TITLE: US Not Sure What's Biopiracy AUTHOR: Someshwar Singh PUBLICATION: SUNS (South-North Development Monitor) #4712 DATE: 20 July 2000 SOURCE: Third World Network URL: http://www.twnside.org.sg/ NOTE: A compilation of references to further material is provided after the article. US NOT SURE WHAT'S BIOPIRACY Geneva, July 14 (Someshwar Singh) -- The United States, which led a well-orchestrated campaign about "piracy" to get the Third World to sign on to a global monopoly intellectual property regime (TRIPS agreement at the WTO), in effect now says it is not sure what is meant by 'bio-piracy'. At the recent (5-6 July) meeting of the WTO's Committee on Trade and Environment (CTE), India's new paper on 'Protection of Biodiversity and Traditional Knowledge', calling for international action to counter bio-piracy and to promote benefit sharing in cases where the use of genetic resources is legitimate, drew support from a number of other developing countries. Brazil, Cuba, Malaysia, Peru and others endorsed the need for international action, with Brazil saying that it is necessary to establish minimum multilateral standards to protect traditional knowledge. But the US was not sure about the term 'bio-piracy' or that there was a phenomenon that could be termed 'bio-piracy' to be addressed. In the discussions over the Indian paper, Japan noted that the TRIPs Agreement was not adapted to deal with the collective nature of traditional knowledge. Canada said it was examining current intellectual property regimes to identify holders of indigenous knowledge and to document this knowledge. Reference was made by Brazil, Canada, Japan, Switzerland, the EC and others,to the expertise in the World Intellectual Property Organization (WIPO) to discuss the issues related to traditional knowledge raised in India's paper, and to establish technical cooperation in this area. Referring to India's paper and the discussions at the CTE, the WTO Secretariat in its Trade and Environment Bulletin says that WTO "members welcomed this 'real world' paper, which sets out the concrete ways in which India is actively pursuing the implementation of the Convention on Biological Diversity." While a 'real world' description of this kind to papers submitted in the WTO can have many interpretations, depending on the perspective used, but the implication about "other-worldly" papers that circulate at the World Trade Organization, is perhaps troubling. However, the most interesting response to India's paper came from the United States. The US has not ratified the UN Convention on Biological Diversity (CBD) which came into force on 29th December 1993, but as an observer used a few 'friends' to put up stiff resistance in the negotiations on the Biosafety Protocol, and to water it down. The WTO Bulletin summarises the US response to the Indian paper thus: "Whilst there were often disputes about whether something was patent-worthy, the US noted that the examples in India's paper had been successfully addressed. The US was not sure it accepted that there was a phenomenon that could be termed 'bio-piracy'." The Indian paper, on the other hand, cites several instances of bio-piracy of Traditional Knowledge from India in the recent past. More importantly, it highlights the need to find international solutions in addition to finding a way out at the national level. For, even if cases of wrong patenting have been found and revoked, the process is very expensive - something that developing countries can ill-afford to engage in all the time. First, it was the patent on wound healing properties of haldi (turmeric); now patents have been obtained in other countries on hypoglyceimic (anti-diabetic) properties of karela (bitter gourd), brinjal etc. An important criticism in this context relates to foreigners obtaining patents based on Indian biological materials, and the pharmacoepia and oral knowledge of the Indian Ayurveda and other traditional systems of medicine. "There is also the view that the TRIPS Agreement is aiding the exploitation of biodiversity by privatizing biodiversity expressed in life forms and knowledge." Patents are granted under national patent laws and have territorial application only. The TRIPS Agreement provides minimum standards of protection for intellectual property rights including patents, while WTO Members are free to grant a higher level of protection under their national laws. Thus, India is free to deny patents on life forms, except on micro-organisms and micro-biological and non-biological processes, as per the provisions of the TRIPS Agreement. At the same time if another country, for example the USA, chooses to grant patents on plants or other life forms, India cannot object. Nevertheless, such patents will have force only in USA and cannot be enforced in India. To assess the WTO compatibility of a patent granted by a foreign patent office to an invention based on biological material obtained from India, the paper says "we need to check whether the criteria of patentability (novelty, non-obviousness and usefulness) are satisfied, and to challenge it where the criteria are not met. We examine cases that need to be examined. A patent granted in USA on the wound healing properties of turmeric, for example, was revoked after such an examination. 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 Indian paper says. The problem of bio-piracy may not be resolved with such revocation actions and domestic biodiversity legislation alone, India said in its paper. "There is a need to provide appropriate legal and institutional means for recognizing the rights of tribal communities on their traditional knowledge based on biological resources at the international level. There is also a need to institute mechanisms for sharing of benefits arising out of the commercial exploitation of biological resources using such traditional knowledge. "This can be done by harmonising the different approaches of the Convention on Biological Diversity on the one hand and the TRIPS Agreement on the other as the former recognizes sovereign rights of States over their biological resources and the latter treats intellectual property as a private right." India has proposed, in this context, that under the TRIPS Agreement, patent applicants should be required to disclose the source of origin of the biological material utilized in their invention and should also be required to obtain prior informed consent 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 traditional knowledge has been used. Simultaneously, in India, provisions have been introduced (in proposed legislation) for disclosure of the source of biological material in the amendments proposed to India's Patents Act 1970 through the Patents (Second Amendment) Bill 1999. The Bill is currently before the Parliament. What is required in addition, to prevent bio-piracy, is the acceptance of this practice of disclosure and PIC by all patent offices in the world. The Indian paper does acknowledge that issues relating to protecting, recognizing and rewarding of traditional knowledge associated with biological resources are very complex. The modalities for protecting TK are still emerging and evolving. The nature of entitlements and share in benefits is also a gray area. Even at the international level, clarity has as yet not emerged and countries are grappling to understand the issue. As regards protection of knowledge, innovations and practices associated with biological resources, these do not seem to fall within the conventional legal systems of IPR protection (e.g. patents, copyrights, trademark, etc.). These conventional forms of IPRs are inadequate to protect indigenous knowledge essentially because they are based on protection of individual property rights whereas traditional knowledge is by and large collective. Further, the informal knowledge presents other difficulties in being recognised for the purpose of IP protection, such as: * Knowledge is developed over a period of time and may either be codified in texts or retained in oral traditions over generations. The conditions of novelty and innovative step necessary for grant of patent are therefore not satisfied. * Communities quite often hold knowledge in parallel. Nevertheless, the development of an appropriate form of protection for the knowledge of local communities is of great interest to countries, which are rich in biodiversity and also rich in traditional knowledge such as India. The Indian paper also notes that biological diversity encompasses all species of plants, animals and microorganisms and the variation between them, and the eco-systems of which they form a part. It occurs at three levels, namely, (i) species level - the number and kinds of living organisms, (ii) genetic level - the genetic variation within a population of species, and (iii) eco-system level - the variety of habitats, biological communities and ecological processes that occur in such habitats. Traditional knowledge (TK) associated with biological resources is an intangible component of the resource itself. 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 traditional knowledge save time, money and investment of modern biotech industry into any research and product development. Hence, a share of benefits must accrue to creators and holders of TK. As one of the twelve mega-biodiversity countries of the world, India has only 2.4% of the land area but accounts for 7-8 percent of the recorded species of the world. 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 biodiversity. India is equally rich in traditional and indigenous knowledge, both coded and informal. In its suggestions/options for protecting the Traditional Knowledge, the Indian paper examines three areas to extend protection to knowledge, innovations and practices. These include (i) documentation of traditional knowledge; (ii) registration and innovation patent system; and (iii) development of a sui generis system. With respect to the documentation of traditional knowledge, the paper notes it is sometimes believed that proper documentation of associated traditional knowledge could help in checking bio-piracy. It is assumed that if the materials/knowledge is documented, it can be made available to patent examiners the world over so that prior art in the case of inventions based on such materials/knowledge is readily available to them. It is also hoped that such documentation would facilitate tracing of indigenous communities with whom benefits of commercialization of such materials/knowledge has to be shared. On the other hand, others believe that documentation may facilitate bio-piracy. They argue that a trade secret of an indigenous community would be maintained only so long as it is closely held by the community. As soon as it is put down on paper, it will become accessible to pirates and would be purloined. This dilemma is the subject of discussions in national and international debates on benefit sharing. Some suggest the empowerment of the indigenous communities themselves so that they are able to get legal protection for closely held knowledge without the involvement of outside agencies. Nevertheless, documentation has one clear benefit. It would check patents based on traditional knowledge in public domain that are today difficult to prevent due to lack of availability of information with patent examiners. In India, preparation of village-wise Community Biodiversity Registers (CBRs) for documenting all knowledge, innovations and practices has been undertaken in a few States and the paper outlines progress in this regard. As for development of Traditional Knowledge Digital Library, the paper notes that to prevent cases of biopiracy in the future, there is a need for developing digital databases of prior art related to herbs which is already in public domain. Following the patents on brinjal etc., an exercise has been initiated in India 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 Traditional Knowledge 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. Documentation of traditional knowledge 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. This necessitates the need for extending some kind of protection to traditional knowledge. Documentation of traditional knowledge 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 traditional knowledge. With respect to Registration and innovation patent system, the paper says this involves creating a system for registration of innovations by inventors. Such registration will be tantamount to giving right to the inventor to challenge any use of the innovation without prior permission. For novel and useful innovations, some kind of petty patent giving protection for a limited duration may be worked out. Regarding registration, some limited efforts have been made in India. For example, the HoneyBee database established ten years ago in India is a facility for registration of innovations by innovators. The database can be accessed for adding value to these innovations and sharing benefits with the knowledge providers and innovators. Thus the HoneyBee Network involves documentation, experimentation and dissemination of indigenous knowledge. The network has probably the world's largest database on grassroots innovations, having now about 10,000 innovations, with names and addresses of the innovators (individuals or communities). Through the HoneyBee Newsletter, grassroots innovations have been disseminated to more than 75 countries. For e.g., this database has entries on traditional use of fish and fish products, improving crop productivity etc. On the development of a sui generis system, the Indian TRIPs paper says 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. This is in addition to the sui generis system of protection for plant varieties. The sui generis system of protection for plant varieties is separately developed in India and a Bill in this regard is before the Parliament." Another relevant aspect relating to TK, the paper adds, 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. It was also proposed as part of the 1999-2000 national budget of India that a National Innovation Foundation would be set up. This foundation, with an initial corpus of Rs.20 crore (US$5 million), is intended to build a national register of innovations, mobilize intellectual property protection, set up incubators for converting innovations into viable business opportunities and help in dissemination across the country. The foundation is in the process of being set up. On the need for international action, the paper says even though provisions of Article 8(j) of CBD are subject to national legislation, India is of the view that securing benefits arising out of the use of traditional knowledge related to biodiversity cannot be limited to national action alone, and a basic understanding and respect for an internationally recognised regime to ensure rights to these communities is an absolute must. These two requirements therefore, have to go hand in hand. To secure this, suggestions have been made by India in international fora under the aegis of CBD as well as WTO, that applications for patents should disclose the following: * the source of knowledge and biological material; * an undertaking that the prevalent laws and practices of the country of origin have been fully respected. "While securing benefits to the creators and holders of knowledge for the use of this knowledge is subject to national legislation, national action alone is not sufficient to ensure realization of benefits," the paper said. "The onus must also be shared by the user of this knowledge all over the world so as to ensure compliance of the consent requirement for using the knowledge and equitable sharing of benefits as visualized in the Convention on Biological Diversity." The CTE is scheduled to meet on 24-25 October 2000 to hold a second information session on MEAs (multilateral environmental agreements). But for all the so-called integration of environmental concerns into the WTO, it is perhaps ironic that two premier organizations involved in environment are still struggling to get an observer status at the WTO. At the 5-6 July 2000 meeting, the CBD reiterated its request for observer status in the TRIPs Council and the Agriculture Agreement; and the UNEP called on Members to give favourable consideration to its request for observer status in the General Council, the TRIPs Council and the Committee on Trade and Development! The US has blocked the CBD from being granted an ad hoc observer status at the TRIPS Council at its last meeting; Brazil, India and several others have asked the US to reconsider its position. Otherwise, as one trade diplomat put it, this would 'create a stink'. SUNS #4712 | 20 July 2000 | Third World Network © 2000, SUNS. Posted on BIO-IPR with the permission of the Editor. For information contact suns(at)igc.apc.org GOING FURTHER (compiled by GRAIN) "Protection of Biodiversity and Traditional Knowledge - The Indian Experience", Submission by India to the CTE meeting of 5-6 July 2000, World Trade Organisation, Geneva, 14 July 2000. To download, go to http://www.wto.org/wto/ddf/ep/search.html and enter WT/CTE/W/156 in the Document Symbol box. The CTE Secretariat reported on the 5-6 July meeting in its Trade and Environment Bulletin TE/033 of 10 July 2000, available at http://www.wto.org/english/tratop_e/envir_e/te033_e.htm Committee on Trade and Environment, "The Relationship Between the Convention on Biological Diversity (CBD) and the Agreement on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) with a Focus on Article 27.3(b)", Background Note by the Secretariat, World Trade Organisation, Geneva, 5 October 1999. A 33-page report that was only recently de-restricted. To download, go to http://www.wto.org/wto/ddf/ep/search.html and enter WT/CTE/W/125 in the Document Symbol box. The Honey Bee network website is at http://www.sristi.org/honeybee.html For more information on the National Traditional Knowledge Digital Library that the Indian government is now setting up, see a news item published in The Hindu Business Line newspaper on 4 June 2000 http://www.indiaserver.com/businessline/2000/06/04/stories/ 14043908.htm or visit the website of the Department of Indian Systems of Medicine and Health http://mohfw.nic.in/ismh/.