for details on patent processed for applicants. Table 3 below indicates the number of Patent Applications submitted to NOTAP from 1999 to 2008. A Review of the Nigerian System of Intellectual Property 19

Table 3: Summary of R&D results/inventions submitted to NOTAP for assistance to file application for Patent January,1999 –September, 2008 NUMBER OF NUMBER OF PATENT NUMBER OF YEAR NUMBER OF PATENT APPLICATION PATENT INVENTIONS APPLICATIO PENDING (UNDER APPLICATION SUBMITTED N GRANTED EVALUATION/AWAITI FILED BY THE TO THE / APPROVED NG RESPONSE OFFICE AT OFFICE BY FROM INVENTOR PATENT REGISTRY REGISTRY 1999 2 1 1 1 2000 32 14 18 9 2001 14 8 6 3 2002 17 2 15 3 2003 8 0 8 0 2004 27 12 15 7 2005 41 14 27 18 2006 24 16 8 14 2007 28 13 15 4 2008 40 6 34 2 Sept. TOTAL 233 86 147 61 Figure 2: Number of inventions submitted to the office between 1999 - Sept. 2008 1999 2000 2008 Sept. 2001 1999 2000 2001 2002 2007 2002 2003 2004 2005 2006 2003 2007 2008 Sept. 2006 2004 2005 A Review of the Nigerian System of Intellectual Property 20

Figure 3: Number of Patent applications granted/approved by the patent office between 1999 - Sept. 2008. 2008 Sept. 1999 2007 2000 1999 2001 2000 2001 2006 2002 2002 2003 2004 2003 2005 2006 2007 2008 Sept. 2004 2005 3.6 Developing Intellectual Property Culture in Nigeria The IP culture in Nigeria especially patent is very low as compared to other countries e.g. Japan, China and South Korea. The evolution of patent applications and patent granted is analyzed below. In Nigeria, the data collated in Table 4 below from 1998-2007 (span of 10years) shows that out of a total of 4,823 patent applications filed, 4,257 patent applications were filed by foreign applicants, while 566 were filed by local applicants at the Nigerian Registry for Trademark, Patent and Industrial Design. The non-conventional (local) patents filed was 566 representing 11.7% of the total applications filed at the registry, while the conventional(foreign) patents filed was 4,257 representing 88.3% of the total patents filed. For patents granted, non-conventional (local) has 318 applications granted representing 11.7% of the total granted, while the conventional (foreign) has 2,398 representing 88.3% of the total number of patents granted. The trend of the patent applications filed in Nigeria as shown in Figures 3 and 4 also reveals that more foreign patents (conventional) are filed in Nigeria than local patents compared with countries like Japan, China and Korea where more local patents are filed than foreign patents. For instance, in 2007, 565 foreign patents were filed in Nigeria while only 84 local patents were filed representing 12.9% of the total number of patents filed in the country; whereas in Japan, China and Korea in 2007, 333, 498, 153,060 and 128,701 local patent applications were filed representing 84.1%, 62.4% and 74.6% of the total patents filed in the countries respectively. Table 4: Number of Patent applications filed and granted in Nigeria from 1998 – 2007 FOREIGN PATENTS LOCAL PATENTS (CONVENTIONAL) (NON CONVENTIONAL) YEARS No. of Applications No. of No. of No. of Filed Applications Applications Applications Granted Filed Granted 1998 411 185 39 2 1999 439 312 5 19 2000 473 351 49 42 2001 476 142 34 13 2002 466 62 36 3 2003 450 179 55 15 2004 425 421 88 40 A Review of the Nigerian System of Intellectual Property 21

2005 297 316 81 64 2006 255 212 95 87 2007 565 218 84 33 Total 4257 2398 566 318 Source: Compiled by NOTAP from Trademarks, Patents and Industrial Design Office, Abuja, October 2008 The low turnout of patent in Nigeria is as a result of lack of IP culture in the tertiary and research institutes’ environment and the society in its entirety. This low level of evolution of patent is also a reflection of current level of technological development, using patent as one of the indices or determinants of economic growth. Figure 4 NIGERIA EVOLUTION OF PATENT APPLICATIONS (Domestic vs. Foreign) 700 NIGERIAN 649 NON-NIGERIAN 600 TOTAL 522 513 510 505 502 500 450 444 400 378 350 300 565 476 473 466 450 439 425 411 200 297 255 95 88 84 81 100 55 49 39 36 34 5 0 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 YEAR OF SUBMISSION Source: Compiled by NOTAP from Trademarks, Patents and Industrial Design Office, Abuja, October 2008 A Review of the Nigerian System of Intellectual Property 22

NIGERIA EVOLUTION OF GRANTED PATENTS Figure 5 (Domestic vs. Foreign) 500 461 NIGERIAN 450 NON-NIGERIAN TOTAL 400 393 380 350 331 300 299 251 250 421 200 194 187 351 316 312 155 150 218 212 87 100 185 179 64 142 65 42 40 50 33 19 62 15 13 3 2 0 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 YEAR GRANTED Source: Compiled by NOTAP from Trademarks, Patents and Industrial Design Office, Abuja, October 2008 3.7. Promotion of Incentives/Reward System NOTAP is promoting a framework on Incentives and Reward-System for creators of Intellectual Property in Tertiary and Research Institutions. Empirical study of the Incentives and Reward System in Tertiary and Research Institutions in industrialized and most developing countries like India, Brazil, South Korea, etc, shows that creators of intellectual property receive from 33% to 50% net income of revenue generated by the institutions due to commercial exploitation of intellectual property. The existence of such reward systems encourages the creators to devote their time and energy to carry out research in demand/market- oriented projects for the generation of revenue. In the pursuit of this, an Intellectual Property Policy Guideline to assist University and Research Institutes to develop Incentives/Reward System was published by NOTAP and forwarded to all Universities, Polytechnics and Research Institutes in Nigeria. 4. The Place of IP in Nigeria’s R&D System 4.1. Agricultural research 4.1.1 Public Sector Investment in Agricultural Research Nigeria The development of agriculture in Nigeria has, and is still benefiting mainly from public investments; the private sector plays an insignificant role. However, the public goods investments policy in agriculture is facing a bleak future for a number of reasons, principal amongst which are: i). Increased emphasis on market mechanisms facing public funded organizations to respond to broad economic opportunities; ii) Tendency to limit freely, germplasm for National Agricultural Research; and iii) Changes brought about by the introduction of intellectual property rights (IPR). A Review of the Nigerian System of Intellectual Property 23

The Nigeria Agricultural Research System (NARS) comprises the National Agricultural Research Institute (NARIs), universities of agriculture and faculties of agriculture and veterinary medicine in conventional universities, non-governmental organizations (NGOs), and the private sector. The bulk of the research is, however, publicly funded and goods produced are public goods. These goods, which are information, data, or products, are released into the public domain for adoption and utilization by and for the benefit of all people of the nation. As a matter of fact, the refusal of the NARIs for free assess to their research results is contradictory to their mandate and mission. The Agricultural Research Council of Nigeria (ARCN) in the Ministry of Agriculture is supervising 15 agricultural research institutes. Some agricultural research institutes are not placed in the ministry of agriculture and fall outside the supervision of the Ministry of Agriculture 20 . 4.1.2. Changes in the Ownership of Research Results Recent external developments like the integration of markets, growing activities of the private sector and innovations in national and international legal and regulatory regimes are, however, changing trends in research management and management of intellectual property in the developing countries. These changes are occurring in response to global trends, each having the potential to redefine how the national agricultural research system would provide public goods to meet the national needs for crop and animal varieties. Management needs to ensure that all who use the property respects ownership of intellectual property used by a research institution. It should also ensure that organizations are in a position to identify, secure, manage and exploit the intellectual property they generate. 4.1.3 Current Situation in Agricultural Research in Nigeria In Nigeria as in many developing countries, no structure has been put in place for the management of IP in agriculture particularly Plant Variety Protection (PVP), Animal Breeders Rights. In April 2002, Nigeria held its first workshop to review the first draft of the Nigeria Intellectual Property Laws titled “Fostering a New Intellectual Property Regime”. It was co-sponsored by the United States Department of Commerce, Commercial Law Development Programme; the Federal Ministry of Commerce (Trademarks, Patents and Design Registry); the Nigeria Copyright Commission; and the National Office for Technology Acquisition and Promotion (NOTAP)-Federal Ministry of Science and Technology- in a public/private partnership with the Nigeria Intellectual Property Bar. When this document is put into law, it will form a basis to put in place regulatory framework to manage IP in the Nigeria NARS. This is because the resulting draft IP bill has provision for Plant Variety Protection (PVP) or Plant Breeders Right (PBR) as well as Farmers Right.. Currently, there are no institutional frameworks for agriculture related IPR issues nor any office or persons responsible for assisting the researchers on issues of IP, access to adapted technologies, technology transfer, or ways to protect their inventions. The researchers have been functioning without institutional support needed to address these issues for their research. However, it should be noted that the National Office for Technology Acquisition and Promotion (NOTAP) is assisting researchers particularly on patents to register their inventions with the Trademarks, Patents and Designs Registry free of charge as government measure to promote technological development. It is also establishing Technology Transfer Offices (TTO) in universities and research institutes across the country. But IP in agriculture require specialized tools and specialized approaches to handle. Now is actually the beginning of a transition from periods when products and processes for research resided in the public dormain. Nigeria and the rest of the developing countries are seeking for appropriate IPR arrangements for owning and protecting IP and for the use of proprietary technologies in their research so that the final products developed would have legal instruments to support their dissemination to clients. Proprietary technology and materials are technologies and 20 Abubakar B. Y.(Prof); Executive Secretary, Agricultural Research Council of Nigeria(ARCN); Nigeria Agricultural Research System (NARS): Prospects For Intellectual Property Promotion: A paper contribution, 2008 A Review of the Nigerian System of Intellectual Property 24

materials that are privately owned, managed and protected through some sort of IPRs. The United States Bayh Dole Act seeks to address this issue within the Universities and RIs in USA. Presently, the CGIAR centres and some few larger national agricultural research organizations in the developing countries address such institutional mechanisms, for example Brazil Research and Development Agency EMBRAPA, Agency for Agricultural Research, and Development (AARD) in Indonesia and Malaysia Agricultural Research and Development Institute (MARDI). 4.1.4. Central IP Management Body Considering these challenges and the objectives of establishing the Agricultural Research Council of Nigeria (ARCN), the Council has plans of setting up a central IP management body to be housed in the Legal Unit of the Council. A committee on, “Establishment of effective IPRs policy and management guidelines for Agricultural Research in Nigeria” has been set up and is already collecting information. The central IP management body will have the following functions: • Develop institutional or legal frameworks for related IPRs issues ; • Educate research institutions on the importance of international collaboration and purchase of proprietary technologies; • Assist the researchers in issues of IP, access to adapted technologies, technology transfer and ways of protecting their inventions; • Initiate and promote negotiations needed for licensing proprietary assets at institutional level; • Develop and introduce criteria for the management of information related to proprietary technologies in the research institutions, that is confidentiality and timing of publications; and • Introduce the use of IP management parameters during research project planning. 4.2. The Bayh Dole Act. (University and Small Business Patent Procedures Act) and IP in Nigeria This is a United States legislation dealing with intellectual property. However, many developing countries are modeling their patent laws after this US law as part of the transition away from public ownership of research results and thus making it very significant to Nigeria. Passed in 1980, the Bayh-Dole Act (Patent and Trademark Act Amendments of 1980) created a uniform patent policy among the many federal agencies funding research. As a result of this law, universities retain ownership to inventions made under federally funded research. In return, universities are expected to file for patent protection and to ensure commercialization upon licensing. The royalties from such ventures are shared with the inventors; a portion is provided to the University and department/college; and the remainder is used to support the technology transfer process. The main purpose of the act is to further development and commercialization. 4.3. Policy Linkage of Nigerian R & D Institutions A knowledge of the linkage between the science, technology, research and related institutions in formulating S & T policy can be harnessed to support the effort to reform the country’s IPR system to meet our national aspirations and the demands of our bilateral partners. This is because of the positive impact a functional IPRs system will have on R & D. Since the colonial era Government of Nigeria has taken steps to establish research institutes in different sectoral areas of Agriculture, Health, Environment and Industry. Similarly science based facilities in the Universities were also engaged in scientific research activities. It became obvious that science and technology –based research and development system in Nigeria could only make impact on the national development if the R&D activities were coordinated. The first major and concrete step taken by Government towards coordinating research efforts was the establishment of the Nigerian Council for Science and Technology (NCST). The mandate of the NCST was: • To determine priorities for scientific activities in the federation in relation to the economic and social policies of the country and its international commitments: • To ensure the application of the results of scientific activities to the development of agriculture, industry and social welfare in the federation; • To advise the Federal Government on a national science policy, including general planning and assessment of the requisite financial resources: A Review of the Nigerian System of Intellectual Property 25

• To ensure cooperation and coordination between the various agencies involved in the machinery for making the national science policy; and • To promote public confidence in scientific expenditure and create an atmosphere conducive to scientific activities. The NCST through various stages eventually evolved to the present Federal Ministry of Science and Technology. However, under the aegis of the Federal Ministry of Science and Technology a National Council of Science and Technology (NCST) comprising the Minister of Science and Technology, representatives of other Ministers connected with S& T and State Commissioners of Science and Technology meets once a year to deliberate on national S&T policy issues. In a similar effort aimed at R&D coordination, the government under the aegis of the Federal Ministry of Science and Technology in 2008 established the National Research and Development Coordinating Council (NRDCC) with a mandate of coordinating R&D policy. This council though still very young has proposal for two organs: the technical committee which is made up of directors of research institutes and the relevant directors in the various ministries. The other organ is the board of the council which is made up of the Ministers of the various relevant ministries. While the technical committee is to meet every month, the board is to meet every quarter. The NCST and the NRDCC are important organs through which S&T policy issues including IPR affecting R&D can be harmonized and addressed. They are therefore important instruments of national technology policy. 4.4. National Biotechnology Development Agency (NABDA) Biotechnology is a package of techniques that employ organisms, or parts of organisms to make or modify products, improve plants and animals, or to develop microorganisms for specific applications. The Nigerian government, convinced of the fact that biotechnology is a cutting-edge technology that will drive the 21st century’s global food, health, industrial and environmental sectors, took appropriate steps to ensure that Nigeria becomes a key global participant in the biotechnology revolution for the benefit of all Nigerians. As a move to enhance coordination and give a boost to the biotechnology research work in our universities and research institutes, the government took a major step by putting the National Biotechnology Policy in place by April, 2001.This led to the establishment of the National Biotechnology Development Agency in November of that year. The objectives of the agency include amongst others: • Develop appropriate legislation compatible with international regulations, so as to ensure biosafety, in line with social and ethical considerations and to protect intellectual property, industrial property and farmers’ rights. • Maintain sustainable exploitation of bioresources for our food and agriculture, healthcare delivery and industrial utilization • Ensure that Nigeria become self reliant in the development and application of biotechnology- based products and services. In line with these objectives NABDA can take the necessary steps to support the enactment and reform of the nations laws that will enhance the development of biotechnology including the nations obligations to WTO TRIPS which made provisions for biotechnology products and processes, genetic resources/bioresources exploitation for food, drugs and nutraceuticals as well as laws on microorganisms, plants and animals. Biochemistry, Microbiology, Molecular Biology and Bioinformatics are essential tools of biotechnology. 4.5 OBD-Plus Technology- a Nigerian microbial invention OBD-Plus, the microbial formula invented by Professor B.A. Oso, of Arati Environmental Ltd Lagos, Nigeria (formerly of the University of Ibadan, Nigeria) has been shown to be a very effective agent in the management of oil pollution, liquid and solid wastes. It bio-degrades crude oil and their refined products as well as solid and liquid wastes at a fast rate. Hence, it is a useful agent in the bio-remediation of polluted environment (land and water). Oil polluted soil bio-remediated with OBD-Plus for example becomes more fertile than before. Professor Gideon Okpokwasili of the University of Port Harcourt, Nigeria is another expert on bioremediation, employing microorganisms. Such inventions are very significant in the discussion on whether or not to A Review of the Nigerian System of Intellectual Property 26

patent microorganisms in Nigeria as it shows that such inventions (local or foreign) may be common and thus calling for an urgent need for a protection system to spur investment in R&D and Commercialization. 4.6. Nigeria’s Draft National Biosafety Bill and the Cartagena Protocol A related regulatory framework, Biosafety refers to efforts to reduce and eliminate the potential risks resulting from modern biotechnology and its products including possible harm/effects that might be done to the environment, biodiversity and human health. With the advent of modern biotechnology, genetically modified organisms and other products, and their perceived adverse impacts on the environment and human health, Nigeria joined the league of nations in taking precautionary safety measures, by signing and ratifying Cartagena Protocol on Biosafety (CPB) of year 2000. The vision of Nigeria’s Biosafety is to ensure that the practice, processes and procedures of Modern Biotechnology are undertaken within the limits of a regulatory system, that guarantees its safe use, protects Nigeria’s Biodiversity and provides minimum risk to human health and the environment.The Draft Biosafety Bill prepared under the aegis of the Federal Ministry of Environment and presented to the Federal Executive Council is undergoing passage at the National Assembly as an Executive Bill. 4.7. National Varietal Release Committee and the National Agricultural Seed Service (NSS) The National Crop Varieties and Livestock Breeds Registration and Release Committee Decree 33 of 1987 was promulgated to inject sanity into the system of naming, release and registration of crop varieties and livestock breeds and consequently checkmate the seed industries. The decree spelt out the responsibilities of members and functions of the National Varietal Release Committee. The committee was charged with receiving the processing applications for the registrations, naming and release of old and new crop varieties and livestock breeds: officially releasing the list of superior crop varieties and livestock breeds recommended by the sub-committee established for that purpose. Decree 33 was later complimented by the Seed Decree 72 of 1992. In a meeting held on January 13, 2000, the committee noted the need for harmonization of the Decree 33 of 1987, establishing the National Crop Varieties and Livestock Breeds Registration and Release Committee and Decree 72 of 1992 establishing the National Agricultural Seed Service. While Decree 72 focused on seed only, Decree 33 of 1987 on the other hand had in addition to provisions on crop varieties release and registration the provision on livestock breeds release and registration. On the last count, since the inauguration of the National Committee in 1989 about 361 crop varieties have been officially registered and released. These were done retroactively and actively. However, not many achievements have been recorded in the area of livestock breeds. Shika Brown from National Animal Production Research Institute (NAPRI), which was a product of about 15 years of research, remains the only livestock breed to be officially registered and released. The release procedure is as follows: • The release process of 2 – 3 years. • Adequate seed quantity must be available with the breeder nominating the crop variety for multi-location testing. • The breeder or the Institution concerned must submit the appropriate name for the new variety which must be simple, brief and pronounceable. • Data from 2 years multi-location and OFAR (On Farm Adaptive Research) must be available before the nomination of crop variety. • 1 kg (or adequate quantity in case of vegetables) of the newly released varieties must be sent to the National Centre For Genetic Resources and Biotechnology (NACGRAB) to be kept in the Gene Bank. • National Seed Service (N.S.S). is mandated to produce Foundation Seed after signing an M.O.U. with the concerned N.A.R.I’s. From the above procedure it can be seen that Plant Variety Protection (PVP), Animal Breeders Rights and Farmers Rights does not form part of the above process requiring that another mechanism A Review of the Nigerian System of Intellectual Property 27

is in need. This requires that the Plant Variety Release Act may be modified to include Plant Variety Protection provisions or a new PVP law should be put in place. 4.8. Nigeria Natural Medicine Agency The Nigerian Natural Medicine Development Agency (NNMDA) is working to develop a legal framework for IPR regime to enable the exploitation of our indigenous Traditional Medicine Knowledge (TMK). This will compliment the effort towards development and promotion of the nation’s biodiversity and bioresources. NOTAP is supporting NNMDA in this direction. The two agencies (which are in the Ministry of Science and Technology), with the support of World Intellectual Property Organization(WIPO), the International Association for the Promotion of Traditional Medicine (PROMETRA), Dakar, Senegal, the African Union Scientific, Technical and Research Commission(AU-STRC) and other local organizations jointly organized a workshop in 2005 with the theme “Appropriate Intellectual Property Rights(IPR) Regime – a necessity for Maximizing the potentials of Traditional Medicine for Improved Healthcare Delivery, Economic Growth and Development.” A draft law on Nigeria’s Traditional Medicine Knowledge is being put in place by the NNMDA. 4.9. Space and Information Technology Strategies As part of government’s effort to reform the Science, Technology and Innovation sector, attention was also directed at building capacity in Space Technology and Information Technology. Thus, the National Space Research and Development Agency (NASRDA) was established. In realization of one of the objectives for which it was established NASRDA successfully launched the Nigerian Satellite (Nigeria Sat 1) in November 2003 which is currently yielding data for local and international use on weather and environment. Nigeria with technical support from China also successfully launched the first African Communication Satellite, (NIGCOMSAT), in the first quarter of 2007 meant to meet the communication needs of our nation. Furthermore, for the purpose of managing the products of NIGCOMSAT, two companies, Nigerian Communications Satellite Ltd and the Galaxy Backbone Plc have been registered and are now operating. Both companies are together expected to coordinate to manage the National Information and Communication Technology Infrastructure Backbone (NICTIB). Also established by government is the National Information Technology Development Agency (NITDA) as the clearing house for IT projects in the public sector. The Agency is committed to the drive to bring government and its services closer to the people through IT. Entrusted with the implementation of the National IT policy, which seeks to make Nigeria an IT capable country in no distant future, NITDA has been mandated to supervise the management of the country code Top Level Domain as a national resource. The operations of NASRDA and NITDA have wide IP implications including the emerging IP issues like dormain names: for instance bbc.com, wsu.edu, nabda.ng. These names are being protected. Just as postal addresses indicate physical locations, dormain names indicate unique locations in the “cyberspace”. Some of the names assume celebrity persons, places and institutions with greater need to be protected. Various entities control the registration, renewal and transfer of domain names, depending on the final portion of any alphanumeric address. Addresses ending with country codes “fr” or uk are subject to laws of France and the UK respectively. Those ending with “com” and a few other terms have a global reach. They are governed by rules established by the Internet Corporation for Assigned Names and Numbers 21 (ICANN), under agreement with the US Department of Commerce . Nigeria’s domain name is .ng and NITDA has been mandated to supervise it. NITDA should also explore the possibility of developing an IP system for Semiconductor Integrated Circuits Layout-Design for Nigeria. “The United States, Japan, and many EU countries protect the topography of semiconductor chips and integrated circuits under sui generis laws, some of whose aspects are borrowed from patent 21 Field Thomas G. What is Intellectual Property: file://E:IPRFocus on Intellectual Property, http://www.piercelaw.edu/tfield/tgf.htm.,19th March, 2007 A Review of the Nigerian System of Intellectual Property 28

or copyright law|”. The U.S. law, is called the Semiconductor Chip Protection Act of 1984 22 . In India this is administered in the Department of Information and Communication Technology of the Ministry of Communication and Information Technology (Table 2 above). 5. Case Study of A Licensed Nigeria Patent Development Of Nicosan /Hemoxin: A Drug For The Management Of Sickle Cell Disease 23 24 25 5.1 Historical Background NICOSAN/HEMOXIN (formerly called and patented as NIPRISAN) is a drug first developed by the Nigerian National Institute for Pharmaceutical Research and Development (NIPRD) for the management of Sickle Cell Disease (SCD). NIPRD was then in the Federal Ministry of Science and Technology before it was transferred to Federal Ministry of Health. NICOSAN consists of a mixture of extracts from four tropical medicinal/food plants some of which are cultivated and others found in the wild both within and outside Nigeria- Piper guineenses seeds, Pterocarpus osun stem, Eugenia caryophyllum fruit and Sorghum bicolor leaves. The story of NICOSAN (outside of Africa the medicine is known as HEMOXIN will be incomplete without acknowledging some of the great minds, which have contributed immensely towards its development. Historically, a similar remedy was mentioned in the book titled “Iwosan” published by the late Dr. Odumosu at the turn of the century. However, the modern day origin of what later became patented as NIPRISAN was due to the late Rev. Paul Ogunyale, then Pastor of the First Baptist Church in Ibadan, Oyo State, Nigeria, who brought the attention of Prof. Charles Wambebe, former Director General, NIPRD in late 1992 to a herbal recipe of the drug. He practiced traditional medicine after his retirement as a pastor before his death. From 1992 to 2001, Prof. Wambebe and his team of researchers at NIPRD, supported by the Federal Government of Nigeria (FGN) and the World Health Organization (WHO), worked tirelessly to develop NIPRISAN as a potent drug for the management of SCD and was patented in the United States of America(as NIPRISAN) under the leadership of Prof. Wambebe. After the retirement of Prof. Wambebe from NIPRD, his successor, Dr. Uford S. Inyang continued tirelessly with more developmental work in taking NIPRISAN to a higher level. 5.2 The Birth of NICOSAN/HEMOXIN In August 2001, a joint conference on biotechnology was organized at Cook College, New Brunswick, NJ between the Sheda Science and Technology Complex (SHESTCO) of the Federal Ministry of Science and Technology, Abuja, Nigeria and Rutgers University New Jersey USA, under the leadership of two Nigerians in the US Diaspora - Dr. Soji Adelaja, who was then Dean of Research at Cook College and New Jersey Agricultural Experiment Station (Cook/NJAES), and Dr. Albert Ayeni, then Weed Scientist at Cook/NJAES and later Coordinator of International Programs of 22 http://en.wikipedia.org/wiki/Sui_generis 23 Sheda Science and Technology Complex -SHESTCO Sheda Science and Technology Complex (SHESTCO): In Focus Abuja Nigeria, http:// www.shestco.org , 2006 24 Xechem Pharmaceuticals Nigeria Limited, Abuja, Nigeria. Interview with the Managing Director, Mr. Iretiolu Oniyide Dec. 2008 25 National Institute of Pharmaceutical Research and Development (NIPRD), Abuja, Nigeria. Interview with Prof. Oloyode Kunle. Head, Dept of Pharmaceutical Technology (NIPRD). February, 2009 A Review of the Nigerian System of Intellectual Property 29

Cook/NJAES on the one hand, and Dr. Ayodele Coker, Director-General/CEO of SHESTCO on the other hand. It should be noted that while NIPRD developed and owns the patent for NICOSAN, SHESTCO took interest to promote the commercialization of the product because one of its mandates is Advanced Biotechnology R & D. New Jersey was a favourable place to hold such a biotechnology conference. Known in US as “the nation’s medicine cabinet”, New Jersey ranks first in the United States in the manufacturing of pharmaceutical products. Annual sales for pharmaceutical firms in New Jersey exceeds $700 billion, fueled by the fact that fifteen of the twenty largest drug companies in the world have major facilities in New Jersey. With 116 biotechnology companies, New Jersey currently ranks fourth in the US for its cluster of biotechnology companies 26 . Dr. Ramesh C. Pandey, Chairman & CEO, Xechem International, Inc. (USA) represented his company at this conference. What transpired during and after the conference propelled Dr. Pandey to explore the possibilities in the applications of biotechnology for drug production in Nigeria. At the instance of Prof. Turner T. Isoun, the Honourable Minister of Science and Technology, Dr. Pandey visited Nigeria for the first time in October 2001 with Dr. Albert Ayeni. This visit aroused in Dr. Pandey the interest in exploiting biotechnology for drug development in Nigeria. The first product of interest, NIPRISAN was thus, introduced to him by Dr Ayodele Coker, the Director-General of SHESTCO, and later by Dr. Uford S. Inyang, the Director General of NIPRD. In July 2002, negotiations were successfully concluded between NIPRD and Xechem International under the direction of Prof. A. B. C. Nwosu, then the Honourable Minister of Health- NPRD’s supervising ministry. Xechem International was granted the exclusive rights for development, production and marketing of NIPRISAN. To give effect to the agreement, Xechem Pharmaceuticals Nigeria Ltd, with its production factory located within the premises of the Sheda Science and Technology Complex (SHESTCO), Abuja Nigeria, was incorporated in 2002 while production was launched on July 6th, 2006 by the then Nigerian President Olusegun Obasanjo. 5.3 About Sickle Cell Disease Sickle cell Disease is a hereditary blood disorder caused by an abnormality in the hemoglobin molecule. The condition causes the production of abnormal hemoglobin that contains portions that stick together after the release of oxygen. This phenomenon produces stiff, sickle shaped red blood cells that do not flow freely through blood vessels. These sickle-shaped cells create clogs in the blood vessels which prevent the flow of normal hemoglobin and oxygen round the body. The result is severe pain or “crises”, ulcers, organ and tissue damage and breakdown, which eventually lead to stroke and acute chest pain. The body’s immune system also attacks and seeks to destroy the abnormally shaped cells, often leaving the body with an insufficient number of normal oxygen-carrying red blood cells, which in turn results in anaemic condition that manifest in fatigue and enhanced susceptibility to infection. It is estimated that there are 12 million sufferers of SCD worldwide with greater prevalence among black people, out of which about 4 million are Nigerians. Repeated crisis can also result in damage to the kidneys, lungs, bones, eyes and the central nervous system. The most feared complication for children with SCD is a stroke which affects infants as young as 18 months. Many children with SCD do not survive infancy or early childhood. Adults with SCD often experience a reduction in the quality of life due to severe physical problems such as pain, Hard-foot syndrome and acute lung complications that can result in death. Frequent episode of severe bone pain, crises and hospitalization significantly affect the lives of these patients. It limits their ability to participate in normal physical activities, thus retarding their social and economic advancement; it also deprives them of the joy of living life to the fullest and instills the fear of early death in them. Before the advent of NICOSAN/HEMOXIN the only known cure for the disease is a bone marrow transplant to replace defective red blood cells with donor healthy cells. Treatment has generally consisted of supporting therapies, which include folic acid for anemia, penicillin to prevent infections, pneumococcal and influenza vaccination, pain killing drugs and intravenous injection of fluids. In the United States of America, Hydroxyurea is the only drug approved by the US Food and Drug 26 Witriol Andrew S (Author), Prepared under the supervision of Dr. Fernando Alvarez Biotechnology and Entrepreneurship. January 20, 2004, P. 14 A Review of the Nigerian System of Intellectual Property 30

Administration (FDA) for the treatment of SCD. It is very expensive and toxic and patients treated with hydroxyurea exhibit severe side effects. 5.4 Hope for the Sicklers NICOSAN/HEMOXIN is a non-toxic, phyto-pharmaceutical product composed of extracts from four tropical plants, seeds, stems, fruits and leaves. Each plant is indispensable in the manufacturing of NICOSAN/HEMOXIN as the extracts are more potent when used as a group than when used independently. Xechem Pharmaceuticals Nigeria Limited has developed refined and standardized small-scale formulations of NICOSAN/HEMOXIN for consistent production in strict compliance with the recommended procedures and policies of the World Health Organization (WHO). NICOSAN/HEMOXIN has already undergone phase I, phase IIa and phase IIb clinical trials conducted in Nigeria by the NIPRD. A Phase IIb trial of Nicosan was conducted at an army base hospital in Yaba, Lagos, Nigeria between 1996 and 1997. Xechem reports that quot;73% of the 30 patients who participated in the study experienced no crisis during the 12 month trial period and the 27 remaining 27% experienced less frequent and less severe crises.quot; Based on phase IIa and IIb trials Nicosan was given a 2 year listing license by National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria on July 3, 2006. Results from the phase Ill trials which require greater number of samples and is multi-locational, if found satisfactory, will form the final basis for an application to NAFDAC for regulatory approval that will last for 5 years but subject to renewal 28 . Further laboratory testing among others have also been done at the National Heart, Lung and Blood Institute - Sickle Cell Disease Reference Laboratory (NHLBI-SCDR Lab) located at the Children’s Hospital, Philadelphia, Pennsylvania, USA. The results of these trials show that NICOSAN/HEMOXIN has quot;a strong antisickling effectquot; 29 and drastically reduced the frequency and severity of SCD crises. Liver and kidney functions remained normal and patients gained appreciable weight. No adverse effects were reported during the trials. These clinical studies suggest that NICOSANTM is a safe and efficacious phytomedicine for the management of SCD. It may have just paved the way for ending the misery and pain of millions of SCD sufferers in Nigeria and the world at large. Through the instrumentality of Dr. Pandey, and based on the background of work done at the Children’s Hospital, Philadelphia (CHOP) and other published literature in various indexed journals, on August 15th, 2003, NICOSAN (NIPRISAN) was granted an Orphan Drug status by the Food and Drug Administration of the United States of America (US-FDA). An orphan drug is a drug produced for orphan diseases, a class of rare conditions that the larger pharmaceutical companies tend to ignore because the profit potential is low. The Orphan Drug designation, entitles a company to various incentives including the waiver of Regulatory filing fees, access to potential funding for non-clinical and clinical research to generate required data for marketing approval, and seven years of marketing exclusivity once approved by the FDA. This was a major break-through since it was a far-fetched possibility that the US-FDA would designate NICOSAN (NIPRISAN) Orphan Drug status. The Orphan Drug status has thus, added credibility and international acceptability to NICOSAN (NIPRISAN) as a potent drug for the management of SCD. 27 quot;Xechem International - Annual Reportquot;. December 31 2005. http://sec.gov/Archives/edgar/data/919611/000114420406015544/v040579_10ksb.txt. Retrieved on 2006-07-21. - submission to U.S. Securities and Exchange Commission 28 Kella Hauwa (Mrs.), Director of Enforcement, National Agency for Food and Drug Administration and Control (NAFDAC),Abuja, Nigeria. Interview, February, 2009. 29 Iyamu E, Turner E, Asakura T (2002). quot;In vitro effects of NIPRISAN (Nix-0699): a naturally occurring, potent anti-sickling agent.quot;. Br J Haematol 118 (1): 337–43. doi:10.1046/j.1365-2141.2002.03593.x. PMID 12100171. A Review of the Nigerian System of Intellectual Property 31

5.5 Production and Marketing of NICOSAN by Xechem Pharmaceuticals Ltd The factory buildings for Nicosan production was built by the Federal Government of Nigeria through Sheda Science and Technology Complex(SHESTCO) where it is located supposedly under an agreement for a certain period of time and with the intention to support the company in its infancy. At its new location, “the company used U.S.-built plant, equipment and machinery. For this, Ex-Im Bank (of USA) provided a comprehensive guarantee for a $9.4 million loan, which funded about three- quarters of the project’s total cost”.30 From production of 5000 capsules per day in January 2007 the company is presently producing 50,000 capsules daily as at December, 2008. The drug is mainly marketed in bulk through state governments and some major hospitals in Nigeria. Some of the state hospitals have reported significant reduction in SCD patients coming to the emergency room. Effort is being made to make the drug more affordable to the general public. Record of sale of the drug outside Nigeria was not available at the time of this write up. In 2004 with 19 employees and $300,000 in revenue, Xechem was still in the high-growth startup because of its investment in low revenue orphan therapies. Xechem has had a negative operating income since 2002 and has dropped from around $40.00 per share two years ago and traded at around $0.15 per share31. On December 30th, 2003, Xechem acquired Ceptor Inc., a privately held biotechnology company. Ceptor provides Xechem a neuromuscular platform technology that will produce both orphan drug products for the Company to develop under its business model as well as large-market products appropriate for partnering with major companies. Xechem also acquired the exclusive worldwide rights for five membered heterocyclic anti-sickling compound known as 5- HMF, in December 2005 under a license agreement with Virginia Commonwealth University (VCU) , USA and on May 26th, 2006, Xechem was successful in obtaining Orphan Drug designation from the US Food and Drug Administration (FDA) for the drug. The research for the drug was led by Dr. Donald Abraham of VCU. It is however disturbing to learn that Xechem International, Inc. announced on November 10, 2008, that it and one of its subsidiaries, Xechem, Inc., filed voluntary petitions for relief under Chapter 11 of the United States Bankruptcy Code in the United States Bankruptcy Court for the Northern District of Illinois (the quot;Bankruptcy Courtquot;) to suspend all litigation and to restructure its debt. The Company intends to work with all of its constituencies to reach mutually acceptable resolutions and to exit bankruptcy as expeditiously as possible. Xechem's operations are expected to continue as normal throughout the bankruptcy process, while the Company executes on its reorganization plans. Xechem's other subsidiaries are not part of this Chapter 11 filing including Xechem's Nigerian subsidiary, Xechem Pharmaceuticals Nigeria Limited which will continue its normal operations of the manufacturing and sale of NICOSAN™. 5.6. Intellectual Property issues arising from NICOSAN The birth of NICOSAN a phyto-pharmaceutical drug for the management of sickle cell disease SCD represents a milestone in IP management in Nigeria. This drug is of significance in IP management in many ways. It was developed Nigeria’s National Institute for Pharmaceutical Research and Development (NIPRD) and patented in US (U.S. Patent # 5,800,819 - September 1, 1998) in a total of 42 countries which was informed by the fact that patent registration is country specific. The traditional knowledge as a herbal remedy for the treatment of SCD was made known to NIPRD by the late Rev. Ogunyale who practiced traditional medicine. NIPRD developed it into a drug, patented it and later licensed it to a United States company. When the issue of benefit sharing by both arties in the exploitation of genetic resources/bioresources as required by the Convention on Biodiversity(CBD) and the AU Model Law is considered with respect to NICOSAN, it was reported that the name of the holder of the traditional knowledge was mentioned 30 Lambright James H. (Chairman and President Export-Import Bank of the United States ) Remarks before the Africa Trade & Investment 2007 Conference Cape Town, South Africa , February 1, 2007. Office of Communications 202.565.3200 • www.exim.gov 31 Witriol Andrew S., Ibid A Review of the Nigerian System of Intellectual Property 32

in the patent and in some of the journal publications and that he was considered for royalty along with NIPRD. Though late, he was said to have set up a foundation before his death where the royalty is to be paid and utilized. However, Xechem has not started paying any royalty but NIPRD is optimistic that the company will pay when it is fully established. On the issue of the effect of cost of patent, the observation is that the cost of patenting is a very significant factor in the whole process of commercializing a product. Although it was not possible to find out the amount for which the product was patented at the IP national offices or licensed to Xechem, what is obvious is that the issue of paying the patent renewal fee became a problem and UNIDO came to the rescue and paid the fees. The implication is that in the absence of the support that came from UNIDO the patent would have been badly affected without a renewal. If this is the case with a government institution then an individual inventor would have been worse off. It was also not clear whether it is the patent owner or the licensee that ought to have paid the renewal fees and whether this clause was reflected in the licensing agreement. 5.7. Challenges in the Commercialization of Nicosan i. Resistance to the drug. In spite of the laudable attributes of this new drug, some people including the Sickle Cell Foundation of Nigeria are still resisting the drug. Its acceptability in the international market was not assessed in the course of this study. ii. Quality of local manpower in Nigeria: The average science graduates in biochemistry and microbiology in Nigeria are not adequately prepared for quality of scientific analysis needed in the company. They are unfamiliar with the use of state of the art equipment for chemical analysis of substances such as High Performance Liquid Chromatography(HPLC). The company also observed low morle among some of the young graduates that resulted from their inappropriate career choices- a feeling that they would have read other things other than the science courses. This could also have resulted from inadequate motivation by the company as well. iii. Patent renewal: There was problem of renewal of the patent on the drug. The question arose as to who should be responsible for payment of renewal fees that requires further investigation: the patent owner or the licensee. Having reportedly patented the product in USA and a total of 42 countries, the amount of money required for patent renewal was substantial and UNIDO was reported to have assisted to pay the fee. iv. Power Supply: Located in Nigeria, the company is experiencing epileptic power supply for its operations. Stable and constant power supply is important to avoid equipment breakdown which when it occurs may need to be replaced from the manufacturers abroad. This requires after-sales service support. With foreign manufactures involved, this takes money and time and disrupts production. Even when generators are made available there is the problem of high cost of diesel which sometimes could be adulterated by some mischievous suppliers, causing serious damage to the generators. 6. Lessons and Recommendations of the Study i. Reform of Nigerian IP laws A number of recommendations have been offered with respect to reforms in the IP system of the country. a. The impasse between the Copyright Commission under the aegis of the Ministry of Justice and the Trademarks, Patents and Designs Registry under the aegis of the Ministry of Commerce and Industry on hosting host of the proposed national umbrella body on IP is delaying the reform of the country’s IP laws in line with WTO requirements. The matter should be taken to the Presidency for quick resolution. b. It should be noted that having one umbrella body on IP is one (but a very rare) model that countries could adopt in the course of reforming their IP laws. Another model is to leave the different registries where they are presently historically located and allow the emergence of the expected new ones that will be placed in the ministries where they are most suited. This argument is based on the fact that some of the specialized IP registries such as Plant Variety A Review of the Nigerian System of Intellectual Property 33

Protection may be marginalized and will not attract enough of the right caliber of specialists and infrastructure if it is lumped together under an umbrella Intellectual Property Office. More importantly, the new offices will also address the issue of the sui generis patents (PVP, Animal Breeders Rights, Farmers Rights and microorganisms and Semiconductor Integrated Circuit Layout- Design which are different, ‘standalone’ systems and should be administered differently. c. The AU Model law with respect to patent of living organisms was endorsed by all AU Heads of State. It provides for non patent of any living organism because of the sacred nature of life. This is in line with one of the fears expressed by many countries over TRIPS thus requiring that the country shall develop a sui generis (different) system of IP for patenting microorganisms, plant and animal varieties, and farmers’ rights. Such a sui generis scheme will function better if located in the technology related ministries. This will allow for due processes that guarantees respect to life forms to be employed and for better technical capacity development of the offices. They should however employ full compliment of needed professionals including lawyers. Consequently, it is recommended that i. An amendment to the National Crop Varieties and Livestock Breeds Registration and Release Act to include PVP, Animal Breeders Rights and Farmers Rights. The existing Plant Variety Release Act is now administered by National Centre for Genetic Resources and Biotechnology (NACGRAB) in the Ministry of Science and Technology. This recommendation is a variant of the UK model. Alternatively, a separate PVP law with its own registry may be created. ii. A National Biotechnology Law should be enacted which will give a legal backing to the establishment of the National Biotechnology Development Agency (NABDA) and regulate research on new microorganisms in terms of IP as well as regulate biotechnology research with respect to benefit sharing in biopharmaceuticals and nutraceuticals developed from biological resources. Similarly, a separate sui generis law on microorganisms patent may be enacted as an alternative. d. The reform should also include improved funding that will bring the IP system to international standard. There is a lot of international collaboration in IP matters especially with the expectations of WTO. Databases need to be computerized and brought to international standard. There is more emphasis towards a paperless system in the IP official transactions. This system is already being adopted by other sectors of the economy such as the Corporate Affairs Commission of Nigeria. e. To give support to the reform process, Nigeria’s membership of relevant international conventions should be vigorously pursued including Union for the Protection of Plant Varieties (UPOV). ii. Change of perception on IP as only a profession of law. There is need to change the perception of IP as merely a judicial matter meant mainly for the legal professionals in Nigeria. It is perhaps this perception that informed the transfer of the National Copyright Commission from the Ministry of Information to the Ministry of Justice as well as the recent move to host the proposed NIPCOM in the Ministry of Justice. This perception may have contributed to the imbalanced development of IP in Nigeria especially with respect to technology patents relative to many countries of the world resulting from sustained denial of the system the right caliber of technologists and other professionals to make the needed input. For instance the UPOV system of plant variety protection came into being with the adoption of the International Convention for the Protection of New Varieties of Plants by a Diplomatic Conference in Paris since December 2, 1961 32 . 32 source: http://www.upov.int/eng/brief.htm 10oct02 A Review of the Nigerian System of Intellectual Property 34

This was however the point at which there was recognition of the intellectual property rights of plant breeders in their varieties on an international basis. Today there are over 60 members of UPOV without Nigeria while some countries with PVP are not yet UPOV members. A very good point to start is a change of IP Curriculum in Nigerian Universities. Although the range of students that can benefit from IP education in this respect is very wide, as students from disciplines including business, law, fine arts, engineering, the sciences, and journalism could be prime beneficiaries, and indeed, many teaching program should include IP in their curricula, IP presently and unfortunately is taught as a course only in faculties of law in Nigerian universities as part of the basic law degree program that gives students a general understanding of the philosophy and application of IP law. As a law course it is not a compulsory course in the law curriculum approved by the Nigerian University Commission (NUC). And as result of the poor level of awareness of the importance of IP in the country, enrollment for it among law students is very poor. The number of law faculties offering the course at undergraduate level is few while the number offering it at postgraduate level is fewer. As of now, there is no university offering IP as a specialized course in Nigeria. Although at the Nigerian Law School, IP is taken as one of the topics under commercial law which is done through an hour or two lecture often delivered by a guest lecturer, this is grossly inadequate in the light of present day realities of information technology revolution, and increasing pace, impact, and importance of 33 invention and innovation, linked to rapid globalization which have brought IP to the centre stage . This is a sharp contrast to what obtains in the advanced countries of the world and even some so called developing countries like India where IP, Technology Transfer and even Commercial law (with IP curricular for non lawyers) are taught as specialized courses in universities. This step will help to boost the number of IP professionals in the country some of whom can be employed by the emerging technology transfer offices in the universities and research institutes at home and abroad. Recently, NOTAP established 23 of such offices in universities and research institutes across the country. iii. Low Patronage of Copyright in Nigeria Low patronage of operations of the NCC by authors and copyright owners is a cause for serious concern for any well meaning Nigerian. Statistics is showing that between 2005 when the scheme was introduced in its present form and June 2008, the NCC received 995 applications only. This does not reflect the robust capacity of the creative industries today in Nigeria. For instance the Nigerian film industry often called Nollywood is ranked as one of the most vibrant in the world. While such may hold true for some authors, especially the uneducated ones, we cannot say the same of the more enlightened sections of the creative industries. The often cited reason for this low patronage which is low level of awareness among authors can be overcome by aggressive marketing and awareness creation strategies by the NCC. NCC should operate as a business agency. iv. Nigeria’s System of technology policy. Institutions concerned with Nigeria’s technology policy such as the National Council on Science and Technology (NCST) and National Research and Development Coordination Council (NRDCC) whose activities are affected by the developments in IP should champion the reform of the IP system. Similarly an act similar to the United States Bayh-Dole Act should be enacted by the Federal Government of Nigeria. This will make the research institutes and the universities to see their research results as their own properties instead of seeing it as that of public property which does not motivate thwm to commercialize their inventions.. Since the main purpose of the act is to further development and commercialization of research, Nigeria will stand to benefit from the act’s lofty ideals just like other developing countries that have adopted it are reaping the benefits through licensing revenues and formation of start up companies from the research results. 33 Adedeji Oluwale-Dr.(Special Assistant to the Director General NCC), Intellectual Property Education In Nigeria, Nigerian Copyright Commission, Federal Ministry of Justice, Abuja, Paper Contribution, 2008 A Review of the Nigerian System of Intellectual Property 35

v. Harnessing the talent of Nigerians in Diaspora. The role played by the two Nigerians in Diaspora in the USA in the licensing of Nicosan is a classical example of the contribution that Nigerians in Dispora can make in economic development of Nigeria. Two Nigerians in the US Diaspora - Dr. Soji Adelaja, who was then Dean of Research at Cook College and New Jersey Agricultural Experiment Station (Cook/NJAES), and Dr. Albert Ayeni, then Weed Scientist at Cook/NJAES and later Coordinator of International Programs of Cook/NJAES created the enabling collaboration with their employer-The Rutgers University of New Jersey for the conference where NICOSA was discovered by the licensee to take place. Many such Nigerian professionals whose talents could be sought abound in many other institutions abroad. Similarly, Nigeria and indeed Africa has been benefitting from the contribution of a person like Mr Geoffrey Onyeama, Director, Economic Development Bureau for Africa, WIPO, Geneva, Switzerland who on behalf of WIPO has been giving support for the reform of the country’s and continents’ IP system. It is in recognition of these talents that Nigeria set up the Nigerians in Diaspora Conference under the aegis of the Federal Ministry of Science and Technology in which it holds a conference annually with Nigerian professional abroad. Such a forum can also be used to tap more talents on Nigeria’s IP and Technology transfer reforms. vi. IP in ICT sector The operations of NASRDA and NITDA have IP implications including the emerging IP issues like dormain names, for which Nigeria’s dormain name is .ng. Just as postal addresses indicate physical locations, dormain names indicate unique locations in the “cyberspace”. Some of the names assume celebrity persons, places and institutions with greater need to be protected against abuse. NITDA has been mandated to supervise Nigeria’s dormain name. NITDA should also explore the possibility of developing an IP system for Semiconductor Integrated 34 Circuits Layout-Design for Nigeria. These as earlier pointed out are sui genesis IP systems that cannot be adequately administered under the existing IP framework. vii. Development and licensing of NICOSAN The study on NICOSAN was not exhaustive enough within the time limit available to produce this report. Hence it is recommending that a more detailed study should be carried out especially on the IP issues arising out of the project. The experience with the drug should prompt our government to develop policies and laws guiding traditional knowledge and benefit sharing of gains resulting from exploitation of genetic resources in view of its enormous potential, and considering the nation’s wealth of knowledge of and endowment in genetic resources. However, enough attention should be paid to benefit sharing between the contracting parties in the exploitation of the nation’s genetic resources as required by Convention on Biodiversity (CBD) If NICOSAN becomes a success it will encourage researchers and entrepreneurs to invest in the search for treatment of other diseases such as malaria, tuberculosis, diabetes and AIDS through traditional knowledge of genetic resources in Africa. Since inability to generate enough similar competitive patents relative to the developed countries is one of the fears of the developing countries on the WTO, capacity building in this area is urgently needed. Meanwhile NIPRD is said to be working on an anti-diabetic drug that has anti-diuretic effect. Similar opportunities could be lurking in other sectors of the economy such as agriculture, food processing, environment and industry as research results of similar potential could be locked away in the file cabinets of our universities and research institutes without hope of commercialization. NICOSAN also offers lessons in international technology transfer management, coming from a research institute in a developing country and licensed in a developed country. 34 http://en.wikipedia.org/wiki/Sui_generis ibíd. A Review of the Nigerian System of Intellectual Property 36

A Review of the Nigerian System of Intellectual Property 37

7. Conclusion Like in its other colonies at that time, Britain introduced the British Trademark Ordinance in Nigeria during the colonial era which ushered in the practice of Intellectual Property as an instrument of trade. Since then intellectual property practice in the country has evolved to include legislations on patents, designs and copyright. With the emergence of WTO Trade Related Aspects of Intellectual Property Rights (TRIPS), intellectual property has assumed greater prominence and WTO member countries including Nigeria are obliged to include a minimum number of Intellectual Property in their laws with a given period for implementation. Nigeria ought to be taking the necessary steps to comply. The new IP issues are generally technological in nature and have sui generis provisions that make them more generally acceptable. Their sui generis status implies that they should be administered outside the existing IP framework. This is the spirit of the AU Model Law which was crafted under the sui generis option and endorsed by all African Heads of State. The proposed new offices will perform more efficiently if they are located within the context of the S & T and Agricultural systems of Nigeria as is the case in other countries. This will give them a balanced development by attracting the right compliment of professionals and infrastructure. Also in recognition of the important role that intellectual property and technology transfer management can play to enhance access to agricultural research results by the resource poor farmers and promote investment in agriculture, the Central Advisory Service on Intellectual Property launched the National Partners Initiative (NPI) for which Nigeria was graciously chosen among the participating countries and for which this study is also carried out. Nigeria should use the opportunity offered by this study to implement necessary and relevant legal and institutional reforms required to have a functional and balanced intellectual property system so as to join the comity of nations that are reaping the benefits of this new intellectual property regime including agricultural development. It is also hoped that Nigeria’s experiences in terms of any gains or lapses will be useful to other NPI member countries when they are shared. A Review of the Nigerian System of Intellectual Property 38

Acknowledgements The following institutions and individuals have been very instrumental to making this study a reality. The National Biotechnology Development Agency is very appreciative. The grant for this study was provided by the Central Advisory Service on Intellectual Property (CAS- IP) of the Consultative Group on International Agricultural Research (CGIAR), Rome, Italy. The following persons contributed papers about their institutions: Adebambo Adewopo - Director General of Nigeria Copyright Commission (NCC). Michael Akpan is an Assistant Director in the Nigeria Copyright Commission (NCC). Dr Adewole Adedeji, Special Assistant to the Director General, Nigeria Copyright Commission (NCC). Shafiu Adamu Yauri is Senior Asst. Registrar, Trademarks, Patents and Designs Registry, Federal Ministry of Commerce and Industry, Abuja. Mrs. Funke Araba is Director, Technology Acquisition, Documentation and Information (TADI), National Office for Technology Acquisition & Promotion (NOTAP), Abuja, Nigeria. Prof B. Y. Abubakar is the Executive Secretary, Agricultural Research Council of Nigeria (ARCN). Prof. Mohammed Magaji is Director of Plants Research, Agricultural Research Council of Nigeria (ARCN) The following persons granted interviews: Mr. Eric Egbuonu is the deputy registrar Trademarks, Patents and Designs Registry, Federal Ministry of Commerce. Mr. Ireti Oniyide is the Managing Director, Xechem Pharmaceuticals Ltd, Abuja Nigeria. Mrs. Hauwa Keri, Director, Enforcement, National Agency for Food and Drugs Administration and Control (NAFDAC) Prof. Oloyede Kunle is the Head Department of Pharmaceutical Technology, National Institute of Pharmaceutical Research (NIPRD). Mr. Akintayo Akinrelere of the National Biotechnology Development Agency (NABDA) assisted in word processing sourcing information from the internet Prof. Bamidele O. Solomon, Director General, National Biotechnology Development Agency (NABDA) was generally very supportive. A Review of the Nigerian System of Intellectual Property 39

Establishing a Technology Transfer Office in a Developing Country Academic Institution: Experience of Moi University A Case Study Under Moi University, Kenya -CAS-IP NPI Collaboration Project Antony S Mbayaki Technology Transfer Manager Moi University Email: antombeks@gmail.com Moi University PO Box 3900-30100, Eldoret, Kenya Tel: +254 (0)53 43355, Fax: +254 53 43355 Email: dvcre@mu.ac.ke

Contents Executive Summary Acronyms 1 Introduction 4 2 Purpose of the Study 5 3 Rationale for the Establishment 6 3.1 MOI University 3.2 Kenya Industrial Property Institute 3.3 Nairobi University / Oxford University Aids Vaccine Controversy 4 The Establishment of the TTO 8 4.1 MOI University Capacity Enhancement 4.2 Staffing 4.3 Office Placement 4.4 Structure and Functions of the Technology Transfer Office 4.4.1 Objectives of the TTO 4.4.2 Office Structure & Functions 4.5 Technology Transfer Support Activities 4.5.1 Creating IP Awareness 4.5.2 Skills Upgrading 4.5.3 Internal Collaborations 4.5.4 Networking 4.5.5 TT Committee 5 Challenges and Proposed Solutions 12 5.1 Expectations and Assumptions 5.2 Recruitment and Training of Assistants 5.3 Funding 5.4 Application Drafting, Prosecution and Licensing 5.5 Institutional Social Dynamics 6 Main Experiences 15 6.1 WIPO Distance Learning Course 6.2 Institutionalizing the IP Policy 6.2.1 Process and Stakeholders 6.2.2 Challenges and Possible Solutions 6.3 Links with the Private Sector 6.4 Examples 6.4.1 Effluent Color Remover Technology 6.4.2 French Beans 6.4.3 Food Supplement 6.4.4 Patent Information Technology Transfer 7 20 Conclusion 24 Acknowledgments Establishing a Technology Transfer Office in a Developing Country Academic Institution: 1 Experience of Moi University

Acronyms ARIPO African Regional Intellectual Property Organization ASARECA Association for Strengthening Agricultural Research in Eastern and Central Africa BIOEARN East African Regional Programme and Research Network for Biotechnology, Biosafety and Biotechnology Policy Development CAS-IP Central Advisory Service on Intellectual Property CGIAR Consultative Group of International Agricultural Research EPO European Patent Office GRIP Genetic Resources and Intellectual Property HoD Head of Department ILRI International Livestock Research Institute IP Intellectual Property IPR Intellectual Property Right(s) KARI Kenya Agricultural Research Institute KEPHIS Kenya Plant Health Inspectorate Services KIPI Kenya Industrial Property Institute KIPO Kenya Industrial Property Office KIRDI Kenya Industrial Research and Development Institute MD Managing Director Moi Moi University PIIPA Public Interest Intellectual Property Advisors R&D Research and Development RDTI Research Development and Technology Institutions SIDA Swedish International Development Agency SME Small and Medium Enterprises TT Technology Transfer TTO Technology Transfer Office TTM Technology Transfer Manager UoN University of Nairobi USA United States of America VC Vice Chancellor (president of university) WIPO World Intellectual Property Organization Establishing a Technology Transfer Office in a Developing Country Academic Institution: 2 Experience of Moi University

Executive Summary The Moi University (Moi) Technology Transfer Officer can be traced back to the collaboration between Moi and the Kenya Industrial Property Institute (KIPI) 1 in 2002. Under that collaboration KIPI supported the establishment of a technology transfer office (TTO) by raising the general awareness, initially through targeted seminars and workshops. KIPI also seconded its staff to Moi to help establish in-house capacity for IP management and technology transfer. Further, the University received technical assistance from the World Intellectual Property Organization (WIPO) in terms of providing patent documentation. In 2004, the University developed its first Intellectual Property (IP) policy which also formalized the establishment of the TTO. Presently, Moi is among a small but growing number of public universities in Kenya that have experience in filing and processing applications for IP protection. Having a TTO has increased overall institutional awareness of IP. The TTO has been an inspiration for the creation of other IP/TT offices in Kenya and the East African region as a whole. In Kenya, the intellectual property right regime, like that of most African countries, is a relatively new one. Kenya was colonized by the British who extended the United Kingdom intellectual protection regime to the country. This system provided that innovators enjoying protection in the UK could have their rights extended in Kenya through registration. Even after obtaining independence in 1963, this system remained up to 1992 when a new act of parliament, the Industrial Property Act Cap 509 was enacted, establishing the Kenya Industrial Property Office (KIPO) in the early 1992 among other stipulations. For the first time since the country became independent, patents, industrial designs, and utility models could be registered directly in the country. The establishment of KIPO, the predecessor of KIPI, jumpstarted an increase in IP awareness amongst the general public and particularly institutions of higher learning and other public research institutions. The pressure that arose from diminishing government funding for public universities and research institutions, prompted these institutions to explore other ways to generate income to supplement government and donor funding, and created a need to explore generation of income from technology. Perhaps to a lesser degree, there was the pressure from the expectations of the general public for institutions of higher education to account for their research in terms of tangible solutions. All these factors combined together created the need to establish a technology transfer office at Moi and at other research and development institutions. As with any new undertaking, establishing the office has not been without challenges. First, there were the initial costs associated with setting up the office as well as the costs to keep the office running. While TTOs are generally expected to facilitate commercialization of research results and therefore bring in income, that expectation is hypothetical, at least during the first years of operation. The University had to make budgetary provisions to set up and run the office. Secondly there was the challenge of where the TTO fitted in the overall university administrative structure. The question was whether the function of the TTO was primarily administrative or research oriented. Thirdly, there was the challenge of managing expectations of the university fraternity and other collaborators that the office serves. In spite of the different expectations from the office, the primary mandate was to ensure that research products were transferred to the beneficiaries because technology transfer may or may not involve income generation. Other challenges included having to deal with an established institutional culture which may not always hold similar views. However, the challenges were not insurmountable. A big part of overcoming the challenges was and still is to focus on supporting the University’s mission. Like in any process for the establishment of a new office, the understanding of the complex nature of human relationships and organizational cultures, in their perpetual dynamism, is a fundamental ingredient for success. 1 The Successor to Kenya Industrial Property Office (KIPO) Establishing a Technology Transfer Office in a Developing Country Academic Institution: 3 Experience of Moi University

Establishing a Technology Transfer Office in a Developing Country Academic Institution: Experience of Moi University2 1. Introduction Intellectual Property (IP) is a major tool for Technology Transfer (TT) making the two so closely related that IP management and technology transfer management are often believed to mean the same thing and used interchangeably. IP protection has become the tool for enabling the disclosure and exchange of works of creativity (inventions/innovations) for the reward to the owner of the IP. Historically the IP system in Europe developed overtime 3 culminating in the Berne Convention for the Protection of Literary and Artistic Works (1886) and the Paris Convention for the Protection of Industrial Property (1883). In Kenya IP laws were introduced by the British who colonized Kenya until 1963. Despite these many years of existence, IP in Kenya is still considered a new concept by many. This can be deduced, generally, by the low patent applications that Kenyans present as compared to those in developed countries and countries of the emerging economies of South East Asia. In 1997 residents of United Kingdom filed 17,938 patents, USA 198,953 Germany 44,438 and Japan in 1998 357,3794. Records from Kenya Industrial Property Institute (KIPI) Indicate 23, 27, and 19 patent filings by Residents in 97’ 98’ and 2003 respectfully. In 2006, Japan had the largest number of resident patent filings (347,060), followed by the United States of America (221,784), the Republic of Korea (125,476) and China (122,318)5. The UK and Germany had over 10,000 filings. In KIPI it was 42 with no international (PCT) filings. This was and is still due to a number of reasons some of which will be clear in this study. Higher Education Institutions too have not been spared by this unfortunate situation. They are still far behind in IP matters when compared to those in developed countries in Europe, America and in the emerging economies of Asia 6 . There are several and different reasons which prevented not only Moi University (Moi) but also Research Development and Technology Institutions (RDTI) in Kenya from protecting IPs and thus delaying the set up of IP management offices long after Kenya independence. Some of these reasons are: (i) As mentioned in the introduction, historically the IP system in Kenya was administered in the UK, the colonizing nation, and this status was maintained even long after independence (till the 90’s). It was obviously a costly and almost impossible process for any citizen to protect their IPs; (ii) Both before independence and after independence up to mid 90’s IP was not given relevance in teaching from elementary to higher education. As a result when those who went through this education system took leadership/managerial positions in RDTI they had limited or no IP knowledge to realize the need for setting up management or training units; (iii) IP experts were rare or non-existing; 2 In November 2007 the Central Advisory Service on Intellectual Property (CAS-IP) entered into an agreement for a case study on the establishment of the Moi University (Moi) Technology Transfer Office (TTO). The agreement was signed by Dr Victoria Henson-Apollonio (Senior Scientist and pioneer and Manager of CAS-IP) on behalf of CAS-IP and Mr Antony Sisa Mbayaki (Technology Transfer Manager of Moi) on behalf of Moi.CAS-IP is under the CGIAR-the consultative Group on International Agricultural Research. 3 Technical Article On: Role of Intellectual Property System in Development: Patent Law Perspective by Mboi E. Misati-http://www.kipi.go.ke/patents/KIPI_Articles_Misati_Patent_Law_ 4 WIPO Guide to Intellectual Property Worldwide 5 http://www.wipo.int/ipstats/en/statistics/patents/wipo_pub_931.html#a12: B.1.1& B.1.2 6 Association of University Technology Managers (AUTM) reports some 3846 licenses executed in 2003 by a number of USA universities –see Table 1 pg 217, fig 2233 of Intellectual Property Management in Health and Agricultural Innovation a handbook of best practices- Anatole Krattiger et al Establishing a Technology Transfer Office in a Developing Country Academic Institution: 4 Experience of Moi University

(iv) Individual career development in universities and research and development (R&D) institutions is usually based on the number of publications that the academic has. As a result, skilled personnel in these institutions give high priority to publications than obtaining IPR; (v) IP policy was either unheard of or inexistent in institutions of higher education; (vi) there were no real examples of people who had made a living on protected inventions/innovations; (vii) for universities like Moi and other RDTIs institutions and stations in the countryside, the national IP offices, KIPI, Copyright Board and Kenya Plant Health Inspectorate Services (KEPHIS), are too far away being based in Nairobi which is reasonably far from many universities or institutions. 7 Due to all the above reasons many IPs of universities and RDTI have gone unnoticed and therefore unrewarded. Lately though there has been pressure from the government and the general public at large for public universities to expand from the traditional mandates of training and knowledge creation only to generating income which would not only assist the government with its increasingly overburdened budget 8 but also make the tax payers (public) realize and benefit from results from resources spent on R&D 9 . Moi has not been spared from this pressure. One of the ways Moi recognized the establishment of an IP office, later called Technology Transfer Office (TTO) as a tool to obtain tangible impacts. The University established a TTO (which mainly manages IP) in 2004, the first of its kind among the country’s public institutions. Today there are 6 institutions with active IP/Technology Transfer management offices. In all these cases Moi’s TTO had and continues to have a direct or indirect role in the TTO establishment across the East African region. Being a developing country, Kenya gives unique experiences and challenges to somebody who intends to establish such an office over and above those experienced in other developed countries in the same area 10 . Some of these will be explored in detail in this study. 2. Purpose of the study Since more IP management Offices have been created in other universities and research institutions in Kenya based on Moi experience, it is worthwhile to document the unique experience of this pioneer activity as a way of lighting up the path for other universities or research institutions intending to establish IP/TT offices. These and other case studies, sponsored by the Central Advisory Service on Intellectual Property (CAS-IP) 11 and supported by its members, will be documentations of experiences to be shared not only among the National Partners Initiative (NPI) 12 of (CAS-IP) 7 Development and Implementation of Institutional IP policy-Moi University Experience by Gudu et al: paper presented at a workshop on implementation of institutional IP policy in The BIOEARN network partners 2005. (Gudu is a Professor and Deputy Vice Chancellor Moi Univerity) 8 Moi University Strategic Plan 2005-2015 (Executive summary section 01 and section 2.16 pg6) 9 IPR issues for Technology Transfer from Universities and R&D Organizations to Industries by T Ogada (Ass Prof Moi and current MD Kenya KIRDI. Email: proftomogada@yahoo.co.uk) 10 See case studies of “Intellectual Property Management in Health and Agricultural Innovation a handbook of best practices” volume one especially section 6 of heading “Establishing and Operating Technology Transfer Offices” 11 CAS-IP is a programme created in 2000 within the Consultative Group of International Agricultural Research (CGIAR) which provides advice on agricultural intellectual property management issues to the 15 CGIAR worldwide agricultural research centers. It is hosted by Bioversity International in Rome, Italy. In 2007 CAS-IP began an initiative to support a number of agricultural research institutions in 12 developing countries which host some of the CGIAR centers. Among them is Moi University which was selected courtesy of International Livestock Research Institute-(ILRI) Kenya, a CGIAR centre. The selection was done by the Intellectual Property Manager of ILRI, Ms Rose Ndegwa who has been on the forefront in IP capacity building in Kenya and the East African region as a whole. The other participating Kenyan institution is Kenya Agricultural Research Institute (KARI) represented by its IP manager. CAS-IP held its first National Partners initiative meeting in May 2007where the selected national partners were attached to experts from the CGIAR centers for mentorship. It was after this meeting that Moi was selected among four other institutions to do a case study. 12 The NPI is the beginnings of an IP and Technology Transfer professional society and Community of IP practitioners. Currently its members are drawn mainly from developing and emerging economies’ countries consisting of CGIAR Centre IP managers and their partner organizations. It was started in 2007 (http://www.cas- ip.org/?page_id=40). Establishing a Technology Transfer Office in a Developing Country Academic Institution: 5 Experience of Moi University

members but also other IP practitioners. This study, for example, would help not just pioneer technology or IP managers but also those in established TTOs to avoid pitfalls and to apply effective techniques. The study can also be used by researchers in, for example, comparative studies to analyze trends and draft recommendations on practices in establishing TT/ IP management offices. It would enable managers of institutions to make informed decision on whether to set up the office and what they would need to put in place. The study looks at the realisation of the office within Moi and its achievements, despite all the challenges, becoming a reference point for the entire university. The study will especially act as a reference document for the TTOs future operations. 3. Rationale for the Establishment The rationale for the establishment of Moi TTO can be appreciated better when looked at from the perspective of two institutions, Moi itself and KIPI, and in particular a controversy between University of Nairobi (Kenya) and Oxford University (UK) over the ownership of an Aids vaccine invention. 3.1 Moi University 13 Moi is the second public University to be established in Kenya after the University of Nairobi (UoN), planned and built in the post independence era from scratch. It was established by the Moi University Act of 1984, Chapter 210A of the laws of Kenya. It is located in the town of Eldoret about 310km northwest of Nairobi, the nation’s capital. This university has a student population of about 15,000 and staff of 2,748 of which about 700 are academic/researchers. Every year its students and staff participate in national and international technical exhibitions and national agricultural shows where they display their works of creativity. Some of the products of final year undergraduate projects are used on the market but without any royalties or other IP benefits back to the Moi. This university engages in collaborative research with both local and international institutions and organisations, and even the private sector 14 . Researchers too privately engage in contract research with the private sector and other organisations both on a national and international level. In such a case it is impossible to determine whether the University’s IP assets or resources were utilised. In all these cases issues of IP generally arise especially when institutions from developed countries are involved because they bring it up. Monitoring and determining the university’s stake in such circumstances requires an effective IP policy and expertise in the establishment of the office. Since the expertise on this matter was lacking, it became increasingly necessary, as more collaborative contracts were made, that capacity needed to be built. The objectives of Moi before 2005 were 15 : To pursue excellence in teaching, learning, research and extension services 16 i. ii. To produce graduates who are practical, well informed, efficient and self reliant iii. To offer expertise in areas of national and international development iv. To promote science and technology through academic programs and services v. To participate fully in the promotion of culture and develop individuals who are responsive to the needs and well being of others vi. To offer a range of opportunities for education and training vii. To ensure and administer resources to achieve the above objectives efficiently. Looking at these objectives, each of them involves IP or tech transfer in one way or another. For example in (i), research results are disseminated to society through extension service. Some of the 13 www.mu.ac.ke 14 Moi University Strategic Plan 2005-2015 (Section 2.10 pg5 and section 2.25 pg7) 15 Moi University Intellectual Property Policy 16 In disseminating some of its research findings and other available expert service, to the community/society, through ways such as conducting legal, medical and agricultural clinics, usually at no cost, Moi refers to it as “Extension Services”. Establishing a Technology Transfer Office in a Developing Country Academic Institution: 6 Experience of Moi University

research is done in collaboration with, or with contribution from, the society at large, hence the need for benefit sharing; IP is essential here. In (ii) practical graduates must be able to transfer knowledge effectively in solving life’s problems; in (iii) offering services for national and international transfer is just knowledge transfer even beyond borders; in (iv) IP is essential in encouraging innovation hence promoting science and technology whether through academic programmes or otherwise; in (v) promotion of culture and response to the needs of others engage issues of Indigenous Knowledge and benefit sharing among other things where IP engagement rules are even more fluid in the current knowledge age. In (vi) training in IP and TT offers an extra career range of opportunities both for trainees and trainers; in (vii) IP audit can be a major indicator on how research funds and other resources are prioritized. However even though all of the above factors are relevant, (i ) and (iv) were the most influential in inspiring the need for an IP/TT office. 3.2 Kenya Industrial Property Institute 17 Kenya Industrial Property Institute (KIPI) is a governmental department under the Ministry of Industry established under the Industrial Property Act 2001 as an improvement to the Kenya Industrial Property Office (KIPO) of February 1990 18 . One of KIPOs, and still is KIPIs, mandates was to promote inventiveness and innovativeness in Kenya. This inevitably meant encouraging the citizens to innovate and invent or utilise the technological information available at KIPO or accessed by its experts for industrial development. In the course of training and execution of duty and with added exposure, KIPO realised, from the record analysis, that most of the protected industrial properties especially patents, were foreign. They further noted that even for the local applicants it was the Small and Medium Enterprises (SME’s) 19 which were leading in terms of those seeking protection at KIPO/KIPI (table below shows distribution of applications in 2002) 20 . KIPO therefore began raising awareness among universities and other R&D institutions through its Outreach and Education Programme. Despite the efforts, IP protection within RDTI was far below expectations and thus a different approach was required. The institutions had to have their own IP management units. Table1: Analysis of the generators of IPRs (patents)in Kenya 21 Applicants Total Number of Applicants SME’s (Jua-Kali) 116 Industry 45 R & D Institutions 14 Individuals from Universities 2 Secondary Schools 1 3.3 Nairobi University/Oxford University Aids Vaccine Controversy While these efforts were going on, an unfortunate incident was reported by the Kenyan media in 2000 22 that gave a major boost to IP awareness and the need to have IP/TT management systems. 17 www.kipi.go.ke 18 Technology Transfer - The Kenyan Experience, by Mbayaki A S : Paper presented at the East Africa Regional th Workshop (18th-20 May, 2005) organized by the African Programme for Health Innovation-APHI at the National Institute of Medical Research Dar es Salaam, Tanzania 19 Also known as Small Micro and Medium Enterprises (SMME) referred to as Jua Kali in Kenya 20 Technology Transfer - The Kenyan Experience, by Mbayaki A S : Paper presented at the East Africa Regional th Workshop (18th-20 May, 2005) organized by the African Programme for Health Innovation-APHI at the National Institute of Medical Research Dar es Salaam, Tanzania 21 Ogada, T. and Mbayaki, A. (2006). Research Products and Intellectual Property Rights. Campus Based Research Workshops. Accessed at http://www.mu.ac.ke/research/ipr.ppt . Also KIPO The inventor. Issue No. 003. Technology Onnovation( Invention and Nation Building). Kenya Industrial Property News. Published by Kenya Industrial Property Organisation (KIPO), Nairobi, Kenya. Establishing a Technology Transfer Office in a Developing Country Academic Institution: 7 Experience of Moi University

It was the controversy over an HIV/AIDS vaccine invention where the University of Oxford claimed it had been developed solely by its scientists despite a close collaboration with the University of Nairobi (UoN). As a consequence, almost every research institute realized the importance to avoid the same event. KIPI focused immediately on solutions to resolve the controversy and to prevent similar ones in the future. 4. The Establishment of the TTO It must be appreciated that in a developing country where resources are scarce and personnel in RDTI is overstretched, it is not easy to find someone to take the burden of establishing a new unit as demanding as a TTO because it requires altruistic interest and additional efforts. To pioneer such an initiative, it requires initiative from the national IP offices (which are the first ones to receive IP knowledge in the country) to launch the idea within research institutions. KIPI, which have this role, had to identify both institutions and individuals who would lead this work. KIPI identified Moi and a number of its academic staff as having more interest in setting up a TTO than other universities or research institutions, and hence it gave particular assistance. KIPI enabled the identified leading staff at Moi to attend IP seminars organized by KIPI to ensure that they could serve as examples and insiders, and to support in reaching out more members of staff. Eventually these people and/or their institutions become examples of successful stories that inspired others. Targeting heads of research institutions is also an excellent strategy which should, ideally, be handled by the chief executive of the national IP office, something KIPIs director did, not only in relation to Moi, but to all the other research and development institutions, higher education institutions, and middle level colleges. As heads of institutions are the decision makers or the officers accounting for internal policies, if they are convinced of the benefits of a TTO, getting into a research institution or university becomes much easier. 4.1 Moi University Capacity Enhancement The university too took the initiative to expose its personnel to available IP/TT forums not necessarily organized solely by KIPI. Within a short period of time, 23 between 1996 and 2002 various Moi academic staff/researchers participated in seminars, workshops, and conferences by the EPO, WIPO, KIPI and the national Copyright Office, the National Council of Science and Technology, East African Regional Programme and Research Network for Biotechnology, Biosafety and Biotechnology Policy Development (BIOEARN), among others. In 2002 Moi organized with KIPI, in partnership with WIPO, the African Regional Intellectual Property Organization (ARIPO) and a local private electrical company, Power Techniques (also a promising company for the support and protection of IP), an IP seminar for all Kenyan universities. The seriousness with which Moi was taking IP was noticed by WIPO which selected the University for a pilot WIPO-University initiative in 2003. In this collaboration WIPO has been supportive by providing books, pamphlets, and most importantly CDs and DVDs. In 2004 KIPI seconded a patent examiner to assist Moi in its IP management and with the establishment of the TTO. Until today the university is continuing to expose its personnel to IP issues in and outside the country. It has even gone even a step further and introduced an IP course in its undergraduate law degree. Though over 310 Kilometers from KIPO, Moi had personnel and a management unit that took IP seriously as soon as the information was introduced to them. They then took proactive steps to increase IP awareness and eventually its management. The university management also took appropriate steps to work with the national IP office to set up the TTO. 4.2 Staffing An institution needs a competent person to manage Technology Transfer. Someone with a background and training in IP is preferable. Where possible the management identifies a particular person and approaches the person to discuss the terms. In a country with limited experienced job 22 Daily Nation, October 12, 2000, Daily Nation ,Saturday, October 14, 2000 , BIOEARN PolicyBrief 1 January 2008 23 Development and Implementation of Institutional IP policy-Moi University Experience by Gudu et al: paper presented at a workshop on implementation of institutional IP policy in The BIOEARN network partners 2005. Establishing a Technology Transfer Office in a Developing Country Academic Institution: 8 Experience of Moi University

advertisements for Technology Transfer Managers (TTM) 24 have proved impracticable as nobody may come forward for an interview. As already mentioned, close ties with the national industrial property office enabled Moi to recruit a patent examiner for a given period. The other institutions that have IP offices have opted to utilize/recruit/one of their teaching/research staff to manage IP/TT as they learn, on job, over and above their employment duties. In some cases, the institution assigns the task to the legal office. 4.3 Office Placement Given that IP and technology transfer are new concepts in Kenya institutions might recruit out of good intentions but find out later that they had not put in place systems to accommodate the TTM in the institutional structure. Moi experience shows that the process of inclusion of the TTM on the payroll and the TTO on the institutional budget takes time due to the legal and administrative implications in the public sector. The confusion of placement and the lack of office space can be traumatizing to the TTM since IP/TT matters are usually very confidential. In such a situation the TTM too will be required to be understanding, exhibit patience and be creative. With good interpersonal skills one should be able to share desk space and office with colleagues especially for general IP work and create a confidential place to discuss new technology or IP as the case may arise. For example the TTM could go to a researchers’/inventors’ offices/workshops/laboratory depending on the confidential environment that it is provided. Places like quiet restaurants can be used too depending on the circumstances and rapport built with the inventor though precaution and ethics must be observed. In Moi, the campuses are far apart on opposite sides of Eldoret town hence sometimes it is preferable to meet in a venue in town due to time constraint to visit the researcher at the office or simply for convenience. Since TTMs usually have a different job before turning towards issues of technology transfer, and the appointment of personnel within an institutional structure is a challenge, a pioneer TTM can be incorporated in the department of his/her area of professional specialty, at the beginning while the other procedures are put in place. Another alternative is to place the TTM in the commercial/income generating unit if it exists. In the case of Moi, the TTM position was incorporated as a junior lecturer in one of the technology departments and shared office space in the commercial unit which was also just starting. However this meant participating in the management of other commercial issues not related to Technology Transfer. The advantage was that, although it was side tracking, it provided a good commercial and management experience. In all the issues mentioned above and other similar ones that may arise, support from the CEO is crucial because he/she can make decisions to accommodate the TTO and the TTM as adjustments are made. 4.4 Structure and Functions of the Technology Transfer Office From the explanations in the preceding sections it is possible to realise that the scope of service for this TTO within the university was broader than what had been envisaged by KIPI; it was in fact an IP focal point for the western region of the country. Its success would also serve as an inspiration to setting up others in various parts of the country to help disseminate IP information and provide “closer” services to those inventors/innovators who are far from Nairobi and who therefore cannot afford to travel to KIPI and other national IP offices (all located in the city) due to the high costs involved. 4.4.1 Objectives of the TTO It is envisaged the TTO will; i. Enable acquisition, transfer and utilization of technology to and from the university in a more responsible manner so that the institution becomes accountable to the government, the public (the tax payers) and the inventors. ii. Facilitate and strengthen links between the university and the private sector including the industry and SME thanks to the increased confidence of the private sector that their business secretes and confidential information can be safeguarded by the public sector during and after their collaboration. 24 National IP Audit 2004 by Prof T. Ogada et al ( WIPO document) Establishing a Technology Transfer Office in a Developing Country Academic Institution: 9 Experience of Moi University

iii. Play a role in the reduction of brain drain in the institution because researchers will become assured and inspired by the provision in the IP policy of sharing benefits arising out of their inventions/innovations that reach the market and generate royalties. iv. Enable the generation of income for the institution and hence for the government v. Enable the harmonization of interests of the stakeholders in the university and the society chain of creativity and its utilization vi. Provide expertise in handling research contracts especially involving collaborative research, genetic resources and indigenous knowledge. vii. Guard against premature disclosure of inventions at the university. viii. Facilitate the resolution of IP disputes. ix. Contribute significantly to national development and economic empowerment because many useful inventions translate into many jobs. x. Be an IP/TT focal point for the western region of Kenya especially for those who cannot afford to reach the national IP offices. 4.4.2 Office Structure and Functions With the above in mind, the envisaged IP/TT Services Organisation Structure is as follows below. IP/TTO IP/TT IP/TT IP PROSECUTION BUSINESS INFORMATION TRAINING INCUBATION DISSEMINATION IP /TT CONSULTANCY IP /TT IP AUDIT LICENSE/AGREEMENT IP/TT & NEGOTIATION CURRICULUM EVALUATION DEVELOPMENT Fig1: Technology Transfer Office Organisation structure Though ambitious, this structure is a good starting point to enable the university management and TTO visualise the way forward especially in planning the recruitment of TTO personnel. In this structure, IP prosecution involves IP protection processes; Business Incubation will involve the assistance of SMEs or the involvement of emerging SMEs with the aim of growing industries/companies in Kenya for the industrialisation of the country as envisaged in the national vision of industrialisation by year 2020 (which has been now incorporated in the current vision 2030 of transforming Kenya into a newly industrialised, “middle-income country by then) 25 ; IP/TT Information Dissemination will involve raising awareness; IP/TT Training will involve proactive training on IP/TT issues or support the institution with IP training; IP/TT Consultancy will provide consultancy services to other organisations and public institutions on IP agreements such as negotiating and drafting agreements/licenses; IP Curriculum Development will offer assistance to institutions intending to offer 25 http://www.planning.go.ke/Ministry of State for Planning National Development and Vision 2030/popular version Establishing a Technology Transfer Office in a Developing Country Academic Institution: 10 Experience of Moi University

IP/TT courses; IP Audit and IP Evaluation will involve the evaluation of technologies either to be protected, licensed or acquired by the institution. 4.5 Technology Transfer Support Activities Some of the TTO activities to support the TT management will be covered here in more detail for illustrative purposes. 4.5.1 Creating IP Awareness Campaigns to raise IP awareness is an activity undertaken constantly. Initially the staff was the main target but students have now become an important target of such campaigns. When academic staff becomes sensitive to and aware of IP issues, such awareness is then passed it to their students. Tools used to raise awareness include laptops and power point projectors, IP pamphlets (from WIPO mainly), presentation of papers from knowledgeable staff and external facilitators. In certain departments or target groups like the department of medicine, where doctors are extremely busy due to high demand either in class or at the clinic, it is not easy to get a decent attendance. One strategy considered, but yet to be tested is to develop a strong relationship with the Heads of Department (HoDs) first so that they can slowly influence their colleagues a few at a time even if it means meeting them in their offices individually or in small groups. 4.5.2 Skills Upgrading Given the fact that IP covers all areas of knowledge and TTMs are expected to provide satisfactory answers to all questions, even in fields they are not specialized in and compounded by the fact that IP is a dynamic subject, a TTM has to improve continually his/her skills. Some of the ways to ensure that this happens include: advanced degrees, diplomas and/or focused training, and attending seminars and short courses on IP related subjects like marketing. Besides seminars, the templates of agreements from IP books such as “Handbook of Best Practices for Management of Intellectual Property in health Research and Development (by Richard Mahoney et al)” have been of great assistance. Therefore a TTO needs to develop a library of IP resources which needs to be constantly updated due to the fast-changing character of IP and technology so much so that even national and international legislators find difficult to remain current. Because of the limited training resources, various organizations have assisted in training the TTM at Moi, some of which are CAS-IP, 26 SIDA (through Svalof AB of Sweden), ARIPO/EPO (through their seminar), BIOEARN/ASARECA (Association for strengthening agricultural Research in Eastern and Central Africa), and APHI (African Programme for Health Innovation). 4.5.3 Internal Collaborations The TTO works closely with the university’s legal office on TT/IP agreements. When the TTO or the legal office draft agreements such as memoranda of understanding, collaborative research agreements, confidential agreements, or licenses, they need each other’s approval. The heads of departments, the office of student affairs, and even the students themselves are a great resource for raising IP awareness and support the TTO in its work. 4.5.4 Networking TTMs should be aware of their limits and realize that they cannot be experts in everything; therefore seeking assistance from other IP colleagues both nationally and internationally is advisable. Contacts with organizations like Public Interest Intellectual Property Advisors (PIIPA) and experienced universities can provide useful support. Staff of other universities engaged in IP management, and even those in the national IP offices, are good resources to create networks within and outside Kenya. In Moi the TTO has been in close contact with the TTO of Michigan State University in the USA, the International Livestock Research Institute (ILRI) Kenya, Bridgeworks Africa-Kenya (a venture capital company incubating and commercializing technologies) 27 , and BIOEARN partner institutions 28 KIPI, KEPHIS and the Kenyan Copyright Board. The TTM has created good networks with the participants 26 http://www.svalofconsulting.com 27 http://www.bridgeworks.ch 28 University Of Nairobi-Kenya , Kenyatta University Kenya, Kenya Agricultural Research Institute-Kenya, University f Dar es Salaam-Tanzania, Mickocheni Agricultural Research Institute-Tanzania, Makerere University- Uganda, National Crop Resources Research Institute-Uganda, Addis Ababa University-Ethiopia and Ethiopian Agricultural Research Institute-Ethiopia Establishing a Technology Transfer Office in a Developing Country Academic Institution: 11 Experience of Moi University

to the CAS-IP’s NPI, EPO staff, former colleagues of GRIP 29 training courses, and other people met at various IP meetings. In their networking activities, TTMs must be careful not to enter into any commitments on behalf of their institution without prior authorization. Pro bono-based organizations like PIIPA need to be made aware of the complexities of developing countries which make it difficult for TTOs to benefit fully from the free support provided by such organizations. 4.5.5 TT Committee An institution can form an IP/TT committee composed of representatives from the various knowledge clusters, not necessarily faculties, that the TTM must evaluate before making any controversial decision like whether to terminate an application in process of protection or not. In Moi, with advice from the IP manager of ILRI-Kenya, the TTM has made a proposal to the university management for an interim committee of five people drawn from faculties of humanities, physical sciences (engineering included), life sciences, Managing Director of the university company (MUHL), a legal staff and the TTM as the secretary of the committee. Ideally the committee is to be chaired by the Deputy Vice Chancellor for Research and Extension. This committee, if approved, will be required to prepare its terms of reference. The meetings for such a committee can be conducted over a video conference the and not necessarily face to face so that action is taken by the TTM as soon as possible if there is agreement on a matter. 5. Challenges and Proposed Solutions Establishing a technology transfer management unit at Moi had its share of challenges some of which will be explored in this section, together with any possible solution. 5.1 Expectations and Assumptions The following assumptions have been noticed in the management of TT at the university. They have to be considered not as something negative but as a means of learning. Points of view can change over time. a. TT will produce a huge amount of money soon which will make the institution self sufficient and maybe independent from any governmental or other sponsorship: To be realistic some of the institutions researchers or management is not entirely to blame for having this unrealistic perception. To some extend TTMs and national and international IP offices and organizations knowingly or not contribute to this unrealistic assumption in the way they talk about IPs and their industrial application to attract more attention and make news. Their depicting of patents and of IP in general as money-makers to all who obtain protection rights, has a large impact on this assumption. Even when rights are obtained, marketing and other inputs are needed before they can generate some returns (if accepted on the market). b. Patent protection (and all IP protection) is automatically international: This would mean that once a patent is protected for example in Kenya it is protected internationally. This wrong understanding is due to the incomplete information disseminated during the IP and TT raising awareness exercise because of the limited time spent in doing this and therefore covering only part of the information. To minimize this risk, constant awareness raising helps clarify aspects of IP protection because it is usually not possible to address all aspects adequately in one sitting. Territoriality of patent regime usually needs slow explanations which sometimes are not possible when an IP campaign is just part of a bigger seminar or meeting of senior management where other subjects are considered more pertinent to be discussed. c. IP protection is going to hinder knowledge sharing and interfere with the publication of research findings. Some researchers fear that IP will prevent colleagues from sharing and disseminating information freely, as they have always done, and therefore this induce them to keep the 29 Genetic Resources and Intellectual Property Training Course conducted by Svalof AB ,http://www.svalofconsulting.com Establishing a Technology Transfer Office in a Developing Country Academic Institution: 12 Experience of Moi University

information secret, with the effect of slowing research down. To some extend this fear may be justified; however once the systems for information disclosure and protection are in place, not only research will not be prevented but it will be stimulated by researchers motivated by the potential economic benefits from their research. A researcher will also take extra care in using information or material which has been provided under confidentiality than information which was on the public domain; as a consequence he/she will maximize its use, and minimize any waste among other advantages. An institution’s IP policy could emphasize that patent protection is paramount for the institution and reassure those researchers who want a quick publication, as part of their career development, that their invention can still be protected and be considered for career promotion. One way of reassuring them is to make them realize that, except for new plant variety protection, patents and other industrial property protections can be filed even before the complete result has been achieved. In essence it is a matter of communication of the research and the expected or obtained results from the inventor to the TTO which might result in filing a patent or other IP application long before the actual results can be published. d. Cost of filing IPs and running a TT is very insignificant in comparison to the budget that public institutions have. No matter how true this statement may be, the result of this assumption is that the TTO does not get funded except for the amount it receives to pay its staff. As a result, the registration and maintenance of patents, including filing and prosecution of and IP application and patents, as well as their commercialization, dissemination of information, and technology scouting, among other activities, become difficult to be carried out. Continual awareness creation to management will gradually change this view. e. Unlike in a national IP office, where, generally, various IP experts in various IP fields are available, researchers, students, institutional CEO’s and senior managers and staff in general expect that an IP manager is knowledgeable in all areas of IP and TT. For example the TTM is expected to draft applications for all fields of technology, which is a really challenging task. This is further worsened by the university’s limited finances which make hiring an external (international) expert in certain specialized matters, like drafting applications in fields unfamiliar to the TTO personnel, difficult to approve. Therefore, in the short term, the TTM must make every effort to come up with solutions. The TTMs’ attitude should be “something is better than nothing”. In such circumstances the TTO’s relationship with the national IP office is crucial. For example patent examiners can point out clear mistakes in a poorly drafted application. If National laws/Acts guaranteed provisional 30 application filing , TTMs and their institutions would have the opportunity to buy time and find experts to draft patent specifications in specialized fields or make corrections and minimize errors if they cannot afford to hire expertise. Universities need to start setting up training programmes on specialized IP through collaborations with experienced institutions, especially, in developed countries, as a way to resolve the problem of shortage of staff. Formal training is the most effective way of reaching a critical mass of IP practitioners, like IP attorneys, to support institutions and, as an indirect consequence the nation as a whole. Another way an institution can do to resolve the problem is to recruit trainees and interns for on job training in the TTO. Alternatively the trainees and interns could have similar involvement in the process if arrangements are made to be affiliated with the national IP offices or other experienced institutions in the country or in other countries. f. Researchers/inventors/innovators expect the TTM to reach them quickly Researchers in general believe that once they have made their major discovery it is the TTMs responsibility to make immediate contact with them and discuss the ways of protecting their invention. However, the TTM can only reach the inventors as fast as it is convenient. With time and with awareness, researchers will realize that it is also their responsibility to contact the TTO. g. TT is a simple activity therefore the TTM should be able to support other staff in their duties. 30 http://www.kipi.go.ke/patents/application.htm Establishing a Technology Transfer Office in a Developing Country Academic Institution: 13 Experience of Moi University

The TTM may end up being burdened with other non-IP related issues. The problem is that such issues can be time consuming and may not be reflected in the accountability report. The obvious solution to this problem is for the TTM to decline accepting non-IP related work; however, this is not so easy in a developing country. 5.2 Recruitment and Training of Assistants The experience at Moi shows that recruitment and training of assistants can be difficult: those people who have an established career would not change profession for something unknown, while young people may likely continue their professional training or move to more attractive professions. One possible solution is to encourage one or more of the existing members of staff to assist the TTM in his/her duties despite having a different job position. If it works well, the result is that some may decide to move to work for the TTO. No matter what the result is, the assistance to the TTO of an extra person is important to ensure that the office is not closed when the TTM is away. 5.3 Funding Ensuring that IP activities are funded is necessary as the institution’s limited resources are often directed to pay students’ tuition and staff salaries. At Moi, a clear way of funding activities of the TTO is yet to be put in place but suggestions have been made. One way could be to seek external funding. In order to do this, the TTO would be responsible, as part of its activities, to draft funding proposals. Another way would be to request researchers to include IP funds in their research proposals to support IP prosecution and where possible the commercialization of any results. Currently BIOEARN has been a supportive partner not only to Moi but to all its network institutions in the East African region 31 . BIOEARN has donated some office equipment, funded IP short course/trainings and awareness raising talks and IP audit for all its sponsored research projects. It is currently in the process of providing standard laboratory notebooks for researchers’ record keeping IP management literature for the TTO managers and other office equipment. These will boost research/IP accountability to the university. 5.4 Application Drafting, Prosecution and Licensing As already implied earlier, in Kenya, experts for drafting and prosecuting IP applications are few or do not exist 32 depending on the technical field. Institutions like Moi too have limited finances to prosecute adequately IP applications, especially patents. Even if the financial support were to be provided, the system is very bureaucratic and hence very slow which have a clearly negative impact on IP processing which follows legal timelines. At MOI, the drafting and prosecuting of patents (and other IPs) have entirely been handled by the TTM; researchers’ project funds and the TTM’s personal funds have to be advanced to pay for the filing of patent applications either to ensure that international deadlines were met or to enable a student defend his/her thesis in time which could not be achieved if the TTM waited for funds sought through standard channels because of the red tape. This means that a TTM has to be prepared to make sometimes personal financial sacrifices. The TTM must ensure that he or she obtains consent from his or her immediate supervisors (institutional managers) to avoid creating an impression that the TTM is pursuing a personal agenda. Building rapport with patent examiners at the national office can be of great help in processing patent applications. Where it is difficult to find a drafting expert nationally for a complex invention/innovation and the invention is promising, services of a foreign attorney can be sought. This avoids the TTM to take risks in drafting and prosecuting patent applications in the wrong or inaccurate way, and shifts the responsibility to somebody else more expert in the field considering the high economic and personal expectations associated with inventions and ownership of patents. Further, the TTM should work closely with the CEO, or someone in management, who should be briefed 31 University Of Nairobi-Kenya , Kenyatta University Kenya, Kenya Agricultural Research Institute-Kenya, University f Dar es Salaam-Tanzania, Mickocheni Agricultural Research Institute-Tanzania, Makerere University- Uganda, National Crop Resources Research Institute-Uganda, Addis Ababa University-Ethiopia and Ethiopian Agricultural Research Institute-Ethiopia 32 National IP Audit 2004 by Prof T. Ogada et al ( WIPO document) Establishing a Technology Transfer Office in a Developing Country Academic Institution: 14 Experience of Moi University

continuously of the progress of patents prosecution or the decisions and reasons for licensing the university’s technology. The TTM will help clarify any issues that may arise, especially if there is a real or apparent mistake on the part of the TTM. With time, these briefings can be reduced as the CEO acquires a better understanding of IP issues. Unless they have a commercial unit like MUHL, institutions do not have marketing/sales departments/experts therefore, the TTM should acquire some marketing skills to enable the marketing of any new technology coming out of the institution’s research. Rapport and support from the national patent office can ensure that certain services like patent searches are offered for free as a way of promoting inventiveness in the country. When discussing a potential invention with an inventor, the TTM should have the attitude of “the inventor is always right!” to avoid a quick dismissal of the inventor. Even if the invention is obvious or not eligible for protection, it is wise to point out other innovative ideas though not protectable and applaud the effort made. In this way the person will be encouraged to keep trying out new ideas and approach the TTO if and when he/she comes up with another potential invention. Moi has experienced this on various occasions. TTMs need be aware that some researchers might be impatient and take matters in their own hands especially when they have planned to publish or when they feel the technology should be made public as quickly as possible. In this case it is wise not to oppose the researcher but to inform the immediate supervisor of the situation. It is important to realize that it takes time for all to understand and appreciate the new procedures. Sometimes researchers are not available to enable the completion of the drafting process because of their busy schedules or because they may decide to drop the application if they do not believe it is worth. Moi has experienced this a few times. Constant dialogue between the TTM and the researchers is important. When dealing with the private sector to license the institution’s technology, it is important to be aware of their expectations and desired outcomes. A private company expects that its confidential information and trade secrets, if disclosed to the public institution, are kept confidential, and that it is granted exclusive licenses over the technology that arise out of the collaboration. The TTM needs to bear in mind that the private industry is a major stakeholder in the TT chain and applied research funding. The TTM must manage these expectations well to avoid any damage to the reputation of the institution both in case the deal falls through or the name of the institute is misused during the license. 5.5 Institutional Social Dynamics A TTM has to content, to some extent, the different groups in the organization and carefully navigate within it. Sometimes quality and quantity of effort and or output is not all that is considered when making decisions especially those that affect personnel. Some decisions are taken from a social and political point of view and this can result in mistrust which is a challenge for a TTM as he/she has to be seen to balance social, political, and gender considerations in the recruitment of personnel and provision of services. Although this is expected everywhere, in a developing country like Kenya, it is more complex and needs serious consideration. The inevitable outcome is that certain expectations will never be met whatever the effort is. In such instances, one has to rely on intuition or faith 33 to make decisions in dilemmas (as long as the decisions taken are the best there can be taken). 6 Main Experiences Despite the challenges described above in setting up the TTO at Moi, progress has been made and a number of accomplishments have been achieved. The processes and experiences are shared below. 6.1 WIPO Distance Learning Course 33 Competing values leadership: Creating value in organisations by Kim Cameron et al. Establishing a Technology Transfer Office in a Developing Country Academic Institution: 15 Experience of Moi University

In 2004, 2 lecturers from the school of engineering and 4 employees of MUHL from the company completed the WIPO, 6 weeks, and distance learning course (DL-01). The lecturers have taken the initiative, even informally, to make their students more sensitive on IP issues. The number of academics who completed the course was though below expectations. The reason given by a number of them who intended to take the course was workload, as the course coincided with the undergraduate exams and the lecturers were involved in supervising and marking exams thereafter. Besides this reason, the TTM suspects that the low interest in the course was due to their concern to overburden themselves with work from another new field (because none of those who had shown interest earlier has come forth to make further enquiries on the next registration), as well as perhaps a lack of constant encouragement from the TTM. This last assumption is based on the fact that the TTO was located at the MUHL at the time so the MUHL staff who registered received constant encouragement to complete from the TTM, which they all did. 6.2 Institutionalizing the IP Policy 34 In 2002 the first IP policy draft of Moi, with the help of KIPI’s experts, commenced following the declaration 35 , made by participants in the IP seminar at Moi (4.1). A committee with representatives of all Kenyan universities (at the time), one polytechnic and national IP offices, was set up during the seminar with the intention of formulating recommendations on IP management and training in universities and the country in general. However, despite being a noble idea, shortly after the seminar the Moi ‘champions’ deliberated that it would have been too difficult to obtain an IP policy common to all the universities for drafting, funding, and logistic reasons. Moi therefore decided to draft its own policy. Eventually this turned out to be the correct approach which is being followed by the rest of the universities and even research and development institutions. 6.2.1 Process and Stakeholders Before embarking on drafting an IP policy, commitment from the top management, who are the official policy makers, was first sought. With them convinced, it became easy to set up a drafting committee and to obtain the required resources and other intangible support. It is advisable to have a small team of drafters to manage costs and personalities of the team members. The initial drafting team in Moi was composed of 5 academic staff; one staff from the engineering/technology faculties, one from the science faculties with a biological background, one from the business school, one from the law school and another from the social sciences. This was considered a good distribution across the professions. They came up with the working draft, developed by analyzing IP policies of other universities and research institutions in Europe, Asia, Australia, North America and Africa (South Africa mainly) downloaded from the internet. Language barrier made it difficult to access/or read South American documents. The majority of examples were from the USA. The team then requested the assistance of KIPI’s experts. The KIPI staff was composed of two patent examiners (one with an engineering background and one with a physical science background) and their supervisor who had a background in plant breeding bringing the drafting team to 8 people. It would have been advisable to include members from the other two national IP offices in charge of copyrights and new plant varieties protection; however, this was not possible because of their more limited IP area of practice and links with the Moi team and restricted funds. Involving external participants, in a way, creates in, advance, awareness and closer ties with stakeholders in the TT chain. If it is not possible to have all the stakeholders at start the Policy should contain a clause which provides for its review after a given short period (about two years) to take care of any issues which arise based on experiences during the implementation of the first edition. Also, as issues and disagreements may arise, a clause which provides for a dispute resolution committee or equivalent authority would be another safety net. The TTO can then, with time, keep noting the changes that need to be reflected in the review. A shorter drafting route would be to engage services of an expert. When a satisfactory draft is agreed, it is exposed to stakeholders for awareness and debate to ensure that their views are incorporated as much as possible and in this way build in them a sense of ownership. Stakeholders are basically institutional staff/researchers, the university management, university council (board) and where possible students, a selection from the private 34 Moi Intellectual Property Policy: The Policy, The Experiences by Tom Ogada (2004) during the launching of the Moi IP policy. Email: proftomogada@yahoo.co.uk) 35 Kenya Industrail Property Institute Rapportuer’s Report on the Intellectual Rights Seminar held at The Moi University on Sept 3-6, 2002, pg 46 Establishing a Technology Transfer Office in a Developing Country Academic Institution: 16 Experience of Moi University

sector especially industry and copyright organizations and IP agents/ attorneys. In Moi the stakeholders were just the university academic staff, university management and council. After the stakeholders have had their input incorporated, to the satisfaction of the TTO or the drafting team, the document was handed to the management including the board (council). This was also a good opportunity to create IP awareness even among board members whose views should be incorporated and, when not possible, efforts should be made to explain to them why not. In reality if the majority of the board members are convinced about the importance of the process, they will persuade their colleagues to go too. When the Policy has been approved, the launching ceremony can then be planned. Let it be as grand as the fund can allow involving, where possible the media! This is meant to capture the attention of the private and public sector and make them realize that the institution is serious about inventions and respect of the ownership of intangible rights even of private companies. It is also the right time to announce the existence of the IP/TT office. 6.2.2 Challenges and Possible Solutions It must be said, as a word of caution, that not everybody will be impressed with an IP Policy especially if it is the first draft. There are high chances that a number of scientists will argue against it as being a hindrance to research. Others will disagree with certain provisions, usually on ownership and benefit distribution ratios. Benefit distribution clause can take hours to discuss for well known reasons as it determines individual remuneration. For example, a number of researchers believe that the university should get very little or no remuneration while the inventor should get all or most of the remuneration. This is because many times research is funded by donors as the result of the initiative and efforts of individual researcher(s) who put in extra hours to write (a)research proposal(s), and to seek and convince donors with little or no support from the university (so it is perceived). In addition as some institutions, like Moi, require that a certain percentage of the funds go towards administration, researchers argue that the institution has already been paid. To sort this issue out, diplomacy is required. Identifying and categorizing the people involved in an invention help the TTM to convince researchers about the roles played by various people and not just by the inventors and so to justify their inclusion in the benefit sharing. In the draft of Moi IP Policy, several stakeholders were identified, in particular inventor(s), inventor(s’) research team (where the research team may be given some incentives), inventors’ department, and the university as a whole among others. Initially drafters proposed that the inventor got 40% of net income (less costs incurred in research, IP protection and IP management among others); however, this provoked a long debate as for example some people wanted it to be raised to 60%, while others proposed a tapering system with the percentage increasing for the inventor if the royalty income increases. The researchers also need to be informed that it is important to invest for future research. The university/institution apart from the goodwill in the name, to attract funding needs a research environment where managers, administrators, support staff, and research assistants play a role either directly or indirectly in the generation of technology. In Kenya the general spirit of IPR law 36 points to the employer as the owner of rights, even though for Seed and Plant Varieties Act and Trade Marks Act, ownership by employer/commissioner of assignment is not clearly stated 37 . In the patent and copyright law generally the invention (works of creativity) belongs to the employer when the researcher had been employed to carry out the research and it is a clear term of employment. The employee researcher could then be entitled to equitable remuneration depending on the IP 38 to motivate the hard working/creative researcher (employee). Though least advisable, where discussions seem not to reach conclusion, percentages should be left out all together and a proposal to deal as the case arises may be recommended, even though it runs the risk of more bitter disagreements when a new technology draws in royalties later on. This model was opted at Moi to enable the first draft, which had taken 2 years, to be launched. 36 Laws of Kenya ,Act No. 3 of 2001 - Industrial Property section 32 and Copyright Act cap 130 section 13: http://www.kenyalaw.org/update/ 37 Laws of Kenya The Seeds and Plant Varieties Act cap 326 section 18: and trademarks Act cap 506:http://www.kenyalaw.org/update/ 38 Laws of Kenya Act No. 3 of 2001 - Industrial Property section 32: http://www.kenyalaw.org/… Establishing a Technology Transfer Office in a Developing Country Academic Institution: 17 Experience of Moi University

The quorum in the meetings on IP and TT awareness between academic, administrative and management personnel is usually very low. In the department of medicine at Moi, for example, none of the academic staff attended and only a handful of administrators. The reasons given were their schedules were full because of other engagements either at the main referral hospital or at their private clinics. This was one of the true realities given the generally low number in doctors in Kenyan hospitals more so in upcountry towns like Eldoret. It was realized that advertising the meetings simply on the notice board and by informing the dean or HoD was not enough. Having someone on the ground who takes the initiative to mobilize colleagues and take care of certain logistics aspects, as was the case in some of the departments, guarantees a better attendance. Another way is that the TTO calls the members of the targeted groups informing them of the meeting and encouraging them to attend. Emails and the institution’s website are also tools to inform staff about upcoming meetings. For top management and council the way to reach the necessary quorum is to incorporate awareness in one or more of their scheduled meetings. As much in advance as possible the drafters need to secure an appointment with each member of the management unit once the document has been distributed to each of them. In this way one is able to raise individual concerns he/she might be embarrassed to raise in a public forum. It is therefore important that rapport with the senior people is build. If the draft team is well constituted, there will be members specifically in charge with the lobbying of the policy either because they have rapport with the targeted group or have the required skills, naturally or acquired through training. Care must be taken in including in the lobbying team, those who might still oppose the IP policy (if the opposition is evident though, such people can be useful as they provide an alternative view to the policy, and can be included in the drafting team; however, it seems proved that they start to appreciate the benefits of IP and of an IP Policy during discussions or during its implementation especially when they eventually get involved in an IP issue in the course of duty. 6.3 Links with the Private Sector Some of the student projects and research is undertaken at local industries on their request and on acceptance by the university. The request/acceptance letters rarely spells out IP issues. In Kenya very few industries have IP policies (usually only the subsidies of multinational or international companies). If from such work an invention occurs, the TTM will make efforts to convince the company management to joint ownership of the invention. This is advisable as in this way the company which knows the market and knows how to reach the end-users deals with the use of the technology through an exclusive license with the university whilst the TTO will handle the aspects of IP protection, including processing and licensing. This is a win- win situation as the university will have achieved its goal of TT while the industry will not only jointly own an advantageous technology but will have also acquired IP awareness, where there was none, and accessing IP licensing expertise easily. In addition, the institution can be guaranteed more collaboration, with the same and other private collaborators as well as the benefit of more experience and recognition. The TTM’s main focus in such a public institution should be the transfer of the technology that the institution creates to ensure that it is not wasted but exploited given the costs involved to develop such new technology. At Moi University everyone now agrees that concrete efforts must be made to transfer technology to the industry. The current challenge is how to deal with company workers (scientists, engineers and technicians) who provide useful assistance or recommendations during the course of the research/project, but who are left out in any benefit sharing, due to absence of IP policy, unlike their counterparts at the university who might be considered as inventors’ support team. In such a case the TTM has to advise tactfully the company’s management staff on rules of inventorship and alternative incentive mechanisms to boost the morale of such contributors. 6.4 Examples A number of technology products have been transferred by the TTO, some successfully others partially successfully, and others unsuccessfully. These cases are explored below. Establishing a Technology Transfer Office in a Developing Country Academic Institution: 18 Experience of Moi University

6.4.1 Effluent Color Remover Technology 39 A Moi University scientist together with his Mphil student came up with a novel way of removing colour from waste water or raw water in 2003. The electro-chemical patent application, which belongs to Moi was the first patent to be filed by a Kenyan university in 2004. In 2005 it was filed as a Patent Cooperation Treaty (PCT)/international application with WIPO International Bureau. This discovery has been successfully tested with soft tissue and paper, coffee, tea and molasses factory effluents. As the head of MUHL, the Management Director wrote to various companies emitting colored effluent inviting them to share the technology through a license. Despite having tested and proofed it, even if at small scale, no companies came forward. One of the possible reasons for this was the lack of a large scale demonstration plant for companies’ CEOs to appreciate fully the applicability of the discovered technology; CEOs are probably cautious to invest in something which might turn out to be costly or not working. Many at Moi also believed that the disinterest of the private sector was caused by the general lack of confidence in research findings by local RDTIs as local examples are rare in a developing country. A scientist, of one of the company targeted by Moi, advised the university to protect the technology via KIPI. The TTO in conjunction with the MUHL is now working to seek collaboration with Kenya Industrial Research and Development Institute 40 (KIRDI) and a company to set up a demonstration plant. Using its network in Michigan State University, the TTM tried to market the product in USA; even though it was not successful, Moi gained a lot of experience. All this efforts are made because this invention is an opportunity to demonstrate the benefits that the protection and transfer/commercialization of an invention have. In drafting the application, the TTM interviewed the lead researcher who also provided written documents on the published work. The lead researcher on the TTM direction provided the application drawings. With this information and in consultation with the lead researcher the TTM concluded the application drafting and embarked on filing the application form at KIPI. The most challenging part in filing the form was on the identification of the real inventors. The TTM felt that only two of the 4 persons mentioned as involved in the project were eligible as inventors (contributed intellectually in the invention process) while the lead researcher felt that three of them had to be named. Being the first application and that the inventor has to be given a benefit of doubt in such controversial cases, the TTM filled three names as inventors in the application form. Also, such decision would have affected only the inventors and not also the university in relation to the distribution of royalties. Whatever the reasons for such a decision, the lead-researcher was to be highly commended for his altruism in trying to ensure that all those who participated could benefit equitably. After the application documents were duly prepared, as required by KIPI, the TTM presented them to the university Vice Chancellor (CEO) to be signed. Being the first application, a short signing ceremony was organized, with photographs. Thereafter an application was filed at KIPI in 2004. It was later filed internationally through the PCT system which is designed to be cheaper for developing countries. This application process unfortunately has been delayed because the receiving officer did not notice that a copy had not been transmitted to the search authority. Completion of the process is expected soon. If successful, the patent might be framed and displayed in one of the senior offices. Though minor, a notable uniqueness of this case is that the lead researcher is a citizen of another country; as Moi IP Policy states that researchers and their heirs will benefit from the patented and commercialized invention, even after leaving the university, for the whole duration of the IP right. This alone has boosted the morale of the scientists and of the University. It enhanced awareness among scientists and changed the mind of those who were against IP. 6.4.2 French Beans In 2005 scientists from the Moi seed technology department brought to the attention of the TTM two French seed varieties they had developed and were undergoing testing for Distinctiveness, Uniformity and Stability (“DUS”) () at KEPHIS. Selected commercial seed companies and traders had 39 Presented in a Pulp and Paper technical Association of Canada (Paptac) Conference;- January 26th-29th, 2004 Montreal, Quebec Canada. PP.C5-C10 by Dr Etiegni Lazare (lead researcher, now Ass. Prof.). Title, ‘Colour Removal from Waste water of Pulp amd Papermill in Webuye Kenya by a combination of electrochemical coagulation methods B.O. Orori, L. Etiegni, M.S. Rajab M. L. Situma and K. Ofusu-Asiedu, published in “Pulp and Paper Canada entitled “ Decolorisation of a Pulp and Paper Mill effluent in Webuye Kenya by a combination of electrochemical and Coagulation Method , B.O Orori, l. Etiegni, M.S. Rajab, L.M Situma and K.Ofusu-Adiedu “(Paper Canada, Vol 106:3(2005)pp.T50-T55). 40 A national research institution Establishing a Technology Transfer Office in a Developing Country Academic Institution: 19 Experience of Moi University

participated in a field quality test and some had a commended the new varieties and shown interest in marketing them on the international market. The TTM therefore advised the inventors (breeders) that they needed to enter agreements with the company(s) they wanted to handle their new material to safeguard the rights to materials of the new varieties. The TTO therefore drafted an MTA. Unfortunately the scientists disagreed with the TTM and MD of MUHL on the trial seed pricing modalities. The TTM and MD advised that the researchers left the price negotiations to them because the researchers did not have the business negotiation expertise. On the other hand, the researchers wanted to give free seed to certain companies since they had worked with the companies before and had developed relationship. They also did not want impediments or delays in transferring the seed to the companies. This can be understood as a researcher finds joy when his/her invention is transferred to the society while the university is aware that companies would be pleased to received cutting edge technology for free. During one of the plant breeders’ association meetings the CEO of one of the leading seed companies pointed out to the TTM and MUHL MD, who attended, that giving the seed to every company was the wrong way to go because certain companies are cautious to invest heavily in variety, even if good, without the guarantee of some monopoly, in order to recover costs. This is because in the horticulture industry the possibility of a new variety being developed in few years/months, and hence becoming available on the market is high. When many companies are awarded a new variety, there is a danger of market flood. At the moment, it is not possible to state yet whether this has been successful or not on the market. 6.4.3 Food Supplement An HIV/AIDS food supplement developed by a nutrition specialist in Kenya was protected at KIPI as a utility patent (model No. UM00185). The inventor, a director of BULLS pharmacy (an SME) was referred to Moi University for assistance in large scale manufacture of the product and for further R&D because of the established TTO. The TTO, under the MUHL at the time, signed a Memorandum of Understanding and Business Incubation agreement with BULLS where IP issues were taken care of in accordance with the IP laws of Kenya and the IP policy of Moi University. MUHL made efforts to provide funds to manufacture the product but was unsuccessful. The project was eventually abandoned. Despite this unfortunate occurrence, lessons were learned and experience gained. 6.4.4 Patent Information Technology Transfer In mid 2004 a literature teacher at a school in the neighborhood of MUHL had an interest in detergent technology and so was briefed on how he could obtain cheap information on patenting on WIPO CD-ROMs held at the TTO or on the internet. A patent search was conducted, by one of the assistants who had been trained by the TTM at the time, and various patent documents of his interest were downloaded for him at a fee. They were documents on detergents, office cleaner chemicals and shampoos. After coming back several times in June 2004, he returned in February 2005 with a sample of a detergent he had manufactured which was already on the market. He informed the TTO that he had as a result setup a micro backyard/cottage manufacturing industry of two employees not only manufacturing detergents but shampoo and office cleaner chemicals. That is the wealth in patent documents! The TTO then proceeded to assist him with the registration of the company’s trademark using its KIPI network for free, as it was the first case of this kind and hence an opportunity for learning, with the hope that it would attract more people to use the service. The mark needed modifications in order to qualify for registration. It is worth mentioning here that also the KIPI trademark examiners provided free advice as it was the first case of this kind and a way of encouraging SME’s from western Kenya to register their trademarks. A number of other SMEs have come forth for technology/IP advice including protection but have not been as determined to complete the process yet. 7. Conclusion A number of books on Technology Transfer Offices point out specific practice that needs to be followed when establishing or running an IP/TT office. One of these books is the “Intellectual Property Management in Health and Agricultural Innovation; a handbook of best practices” especially section 6 (volume one) “Establishing and Operating Technology Transfer Offices”. In this section there are brilliant guidelines and explanations from practical experiences of experts in various countries. However, most documented examples are from relatively advanced countries in comparison to Kenya Establishing a Technology Transfer Office in a Developing Country Academic Institution: 20 Experience of Moi University

or other African countries that are barely starting. In this study the author has given additional recommendations, trying to avoid repeating what is in the handbook. In particular: i. For an IP office to be established, it needs the undivided support of the institution’s management. The institution’s management must be willing to spend money on salaries and other support services without expecting immediate returns in the short or medium run. According to Paul Asiimwe, “verbal good will from institutional administration but no specific resources, neither human nor financial being invested in enhancing capacity for tapping the commercial potential of IP/TT is not adequate 41 . Though a lot still needs to be done Moi’s management, commendably, decided to shoulder TTMs salary and other administrative costs without surety of immediate results. Another way of undivided support is, where possible, the CEO directly gets involved in the initial stages by being personally connected with the TTM in terms of frequent communications (mostly verbal). This will ensure quick decision making on any changes to the initial plans. It is also advantageous to the CEO and top management as they get to understand IP/TTO more and more without the formal and tedious training. As for the TTM he/she gets motivated and is cushioned about internal politics that, though part of life in any institution whether in developed or developing country, can cause unnecessary negative consequences. Indeed as mentioned by Lita Nelsen, in the first chapter of section 6 of the Handbook, people who embody all of the qualifications needed for technology transfer management are indeed difficult to be found even more so in developing countries as the institutions that have competent TTMs need to value them highly and give them undivided support. As mentioned at 4.5.5, besides the CEO getting involved or as an alternative, the institution can form an IP/TT committee composed of representatives from the various knowledge clusters to backup the TTM in crucial decisions. ii. One noticeable difference between developed countries and developing countries is the speed at which decision are not only reached but executed. From this it is not hard to theorize that these countries have recognized, whether consciously or otherwise, that the wealth of their nation is embedded in the intellect (IP) of its citizens and must be mined as quickly as possible before they pass on. All managers including the TTM must be entrusted with funds that he/she can access in the shortest time possible so that they can meet set targets in stipulated time. When speed of operations increase, creativity increases and even the transfer of the knowledge to society. It is actually impossible to deal with the private sector which is the major stakeholder in the research products value adding chain as in this sector speed is of essence and not necessarily money spent. Expenditure is viewed in terms of investment not necessarily of loss. In such a case, the loss is not just the opportunity to produce products but human hours lost in waiting for funds causing delays in other decisions which set off a chain of slowness and even stagnation. Eventually very brilliant documents are left lying on shelves some of which get adopted by others, who are faster, without sweat. iii. Apart from the mentioned losses the loss of morale for the researcher and other personnel has many repercussions even to future generations which may result in brain drain. Alternatively the researchers and their assistants might divert their interest and energies into other non-intellectual businesses resulting in a lot of intellectual property loss to the institutions and nation as a whole. iv. It is obvious from the spirit of the “Bayh-Dole Act of 1979,” in the USA that the objective was to expedite technology transfer by motivating the individual institutions and hence the individual researchers. This act permitted institutions to own and manage research findings they generate even that which is public/government funded (and therefore supposed to be government owned) thus reducing bureaucracy in rewarding generators of technology. The Kenyan government though, commendably having legislation that allows the institutions to own IP in principle could learn from this and support the institutions IP offices more because as a developing country, these offices could be having more challenges than those in developed countries and so they need special attention from the national IP offices. In the long run, the government will reap the dividends of technology transfer just like the USA has from the effects of the Bayh-Dole. v. The TTM must be aware that the process of establishing an IP office demands more patience than hard work. This has also been emphasized by various writers in section 6 of the Handbook mentioned above. In the initial stages there is lack of IP/TT knowledge by researchers and management and, even where there is understanding it is usually low to the extent that the expectations from the TTM are unrealistically higher than what is humanly possible because the support is usually lip with less action backup. Also, as mentioned earlier, the management has 41 Paul Asiimwe-Report on Audit of Intellectual Property Assets and Freedom to Operate in BIOEARN Network Institutions in Ethiopia Kenya Tanzania and Uganda Establishing a Technology Transfer Office in a Developing Country Academic Institution: 21 Experience of Moi University

what it considers priority and IP might not be on that list at start. However with time they will start paying attention as IP becomes less mysterious. vi. The TTM should avoid promising too much either intentionally as a way of enticing the researchers or unintentionally because not all can be learned in one sitting. Showing only the good side of IP helps get the initial attention of the researcher but tactfully the other side should be opened to them because when the researcher does not get the results as quickly as perceived he/she may get discouraged and even cause trouble. Basically the information disseminated should be balanced and it takes experience to do this. vii. An IP/TT Manager must have or develop interpersonal skills. There will be all sorts of researchers and students with differing temperaments to handle. In Africa academicians are held in very high esteem and some of them it gets in the wrong way of interpersonal relation. A TTM has therefore to develop a self esteem that wades of inferiority or superiority complexes from self or others. viii. It is important to keep in touch with other IP experts in different institutions not only in the country but in the world as a whole. Making friends with people in the meetings one attends many times turn out to be very useful in providing support. It is amazing how IP/TT managers in the world bond quickly with each other. This I guess could be as a result of their good interpersonal skills. It is also important to get connected with international bodies that support IP in developing countries such as CAS-IP and Public Interest Intellectual Property Advisors (PIIPA). ix. A TTM must build capacity of self, office and staff if any. This will enable efficiency, delegation and continuity. A lot on this has been covered earlier at 4.5.2. x. Integrity of the TTM and of the entire staff of the TTO is paramount as it ensures confidence of researchers, management, students and even SMEs, and the public. IP is basically a field of confidentiality hence the creator of an IP will only disclose to an individual they trust. xi. The TTO need to work closely with other arms of the institutions especially the legal, research and development unit of the institution, and extension offices and the commercial wing if in existence. The legal office is crucial in advising on binding agreements. The research and development is connected with researchers and hence they have a lot of respect for it. It is crucial for information on research and researchers. The extension and commercial wings are crucial for technology transfer to society either freely or commercially. xii. Support from the national IP offices both at the initial stages and continuously thereafter, not only in a developing country, is necessary because they have the responsibility of encouraging creativity therefore they are partners with TTOs both in public and private sector institutions and organizations. Ideally, these offices should be seen as extension arms of the national IP offices. National IP offices could give support in capacity building, assisting with creating IP awareness, providing essential services such as patent search, guidance in both patent/IP search and application drafting among others. As much as possible these services should be provided for free in a developing country with situations similar to the ones in Kenya, for example, where IP skilled 42 personnel are concentrated in national IP offices . These national IP offices need to understand that there are indirect and long-term benefits when IP management capacity is built in TTOs whether in the public or private institutions/companies. In RDTIs, in particular, the TTOs stimulate human capacity building in IP whether through formal training courses or practical hands-on-job training. In both industry and RDTIs, private or public, these becomes a national pool of expatriates from which they too can recruit from for short term or long term service on specific national assignments. Examples being in formulating a government position in international negotiations, and or being engaged in the negotiations themselves or drafting IP related policies and laws. The pool of intellectuals will have developed a practical understanding of how IP is applied in various fields in the country and its effects to the citizens and national socio-economic development. Support from collaborators in research or development such as donors is also essential because xiii. they too are stakeholders in the management of IP. As seen from this study, SIDA through BIOEARN has been very supportive in IP capacity building both human and material in Moi and other institutions in East Africa 43 . xiv. Though usually assumed by TTOs in RDTs as clients, the private sector especially the manufacturing sector too cannot be left out as an important stakeholder who also needs to support IP offices. Competent institutional TTOs/IP offices are crucial in safeguarding their interests 42 Intellectual Property Management in East African Universities and Research Institutions paper presented at 1st BIOEARN/VICRES Scientific Conference 2008-Mbayaki et al . 43 Intellectual Property Management in East African Universities and Research Institutions paper presented at 1st BIOEARN/VICRES Scientific Conference 2008-Mbayaki et al . Establishing a Technology Transfer Office in a Developing Country Academic Institution: 22 Experience of Moi University

in matters such as contract research where confidentiality is required which we know is crucial for cutting edge market competitiveness 44 . xv. From the experiences at 6.4.3 and 6.4.4, institutional TTOs in developing countries in the countryside must be supportive to SME’s and the poor individuals seeking IP protection. The institution/university should be flexible enough to partner with such to the extent of developing products and/or incubating a company out of the technology by so doing society gets to “feel” the institution especially if it is public 44 Intellectual Property Management in East African Universities and Research Institutions paper presented at 1st BIOEARN/VICRES Scientific Conference 2008-Mbayaki et al . Establishing a Technology Transfer Office in a Developing Country Academic Institution: 23 Experience of Moi University

Acknowledgments The realization of this document has been made possible thanks to the following: a) Central Advisory Services on Intellectual Property (CAS-IP) of the Consultative Group on International Agricultural Research (CGIAR) for funding the study b) Rose Ndegwa (NPI and ILRI-Kenya) for advice right from the beginning on contents layout and providing inspirational support. c) Dr Victoria Henson-Appolonio (CAS-IP-Italy), D.ssa Francesca Re Manning (CAS-IP-Italy), Karine Malgrand (NPI-France), and Silvia Salazar (Costa Rica University-Costa Rica) for encouragement and editing; Francesca in particular doing it severally tirelessly. d) Other National Partners Initiative members for encouragement and useful comments during the NPI meeting in Mombasa Kenya; January 2009. e) My nephew David Mulanda for typing some of the work. f) Bob Otiende of Techzones Solutions Ltd in Eldoret town for assisting with the table of contents. g) The Office of Deputy Vice Chancellor in Charge of Research and Development at Moi University, the department where the author works, for providing a working environment. h) The Moi University Information and Communication Technology (ICT) especially Ms Dorine for ensuring my laptop was in working condition by constantly checking and cleaning virus and related computer infections. i) Moi University Holdings Limited for allowing use of their office that provided an alternative quiet working environment even, at late hours. +++ Establishing a Technology Transfer Office in a Developing Country Academic Institution: 24 Experience of Moi University

Institutionalization of Intellectual Property Management: Case Studies from Four Agricultural Research Institutions in Developing Countries

by CGIAR Central Advisory Service on Intellectual Property on Apr 29, 2009

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Institutionalization of Intellectual Property Management: Case Studies from Four Agricultural Research Institutions in Developing Countries — Document Transcript