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TRIPS COUNCIL
FOCUSES ON BENEFIT-SHARING FOR GENETIC RESOURCES
During the 8-9
March meeting of the WTO Council for Trade-related Aspects of Intellectual
Property Rights (TRIPS) in Geneva, Brazil on behalf of Bolivia,
Cuba, Ecuador, India, Pakistan, Peru, Thailand and Venezuela tabled
the third proposal in a series of three on the relationship between
the TRIPS Agreement and the Convention on Biological Diversity (CBD).
The latest submission focuses on the need to provide evidence of
benefit-sharing in patent applications, complementing previous proposals
on disclosure requirements and prior informed consent.
Finalising
the checklist
The new submission
is based on a broader proposal made by the Brazil- and India-led
group in March 2004 setting out a checklist of issues to be considered
in the discussion (see Bridges
Trade BioRes, 19 March 2005). It addresses the third and final
issue of the checklist, i.e. requirements for patent applicants
to provide evidence of fair and equitable sharing of benefits arising
from the use of genetic resources. Previous submissions to the TRIPS
Council in September (see BRIDGES
TradeBioRes, 22 September 2004) and December 2004 (see BRIDGES
Weekly, 8 December 2004) had addressed the first two issues
of the checklist, i.e. elements of the obligation in patent applications
to (1) disclose the source and country of origin of biological resources
and/or traditional knowledge used in an invention and (2) provide
evidence of prior informed consent under the relevant national regime.
The new proposal
(IP/C/W/442) outlines a number of criteria for the determination
of evidence for sharing the benefit arising from the use of genetic
resources. Regarding the legal effects of non-compliance by a patent
applicant with the obligation to provide such evidence, the submission
distinguishes between the pre- and the post-grant phase. Failure
to provide evidence before the grant of the patent should result
in a discontinuation of the application procedure, combined with
penalties, time limits and eventually the withdrawal of the application.
Failure to provide evidence after the grant of the patent could
result in the revocation of the patent or/and criminal and administrative
sanctions, including punitive damages. In line with their previous
proposals on first two issues of the checklist, the proponents of
this submission favour an amendment of the TRIPS Agreement that
would mandate the requirements for disclosure of origin, and evidence
of prior informed consent and benefit-sharing.
Positions
remain largely unchanged
Discussion and
comments on the submission echoed those in previous meetings on
the first two issues of the checklist. Developing country Members
stressed the importance of an international mandatory system reflected
in the TRIPS Agreement to address cross-border misappropriations
of genetic resources. They noted that the current patent system
was inappropriate to prevent misappropriation, and pointed to the
high costs involved in examining whether patent applications in
third countries involved domestic genetic resources. Brazil also
recalled that the CBD contains a provision requiring that intellectual
property rights should be supportive and not run counter to the
CBD objectives of preservation of, access to and benefit-sharing
for the use of genetic resources.
For their part,
several developed country Members reiterated their view that the
TRIPS Agreement and the CBD were not in conflict with each other
and that any amendment of the Agreement was unnecessary. The US,
supported by Japan, again stressed its preference for national and
contract-based solutions outside the realm of patent law, and expressed
concern about possible legal uncertainty of the proposed solution,
which might impact on the role of patents to promote innovation.
Australia, while indicating its flexibility, expressed concern about
additional costs of the proposed multilateral solution and noted
that the patent system was not the primary solution for the prevention
of misappropriation of genetic resources.
Also at the
meeting, Peru presented an additional proposal on its experience
of its National Comission on Biopiracy (IP/C/W/441) while India
and Brazil submitted a paper (IP/C/W/443), reacting to a US submission
on the relationship between the TRIPS Agreement and the CBD put
forward at the December meeting.
The next meeting
of the TRIPS Council is scheduled for 14-15 June.
WTO submissions
are available here.
ICTSD reporting.
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