Biodiversity and IP: The Struggle Is Real

The Indian Patent Office has seen a steady increase in the number of patent filing in the last few years. A number of these patent applications are centered around biological resources. If you or your company are applying for a patent that uses or is based on biological resources, an important piece of legislation that must considered is the Biological Diversity Act (BDA), 2002. This article aims to provide an insight on some provisions of the BDA that must be kept in mind while accessing and using biological resources from India. The next article in this series discusses some practical aspect of filing and prosecuting patent applications that use biological resources.

BIOLOGICAL DIVERSITY ACT – SOME IMPORTANT PROVISIONS

The Biological Diversity Act, 2002 was passed by the Indian Parliament keeping in mind the rich biological diversity of India and the wealth of traditional knowledge associated with this diversity. The aim of this act was “to provide for conservation of Biological Diversity, sustainable use of its components and fair and equitable sharing of the benefits arising out of the use of biological resources, knowledge and for matters connected therewith or incidental thereto.”

To achieve this aim, BDA includes various provisions to regulate the access and use of biological resources from India and knowledge associated with it, by Indian and foreign nationals as well as companies.

Before discussing these provisions in detail, it is important to answer the question, “What are biological resources? The BDA, defines them as “Biological resources means plants, animals and micro-organisms or parts thereof, their genetic material and by-products (excluding value added products) with actual or potential use or value but does not include human genetic material”. Thus, while the definition of biological resources is quite exhaustive and includes within its ambit plants, animals and micro-organisms, their parts, their genetic material and by-products, there are some exceptions. These exceptions include value added products and human genetic material.

Accessing and use of Biological Resources-

Under section 3 of the BDA, foreign citizens, foreign corporations, Non-resident Indians (as defined by the Indian Income Tax Act) and Indian corporate bodies having non-Indian shareholding or management require prior approval of National Biodiversity Authority(NBA), an authority established under the BDA to access biological resources occurring in India or knowledge associated with it. Approval is required for research, commercial utilization, for bio-survey and for bio-utilization.

While Indian citizens are not required to seek prior approval for accessing biological resources for research, Section 7 of the BDA mandates that people who are citizens of India and entities registered in India can obtain biological resources occurring in India for “commercial utilization” or “bio- survey and bio-utilization for commercial utilization” only after giving an intimation of said access to the concerned State Biodiversity Board (SBB) in the form and manner prescribed under the concerned State Biodiversity Rules.

Transfer of Research Results:

Although, Indian citizens can carry out research on Indian Biological resources, without seeking prior approval under BDA, they cannot transfer the results of their research to any foreign citizens, foreign corporations, Non-resident Indians, Indian corporate bodies having non-Indian shareholding or management, without prior approval of NBA, as per Section 4 of BDA. Permission is required in all cases including when results are transferred without any monetary consideration. However, publication of research paper or dissemination of knowledge in any seminar or workshop is exempted under section 4 of BDA.

Filing of Patent Applications

Understanding the importance that patents play, BDA requires that every applicant irrespective of their nationality, must seek permission from NBA before applying for any Intellectual Property Right within or outside India, for inventions based on any research or information on biological resources obtained from India under Section 6 of the BDA. A request under this section may however be filed and obtained after the acceptance of the patent but before it is sealed. NBA may, while granting the approval, 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.

Penalties

Any contravention or attempt to contravene, these provisions, is punishable with imprisonment for a term, which may extend to five years, or with fine, which may extend to ten lakh rupees under Section 55(1) of BDA. Where the damage caused exceeds ten lakh rupees such fine may commensurate with the damage caused, or with both.

For details on some practical aspect of filing and prosecuting patent applications that use biological resources, please refer to the article titled “Biodiversity and IP – Filing and Prosecuting Patent Applications That Use Biological Resources”.