By: Ms Dhanada Deshpande.
Recently, there has been a steady increase in patent filing and granting trends in the biotechnological field. Apart from meeting the patentability criteria of novelty, inventive step, and industrial applicability, the subject matter of the invention should contain matter which is not excluded by clauses 3(b), (c), (d), (e), (h), (i), (j) and (p) of the Indian Patent Act, 1970. In addition to these criteria, any patent application containing any research or particulars on the biological resources of India needs to take approval by National Biodiversity Authority (NBA) as per the Biological Diversity Act, 2002. This approval is essential for acquiring a patent in India as well as outside India.
What is the motive of “The Biological Diversity Act, 2002” and what is the role of the National Biodiversity Authority in Achieving this motive?
Various countries including India approved and became a part of a Convention on Biological Diversity (CBD) to address the concerns related to biological diversity and ecosystem globally. In this regard, the Government of India introduced The Biological Diversity Act, 2002 to conserve biological diversity as well as to provide a mechanism for its sustainable use and equitable sharing of benefits arising out of the use and information of the biological resources. The term Bioresources include plants, animals, and micro-organisms or parts thereof, their genetic material and by-products which have potential value. It does not include value-added products and human genetic material. The Act is executed in India through a decentralized system containing various authorities at the local, state, and national levels which help in the smooth implementation of the Act.
At the national level, National Biodiversity Authority (NBA) is an autonomous body headquartered in Chennai, Tamil Nadu is authorized to regulate the use of India’s biological resources, ensure conservation, and provides advice to Central and State Governments on issues of conservation, sustainable use, and access and benefit-sharing. NBA also provides technical and financial assistance to the State Biodiversity Boards (SBBs) and Biodiversity Management Committee (BMC) operational at the state and village level. The NBA was established under the Ministry of Environment, Forests and Climate change, Government of India in 2003 to enact the provisions of the Biological Diversity Act, 2002.
The Act manages the utilization of biological resources available in India. Consumption of Indian biological resource or its information either for commercial purposes or for research purposes, bio-utilization or bio-survey by non-resident Indians, foreigners, foreign companies, or Indian corporate with non-Indian participation is prohibited without prior approval of the NBA as per Section 3 of the Act. Licensing of any research involving a biological resource from India to a foreigner, foreign companies, Indian corporate with non-Indian participation, or non-resident Indians requires prior approval from the NBA under the provision of Section 4 of the Act. Section 6 of the Act makes it mandatory for prior approval from the NBA before applying for IPR originating from an Indian biological resource or the valuable knowledge related to it. These approvals are essential to prevent exploitation of bioresources and keep a check on Biopiracy. The Act also provides for benefit sharing fees and royalty for the conservers of biological resources, creators and holders of knowledge and information relating to the uses of biological resources. The NBA considers requests and then grants or refuses the same for undertaking any activity as per sections 3,4 and 6 of the Act.
Who is required to apply for approval from the NBA under this Act?
- An Indian citizen
- Body corporate registered in India
- Non-resident Indian
- Foreigner(s)
- Body corporate not registered in India
- Body corporate registered in India and having non-Indian participation
How to apply to the NBA for approval and what are the prerequisites?
The application to the NBA can be made through the online interface available on the website of the National Biodiversity Authority and payment of the prescribed fees. There are 4 different forms available for various purposes. Applicants have to file form No. 1 to access biological resources and /or associated knowledge occurring in India for research or bio-survey or bio-utilization or commercial utilization. Form 2 has to be filed to transfer the result of research involving biological resources or knowledge associated with it. Similarly, Form 3 is essential for approval to apply for a patent based on biological resources in India or outside India and Form 4 is applicable in scenarios where the biological material already approved by form 1 has to be transferred to a third party.
Thus The National Biodiversity Authority is instrumental in implementing the provisions of the Biological Diversity Act, 2002. The NBA also has the right on behalf of the Central Government to oppose the grant of intellectual property rights in any country outside India on any biological resource obtained from India or knowledge associated with such a biological resource which is derived from India. Thus NBA plays a vital role in prohibiting the improper use of biological resources and safeguarding the natural biological resources available in India.
Bibliography:
1.National Biodiversity Authority of India website