TRIPS AGREEMENT AND CONVENTION ON BIO-DIVERSITY(CBD)

India is one of the twelve-mega bio-diversity rich countries of the world. With only 2.4 per cent of the land area, India already accounts for 7 per cent to 8 per cent of the recorded species of the world. This number is based on the survey of 65 to 70 per cent of the total geographical area of the country. Over 47,000 species of plants and 81,000 species of animals have been recorded by the Botanical Survey of India and the Zoological Survey of India respectively. India is also one of the twelve primary centres of origin of cultivated plants and is rich in agricultural bio-diversity. India is equally rich in traditional and indigenous knowledge, both coded and informal.

Traditional knowledge (TK) has the potential of being translated into commercial benefits by providing leads for development of useful products and processes. The valuable leads provided by TK save time, money and investment of modern biotech industry into any research and product development. As such, a share of benefits must accrue to creators and holders of TK.

The Convention on Biological Diversity (CBD) has three main objectives, namely, the conservation of biological diversity, the sustainable use of its components and fair and equitable sharing of benefits arising out of the utilization of genetic resources. The CBD envisages that the benefits accruing from commercial use of TK have to be shared with the people responsible for creating, refining and using this knowledge. Article 8(j) of the CBD provides for respecting, protecting and rewarding the Knowledge, Innovations and Practices (KIP) of local communities.

The Indian Bio-diversity Act, 2002 addresses the basic concerns of access to, and collection and utilization of biological resources and knowledge by foreigners, and sharing of benefits arising out of such access. Section 6 or the Act provides that any person seeking any kind of IPRs in or outside of India for any invention based on any biological resource or information on a biological resource obtained from India, is required to obtain prior permission of the NBA, which may determine benefit sharing fee or royalty for the benefits arising out of the commercial utilization of such rights.

In the past, there have been several cases of bio-piracy of TK from India. First it was the patent on wound-healing properties of haldi (turmeric); then patents were obtained in other countries on hypoglycaemic properties of karela (bitter gourd), brinjal, etc. An important criticism in this context relates to foreigners obtaining patents based on Indian biological materials. There is also the view that the TRIPS Agreement is aiding the exploitation of bio-diversity by privatising bio-diversity expressed in life forms and knowledge.

A patent granted in the United States on the wound-healing properties of turmeric, for example, was revoked on the grounds that it lacked novelty and there was no inventive step involved in the patent. Similarly, a patent granted on the neem as a fungicide was revoked in the European Patent Office in May 2000. The exercise could be extended to other such patents also. But the time, effort, and money involved in getting individual patents examined and revoked in foreign patent offices is prohibitive. Hence, an internationally accepted solution to such bio-piracy is necessary.

The problem of bio-piracy can not be resolved with such revocation actions and domestic bio-diversity legislation alone. There is a need to provide appropriate legal and institutional means for recognising the rights of communities on their TK based biological resources at the international level. This can be done by harmonizing the different approaches of the CBD on the one hand, and the TRIPS Agreement on the other. The TRIPS Agreement contains no provisions preventing a person to claim patent rights in one country over genetic resources that are under the sovereignty of another country. In particular, TRIPS Agreement contains no provisions allowing a Member’s claims to enforce fair and equitable sharing of benefits from the patenting of its own genetic resources abroad. In the absence of clear provisions in TRIPS Agreement providing for a mutually supportive relationship of that Agreement with Members’ obligations under the CBD, implementation of the TRIPS Agreement may allow for acts of bio-piracy and thus result in systemic conflicts with the Convention. With a view to avoiding conflicts in the implementation of TRIPS Agreement, an amendment of the Agreement to accommodate some essential elements of the CBD is considered necessary. India has proposed, in this context, that patent applicants should be required to disclose the source of origin of the biological material utilized in their invention under the TRIPS Agreement and should also be required to obtain prior informed consent (PIC) of the country of origin. If this is done, it would enable domestic institutional mechanisms to ensure sharing of benefits of such commercial utilization by the patent holders with the indigenous communities whose TK has been used. Simultaneously, provisions have been introduced for disclosure of the source of biological material in the Indian Patents Act 1970. Section 10 (3) (D) of the Patents Act, 1970 provides that the Applicant in a patent application shall disclose the source and geographical origin of the biological material in the specification. Failure to disclose this information could lead to revocation of patent.

Development of an appropriate form of protection for the knowledge of local communities is of great interest to countries which are rich in bio-diversity, and also rich in TK, such as India. Various suggestions have been advanced to extend protection to knowledge, innovations and practices. These include: (i) documentation of TK; (ii) registration and innovation patent system; and (iii) development of a sui generis system.

In India, preparation of village-wise Community Bio-diversity Registers (CBRs) for documenting all knowledge, innovations and practices has been undertaken in a few States. We have also initiated an exercise to prepare easily navigable computerized database of documented TK relating to use of medicinal and other plants (which is already under public domain) known as TK Digital Library (TKDL). Such digital database would enable Patent Offices all over the world to search and examine any prevalent use/prior art, and thereby prevent grant of such patents and bio-piracy. It is also hoped that such documentation would facilitate tracing of indigenous communities with whom benefits of commercialisation of such materials/knowledge has to be shared.

Documentation of TK is one means of giving recognition to knowledge holders. But mere documentation may not enable sharing of benefits arising out of the use of such knowledge, unless it is backed by some kind of mechanism for protecting the knowledge. Documentation of TK may only serve a defensive purpose, namely that of preventing the patenting of this knowledge in the form in which it exists. Documentation per se, however, will not facilitate benefit sharing with the holders of TK.

Some experts have suggested that a sui generis system separate from the existing IPR system should be designed to protect knowledge, innovations and practices associated with biological resources. However, the parameters, elements and modalities of a sui generis system are still being worked out.

Another relevant aspect relating to TK is the need for value addition to this knowledge for converting it into economically profitable investments or enterprises. Many of the innovators, however, do not have the capacity for value addition. Thus, there is a need for providing institutional support in scouting, spanning, sustaining and scaling up of grassroots innovations and to enhance technical competence and self reliance of these innovators, through establishment of green venture promotion funds and incubators.

India and other developing countries have been raising the issue of protection of TK and the relationship between the CBD and the TRIPS Agreement for the last few years in the WTO. India had submitted a paper in the TRIPS council in July 2000 proposing for incorporation in the TRIPS Agreement of the provisions of disclosure, PIC and benefit sharing. Submissions were also made by Venezuela, Bolivia, Colombia, Ecuador, Nicaragua, Peru, African group, Cuba, Brazil and other countries on this issue in the TRIPS Council. As part of outstanding implementation issues of the WTO Agreement, developing countries proposed that the patents inconsistent with Article 15 of the CBD shall not be granted and also proposed for addressing these issues in the mandated review of Article 27.3 (b) of the TRIPS Agreement. These issues could not be resolved under the mandated review of the TRIPS Agreement under Article 27.3 (b) due to strong opposition from the US.

Doha Ministerial Declaration in paragraph 19 provided a mandate to the TRIPS Council, "in pursuing its work programme including under the review of Article 27.3(b), the review of the implementation of the TRIPS Agreement under Article 71.1 and the work foreseen pursuant to paragraph 12 of this Declaration, to examine, inter alia, the relationship between the TRIPS Agreement and the Convention on Biological Diversity, the protection of traditional knowledge and folklore, and other relevant new developments raised by Members pursuant to Article 71.1." Paragraph 12 of the Doha Ministerial Declaration dealing with outstanding implementation issues gave a mandate to the relevant WTO bodies to address outstanding implementation issues as a matter of priority and to report to the Trade Negotiations Committee by the end of 2002 for appropriate action.

India along with Brazil, Peru, Venezuela, Thailand, Indonesia, Philippines, etc. submitted a joint paper in June 2002 in the WTO proposing that the TRIPS Agreement should be amended in order to provide that Members shall require that an applicant for a patent relating to biological materials or to traditional knowledge shall provide, as a condition to acquiring patent rights:

(i) disclosure of the source and country of origin of the biological resources and of the traditional knowledge used in the invention;

(ii) evidence of prior informed consent through approval of authorities under the relevant national regimes; and

(iii) evidence of fair and equitable benefit sharing under the national regime of the country of origin.

India, along with other developing countries made another submission in June 2003 arguing that these issues should be incorporated in the TRIPS Agreement as patents have been mandated through the TRIPS Agreement. India further argued that provisions for PIC and benefit sharing in the national legislation alone are not sufficient when access and commercial use are undertaken by foreign nationals as the provisions in the national legislation are difficult to be enforced against such use. Therefore, an international solution through the TRIPS Agreement is essentially required to address this issue.

The first draft of the Cancun Ministerial Text did not propose any resolution of this issue and merely mentioned with regard to outstanding implementation issues that:

Thereafter, the revised Draft Cancun Text proposed a language on TK in paragraph 23 which was as under;

With the failure of the Cancun Ministerial Conference, to take a decision on the Draft Ministerial Text proposed by the Mexican Trade Minister Mr. Luis Ernesto Derbez, no decision could be taken on this issue also.

In the TRIPS Council meeting held on 8^th March 2004, India along with other developing countries submitted a paper (IP/C/W/420) containing ‘checklist of issues’. The checklist was drawn up on the basis of the issues raised and points made by various delegations in their communications and statements since 1999, particularly during post-Doha period. The purpose of ‘checklist of issues’ was to facilitate more focussed, structured and result-oriented discussions and to assist and expedite the process. The US & Japan, however, opposed the proposed checklist approach and stated that WIPO was a better forum for detailed discussion on these issues. Brazil, Pakistan, Peru, Venezuela, China, Switzerland, Indonesia, South Africa supported India. The Chairman deferred the decision on how to proceed further on these issues for the next meeting of the TRIPS Council to be held in June, 2004.