Section 6 and Rule 16: The legal framework
Section 6 of the Biological Diversity Act, 2002 (‘BDA’) as amended in 2023, mandates that no person shall apply for intellectual property rights based on research or information on Biological Resources (‘BR’) accessed from India without approval from the National Biodiversity Authority (‘NBA’).
Rule 16 of the Biological Diversity Rules, 2024 (‘Rules’) outlines the procedure for implementing Section 6. For non-Indian entities falling under Section 3(2), prior approval is mandatory before the grant of patent in India or abroad. Applications must be filed online in Form 7, accompanied by the prescribed fee. Approval is formalized through a signed agreement with ABS obligations, and applicants must notify NBA within 45 days of grant of the patent.
For Indian entities under Section 7, the process differs. They do not require prior approval before the grant of the patent but must register with NBA (Form 8) before the grant and undertake to seek approval before commercialization. At the commercialization stage, they must apply for prior approval through Form 9.
Unclear boundaries: How interpretation creates compliance challenges
A major challenge under Section 6 and Rule 16 is the interpretation of the term ‘access’. The law requires approval or registration only when an invention is based on research or information including digital sequence information (‘DSI’) on BR accessed from India, including those deposited in repositories outside India, or traditional knowledge associated thereto. This creates two clear conditions: 1) The invention must be based on research or information on BR; and 2) BR must have been accessed from India.
The prescribed forms under Rule 16, Form 7 for non-Indian entities and Forms 8 and 9 for Indian entities, reflect this intent. For instance, Form 7 mandates providing the ‘Nature of the accessed biological resource(s)’ and includes a declaration that prior approval is mandatory for access to BR and associated knowledge while commercializing of the granted patent. This language clearly limits the requirement for resources that have been accessed.
However, recent scrutiny by the Indian Patent Office and the NBA has seemingly extended this scope. Objections are now raised for any BR disclosed in the patent specification and claims, even when such BRs appear only as part of a laundry list of alternatives, which is a common drafting practice. These may include commercial host cells such as E. coli or yeast, natural sugars/polymers, or other widely available components not actually accessed from India. In many cases, the invention is not based on these materials, nor have they been accessed from India. Nevertheless, the NBA requires Applicants to provide details regarding the source or access of such biological resources, which can impose an additional compliance burden on the Applicant, that is not contemplated under the law.
For example, consider an invention involving a recombinant construct comprising a gene from Banyan (Ficus benghalensis), which originates in India. NBA approval is required because the invention is based on digital sequence information (DSI) from an Indian BR. However, if the claims also mention host cells like E. coli for gene expression, the NBA may require the Applicant to provide the source of such host cells. Similarly, if the patent specification lists media components for culturing these cells, even if chemically synthesized, the NBA may seek source details for such components. This raises the question: should approval be required for commercially sourced host cells or standard biological components? The BDA does not support such an interpretation, as the invention is not based on these materials and these may not even be accessed from India.
Another scenario: If an invention involves a recombinant gene conferring herbicide tolerance and is tested in a model organism (e.g., rice), the invention is based on the recombinant construct, not the model plant. Should NBA approval be required for the model plant? Further, if the claims include an exhaustive list of rice species commonly used as models, should the Applicant provide source details for all listed plant species to the NBA, even if these were not actually used? This ambiguity creates unnecessary and burdensome compliance hurdles.
Additional uncertainty arises from the definition of ‘access’ under Section 2(a) of the BDA, which includes collecting, procuring, or possessing any BR occurring in or obtained from India for research, bio-survey, or commercial utilization. If host cells, model organisms, or media components are purchased from an Indian vendor who sourced them internationally, does this constitute ‘access’ of Indian BRs? The Act does not clarify this scenario, leaving Applicants uncertain about compliance obligations. Such lack of clarity, combined with seeking information beyond the purview of the BDA, imposes an undue burden on innovators and discourages research, which runs contrary to the objectives of the BDA.
Conclusion
To ensure fairness and promote innovation, scrutiny under Section 6 and Rule 16 should remain consistent with the statutory provisions, their intended purpose, such that approvals should be mandated only when an invention is genuinely based on BR accessed from India. Extending compliance to ancillary biological materials or globally available biological materials used merely for testing, introduces unnecessary complexity and discourages research, ultimately disincentivizing Applicants from seeking patent protection in India. Clear procedural guidance and a precise interpretation of ‘access’ as actual collection or procurement of Indian-origin BR will help maintain transparency and ease of compliance.
[The authors are Executive Director and Associate, respectively, in IPR practice at Lakshmikumaran & Sridharan Attorneys, New Delhi]
