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meier _ewert_e.ppt
1. The Relationship between
TRIPS and the Convention on
Biological Diversity (CBD)
- State of play in the TRIPS Council -
WTO Symposium on Trade and Sustainable
Development – Geneva, 11 October 2005
Wolf MEIER-EWERT
Legal Affairs Officer
Intellectual Property Division
World Trade Organization
2. Doha Work Programme
Doha Ministerial Declaration: WT/MIN(01)/DEC/1
Para. 19: “We instruct the TRIPS Council, in pursuing
its work programme including under the review of
Article 27.3(b), the review of the implementation of the
TRIPS Agreement under Article 71.1 and the work
foreseen pursuant to paragraph 12 of this Declaration,
to examine, inter alia, the relationship between the
TRIPS Agreement and the Convention on Biological
Diversity, the protection of traditional knowledge and
folklore... ”
Para. 12: Outstanding implementation issues
3. The Relationship between TRIPS and the CBD (1)
Main issues under discussion
Compatibility between TRIPS & CBD
How to implement TRIPS and CBD in a
mutually supportive way so as to achieve
shared objectives on access and benefit-
sharing
The Secretariat’s summary note IP/C/W/368
(being revised)
4. Convention on Biological Diversity
Article 1. Objectives
“The objectives of this Convention … are the
conservation of biological diversity, the sustainable
use …and the fair and equitable sharing of the
benefits arising out of the utilization of genetic
resources, including by appropriate access to genetic
resources and by appropriate transfer of relevant
technologies, taking into account …”
Article 3. Principle
“States have, in accordance with the Charter of the
United Nations and the principles of international law,
the sovereign right to exploit their own resources …
5. The Relationship between TRIPS and the CBD (2)
Compatibility between TRIPS & CBD:
Inherent conflict
• TRIPS needs to be amended to remove such conflict.
No conflict
• The two agreements can be implemented in a mutually
supportive way through national measures.
No inherent conflict, but case for international
action
• Both can and should be implemented in a mutually
supportive way but action required at the international
level: three distinct proposals for a disclosure requirement
6. The Relationship between TRIPS and the CBD (3)
National solutions, including legislation on access and
benefit-sharing, and contracts
Claimed advantages of a contract-based system
• Ensuring the achievement of prior informed consent and
benefit sharing
• Providing flexibility in determining terms, including monetary
and non-monetary benefit sharing
• Effective enforcement of the contract through criminal
provisions and/or civil liability, choice of law and jurisdiction
Examples of national practice given
• US National Cancer Institute’s Departmental Therapeutics
Programme
• US National Park Services
7. The Relationship between TRIPS and the CBD (4)
Three distinct proposals for a disclosure requirement
Brazil, India and others
• TRIPS should be amended so that Members shall require patent applicants to
disclose:
• the source and country of origin of any biological resources or traditional knowledge
used in inventions
• Evidence of prior informed consent from the competent authority in the country of
origin
• Evidence of fair and equitable appropriate benefit-sharing arrangements or have
followed national law.
Switzerland
• the Patent Cooperation Treaty of WIPO (PCT) should be amended so as to
allow countries the option of asking patent applications to disclose the source
of genetic resources or traditional knowledge used in inventions.
EC
• Having a mandatory disclosure requirement on national, regional and
international patent applicants to disclose information on the country of origin
or source of genetic resources or traditional knowledge used in the invention.
8. The Relationship between TRIPS and the CBD (5)
Brazil, India Switzerland EC
Proposals to amend the TRIPS to
require disclosure (Article
27.3.(b) or Article 29 or
new article)
to amend the Patent
Co-operation Treaty
(PCT) of WIPO to
permit disclosure
Elements of
disclosure
the source and country of
origin of GR & related TK;
evidence of prior informed
consent;
evidence of fair & equitable
benefit sharing
source of GR and
associated TK
country of origin,
but if unknown,
source of GR/TK
associated with GR
Optional vs.
mandatory
International
vs. national
mandatory both at the
international and national
level
optional at the
international level but
can be mandatory at
national level
mandatory at
international,
regional and
national level
9. The Relationship between TRIPS and the CBD (6)
Brazil, India Switzerland EC
The trigger for the
disclosure
Any use, including
incidental use
GR: immediate use +
physical access
TK: direct basis for
invention
GR: direct basis
Source: physical
access + awareness
TK: direct basis &
awareness
Nature of
requirement
Substantive Formal Formal
Legal effects of
non-compliance
Delay in
processing of
application;
revocation of the
patent; criminal/
administrative
sanctions; full or
partial transfer of
the rights
Delay in processing
application; any legal
effects of wrongful or
non disclosure allowed
for under the PCT & PLT,
including invalidation of
granted patents if the
wrongful or non
disclosure due to
fraudulent intention
Legal effects should
be outside the ambit
of patent law, (civil
and/or administrative
law)
Burden of proof Patent applicants Alleging party
10. The Relationship between TRIPS and the CBD (7)
Continuing Discussion in the TRIPS Council
• Merits of “contractual approach” vs. “disclosure approach”
Recent submissions
• Amendments to Articles 27.3 and 29 of TRIPS proposed
(Peru IP/C/W/447)
• Questions regarding the legal and technical implications of
the different proposals (Switzerland IP/C/W/446)
• Further discussion of the national approach (United States
IP/C/W/449)
Next TRIPS Council meeting on 25-26 October 2005
Consultations on the matter as an outstanding
implementation issue