1. Intellectual Property Rights in Living Matter Drew L. Kershen Earl Sneed Centennial Professor University of Oklahoma College of Law © 2006 Drew L. Kershen, all rights reserved

2. Legal Foundation -- Fundamentals U.S. Const. Art. I, Sec. 8: “The Congress shall have the Power [cl. 8] To promote the Progress of Science and useful Arts by securing for limited Times to Authors and Inventors the exclusive Right to the respective Writings and Discoveries.” Federal Copyrights, Trademarks, Patents, Plant Variety Certificates State Trade Secrets: e.g. parental lines for hybrids Geographical Designations: e.g. Hawaiian Kona coffee Patents on living organisms Canada, European Union, Japan, Australia UPOV (1961/1991) TRIPs Agreement of the World Trade Organization (WTO) There are no international patents -- WIPO

3. United States Plant Patent Act of 1930 Asexually reproduced plants – cuttings, grafting Single plant – one claim, clones Requirements Novelty Distinctiveness Non-Obviousness Description as complete as reasonably possible Biological deposit Subpart of General Patent Law – USPTO Horticultural industry– flowers, fruits Plant Variety Protection Act of 1970, amend. 1994 Sexually reproduced plants by pollination, seeds – the variety Requirements New Distinct Uniform Stable Seed Deposit Plant Variety Certificate – sub-patent IPR -- USDA Exemptions from infringement Public Interest Exemption Research Exemption Farmer’s Exemption

4. United States Patent Act of 1952 (1791) – the general utility patent law Scope: useful process, machine, manufacture, composition of matter Requirements New Useful Non-Obvious Description Written description (reduced to practice) Enablement Biological deposit Funk Brothers Seed Company v. Kalo Inoculant Company (1948) – invention v. discovery Diamond v. Chakrabarty (1980) – scope of patents – man-made, genetically engineered bacteria for breaking down crude oil J.E.M. Ag. Supply, Inv. v. Pioneer Hi-Bred Int’l, Inc. (2001) – inbred & hybrid seed corn, non-transgenic Scope of patent Relationship to other IPR laws Dual protection

5. Legal Issues: Infringement Protection of intellectual property (seed breeding) All crops, not just transgenic crops J.E.M. Ag Supply v. Pioneer Hi-Bred Plant variety certificates, Plant Patent Act (asexually reproduced), Utility Patents Trade Secrets (hybrids) – parental lines Saving seeds For own farm only for plant varieties (only PVPA) Bin run, not brown bag or seed exchange Contractual prohibition for patented plants For agronomic reasons not feasible for hybrids Self-pollinated crops: Soybeans, wheat, canola (rarely) Farmers quite capable on economic calculation about seed costs Infringement Litigation As of Jan 2005, 98 lawsuits Monsanto and farmers Monsanto has won 73 of 73 resolved lawsuits Numerous other settlements; in fact, most settle quickly

6. Legal Issues: Infringement of Patents All infringement cases, both conventional and transgenic, except two, farmers admitted that they saved patented seeds intentionally. Schmeiser v. Monsanto Canada, Inc. In 1997 Schmeiser sprayed canola with Round-up; purposefully harvested seed from surviving plants; purposefully segregated the harvested seed; purposefully used the harvested, segregated seed for the 1998 crop – approximately three acres Tests on 1998 seed sample from Humbolt Elevator divided into three portions and sent directly to Schmeiser, Monsanto, and an independent expert; Schmeiser subdivided his portion and sent half to the independent expert Results: S65%; M95-98%; IES 65%; IEH 95-98% The Canadian courts (trial, appellate, and Supreme Court) found factually that he purposefully saved and planted patented seed that he knew or should have know contained a patented gene for herbicide tolerance. Canadian judges concluded that Schmeiser’s explanations for 1997 presence were not plausible – legally irrelevant because 1998 claim

7. References: Infringement Adventitious presence should not create legal liability for infringement under patents. Patent law will protect the truly innocent infringer Trace levels of patented trait are commercially irrelevant at trace levels Seed developers have no incentive to pursue innocent infringer Company pledges to pursue only intentional infringers Kershen, Of Straying Crops and Patent Rights, 43 Washburn L. J. 575-610 (2004) Siebrasse, The Innocent Bystander Problem in the Patenting of Higher Life Forms, 49 McGill L. J. 349-392 (2004) Siebrasse, A Remedial Benefit-Based Approach to the Innocent User Problem in the Patenting of Higher Life Forms, 20 Can. Intell. Prop. Rev. 79-134 (2003)

8. University of Hawaii Taro Patents Three patents obtained in 2002 Plant patents, not utility patents Palauan and Hawaiian varieties as parental lines Conventional sexual breeding from which the single plant selected Single plant claimed from asexual reproduction by tissue culture and stem (huli) propagation No claim to taro as taro; no claim to taro by sexual reproduction – these are not legally possible Stem (huli) exchange would be prohibited by the law Common prohibition in the horticultural industry

9. Taro Patent Questions University of Hawaii owns the patents Can grant a license to whomever and under whatever conditions Prudential judgments How to distinguish from other “sacred” plants? Unique to Hawaiian culture First Amendment – establishment of religion questions

10. Taro Patent Questions How to deal with escalating demands? The charge of biopiracy Permission from Palau Women’s Council (oversight of lo’I kalo) and Palauan government in 1993; collection in 1994 No need for permission in the United States – plants within the United States are basically common heritage Convention on Biological Diversity – 1992/1993 Art. 15 Access to Genetic Resources prior informed consent on mutually agreed terms aim of sharing fairly and equitably the commercial utilization Art. 16 Access to and Transfer of Technology – clear recognition of intellectual property Palau is a member of CBD

11. Taro Patent Questions Charge of Biopiracy continued FAO & Consultative Group on International Agricultural Research (CGIAR) – 1994 Materials Transfer Agreement Intellectual Property Rights recognized and protected Plant Genetic Resources for Food & Agriculture Treaty (PGRFA) – 2002/2004 Art. 12 Facilitated access to plant genetic resources Purpose of treaty is to create multilateral system of exchange no IPRs “in the form received” but IPRs for plant genetic resources that have undergone innovation Art. 13 Benefit-sharing information, technology transfer, capacity building, sharing of monetary benefits of commercialization mandatory trigger comes from IPRs Palua is not a member of PGRFA Treaty Charge of Biopiracy rejected; praise for UH and its scientists

12. Taro Patent Questions What impact on the Samoan farmers? Samoan farmers requested help due to disease infestation (leaf blight and root rot) Agreement that only commercial Samoan farmers will pay any royalty Differentiation endorsed by PGRFA Art. 13.d(ii) Native Hawaiian group with patent could prevent Samoan farmers from growing the taro developed for them Palau and Hawaii gave lost nothing and gained knowledge and three excellent taro varieties

13. Thank you. I look forward to answering questions about IPRs in living matter or other questions about agricultural biotechnology law and policy