Bioresources, IPR & WTO Regime in 21 st Century

1. Bioresources, IPR & WTO Regime in 21st Century P. Pushpangadan National Botanical Research Institute (Council of Scientific &Industrial Research), Rana Pratap Marg, Lucknow-226001 July 20, 2004 IIM, Lucknow

2. WORLD TRADE AND ECONOMIES: THE PARADIGM SHIFT • “Resource – based economies’ to ‘Knowledge –based economies’ • 21 st Century will be the Century of Knowledge”…… “A nation’s ability to convert knowledge in to wealth and social good through the process of innovation will determine its future” ( R A Mashelkar, 2001)

3. 21st Century 21st century is the century of Biology powered and propelled by scientific knowledge and technological expertise • Three technologies namely • Biotechnology • Herbal technology • Information technology (Bioinformatics) • are going to be the most powerful elements that are crucial for prosperity and welfare for the people of nations.

4. Genesis of the Global Concern on Biodiversity • First discussed in 1972 U. N. Conference at Stockhlom • U. N. General Assembly by a resolution on 15th December 1972 established UNEP. . • First Governing Council of UNEP met in 1973 identified Conservation of Nature, Wildlife and Genetic Resources as Priority areas. • The World Commission on environment and Development (WCED) was constituted in 1983. • WCED submitted its report ‘Our Common Future’ in 1987 called for Conservation of Biodiversity for Sustainable Development.

5. Genesis of the Global Concern on Biodiversity (Contd..) • UNEP constituted an ad-hoc Working Group of Technological and Legal experts to prepare an international legal instrument for conservation and sustainable use of Biodiversity which resulted in ‘CONVENTION ON BIOLOGICAL DIVERSITY’ (CBD). • 171 countries signed CBD in June 1992 during the Earth summit at Rio de Janeiro. • CBD came - into force as an International Law on 29th Dec. 1993.

6. Genesis of the Global Concern on Biodiversity (Contd..) • India ratified CBD on 18th February 1994 and came into force from 19th May 1994 • 186 countries are now parties to CBD (as on Feb 2004) • OBJECTIVES OF CBD • Conservation of Biological Diversity • Sustainable use of its components • Fair and equitable use of the benefits arising out of the utilization of genetic resources

7. 700 B.C. Greece Idea of Monopolistic Rights/Privilege 15th Century Italy Patent introduced 1421 Republic of Florence First known patent grant by a “State” to an inventor 1474 Venice Patent Ordinance Great Britain Granting rights and privileges to inventors by Queen Elizabeth I 1623* Great Britain Statute of Monopolies proposing grant of exclusive rights to inventors for new inventions for a period of 14 years. Chronology of Patent/Monopolistic Rights * In 1623, Great Britain proposed granting exclusive rights for new inventions with a term of 14 years through an act of the Parliament, known as the Statute of Monopolies Act of 1623. It was only towards the end of the eighteenth century and during the nineteenth century that comprehensive patent statutes got formalized in various countries, including France and USA.

8. 1883 A.D. Paris Convention for the Protection of Industrial Property 1886 A.D. Berne Convention for the Protection of Literary and Artistics Works 1891 A.D. Madrid Agreement Concerning the International Registration of Trademarks 1947 A.D. Formation of General Agreement on Tariffs & Trade (GATT) 1958 A.D. Lisbon Agreement for the Protection of Apellations of Origin and their International Registration 1961 A.D. Rome Convention for the Protection of Performers, Producers of Phonograms and Broadcasting Organizations 1967 A.D. Decision to form World Intellectual Property Organization (WIPO) 1970 A.D. WIPO came into being at Geneva 1970 A.D. Patent Cooperation Treaty (PCT) 1974 WIPO became a UN Agency 1977 A.D. Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purpose of Patent Procedure 1986-1994 GATT Ministerial Meetings (Uruguay Round Conference- URC) 1994 A.D. Final Round of URC at Marrakesh and declaration of the Final Act to form WTO. Decision to form WTO on 15th April 1994 1995 A.D. World Trade Organization (WTO) came into being World Intellectual Property Organization (WIPO) & World Trade Organization (WTO)

9. The fundamental conflicts between CBD and WTO • CBD recognizes the sovereign rights of nations over their biological resources and associated knowledge systems. • Do not recognize any informal knowledge/ innovations of traditional communities for intellectual property rights. • Do not insulate Traditional Knowledge (TK) from intellectual piracy.

10. IPR & TK • IPR: The prime driving force behind industrial growth and development in the 19th & 20th centuries. • Do not recognize the informal system of innovation of indigenous people. • Do not provide mechanism for compensation or benefit sharing with indigenous people.

11. IPR & TK (Contd..) • IPR laws in general ignore the interest of traditional/local communities- • because their concept of intellectual property and resource rights are different from those of the advanced societies of developing countries and the developed North countries. • But there are ways in which these laws can serve the interests of these communities. • However, acquiring and defending IPR protection require access to information, good legal advice and financial resources-which are mostly beyond the reach of most of the indigenous people.

12. International Movements for Protection of TKS • First International Congress on Ethnobiology at Belem, 1987, came out with the ‘Declaration of Belem’. • The declaration recognized a basic obligation that procedures to be developed to compensate native people on their knowledge and on their biological resources. • Second International Congress on Ethnobiology at Kunming, China in 1990 resolved to establish a Global Action Plan, The “Kunming Action Plan” for • Specific and urgent action to stop the destruction of biological and cultural diversity as mandated in the ‘Declaration of Belem’. • Global Coalition for Biocultural Diversity to unite the indigenous people, scientists and environmentalists concerned with the protection of indigenous/ local people rights.

13. Relevant Provisions of CBD • Article 3 recognizes the sovereign rights of States over their biological resources. • Article 8(j) underlines the need to protect TK and points to the potential benefits to be realized from such knowledge through involvement of its holders and equitable benefit-sharing. • Article 15 states that when access to genetic resources is granted, it shall be on mutually agreed upon terms and subject to Prior Informed Consent. Incentives to biodiversity-rich countries to conserve and sustainably use their genetic resources, including joint research, access to & transfer of technology (Articles 15,16).

14. Relevant Provisions of CBD(Contd...) • Article 16.2 addresses issues surrounding the access to and transfer of technology, governed by patents. • Article 16.5 anticipates the difference in objectives between IPR regimes and the CBD and seeks to ensure that IPRs don't run counter to the CBD.

15. Relevant Provisions of TRIPs on Biological Resources • Under Article 27, virtually all inventions are to be patented if they are new, involve an innovative/inventive step and are capable of industrial application. • Exceptions to patentability include plants, animals ( other than microbes) and biological processes for the production of the above. However plant varieties must be protected either by sui generis or by patenting (27.3(b)).

16. TRIPS-CBD Relationship • Absence of explicit compatibility, Difference of approach and priority given to issues which are ultimately related. This has led to violation of the CBD (Articles 8,15 &16). • TRIPs ignores a vast range of valuable, traditional knowledge (TK) because it doesn't meet the standards of patentability.

17. TRIPS-CBD Relationship(Contd..) • TRIPs undermines CBD in cases of biopiracy, by putting the burden of proof on the source country rather than patentee. Identification of unique source material as required in Art.29 of TRIPs is insufficient. Lack of transparency in the patent application procedure. • TRIPs doesn't require the recognition of domestic laws protecting access to genetic resources and TK and subsequent benefit sharing.

18. IPR Issues / Benefit Sharing Strategies • Appropriate Procedures for IPR Protection/Benefit sharing • Documentation & Registration of TK – Medicinal plant use & Conservation at local , state and national level. • Contribution to TKDL & TKRC • Value addition to TK & Indigenous Medicinal Plants – Scaling up IPRs • Herbal drugs, Pharmaceuticals, Natural products & byproducts, Nutraceuticals, Functional foods, etc.

19. Strength of India in Biodiversity • Rich in all levels of biodiversity species, genes, habitat • Rich in cultural diversity that generated rich fund of indigenous knowledge systems • Humanity has tapped only a fraction of this nature’s vast genetic library • Over 70-80% genetic resources of India and other South Asian countries are hitherto untapped. • Excellent opportunity for hunting novel genes, drugs, pharmaceuticals, new chemicals/raw materials for new industrial ventures.

20. Bioprospecting and the new IPR regime Given the global trends in capturing the intellectual property markets, the Third World nations like India needs to look ahead for the best possible ways and means by which they can generate IPR and build up IPR covered bioindustrial regimes. Biotechnology (BT), Information Technology (IT) and Herbal Technology (HT) are the three fast emerging and powerful areas of R&D in current century. The rich biodiversity, associated knowledge systems and human resources etc. are the strength of Asia-pacific countries, and therefore have the best opportunity.

21. Bioprospecting • Gene Prospecting • Genetic engineering • Crop development • Fermentation • Cell culture • Chemical Prospecting • Drugs and pharmaceuticals • Pesticides • Cosmetics • Food additives • Other industrially valuable • Chemical products • Bionic Prospecting • Designs • Sensor technologies • Architecture • Bioengineering • Biomodeling

22. Bioprospecting: Linkages and leads Biodiversity & IK/TK Biotechnology Bioprospecting Information technology • Drug development • Pharmaceuticals • Agrochemistry • Cosmetics • Proteins • Enzymes • New crop varieties • GMOs • GM foods • Designs etc. Herbal technology Conservation Sustainable use Benefit sharing Bioinformatics IPR

23. Thank You