If an invention draws on a plant, animal, micro-organism or other biological material obtained from India — or on traditional knowledge about it — the patent application carries two obligations that most applicants never meet. The specification must say where the material came from. And the patent cannot be granted until the National Biodiversity Authority has cleared the use. Both are regularly missed, and either can cost the patent.
Quick reference
| Trigger | Biological material obtained from India, or associated traditional knowledge, used in the invention |
| In the specification | Disclose the source and geographical origin |
| Before grant — foreign applicant | Prior approval of the National Biodiversity Authority |
| Before grant — Indian applicant | Registration with the Authority; approval later, at commercialisation |
| Form 1 | A declaration on the point |
| If skipped | Ground of opposition and revocation; grant withheld |
What triggers it
Two separate laws are engaged.
The Patents Act requires the complete specification to disclose the source and geographical origin of any biological material used in the invention, and makes failure to do so — or doing it wrongly — a ground of pre-grant opposition, post-grant opposition and revocation. It is a formal ground and does not depend on the merits of the invention.
The Biological Diversity Act governs access to India’s biological resources and the knowledge associated with them, and it requires the Authority’s involvement before intellectual property rights are obtained over inventions based on them. The Patent Office will not grant a patent until that requirement is shown to be met.
“Biological material” is read broadly: plants and plant extracts, animals and animal products, micro-organisms, genetic material, and — since the 2023 amendment — digital sequence information relating to Indian resources. The trigger is that the resource was obtained from India, whether directly or from a repository, in India or abroad.
Indian and foreign applicants — different routes since 2023
The Biological Diversity (Amendment) Act 2023, with rules in force from December 2024, split the requirement in two.
Foreign applicants — non-citizens, non-residents, and Indian companies with foreign shareholding or control — need the Authority’s prior approval before the patent is granted. The application for approval is made to the Authority, which may attach benefit-sharing terms, and the approval is filed at the Patent Office.
Indian citizens and Indian entities no longer need approval before grant. They must register with the Authority before the patent is granted, and obtain its approval later, at the point of commercialising the patent. The intention is to remove the Authority from the path to grant for domestic applicants while keeping it in the path to the market.
Either way, the Patent Office needs to see that the relevant step has been taken, and examiners raise the point where the specification discloses Indian biological material. Form 1 carries a declaration on the subject, and a wrong declaration is its own problem.
Exemptions
The Authority’s process does not apply to everything biological. Resources normally traded as commodities on a notified list are outside it. So is codified traditional knowledge — material already recorded in the classical texts of the Indian systems of medicine — and, since 2023, cultivated medicinal plants and certain other categories the amendment excluded to ease research. The exemptions are specific, and whether a resource falls within one is a question to answer before filing, not after the examiner asks.
What goes wrong
The specification is silent on source. The material is described by its scientific name and nothing more. The examiner asks; the applicant cannot answer with certainty; the omission becomes a ground.
The material came from a collection abroad. An applicant assumes that a strain obtained from a foreign culture collection is outside the Indian rules. If the strain originated in India, it is not.
The approval is sought late. The Authority’s process takes time. An applicant who starts it when the examiner raises the point can find the application ready for grant and the approval months away.
The declaration on Form 1 is ticked without thought. The form asks whether the invention uses biological material from India. Ticking “no” when the answer is “yes” is a false statement to the Office, separate from the substantive failure.
Getting it right
Identify at drafting whether any biological material in the invention originated in India. If it did, disclose the source and origin in the specification precisely — where it was collected or obtained, and from whom. Check the exemptions. Then, depending on who the applicant is, either apply to the Authority for approval or register with it — early enough that the answer arrives before the application is ready for grant.
Frequently asked questions
When does an Indian patent application need NBA approval? When the invention is based on biological material obtained from India, or on traditional knowledge associated with it. Foreign applicants need the Authority’s prior approval before grant; since the 2023 amendment, Indian citizens and entities register before grant and obtain approval at commercialisation.
What must the specification disclose about biological material? The source and geographical origin of any biological material used in the invention. Failure to disclose it, or disclosing it wrongly, is a ground of pre-grant opposition, post-grant opposition and revocation.
Does the NBA requirement apply to Indian companies? Indian citizens and Indian entities without foreign shareholding or control now register with the Authority before grant and seek approval when commercialising. Indian companies with foreign control are treated as foreign applicants and need prior approval before grant.
Does material from a foreign culture collection count? Yes, if the material originated in India. The trigger is the origin of the resource, not where it was obtained, and the 2023 amendment extended it to Indian resources held in repositories abroad and to digital sequence information.
What is exempt from NBA approval? Biological resources normally traded as commodities on the notified list, codified traditional knowledge, and certain categories such as cultivated medicinal plants excluded by the 2023 amendment. The exemptions are specific and should be checked against the current notifications.
What happens if NBA approval is not obtained? The Patent Office withholds grant until the requirement is met, and the non-disclosure of source in the specification is independently a ground for opposition and revocation.
Useful official resources
- National Biodiversity Authority — applications, forms and the exemption notifications
- IP India — patents — Form 1 and the Manual of Patent Office Practice
See our related notes on what can and cannot be patented and how examination raises these points.
An invention that uses a plant extract, a strain or a genetic sequence with Indian origins? Talk to us before filing, not after the examiner asks.