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Role of National Biodiversity Authority in the Patent Grant

The National Biodiversity Authority [1] (NBA) is an autonomous and statutory body under the Ministry of Environment, Forests, and Climate Change. It was constituted in 2003 to implement India’s Biological Diversity Act (2002). NBA performs facilitative, regulatory, and advisory functions for the Indian Government on the issues related to conservation, sustainable use of biological resources, and fair and equitable sharing of benefits of the use of biological resources. The headquarters of the NBA is located in Chennai. The structural composition of the Biodiversity Authority comprises of the Authority, Secretariat, State Biodiversity Boards, Biodiversity Management Committees, and Expert Committees.

The implementation of the provisions of the Biological Diversity Act (2002) is mandated through The National Biodiversity Authority’s decentralized with emphasis on advising the Central Government on the relevant matters mentioned above and advising the State Governments

The function of the National Biodiversity Authority:

1. The National Biodiversity Authority regulates activities referred to in sections 3, 4, and 6 of the Biological Diversity Act (2002) and by regulations issue guidelines for access to biological resources and fair and equitable benefit sharing.[2]
2. The National Biodiversity Authority considers requests by approving or otherwise for undertaking any activity referred to in Sections 3, 4, and 6 of the Biological Diversity Act (2002) as given below:

i) Access to biological resources and knowledge associated thereto[3]
ii) Transfer of research results relating to biological resources occurring in or obtained from India[4]
iii) Intellectual Property Rights (IPR) based on any research or information on biological resources obtained from India[5]
iv) To take measures necessary to oppose the grant of IPR in any other country outside India on biological resource or knowledge associated thereto, obtained from India[6]

3. To advise the Central Government on biodiversity-related matters.[7]
4. To advise State Governments in certain issues under the Act.[8]
5. The National Biodiversity Authority, on behalf of the Central Government, take any measures necessary 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 biological resource which is derived from India.[9]

Role of the National Biodiversity Authority in the Patent process

The Biological Diversity Act, 2002, was passed with the aim of the provision of equitable sharing of benefits of the usage of biological resources and knowledge. Under this objective, Section 6 of the Biological Diversity Act strictly forbids an application for any intellectual property right within or outside India, about any invention with a basis in research or information on biological resources obtained from India, without prior approval of National Biodiversity Authority (NBA).

However, Section 6 provides an exception for a patent applicant. The Patent applicant may obtain permission from the Biodiversity Authority following acceptance of the patent, however, it must be prior to the sealing of the patent by the concerned patent authority.[10] Section 6 of the Biodiversity Act 2002 which mandates that if biological material obtained from India is used in the application for patent, then permission and other information for making an application for patent should be obtained from the National Biodiversity Authority and details should be furnished in the application form 1 column 9 (iii). Appropriate application form (Form 3, Rule 18) for such permission is available on the website of the National Biodiversity Authority.

The Patents Act (1970) is interconnected with the Biodiversity Act in the fact that it is mandatory to mention the source and geographical origin of the biological resource obtained. If the biological resource used by the patent applicant is of Indian origin, a declaration should be given during the filing of the patent application that the necessary permission from the National Biodiversity Authority would be submitted prior to the grant of the patent. In the case where the resource is not of Indian origin, the same should be mentioned in the specification along with the foreign source and geographical origin. The Patents Act further complements the Biodiversity Act in that failing to disclosure or false disclosure of the source and geographical origin of biological resource may amount to a ground for opposition or even revocation of the patent grant.

Implementation of mandates toward proper disclosure of source and geographical origin of the biological material obtained is country checkpoints to prevent misappropriation of biological resources. Thus, this is in furtherance of the critical focus of the National Biodiversity Authority as outlined in the “aims and objectives” to ensure the “fair and equitable sharing of the benefits arising out of the use of biological resources.”

[1] It is established as under Section 8 in Chapter III of The Biological Diversity Act, 2002.
[2] Section 18(1) of the Biological Diversity Act, 2002.
[3] Section 3 of the Biological Diversity Act, 2002.
[4] Section 4 of the Biological Diversity Act, 2002.
[5] Section 6 of the Biological Diversity Act, 2002.
[6] Section 6 of the Biological Diversity Act, 2002.
[7] Section 18(3) (a) of the Biological Diversity Act, 2002.
[8] Section 18(3) (b) of the Biological Diversity Act, 2002.
[9] Section 18(4) of the Biological Diversity Act, 2002.
[10] Provided further that the National Biodiversity Authority shall dispose of the application for permission made to it within ninety days from the date of receipt thereof though the timeline can be extended due to issues such as incomplete applications and procedural delays resulting from the need to consult other authorities at the state and local levels or expert committees for ABS (Access and Benefit Sharing) arrangements.

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