Implications of Decisions on Access & Benefit Sharing of Genetic Resources on the

1. Implications of Decisions on Access & Benefit Sharing of Genetic Resources on the International Intellectual Property System Presentation at Workshop on Governance of Marine Areas Beyond National Jurisdiction • 4 November 2008

2. IPR & ABS – Some perspectives Intellectual Property Rights • Creations of the human mind • Implies existing owner to such rights • Registration may or may not be required Access & Benefit sharing schemes viz GR • Generally deal with fair & equitable sharing of benefits arising from the commercial use of GR • Imposes conditions to the utilization of GR

3. IPR & ABS – Some perspectives IPR “relating to marine genetic resources beyond areas of national jurisdiction” (para 37, draft Joint Statement of Co-Chairs, 2nd Meeting of UN Ad-hoc Open-ended Informal Working Group) • Refers to IPR arising from accessing and using marine GR in the high seas Options for Access & Benefit sharing – preliminary qns • Who owns the marine GR in question ? • Who benefits from the marine GR ? • Criteria for ownership/being a beneficiary ? • What is the IPR that arises ? • How is the IPR to be protected ?

4. Existing experiences with ABS Overview of 3 fora • Convention on Biological Diversity : Ad hoc Working Group on Access & Benefit Sharing • Food & Agricultural Organization : International Treaty on Plant Genetic Resources for Good & Agriculture • World Trade Organization : Proposed amendment to Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS)

5. Existing experiences with ABS • Convention on Biological Diversity : Ad hoc Working Group on Access & Benefit Sharing Proposition : CBD provides that there should be no conflict between ABS for GR and protection of IPR arising from the utilization of GR • Food & Agricultural Organization : International Treaty on Plant Genetic Resources for Good & Agriculture Proposition : Donor’s existing IP rights preserved

6. WTO : Amendment to TRIPS Mischief alleged : Biopiracy → a person may claim patent rights in one country over genetic resources that are under the sovereignty of another country → note no agreed international definition → may cover wide spectrum of other situations

7. WTO : Amendment to TRIPS “Friends of Development” proposed solution : Amendment to Art 29 of TRIPS - patent applicants to disclose : • origin of GR used in their inventions • evidence that they received “prior informed consent” • evidence of “fair and equitable” benefit sharing • consequences for non-disclosure ♦ Co-sponsors ♦ Main opponents

8. WTO : Amendment to TRIPS Issues to consider • Definition of “biological resources” : covers “genetic resources” or more? • Scope/extent of disclosure (e.g. mandatory or optional, country of origin, etc) Content of disclosure? • Effect of non-compliance : consequences on patent applications/granted patents/ acquired IPR? • Sanctions for non-compliance : criminal or civil ? Within or outside patent system ?

9. WTO : Amendment to TRIPS Possible concerns viz impact on international patent system • Additional burden/costs on patent applicants, IP offices & patent system ? • Type of expertise in IP offices reqd to determine these questions? • Possible disputes over whether disclosure reqmt discharged ? What if >1 party claims ownership of GR ? → uncertainty for patent applicants (esp industries with R&D) ?

10. WTO : Amendment to TRIPS Possible concerns viz impact on international patent system • Consequences of non-compliance : may result in granted patents being revoked? Reasonable ? → uncertainty for existing patent holders ? • Overall effect : Innovation may be hindered ? Potential benefits from possible patents diminished ?

11. Conclusion 2 messages : • Access & benefit sharing : issue of ownership & beneficiaries must be resolved viz GR • Any international ABS arrangements should not adversely impact efficiency and integrity of the IP system

12. Thank You

13. CBD : Ad hoc Working Group on ABS • Art 15 of CBD : contracting parties to facilitate access to GR on mutually agreed terms & subject to prior informed consent; parties to share in “fair and equitable way” the benefits arising from commercialization of GR with provider of GR • Art 16(2) of CBD : transfer of technology – to be provided on terms that are consistent with “adequate and effective protection” of IPR Idea: there should be no conflict between ABS for GR and protection of IPR arising from the utilization of GR • Working Group examining draft outline text for international regime on ABS; continued activity in 2009 • Issues sketched out for such a regime in Decision IX/12 but no text-based discussion yet; issues viz IPR yet to be fleshed out

14. FAO : Intl Treaty on Plant GR for Food/Agriculture Objectives of ITPGRFA • Establishes a global system to provide farmers, plant breeders and scientists with access to plant genetic materials • Ensures that recipients share benefits derived from the use of these genetic materials with countries of origin • Ultimate aim to ensure food security

15. FAO : Intl Treaty on Plant GR for Food/Agriculture Key tenets of ITPGRFA Access : • Multilateral system of facilitated access to member states’ plant GR via standard form MTAs (Art 12.4) • Recipients cannot claim IP rights existing under the plant GR so accessed (Art 12.3(d)) • Access to plant GR protected by IPR must be consistent with other international agreements & national law (Art 12.3(f)) Idea: Donor’s existing IP rights preserved

16. FAO : Intl Treaty on Plant GR for Food/Agriculture Key tenets of ITPGRFA (cont’d) Benefit Sharing (Art 13) – comprehensive scheme covering : • Exchange of information • Access to/transfer of technology – provided on terms which recognize/are consistent with “adequate and effective protection of intellectual property rights” • Capacity building • Sharing of monetary benefits – recipients who commercialize GR subject to royalty mechanism in MTA; benefits paid to a common Trust Account