TITLE: Developing countries propose TRIPS amendment on disclosure AUTHOR: Tove Iren S. Gerhardsen PUBLICATION: Intellectual Property Watch (Geneva) DATE: 1 June 2006 URL: http://www.ip-watch.org/weblog/index.php?p=323 NOTE: The full text of the proposal is provided below. A formatted version can be downloaded at http://www.ip-watch.org/files/PROPUESTA%20ENMIENDA%20ART%20 29BIS.doc Intellectual Property Watch | 1 June 2006 DEVELOPING COUNTRIES PROPOSE TRIPS AMENDMENT ON DISCLOSURE by Tove Iren S. Gerhardsen 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 hina is expected to co-sponsor 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 maybe 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". 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 below. World Trade Organization WT/GC/W/564 TN/C/W/41 31 May 2006 (06-2605) General Council Trade Negotiations Committee Original: English DOHA WORK PROGRAMME - THE OUTSTANDING IMPLEMENTATION ISSUE ON THE RELATIONSHIP BETWEEN THE TRIPS AGREEMENT AND THE CONVENTION ON BIOLOGICAL DIVERSITY Communication from Brazil, India, Pakistan, Peru, Thailand and Tanzania The following communication, dated 29 May 2006, is being circulated at the request of the delegation of India also on behalf of the delegations of Brazil, Pakistan, Peru, Thailand and Tanzania. _______________ In the Doha Ministerial Declaration, Ministers agreed that negotiations on outstanding implementation issues shall be an integral part of the Work Programme they established. The relationship between the TRIPS Agreement and the Convention on Biological Diversity (CBD) is an outstanding implementation issue. In addition to the intensive technical work in the TRIPS Council since then, the Director General has undertaken dedicated consultations through his Friends, including more recently through Mr. Rufus Yerxa, Deputy Director General. There have been extensive discussions in these processes on the introduction into the TRIPS Agreement of a mandatory requirement for the disclosure of origin of biological resources and/or associated traditional knowledge used in inventions for which intellectual property rights are applied for. In the Hong Kong Ministerial Declaration, the Ministers requested the Director General to intensify the consultations and to report to each regular meeting of the TNC and the General Council. Further, the Ministers instructed that the General Council shall review progress and take any appropriate action no later than 31 July 2006. In order to enable the Members to take appropriate action by this date, a number of Members have proposed moving towards text-based negotiations on the disclosure of origin requirement. Accordingly, this communication presents a proposal for such a text, taking into account the objectives of the requirement as well as the questions, comments and concerns raised by various Members in the negotiations so far. The proposed text will assist the consultations being undertaken by the Director General. The said text is attached. _______________ ARTICLE 29BIS DISCLOSURE OF ORIGIN OF BIOLOGICAL RESOURCES AND/OR ASSOCIATED TRADITIONAL KNOWLEDGE 1. For the purposes of establishing a mutually supportive relationship between this Agreement and the Convention on Biological Diversity, in implementing their obligations, Members shall have regard to the objectives and principles of this Agreement and the objectives of the Convention on Biological Diversity. 2. Where the subject matter of a patent application concerns, is derived from or developed with biological resources and/or associated traditional knowledge, Members shall require applicants to disclose the country providing the resources and/or associated traditional knowledge, from whom in the providing country they were obtained, and, as known after reasonable inquiry, the country of origin. Members shall also require that applicants provide information including evidence of compliance with the applicable legal requirements in the providing country for prior informed consent for access and fair and equitable benefit-sharing arising from the commercial or other utilization of such resources and/or associated traditional knowledge. 3. Members shall require applicants or patentees to supplement and to correct the information including evidence provided under paragraph 2 of this Article in light of new information of which they become aware. 4. Members shall publish the information disclosed in accordance with paragraphs 2 and 3 of this Article jointly with the application or grant, whichever is made first. Where an applicant or patentee provides further information required under paragraph 3 after publication, the additional information shall also be published without undue delay. 5. Members shall put in place effective enforcement procedures so as to ensure compliance with the obligations set out in paragraphs 2 and 3 of this Article. In particular, 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 Agreement, or render unenforceable a patent when the applicant has, knowingly or with reasonable grounds to know, failed to comply with the obligations in paragraphs 2 and 3 of this Article or provided false or fraudulent information.