Siddharth Dubey
Pirates of life, are pillaging a new kind of wealth, that of biodiversity and the traditional knowledge and techniques of rural and indigenous peoples. Biopiracy can be defined as, “the misappropriation and commercialization of genetic resources and traditional knowledge of rural and indigenous people” Pharmaceutical biopiracy is a term used generally to describe the legal practice by pharmaceutical companies exploiting the indigenous people’s traditional knowledge of medicine. India and other developing countries are rich in bio-resources and TK are favourite targets and victims of biopiracy. Turmeric, neem and basmati rice were well known examples of biopiracy. Renowned economist and Nobel Prize winner Joseph E. Stiglitz comments on the World Trade Organization’s Trade Related Aspects of Intellectual Property Rights Agreement (TRIPS) – What we were not fully aware of was another danger, what has come to be termed bio-piracy, international companies patenting traditional medicines and foods. It is not only that they seek to make money from ‘resources’ and knowledge that rightfully belongs to the developing countries, but in so doing, they squelch domestic firms that have long provided the products. Biopirates are mainly pharmaceutical, cosmetic and agrifood firms. Biopiracy of genetic resources and genetic materials are also noticed. They draw on biodiversity hotspots in order to create supposedly “innovative” products and guarantee their monopoly on them through the patent system. Such misappropriation of TK results in grant of patent for the invention to the “first-to-file” (the pharmaceutical company) rather than to the “first-to-invent” (the indigenous community). It involves making profit from freely available natural products (plants, seeds, leaves etc.), by copying techniques used daily for generations by local peoples in order to feed or take care of themselves. This article provides that “patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an incentive step and are capable of industrial application. However, nations can choose to exclude certain inventions, such as those that harm the public, types of medical treatments, and certain plants from patentability. Individual nations have the power to interpret the terms of such agreements in terms as broad or narrow as they wish. Agreements such as TRIPs have been criticized as instruments used to secure enforcement of US intellectual property rights abroad. In the words of well known Indian environmental activist Vandana Shiva, “Patents are given for an invention and a patent on life necessarily means biopiracy.” If a patent does not respect one of the three criteria for access (novelty, inventiveness and commercial application), it is not legally admissible and must be canceled. Thus, a patent based on traditional knowledge is illegal, because it does not respect the principle of novelty, nor does it respect the criteria of inventiveness.
India is one of the 17 mega-biodiversity countries with 2.4 per cent of the global land area and accounts for 7 to 8 per cent of the recorded species of the world, making it more prone to biopiracy . The turmeric case, in which India succeeded in overturning a patent granted by the United States Patent and Trademark Office on turmeric powder, was a landmark in the battle against ‘bio-piracy’. It was the first case in which a Third World country succeeded in its objection to a foreign patent on the grounds that it was based on traditional knowledge known to the country for generations. In 1995, two expatriate Indians at the University of Mississippi Medical Centre were granted a US patent on use of turmeric in wound healing. The Council of Scientific & Industrial Research (CSIR), India, New Delhi filed a reexamination case with the US PTO challenging the patent on the grounds of existing of prior art. CSIR argued that turmeric has been used for thousands of years for healing wounds and rashes and therefore its medicinal use was not a novel invention. Their claim was supported by documentary evidence of traditional knowledge, including ancient Sanskrit text and a paper published in 1953 in the Journal of the Indian Medical Association. Despite an appeal by the patent holders, the US PTO upheld the CSIR objections and cancelled the patent. Grant of patent for fungicidal effect of neem oil in 1994 is another such example. European Patent Office (EPO) granted a patent to the US Corporation W.R. Grace Company and US Department of Agriculture for a method for controlling fungi on plants by the aid of hydrophobic extracted Neem oil. In 1995, a group of international NGOs and representatives of Indian farmers filed legal opposition against the patent. They submitted evidence that the fungicidal effect of extracts of Neem seeds had been known and used for centuries in Indian agriculture to protect crops, and therefore, cannot be patented. In 1999, the EPO determined that according to the evidence all features of the present claim were disclosed to the public prior to the patent application and the patent was not considered to involve an inventive step. The patent granted on was Neem was revoked by the EPO in May 2000.
Learning from such bitter experiences, framed following acts and projects to fight against biopiracy:- 1. Biological diversity act (2002), India. In India, enabling provisions have been made for protecting the traditional knowledge in the Biodiversity Bill 2000. Section 36(iv) provides for protection of knowledge of local people relating to biodiversity through measures such as registration of such knowledge, and development of a sui generis system. For ensuring equitable sharing of benefits arising from the use of biological resources and associated knowledge, sections 19 and 21 stipulate prior approval of the National Biodiversity Authority (NBA) before their access. It provides that anybody seeking any kind of intellectual property rights on a research based upon biological resource or knowledge obtained from India; need to obtain prior approval of the NBA. The NBA will impose benefit-sharing conditions. It stipulates that one of the functions of NBA is to take measures to oppose the grant of IPRs in any country outside India on any biological resource obtained from India or knowledge associated with such biological resource. India’s Biological Diversity Act, 2002 (BDA) seeks to do several tasks, including to regulate access to biological resources with the purpose of securing equitable share in benefits arising out of the use of biological resources and associated TK to conserve and sustainably use biological diversity; to respect and protect TK of local communities to secure sharing of benefits with local people as conservers of biological resources and TK holders. The Biological Diversity Rules of 2004 further identifies benefit sharing methods such as joint ventures, technology transfer, product development, education, awareness raising, institutional capacity building, and venture capital funds, and states that applications will be determined on a case by case basis. Protection of plant varieties (ppv) and farmers’ rights act (2001) The Indian legislation for the Protection of Plant Varieties and Farmers’ Rights Act, 2001, also acknowledge that the conservation, exploration, collection, characterization, evaluation of plant genetic resources for food and agriculture are essential to meet the goals of national food and nutritional security as also for sustainable development of agriculture for the present and future generations. Traditional knowledge digital library (TKDL) India has taken various initiatives regarding the protection of traditional knowledge under intellectual property rights, including the Traditional Knowledge Digital Library (TKDL), to protect its traditional knowledge and to prevent grant of wrong patents.
A collaborative project between CSIR and Department of AYUSH, Ministry of Health and Family Welfare, TKDL is a maiden Indian effort to help prevent misappropriation of traditional knowledge belonging to India at International Patent Offices. By recording the traditional knowledge, legally, it becomes public domain knowledge. Under the patent law, this means that it is considered to be prior art and hence is not patentable. Such a written record, in a form easily accessible to patent offices around the world, would provide all such offices with arecord of India’s prior art. Patent examiners could easily check this database and reject any patent application that might be a mere copy of traditional knowledge. Being in document form, it would be acceptable to patent offices that insist on a written record of prior art, as in the United States. To this extent it would prevent cases of ‘bio-piracy’. Around the time the TKDL was established in 2001, the TKDL expert group estimated that, annually, some 2,000 patents relating to Indian medicinal systems were being erroneously granted by patent offices around the world. TKDL thus enables cancellation/withdrawal of wrong patent applications concerning India’s traditional knowledge at zero cost and in few weeks time.
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