RIGHTS AND PROTECTION MECHANISMS FOR TRADITIONAL KNOWLEDGE HOLDERS IN INDIA

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1 RIGHTS AND PROTECTION MECHANISMS FOR TRADITIONAL KNOWLEDGE HOLDERS IN INDIA Palada Dharma Teja 1 & Shashwat Bhaskar 2 INTRODUCTION Protection of Traditional Knowledge and Indigenous Intellectual Property has become an important issue in the international legal scenario. TK is capable of producing large scale benefits in both commercial and social capacities which is integral for the betterment of mankind. There arises a need for proper legal framework to ensure that a share of benefits of TK are accrued to creators and holders of TK. In India, the need to protect the traditional knowledge of India has gained importance. India has taken an initiative through The Traditional Knowledge Digital Library (TKDL) which was set up in 2001 by The Government of India after the Neem Patent Controversy. The major forms of intellectual property related protection systems with regards to TK- Positive Protection and Defensive Protection shall be discussed in this paper. This research paper elaborates on the nature and scope of TK and attempts to offer plausible actions that could be taken to strengthen the mechanism for protection of TK. It discusses efforts, both national and international, for the protection, conservation and systematization of TK. It shall further shed light on the perspective of the Indian Judiciary on rights of the TK holders. It shall also examine instances of dispute over TK elements, which would include the aforementioned Neem Patent Case. NATURE AND SCOPE Traditional Knowledge encompasses indigenous and local community knowledge, innovations and practices from around the world. 3 The World Intellectual Property Organization (WIPO) defines traditional knowledge as indigenous cultural and intellectual property, indigenous 1 2nd Year BA LLB Student, The National University of Advanced Legal Studies, Kochi 2 2nd Year BA LLB Student, The National University of Advanced Legal Studies, Kochi 3 Bryan Bachner, Facing the Music: Traditional Knowledge and Copyright, 12 Human Rights Brief 9 (Spring, 2005). 1 P a g e JOURNAL ON CONTEMPORARY ISSUES OF LAW

2 heritage, and customary heritage rights. Traditional Knowledge means the collective knowledge of a traditional community including of a group of families, on a particular subject or a skill and passed down from generation to generation, either orally or in written form, relating to properties, uses and characteristics of plant and animal genetic resources; agricultural and healthcare practices, food preservation and processing techniques and devices developed from traditional materials; cultural expressions, products and practices such as weaving patterns, colors, dyes, pottery, painting, poetry, folklore, dance and music; and all other products or processes discovered through a community process including by a member of the community individually but for the common use of the community. 4 However, no single definition can elucidate completely on the extensive concept of TK, as it encompasses several diverse ideas. It can best be described as knowledge developed by indigenous communities. 5 Because the knowledge is often central to a community's cultural value system, the community generally holds and owns the knowledge collectively, although use of the knowledge may be restricted to certain community members. 6 Traditional Knowledge has moved across generations being driven into a state of stupor. The Traditional in TK has transformed from what was once habitual to what is now conventional for the practicing communities. It is a scheme of information which has spread and evolved over centuries, yet it remains confined to the extent of one definite region. Such knowledge constitutes a vital part of their cultural heritage, contributes to the sustainable use and preservation of biodiversity, and is fundamental to their sustainable development. 7 The existence of Intellectual Property law, which facilitates the patenting and/or copyright of such TK has been a boon for multi-national entities. However, this has come at the cost of indigenous people, their culture and the novelty of TK. Protection mechanisms, whether centered on Intellectual Property, or on sui generis, have to be backed by some objective. Capitalizing on the availability of widespread TK for the furtherance of national economic interests can be seen as one 4 Rule 2(v), The Protection, Conservation and Effective Management of Traditional Knowledge Relating to Biological Diversity Rules, Daniel J. Gervais, Traditional Knowledge and Intellectual Property: A TRIPS Compatible Approach, Michigan State Law Review 137, 140 (Spring 2005). 6 Ibid, at Carlos Correa, Traditional Knowledge and Intellectual Property: Issues and Options surrounding the protection of Traditional Knowledge, Quaker United Nations Office Discussion Paper (November, 2001), available at last seen on 20/04/ P a g e JOURNAL ON CONTEMPORARY ISSUES OF LAW

3 objective, while concerns for safeguarding the novelty of TK can be seen as another objective. However, ensuring that TK is not inappropriately exploited by third parties is by far the principal objective. From the perspective of the TK holders, TK is at risk of vanishing; its survival is in question. Moreover, modern methodology in use for a variety of purposes seems far more feasible. The lack of efforts for expansion of TK only adds to the problem. In its report on a series of factfinding missions, WIPO 8 sought to summarize the concerns of traditional knowledge holders as follows: (a) Concern about the loss of traditional life styles and of traditional knowledge, and the reluctance of the younger members of the communities to carry forward traditional practices; (b) Concern about the lack of respect for traditional knowledge and holders of traditional knowledge; (c) Concern about the misappropriation of traditional knowledge including use of traditional knowledge without any benefit sharing, or use in a derogatory manner; (d) Lack of recognition of the need to preserve and promote the further use of traditional knowledge. If we take the example of Traditional Medicine, it not only serves purpose of health care for the indigenous communities, but also provides for their income. A standard illustration of traditional medicine is that the use of a specific plant with a precise technique helps cure a disorder. It is estimated that at least 25% of all modern medicines are derived, either directly or indirectly, from medicinal plants, primarily through the application of modern technology to traditional knowledge. 9 According to data provided to World Health Organization, in India 70 percent of the population and in Ethiopia more than 90 percent of the population depends on TM for primary health care. 10 It is reported that more than 70 percent of the population in Chile and 40 percent of the population in Colombia have used traditional medicine. In China, traditional medicine accounts for approximately 40 percent of all health care delivered. Thus, Traditional Medicine plays its part 8 World Intellectual Property Organization, Intellectual Property Needs and Expectations of Traditional Knowledge Holders, WIPO Report on Fact-Finding Missions ( ) available at last seen on 30/04/ Molly Meri Robinson and Xiaorui Zhang, The World Medicines Situation 2011 (WHO, 2011). 10 WHO Traditional Medicine Strategy , World Health Organisation, available at last seen on 30/04/ P a g e JOURNAL ON CONTEMPORARY ISSUES OF LAW

4 in the contemporary world. It is an alarming matter that in spite of the pervasive use of TK in the current world, there remains so much concern for its conservation. INTERNATIONAL FRAMEWORK FOR PROTECTION OF TRADITIONAL KNOWLEDGE The Convention on Biological Diversity (CBD), signed at the United Nations Conference on Environment and Development (UNCED) in 1992, was the first international environmental convention to develop measures for the use and protection of traditional knowledge, related to the conservation and sustainable use of biodiversity. Article 8(j) of the Convention on Biological Diversity made the first ever attempt to create an international obligation to provide protection for traditional knowledge associated with biological diversity. It reads thus: Each contracting party shall, as far as possible and as appropriate: (j) Subject to national legislation, respect, preserve and maintain knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity and promote their wider application with the approval and involvement of the holders of such knowledge, innovations and practices and encourage the equitable sharing of the benefits arising from the utilization of such knowledge innovations and practices. Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) sets out certain conditions under which certain biological materials or intellectual innovations may be excluded from patenting. 11 In 2000, WIPO established an Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC). In 2009, WIPO 11 Article 27.3 (b), TRIPS Agreement 4 P a g e JOURNAL ON CONTEMPORARY ISSUES OF LAW

5 agreed to develop an international legal instrument that would give traditional knowledge, genetic resources and traditional cultural expressions (folklore) effective protection. 12 The UN Draft Declaration on Rights of Indigenous Peoples 13 Article 29 of the UN Draft Declaration on Rights of Indigenous Peoples reads thus: Indigenous peoples are entitled to the recognition of the full ownership, control and protection of their cultural and intellectual property. They have the right to special measures to control, develop and protect their sciences, technologies and cultural manifestations, including human and other genetic resources, seeds, medicines, knowledge of the properties of fauna and flora, oral traditions, literatures, designs and visual and performing arts. The existing international intellectual property system does not completely protect traditional knowledge and traditional cultural expressions. Hence many communities and governments have called for an international legal instrument providing sui generis protection. Sui generis protection of TK attempts to resolve several intellectual property issues regarding traditional knowledge. Principally, a sui generis system might be defined to create legal rights that recognise any associated TK relating to generic resources and promote access and benefit sharing. FORMS OF INTELLECTUAL PROPERTY RELATED PROTECTION SYSTEMS WITH REGARDS TO TK IP related protection systems regarding TK can be broadly classified into positive protection and defensive protection. Positive protection includes preventing unauthorised use and active exploitation of Traditional Knowledge by the originating community itself. On the other hand, defensive protection refers to a set of strategies to ensure that third parties do not gain illegitimate 12 Traditional Knowledge and Intellectual Protection, World Intellectual Property Organisation, available at last seen on 30/04/ U.N. General Assembly, United Nations Declaration on the Rights of Indigenous Peoples, Res. 61/295, (13/08/2007) available at last seen on 30/04/ P a g e JOURNAL ON CONTEMPORARY ISSUES OF LAW

6 or unfounded IP rights over TK. These measures include the amendment of WIPO-administered patent systems (the International Patent Classification System and the Patent Cooperation Treaty Minimum Documentation). Some countries and communities are also developing TK databases that may be used as evidence of prior art to defeat a claim to a patent on such TK. 14 The Traditional Knowledge Digital Library initiative taken up by India is one such example of defensive protection. TRADITIONAL KNOWLEDGE DIGITAL LIBRARY In India after the neem patent controversy, the need to protect India s traditional knowledge has gained significance. India has taken initiative through the Traditional Knowledge Digital Library, a collaborative project between the Council of Scientific and Industrial Research (CSIR) and Department of Ayush which is a digital knowledge repository of India s traditional knowledge especially relating to medical formulations. It is a home grown effort to prevent misappropriation of India s traditional medical knowledge at International patent offices. Traditional Knowledge Digital Library has overcome language and format barriers by methodically converting and structuring the available contents (around million medical formulations) of the ancient texts on Indian Systems of Medicines i.e. Ayurveda, Siddha, Unani and Yoga, into five international languages, namely, English, Japanese, French, German and Spanish, with the help of information technology tools and an innovative classification system called the Traditional Knowledge Resource Classification (TKRC). 15 TKRC has enabled incorporation of about 200 sub-groups under A61K 36/00 in International Patent Classification instead of few sub-groups earlier available on medicinal plants under A61K 35/00 thus enhancing the quality of search and examination of prior-art with respect to patent applications field in the area of traditional knowledge. The TKDL is available to all patent offices that have signed a TKDL Access Agreement which has built-in, non-disclosure mechanisms to safeguard India s interests and counter any possible 14 Traditional Knowledge, World Intellectual Property Organisation, available at last seen on 30/04/ About TKDL, Traditional Knowledge Digital Library available at last seen on 31/04/ P a g e JOURNAL ON CONTEMPORARY ISSUES OF LAW

7 misuse. Under such an agreement, patent examiners may use the TKDL for search and examination purposes only and its contents may only be revealed to third parties for the purposes of citation. 16 So far, India has signed TKDL Access Agreements with the EPO and the patent offices of Australia, Canada, Japan, Germany, Chile, the United Kingdom and the United States. TKDL is proving to be an effective deterrent against bio-piracy and is being recognized as a global leader in the area of traditional knowledge protection. IPR POLICY OF KERALA GOVERNMENT, INDIA The Government of Kerala released the Intellectual Property Rights (IPRs) policy for Kerala in It envisaged adoption of concepts such as knowledge commons and common license for protection of traditional knowledge. The policy seeks to put all traditional knowledge into the realm of knowledge commons, distinguishing this from the public domain. The chief architects of the Policy are Prof. Prabhat Patnaik and Mr. R.S. Praveen Raj. Under the said policy, all rights holders of traditional knowledge will be deemed to be holding their rights under a commons license. Under this license, the right holder permits others the use of the knowledge for noncommercial purposes. The policy proposes that the State should make it mandatory for all applications from foreigners to the National Biodiversity Authority for making use of traditional knowledge of Kerala to be referred to the State Biodiversity Board. The policy also specifies that patents taken out on research output by State government research institutions funded by private or foreign sources should be in the domain of commons. CONTROVERSIES Accessibility to TK has never been a hurdle. The ready availability has however, rendered TK vulnerable to misappropriation. Bio piracy is essentially the stealing of such knowledge without acknowledgement of its original source. Bio piracy occurs when genetic resources and traditional 16 Protecting India s Traditional Knowledge, World Intellectual Property Organisation, available at last seen on 30/04/ IPR Policy proposes knowledge commons, The Hindu (28/06/2008). 7 P a g e JOURNAL ON CONTEMPORARY ISSUES OF LAW

8 knowledge is taken from biodiverse countries without permission. This knowledge is then used to patent related inventions without sharing the resulting commercial profits.18 It is not only that they seek to make money from resources and knowledge that rightfully belong to the developing countries, but in so doing, they squelch domestic firms that have long provided the products.19 There have been quite a few cases in point wherein patents have been wrongly demanded, and patent offices like the European Patent Office (EPO), United Kingdom Trademark & Patent Office (UKPTO) and the United States Patent and Trademark Office have incorrectly granted these patents. The misuse of these patents has been witnessed most in the pharmaceutical sector. The Secretariat of the CBD has estimated that the world market for herbal medicines has reached US$ 43 billion, with annual national growth rates of between 5 and 15%. India has been involved in controversies regarding bio piracy. The turmeric controversy and the neem patent cases are some of the prominent examples. THE TURMERIC CONTROVERSY In 1995, two Non-Resident Indians, associated with the University of Mississippi Medical Centre, USA obtained a patent for the use of turmeric in wound healing. However, turmeric has been used as a traditional wound healer in India since time immemorial and the Council of Scientific and Industrial Research (CSIR) challenged the patent on the ground that it lacked novelty. CSIR could locate 32 references (some of them being more than one hundred years old, in Sanskrit, Urdu and Hindi) that showed that this finding was well known in India prior to filing of this patent. The inventors based their argument on the difference of physical attributes in the powder and paste form of turmeric and that someone ordinarily skilled in the use of turmeric would not expect with any reasonable degree of certainty that the powdered form would be useful for the same purposes as the paste form. The inventors further mentioned that oral administration was available only with honey and honey itself was considered to have wound healing properties. However, the examiner rejected all the claims put forth by the inventors and upheld the contentions raised by CSIR. The 18 Cynthia M. Ho, Bio piracy and Beyond: A Consideration of Socio-Cultural Conflicts with Global Patent Policies, 39 University of Michigan Journal of Law Reform 433, 436 (2006). 19 Stiglitz JE, Globalization and its Discontents, (2002). 8 P a g e JOURNAL ON CONTEMPORARY ISSUES OF LAW

9 turmeric patent case is among the first successful cases in the arena of intellectual property rights violations. NEEM PATENT CONTROVERSY In 2005, India won a 10-year-long battle at the European Patent Office (EPO) against a patent granted to an anti-fungal product derived from neem. The EPO had granted the patent to the US Department of Agriculture and the multinational W.R. Grace in 1995, though neem derivatives had also been traditionally used to make insect repellents, soaps, cosmetics, tooth cleaners and contraceptives. Under usual circumstances, an application for a patent should always be rejected if there is prior existing knowledge about the product sought to be patented. However, in the United States, "prior existing knowledge" is only recognized if it is published in a journal and not if it has been passed down through generations of oral and folk traditions. The Indian Government still argued that the medicinal neem tree is part of traditional knowledge in India and that the fungicide qualities of the neem tree and its use as such fungicide had been known in India for over 2,000 years. 20 NOVARTIS V. UNION OF INDIA The Hon ble Supreme Court in a landmark judgment in Novartis AG v. Union of India21 delivered on April 1, 2013, dismissed the appeal of the Swiss drug maker Novartis for grant of a patent over its anti-cancer drug Glivec in India. The judgment was a massive blow to the pharma major, and came down strongly on ever greening of drugs. Supreme Court accepted the existence of imatinib mesylate as prior art by looking into Zimmerman patent and thus declared it not to be a invention under section 2(1)(j) and section2(1) (ja) of the Patents Act, A. Panaganiya, Myths & Realities of Neem-Based Patent (1996), available at http.// PatentsJanl696.htm, last seen on 30/04/ Novartis AG v. Union of India, AIR 2013 SC Ibid, at P a g e JOURNAL ON CONTEMPORARY ISSUES OF LAW

10 WIPO DRAFT PROVISIONS ON TRADITIONAL KNOWLEDGE AND TRADITIONAL CULTURAL EXPRESSIONS The existing international mechanisms available for protection of traditional knowledge are inadequate. The WIPO Intergovernmental Committee on Intellectual Property, Genetic Resources, Traditional Knowledge and Folklore (IGC) has brought out draft provisions on traditional knowledge (TK) and traditional cultural expressions. 23 It identified that there may be varied indigenous interests with regard to the use of Indigenous Knowledge: (a) IK which the indigenous community may not want to make known to others, for example sacred art or rituals but which may be misappropriated for commercial benefit; (b) IK that may be made known to others for commercial exploitation like medicinal knowledge, for which the indigenous community would want both sharing of benefits and acknowledgement of source; (c) IK which the particular community may want to develop further, use and preserve without making it known to others. The draft provisions with regard to TK expand the scope of indigenous knowledge as they seek to protect all knowledge that is generated in a traditional context 24 or created in a manner that reflects the traditions of communities. 25 It recognizes that protection should be extended to at least those forms of traditional knowledge that provide a sense of linkage and distinctive association with the particular indigenous community. 26 This is a breakthrough from individual ownership of IPR by recognizing the concept of the indigenous community as the custodian of the traditional knowledge and the inherent link between the indigenous knowledge and the indigenous community. To address the current problem of misappropriation 27, the provisions allow for its protection through a variety of measures like that of a sui generis systems, intellectual property law and other existing laws. Hence, it allows maximum amount of flexibility to the 23 Draft Provisions for the Protection of Traditional Knowledge and Traditional Cultural Expressions, and IP & Genetic Resources, available at last seen on 31/04/ Article 3(2), Revised Provisions for the Protection of Traditional Knowledge. 25 Megan M. Carpenter, Intellectual Property Law and Indigenous Peoples: Adopting Copyright Law to the Needs of a Global Community, 7 Yale Human Rights and Development Journal 51 (2004). 26 Commentary on Article 4 of the Revised Provisions for the Protection of Traditional Knowledge. 27 Article 1(1), Revised provisions for the Protection of Traditional Knowledge. 10 P a g e JOURNAL ON CONTEMPORARY ISSUES OF LAW

11 national governments to enact laws according to the legal system and to use all means to protect indigenous knowledge. 28 Further, to prevent future misappropriation and to prevent commercial exploitation, the principle of prior informed consent 29 is introduced that prohibits others from using traditional knowledge without the formal permission of the indigenous community. This empowers the indigenous community to determine the traditional knowledge it wants to make known to others and the reasons for doing so, making it capable to earn benefits and also refuse the access of traditional knowledge. Thus, the ultimate repository of traditional knowledge is the indigenous community and the authority created by states under these provisions is to play an enabling role to help the enforcement of these provisions. By recognizing that the indigenous community is to control the TK, the draft provisions address the issue of control, which the CBD does not address. Even the provisions with regard to folklore recognise both tangible and non-tangible forms of expression. 30 ANALYSIS OF WIPO DRAFT PROVISIONS ON TRADITIONAL KNOWLEDGE AND TRADITIONAL CULTURAL EXPRESSIONS The WIPO draft provisions on traditional knowledge do not have a formal status in international law but they can be useful for furthering indigenous interests. They recognize that the type of protection to be given to indigenous knowledge will have to depend on the nature of the relationship between the various forms of indigenous knowledge and the indigenous community. However, these provisions to be really effective, rely on sui generis which are intellectual property systems that are specially tailored to suit local interests. This system relies on states to enact laws keeping in mind prevailing local conditions. While sui generis systems have been developed by countries like Panama, the territorial approach of these laws prove a limitation towards the enforcement of such protection at an international level, as most of the commercialization of indigenous knowledge takes place in developed countries. However, the recognition of the WIPO draft provisions will depend on the status of the Draft Declaration and changes in TRIPS. TRIPS does not prevent states to enact legislations to protect indigenous knowledge but to make sui generis legislations effective in the international regime, 28 Commentary on Article 2 of the Revised Provisions for the Protection of Traditional Knowledge. 29 Supra 27, Article 7(1). 30 Ibid, Article 1(a). 11 P a g e JOURNAL ON CONTEMPORARY ISSUES OF LAW

12 changes may have to be incorporated into TRIPS to recognise the sui generis systems of various states. While this will ensure that the scheme of protection is national, it will make it obligatory on states that do not have such systems to respect the sui generis laws of other states. RECOMMENDATIONS TO STRENTHEN THE CURRENT IPR REGIME For ensuring effective protection, the priorities have to be outlined. There has to be clarity over the issues which should be put on a stronger threshold the economic benefits, the legal rights, or the issue of conserving novelty. Defensive protection would ensure that none other than the holders of TK would be able to acquire intellectual property rights over that knowledge. 31 There are numerous solutions to the problem. If we see the existing mechanism, better utilization of the Intellectual Property system can be reflected upon. IPR s provide rights to a certain person or company to exercise sole rights over a product or component. The IPR system has been utilized effectively in the past for the protection of TK. In 1958, the igloo trade mark was established to protect works created by the Dene, Metis and Inuvialuit peoples of Northern Canada. In 2002, the toi iho trade mark was established was developed by Te Waka Toi, Creative New Zealand s Maori Arts Board. 32 These however, are rare illustrations. In order to ascertain utmost effectiveness of the current IPR system, there has to be made a rational relation between the instruments of Intellectual Property and the TK which is to be protected. Patents under Intellectual Property are what concern Traditional Knowledge. Patenting of TK has largely been discouraged because of several reasons. Patenting requires proof of novelty, which is not as simple as it might sound. Further, patenting requires the product/plant/herb to be put out on public domain, as information of patent is published by the patenting authority. This process itself is a risk to the protection of novelty of TK. The use of Geographical Indications has also been mentioned in various instances, but GI s can only give a geographical extent to a certain TK, it cannot be effectively used to prevent the misuse of TK. 31 WIPO, Intergovernmental Comm. on Intellectual Property & Genetic Res., Traditional Knowledge and Folklore, Consultation Paper: Recommendations on the Recognition of Traditional Knowledge in the Patent System, WIPO/GRTKF/IC/13/7 Annex (Sept. 18, 2008). 32 Ros Stein, Trade Marks Protection and ICIP: How Does Australia Fare?, Arts Law Centre Of Australia, (2006). 12 P a g e JOURNAL ON CONTEMPORARY ISSUES OF LAW

13 The use of instruments of Intellectual Property Law for the safeguarding of TK has been planned upon for much over a decade now; yet, there is not much on the international scene to show for it. Protection systems on the international scale are ineffective if national legislations do not exist. If light of the same, several countries, India included have enacted legislations for the protection of TK and its subsidiaries. Pharmaceutical companies have invested millions in 'bio-prospecting,' a process by which companies dispatch researchers to search for biological source material and active compounds that can be turned into a commercial product. 33 There have been successful efforts to prevent bio piracy, examples of which were the Neem and Turmeric patent cases. CONCLUSION In light of the abovementioned discussions, it is seen that protection of Traditional Knowledge and Indigenous Intellectual Property is an issue of utmost importance in the international legal scenario. A good legal framework is necessary for protection of TK. Traditional Knowledge has huge scope, provided its utilization is carried out properly. Protection mechanisms both IP and sui generis have been implemented, and success has been achieved. Nevertheless, these mechanisms for protection for TK have to be further strengthened. National and international efforts have also helped to serve the purpose of protecting TK. However, this has not been free from controversies, which have even lead to international disputes. 33 Marcia E. De Geer, Biopiracy: The Appropriation of Indigenous Peoples' Cultural Knowledge, 9 New England Journal of International and Comparative Law, 180 (2003). 13 P a g e JOURNAL ON CONTEMPORARY ISSUES OF LAW

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