Developing Countries Propose TRIPS Amendment On Disclosure

A group of six developing countries led by India have submitted a proposal to the World Trade Organization (WTO) suggesting changes to international trade law to include specific requirements for disclosure of where biological material has been obtained from in patent applications.

If adopted, this could mean that anyone applying for a patent based on genetic resources or traditional knowledge would have to disclose what country or region they got the material from. It would also require that the patentee show that the owners of the material agreed to let them use it and that there will be appropriate sharing between the two parties of potential commercial or other benefits arising from the process.

One example could be if a company from a developed country makes a medicine or cosmetic item based on genetic resources found in a developing country.

The proposal comes in advance of the next meeting of the Council on the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to be held on 12-15 June.

It also comes as a broader 31 July deadline at the WTO is drawing nearer, by when the “General Council shall review progress and take any appropriate action,” according to the Hong Kong Ministerial Declaration from December 2005. In the meantime, the WTO director general was instructed to “intensify” discussions and report continuously to the General Council and the Trade Negotiations Committee.

The proposed amendment was submitted to the WTO on 29 May and was at that time supported by Brazil, India (coordinator), Pakistan, Peru, Thailand and Tanzania. On 6 June they will present the paper for interested member states.

The paper suggests adding a new Article 29bis to the TRIPS agreement. The title of the proposed text is, “Disclosure of Origin of Biological Resources and/or Associated Traditional Knowledge.”

TRIPS Article 29 covers disclosure requirements of inventions for patent applicants.

The first paragraph of the proposed amendment refers to the need for having a “mutually supportive relationship” between the TRIPS agreement and the UN Convention on Biological Diversity (CBD) and their respective objectives and principles.

The proposal states that whenever the subject matter of a patent application “concerns, is derived from or developed with biological resources and/or associated traditional knowledge,” member countries “shall require” the applicants to disclose not only the country from where the applicant obtained the material, but also by whom in that country the material was provided, and, “as known after reasonable inquiry, the country of origin,” the paper says.

Under the change, member countries would also require the applicant to provide evidence of compliance with “the applicable legal requirements in the providing country” regarding prior informed consent for access of the provider of the material as well as fair sharing of potential benefits arising from “the commercial or other utilization of such resources,” the paper states.

The paper also says that member states shall require the applicants or patentees to “supplement and to correct the information” if they become aware of new information. If this happens after the patent has been granted, the new information should be published “without undue delay,” the paper states.

All required information shall be disclosed “jointly with the application or grant, whichever is made first,” it states.

And finally, members will be obliged to install effective enforcement mechanisms to make sure the requirements are complied with. The paper states:

“Members shall ensure that administrative and/or judicial authorities have the authority to prevent the further processing of an application or the grant of a patent and to revoke, subject to the provisions of Article 32 of this [TRIPS] Agreement, or render unenforceable a patent when the applicant has, knowingly or with reasonable grounds to know, failed to comply with the obligations … or provided false or fraudulent information.”

Ten Years Later

An Indian official said that other countries may support the proposal once their capitals clear it. Potential sponsors could include the entire South as this is particularly an important issue for developing countries, the official said. Another official indicated that China is expected to cosponsor the draft amendment.

“We think that an amendment is necessary,” a Peruvian official told Intellectual Property Watch.

A Thai official said that it was “sad” that developing countries had to negotiate the inclusion of genetic resources and traditional knowledge into the TRIPS agreement 10 years after it was negotiated. He added that Article 29bis is necessary because of problems with “biopiracy” which developing countries charge is misappropriation of their genetic resources and traditional knowledge.

The Thai official said that personally he believes it would be “a long way” to negotiate the text and he said it was unfortunate that this had not been done during the Uruguay Round of trade negotiations (which ended in 1994) as the countries could perhaps have had some “quid pro quo” in terms of negotiating power.

But he said there could still be some bargain chips for developing countries, referring to digital rights in the area of copyrights and broadcasting that are being discussed at the World Intellectual Property Organization (WIPO) that developed countries might like to see reflected in the TRIPS agreement.

Outstanding Implementation Issue

The relationship between the TRIPS agreement and the CBD is being discussed as an “outstanding implementation issue” under the Doha Round work programme, which was set up at the WTO ministerial in Doha, Qatar in 2001, and outlines the current round of trade talks intended to be completed by the end of 2006.

On 5 May the sponsors of the paper said that it would be ready “in days and not weeks” (IPW, WTO/TRIPS, 5 May 2006). But an Indian official said that the paper had been delayed because they had tried to take into account “discussions, concerns and questions” expressed about their proposal in TRIPS Council consultations.

The proposal is available here: Article 29bis