Title: Intellectual property questions in relation to genetic resources Information meeting on intellectual property and genetic resources Geneva, September 15, 2004
1Intellectual property questions in relation to
genetic resources Information meeting
onintellectual property and genetic
resourcesGeneva, September 15, 2004
2Overview
- 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
3Overview
- 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
4Access 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)
5Access 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?
6Access 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)
7Access 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
8Access 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
9Overview
- 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
10WIPO 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
11Overview
- 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
12(No Transcript)
13Technical 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
14Technical 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
15Technical 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
16Technical 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
17- 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)
18- 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
19(No Transcript)
20UNEP-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
21Overview
- 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
22CBD 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
23- 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
24- 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
25possible 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
26Possible 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.
27Overview
- 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
28Some 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
29The 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
30(No Transcript)