Volume 5 Number 5 Date: 18 March 2005

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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