BIODIVERSITY ACT 2002 P. ILANANGAI IP CONSULTANT ALTACIT GLOBAL
Biodiversity means Biological diversity, or "biodiversity," refers to the variety of life on earth. It includes diversity of ecosystems, species and genes, and the ecological processes that support them. India is one of the 12- mega biodiversity countries of the world.
Patenting Life Form Article 27(3) of the TRIPS agreement exclude plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes from patentability. This can be barrier to the technological and economic development of the least developed countries, but such exclusion in their respective country does not protect the same from patentability in other region or country. Example includes the issuance of U.K. patent covering nuclear transfer technology, which was used to clone the first animal, the famous „Dolly the Sheep‟
Biopiracy Biopiracy is the illegal appropriation of life -- microorganisms, plants and animals (including humans) -- and the traditional cultural knowledge that accompanies it. Biopiracy commonly operates through the application of Intellectual Property Rights (IPR) (primarily patents) to genetic resources and traditional knowledge. Bioprospecting Bioprospecting is the search for biological resources and accompanying indigenous knowledge primarily for the purpose of commercial exploitation.
Legal Cases TURMERIC: In 1995, two non resident Indians at the University of Mississippi Medical Centre, Jackson, (Suman K.Das and Hari Har P.Cohly) were granted a US patent (Patent number 54015041) for turmeric to be used for healing wounds. The Indian Council for Scientific and Industrial Research (CSIR) filed a re-examination case with the US Patent Office challenging the patent on the grounds of “prior art”, i.e. existing public knowledge . The claim had to be backed by written documentation claiming traditional wisdom. CSIR submitted a document proof in the form of research paper published in 1953 in the Journal of the Indian Medical Association. The US Patent Office upheld the objection and cancelled the patent in 1997.
Neem Indias 10-year-long battle against the grant of a patent on the use of NEEM as a fungicide has finally been won at the European Patent Office (EPO). Patent rights on a method for controlling fungi on plants by the aid of a hydrophobic extracted neem oil had originally been granted by the EPO in September 1994 to the United States Department of Agriculture (USDA) and the New York-based multinational agribusiness corporation WR Grace. In June 1995, a legal opposition to the grant of this patent was filed jointly by Dr Vandana Shiva, director of Delhi-based Research Foundation for Science, Technology and Ecology (RFSTE), Ms Magda Aelvoet of the Green Group in European Parliament and Ms Linda Bullard of International Federation of Organic Agriculture Movements (IFOAM). Consequently, the EPO revoked the patent in May 2000. The MNC, however, appealed the patent revocation. It is against this appeal that the EPO has finally upheld its earlier decision, thereby revoking in its entirety the patent rights once and for all on March 8, 2005.
Convention on Biological Diversity (CBD) The Convention is founded on the principle that local communities generate and are dependent on biodiversity and should continue to benefit from it. Signed in 1992 at the 1992 UN Conference on Environment and Development (UNCED) in Rio de Janeiro entered into force on 29 December 1993. more than 170 countries India became a signatory to the Convention on Biological Diversity (CBD) in June 1992. Three goals To promote the conservation of biodiversity the sustainable use of its components and the fair and equitable sharing of benefits arising out of the utilization of genetic resources.
Why do we need this legislation on biodiversity? To realize equitable sharing of benefits arising out of the use of biological resources and associated knowledge. The proposed legislation primarily addresses the issue concerning access to biological resources by foreign individuals, institutions or companies. to combat what has been termed biopiracy. How will the proposed legislation check biopiracy? The proposed legislation provides that access to biological resources and associated knowledge is subject to terms and conditions, which secure equitable sharing of benefits. Further, it would be required to obtain the approval of the National Biodiversity Authority before seeking any IPR based on biological material and associated knowledge obtained from India.
The Structures of Biodiversity Act- 2002 National Biodiversity Authority (NBA): All matters relating to requests for access by foreign individuals, institutions or companies, and all matters relating to transfer of results of research to any foreigner will be dealt with by the National Biodiversity Authority. State Biodiversity Boards (SBB): All matters relating to access by Indians for commercial purposes will be under the purview of the State Biodiversity Boards (SBB). The Indian industry will be required to provide prior intimation to the concerned SBB about the use of biological resource. The State Board will have the power to restrict any such activity, which violates the objectives of conservation, sustainable use and equitable sharing of benefits. Biodiversity Management Committees (BMCs): Institutions of local self government will be required to set up Biodiversity Management Committees in their respective areas for conservation, sustainable use, documentation of biodiversity and chronicling of knowledge relating to biodiversity.
Salient features of the Biological Diversity Act, 2002:- to regulate access to biological resources of the country; to conserve and sustainably use biological diversity; to respect and protect knowledge of local communities related to biodiversity; to secure sharing of benefits with local people as conservers of biological resources and holders of knowledge and information relating to the use of biological resources; conservation and development of areas of importance from the standpoint of biological diversity by declaring them as biological diversity heritage sites; protection and rehabilitation of threatened species; involvement of institutions of state governments in the broad scheme of the implementation of the Biological Diversity Act through constitution of committees.
Regulation of Access to Biological Diversity[sec (3)] A person who is not a citizen of India or who is a citizen of India but is a non-resident , or a body corporate, association or organization that is not incorporated or registered in India or if incorporated or registered in India has any non- Indian participation in its share capital or management, is prohibited from obtaining any biological resource occurring in India or knowledge associated thereto for research or commercial utilization or for bio-survey or bio-utilization without the prior approval of the National Biodiversity Authority
Application for intellectual property rights not to be made without approval of NBA[Sec (6)] previous approval of the NBA before making application on approval, NBA impose benefit sharing fee or royalty or both or impose conditions including the sharing of financial benefits arising out of the commercial utilization of such rights.
Prior intimation to SBB for obtaining biological resource for certain purposes [Sec(7)] Any biological resource for commercial utilization, or bio survey and bio utilization for commercial utilization shall be obtained after giving prior intimation to the SSB. Exemptions- shall not apply to the local people and communities of the area, including growers and cultivators of biodiversity, and vaids and hakims, who have been practicing indigenous medicine.
The main functions of the NBA [sec(18)] To lay down procedures and guidelines to govern the activities provided under Section 3, 4, and 6. (Permission to foreigners/NRI‟s foreign companies) i)For obtaining any biological resource (Section -3) ii)For transferring the results of any research (Section -4) iii)Certain collaborative research projects exempted (Section 5) To encourage setting up State Biodiversity Boards To build up database and documentation system To create awareness through mass media
The benefits While granting approvals, NBA will impose conditions, which secure equitable share in the benefits arising out of the use of biological resources occurring in India or knowledge relating to them. These benefits could include monetary gains, grant of joint ownership of IPRs, transfer of technology, association of Indian Scientists in R&D, setting up of venture capital fund etc. For individuals , the monetary benefits will be paid directly to them. Otherwise, the amount will be deposited in the National Biodiversity Fund.
Amendments to the Biodiversity Act The Biodiversity Act was amended in May 2009 to specify that bioprospecting permits are only required for the commercialization phase of bioprospecting projects and/or for export. The Minister of the Department of Water and Environmental Affairs must be given notice of a bioprospecting project before the discovery phase begins. An undertaking by the project leaders to comply with the requirements of the Act if the project enters the commercial phase also needs to be given. Researchers should note that a bioprospecting project will be regarded as having entered the commercialization phase once a complete patent application has been filed, irrespective of the actual commercial prospects of the project at that stage. The interests of specific individuals who possess traditional knowledge have now also been protected. Anyone who carries on the commercialization phase of a bioprospecting project based on the traditional knowledge of a specific individual, must now enter into a benefit sharing agreement with the individual. Prior to this amendment, the Act only applied to traditional knowledge which belonged to indigenous communities; and The penalties for contravening the Act have been increased to a fine of up to R5 million for a first offence and up to R10 million for a subsequent offence, and/or imprisonment for up to 10 years