Balancing Innovation And Conservation: The Intersection Of Indian Patent Law And Biodiversity Law

Introduction

India's legal landscape reflects a unique challenge: how to foster innovation while preserving its rich biodiversity and traditional knowledge systems. This balance is maintained through two pivotal statutes: the Patents Act, 1970 ('Patents Act')¹, and the Biological Diversity Act, 2002 as amended in 2023 ('BDA')². While the Patents Act promotes innovation by granting patents, the BDA ensures that biological resources ('BRs') and associated traditional knowledge occurring in India are conserved and the benefits therefrom are equitably shared. Though these laws serve distinct purposes, they intersect in meaningful ways, acting as checks and balances on each other to prevent biopiracy and unethical commercialization.

Legal history and evolution

India became a founding member of the World Trade Organization (WTO) on 1 January 1995, which necessitated compliance with TRIPS. This led to amendments in the Patents Act to align with global standards, culminating in the 2005 amendment that introduced product patents in all fields of technology. In 2001, India also acceded to the Budapest Treaty, an international convention that governs the deposit of microorganisms in recognized depositories. This treaty addresses the challenge of describing microorganisms in patent specifications by allowing applicants to deposit biological material in culture collections for enablement purposes.

BDA aims to conserve biodiversity, promote sustainable use, and ensure equitable benefit-sharing. It established a three-tier governance structure comprising the National Biodiversity Authority ('NBA'), State Biodiversity Boards ('SBBs'), and Biodiversity Management Committees ('BMCs'). The BDA is aimed at inter alia regulating access to Indian genetic resources and protecting traditional knowledge.

Key provisions of the Patents Act

Under Section 10(4)(d)(ii)(D) of the Patents Act, if a biological material is used in an invention, cannot be sufficiently described in the specification and is not available to the public, the applicant must deposit the material with an International Depository Authority (IDA) under the Budapest Treaty. The specification must include all identifying characteristics, such as the name and address of the depository, the date of deposit, and the accession number. Access to the material must be restricted until the publication of the patent application, and the applicant is required to disclose the source and geographical origin of the biological material. India has two IDAs namely the Microbial Type Culture Collection and Gene Bank (MTCC) in Chandigarh and the Microbial Culture Collection (MCC) in Pune. If the biological material is obtained from India, the applicant must obtain approval from the NBA before the grant of the patent. While submitting an application for the grant of a patent (Form-1), as prescribed under the Second Schedule of the (Patent Rules), the Applicant is required to furnish a declaration indicating whether the invention disclosed in the specification involves the use of any biological material sourced from India and if such material is used, the Applicant must also declare that the necessary permission from the competent authority shall be submitted prior to the grant of the patent.

Key provisions of the BDA

BDA provides the compliance framework which varies for Indian and non-Indian entities seeking IPRs based on BRs accessed from India. The authors have discussed these compliances in detail in a previous article titled "Navigating nature's law: India's legal overhaul of biodiversity access and benefit sharing"³.

For non-Indian entities, Section 6(1) of the BDA mandates prior approval from the NBA before the grant of the Patent, whether in India or any other country. Rule 16(1)(a) of the Biological Diversity Rules, 2024 ('BDARules')⁴ requires such applications to be e-filed using Form 7 for inventions based on Indian BRs and digital sequence information derived from Indian BRs. Regulation 8 of the Biological Diversity Regulation, 2025 ('BDA Regulations')⁵ outlines access and benefit-sharing obligations, which may include up to 1% of the annual gross ex-factory sale price, excluding taxes. If traditional knowledge is utilized, the benefit-sharing amount increases by 25%. Additionally, if the IPR is assigned or licensed to a third party, the applicant must share up to 5% of the license or assignment fee and up to 5% of the annual royalty received. If the IPR is revoked or lapses but the BRs continues to be used in the product commercially, fresh approval under Rule 13 of the BDA Rules is required, and benefit-sharing is governed by Regulation 4 of the BDA Regulations.

For Indian entities, the BDA provides a slightly different compliance pathway. While prior approval from the NBA is not required before the grant of a patent, Section 6(1A) mandates registration with the NBA via Form 8. At the time of commercialization, Section 6(1B) requires prior approval through Form 9. Regulation 9 outlines benefit-sharing obligations similar to those for non-Indian entities, including up to 1% of the annual gross ex-factory sale price and a 25% increase if traditional knowledge is involved. Continued commercial use of BRs after IPR revocation/lapse necessitates fresh approval under Regulation 5, and benefit-sharing obligations must be fulfilled accordingly. If the IPR is assigned or licensed, the applicant must pay up to 5% of the license or assignment fee and up to 5% of the annual royalty, based on sectoral norms and case-specific evaluation.

Intersection and mutual checks

The intersection between the Patents Act and the BDA is inevitable given their respective scopes of operation. Controllers at the Indian Patent Office may request for disclosure of the source and origin of biological materials, to be in line with the BDA's compliance. This ensures transparency and accountability in the use of India's BRs. Both laws work together in consonance to prevent misuse of Indian BRs by requiring NBA compliance, thereby safeguarding indigenous knowledge and biodiversity. While the Patents Act does not mandate benefit-sharing, the BDA fills this gap by ensuring that communities contributing BRs are compensated fairly. Together, these laws harmonize innovation with conservation, promoting research while respecting traditional and cultural heritage.

Challenges and Recommendations

India's legal framework governing patents and biodiversity reflects a nuanced and progressive approach to balancing technological advancement with ecological stewardship. While the Patents Act encourages innovation, the BDA ensures that such innovation is aligned with the principles of conservation and equitable benefit-sharing. However, despite the strengths of both statutes, several implementational challenges persist.

A key concern is the lack of coordination between the Indian Patent Office and the NBA, which often leads to procedural inconsistencies. Additionally, there is limited awareness among inventors, researchers, and applicants regarding their obligations under the BDA. Delays in approvals and rigidity in assigning the access and benefit-sharing (ABS) obligations as part of the agreements further hinder compliance and discourage timely innovation.

For instance, Section 2(c) of the BDA excludes value-added products (VAPs) from the definition of BRs. However, in practice, Controllers at the Indian Patent Office, while assessing compliance under Section 6 often do not consider this exemption, creating uncertainty about whether VAPs are indeed excluded from the scope of BRs. This inconsistency in interpretation has led to confusion among stakeholders.

Moreover, Section 40 of the BDA, which exempts BRs "normally traded as commodities (NTACs) or their derived items, including agricultural wastes, medicinal plants and their products for entities covered under section 7" from the Act's provisions, also requires judicial interpretation. A literal reading, especially considering the placement of the comma before "medicinal plants", suggests that the general exemption under Section 40 may apply to both Indian and foreign entities, while the specific exemption for "medicinal plants and their products" may be limited to Indian entities. However, clarity by way of judicial interpretation on this matter would be instrumental in ensuring consistent and predictable application of the law.

To address these challenges, future reforms should focus on enhancing inter-agency collaboration, expediting NBA approvals, and increasing outreach and training for stakeholders. Importantly, compliance with the BDA should be streamlined in a manner that supports the Indian Patent Office's functioning, rather than becoming an administrative roadblock.

Conclusion

India's legal framework governing patents and biodiversity reflects a nuanced and progressive approach to balancing technological advancement with ecological stewardship. The Patents Act fosters innovation, while BDA ensures that such innovation respects and rewards the contributions of India's biodiversity and indigenous communities. Under the BDA, compliance requirements have been streamlined for Indian individuals and entities. Specifically, when Indian BRs are accessed for research purposes, no prior approval is required. In cases of commercial utilization, only an intimation to the respective State Biodiversity Board is necessary.

For patent applications based on Indian BRs, Indian applicants are required to register with the NBA before the grant of the patent using Form-8. Prior approval via Form-9 is mandated only if the invention is commercialized, thereby offering a faster and more efficient compliance pathway. In contrast, foreign individuals or entities must obtain prior approval from the NBA for accessing Indian BRs, whether for research (Form-1) or commercial utilization (Form-2). Furthermore, if a foreign applicant seeks to file a patent application based on Indian BRs, prior approval must be obtained through Form-7 before the grant of the patent.

This intersection of patent law and biodiversity regulation is a collaborative safeguard. It ensures that India's future remains both inventive and inclusive, while its rich biodiversity is sustainably protected.

Footnotes

1. Indian Patents Act, 1970.

2. Biological Diversity (Amendment) Act, 2023.

3. See the article here.

4. Biological Diversity Rules, 2024.

5. Biological Diversity (Access to Biological Resources and Knowledge Associated thereto and Fair and Equitable Sharing of Benefits), 2025.

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