The Intersection of the Patents Act and the Protection of Bio-Resources in India

India is one of the world’s most biodiverse nations, home to thousands of plant species, indigenous medicinal traditions, and centuries of documented knowledge about the natural world. This wealth of biological resources has long attracted the attention of pharmaceutical companies, biotechnology firms, and researchers worldwide. While innovation built on natural resources is entirely legitimate, a serious problem has historically plagued the system: inventors sometimes sought patents for ideas that communities in India had known and used for generations – without any disclosure, credit, or compensation. This is where the Indian Patents Act, 1970 and the Biological Diversity Act, 2002 work in tandem to create a transparent, accountable framework for anyone seeking patent protection that involves India’s bio-resources.

Why bio-resources and patents need to intersect 🔗

A patent grants an inventor the exclusive right to commercially exploit an invention for a limited period. To receive that right, the invention must be novel, involve an inventive step, and be capable of industrial application. But what happens when the “invention” is really just the extraction or slight modification of knowledge that indigenous communities have held for centuries? Left unregulated, the patent system can become a tool for misappropriation – what experts call biopiracy.

India’s response was to embed disclosure obligations directly into the Patents Act itself and to create a separate statute governing access to biological resources. Together, these two laws ensure that if a biological resource or traditional knowledge forms the basis of a patent, that fact must be declared, approved, and accounted for.

The disclosure mandate under the Patents Act 🔗

Section 10(4)(d)(ii): source and geographical origin 🔗

Section 10(4)(d)(ii) of the Patents Act requires every patent applicant to fully disclose the source and geographical origin of any biological material used in their invention. This is not optional or advisory – it is a statutory obligation embedded in the specification requirements of the patent application itself. If a company develops a pharmaceutical compound using a plant found in the Western Ghats, the application must name the species and state where it was sourced.

This requirement was significantly strengthened through the Patents (Amendment) Act, 2002 and the subsequent 2005 amendments, which aligned Indian law with India’s obligations under international agreements, particularly the Convention on Biological Diversity (CBD).

Form 1 declaration 🔗

Beyond the specification itself, Form 1 of the patent application contains a specific declaration that the applicant must sign. This declaration requires the applicant to confirm whether any biological material from India has been used in the invention and to state that necessary permission from the competent authority will be submitted before the patent is granted. The declaration also requires disclosure of any traditional knowledge associations – that is, whether the invention draws from knowledge historically used by local or indigenous communities.

Failure to provide accurate information through this declaration has serious consequences: the application can be rejected outright, and if a patent has already been granted, it can be revoked. Additionally, non-compliance can attract a penalty of at least one lakh rupees under the Biological Diversity Act.

The Biological Diversity Act, 2002: the regulatory gateway 🔗

While the Patents Act handles disclosure, the Biological Diversity Act, 2002 (BD Act) governs who can access India’s biological resources and under what conditions. It establishes a three-tier institutional structure: the National Biodiversity Authority (NBA) at the national level, State Biodiversity Boards (SBBs) at the state level, and Biodiversity Management Committees (BMCs) at the local body level.

Section 6: prior approval for intellectual property rights 🔗

Section 6 of the BD Act directly addresses the link between biodiversity and intellectual property. It provides that no person shall apply for any intellectual property right – including patents – in India or abroad, for any invention based on research or information on a biological resource obtained from India, without obtaining prior approval from the NBA. This applies whether the patent is being filed at the Indian Patent Office, the USPTO, the EPO, or any other jurisdiction.

There is a practical carve-out for Indian applicants: where a person applies for a patent, NBA permission may be obtained after the acceptance of the patent but before the patent is sealed (i.e., before grant). However, the requirement is still mandatory – it cannot be bypassed entirely.

Different rules for Indian and foreign applicants 🔗

The BD Act draws an important distinction based on who the applicant is. Foreign applicants – meaning those who are not Indian citizens or residents, or body corporates not registered in India or those with foreign participation in capital or management – must obtain prior NBA approval before accessing any biological resource and before filing a patent application. Indian entities, following the 2023 amendments to the BD Act, are required to register with the NBA rather than seek prior approval, easing the compliance process while retaining regulatory oversight.

Section 3(p): when traditional knowledge itself bars a patent 🔗

The Patents Act goes one step further than mere disclosure. Section 3(p) explicitly bars the grant of a patent for any invention that is, in effect, an aggregation or duplication of known properties of traditionally known components. In other words, if the claimed invention is simply restating or recombining knowledge that already exists within indigenous or traditional systems of medicine, it cannot be patented in India.

This provision is paired with Sections 25(1)(k) and 25(2)(k), which allow any person to file pre-grant and post-grant oppositions to a patent application on the ground that the claimed invention is anticipated by knowledge available within any local or indigenous community in India – including oral knowledge. These opposition mechanisms provide a practical route to challenge wrongful patents even after they are filed.

Benefit sharing: ensuring communities are compensated 🔗

Disclosure and approval alone are not enough. The BD Act also mandates fair and equitable benefit sharing as a condition of accessing biological resources. Under Section 21 of the BD Act, the NBA is required to ensure that any approval for accessing biological resources includes terms that secure equitable sharing of benefits with the communities from which those resources were sourced.

Benefit sharing is not limited to cash payments. The Act provides for several modes, including joint ownership of intellectual property rights between the applicant and the NBA or identified benefit claimers, technology transfer, setting up venture capital funds for benefit claimers, association of local scientists and community members with ongoing research, and payment of monetary or non-monetary compensation. The 95% of any royalty collected is directed toward the indigenous and local communities recognised as benefit claimers under the Act.

A landmark example of benefit sharing in practice is the Jeevani case. The Tropical Botanic Garden and Research Institute (TBGRI) in Kerala collaborated with the Kani tribal community to develop a drug based on the Arogyapacha plant, traditionally used by the tribe for energy and stamina. The agreement that followed shared 50% of licensing fees and royalties with the Kani tribe through a dedicated trust fund – one of the first formal benefit-sharing arrangements of its kind in India.

The TKDL: a defensive shield against biopiracy 🔗

Legal provisions work best when backed by evidence. India’s most powerful practical tool against biopiracy is the Traditional Knowledge Digital Library (TKDL), established in 2001 as a joint initiative of the Council of Scientific and Industrial Research (CSIR) and the Ministry of AYUSH. The TKDL is a searchable digital database cataloguing India’s traditional medicinal knowledge – from Ayurveda, Unani, Siddha, and Yoga – translated into five international languages and formatted according to international patent classification systems so that patent examiners worldwide can use it.

The TKDL was born directly out of two embarrassing biopiracy episodes that galvanised Indian policymakers.

The turmeric and neem cases 🔗

In 1995, researchers at the University of Mississippi obtained a US patent for using turmeric in wound healing. India’s CSIR challenged the patent, presenting evidence from ancient Sanskrit texts and a 1953 scientific paper demonstrating that this use was centuries-old traditional knowledge. The USPTO revoked the patent in 1997. Shortly after, the American chemical company W.R. Grace had obtained European patents over neem’s antifungal properties. After a decade-long battle, the European Patent Office revoked those patents in 2000, acknowledging that neem’s pesticidal use was well-established traditional knowledge. Both cases revealed that the absence of easily accessible, patent-office-compatible documentation of Indian traditional knowledge was the root problem.

Since its establishment, the TKDL has contributed to the withdrawal or rejection of over 300 patent applications worldwide that attempted to claim traditional Indian knowledge as novel invention. The Indian Patent Office also issued detailed guidelines in 2012 for examining patent applications relating to traditional knowledge and biological material, directing examiners to mandatorily search the TKDL before granting such patents.

What happens when disclosure requirements are not met 🔗

Non-disclosure of source and geographical origin is not a mere procedural lapse – it is a substantive ground for action. Under the Patents Act, wrongful or incomplete disclosure of biological material can be cited as a ground for pre-grant opposition under Section 25(1) and for post-grant revocation under Section 64. This means a patent that was incorrectly granted on the basis of undisclosed bio-resources can be cancelled entirely at a later stage. The BD Act independently imposes financial penalties for access without NBA approval and for applying for intellectual property rights without the required clearance.

India’s position in the international framework 🔗

India’s domestic framework is also shaped by – and shapes – international law. India ratified the CBD in 1994 and became party to the Nagoya Protocol in 2014, an international agreement under the CBD that operationalises access and benefit-sharing requirements for genetic resources. The Protocol obligates signatory countries to ensure that users of genetic resources in their jurisdiction comply with the prior informed consent requirements and benefit-sharing obligations of the country of origin.

At the World Trade Organization, India has consistently pushed for amendments to the TRIPS Agreement to require all member countries to implement disclosure-of-origin requirements similar to those in the Indian Patents Act. In May 2024, WIPO member states adopted a new treaty on intellectual property, genetic resources, and associated traditional knowledge that mandates disclosure requirements for patent applicants using genetic resources – a significant step toward the global standard India has long advocated for.

The balance the law is trying to strike 🔗

It is important to understand that the law does not prohibit innovation based on biological resources or traditional knowledge. What it prohibits is undisclosed, uncomensated extraction. A pharmaceutical company can still develop a genuine new drug based on a plant compound found in India – but it must disclose the source, obtain the necessary approvals, and share the benefits with those who conserved and maintained that knowledge. The system is designed to reward innovation while ensuring that the communities whose generations of knowledge made that innovation possible are not left out of the equation.

As the National Law School’s ABS portal notes, India is among the first countries in the world to operationalise access and benefit-sharing at scale, handling a large volume of approvals and compliance cases annually. Challenges remain, particularly around oral traditional knowledge that is not yet documented in the TKDL and around the complexity of compliance for smaller Indian research institutions. The 2023 amendments to the BD Act addressed some of these concerns by easing registration requirements for Indian entities and AYUSH practitioners, signalling that the framework is evolving – but the core principle of transparency and equitable benefit sharing remains firmly in place.

What do you think? Does mandatory disclosure of biological resource origins strike the right balance between protecting indigenous knowledge and incentivising genuine scientific innovation? And given that oral traditional knowledge remains largely outside the TKDL, how should Indian law evolve to protect knowledge that was never written down?

References

1. https://www.ipindia.gov.in
2. https://www.indiacode.nic.in/bitstream/123456789/21545/1/the_biological_diversity_act,_2002.pdf
3. https://stratjuris.com/biodiversity-2/
4. https://www.cbd.int
5. https://www.rkdewan.com/articles/source-and-geographical-origin-understanding-section-10-of-the-indian-patent-act-1970/
6. https://www.legalbites.in/environment-law/the-biological-diversity-act-2002-overview-of-access-and-benefit-sharing-provisions-1128830
7. https://indiankanoon.org/doc/548841/
8. https://chambers.com/articles/safeguarding-traditional-knowledge-under-indian-patent-law-can-legal-frameworks-keep-pace
9. https://www.lakshmisri.com/insights/articles/a-rising-need-for-a-modern-understanding-of-traditional-knowledge-under-indian-patent-law/
10. https://www.wipo.int/en/web/traditional-knowledge/w/tklaws/article_0011
11. https://www.lexology.com/library/detail.aspx?g=88e00ba9-d3c8-43dc-a6af-f76d62bd0aed
12. https://en.wikipedia.org/wiki/Traditional_Knowledge_Digital_Library
13. https://www.taxtmi.com/article/detailed?id=14431
14. https://pmc.ncbi.nlm.nih.gov/articles/PMC9999701/
15. https://www.puthrans.com/combating-biopiracy-how-indias-tkdl-protects-traditional-knowledge/
16. https://pmc.ncbi.nlm.nih.gov/articles/PMC4588132/
17. https://www.lexology.com/library/detail.aspx?g=18044b89-4c2d-4516-904c-34f7779c6a22
18. https://abs.nls.ac.in/?page_id=219