Bridges Trade BioRes • Volume 4 • Number 17 • 23rd September 2004

TRIPS COUNCIL ZOOMS IN ON DISCLOSURE REQUIREMENTS

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TRIPS COUNCIL ZOOMS IN ON DISCLOSURE REQUIREMENTS

Meeting on 21 September, the Council for Trade-related Aspects of Intellectual Property Rights (TRIPS) considered a proposal by Brazil, India, Pakistan, Peru, Thailand, and Venezuela to advance discussions on the relationship between the TRIPS Agreement and biodiversity issues and traditional knowledge. Members remained locked in their positions, so no substantive progress was made and the meeting closed after one day rather than the scheduled two.

The meeting was the first TRIPS Council held after the WTO agreed on a "July package" to move the Doha Round forward. The TRIPS Agreement was only briefly mentioned in the July package — with Members reaffirming their commitment to progress in line with the Doha mandate — with the focus of the package on other areas of the Doha Round, such as agriculture. Discussions at the TRIPS Council therefore continued where they had left off at the previous session of the Council in June (see BRIDGES Trade BioRes, 25 June 2004).

The new proposal (IP/C/W/429), endorsed also by Cuba and Ecuador, followed on a broader proposal made by a number of developing countries in March 2004 (IP/C/W/420), which suggested a checklist of issues to be covered in the negotiations on biodiversity, traditional knowledge and folklore. Members continue to disagree on whether to use this checklist as a basis for discussion. The US and Japan again voiced their opposition to using the checklist, which they felt did not reflect their views. In the new proposal, the group of developing countries elaborates on possible disclosure requirements in patent applications relating to the source and country of origin of a biological resource and/or traditional knowledge used in an invention.

The proposal first considers ways that disclosure requirements could improve patent examination and prevent "bad" patents. In this regard, it provides examples of "bio-piracy" in which, for example, traditionally used herbal remedies have been patented by multinationals, with no revenues flowing back to the communities where the genetic material was sourced. The countries note that processes for improving patent examination have been proposed, but they either lack cultural sensitivity or are voluntary and provide no guarantees. Therefore, the proposal suggests "a legally binding obligation to disclose the source and country of origin of biological resource and/or traditional knowledge". In addition, disclosure requirements would be helpful in cases of patent challenges, which usually are long and costly processes, and would help ensure patent quality.

The proposal then goes on to discuss the meaning of disclosure, dealing with questions such as whether the obligation would be a substantive or formal requirement relating to patentability; what level of use of the resource in the invention would be sufficient to trigger the obligation; and what the administrative and cost burdens would be. According to the paper, the obligation would be both substantive and formal. Even incidental use would trigger the disclosure obligation. The proposal indicates that costs would not be substantial in relation to the patent application process as a whole, as some Members already have a disclosure requirement in place.

The proposal also discusses the legal implications of non-compliance and wrongful disclosure, noting that the application process could be suspended or penalties imposed. If non-compliance was discovered after a patent had been granted, the patent could be revoked or the rights could be transferred back to t he original sources. The burden of proof would lie with the patent applicant, and, according to the proposal, the disclosure obligation could be introduced into the TRIPS Agreement through an amendment.

The next TRIPS Council is scheduled for 1- 2 December.

ICTSD reporting.