Intellectual property questions in relation to genetic resources Information meeting on intellectual property and genetic resources Geneva, September 15, 2004

Overview Linking equitable benefit-sharing from genetic resources and the patent system Issues and processes in WIPO fora Some working materials Cooperation with the Convention on Biological Diversity (CBD) Some substantive questions

Overview Linking equitable benefit-sharing from genetic resources and the patent system Issues and processes in WIPO fora Some working materials Cooperation with the Convention on Biological Diversity (CBD) Some substantive questions

Access & equitable benefit-sharing: what links to the patent system? Access and benefit-sharing in line with objectives of CBD and FAO International Treaty –e.g. CBD objectives: (i) conservation of biological diversity (ii) sustainable use of its components (iii) fair and equitable sharing of the benefits arising out of the utilization of genetic resources Patent system - in particular treatment of inventions that arise out of the utilization of genetic resources (and associated TK)

Access & equitable benefit-sharing: what links to the patent system? Two essential scenarios put forward: –Direct patenting of source material a patent (or application) directly claims as an invention genetic resources (or associated traditional knowledge) obtained from a separate source –Patenting inventions derived from source material a patent (or application) claims an invention that is somehow derived from or somehow uses genetic resources or TK - this link expressed in several ways Has the GR/TK been legitimately accessed? Is the patent consistent with equitable benefit- sharing?

Access & equitable benefit-sharing: what links to the patent system? Opens up some fundamental questions: Legal: what obligations arise (or should arise) from the circumstances of access and the nature of use of genetic resources (and associated TK)? How does (or should) this affect: –the entitlement to apply for and be granted a patent (should the applicant receive a patent?) –the patentability of the invention as such (does the invention –other interests and entitlements (e.g. equitable or ownership interests, expectation to benefit) –other obligations (e.g. obligation to report on patenting activity, obligation to disclose)

Access & equitable benefit-sharing: what links to the patent system? Disclosure requirements: –various existing mechanisms, national/regional legislative initiatives, and international proposals –create or confirm a legal linkage between GR or TK used and the claimed invention –beyond disclosure per se (provision of information), have variously been linked to: patentability of invention as such entitlement to apply or be granted a patent capacity to enforce a patent

Access & equitable benefit-sharing: what links to the patent system? Supplementing basic legal issues, some practical questions: E.g. what kinds of practical arrangements would: –reduce the likelihood of illegitimate patents being granted that claim GR/TK directly, or non-inventive derivatives of GR/TK continuing work on various defensive protection and enhanced search and examination measures –facilitate equitable sharing of benefits from legitimate patenting of derivative inventions (what kinds of agreements and partnerships promote monetary and non-monetary benefit sharing - Bonn Guidelines) information and capacity building work (database of benefit sharing agreements, practical guide to supplement general ABS capacity- building projects) UNEP-WIPO study on IP aspects of access and benefit-sharing

Overview Linking equitable benefit-sharing from genetic resources and the patent system Issues and processes in WIPO fora Some working materials Cooperation with the Convention on Biological Diversity (CBD) Some substantive questions

WIPO fora and GR/patent issues Intergovernmental Committee on IP and Genetic Resources, TK & Folklore –considers legal issues (technical study) –oversees capacity-building initiatives Standing Committee on Patent Law – proposed text for Article 2 of draft Substantive Patent Law Treaty –reference to issue of disclosure at last meeting Working Group on PCT Reform –Swiss proposal for amendment of PCT Regulations to allow for disclosure mechanisms

Overview Linking equitable benefit-sharing from genetic resources and the patent system Issues and processes in WIPO fora Some working materials Cooperation with the Convention on Biological Diversity (CBD) Some substantive questions

Technical study on disclosure mechanisms Prepared initially under the supervision of the IGC, responding to invitation from Sixth CBD Conference of Parties –based on questionnaire responses from WIPO Member States –successive drafts considered by IGC –transmitted to CBD COP VII by the WIPO General Assembly –triggers request for follow-up work from CBD COP, and proposed further feedback from CBD to WIPO

Technical study...to contribute to international discussion and analysis of this general issue, and to help clarify some of the legal and policy matters it raises......technical input to facilitate policy discussion and analysis in the CBD and in other fora, and it should not be considered a formal paper expressing a policy position on the part of WIPO, its Secretariat or its Member States......explored issues relevant to the interaction between the patent system and GR/TK used in an invention... not sought to resolve these issues but rather to illustrate and elucidate them. … may wish to consider future work in this area … including additional exchange of national experience, and the elaboration of case studies and the analysis of some of the specific disclosure scenarios described and discussed in the draft study…

Technical study...to contribute to international discussion and analysis of this general issue, and to help clarify some of the legal and policy matters it raises......technical input to facilitate policy discussion and analysis in the CBD and in other fora, and it should not be considered a formal paper expressing a policy position on the part of WIPO, its Secretariat or its Member States......explored issues relevant to the interaction between the patent system and GR/TK used in an invention... not sought to resolve these issues but rather to illustrate and elucidate them. … may wish to consider future work in this area … including additional exchange of national experience, and the elaboration of case studies and the analysis of some of the specific disclosure scenarios described and discussed in the draft study…

Technical study...to contribute to international discussion and analysis of this general issue, and to help clarify some of the legal and policy matters it raises......technical input to facilitate policy discussion and analysis in the CBD and in other fora, and it should not be considered a formal paper expressing a policy position on the part of WIPO, its Secretariat or its Member States......explored issues relevant to the interaction between the patent system and GR/TK used in an invention... not sought to resolve these issues but rather to illustrate and elucidate them. … may wish to consider future work in this area … including additional exchange of national experience, and the elaboration of case studies and the analysis of some of the specific disclosure scenarios described and discussed in the draft study…

Analyses options under five aspects (Section VI): relationship between the claimed invention and the GR/TK; or what would be a sufficient link between the two to trigger a disclosure requirement legal principle forming basis of requirement nature of the obligation placed on the applicant consequences of failure to comply with the requirement how the requirement would be implemented, verified or monitored Sets out specific methods for disclosure (Section VIII)

Possible disclosure scenarios ( ): TK as relevant prior art TK holder as inventor Disclosure of origin of genetic resources (enablement and best mode) Disclosure of the actual genetic resources Evidence of entitlement to apply Registration of equitable/ownership interests Disclosure of information in compliance with other legal obligations (e.g. access regimes) Specific GR/TK disclosure mechanisms –various specific mechanisms, various legal bases for requirements

UNEP-WIPO study on ABS and IP Pre-launch version submitted to Ministerial Conference, CBD COP VII Joint UNEP-WIPO launch imminent –(inspection copies available today) Professor AK Gupta (Honey Bee Network) –explores three case studies of the role of patents in access and benefit sharing –independent analysis of the practical and legal issues that arise, limitations of current approaches

Overview Linking equitable benefit-sharing from genetic resources and the patent system Issues and processes in WIPO fora Some working materials Cooperation with the Convention on Biological Diversity (CBD) Some substantive questions

CBD invitation to WIPO Convention on Biological Diversity (CBD) Conference of Parties (COP) VI: Decision VII/19 - interrelation of access to genetic resources and disclosure requirements in IP rights applications

Invitation to WIPO to... examine, and where appropriate address, taking into account the need to ensure that this work is supportive of and does not run counter to the objectives of the [CBD], issues regarding the interrelation of access to genetic resources and disclosure requirements in IP rights applications, including, inter alia:

Invitation to WIPO to... examine, and where appropriate address, taking into account the need to ensure that this work is supportive of and does not run counter to the objectives of the [CBD], issues regarding the interrelation of access to genetic resources and disclosure requirements in IP rights applications, including, inter alia: –Options for model provisions on proposed disclosure requirements; –Practical options for IP rights application procedures with regard to the triggers of disclosure requirements; –Options for incentive measures for applicants; –Identification of the implications for functioning of disclosure requirements in various WIPO-administered treaties; –IP-related issues raised by proposed international certificate of origin/source/legal provenance;

possible reporting procedure … and regularly provide reports to the CBD on its work, in particular on actions or steps proposed to address the above issues, in order for the CBD to provide additional information to WIPO for its consideration in the spirit of mutual supportiveness …

Possible future work proposed to IGC …in the light of developments … to consider possible future work for the Committee on this issue, including the proposals in para 12(ii) of WIPO/GRTKF/IC/5/10: including the continued exchange of national experience and case studies, and the development of guidelines and recommendations concerning the interaction between access to genetic resources and patent disclosure.

Overview Linking equitable benefit-sharing from genetic resources and the patent system Issues and processes in WIPO fora Some working materials Cooperation with the Convention on Biological Diversity (CBD) Some substantive questions

Legal and policy issues concerning: –eligibility of inventions per se for protection –eligibility of applicants to gain patents –ownership, inventorship and equitable interests –capacity to exploit and benefit from patents –interplay between obligations incurred in one jurisdiction arising from access to genetic resources, and the operation of the patent system in another jurisdiction Incentives to use patent system to promote ABS Sanctions for failure to comply with ABS regulations

The various avenues proposed CBD invitation –model provisions –practical options for triggers of disclosure requirements –options for incentive measures for applicants; –implications for various WIPO-administered treaties; –IP-related issues from proposed international certificate PCT system: Swiss proposal to enable disclosure requirements Standing Committee on Patent Law: reference to genetic resources in draft, disclosure issue raised Intergovernmental Committee: proposed guidelines and recommendations, policy and legal development