Biological Diversity Act Section 6: NBA Approval for IP on Indian Biological Resources

The Biological Diversity Act, 2002 is one of the most distinctive elements of Indian IP-adjacent regulation. Section 6 requires anyone applying for an IP right (patent or otherwise) based on research or information on biological resources obtained from India to obtain prior approval from the National Biodiversity Authority (NBA). The provision implements India's obligations under the Convention on Biological Diversity (CBD) and (subsequently) the Nagoya Protocol on access and benefit-sharing. For Indian biotech, pharma, Ayurveda, food technology and agricultural companies — and for foreign applicants seeking patents on inventions developed using Indian biological material — the Section 6 approval is mandatory and the framework is enforced criminally. This guide covers what triggers the requirement, the approval procedure, the benefit-sharing mechanism, and the consequences of non-compliance.

What Section 6 requires

Section 6(1) of the Biological Diversity Act 2002 provides: 'No person shall apply for any intellectual property right, by whatever name called, in or outside India for any invention based on any research or information on a biological resource obtained from India without obtaining the previous approval of the National Biodiversity Authority before making such application.'

The provision applies to:

• Patents — including Indian patents and foreign-filed patents (PCT, US, EP, etc.)
• Other IP rights — plant variety registration under PPV&FR, design registration, copyrights where the invention is based on biological resources
• Any biological resource obtained from India — plants, animals, micro-organisms, genetic material, derivatives, products

The provision is broad and applies even to Indian residents and Indian companies — not just foreign applicants. The compliance requirement is universal.

If the invention used Indian biological material, NBA approval comes before the patent application — not after.

What 'biological resource' means

Section 2(c) defines biological resources broadly: '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'.

The breadth captures:

• Whole plants, animals, micro-organisms
• Plant parts, animal parts, microbial cells
• Genetic material (DNA, RNA, plasmids)
• Cell lines, cultures, isolated extracts
• By-products of biological processes

Excluded: human genetic material (covered by separate frameworks), value-added products (where the original biological resource has been substantially transformed into something not recognisably biological).

The NBA approval process

The application for NBA approval involves:

1. Form III application — identifying the applicant, the biological resource, the research/invention, the IP right being sought, and any commercial intent
2. Application fee — varies by applicant category
3. Disclosure of source — geographic origin of the biological resource, including the specific community or region
4. Benefit-sharing proposal — proposed mechanism for sharing benefits with the relevant community, state biodiversity board or national authority
5. NBA review — internal review of the application, consultation with state biodiversity boards and (where applicable) the originating community
6. Approval, conditional approval, or rejection — typically issued within 6-12 months

Conditional approvals are common — the NBA may grant approval subject to specific benefit-sharing terms, royalty obligations, or restrictions on commercial use.

Benefit-sharing under Sections 21 and 41

Section 21 of the Act requires the NBA to ensure equitable sharing of benefits arising from the use of biological resources. The benefit-sharing mechanism can take several forms:

• Royalty payments on commercial use of inventions based on the biological resource — typically 0.5%-5% of sales
• Lump-sum payments to the originating community or state biodiversity board
• Capacity-building support — funding research, training, infrastructure in the originating region
• Joint ownership of the resulting IP in some cases
• Access to commercial products on preferential terms for the originating community

The benefit-sharing terms are negotiated as part of the NBA approval process and form part of the approval order. Compliance is monitored by the NBA and the state biodiversity boards.

Disclosure requirements in patent applications

Indian patent applications include a specific declaration on biological resources. Form 1 includes Section 8 of the form addressing 'Source and geographical origin of any biological material used in the invention'. The applicant must:

• Disclose the source and geographical origin of any biological material used
• Confirm whether NBA approval has been obtained where required
• Provide the NBA approval reference

Inadequate or false declarations are a separate ground for opposition and revocation under Section 64.

The TKDL and the Biodiversity Act overlay

The Biodiversity Act framework operates alongside the Traditional Knowledge Digital Library and the Section 3(p) prior-art framework. The combined effect:

• TKDL — patent offices search the database for prior art on traditional formulations
• Section 3(p) — Indian examiners apply the exclusion for traditional knowledge under the Patents Act
• Biodiversity Act Section 6 — requires NBA approval and benefit-sharing before IP rights are obtained on biological-resource-based inventions
• Source disclosure in patent applications under Section 10(4) of the Patents Act and Form 1

Together, the framework substantially protects Indian biological resources and traditional knowledge from inappropriate patenting and ensures benefit-sharing flows to originating communities.

Penalties for non-compliance

Section 55 of the Biodiversity Act makes non-compliance with Section 6 (and other Act provisions) criminal:

• Imprisonment up to 5 years
• Fine up to ₹10 lakh, or where the damage caused exceeds ₹10 lakh, the fine can be commensurate with the damage
• Subsequent offences carry enhanced penalties

The NBA has prosecuted high-profile non-compliance cases, including against multinational companies that obtained patents based on Indian biological resources without prior NBA approval. Several pending IP applications have been challenged on Section 6 grounds.

The takeaway

The Biological Diversity Act 2002 Section 6 framework is mandatory for any IP application based on Indian biological resources. The NBA approval process, the benefit-sharing mechanism, the source-disclosure requirements in patent applications and the criminal penalties for non-compliance together create a substantial regulatory layer alongside the patent system. For Indian biotech, pharma, Ayurveda, food technology and agricultural companies, integrating NBA approval into the patent filing calendar is operational discipline. The framework protects Indian biological heritage and ensures equitable benefit flows from commercial use of national resources. IPForte's IP audit practice handles NBA approval coordination as part of patent strategy in biotech and Ayurveda contexts.