BIOLOGICS IN INDIA
BRIDGING THE GAP
The Indian Patent Office has issued guidelines aimed at bringing together the intentions of the Patents Act and the Biological Diversity Act, but this has posed serious challenges in obtaining patent protection, say Ranjna Mehta-Dutt and Neha Srivastava of Remfry & Sagar.
36 Life Sciences Intellectual Property Review S
ection 10(4)(ii)(D) of India’s Patents Act, 1970 mandates the disclosure of the source and geographical origin of
biological
material whenever it’s mentioned in a patent specification but not sufficiently described in it or made available to the public.
Te provision is supplemented by the requirement to declare in the application form that “the invention as disclosed in the specification uses the biological material from India and the necessary permission from the competent authority shall be submitted before the grant of patent”.
Te above requirement was introduced in 2005 to complement the provisions of the Biological Diversity Act, 2002 (BDA), which stems from the Convention of Biological Diversity (CBD). Te CBD acknowledges its signatories’ sovereign rights to their genetic resources, and mandates that any access to a country’s genetic resources or any intellectual property derived from them be subject to the equitable sharing of benefits.
Volume 2, Issue 1 Specifically, section 6 of the BDA requires
obtaining prior approval from the National Biodiversity Authority (NBA), an independent body, before applying for a patent for inventions that use biological material from India. Te statute also provides for penalties/sanctions in cases of non-compliance with this requirement.
Although the Patents Act was amended to meet the objectives of the BDA, in practice section 10(4)(ii)(D) and the requirement to obtain NBA approval was not being strictly complied with. Terefore, the Patents Act had failed to serve as a useful check in ensuring the effective implementation and enforcement of the BDA provisions.
In the wake of this missing link, the Indian
Patent Office (IPO) has issued guidelines for the processing of patent applications
related
to biological material. Te guidelines have reaffirmed the requirement to obtain NBA approval before securing the grant of a patent.
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