H.E. Ambassador Dr Walter Werner

India

4; 5; 6 REVIEW OF THE PROVISIONS OF ARTICLE 27.3(B); RELATIONSHIP BETWEEN THE TRIPS AGREEMENT AND THE CONVENTION ON BIOLOGICAL DIVERSITY; PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE

50.   India is an ancient civilization with a rich body of traditional knowledge associated with biological resources. This traditional knowledge is both coded, as in the texts of Indian systems of medicine such as Ayurveda, Unani and Siddha; and non-coded, which exists in the oral undocumented traditions. India is also one of the seventeen identified mega bio-diverse countries of the world, home to a vast and a rich diversity of biological resources. 51.   TRIPS CBD linkage is important for India and other developing countries because it seeks to address bio-piracy. It has been a long-standing demand that patents should not be granted for existing traditional knowledge and associated genetic resources. This is all the more important for India, which has been a major victim of bio-piracy. 52.   Pursuant to the Convention on Biological Diversity (CBD), India has been active, in taking steps to implement its provisions leading to conservation of biodiversity, its sustainable use and equitable sharing of benefits. We enacted the Biological Diversity Act in 2002, notified the Biological Diversity Rules in 2004 and also established a three-tier institutional structure. 53.   India also developed a Traditional Knowledge Digital Library (TKDL) database to prevent misappropriation of traditional knowledge at international patent offices to tackle bio-piracy. India has signed TKDL Access Agreement with ten International Patent Offices. 54.   TKDL attempts to overcome language and format barriers by scientifically converting and structuring the available contents (Around 0.3 million medicinal formulations) of the ancient texts on Indian Systems of Medicines into five international languages, namely, English, Japanese, French, German and Spanish. The results obtained by India's Traditional Knowledge Digital Library (TKDL) in 206 cases where the patent applications were either withdrawn/cancelled/declared dead/terminated, or where the applicant had to amend the claims or when the examiners rejected the application on the basis of TKDL submissions brings out the interaction that traditional knowledge can have with the patent system. 55.   But, improving prior art searches through the TKDL was only one part of the solution. Further, TKDL represented only a subset of the universe of available traditional knowledge and the realm of traditional knowledge in areas other than herbal cures and genetic resources was not covered by it. 56.   While India is undertaking a number of measures at the national level in order to prevent misappropriation of genetic resources and / or associated traditional knowledge, the problem has an obvious international dimension and this requires an international solution, to be effective. 57.   Article 16.5 of the Convention on Biological Diversity clearly recognizes “that patents and other intellectual property rights may have an influence on the implementation of this Convention”. It mandates that the Parties “shall cooperate in this regard, subject to national legislation and international law, in order to ensure that such rights are supportive of and do not run counter to its objectives.” 58.   The Nagoya Protocol of the Convention on Biodiversity (CBD) entered into force on 12 October 2014 and 105 Countries, including India have ratified the Protocol, till now. The Doha Ministerial Declaration in paragraph 19 mandated that the TRIPS Council examine the relationship between TRIPS and CBD, and the protection of traditional knowledge and folklore. 59.   However, TRIPS Agreement continues to ignore numerous IPR-related obligations in the CBD which are of interest to the developing countries. The disclosure proposal (IP/C/W/474) which was submitted in 2006 was followed up by the submission TN/C/W/52 in June 2008 with the support of 109 Members. The latest submission on this issue TN/C/W/59 in April 2011, which is a draft decision to enhance mutual supportiveness between TRIPS Agreement and CBD" has been proposed by a vast majority of WTO Membership, including India. This proposal seeks amendment of TRIPS Agreement by inclusion of a new Article 29 bis for disclosure of origin of genetic resources and/or associated traditional knowledge. 60.   We also need to take note of the recent developments of the 2030 Agenda for Sustainable Development to which we are all committed, specifically calls for promoting access to and fair and equitable sharing of benefits arising from the utilization of genetic resources and associated traditional knowledge, as internationally agreed, in targets 2.5 and 15.6; 61.   Given the mandate given by our Ministers in Doha and the mandate under the Sustainable Development Goals 2.5 & 15.6, to avert misappropriation of existing knowledge, promote conservation of the genetic resource with the view to maintain diversity and protect livelihoods of those who are directly dependent on them, it is imperative we expedite our work towards a positive outcome. 62.   In light of these and to look at possible ways to energize negotiations on the subject in the WTO, I am happy to inform that Centre of WTO Studies, Indian Institute for Foreign Trade, New Delhi and South Centre, Geneva are organizing an International Conference on the TRIPS-CBD Linkage: Issues and Way Forward on 07-08 June at Room no. IX of the UN Palais. The event is co-sponsored by the Permanent Missions of Brazil, India, Indonesia and South Africa to the WTO. We invite you all for the two-day deliberations. 63.   It would be quite useful to the delegates of the TRIPS Council, if the CBD Secretariat is requested to brief the TRIPS Council on the latest developments in the implementation of the Nagoya Protocol. The briefing by the CBD Secretariat would be very important to understand the implications of the entry into force of the Nagoya Protocol, which has been acceded by 105 Members, on the TRIPS Agreement. We reiterate our demand for a formal briefing by the CBD Secretariat in the interest of the large majority of Members. We also support Ecuador's proposal for updating the three factual briefs by the Secretariat. 64.   I conclude by stating that the TRIPS-CBD issue is one of the outstanding implementation issues and positive outcomes on this is an important deliverable of the Doha Round for the developing countries.

16.   The Chair said that, as had already been noted during previous meetings, WTO Members had seen important developments in this area over the last decade. However, they had not shared information on those developments with the TRIPS Council. He believed that such information would enrich discussions. The Council had agreed on an Illustrative List of Questions (IP/C/W/122), which served as the basis for the review of on Article 27.3(b). However, only a minority of Members had provided responses; and there had been no response or updates since 2003. Similar gaps were also apparent with regard to Members' obligations under Article 63.2, as important legislative developments had not been notified to the TRIPS Council. He encouraged delegations to submit or update responses and to notify relevant laws and regulations to the TRIPS Council.
17.   The Chair noted that there were also two long-standing procedural issues which have been discussed for many years:
a. The suggestion made in November 2012 that the Secretariat update the three factual notes on the Council's previous discussions on the TRIPS and CBD and related items; these notes had been initially prepared in 2002 and last updated in 2006; and

b. The request that the CBD Secretariat be invited to brief the Council on the Nagoya Protocol to the CBD, initially proposed in October 2010.
18.   The Chair reported that there had been no developments on these procedural issues, during the informal consultation that had taken place the previous week. He invited delegations to share their suggestions on how to make progress.
19.   The representatives of India; Ecuador; South Africa; Brazil; Benin, on behalf of the LDC Group; the United States; Bangladesh; Japan; Switzerland; Australia; the Republic of Korea; Canada; China; and Indonesia took the floor.
20.   The Chair encouraged Members to have further discussions to resolve the outstanding procedural issues, and said that he stood ready to assist in the consultations.
21.   The Council took note of the statements made and agreed to revert to the matters at its next meeting.

IP/C/M/89, IP/C/M/89/Add.1