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

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Intellectual property questions in relation to
genetic resources Information meeting
onintellectual property and genetic
resourcesGeneva, September 15, 2004
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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

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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

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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)

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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?

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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)

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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 betweenGR 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

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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

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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

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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

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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

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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

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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

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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

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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

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• 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)

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• Possible disclosure scenarios (191-199)
• 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

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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

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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

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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

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• 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

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• 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

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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

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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.

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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

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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

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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
  

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