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Intellectual Property (IPR) : Intellectual Property (IPR) Number of distinct types of legal monopolies over creations of the mind, both artistic and commercial, and the corresponding fields of law. Under intellectual property law, Owners are granted certain exclusive rights to a variety of intangible assets, such as musical, literary, and artistic works; ideas, discoveries and inventions; words and phrases, symbols, and designs. The Common types of intellectual property include copyrights, trademarks, patents, industrial design rights and trade secrets in some jurisdictions. Convention on Biological Diversity (Rio de Janeiro, of June 1992) : Convention on Biological Diversity (Rio de Janeiro, of June 1992) The United Nations Convention on Biological Diversity reaffirms the Sovereign Rights of the States over their Biological Resources and the contracting parties have further agreed to develop national strategies, plans or programmes for the conservation and sustainable use of biological diversity. Biodiversity : Biodiversity Biological diversity encompasses all species of plants, animals and micro- organisms and the variation between them, and the eco-systems of which they form a part. It occurs at three levels, namely: Species level - refers to number and kinds of living organisms; Genetic level - refers to genetic variation within a population of species; and (iii)Ecosystem level - refers to the variety of habitats, biological communities and ecological processes that occur in such habitats. Traditional Knowledge (TK) : 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. Slide 6: India is one of the twelve-mega biodiversity 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 - 70 per cent of the total geographical area of the country. Over 91,000 species of animals and 45,000 species of plants have been recorded by the Botanical Survey of India and the Zoological Survey of India respectively. Slide 7: India is also one of the twelve primary centers of origin of cultivated plants and is rich in agricultural biodiversity. India is equally rich in traditional and indigenous knowledge, both coded and informal. Convention On Biological Diversity (CBD) : Convention On Biological Diversity (CBD) India is a party to the Convention on Biological Diversity (CBD), which came into force on 29 December 1993. It has three main objectives, namely, the conservation of biological diversity, the sustainable use of its components and fair and Fair and equitable sharing of benefits arising out of the utilization of genetic resources. TK Have To Be Shared With People : TK Have To Be Shared With People 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. Biological Diversity Act, 2002 : Biological Diversity Act, 2002 India ratified to the CBD Convention has passed the Biological Diversity Act, 2002 to promote Conservation of biological diversity, Sustainable use of its components and Equitable sharing of benefits arising out of the use of biological resources. The legislation 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. The legislation provides for a National Authority, which will grant approvals for access, subject to conditions, which ensure equitable sharing of benefits. TRIPS, Biodiversity And Patent Issues : TRIPS, Biodiversity And Patent Issues In the recent 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); Now patents have been obtained in other countries on hypoglycaemic properties of karela (bitter gourd), brinjal (egg plant), 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 (Trade-Related Aspects of Intellectual Property Rights) Agreement is aiding the exploitation of biodiversity by privatizing biodiversity expressed in life forms and knowledge. Slide 12: 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 microbiological and non-biological processes, as per the provisions of the TRIPS Agreement (Trade-Related Aspects of Intellectual Property Rights) . Criteria of Patentability : Criteria of Patentability To assess the WTO compatibility of a patent granted by a foreign patent office to an invention based on biological material obtained from India, 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. A patent granted in the United States on the wound-healing properties of turmeric, for example, was revoked after such an examination. Similarly, a patent granted on the need as a fungicide was revoked in the European Patent Office in May 2000. Problem of bio-piracy : Problem of bio-piracy The problem of bio-piracy may not be resolved with such revocation actions and domestic biodiversity legislation alone. There is a need to provide appropriate legal and institutional means for recognizing the rights of tribal communities on their TK 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 TK. This can be done by harmonizing 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. A classic case of biopiracy by transnational corporations is that of the neem tree in India : A classic case of biopiracy by transnational corporations is that of the neem tree in India Several extracts of neem have recently been patented by US companies, and many farmers are incensed at what they regard as intellectual piracy. The village neem tree has become a symbol of Indian indigenous knowledge, and of resistance against companies, which would expropriate this knowledge for their own profit. The neem's many virtues are to a large degree attributable to its chemical constituents. From its roots to its spreading crown, the tree contains a number of potent compounds, notably a chemical found in its seeds named azadirachtin. It is this astringency that makes it useful in so many fields: Medicine Neem is mentioned in many ancient texts and traditional Indian medical authorities place it at the pinnacle of their pharmacopeia. The bark, leaves, flowers, seeds and fruit pulp are used to treat a wide range of diseases and complaints ranging from leprosy and diabetes to ulcers, skin disorders and constipation. Toiletries Slide 16: Neem twigs are used by millions of Indians as an antiseptic tooth brush. Its oil is used in the preparation of toothpaste and soap. Contraception Neem oil is known to be a potent spermicide and is considered to be 100% effective when applied intra-vaginally before intercourse. Intriguingly, it is also taken internally by ascetics who wish to abate their sexual desire. Timber Besides being hard and fast growing, its chemical resistance to termites makes neem a useful construction material. Fuel Neem oil is used as lamp oil, while the fruit pulp is useful in the manufacture of methane. Slide 17: Agriculture The Upavanavinod, an ancient Sanskrit treatise dealing with forestry and agriculture, cites neem as a cure for ailing soils, plants and livestock. Neem cake, the residue from the seeds after oil extraction, is fed to livestock and poultry, while its leaves increase soil fertility. Most importantly, neem is a potent insecticide, effective against about 200 insects, including locusts, brown plant-hoppers, nematodes, mosquito larvae, Colorado beetles and boll weevils. These properties, and others, known to Indians for millennia, have led to the tree's being called in Sanskrit Sarva Roga Nivarini, the curer of all ailments', or in the Muslim tradition, Shajar-e-Mubarak, the blessed tree' Prior Informed Consent (PIC) of the country of origin. : Prior Informed Consent (PIC) of the country of origin. 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 amendments proposed to the Patents Act 1970 through the Patents (Second Amendment) Bill 1999. 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. Protection of Traditional Knowledge Associated with Biological Resources : Protection of Traditional Knowledge Associated with Biological Resources Issues relating to protecting, recognizing and rewarding of TK 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 grey 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 in the conventional legal systems of IPR protection (e.g., patents, copyrights, trademark, etc.). Slide 20: These conventional forms of IPRs are inadequate to protect indigenous knowledge essentially because they are based on protection of individual property rights, whereas TK is, by and large, collective. Further, the informal knowledge presents other difficulties in being recognized 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 TK, such as India. Suggestions/Options for Protecting Traditional Knowledge : Suggestions/Options for Protecting Traditional Knowledge Various suggestions advanced to extend protection to knowledge, innovations and practices includes: (i) Documentation of TK:proper documentation of associated TK could help in checking bio-piracy. (ii) Registration and innovation patent system; and (iii) Development of a sui generis system. Slide 22: It is assumed that if the material/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 are/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 until it is closely held by the community - as soon as it is put on paper, it will become accessible to pirates and would be purloined. Village-wise Community Biodiversity Registers (CBRs) : Village-wise Community Biodiversity Registers (CBRs) In India, preparation of village-wise Community Biodiversity Registers (CBRs) for documenting all knowledge, innovations and practices has been undertaken in a few States. The State Plan for Kerala has also actively promoted documentation of local knowledge regarding biodiversity in people's biodiversity registers. One pilot project on this has been completed in Ernakulam District. Two other projects at a single Panchayat level have been initiated by the Tropical Botanic Garden and Research Institute and the Kerala Forest Research Institute. Another interesting development in Kerala is the development of a benefit-sharing arrangement between the Tropical Botanical Garden Research Institute and the Kani tribe, based on whose knowledge a drug was developed and then marketed. The state of Karnataka presents a unique example of NGO initiatives in the formulation of Peoples' Biodiversity Registers (PBRs). Some experts who were part of the State Planning Board recommended the Karnataka Biodiversity Conservation Order in 1996. This order envisaged biodiversity boards at the state and sub-state levels, with a wide range of stakeholders being members of the board, and envisaged PBRs as part of the responsibilities of the boards. One of the organized and widespread attempts of NGOs has been towards initiating and completing biodiversity registers. Traditional Knowledge Digital Library : Traditional Knowledge Digital Library In the recent past, there have been several cases of bio-piracy of TK from India. For preventing such instances in future there is a need for developing digital databases of prior art related to herbs already in the public domain. Following patents on brinjal, etc., in India, an exercise has been initiated 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. Slide 25: 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 Registration and innovation patent system : Registration and innovation patent system 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. International Action : International Action 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 TK related to biodiversity cannot be limited to national action alone, and a basic understanding and respect for an internationally recognized 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; and • an undertaking that the prevalent laws and practices of the country of origin have been fully respected. Conclusion : Conclusion 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 onus must also be shared by the users 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 CBD. Thanks! : Thanks! Dr.Vinod Khanna Zoological Survey of India Dehra Dun <firstname.lastname@example.org. You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.