Traditional Medicine and Intellectual Property Rights
In developing countries, the issues of traditional knowledge have assumed a critical dimension in the area of intellectual property rights. The phrase “Traditional Knowledge” implies the development and transmission of the knowledge from generation to generation within a system, held by local individuals, families, lineages or indigenous communities. From time immemorial, these local individuals or communities have a store-house of knowledge about their geographical flora and fauna. However, the local individuals and communities do not have the means to safeguard their traditional knowledge in the increasing global process of extraction, exploitation and commercialization of the biodiversity of the Third World. It is a stark reality that globalization is threatening the biodiversity, bio-information and creativity of indigenous approaches into proprietary knowledge for the commercial profit of a few. The existing IPR agenda is oriented around the concept of private ownership and individual innovation which encourages the co-modification of traditional knowledge without benefit sharing to indigenous communities.
Traditional Medicine and IPR Perspective
Traditional Medicine (TM) plays a crucial role in health-care and serves the health needs of a vast majority of people in developing countries. Access to “modem” health care services and medicine may be limited in developing countries. TM becomes the only affordable treatment available to poor people and in remote communities. World Health Organization (WHO) defines traditional medicine as the sum total of all the knowledge and practices, whether explicable or not, used in diagnosis, prevention and elimination of physical, mental or social imbalance and relying exclusively on practical experience and observations handed down from generation to generation, whether verbally or in writing. Health care providers worldwide including major pharmaceutical giants are turning to incorporate many of these into their mainstream activities. As traditional medicines are largely based on medicinal plants, indigenous to these countries, where the system has been in vogue for several centuries, the effort is on accessing them either directly or through the use of modem tools of breeding and cultivation, including tissue culture, cell culture and transgenic technology. IP issues linked to such endeavors remain unresolved.
The protection of Traditional Medicine (TM) under intellectual property rights (IPRs) raises two types of issues. First, to what extent it is feasible to protect, existing IPR system. Certain aspects of TM may be covered by patents or other IPRs. There have also been many proposals to develop sui generis systems of protection. Such proposals are based on the logic that if innovators in the formal’ system of innovation receive a compensation through IPRs, holders of traditional knowledge should be similarly treated. The codification of TM varies significantly. A distinction can be made, particularly in Asia, between the codified systems of ‘traditional medicine’ and non-codified medicinal knowledge, which includes ‘folk’, ‘tribal’ or ‘indigenous’ medicine.
Thus, in India, folk traditions are handed over orally from generation to generation. The ‘folk’ medicine is based on traditional beliefs, norms and practices based on century’s old experiences of trials and errors, successes and failures at the household level. These are passed through oral tradition and may be called, ‘people’s health culture’, home remedies or folk remedies. Traditional Medicine (TM) may be possessed by individuals. In some cases, for instance, healers use rituals as part of their traditional healing methods, which often allow them to monopolize their knowledge, despite disclosure of the photochemical products or techniques used. The codified tradition consists of medical knowledge with sophisticated foundations expressed in thousands of manuscripts covering all branches of medicine. Examples are ayurveda, siddha, unani and the Tibetan tradition. The grant of patents on non-original innovations (particularly those linked to traditional medicines), which are based on what is already a part of the traditional knowledge of the developing world have been causing a great concern to the developing world.
These problems-co modification of traditional knowledge, under
Advantages of patents, ownership of genetic information and information not owned by the true creator-are symptoms of a deeper problem with the whole idea of intellectual property. Unlike goods, there are no physical obstacles to providing an abundance of ideas. Intellectual property is an attempt to create an artificial scarcity in order to give rewards to a few at the expense of the many. Intellectual property aggravates inequality. It fosters competitiveness over information and ideas, whereas cooperation makes much more sense. In the words of Peter Drahos, researcher on intellectual property, “Intellectual property is a form of private sovereignty over a primary good-information.” Here are some examples of the abuse of power that has resulted from the power to grant sovereignty over information.
Turmeric Patent Case
Two US-based Indians Suman K. Das and Hari Har P. Cohly were granted a US Patent 5,40,504 on 28 March 1995 on Use of turmeric in wound healing. The patent was assigned to University of Mississippi Medical Center, USA. This patent claimed the administration of an effective amount of turmeric through local and oral route to enhance the wound healing process, as a novel finding. Any patent, before it is granted, has to fulfill the basic requirements of novelty, non-obviousness and utility. Thus, if the claims have been covered by relevant published art, then the patent becomes invalid. Council of Scientific and Industrial Research (CSIR) could locate 32 references (some of them being more than one hundred years old and in Sanskrit, Urdu and Hindi), which showed that this finding was well known in India prior to filing of this patent. The formal request for re-examination of the patent was filed by CSIR at United State’s Patent and Trademark Office (USPTO) on 28 October 1996. On 20 November 1997, the examiner rejected all the claims once as being anticipated and obvious. The re-examination certificate was issued on this case on 21 April 1998 bringing the re-examination proceedings to a close.
The following points are interesting to note:
1. The turmeric case was a landmark case in that this was the first time that a patent based on the traditional knowledge of a developing country was challenged successfully and USPTO revoked the patent. This eventually opened up the path to the creation of Traditional Knowledge Digital Library, Traditional Knowledge Resource Clarification, and finally inclusion of traditional knowledge in the International Patent Clarification System.
2. Amidst the loud protests against ‘biopiracy’ and ’theft’ of India’s biodiversity and traditional knowledge by foreign nationals, it is interesting to note here that the patentees were Indians (Das and Cohly), the re-examination in USPTO was done by an Indian (Kumar) and the re-examination was sought by an Indian institution (CSIR).
World Intellectual Property Organization (WIPO) has been sensitive to these concerns. At a conference held in October 1998, under the aegis of the WIPO an agenda for the future of IPR in the field of traditional medicines was prepared, which prioritized activities in this area, namely, development of standards for the availability, scope and use of IPRs on traditional medicine in Asian countries, systematic documentation of traditional medicine for protection purposes, regional and inter-regional information exchange and compilation of the requisite databases, etc. This agenda needs to be moved forward.
The case of Amazon Rainforest Plant Patent
Many traditional healers and religious leaders from the indigenous tribes of the Amazon used to collect a plant named Baniste-riopsis caapi, and process it to produce a ceremonial drink - ‘ayahausca’, also called ‘yage’. They used ayahausca in religious and healing ceremonies. According to tradition, ayahausca was prepared and administered only under the guidance of traditional healers. A Plant Patent No. 5,751, issued to Loren Miller on 17 June 1986 by USPTO claimed rights over a supposed variety of B. caapi, which Miller dubbed ‘Da Vine’. The challenge to this patent was made by the Center for International Environment Law (CIEL), on behalf of the Coordinating Body of Indigenous Organizations of the Amazon Basin (COICA) and the Coalition for Amazonian Peoples and Their Environment (Amazon Coalition). COICA is a coordinating body of more than 400 tribes.
Although the patent claimed to have identified a variety of the species with new and distinctive physical features, particularly the colour of the flower. But according to Prof. William A. Anderson of the University of Michigan, a leading expert on the plant family to which B. caapi belonged, the features described as ‘prior art’ were already there in the records of major herbaria. Further, this plant grew naturally throughout the Amazon basin. By law, plant patents cannot be awarded to plants ‘found in an uncultivated state’. On reexamination, USPTO revoked this patent on 3 November 1999. However, the inventor was able to convince the USPTO on 17 April 2001, the original claims were reconfirmed and the patent rights restored to the innovator.
Neem Oil Cases
The US has been taking undue advantage of the low level of patent awareness and laxity in enforcement of law. The Neem tree is used in India in the areas of medicine, toiletries, contraception, timber, fuel and agriculture. Its uses have been developed over many centuries but never patented. Since the mid 1980s, US corporations have taken out over a dozen patents on Neem- based materials, When the US Patents Office (USPTO) granted patent for ‘Neem oil’ for antiseptic use, the Council of Scientific and Industrial Research (CSIR) urged for re-examination of the case, but without success. In this way, collective local knowledge developed by Indian researchers and indigenous communities has been expropriated by outsiders who have added very little to the process.
There is a problem on the grant of such patents linked to the indigenous knowledge of the developing world that needs to be addressed jointly by the developing and the developed world. We need to understand that there is a distinction between the patents that are granted based on modem research and patents, which can be categorized as traditional knowledge-based patents. A recent study by an Indian expert group examined randomly selected 762 US patents, which were granted under A61K35/78 and other IPC classes, having a direct relationship with medicinal plants in terms of their full text. Out of these patents, 374 patents were found to be based on traditional knowledge not that all of them were wrong. The Governments in the Third World as well as members of public are rightly concerned about the grant of patents for non-original inventions in the traditional knowledge systems of the developing world. At international level there is significant level of support for opposing the grant of patents on non-original inventions. For example, more than a dozen organizations from around the world got together to oppose the EPO Neem patent and the entire process took five years. Such a process of opposition is, understandably expensive and time consuming.
The issue of ‘protection’ of traditional knowledge needs to be looked at from two perspectives, the ‘protection’ may be granted to exclude the unauthorized use by third parties of the protected information. On the other hand, the ‘protection’ also means to preserve traditional knowledge from uses that may erode it or negatively affect the life or culture of the communities that have developed and applied it. Further, the protection also promotes self respect and self-determination. While recognizing the market-based nature of IPRs, other non-market-based rights could be useful in developing models for a right to protect traditional knowledge, innovations and practices. To date, debate on IPRs and biodiversity has focused on patents and plant breeders’ rights. Provisions under undisclosed information or trade secrets could be invoked to protect traditional knowledge not available in the public domain. Geographical indications and trademarks, or sui generis analogies, could also be the alternative tools for indigenous and local communities seeking to gain economic benefits from their traditional knowledge. The potential value of geographical indications and trademarks is in protecting plants and germplasms that are specific and unique to geographical regions. They could protect and reward traditions while allowing innovation.
New experiments are beginning to emerge on benefit-sharing models for indigenous innovation. An experience in India is worth sharing. It relates to a medicine that is based on the active ingredient in a plant, Trichopus zeylanicus, found in the tropical forests of southwestern India and collected by the Kani tribal people. Scientists at the Tropical Botanic Garden and Research Institute (TBGRI) in Kerala learned of the plant, which is claimed to bolster the immune system and provide additional energy, while on an expedition with the Kani in 1987. These scientists isolated and tested the ingredient and incorporated it into a compound, which they christened ‘Jeevan’, the giver of life. The tonic is now being manufactured by a major Ayurvedic drug company in Kerala. TBGRI agreed to share the license fee and royalty with the tribal community on a fifty-fifty basis and formed a registered trust with an understanding that the interest accrued from this amount alone can be used for the welfare activities of the Kani tribe. It is significant to note that while the issue of material transfer and benefit sharing was discussed and debated after Convention on Biological Diversity (CBD), India has already pioneered one of the first models.
Developing countries need a systematic documentation of traditional medicine for protection purposes, regional and inter-regional information exchange and compilation of the requisite databases etc. To mitigate this problem, the Indian Government has taken steps to create a Traditional Knowledge Digital Library (TKDL) on traditional medicinal plants and systems, which will also lead to a Traditional Knowledge Resource Classification (TKRC). Linking this to internationally accepted International Patent Classification (IPC) System will mean building the bridge between the knowledge contained in an old Sanskrit Shloka and the computer screen of a patent examiner in Washington. This will eliminate the problem of the grant of wrong patents since the Indian rights to that knowledge will be known to the examiner. It is right time that India must evolve a viable and effective mechanism to protect the biodiversity, bio-information and creativity of indigenous communities.
 Bhawani Shanker Mishra, Huge Commercial Implications of GI in Third World (2003) at page 202.
 R.A. Mashelkar, Intellectual Property rights and the Third World, Special Section: Science in the Third World, Current Science, Volume 81, No. 8,25 October 2001, at page 959.
 Peter Drahos, Decentring Communication: The Dark Side of Intellectual Property, in Tom Campbell and Wojciech Sadurski (eds.) Freedom of Communication (Aldershot: Dartmouth, 1994) at page 274.
 Vandana Shiva and Radha Holla - Bhar, Intellectual Piracy and the Neem Tree, Ecologist, Volume 23, No. 6,1993, at pages 223-227.
 Vandana Shiva and Radha Holla - Bhar, Intellectual Piracy and the Neem Tree, Ecologist, Volume 23, No. 6,1993, at pages 361.
 B.L. Chauhan, The Protection of Traditional Knowledge: Problems and Perspectives (2004) at page 343.
 B.L. Chauhan, The Protection of Traditional Knowledge: Problems and Perspectives (2004) at pages 344-345.
 Ibid, at page 346.