Trips Council: Key Developing Countries Seek To Move Debate Forward On Disclosure Issues
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. 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 Weekly, 23 June 2004). Members remained locked in their positions, so no substantive progress was made and the meeting closed after one day rather than the scheduled two.
Disagreement over technical details of TRIPS amendment
During the TRIPS Council meeting, Members engaged in a brief discussion on how to amend the TRIPS Agreement rules on compulsory licensing to allow the exportation of patented pharmaceuticals to countries without sufficient domestic manufacturing capacities, as agreed in Doha. At the previous meeting, Members had decided to postpone the deadline for making the amendment from 30 June 2004 to 31 March 2005. Delegations have not, however, been able to agree on the content and the legal form of the amendment. Concerning domestic implementation, Norway shared with the Council Members a document explaining the legislative changes that entered into force on 1 June 2004 in Norway (IP/C/W/427, available at http://docsonline.wto.org). The WHO distributed a paper on "Implementation of the WTO General Council Decision on Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health" (available at http://www.who.int/medicines/).
Proposal zooms in on disclosure requirements
The new proposal (IP/C/W/429), endorsed also by Cuba and Ecuador, expands on similar proposals submitted in the past (see below), looking in more detail at 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 the 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 proposal was supported by a number of developing countries, while the US and Japan opposed it.
The proposal discussed on 21 September 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 cover in the negotiations on biodiversity, traditional knowledge and folklore. Under this approach -- which is not supported by the US and Japan -- discussions should proceed with a focus on three clusters covering: disclosure of origin; evidence of prior informed consent; and benefit-sharing. The US and Japan feel that their views have been omitted from the checklist, and Members continued to disagree at the latest meeting on whether the checklist should be used.
Under the Doha mandate, the TRIPS Council, in its review of Article 27.3 (b) of the TRIPS Agreement (patentability of life forms), is instructed to consider the relationship between the TRIPS Agreement and the Convention on Biological Diversity, the protection of traditional knowledge and folklore.
The next TRIPS Council is scheduled for 1- 2 December.