Developing countries propose new TRIPS clause to avoid bio-piracy

A long-standing fight by several developing countries to amend the WTO's TRIPS Agreement to oblige members to get patent applicants to disclose the source of origin of biological resources and associated traditional knowledge took a step forward this week when six countries proposed the text of new provisions to be added to the TRIPS Agreement.

Brazil, India, Pakistan, Peru, Thailand and Tanzania submitted a formal paper to the WTO containing language of the proposed amendment to the TRIPS Agreement. The text makes it mandatory for WTO members to require applicants for patents involving biological resources and/or associated traditional knowledge to:

-- Disclose the country providing the resources and/or associated traditional knowledge, from whom in the providing country they were obtained and the country of origin;

-- Provide information and evidence of compliance with the law in the providing country for prior informed consent for access and fair and equitable benefit-sharing from the use of the resources and/or traditional knowledge;

-- Supplement and correct the information including evidence in light of new information.

The WTO Members are also required to publish the information disclosed together with the patent application or grant, as well as to establish enforcement procedures to ensure compliance with the obligations.

The paper takes forward in a text for amending the TRIPS agreement what several developing countries had for several years been arguing for in various fora within the WTO (including the TRIPS Council and in the process on implementation issues) as well as outside the WTO (for example, in the Convention on Biological Diversity and the World Intellectual Property Organisation).

The WTO's Hong Kong Ministerial conference last December also mandates that the General Council will review progress and take action on this issue by 31 July.

The aim of this effort is to avoid the misappropriation of biological resources and traditional knowledge related to these through their being patented by persons or companies that should not have the right to do so.

The developing countries have been fighting that patent applications be compulsorily accompanied by disclosure of the countries of origin and evidence of prior informed consent and benefit-sharing arrangements.

The group submitted its Communication to the WTO General Council and to the Trade Negotiations Committee of the WTO in the context of the relationship between TRIPS and the Convention of Biological Diversity (CBD) as an outstanding implementation issue under the Doha Work Programme.

The Communication proposes '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'.

The Communication proposes the introduction of the text into the TRIPS Agreement through a new 'Article 29bis' titled 'Disclosure of Origin of Biological Resources and/or Associated Traditional Knowledge'.

The proposed text is expected to be discussed on Tuesday next week, during informal consultations on the issue held by the WTO's deputy director general Rufus Yerxa.

According to a delegate from a co-sponsoring country, several other countries have indicated their interest in co-sponsoring the Communication as well, and are awaiting confirmation from their capitals.

The introductory section of the Communication states that in the Doha Ministerial Declaration, Ministers agreed that negotiations on outstanding implementation issues shall be an integral part of the Work Programme they established, adding that the relationship between the TRIPS Agreement and the CBD is an outstanding implementation issue.

The paper says that 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.

It adds that 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.

It refers to the Hong Kong Ministerial Declaration, wherein the Ministers requested the Director General to intensify the consultations and to report to each regular meeting of the Trade Negotiations Committee and the General Council.

The paper recalled that the Ministers instructed the General Council to review progress and take any appropriate action no later than 31 July 2006. Thus it states that 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.

It says that the 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 of the amendment to the TRIPS Agreement -- by inserting a new Article 29bis (entitled Disclosure of Origin of Biological Resources and/or Associated Traditional Knowledge) -- is as follows:

'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 onBiological 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.'