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Grpc 25 Minutes Final April09

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Minutes from the GRPC meeting. …

Minutes from the GRPC meeting.
March 2009.

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  • 1. MINUTES OF THE GENETIC RESOURCES POLICY COMMITTEE (GRPC) 25th Session, WorldFish Center, Penang, 17-19 March 2009 Members present: Carlos Correa (Chair) Emile Frison (Committee Secretary) Carl-Gustaf Thornström (CGIAR member) Tony Gregson (Alliance Board) Shadrack Moephuli (CGIAR member) Orlando de Ponti (Private sector) Dan Leskien (FAO Observer) Benito Odala Eliasi (Farmers’ Organizations) Chee Yoke Ling (NGOs) Excused absences: Mike Gale (Science Council), Teresita Borromeo (NARS) Mahmoud Solh (Alliance Executive) Members of Secretariat: Michael Halewood (Bioversity) Resource Persons: Victoria Henson-Apollonio (CAS-IP), Guat Hong Teh (CAS-IP), Lim Eng Siang (Bioversity International) Observers: Nguyen Hong Nguyen; Curtis Lind (WorldFish Center) Tuesday 17 March A. Welcome, introductions, logistics, and adoption of the agenda Dr Stephen Hall, the Director General of the WorldFish Center, welcomed participants to the meeting. The agenda was adopted; it is included as Appendix 1 to these minutes. B. Overview of activities from GRPC 24 work plan Michael Halewood summarized progress to date on the work plan developed by GRPC 24. He also introduced the issues raised by the Executive Committee of the Inter Centre Working Group on Genetic Resources (ICWG-GR) in a teleconference held on 9 March 2009, concerning issues they wanted to bring to the committee’s attention. C. Report concerning preparations for the Third Session of the Governing Body of the International Treaty The committee reviewed the agenda of the Third Session of the Governing Body to be held 1-5 June, 2009. Michael described the reports that are being prepared, through the SGRP, on behalf of the Centres, for submission to the Governing Body meeting. D. Report of the intersessional activities of the Secretariat of the Commission on Genetic Resources for Food and Agriculture Dan Leskien provided an update on the relevant intersessional activities of the Secretariat of the Commission on Genetic Resources for Food and Agriculture (the Commission). Minutes of the 25th Session of the GRPC.
  • 2. The Commission’s Intergovernmental Technical Working Group on Animal Genetic Resources for Food and Agriculture held its fifth session in January 2009. The Working Group requested FAO, inter alia, to prepare a draft Funding Strategy for the implementation of the Global Plan of Action for Animal Genetic Resources. The Intergovernmental Technical Working Group on Plant Genetic Resources will hold its fourth session in July 2009; it will focus on the review of the second State of the World’s Plant Genetic Resources for Food and Agriculture. The Working Group will also consider the process for the review of the Global Plan of Action for the Conservation and Sustainable Utilization of Plant Genetic Resources for Food and Agriculture (GPA PGRFA). The Commission will hold its Twelfth Regular Session on 19-23 October 2009. The Session will be preceded by one-day regional consultations and a one-day special event on access and benefit-sharing for genetic resources for food and agriculture. The Commission will focus on (1) Access and benefit-sharing for GRFA; (2) the Strategic Plan for the implementation of the Multi-year Programme of Work; and (3) the up-dated State of the World’s PGRFA and the process for up-dating the GPA PGRFA. The draft Strategic Plan will be circulated to the regions, intergovernmental organizations, the CGIAR and non-governmental organizations, in March/April 2009. The Commission Secretariat has commissioned studies on the use and exchange of genetic resources in the various sectors of GRFA. The CGIAR is directly involved in the preparation of the studies on microbial genetic resources and forest genetic resources and is coordinating a study on climate change and GRFA. It was noted in subsequent discussion that a number of products of the Global Public Goods II (GPG 2) project should be reported to the next meeting of the Commission, including for example, the crop-specific guidelines to address the risk of adventitious introgression of transgenes into ex situ collections. E. FAO/Bioversity/Treaty Secretariat Joint Programme on Treaty Implementation Michael described the activities of the Joint Programme. The committee noted the importance of countries and regions making significant progress with Treaty implementation. In the absence of such progress, the committee expressed concern that the Treaty could become a ‘dead letter’. It was noted that involving plant breeders in Treaty implementation activities is critically important. Victoria Henson-Apollonio provided details about the CAS-IP national partners programme, highlighting the possibility of involving national partners in Treaty implementation. F. Revising/developing a system-wide policy on intellectual assets Emile Frison informed the committee that, following GRPC 24, the draft policy was circulated to the Alliance Executive, and was the subject of a side-meeting held during the CGIAR Annual General Meeting in Maputo, December 2008, attended by a number of Director Generals and other Centres’ representatives. During the Maputo meeting, participants were requested to provide examples of how the draft policy would impact Minutes of the 25th Session of the GRPC.
  • 3. negatively on their Centres’ activities. Participants agreed to send additional comments to Emile, on behalf of the committee, following the Maputo meeting. The committee considered the comments that were sent to Emile. The committee welcomed the approval of the policy, by ICRISAT’s Board of Trustees. The committee took into consideration two papers recently developed by the Science Council as part of a strategic study concerning product stewardship and liability in the context of IPR: Michael Blakeney’s “Liability of CGIAR Centres and NARS partners under intellectual property and biosafety laws arising from the supply of biological resources”; and Rebecca Bratspies’ and Vibha Dhawan’s “A Recommended Stewardship Framework of the Consultative Group on International Agricultural Research”. The committee noted that it has a mandate, as set out in its terms of reference, to “keep development in intellectual property protection under review and advise the CGIAR on the further modification and implementation of the Centres’ IPR guiding principles and related policies”. The committee then reviewed and revised the draft policy to clarify outstanding ambiguities, in the light of comments received. The revisions consisted essentially of clarifications to some paragraphs. The revised draft policy, with changes in ‘track changes’ mode is included as Appendix 3 to these minutes. The same draft, with the changes accepted is included in Appendix 4. It was agreed that the Secretariat will develop, by 9 April 2009, a short explanatory document which will include an introductory paragraph that mentions the evolving international legal framework; the increasing need to be able to address IPR-related issues in the day-to-day work of the Centres; the committee’s mandate; and the collective expertise of its members. The main part of the document will consist of a paragraph-by-paragraph explanation of the draft policy, including examples. The final GRPC-approved explanatory document and policy will be sent to the Chair of the CGIAR and the Chair of the Alliance Executive. G. Patents and Plant Breeding Victoria provided an update concerning the enola bean case. She informed the committee about the amicus brief, filed by CIAT, with support from CAS-IP. Oral arguments will be heard in the Court of Appeals for the (US) Federal Circuit (CAFC) for patent appeals, on 3 April, 2009. The presentation also covered recent developments in patent law, agreements and other intellectual property areas dealing with agriculture and plant breeding particularly noting a letter sent by scientists at public institutions to the US Environmental Protection Agency (EPA). This letter expressed the concerns of scientists about restrictive conditions under which they receive material from the private sector. Victoria’s presentation is included as Appendix 5 to these minutes. Orlando de Ponti described the evolution of policy positions within the International Seed Federation (ISF) concerning the coexistence of plant variety protection and patent protection. Minutes of the 25th Session of the GRPC.
  • 4. In subsequent discussion, it was noted that the new trend in making patent applications for ‘native traits’ (endogenous traits) could have significant impacts on the availability of a broad range of materials for research and breeding. It was also noted that there is a trend, in the US, towards patenting traits and functions, and not genes/gene sequences per se. Wednesday 18 March I. Using the SMTA, including addressing the outcomes of the Meeting of Experts on the SMTA and MLS, with consideration of distribution for non-food/feed purposes, direct use by farmers, reporting, etc Eng Siang Lim joined the committee by telephone for the discussion of the policy concerning distributions of materials for non-food/non-feed purposes. The committee expressed its appreciation for Lim’s important insights. Following the telephone call, the committee reviewed the draft MTA for non-food/non- feed purposes that had been developed by the Secretariat, and made recommendations for further revisions. The Secretariat will make those revisions and circulate it for the approval of the committee members. Once approved by the GRPC, Emile will forward the GRPC-approved draft policy (GRPC 23) and associated draft MTA to the Alliance Executive for approval. The committee reconsidered its previous recommendation as follows: “The committee noted the importance of the principle that the CGIAR Centres should make PGRFA as widely and openly available as possible. The committee further noted that the Centres’ practices and policies in this regard may represent precedents for countries to follow. The vast majority of materials distributed by the Centres as PGRFA under Development since January 1, 2007 has not been subject to additional conditions, and therefore could have been distributed as PGRFA. The committee recommended that the Centres adopt a ‘best practice’ of distributing improved germplasm as PGRFA, and only distribute it as PGRFA under Development when it is necessary to have additional conditions to those included in the SMTA.* Those conditions must be consistent with the Treaty, the SMTA, and the Policy of the Alliance of CGIAR Centres on Intellectual Assets, when it has been adopted. The committee noted that while the Centres’ designation of their improved germplasm as PGRFA under Development should be limited to special circumstances, it should still be open for Centres to do so, where appropriate, including where that germplasm is derived from materials accessed from the in * Article 6.6 of the SMTA states: “Entering into a material transfer agreement under paragraph 6.5 [i.e., as PGRFA under Development] shall be without prejudice to the right of the parties to attach additional conditions, relating to further product development, including, as appropriate, the payment of monetary consideration.” Minutes of the 25th Session of the GRPC.
  • 5. trust collections before the entry into force of the Agreements between the Centres and the Governing Body of the Treaty.” In light of comments received from IRRI, the committee reconsidered the issue, and recommended that: All material in the in trust collections should be distributed as normal PGRFA. • Materials from the Centres’ breeding programmes can be distributed as PGRFA • under Development. The committee discouraged Centres from exercising the option to include additional terms that restrict availability. Reports to the Governing Body should differentiate between PGRFA, PGRFA • under Development with additional conditions, and PGRFA without additional conditions. J. Question and answer session regarding update papers The committee noted that the World Intellectual Property Organization (WIPO) is coordinating technical assistance at regional and national levels for the development of traditional knowledge protection laws. The draft Guidelines for the Acquisition and Use of Traditional Knowledge by CGIAR Scientists will be forwarded, by Emile to the Chair of the Alliance, for subsequent distribution to the Alliance Executive. K. Roundtable on additional genetic resources policy issues of relevance to the CGIAR The committee reconsidered the two papers developed by the Science Council, “Liability of CGIAR Centres and NARS partners under intellectual property and biosafety laws arising from the supply of biological resources” and “A Recommended Stewardship Framework of the Consultative Group on International Agricultural Research”. Committee members expressed their appreciation of the papers, particularly the case studies in the paper by Bratspies and Dhawan. It was noted that the both papers rely disproportionately on US and European laws and contexts. In addition, it was noted that both papers appear to assume that once a patent is granted in a single jurisdiction, the CG Centres and actors in other countries are bound by those patents; it must be recalled that IPRs are territorially bound in application to the jurisdictions granting them. It was noted that uncertainties about liability and stewardship are making it difficult for public sector organizations, including the Centres, to finalize agreements with private companies. It was also noted that while it is important to implement appropriate policies, the increasing costs of complying with liability and other forms of regulation ends-up working to the advantage of big companies that can afford the high costs of compliance. Committee members then identified the following issues, of particular relevance to the CGIAR, which will need to be addressed on a system-wide basis: Implementing agreements with the Governing Body. • Minutes of the 25th Session of the GRPC.
  • 6. Acquiring and distributing PGRFA outside the scope of the Treaty. • Evolving international frameworks that address animal, fish, tree, and microbial • genetic resources Partnerships with the private sector. • Centres’ generation and use of intellectual assets. • Liability and stewardship. • Science and quality control risk management awareness. • Building-up capacity within the system to be able to address complex legal issues. • Developing a framework to promote connections to farmers, creating • opportunities for farmers to inform Centres’ policy priority-setting, and ‘translating’ the relevance of the Centres’ work to farmers. Evolving policy frameworks concerning farmers’ rights, and the contributions • made by the Centres to their realization, both at the level of programmatic activities, and contributions, based on those activities, to meetings of the Governing Body of the Treaty. Evolving policy frameworks in support of sustainable use of PGRFA and • contributions Centres can make to them. Multi-stakeholder perspectives to give ‘heads-up’ to the Centres on nascent policy • issues, and to help the Centres ‘think-through’ policy options. Given the kinds of issues that may arise in the future, it may be necessary to increase representation on the GRPC (or similar body) of people with expertise in microbial, animal, and other kinds of agricultural genetic resources beyond plants. Day-to-day technical assistance dealing with the complexities of access and • benefit-sharing rules (both those that exist, and the complexities that arise when they don’t exist). Genetic resources impact assessments, particularly with respect to the • introduction of exotic species, varieties and breeds. L. Future of the GRPC in the framework of the new CGIAR – suggestions to put to the Transition Management Team Emile Frison provided an update of the CGIAR Change Management process. A new Consortium Board will be created within the next year. It will be up to the Consortium Board to decide what kinds of committees it needs to provide advice. The committee reiterated its earlier observation (GRPC 24) that the CGIAR system will continue to need expert advice on genetic resources and other legal and regulatory issues in the future. The committee reiterated its earlier recommendation that a committee like the GRPC should be established to provide advice to the Consortium Board. The Chair of the committee sent a message to Kathy Sierra on 18 December 2008, regarding the future roles and activities of the GRPC and CAS-IP. On 8 January 2009, Ren Wang replied, saying that the issue will be addressed by the Transition Management Team. The committee agreed that the Chair will send a follow-up message to Kathy Sierra, as the Chair of ExCo, confirming its opinion concerning outstanding genetic resources policy issues that will need to be addressed in the years to come, the importance of maintaining a mechanism for obtaining advice on these issues from a Minutes of the 25th Session of the GRPC.
  • 7. multiplicity of perspectives both inside and outside the CGIAR, and indicating the committee’s willingness to continue to serve if called upon to do so. M. ICWG-GR request to consider coordinating a system-wide process to develop a policy on the implementation of the risk assessment management guidelines The request by the ICWG-GR to the GRPC was introduced by Michael. The committee members noted with appreciation the work that has been done in the development of the risk management guidelines in the context of the Global Public Goods II project. The committee noted that the current drafts are too elaborate to be implementable. The committee noted the importance of having a coordinated system-wide approach to risk management and recommended that the SGRP develop a more manageable, user-friendly framework, which could be considered by GRPC 26 for recommendation to the Alliance. Furthermore the committee noted the need for consideration of science risk management including quality control management. N. Update on the development of CAS-IP’s License Central Guat Hong Teh presented the ongoing work of CAS-IP in the development of a web- based contract tool, to be used by the CGIAR Centres. The first type of document, which will be available on line later this year, will be memoranda of understanding. The committee welcomed the development of license central and recommended that additional funds be made available to CAS-IP for further work on this tool. The Chair of the committee will also send a letter emphasizing such a recommendation to the Director of the CGIAR. The committee commented on the importance of such a tool for the Centres with regards to developing a better capacity and understanding of the language and use of agreements. Such capacity will be needed in particular by the Centres to implement the international assets policy. Thursday 19 March O and P. Review/update of the GRPC work plan, and adoption of main conclusions. The committee amended the GRPC work plan, which is attached as Appendix 2 to these minutes. Q. AOB and next meeting GRPC 26 will be held Sept 22-24, in Rome. Minutes of the 25th Session of the GRPC.
  • 8. Appendix 1: GRPC 25/A.1 GENETIC RESOURCES POLICY COMMITTEE 25th Session WorldFish Center Penang, Malaysia 17-19 March 2009 DRAFT AGENDA Tuesday 17 March 9:00 – 9:30 A. Welcome, introductions, logistics, adoption of agenda. (Introduced by Carlos Correa, Emile Frison, Stephen J. Hall) Documents A.1. Agenda A.2. ICWG-GR teleconference concerning GRPC 24 report and GRPC 25 agenda 9:30 – 10.00 B. Overview of activities from GRPC 24 work plan (Introduced by Michael Halewood) Documents B.1. GRPC 24 work plan (annotated) 10:00 – 10:30 Coffee/Tea break 10.30 – 11.15 C. Report on the intersessional activities of the Governing Body of the International Treaty, including the Meeting of Experts on the SMTA and MLS (Introduced by Michael Halewood) Documents C.1. Second Technical Consultation on Information Technology Support for the Implementation of the Multilateral System of Access and Benefit Sharing 11.15 – 12.00 D. Report on intersessional activities of the Commission on Genetic Resources for Food and Agriculture (Introduced by Dan Leskien) Documents D.1 SGRP/Bioversity coordinated papers concerning sectoral approaches to ABS 12.00 – 12.30 E. FAO/Bioversity/International Treaty Secretariat Joint Programme on Treaty Implementation (Introduced by Michael Halewood) Documents Minutes of the 25th Session of the GRPC.
  • 9. E.1 Capacity Building Project for Developing Countries on Implementation of the Treaty and its Multilateral System of Access and Benefit-sharing 12:30 – 13:30 Lunch 13.30 – 15.00 F. Revising/developing system-wide policy on intellectual assets (Introduced by Emile Frison) Documents F.1 Collected responses from Director Generals of the CG Centres regarding the proposed Intellectual Assets Policy Statement F.2 Liability of CGIAR Centers and NARS partners under IP and biosafety laws arising from the supply of biological resources (Michael Blakeney) F.3 A Recommended Stewardship Framework for the CGIAR (Rebecca Bratspies and Vibha Dhawan) F.4 Draft Summary of Discussion on the GRPC, “Draft Intellectual Assets Policy Statement”, held at Maputo, 30 Nov. 2008 15:00 – 15:30 Coffee/Tea break 15:30 – 17:00 F. Revising/developing system-wide policy on intellectual assets (cont’d) Group dinner Wednesday 18 March 8:30 – 9:00 G. Patents and plant breeding. A discussion led by Orlando de Ponti with presentation by Victoria Henson-Apollonio, including an update on enola, patent case law, etc. Documents 9.00 – 10.00 H. Assessment of Centres' impact concerning technology transfers as benefit-sharing, and contributions to the implementation of farmers' rights. (Introduced by Victoria Henson-Apollonio) Documents 10:00 - 10:30 Coffee/Tea break 10:30 – 12:00 I. Using the SMTA, with consideration of distribution for non-food/feed purposes, direct use by farmers, reporting, etc (Introduced by Michael Halewood) Documents I.1 Draft MTA for non-food/feed purposes with changes I.2 Draft MTA with changes approved I.3 Notes on MTA (including Policy) Minutes of the 25th Session of the GRPC.
  • 10. I.4 Revised Guide for the CGIAR Centres Use of the SMTA I. 5 The SMTA, commercialization and distribution to farmers I.6 Reporting template for Centres 12.00 – 12.30 J. Question and Answer session regarding update papers Documents J.1 Report of the CBD meeting on Group of Legal and Technical Experts on Concepts, Terms, Working Definitions and Sectoral Approaches. 2 – 5 December 2008. Windhoek, Namibia J.2 Update on WIPO J.3 Update on Guidelines for Traditional Knowledge practices in the CGIAR Centres 12:30 – 13:30 Lunch 13.30 – 14.30 K. Roundtable on additional genetic resources policy issues of relevance to the CGIAR (Introduced by Carlos Correa) 14:30 – 15:30 L. Future of the GRPC in the framework of the new CGIAR – suggestions to put to the Transition Management Team (TMT) 15:30 – 16:00 Coffee/Tea break 16.00 – 17.00 M. Request from ICWG-GR regarding risk management guidelines 17:00 – 17:30 N. Update on CAS-IP’s License Central Group dinner Thursday 19 March 08:30 - 10:00 O. Review/update of the GRPC work plan (Introduced by Emile Frison) Documents M.1 minutes GRPC 24 10:00 - 10:30 P. Adoption of main conclusions, action list and report 10:30 - 11:00 Coffee/Tea break and Group photo 11:00 - 11:30 P. Adoption of main conclusions, action list and report (continued) 11:30 - 12:00 Q. AOB, next meeting, closing Minutes of the 25th Session of the GRPC.
  • 11. 12:00- 13:30 Lunch 13:30 – 16:00 Workshop: Policy issues affecting the conservation and use of aquatic genetic resources Minutes of the 25th Session of the GRPC.
  • 12. Appendix 2: GRPC Work Plan (as amended at GRPC 25) Issue Activity/Input Outputs Timetable Consultations with The GRPC Secretariat will work Documents Whenever the the legal experts closely with the Secretariat of prepared for meeting is held convened by the the Governing Body to develop Expert Group in 2009 GB secretariat submissions to the Second Meeting International Expert Group Meeting. Reporting on uses Secretariat will revise the Revisions of June 2009 of the SMTA recommendations in the Centres’ the Centres’ Guide to Using the SMTA. Guide Centres will submit reports on Submissions acquisitions and transfers using to the the SMTA, to the third Session Governing of the Governing Body. Body Template with Secretariat will develop next Revised draft optional conditions draft of the template after the template for PGRFA under intellectual assets policy has Development been finalized and adopted. Guidelines for Secretariat will forward the draft End of March End of March Centres acquisition guidelines and draft GAA to the 2009 of germplasm AE for approval via E-mail. Guidelines for the The Guide for the Centres’ use Revised guide 19 March 2009 Centres’ use of the of the SMTA will be further sent to the SMTA revised to include work on the committee template with optional members conditions for PGRFA under Development, best practices for Comments 19 April, 2009 associated information, and from system-wide policies on members to distributing materials for non- Secretariat by food/feed, acquiring new 19 April, materials and intellectual assets 2009 if/when they are adopted. The revisions in the guide should Final revision be highlighted. of the Centres Guide (version 2) Minutes of the 25th Session of the GRPC.
  • 13. Issue Activity/Input Outputs Timetable Including materials Secretariat to prepare Draft message July 2009, in the MLS communication to the Director following GB3 of the CGIAR concerning the message from the GB Secretariat to Treaty Parties requesting them to provide a list of the collections they are including in the MLS. Distributing Secretariat will revise the MTA Revised draft End of April materials for non- and send it to committee for MTA 2009 food/feed purposes comments/approval. The draft policy document and Comments End of May draft MTA will be forwarded to from 2009 the AE Chair for distribution to members AE for comments/approval. Message to GRPC 26?? AE Chair Guidance for Emile will forward the draft E-mail Centres’ research guidelines to the AE for message to involving approval via e-mail. AE, copied to traditional ICWG-GR. knowledge CAS-IP will prepare information Considered/ap document to be sent to WIPO proved and UN Permanent Forum for guidelines Indigenous Peoples. Report to GRPC 25 Policy on Secretariat will write Draft 9 April 2009 intellectual assets explanatory document. CAS-IP overview will contribute as well. document Explanatory document will be Comments 24 April 2009 sent to committee members. Committee members to Revised comment/approve. overview document Draft policy and explanatory document sent to the Chair of the AE and Chair of the CGIAR. Minutes of the 25th Session of the GRPC.
  • 14. Issue Activity/Input Outputs Timetable Implementation of CAS-IP to conduct a survey of Survey GRPC 26 the IA policy current and future capacity in legal and IP across the Centres. Assessment of CAS-IP will draft paper for Draft paper Before GRPC Centres’ impact presentation to the GRPC. 26 concerning: 1. technology transfers as benefit-sharing, and 2. contributions to the implementation of Farmers’ Rights Demand driven Secretariat will continue to Update papers GRPC 26 GRPC agenda consult systematically with the GRPC by setting process ICWG-GR, AE. Secretariat The Chair will send a message to Message from March 2009 the ICWG-GR executive. the Chair Developments at Secretariat will prepare short Update papers GRPC 26 CBD, WIPO, update paper(s) summarizing WTO, other bodies relevant developments. CGIAR Centres will be represented in relevant meetings. Cartagena Protocol Monitoring progress of the Update paper GRPC 26 on Biosafety international meetings. (Cross)-sectoral Secretariat will continue work Draft papers GRPC 26 approaches to ABS with University of Louvain to and or develop paper on AMiGR to progress submit to the 12th session of the report Commission. Bioversity will make contributions to Plant, AnGR sectoral papers for the Commission. Lead development of paper, through SGRP, on impact of climate change on interdependence. Minutes of the 25th Session of the GRPC.
  • 15. Issue Activity/Input Outputs Timetable Patenting CAS-IP to write 3 page Short paper GRPC 26 strategies document on patenting trends, including focus on developing countries. License Central Message to CGIAR Director Message recommending additional funds for License Central. GRPC at Chair to report to business Chair’s report November ExCo/Business meeting/ExCo. 2009 meeting GRPC in the Follow-up letter to Kathy Sierra Letter to Change Process from the Chair of the committee. Kathy Sierra Minutes of the 25th Session of the GRPC.
  • 16. Appendix 3: GRPC proposal: Policy of the Alliance of CGIAR Centres on Intellectual Assets* Preamble The mission of the CGIAR is: To achieve sustainable food security and reduce poverty in developing countries through scientific research and research-related activities in the fields of agriculture, forestry, fisheries, policy, and environment. The policy on intellectual assets of the Alliance of International Agricultural Research Centres supported by the Consultative Group on International Agricultural Research (CGIAR) is driven by the mission of the CGIAR and the imperative that the products of the Centres' research should be available without restriction. [the order of these two sentence has been reversed] The Centres work with a wide range of partners, including national agricultural research systems (NARS), advanced research institutes (ARIs), civil society organizations, regional and international intergovernmental organizations and increasingly, private Halewood, Michael 18.3.09 8:04 sector. The Centres are supported by funding from countries, international and regional Deleted: private sector companies, and organizations, and private entities. The Centres produce, manage and provide access to the products of their research and development for use by, and for the benefit of, the poor, especially farmers in developing countries. Centres hold their in-trust collections of germplasm for the benefit of the world community, in accordance with agreements signed by Centres and the Governing Body of the International Treaty on Plant Genetic Resources for Food and Agriculture (International Treaty).† Objective The objective of this policy is to establish common standards and procedures for the CGIAR Centres regarding the acquisition, management and release of intellectual assets. All policies of CGIAR Centres that affect the acquisition, management and release of intellectual assets shall conform with this policy. Definitions * Upon approval by the Alliance, this policy will replace the ‘Guiding Principles for the Consultative Group on International Agricultural Research Centres on Intellectual Property and Genetic Resources,’ 1996. It Halewood, Michael 18.3.09 8:05 does not include issues relating to stewardship and liability. It is anticipated that separate policies will be Deleted: yet developed to address those issues in the future. † The text of these agreements is available at: Halewood, Michael 18.3.09 8:05 http://www.sgrp.cgiar.org/sites/default/files/AgreementwithCentresfinal.doc Deleted: the policy will be expanded
  • 17. Halewood, Michael 18.3.09 4:26 ‘Intellectual assets’ refers to all products of research and development activities, Deleted: ‘ including, but not limited to: improved germplasm, technologies, software, information, Halewood, Michael 18.3.09 4:26 publications, vaccines, databases, methodologies and know-how. Deleted: the Centres’ Halewood, Michael 18.3.09 2:32 Formatted: Normal, Left ‘Market segment’ refers to restrictions including territorial and/or field of use. Halewood, Michael 18.3.09 2:43 Deleted: that General conditions of access to Centers’ intellectual assets Halewood, Michael 18.3.09 2:43 Deleted: remains 1. The Centres will make their intellectual assets globally available without restriction, Halewood, Michael 18.3.09 2:37 Deleted: without restriction, at no cost or subject to the following exception: minimum administrative costs Halewood, Michael 18.3.09 2:32 When it is indispensable for the effective utilization or further improvement of Deleted: and Centres’ intellectual assets, the Centres may grant limited exclusivity for Halewood, Michael 18.3.09 2:49 commercialization in a defined market segment, for a limited period of time, Deleted: will provided they continue to make the intellectual asset available, for research and Halewood, Michael 18.3.09 2:44 Deleted: that the development in developing countries as well as for ARIs in support of the Halewood, Michael 18.3.09 2:44 CGIAR mission. Deleted: remains Halewood, Michael 18.3.09 2:42 2. The Centres will not seek or assert intellectual property rights‡ over their intellectual Deleted: without restriction, at no cost or ... [1] assets, subject to the following exception: minimum administrative costs, Halewood, Michael 18.3.09 2:44 Deleted: nd When it is indispensable for the effective utilization or further improvement of Halewood, Michael 18.3.09 3:00 Centres’ intellectual assets, the Centres may seek or assert or allow third parties to Deleted: shall seek or assert intellectual property rights over the Centres’ intellectual assets, Halewood, Michael 18.3.09 2:59 provided they continue to make the intellectual asset available for research and Formatted ... [2] development in developing countries as well as for ARIs in support of the Halewood, Michael 18.3.09 2:45 Deleted: shall remain CGIAR mission. Halewood, Michael 18.3.09 2:44 Deleted: without restriction, at no cost or ... [3] 3. The Centres will not use their intellectual assets with the sole intention to raise income. minimum administrative costs, Halewood, Michael 18.3.09 2:45 Deleted: and The Centres may charge financial compensation in return for providing access to Halewood, Michael 18.3.09 4:29 their intellectual assets, on the condition that this does not divert the Centres from Deleted: Conditions of access to Centres’ ... [4] their research agendas. However, the Centres will continue to make the intellectual assets that Halewood, Michael 18.3.09 4:29 intellectual asset available for research and development in developing countries Deleted: i as well as for ARIs in support of the CGIAR mission. Halewood, Michael 18.3.09 4:29 Deleted: e inputs subject to Incorporation of third party intellectual assets Halewood, Michael 18.3.09 4:31 Deleted: ies’ Halewood, Michael 18.3.09 4:31 4. Centres may only enter into agreements concerning the use of intellectual assets of Deleted: property or contractual rights third parties subject to IPRs or contractual rights that restrict the availability of the Halewood, Michael 18.3.09 4:33 resulting products for commercialization, research or development in developing Deleted: will countries , when: a) the intellectual asset the Centre is producing will result in significant Halewood, Michael 18.3.09 3:37 improvements to food security and or poverty alleviation in the countries where it can be Deleted: use Halewood, Michael 18.3.09 3:39 Deleted: ‡ Concerning copyright, which normally vest automatically upon the creation of a ‘work’, see paragraph 6 Halewood, Michael 18.3.09 3:36 below. Deleted: in ways that are inconsistent with the [5] ... conditions set out in paragraph 1 above
  • 18. made available, and, b) no equivalent intellectual asset is available from other sources under no or less restrictive conditions. Transparency Halewood, Michael 18.3.09 3:08 Deleted: Public disclosure 5. The Centres will promptly make public the justification for, and describe the conditions of, their granting limited exclusivity, or seeking or asserting (or allowing third parties to seek or assert) intellectual property rights (other than copyright) over their intellectual assets, particularly when availability in developing countries is affected. Centres will also make public the justification for entering into agreements described in Halewood, Michael 18.3.09 3:26 paragraph 4. Deleted: The source and amount of income received for providing access to intellectual assets will be made public. Dissemination of research results Halewood, Michael 18.3.09 3:26 Deleted: and the conditions of those agreements. 6. The Centres will publish their research and development results in a timely manner and Halewood, Michael 18.3.09 3:20 in a way that allows open access. This includes results of research and development that Deleted: shall is carried out by the Centre itself, or in partnership with another organization. The Centres will allow the reproduction and distribution of their copyrighted works by third parties without the need to obtain permission from the Centres, provided that proper citation is made and the work is not altered. Preventing misappropriation 7. The Centres should take action, as appropriate, to pre-empt intellectual property claims over their intellectual assets by others without the Centres’ authorization. 8. The Centres shall abide by the ‘CGIAR's Ethical Principles Relating to Genetic Resources,’§ and shall respect the rights of traditional knowledge holders by seeking their prior informed consent for the documentation, use and publication of information associated with their traditional knowledge, consistent with national and international law. § These guidelines can be found at [URL]
  • 19. Appendix 4: GRPC proposal: Policy of the Alliance of CGIAR Centres on Intellectual Assets* Preamble The mission of the CGIAR is: To achieve sustainable food security and reduce poverty in developing countries through scientific research and research-related activities in the fields of agriculture, forestry, fisheries, policy, and environment. The policy on intellectual assets of the Alliance of International Agricultural Research Centres supported by the Consultative Group on International Agricultural Research (CGIAR) is driven by the mission of the CGIAR and the imperative that the products of the Centres' research should be available without restriction. The Centres work with a wide range of partners, including national agricultural research systems (NARS), advanced research institutes (ARIs), civil society organizations, regional and international intergovernmental organizations and increasingly, private sector. The Centres are supported by funding from countries, international and regional organizations, and private entities. The Centres produce, manage and provide access to the products of their research and development for use by, and for the benefit of, the poor, especially farmers in developing countries. Centres hold their in-trust collections of germplasm for the benefit of the world community, in accordance with agreements signed by Centres and the Governing Body of the International Treaty on Plant Genetic Resources for Food and Agriculture (International Treaty).† Objective The objective of this policy is to establish common standards and procedures for the CGIAR Centres regarding the acquisition, management and release of intellectual assets. All policies of CGIAR Centres that affect the acquisition, management and release of intellectual assets shall conform with this policy. Definitions * Upon approval by the Alliance, this policy will replace the ‘Guiding Principles for the Consultative Group on International Agricultural Research Centres on Intellectual Property and Genetic Resources,’ 1996. It does not include issues relating to stewardship and liability. It is anticipated that separate policies will be developed to address those issues in the future. † The text of these agreements is available at: http://www.sgrp.cgiar.org/sites/default/files/AgreementwithCentresfinal.doc
  • 20. ‘Intellectual assets’ refers to all products of research and development activities, including, but not limited to: improved germplasm, technologies, software, information, publications, vaccines, databases, methodologies and know-how. ‘Market segment’ refers to restrictions including territorial and/or field of use. General conditions of access to Centers’ intellectual assets 1. The Centres will make their intellectual assets globally available without restriction, subject to the following exception: When it is indispensable for the effective utilization or further improvement of Centres’ intellectual assets, the Centres may grant limited exclusivity for commercialization in a defined market segment, for a limited period of time, provided they continue to make the intellectual asset available, for research and development in developing countries as well as for ARIs in support of the CGIAR mission. 2. The Centres will not seek or assert intellectual property rights‡ over their intellectual assets, subject to the following exception: When it is indispensable for the effective utilization or further improvement of Centres’ intellectual assets, the Centres may seek or assert or allow third parties to seek or assert intellectual property rights over the Centres’ intellectual assets, provided they continue to make the intellectual asset available for research and development in developing countries as well as for ARIs in support of the CGIAR mission. 3. The Centres will not use their intellectual assets with the sole intention to raise income. The Centres may charge financial compensation in return for providing access to their intellectual assets, on the condition that this does not divert the Centres from their research agendas. However, the Centres will continue to make the intellectual asset available for research and development in developing countries as well as for ARIs in support of the CGIAR mission. Incorporation of third party intellectual assets 4. Centres may only enter into agreements concerning the use of intellectual assets of third parties subject to IPRs or contractual rights that restrict the availability of the resulting products for commercialization, research or development in developing countries , when: a) the intellectual asset the Centre is producing will result in significant improvements to food security and or poverty alleviation in the countries where it can be ‡ Concerning copyright, which normally vest automatically upon the creation of a ‘work’, see paragraph 6 below.
  • 21. made available, and, b) no equivalent intellectual asset is available from other sources under no or less restrictive conditions. Transparency 5. The Centres will promptly make public the justification for, and describe the conditions of, their granting limited exclusivity, or seeking or asserting (or allowing third parties to seek or assert) intellectual property rights (other than copyright) over their intellectual assets, particularly when availability in developing countries is affected. Centres will also make public the justification for entering into agreements described in paragraph 4. Dissemination of research results 6. The Centres will publish their research and development results in a timely manner and in a way that allows open access. This includes results of research and development that is carried out by the Centre itself, or in partnership with another organization. The Centres will allow the reproduction and distribution of their copyrighted works by third parties without the need to obtain permission from the Centres, provided that proper citation is made and the work is not altered. Preventing misappropriation 7. The Centres should take action, as appropriate, to pre-empt intellectual property claims over their intellectual assets by others without the Centres’ authorization. 8. The Centres shall abide by the ‘CGIAR's Ethical Principles Relating to Genetic Resources,’§ and shall respect the rights of traditional knowledge holders by seeking their prior informed consent for the documentation, use and publication of information associated with their traditional knowledge, consistent with national and international law. § These guidelines can be found at [URL]
  • 22. Appendix 5 Patents and Plant Enola Patent Breeding 1 2 Enola patent Enola patent reexamination Larry Proctor, D.B.A. Pod-Ners, filed a patent CIAT requested a reexamination in the application on November 15, 1996 USPTO (Action had to be an ex partes procedure, based on the filing date of the U.S. Patent # 5,894,079 issued April 13, original patent application.) 1999, with 15 claims The reexamination was filed December 20, 2000 An application for reissue of the Patent was filed by Proctor on January 31, 2001 Reexam and reissue merged June13, 2001 3 4 1
  • 23. Appendix 5 Recent events Enola patent reexamination Where were we in this story at the last On January 2009, CIAT filed an Amicus Brief to support the USPTO GRPC meeting? This brief was prepared, pro bono, by the law firm On April 19, 2008 the Board of Patent Morrison & Foerster (MoFo), as a result of a request Appeals and Interferences (BPAI, ultimate by CAS-IP team member, Peter Bloch appeals board in the USPTO) rejected all of An additional brief was filed by the Government of the claims in the reissue application. Mexico; the CIAT brief was coordinated with the On June 17, 2008, Proctor filed an appeal Mexican brief and the brief filed by the USPTO. with the Federal court, the CAFC. This appeal is case#2008-1492, Pod-Ners vs. the USPTO 5 6 The CIAT Amicus brief argues Enola Patent Reexam Yellow beans are not new and are obvious The CIAT Amicus brief points out: • That if this patent were to stand that it would Allowing such broad claims, based on a color, interfere with CIAT’s ability to provide yellow would undermine the patent system –many beans to everyone, particularly people and frivolous utility patent applications would be institutions in the U.S., especially those institutions that work to help poor farmers filed • Yellow beans are not new, even in the U.S. • That the written description, not withstanding the deposit of “Enola” seeds in a Budapest Depository, is indefinite. (What is the role of such deposits, especially as there will be some natural variation in deposits of biological material?) 7 8 2
  • 24. Appendix 5 The CIAT Amicus brief argues Patent deposits are not a substitute for clear written descriptions CIAT would no longer be able to distribute yellow beans without threat If the CAFC does not uphold the USPTO, the question of validity should be remanded (sent back) to the USPTO to take into account all of the types of yellow beans that have been distributed by CIAT over the years 9 10 The Enola matter is scheduled to be held on Friday, April 3, 2009, with Pod-Ners and the Patent update PTO solicitor having 15 minutes each for oral argument. Oral transcripts will be available as podcasts from the CAFC site, 24 hrs. later 11 12 3
  • 25. Appendix 5 Recent Activity in U.S. case law “Quanta” Does the buying of the seed, mean that the Supreme Court Decides Quanta v. LG Electronics, __ U.S. __ (2008), rights on this seed are exhausted? • 19–page unanimous decision that provides some new life “When a self-replicating living invention is to the doctrine of patent exhaustion sold, does the purchaser have a right to reproduce that invention to make one – or thousands or more – copies?” ---Hal Wegner 13 14 One of the grounds to deny patent exhaustion is stated in Monsanto Co. v. Scruggs where the court concludes that a contrary conclusion would have “eviscerate[d] the rights of the patent holder.”105 There is no citation of any authority for or against this position nor is there any public policy position taken for an alternative ground to deny the application of patent exhaustion 15 16 4
  • 26. Appendix 5 17 18 Many other areas where Patent law issues are in the news and could affect the CG Centers 19 20 5
  • 27. Appendix 5 In re Kubin (Kubin v USPTO) • Obviousness --Rejection of claims to gene sequences, arguments heard January 9 in CAFC Jacobsen vs. Katzer et al • Validity of OS Licenses, decided by the CAFC, July 13, 2008 21 22 6