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Bio business and biosafety

The document discusses biobusiness and biosafety, providing definitions and opportunities for biotechnology in developing countries. It examines the market for biobusiness, key opportunity areas, and factors for successful bioenterprise innovation including focusing on high-value opportunities, recognizing that innovation need not have long life cycles, and emphasizing people over technologies. The document also outlines biosafety levels and concepts from containment to facility design to protect laboratory workers and the environment.

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Bio-Business and Biosafety, Biotechnology for developing countries, and relevance of IPR in biotechnology Promila Sheoran PhD Biotechnology GJU S&T Hisar
Biobusiness Definition Commercial activity based on an understanding of life sciences and life science processes: Biomedical (including healthcare, pharmaceuticals, medical devices, diagnostics, etc) Agri-veterinary and Food Environmental/Industrial Related Areas (bioinformatics/computational biology, bioengineering, nanobiotechnology, etc)
Market BioBusiness already constitutes over 25% of global GDP and employs some 40% of the world’s labor force: Accounts for nearly US$12 trillion (2005) Employment figures skewed by > 50% engaged in subsistence level farming and low wage food processing in developing countries (including China and India)
Some Key BioBusiness Opportunity Areas With Health and Development Implications Biomedical BioBusiness Healthcare Pharmaceuticals Biomedical biotechnology Herbal and traditional medicine Medical devices Diagnostics Agri-Veterinary and Food BioBusiness Agriculture Fisheries and aquaculture Animal husbandry Biopharming Pets and recreational animals Forestry and lumber Agri-biotechnology Food processing Environmental and Industrial BioBusiness Management of biodiversity Environmental bioremediation Waste management Environmental biotechnology Marine biotechnology Industrial biotechnology: bioenergy, new biomaterials, etc Other BioBusiness Related Activities Bio-IT and the application of ICT in the life sciences Bioengineering Nanotechnologies as applied to life sciences Life science and biotechnology education Life science and biotech R&D Life science and biotech contract services Source: Shahi, 2002
Some Global Opportunities and Challenges with Potential BioBusiness Implications • Globalization - and the rapidly growing global economy (and growing inequity between “haves” and “have nots”) • Healthcare and Biomedical Sciences - Advances in healthcare and the biomedical sciences, the genomics revolution and the move toward personalized medicine (and the need to manage the cost of healthcare as populations age) • Feeding the World – increased interest in more nutritious and less chemically tainted foods (and the need to feed more people in the face of ever diminishing arable land) • Renewables and Sustainability - Increasing demand for renewables and more sustainable production technologies – biofuels, new biomaterials (and solving the problems of global warming, environmental contamination and waste management) • Responding to Threats – responding to natural and human generated threats to economic development and stability (from pandemics, to natural disasters, to concerns about bioterrorism)
The BioBusiness Innovation Landscape Recommended Approach: Focus on “Summit” opportunities – putting people, technologies and resources together to capture the value proposition Summit Opportunities: Technology and knowledge intensive, few competitors, high barriers to entry; high margins with well- developed business case, “new” economy principles apply. High BioEnterprise interest
Analysis: Successful BioBusiness Innovation Critical Success Factors (given good infrastructure, facilities, policies, etc):  Smart People  Smart Ideas  Smart Money (immaterial if public or private sector driven: Silicon Valley model – driven by private money; European model – driven by public money)  Smart Alliances and Partnerships (throughout the world)
Understanding Innovation… It is pretty simple: You do some stuff. Most fails. Some works. You do more of what works. If it works big, others quickly copy it. Then you do something else. The trick is the doing something else. Thomas Peters
Technology Adoption Challenges Can we afford it? How will we recover our costs? Can it pay for itself? Is it reimbursable? Show me the money. We need to have this reviewed. This is cool. I want it – does not matter how much it costs We'll be the first institution in the region that has it. Makes us look good. Let's get it!
BioPartnering: Capturing the Value Proposition Professional Services Legal /IPR, Media, Recruitment etc Regulatory Bodies Development Agencies Academic Researchers Finance Entrepreneurs Industry Work for win-win Encourage public-private partnership Bet on people Make smart investments Source: Shahi, BioBusiness in Asia… (Pearson Prentice Hall, 2004)
Some Priority Areas for Cooperation and Collaboration: Government-Academia-Industry  Meeting National/Regional/International Economic/Technology Developmental Priorities  Contract Research Initiatives  Facilitating Commercialization of Publicly-funded R&D and Managing IP  Bioethics  Regulatory  Public Health  Biosecurity  Incentivizing BioInnovation and BioEntrepreneurship  Raising Funding and Investment for Biotech – including Cultivating Public Markets for Biotech Stocks, and the development of a viable VC industry  Public Education/Communication and the Training of Life Science Personnel
Making Things Happen in Bio-Business 1. Identify “Summit” opportunities 2. Recognize that Bio-Business innovation need not always be “long life cycle” 3. Life science/biotech/Bio-IT investment need not be high risk – if you know what you are doing 4. More developed countries do not have a monopoly on good science and technology – innovative concepts can be found everywhere 5. Protect IP assets. Recognize that IP is not just patents – knowhow, knowwhy and knowwho can be just as important 6. Bet on people not only on technologies - committed and capable innovators/entrepreneurs will always find a way to win
Biosafety •The maintenance of safe conditions in biological research to prevent harm to workers, non-laboratory organisms or the environment. •Biosafety in Research Universities means promoting safe laboratory practices, and procedures; proper use of containment equipment and facilities; provides advice on laboratory design and risk assesment of experiments involving infectious agents, rDNA in-vitro and in-vivo.
History and Neccesity Of Biosafety History: •On 18 april 1955 the first biological safety conferrence took place at Camp Detrick in Fredrick, Maryland in presence of fourteen representatives from three Principal Laboratories of U.S Army. •Biosafety, chemical, radiological & industrial safety issues were discussed. •Later in the United States, the Centers for Disease Control (CDC) specified 4 different levels of biocontainment which ranges from Biosafety level 1 (BSL-1) to Biosafety level 4 (BSL-4). Neccesity: •In order to avoid infection/biohazard to the laboratory personnel & the environment biosafety levels are very important.
Biohazard Symbol • Charles Baldwin at National Cancer Institute at NIH. • Symbol to be “memorable but meaningless” so it could be learned. • Blaze orange – most visible under harsh conditions
Biosafety Issues • Laboratory Safety • Bloodborne pathogens (BBP) • Recombinant DNA (rDNA) • Biological waste disposal • Infectious substance and diagnostic specimen shipping • Respiratory Protection • Bioterrorism and Select agents • Mold and indoor air quality • Occupational safety and health in the use of research animals • Biohazards used in animal models
Biohazardous Materials • Viruses • Bacteria • Fungi • Chlamydiae/Rickettsiae • Prions • Recombinant DNA • Transgenic Plants, Animals and Insects
Biosafety In Microbiological and Biomedical Laboratories “BMBL” (acronym) CDC/NIH Publication Safety “Guidelines” Regulations of Institution receives NIH funding Clinical & Research Lab. Lab. Animal Facilities Biosafety Concepts
Biosafety Concepts from the BMBL Principles of Biosafety • Practice and Procedures – Standard Practices – Special Practices & Considerations • Safety Equipment • Facility Design and Construction • Increasing levels of protection
Principles of Biosafety Biosafety Levels 1-4 (BSL) • Increasing levels of employee and environmental protection • Guidelines for working safely in research & medical laboratory facilities Animal Biosafety Levels 1- 4 (ABSL) • Laboratory animal facilities • Animal models that support research • Guidelines for working safely in animal research facilities
Biosafety Concepts The BMBL (1) Standard Laboratory Practices • Most important concept / Strict adherence • Aware of potential hazard • Trained & proficient in techniques • Supervisors responsible for: – Appropriate Laboratory facilities – Personnel & Training • Special practices & precautions – Occupational Health Programs
Biosafety Issues The BMBL (2) Safety Equipment • Primary Containment Barrier • Minimize exposure to hazard – Prevent contact / Contain aerosols • Engineering controls/ equipment • Personal Protective Equipment (PPE) – Gloves, gowns, Respirator, Face shield, Booties • Biological Safety Cabinets • Covered or ventilated animal cage systems
Biosafety Concepts The BMBL (3) Facility Design and Construction • Secondary Barrier/ Engineering controls • Contributes to worker protection • Protects outside the laboratory – Environment & Neighborhood • Ex. Building & Lab design, Ventilation, Autoclaves, Cage wash facilities, etc.
Laboratory Design “Warehouse Type Lab”
Types Of Biosafety Levels There are 4 types of biosafety levels according to the risk factors involved depending on the nature of pathogen being handled.
BSL 1 (Basic teaching, Research)  This level is suitable for work involving well characterized agents not known to cause disease to healthy adult human & it gives minimal protection to the operating person.  Work is done on open benches or simple cabinet without laminar air flow or with horizontal laminar (class 1) may be used.  Access limited when work in progress. Cont..
 Basic precaution is taken such as wearing gloves, protective eyewear, sink for washing hands, etc.  The lab is not necessarily saparated from the building.  No eating, drinking, applying cosmetics, mouth pipetting.  Openable windows must have screen.  Regular disinfection/decontamination must be done atleast once per day.
Risk Group 1 Agents • E.coli K-12 • Transgenic Plants • Plasmids • Fungi • Mold • Yeast
BSL 2 (Primary health services, diagnostic service, research)  BSL 2 is same as like BSL 1 but few modifications are made since this level includes risk factors more than BSL1.  Agents associated with human disease.  Effective treatment and preventive measures are available.  Biohazard sign must be at entrance. Cont..
Restricted access, control of waste disposal, protective clothing, no food & drinking.  Class 1 cabinets (horizontal laminar) are used.  Written report for spills, accidents , medical evaluation.  Biosafety cabinets should be decontaminated regularly.  First aid, medications on accidental cases is must.  Expose to mucous membranes must be avoided.
Risk Group 2 Agents • Human or Primate Cells • Herpes Simplex Virus • Replication Incompetent Attenuated Human Immunodeficiency Virus • Patient specimens
A standard lab Working on influenza virus in safety cabinet Class 1 cabinetBiohazard sign
 BSL 3 (Special diagnostic service, reasearch) This level is applicable to clinical, diagnostic, teaching, research, or production facilities in which work is done with indigenous or exotic agents which may cause serious or potentially lethal disease after inhalation.  It includes various bacteria, parasites and viruses that can cause severe to fatal disease in humans but for which treatments exist. Cont..
 Vertical laminar flow hood with front protection.  Strict access control to lab.  Two sets of self closing doors.  Protective clothing, gloves face shield mask, goggles, closed shoes, automatic or elbow taps on sink.  Windows closed and sealed.  Negative pressure in labs, directional airflow & air not re- circulated, proper decontamination of wastes before disposing.  In case of spillage trained staff deals with it.  Common example of pathogens: Yersinia pestis, Mycobacterium tuberculosis, etc
BSL-3
 BSL 4 (Dangerous pathogen units) This level is required for work with dangerous and exotic agents that pose a high individual risk of aerosol-transmitted laboratory infections, agents which cause severe to fatal disease in humans for which vaccines or other treatments are not available. Lab is separate. Totally enclosed system. A completely sealed cabinet (class 3) with glove pockets to allow manipulation of cultures. Biohazard hood(glove box)
Positive pressure personnel suite.  Life support system. Multiple showers at entry & exit Vaccum room, ultra violet room. Special waste disposal. Double ended autoclave through wall. Supervised by qualified scientists who are trained and experienced in working with these agents. Positive pressure suits
Biosafety Level 4 • Lassa Fever Virus • Ebola Hemmorrhagic Fever Virus • Marburg Virus • Herpes B Virus
General Good Lab Technique • Hygienic Practices – No Smoking, Eating, Applying cosmetics, lip balm, contacts – Wash hands after procedures – Decontaminate lab bench before and after work
General Operational Practices • Proper attire – Minimum – lab coat, safety glasses, gloves • Plan your work – Know in advance what you are working with – Read available resources (MSDS)
Biotechnology for developing countries The challenge according to FAO • To feed a population of 9 billion persons by 2050, without allowing for additional imports of food, continents have to increase their food production roughly: – Africa 300% – Latin America 80% – Asia 70% – Even the US has to increase food production by 30% just to supply food for the projected population of 348 million person
“New” constraints • Erosion, water and irrigation problems • Climate change => Global warming? • Soil fertility • Urbanization and land being retired from production • Consumer concerns about intensive agriculture: Organic, Fair Trade • Competition from biofuels production • Social, philosophical, ethical and religious concerns over the food production system • Concerns over globalization and corporate control of agriculture • …
The Green Revolution • Transformation of agriculture during 1940s-1970s that lead to significant increases in yields • Firmly based on: – Agricultural production needs to keep pace with population growth – Agricultural sciences philosophy of maximizing production per unit of land – Plant breeding developments of the late 19th early 20th centuries • Initially focused on a few crops (Wheat, rice, maize) but has been expanded
Norman Bourlag: Father of the Green Revolution • Developed the wheat program that later became CIMMYT in 1963 – Shuttle breeding – Incorporate short-stature genes into wheat – Increased yield and rust resistance in wheat • Mexico: – 1948 self sufficient wheat producer – 1965 Net exporter • Won Nobel Peace Prize in 1970 and World Food Prize • Genesis of the Consultative Group of International Agricultural Research ( CGIAR)
How was the Green Revolution possible? An agronomist perspective on a technological triumph as an engineering feat… • Incorporation of a dwarfing genes from natural populations into wheat and rice • In maize: more vertical orientation of leaves, reduces self-shading while allowing planting of narrower rows and thus increases in densities • Plants bred to dedicate a larger share of photosynthesis efforts to grain rather than to stems and leaves – Harvest index of older varieties was 20% whereas HYV around 50- 55% • Relatively insensitive to day length – can be planted in a wider range of latitudes • Increased responsiveness to fertilizer and water
Green Revolution: Successes • Significant increases in yields and production – From 1950 to 1992, the world’s grain output rose from 692 million tons produced on 1.70 billion acres of cropland to 1.9 billion tons on 1.73 billion acres – India: food production increased from 50 to 205 million tons during the last 5 decades – But, barely happened in Sub-Saharan Africa • Economic output per hectare increases significantly • 30% increase in cereal and calorie availability per person • Poverty reductions—some studies show this is attributed to GR raising farmers incomes
Green Revolution: Social and Economic Criticisms • Does not address underlying social, cultural, ethnical and institutional constraints that create vulnerability and thus affect livelihoods – Is hunger and food insecurity a question of production or unequal distribution of resources? • Increased mechanization affected rural labor employment • Debt effects and credit institutions necessary • Technology not scale neutral – Uneven adoption as larger/wealthier farmers adopted first capturing larger share of benefits • Landowner/Landholder displacement • Dependence on pesticides and fertilizers
Green Revolution: Environmental/Ecological Criticisms • Loss of agricultural biodiversity, not so clear effect on wild biodiversity – Focus on few crops => monocultures • Increased uses of pesticides and the pesticide treadmill • Increased use of fertilizers • Irrigation – Negative impacts of salinization, damage to soils, and lowering of water tables – Need to build dams and irrigation systems
Biotechnology as a tool What is biotechnology? • Manipulation of living organisms for a useful purpose • Definition that covers a broad range of techniques – Traditional: Plant breeding, tissue culture, micropropagation – Modern: Marker assisted selection, Genetic Modifications and Genomics • Only GM products are currently regulated for biosafety
GM Biotechnology – What is its status?
A reality check?
Implications for developing country agriculture • Majority expansion is in four crops and two traits (insect protection and herbicide tolerance) produced by industrialized countries for its agriculture • Diffusion to developing has been a (fortunate) development • Challenge now is meeting explicit needs of – Developing countries – Smallholder / resource poor farmers – Crop / traits
R&D and innovation for and by developing countries • Crops and traits of interest/value have been produced • Capacity to develop GM crops and other biotechnologies – Advanced => China, Brazil, Mexico, India, Argentina – Medium- Advanced => Philippines, Thailand, Indonesia • Next Harvest documented 270 technologies in 16 developing countries
Why GM biotech? • Embodied technologies • Address specific productivity constraints not easily addressed by conventional means • Can be deployed in low resource use production systems • Flexible – fit with other production systems – GM and Integrated Pest Management – GM and organic production methods (!!!) • Impacts can be non-pecuniary, indirect, and scale neutral • Scalable
How does a producer benefit? Insect resistance traits The case of Bt cotton
Bt maize in the Philippines • Growing Bt maize significantly increases profits and yields • Significant insecticide use reductions • Adopters tend to be – Cultivate larger areas – Use hired labor – More educated – have more positive perceptions of current and future status
Bt maize in Honduras •Excellent target pest control •Bt yield advantage 893-1136 Kg ha -1 yield (24-33%) •Bt maize yields preferred even by risk averse producers •100% higher seed cost than conventional hybrid •Institutional issues important
Black Sigatoka Resistant Bananas in Uganda •Consider irreversible and reversible cost and benefits by using the Real Option model •One year delay, forego potential annual (social) benefits of +/- US$200 million •A GM banana with tangible benefits to consumers increases their acceptance for 58% of the population
Productivity: Evidence for Bt Cotton Gains Bt cotton in: • United States: yield effect 0 – 15% • China: yield effect 10% • South Africa: yield effect 20%-40% • India: yield effect 60 – 80 % In every country have reduction in chemical usage
The Impact of Bt Cotton in India • Bt cotton is used to provide resistance to the American bollworm (Helicoverpa armigera). • The technology was developed by Monsanto and was introduced in collaboration with the Maharashtra Hybrid Seed Company (Mahyco). • Field trials with these Bt hybrids have been carried out since 1997 and, for the 2002/03 growing season, the technology was commercially approved by the Indian authorities.
Results • Bt hybrids were sprayed three times less often against bollworms than the conventional hybrids. • On average, insecticide amounts on Bt cotton plots were reduced by almost 70%, which is consistent with studies from other countries. • At average pesticide amounts of 1.6 kg/ha (active ingredients) on the conventional trial plots, crop damage in 2001/02 was about 60%. Bt does not completely eliminate pest-related yield losses.
Results II • Average yields of Bt hybrids exceeded those of non-Bt counterparts and local checks by 80% and 87%, respectively. • 2001/02 was a season with high bollworm pressure in India, so that average yield effects will be somewhat lower in years with less pest problems.
Concluding comments • Biotechnology and Genetically Modified Crops are still only technologies • Similarities and differences with other technologies • Actual and potential benefits from GM technology adoption…important tool to consider. Cannot disregard • Developments in the public sector in developing countries • Additional crops/traits of interest whose limitations can probably be only addressed through biotechnology means, will be available if we manage to resolve institutional and regulatory issues.
Intellectual Property Rights •Patents •Industrial designs •Trade and service marks •Copy rights •Geographical indications or appellations of origins •Layout designs (of integrated circuits). •Neighbouring rights. •Undisclosed INFORMATIONS (trade secrets). •Anticompetitive practices in contractual licenses. •Protection of inventions in biotechnology (plants).
IPR •A legal concept: Copyright, trademarks and geographic indications, patents, trade secrets, plant variety protection •A social construct that defines “intangible” borders (as opposed to tangible, real property borders) •A business asset that can be valued and traded •An instrument to achieve humanitarian objectives •A policy tool to foster investments in innovation
FOR MOST PRODUCTS EVERY FORM OF INTELLECTUAL PROPERTY RIGHTS CAN BE OBTAINED CAMERA “PATENT”  For every individual improved mechanism “DESIGN”  For outer shape & Contour / Configuration “TRADE MARK” Brand name or Logo for goods denoted as ® “Copy right” For Instruction / manual booklet denoted as ©
Major cases of IPR in Biotechnology 1. The IP situation with golden rice 2. Diamond v. Chakrabarty Patent Infringement 3. India-US Basmati Rice Dispute 4. Novartis patent case: cancer drug Glivec
1.The IP situation with golden rice • ~70 patents and patent applications might be applicable to golden rice when all patents issued in or applied for in all countries were considered. •A dozen material transfer agreements were also identified, 1 of which needed a license. •The published analysis, and legal opinion, concluded that, in practice, only a few patents were applicable in developing countries.
Resolving the IP constraints with golden rice 1. Assembly of IP and tangible property rights: - within a few months, in licensing, for humanitarian use, led by Zeneca (Adrian Dubock), of key IP components (Bayer AG, Monsanto, Novartis AG, Orynova BV, Zeneca Mogen BV, others) 2. Out-licensing, by Syngenta, via the inventors, the bundled IP to public sector institutions in developing countries: - Bangladesh India, Indonesia, Philippines, Vietnam and many more - Policy support from Syngenta’s chairman, Heinz Imhof
Principal terms of the humanitarian license • For use by resource-poor farmers (< US$10,000/year from farming) • Use of public varieties • No technology fee • Farmers are allowed to reuse harvested seeds • No release in countries lacking biosafety regulations • Export to licensees for research and use is permitted • Improvements: – Humanitarian use allowed (Syngenta already licensed many improvements) – Commercial rights to improvements are granted back to Syngenta
2. Diamond v. Chakrabarty Patent Infringement  The case was heard in the United Sates Supreme Court in 1980.  It entailed the patentability of genetically modified organisms.  Genetic engineer ,Ananda Mohan Chakrabarty developed a bacterium called Pseudomonas putida.  This was while working with General Electric.  The bacterium can break down crude oil which made it suitable for treating future oil spills.
Chakrabarty • He was an investor of the bacterium by the General Electric. • This was when the company applied for patent. • The patent examiner rejected the application. • This was because living things were not being patentable subject matters at the time. • The examiner quoted Section 101 of the Title 35 U.S.C.
Case  Board of Patent Appeals and Interferences upheld its initial decision.  The United States Court of Customs and patent did not.  It overturned this case in favor of Chakrabarty.  Aegued that all micro-organisms are living things does not have legal significance.  Sidney A. Diamond who was the Patents and Trademarks’ commissioner made an appeal to Supreme Court.  This case was deliberated on 17th March 1980.
Court’s Decision  A decision was made on 16th June 1980 and on 31st March 1981.  This was USPTO granted patent which was to Chakrabarty’s favor.  The court noted that a live micro-organism made by human under Title 35 U.S.C, 101.  The micro-organism of the respondent constituted of a composition of matter.  The decision was written by Warren E. Burger, the Chief Justice.  Others who joined him were Potter Stewart, William Rehnquist, John Paul Stevens and Harry Blackmun.
3. Basmati Rice and Asia • Rice is an important aspect of life in the Southeast and other parts of Asia. • For centuries, it has been the cornerstone of their food and culture. • Basmati has been grown in the foothills of the Himalayas for thousands of years. • Basmati rice is being grown in subcontinent for centuries. • Its flavour and aroma has been developed through selective breeding for thousands of years. • It is common knowledge that what Champagne is to France, Basmati is to subcontinent (Pakistan and India).
Basmati Rice • Basmati means the “queen of fragrance or the perfumed one”. • Origin: Pakistan and India • Indian varieties are Safidon, Haryana, Kasturi (Baran, Rajasthan), Basmati 198, Basmati 217, Basmati 370, Kasturi, Mahi Suganda. • Pakistani varieties Basmati 370, Super Basmati, Pak (Kernal) Basmati, Basmati 386, Basmati 385 and Basmati 198.
The Case Issue In the late 1997, when an American company RiceTec Inc. was granted a patent by the US patent office to call the aromatic rice grown outside India "Basmati", India objected to it. India has been one of the major exporters of Basmati to several countries and such a grant by the US patent office was likely to affect its trade. Since Basmati rice is traditionally grown in India and Pakistan, it was opined that granting patent to RiceTec violated the Geographical Indications Act under the TRIPS agreement. A geographical indication (sometimes abbreviated to GI) is a name or sign used on certain products which corresponds to a specific geographical location or origin (e.g.. a town, region, or country). The use of a GI may act as a certification that the product possesses certain qualities, or enjoys a certain reputation, due to its geographical origin. RiceTec's usage of the name Basmati for rice which was derived from Indian rice but not grown in India, and hence not of the same quality as Basmati, would have lead to the violation of the concept of GI and would have been a deception to the consumers.
Patent Advantage to RiceTech • RiceTec able to not only call its aromatic rice Basmati within the US, but also label it Basmati for its exports. • Captures the whole US trade market. • Exclusive use of the term “basmati”. • Monopoly on breeding 22 farmer-bred Pakistani basmati varieties with any other varieties in the Western Hemisphere. • Proprietary rights on the seeds and grains from any crosses.
Disadvantage of Patent to India and Pakistan • Economic loses. • Global trade losses. • Both countries lose their global market share.
Government of India Response to Patent • Government of India under severe pressure from its exporters and farmers logged an appeal with USPTO. • They submitted the evidence to USPTO. • India exports about 400,000 - 500,000 metric tons of Basmati annually. In 1996-97, India exported approximately 523,000 tonnes of Basmati to Europe.
Result of patent case • RiceTec Inc. took back 15 claims out of 20 • They also took back its claim on the name “Basmati”.
4. Novartis patent case •Glivec is a medicine discovered and developed by Novartis for the treatment of chronic myeloid leukemia (CML), a cancer of white blood cells and for the treatment of a rare form of stomach cancer called gastrointestinal stromal tumor (GIST). •Glivec is one of the first cancer drugs that validate rational drug design, based on an understanding of how some cancer cells function. These molecularly targeted drugs are different because they target abnormal proteins that are fundamental to the cancer itself.
•Glivec, used in treating chronic myeloid leukemia and some other cancers, costs a patient about $2,600 (Rs 1,30,000) a month. Its generic version was available in India for around $175 (Rs 8,750) per month, reported Associated Press. The medicine is the lifeline for poor in many developing countries. •Novartis had argued that it needed to new patent to protect its investment in the cancer drug Glivec while activists said the company was trying to use loopholes to make more money out of a drug whose patent had expired.
•Glivec has been patented in nearly 40 countries but only faced problems in India. The drug was given an EMR by the Indian patent office in the year 2003, which was for the duration of 5 years. Later, Novartis sued Ranbaxy and Cipla before the High Courts of Madras and Bombay for making the generic versions of Glivec. Novartis has fought a legal battle in India since 2006 for a fresh patent. •In a landmark judgement, India's Supreme Court on December 2014, rejected a patent plea by Swiss drugmaker Novartis AG for cancer drug Glivec, boosting the case for cheaper drugs for life-threatening diseases.
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Bio business and biosafety

  • 1.
    Bio-Business and Biosafety,Biotechnology for developing countries, and relevance of IPR in biotechnology Promila Sheoran PhD Biotechnology GJU S&T Hisar
  • 2.
    Biobusiness Definition Commercial activity basedon an understanding of life sciences and life science processes: Biomedical (including healthcare, pharmaceuticals, medical devices, diagnostics, etc) Agri-veterinary and Food Environmental/Industrial Related Areas (bioinformatics/computational biology, bioengineering, nanobiotechnology, etc)
  • 3.
    Market BioBusiness already constitutesover 25% of global GDP and employs some 40% of the world’s labor force: Accounts for nearly US$12 trillion (2005) Employment figures skewed by > 50% engaged in subsistence level farming and low wage food processing in developing countries (including China and India)
  • 4.
    Some Key BioBusinessOpportunity Areas With Health and Development Implications Biomedical BioBusiness Healthcare Pharmaceuticals Biomedical biotechnology Herbal and traditional medicine Medical devices Diagnostics Agri-Veterinary and Food BioBusiness Agriculture Fisheries and aquaculture Animal husbandry Biopharming Pets and recreational animals Forestry and lumber Agri-biotechnology Food processing Environmental and Industrial BioBusiness Management of biodiversity Environmental bioremediation Waste management Environmental biotechnology Marine biotechnology Industrial biotechnology: bioenergy, new biomaterials, etc Other BioBusiness Related Activities Bio-IT and the application of ICT in the life sciences Bioengineering Nanotechnologies as applied to life sciences Life science and biotechnology education Life science and biotech R&D Life science and biotech contract services Source: Shahi, 2002
  • 5.
    Some Global Opportunitiesand Challenges with Potential BioBusiness Implications • Globalization - and the rapidly growing global economy (and growing inequity between “haves” and “have nots”) • Healthcare and Biomedical Sciences - Advances in healthcare and the biomedical sciences, the genomics revolution and the move toward personalized medicine (and the need to manage the cost of healthcare as populations age) • Feeding the World – increased interest in more nutritious and less chemically tainted foods (and the need to feed more people in the face of ever diminishing arable land) • Renewables and Sustainability - Increasing demand for renewables and more sustainable production technologies – biofuels, new biomaterials (and solving the problems of global warming, environmental contamination and waste management) • Responding to Threats – responding to natural and human generated threats to economic development and stability (from pandemics, to natural disasters, to concerns about bioterrorism)
  • 6.
    The BioBusiness InnovationLandscape Recommended Approach: Focus on “Summit” opportunities – putting people, technologies and resources together to capture the value proposition Summit Opportunities: Technology and knowledge intensive, few competitors, high barriers to entry; high margins with well- developed business case, “new” economy principles apply. High BioEnterprise interest
  • 7.
    Analysis: Successful BioBusinessInnovation Critical Success Factors (given good infrastructure, facilities, policies, etc):  Smart People  Smart Ideas  Smart Money (immaterial if public or private sector driven: Silicon Valley model – driven by private money; European model – driven by public money)  Smart Alliances and Partnerships (throughout the world)
  • 8.
    Understanding Innovation… It ispretty simple: You do some stuff. Most fails. Some works. You do more of what works. If it works big, others quickly copy it. Then you do something else. The trick is the doing something else. Thomas Peters
  • 9.
    Technology Adoption Challenges Canwe afford it? How will we recover our costs? Can it pay for itself? Is it reimbursable? Show me the money. We need to have this reviewed. This is cool. I want it – does not matter how much it costs We'll be the first institution in the region that has it. Makes us look good. Let's get it!
  • 10.
    BioPartnering: Capturing theValue Proposition Professional Services Legal /IPR, Media, Recruitment etc Regulatory Bodies Development Agencies Academic Researchers Finance Entrepreneurs Industry Work for win-win Encourage public-private partnership Bet on people Make smart investments Source: Shahi, BioBusiness in Asia… (Pearson Prentice Hall, 2004)
  • 11.
    Some Priority Areasfor Cooperation and Collaboration: Government-Academia-Industry  Meeting National/Regional/International Economic/Technology Developmental Priorities  Contract Research Initiatives  Facilitating Commercialization of Publicly-funded R&D and Managing IP  Bioethics  Regulatory  Public Health  Biosecurity  Incentivizing BioInnovation and BioEntrepreneurship  Raising Funding and Investment for Biotech – including Cultivating Public Markets for Biotech Stocks, and the development of a viable VC industry  Public Education/Communication and the Training of Life Science Personnel
  • 12.
    Making Things Happenin Bio-Business 1. Identify “Summit” opportunities 2. Recognize that Bio-Business innovation need not always be “long life cycle” 3. Life science/biotech/Bio-IT investment need not be high risk – if you know what you are doing 4. More developed countries do not have a monopoly on good science and technology – innovative concepts can be found everywhere 5. Protect IP assets. Recognize that IP is not just patents – knowhow, knowwhy and knowwho can be just as important 6. Bet on people not only on technologies - committed and capable innovators/entrepreneurs will always find a way to win
  • 13.
    Biosafety •The maintenance ofsafe conditions in biological research to prevent harm to workers, non-laboratory organisms or the environment. •Biosafety in Research Universities means promoting safe laboratory practices, and procedures; proper use of containment equipment and facilities; provides advice on laboratory design and risk assesment of experiments involving infectious agents, rDNA in-vitro and in-vivo.
  • 14.
    History and NeccesityOf Biosafety History: •On 18 april 1955 the first biological safety conferrence took place at Camp Detrick in Fredrick, Maryland in presence of fourteen representatives from three Principal Laboratories of U.S Army. •Biosafety, chemical, radiological & industrial safety issues were discussed. •Later in the United States, the Centers for Disease Control (CDC) specified 4 different levels of biocontainment which ranges from Biosafety level 1 (BSL-1) to Biosafety level 4 (BSL-4). Neccesity: •In order to avoid infection/biohazard to the laboratory personnel & the environment biosafety levels are very important.
  • 15.
    Biohazard Symbol • CharlesBaldwin at National Cancer Institute at NIH. • Symbol to be “memorable but meaningless” so it could be learned. • Blaze orange – most visible under harsh conditions
  • 16.
    Biosafety Issues • LaboratorySafety • Bloodborne pathogens (BBP) • Recombinant DNA (rDNA) • Biological waste disposal • Infectious substance and diagnostic specimen shipping • Respiratory Protection • Bioterrorism and Select agents • Mold and indoor air quality • Occupational safety and health in the use of research animals • Biohazards used in animal models
  • 17.
    Biohazardous Materials • Viruses •Bacteria • Fungi • Chlamydiae/Rickettsiae • Prions • Recombinant DNA • Transgenic Plants, Animals and Insects
  • 18.
    Biosafety In Microbiological andBiomedical Laboratories “BMBL” (acronym) CDC/NIH Publication Safety “Guidelines” Regulations of Institution receives NIH funding Clinical & Research Lab. Lab. Animal Facilities Biosafety Concepts
  • 19.
    Biosafety Concepts fromthe BMBL Principles of Biosafety • Practice and Procedures – Standard Practices – Special Practices & Considerations • Safety Equipment • Facility Design and Construction • Increasing levels of protection
  • 20.
    Principles of Biosafety BiosafetyLevels 1-4 (BSL) • Increasing levels of employee and environmental protection • Guidelines for working safely in research & medical laboratory facilities Animal Biosafety Levels 1- 4 (ABSL) • Laboratory animal facilities • Animal models that support research • Guidelines for working safely in animal research facilities
  • 21.
    Biosafety Concepts The BMBL (1)Standard Laboratory Practices • Most important concept / Strict adherence • Aware of potential hazard • Trained & proficient in techniques • Supervisors responsible for: – Appropriate Laboratory facilities – Personnel & Training • Special practices & precautions – Occupational Health Programs
  • 22.
    Biosafety Issues The BMBL (2)Safety Equipment • Primary Containment Barrier • Minimize exposure to hazard – Prevent contact / Contain aerosols • Engineering controls/ equipment • Personal Protective Equipment (PPE) – Gloves, gowns, Respirator, Face shield, Booties • Biological Safety Cabinets • Covered or ventilated animal cage systems
  • 23.
    Biosafety Concepts The BMBL (3)Facility Design and Construction • Secondary Barrier/ Engineering controls • Contributes to worker protection • Protects outside the laboratory – Environment & Neighborhood • Ex. Building & Lab design, Ventilation, Autoclaves, Cage wash facilities, etc.
  • 24.
  • 25.
    Types Of BiosafetyLevels There are 4 types of biosafety levels according to the risk factors involved depending on the nature of pathogen being handled.
  • 26.
    BSL 1 (Basicteaching, Research)  This level is suitable for work involving well characterized agents not known to cause disease to healthy adult human & it gives minimal protection to the operating person.  Work is done on open benches or simple cabinet without laminar air flow or with horizontal laminar (class 1) may be used.  Access limited when work in progress. Cont..
  • 27.
     Basic precautionis taken such as wearing gloves, protective eyewear, sink for washing hands, etc.  The lab is not necessarily saparated from the building.  No eating, drinking, applying cosmetics, mouth pipetting.  Openable windows must have screen.  Regular disinfection/decontamination must be done atleast once per day.
  • 28.
    Risk Group 1Agents • E.coli K-12 • Transgenic Plants • Plasmids • Fungi • Mold • Yeast
  • 29.
    BSL 2 (Primaryhealth services, diagnostic service, research)  BSL 2 is same as like BSL 1 but few modifications are made since this level includes risk factors more than BSL1.  Agents associated with human disease.  Effective treatment and preventive measures are available.  Biohazard sign must be at entrance. Cont..
  • 30.
    Restricted access, controlof waste disposal, protective clothing, no food & drinking.  Class 1 cabinets (horizontal laminar) are used.  Written report for spills, accidents , medical evaluation.  Biosafety cabinets should be decontaminated regularly.  First aid, medications on accidental cases is must.  Expose to mucous membranes must be avoided.
  • 31.
    Risk Group 2Agents • Human or Primate Cells • Herpes Simplex Virus • Replication Incompetent Attenuated Human Immunodeficiency Virus • Patient specimens
  • 32.
    A standard lab Workingon influenza virus in safety cabinet Class 1 cabinetBiohazard sign
  • 33.
     BSL 3(Special diagnostic service, reasearch) This level is applicable to clinical, diagnostic, teaching, research, or production facilities in which work is done with indigenous or exotic agents which may cause serious or potentially lethal disease after inhalation.  It includes various bacteria, parasites and viruses that can cause severe to fatal disease in humans but for which treatments exist. Cont..
  • 34.
     Vertical laminarflow hood with front protection.  Strict access control to lab.  Two sets of self closing doors.  Protective clothing, gloves face shield mask, goggles, closed shoes, automatic or elbow taps on sink.  Windows closed and sealed.  Negative pressure in labs, directional airflow & air not re- circulated, proper decontamination of wastes before disposing.  In case of spillage trained staff deals with it.  Common example of pathogens: Yersinia pestis, Mycobacterium tuberculosis, etc
  • 35.
  • 36.
     BSL 4(Dangerous pathogen units) This level is required for work with dangerous and exotic agents that pose a high individual risk of aerosol-transmitted laboratory infections, agents which cause severe to fatal disease in humans for which vaccines or other treatments are not available. Lab is separate. Totally enclosed system. A completely sealed cabinet (class 3) with glove pockets to allow manipulation of cultures. Biohazard hood(glove box)
  • 37.
    Positive pressure personnelsuite.  Life support system. Multiple showers at entry & exit Vaccum room, ultra violet room. Special waste disposal. Double ended autoclave through wall. Supervised by qualified scientists who are trained and experienced in working with these agents. Positive pressure suits
  • 38.
    Biosafety Level 4 •Lassa Fever Virus • Ebola Hemmorrhagic Fever Virus • Marburg Virus • Herpes B Virus
  • 39.
    General Good LabTechnique • Hygienic Practices – No Smoking, Eating, Applying cosmetics, lip balm, contacts – Wash hands after procedures – Decontaminate lab bench before and after work
  • 40.
    General Operational Practices •Proper attire – Minimum – lab coat, safety glasses, gloves • Plan your work – Know in advance what you are working with – Read available resources (MSDS)
  • 41.
    Biotechnology for developingcountries The challenge according to FAO • To feed a population of 9 billion persons by 2050, without allowing for additional imports of food, continents have to increase their food production roughly: – Africa 300% – Latin America 80% – Asia 70% – Even the US has to increase food production by 30% just to supply food for the projected population of 348 million person
  • 42.
    “New” constraints • Erosion,water and irrigation problems • Climate change => Global warming? • Soil fertility • Urbanization and land being retired from production • Consumer concerns about intensive agriculture: Organic, Fair Trade • Competition from biofuels production • Social, philosophical, ethical and religious concerns over the food production system • Concerns over globalization and corporate control of agriculture • …
  • 43.
    The Green Revolution •Transformation of agriculture during 1940s-1970s that lead to significant increases in yields • Firmly based on: – Agricultural production needs to keep pace with population growth – Agricultural sciences philosophy of maximizing production per unit of land – Plant breeding developments of the late 19th early 20th centuries • Initially focused on a few crops (Wheat, rice, maize) but has been expanded
  • 44.
    Norman Bourlag: Fatherof the Green Revolution • Developed the wheat program that later became CIMMYT in 1963 – Shuttle breeding – Incorporate short-stature genes into wheat – Increased yield and rust resistance in wheat • Mexico: – 1948 self sufficient wheat producer – 1965 Net exporter • Won Nobel Peace Prize in 1970 and World Food Prize • Genesis of the Consultative Group of International Agricultural Research ( CGIAR)
  • 45.
    How was theGreen Revolution possible? An agronomist perspective on a technological triumph as an engineering feat… • Incorporation of a dwarfing genes from natural populations into wheat and rice • In maize: more vertical orientation of leaves, reduces self-shading while allowing planting of narrower rows and thus increases in densities • Plants bred to dedicate a larger share of photosynthesis efforts to grain rather than to stems and leaves – Harvest index of older varieties was 20% whereas HYV around 50- 55% • Relatively insensitive to day length – can be planted in a wider range of latitudes • Increased responsiveness to fertilizer and water
  • 46.
    Green Revolution: Successes •Significant increases in yields and production – From 1950 to 1992, the world’s grain output rose from 692 million tons produced on 1.70 billion acres of cropland to 1.9 billion tons on 1.73 billion acres – India: food production increased from 50 to 205 million tons during the last 5 decades – But, barely happened in Sub-Saharan Africa • Economic output per hectare increases significantly • 30% increase in cereal and calorie availability per person • Poverty reductions—some studies show this is attributed to GR raising farmers incomes
  • 47.
    Green Revolution: Socialand Economic Criticisms • Does not address underlying social, cultural, ethnical and institutional constraints that create vulnerability and thus affect livelihoods – Is hunger and food insecurity a question of production or unequal distribution of resources? • Increased mechanization affected rural labor employment • Debt effects and credit institutions necessary • Technology not scale neutral – Uneven adoption as larger/wealthier farmers adopted first capturing larger share of benefits • Landowner/Landholder displacement • Dependence on pesticides and fertilizers
  • 48.
    Green Revolution: Environmental/Ecological Criticisms •Loss of agricultural biodiversity, not so clear effect on wild biodiversity – Focus on few crops => monocultures • Increased uses of pesticides and the pesticide treadmill • Increased use of fertilizers • Irrigation – Negative impacts of salinization, damage to soils, and lowering of water tables – Need to build dams and irrigation systems
  • 49.
    Biotechnology as atool What is biotechnology? • Manipulation of living organisms for a useful purpose • Definition that covers a broad range of techniques – Traditional: Plant breeding, tissue culture, micropropagation – Modern: Marker assisted selection, Genetic Modifications and Genomics • Only GM products are currently regulated for biosafety
  • 50.
    GM Biotechnology –What is its status?
  • 51.
  • 52.
    Implications for developingcountry agriculture • Majority expansion is in four crops and two traits (insect protection and herbicide tolerance) produced by industrialized countries for its agriculture • Diffusion to developing has been a (fortunate) development • Challenge now is meeting explicit needs of – Developing countries – Smallholder / resource poor farmers – Crop / traits
  • 53.
    R&D and innovationfor and by developing countries • Crops and traits of interest/value have been produced • Capacity to develop GM crops and other biotechnologies – Advanced => China, Brazil, Mexico, India, Argentina – Medium- Advanced => Philippines, Thailand, Indonesia • Next Harvest documented 270 technologies in 16 developing countries
  • 54.
    Why GM biotech? •Embodied technologies • Address specific productivity constraints not easily addressed by conventional means • Can be deployed in low resource use production systems • Flexible – fit with other production systems – GM and Integrated Pest Management – GM and organic production methods (!!!) • Impacts can be non-pecuniary, indirect, and scale neutral • Scalable
  • 55.
    How does aproducer benefit? Insect resistance traits The case of Bt cotton
  • 56.
    Bt maize inthe Philippines • Growing Bt maize significantly increases profits and yields • Significant insecticide use reductions • Adopters tend to be – Cultivate larger areas – Use hired labor – More educated – have more positive perceptions of current and future status
  • 57.
    Bt maize inHonduras •Excellent target pest control •Bt yield advantage 893-1136 Kg ha -1 yield (24-33%) •Bt maize yields preferred even by risk averse producers •100% higher seed cost than conventional hybrid •Institutional issues important
  • 58.
    Black Sigatoka ResistantBananas in Uganda •Consider irreversible and reversible cost and benefits by using the Real Option model •One year delay, forego potential annual (social) benefits of +/- US$200 million •A GM banana with tangible benefits to consumers increases their acceptance for 58% of the population
  • 59.
    Productivity: Evidence forBt Cotton Gains Bt cotton in: • United States: yield effect 0 – 15% • China: yield effect 10% • South Africa: yield effect 20%-40% • India: yield effect 60 – 80 % In every country have reduction in chemical usage
  • 60.
    The Impact ofBt Cotton in India • Bt cotton is used to provide resistance to the American bollworm (Helicoverpa armigera). • The technology was developed by Monsanto and was introduced in collaboration with the Maharashtra Hybrid Seed Company (Mahyco). • Field trials with these Bt hybrids have been carried out since 1997 and, for the 2002/03 growing season, the technology was commercially approved by the Indian authorities.
  • 61.
    Results • Bt hybridswere sprayed three times less often against bollworms than the conventional hybrids. • On average, insecticide amounts on Bt cotton plots were reduced by almost 70%, which is consistent with studies from other countries. • At average pesticide amounts of 1.6 kg/ha (active ingredients) on the conventional trial plots, crop damage in 2001/02 was about 60%. Bt does not completely eliminate pest-related yield losses.
  • 62.
    Results II • Averageyields of Bt hybrids exceeded those of non-Bt counterparts and local checks by 80% and 87%, respectively. • 2001/02 was a season with high bollworm pressure in India, so that average yield effects will be somewhat lower in years with less pest problems.
  • 63.
    Concluding comments • Biotechnologyand Genetically Modified Crops are still only technologies • Similarities and differences with other technologies • Actual and potential benefits from GM technology adoption…important tool to consider. Cannot disregard • Developments in the public sector in developing countries • Additional crops/traits of interest whose limitations can probably be only addressed through biotechnology means, will be available if we manage to resolve institutional and regulatory issues.
  • 64.
    Intellectual Property Rights •Patents •Industrialdesigns •Trade and service marks •Copy rights •Geographical indications or appellations of origins •Layout designs (of integrated circuits). •Neighbouring rights. •Undisclosed INFORMATIONS (trade secrets). •Anticompetitive practices in contractual licenses. •Protection of inventions in biotechnology (plants).
  • 65.
    IPR •A legal concept:Copyright, trademarks and geographic indications, patents, trade secrets, plant variety protection •A social construct that defines “intangible” borders (as opposed to tangible, real property borders) •A business asset that can be valued and traded •An instrument to achieve humanitarian objectives •A policy tool to foster investments in innovation
  • 66.
    FOR MOST PRODUCTSEVERY FORM OF INTELLECTUAL PROPERTY RIGHTS CAN BE OBTAINED CAMERA “PATENT”  For every individual improved mechanism “DESIGN”  For outer shape & Contour / Configuration “TRADE MARK” Brand name or Logo for goods denoted as ® “Copy right” For Instruction / manual booklet denoted as ©
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    Major cases ofIPR in Biotechnology 1. The IP situation with golden rice 2. Diamond v. Chakrabarty Patent Infringement 3. India-US Basmati Rice Dispute 4. Novartis patent case: cancer drug Glivec
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    1.The IP situationwith golden rice • ~70 patents and patent applications might be applicable to golden rice when all patents issued in or applied for in all countries were considered. •A dozen material transfer agreements were also identified, 1 of which needed a license. •The published analysis, and legal opinion, concluded that, in practice, only a few patents were applicable in developing countries.
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    Resolving the IPconstraints with golden rice 1. Assembly of IP and tangible property rights: - within a few months, in licensing, for humanitarian use, led by Zeneca (Adrian Dubock), of key IP components (Bayer AG, Monsanto, Novartis AG, Orynova BV, Zeneca Mogen BV, others) 2. Out-licensing, by Syngenta, via the inventors, the bundled IP to public sector institutions in developing countries: - Bangladesh India, Indonesia, Philippines, Vietnam and many more - Policy support from Syngenta’s chairman, Heinz Imhof
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    Principal terms ofthe humanitarian license • For use by resource-poor farmers (< US$10,000/year from farming) • Use of public varieties • No technology fee • Farmers are allowed to reuse harvested seeds • No release in countries lacking biosafety regulations • Export to licensees for research and use is permitted • Improvements: – Humanitarian use allowed (Syngenta already licensed many improvements) – Commercial rights to improvements are granted back to Syngenta
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    2. Diamond v.Chakrabarty Patent Infringement  The case was heard in the United Sates Supreme Court in 1980.  It entailed the patentability of genetically modified organisms.  Genetic engineer ,Ananda Mohan Chakrabarty developed a bacterium called Pseudomonas putida.  This was while working with General Electric.  The bacterium can break down crude oil which made it suitable for treating future oil spills.
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    Chakrabarty • He wasan investor of the bacterium by the General Electric. • This was when the company applied for patent. • The patent examiner rejected the application. • This was because living things were not being patentable subject matters at the time. • The examiner quoted Section 101 of the Title 35 U.S.C.
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    Case  Board ofPatent Appeals and Interferences upheld its initial decision.  The United States Court of Customs and patent did not.  It overturned this case in favor of Chakrabarty.  Aegued that all micro-organisms are living things does not have legal significance.  Sidney A. Diamond who was the Patents and Trademarks’ commissioner made an appeal to Supreme Court.  This case was deliberated on 17th March 1980.
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    Court’s Decision  Adecision was made on 16th June 1980 and on 31st March 1981.  This was USPTO granted patent which was to Chakrabarty’s favor.  The court noted that a live micro-organism made by human under Title 35 U.S.C, 101.  The micro-organism of the respondent constituted of a composition of matter.  The decision was written by Warren E. Burger, the Chief Justice.  Others who joined him were Potter Stewart, William Rehnquist, John Paul Stevens and Harry Blackmun.
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    3. Basmati Riceand Asia • Rice is an important aspect of life in the Southeast and other parts of Asia. • For centuries, it has been the cornerstone of their food and culture. • Basmati has been grown in the foothills of the Himalayas for thousands of years. • Basmati rice is being grown in subcontinent for centuries. • Its flavour and aroma has been developed through selective breeding for thousands of years. • It is common knowledge that what Champagne is to France, Basmati is to subcontinent (Pakistan and India).
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    Basmati Rice • Basmatimeans the “queen of fragrance or the perfumed one”. • Origin: Pakistan and India • Indian varieties are Safidon, Haryana, Kasturi (Baran, Rajasthan), Basmati 198, Basmati 217, Basmati 370, Kasturi, Mahi Suganda. • Pakistani varieties Basmati 370, Super Basmati, Pak (Kernal) Basmati, Basmati 386, Basmati 385 and Basmati 198.
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    The Case Issue Inthe late 1997, when an American company RiceTec Inc. was granted a patent by the US patent office to call the aromatic rice grown outside India "Basmati", India objected to it. India has been one of the major exporters of Basmati to several countries and such a grant by the US patent office was likely to affect its trade. Since Basmati rice is traditionally grown in India and Pakistan, it was opined that granting patent to RiceTec violated the Geographical Indications Act under the TRIPS agreement. A geographical indication (sometimes abbreviated to GI) is a name or sign used on certain products which corresponds to a specific geographical location or origin (e.g.. a town, region, or country). The use of a GI may act as a certification that the product possesses certain qualities, or enjoys a certain reputation, due to its geographical origin. RiceTec's usage of the name Basmati for rice which was derived from Indian rice but not grown in India, and hence not of the same quality as Basmati, would have lead to the violation of the concept of GI and would have been a deception to the consumers.
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    Patent Advantage toRiceTech • RiceTec able to not only call its aromatic rice Basmati within the US, but also label it Basmati for its exports. • Captures the whole US trade market. • Exclusive use of the term “basmati”. • Monopoly on breeding 22 farmer-bred Pakistani basmati varieties with any other varieties in the Western Hemisphere. • Proprietary rights on the seeds and grains from any crosses.
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    Disadvantage of Patentto India and Pakistan • Economic loses. • Global trade losses. • Both countries lose their global market share.
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    Government of IndiaResponse to Patent • Government of India under severe pressure from its exporters and farmers logged an appeal with USPTO. • They submitted the evidence to USPTO. • India exports about 400,000 - 500,000 metric tons of Basmati annually. In 1996-97, India exported approximately 523,000 tonnes of Basmati to Europe.
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    Result of patentcase • RiceTec Inc. took back 15 claims out of 20 • They also took back its claim on the name “Basmati”.
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    4. Novartis patentcase •Glivec is a medicine discovered and developed by Novartis for the treatment of chronic myeloid leukemia (CML), a cancer of white blood cells and for the treatment of a rare form of stomach cancer called gastrointestinal stromal tumor (GIST). •Glivec is one of the first cancer drugs that validate rational drug design, based on an understanding of how some cancer cells function. These molecularly targeted drugs are different because they target abnormal proteins that are fundamental to the cancer itself.
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    •Glivec, used intreating chronic myeloid leukemia and some other cancers, costs a patient about $2,600 (Rs 1,30,000) a month. Its generic version was available in India for around $175 (Rs 8,750) per month, reported Associated Press. The medicine is the lifeline for poor in many developing countries. •Novartis had argued that it needed to new patent to protect its investment in the cancer drug Glivec while activists said the company was trying to use loopholes to make more money out of a drug whose patent had expired.
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    •Glivec has beenpatented in nearly 40 countries but only faced problems in India. The drug was given an EMR by the Indian patent office in the year 2003, which was for the duration of 5 years. Later, Novartis sued Ranbaxy and Cipla before the High Courts of Madras and Bombay for making the generic versions of Glivec. Novartis has fought a legal battle in India since 2006 for a fresh patent. •In a landmark judgement, India's Supreme Court on December 2014, rejected a patent plea by Swiss drugmaker Novartis AG for cancer drug Glivec, boosting the case for cheaper drugs for life-threatening diseases.
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