The International Treatment of Biocultural Property

1. The International Treatment of Biocultural Property William Fisher June 21, 2004

2. Ways in which Plant-Derived Drugs are Developed (1) Random Screening (2) Investigations by ethnobotanists, followed by purification and testing

3. Ways in which Plant-Derived Drugs are Developed (1) Random Screening (2) Investigations by ethnobotanists, followed by purification and testing Disagreement concerning the relative efficacy of these two approaches --ICBG-Peru Project estimates (2) is 4 times more efficient

4. Examples of Plants developed in the second fashion • Quinine in Peru • Turmeric and Neem in India • Rosy Periwinkle in Madagascar • Plao-Noi and Pueraria in Thailand • African Soapberry in Ethiopia • Stevia rebaudiana Bertoni in Paraguay

5. Neem tree

6. Neem tree • Traditional Uses in India • cleaning teeth • curing psoriasis • control parasitic infections • spermicide • insecticide • W.R. Grace isolates and stabilizes azadirachtin • 1992: U.S. patent on stabilized solution • 1994: U.S. EPA approves “Neemix” as insecticide

7. Rosy Periwinkle Etching by Anne Stromquist -- http://artangel.com/Stromquist/flower.html

8. Rosy Periwinkle • Species probably originates in the West Indies, spreads to many tropical countries, including Madagascar • Traditional Uses: • treatment of diabetes (reported in Jamaica and Philippines) • treatment of sore throat, pleurisy, dysentery

9. Rosy Periwinkle • Eli Lilly tests samples from Madagascar • ineffective for diabetes • effective for childhood leukemia • Eli Lilly secures patents on two derivatives -- vincristine and vinblastine • increase remission rate from 20% to 80% • annual revenue exceeds $200,000,000

10. Pueraria

11. Pueraria • Located in Thailand • Traditional Thai use: • estrogen booster • enlarges women’s breasts • Two Japanese pharmaceutical companies seeking patents on purified forms of its active ingredient

12. Examples of Plants developed in the second fashion • Quinine in Peru • Turmeric and Neem in India • Rosy Periwinkle in Madagascar • Plao-Noi and Pueraria in Thailand • African Soapberry in Ethiopia • Stevia rebaudiana Bertoni in Paraguay

13. Examples of Plants developed in the second fashion • Quinine in Peru • Turmeric and Neem in India • Rosy Periwinkle in Madagascar • Plao-Noi and Pueraria in Thailand • African Soapberry in Ethiopia • Stevia rebaudiana Bertoni in Paraguay

14. Potential Claimants in Case 1 • Individual owners of the plants or animals from which the genetic material is taken • The nation from which the genetic material is taken • The individual or company that purifies or modifies the genetic material for therapeutic uses • The public

15. Potential Claimants in Case 2 • Individual owners of the plants or animals from which the genetic material is taken • The nation from which the genetic material is taken • The individual or company that purifies or modifies the genetic material for therapeutic uses • The public • The developers of biocultural knowledge

16. Rosy Periwinkle Potential Claimants

17. Rosy Periwinkle Potential Claimants Madagascar

18. Rosy Periwinkle Potential Claimants West Indies

19. Rosy Periwinkle Potential Claimants Jamaica Philippines

20. Rosy Periwinkle Potential Claimants Eli Lilly Indianapolis

21. Rosy Periwinkle Potential Claimants Eli Lilly Indianapolis West Indies Jamaica Philippines Madagascar

22. Related Problem • Agricultural Companies derive superior strains of crops from varieties cultivated by traditional communities, then market them world-wide

23. Current Patent Law • Purified forms of the drugs are patentable • The plants themselves and knowledge of how to use them are not • “products of nature” doctrine • nonobviousness • novelty

24. Potential Claimants in Case 2 • Individual owners of the plants or animals from which the genetic material is taken • The nation from which the genetic material is taken • The individual or company that purifies or modifies the genetic material for therapeutic uses • The public • The developers of biocultural knowledge

25. Rosy Periwinkle Potential Claimants Eli Lilly Indianapolis West Indies Jamaica Philippines Madagascar

26. Possible Grounds for Allocating Entitlements • Possession • Labor-desert theory • Utilitarianism • Environmentalism • Imperialism • Respect • Nationalism

27. Possible Grounds for Allocating Entitlements Cf. Allocating rights to oil; Salmond on Adverse Possession • Possession • Labor-desert theory • Utilitarianism • Environmentalism • Imperialism • Respect • Nationalism

28. Possible Grounds for Allocating Entitlements • Possession • Labor-desert theory • Utilitarianism • Environmentalism • Imperialism • Respect • Nationalism Divide rewards “equitably” between: (a) developers of the biocultural knowledge; (b) drug companies

29. Possible Grounds for Allocating Entitlements • Possession • Labor-desert theory • Utilitarianism • Environmentalism • Imperialism • Respect • Nationalism Provide incentives for: --preservation of the knowledge; --willingness to disclose --collecting the knowledge --developing the drugs Offset by: --social losses associated with monopoly pricing

30. Possible Grounds for Allocating Entitlements • Possession • Labor-desert theory • Utilitarianism • Environmentalism • Imperialism • Respect • Nationalism (a) Preserve rainforests; (b) Reduce pesticide use; (c) Preserve biodiversity

31. Possible Grounds for Allocating Entitlements • Possession • Labor-desert theory • Utilitarianism • Environmentalism • Imperialism • Respect • Nationalism President Mwinyi: “Most of us in developing countries find it difficult to accept the notion that biodiversity should [flow freely to industrial countries] while the flow of biological products from the industrial countries is patented, expensive and considered the private property of the firms that produce them. This asymmetry reflects the inequality of opportunity and is unjust.”

32. Possible Grounds for Allocating Entitlements • Possession • Labor-desert theory • Utilitarianism • Environmentalism • Imperialism • Respect • Nationalism Much biocultural knowledge is sacred; cf. “Moral Rights”

33. Possible Grounds for Allocating Entitlements • Possession • Labor-desert theory • Utilitarianism • Environmentalism • Imperialism • Respect • Nationalism The government of each nation has a right and duty to protect its own citizens

34. What do the providers of Knowledge/Genetic Material Want? • Credit • Co-inventor status • Other forms of acknowledgment • Payment • Up-front fees for access • Payments in stages as drugs are developed • Share of profits if drug is successful • Indemnification for the costs of preserving biodiversity • Participation • Training of local scientists in ICBG projects

35. Possible Reforms • LDCs deny patent protection to drugs and plants developed from local materials (novelty; naturally occurring substance) • LDCs recognize prior user rights • LDCs amend patent law to make plants or traditionally medicinal uses thereof patentable locally • DCs constrict rights associated with drug patents • DCs treat holders of biocultural knowledge as coinventors • Physical Exclusion of Bioprospectors • National Natural Resources Laws • Deals between individual countries and pharmaceutical firms (e.g., Costa Rica; ICBG Projects) • Cartel of Tropical Gene-Rich Countries • TRIPS reform: violation of natural-resources laws = affirmative defense (cf. inequitable conduct; patent misuse) or basis of a compulsory license

36. Possible constrictions of the rights associated with drug patents • Expanded definitions of prior art (e.g., elimination of publication requirement for inventions in use in other countries) • Narrowing of the “purified substance” doctrine • Elimination of extended term (Hatch-Waxman)

37. Possible Reforms • LDCs deny patent protection to drugs and plants developed from local materials (novelty; naturally occurring substance) • LDCs recognize prior user rights • LDCs amend patent law to make plants or traditionally medicinal uses thereof patentable locally • DCs constrict rights associated with drug patents • DCs treat holders of biocultural knowledge as coinventors • Physical Exclusion of Bioprospectors • National Natural Resources Laws • Deals between individual countries and pharmaceutical firms (e.g., Costa Rica; ICBG Projects) • Cartel of Tropical Gene-Rich Countries • TRIPS reform: violation of natural-resources laws = affirmative defense (cf. inequitable conduct; patent misuse) or basis of a compulsory license

38. Possible Reforms LDC • LDCs deny patent protection to drugs and plants developed from local materials (novelty; naturally occurring substance) • LDCs recognize prior user rights • LDCs amend patent law to make plants or traditionally medicinal uses thereof patentable locally • DCs constrict rights associated with drug patents • DCs treat holders of biocultural knowledge as coinventors • Physical Exclusion of Bioprospectors • National Natural Resources Laws • Deals between individual countries and pharmaceutical firms (e.g., Costa Rica; ICBG Projects) • Cartel of Tropical Gene-Rich Countries • TRIPS reform: violation of natural-resources laws = affirmative defense (cf. inequitable conduct; patent misuse) or basis of a compulsory license DC LDC Int’l

40. A Global Patent System? • Unitary, global patents issued by branch offices of GPO • Subject matter: • TRIPS standards • [Living things; genes; software?] • First to file + provisional applications + prior-user rights • 1-year grace period for statutory bars • English • Infringement • [Peripheral or central claiming?] • [Equivalents doctrine?] • World Patent Court; judgments enforced by national courts