Summary: The Delhi High Court has clarified that Indian patent applications cannot be
refused solely because approval from the National Biodiversity Authority (NBA) is
pending. For inventions involving biological material, the statutory requirement of NBA
clearance being required before the patent is granted remains, but Controllers must
exercise discretion in handling examination proceedings where such clearance is pending.
In India, applicants seeking patent protection for inventions that use biological material
obtained from India must meet not only the requirements of the Patents Act, 1970 (the Act), but also those under the country’s biodiversity law. Section 10(4)(d)(ii) of the Act requires anapplicant to disclose the source and geographical origin of biological material used in an invention. Relatedly, Section 6 of the Biological Diversity Act, 2002 (BDA), requires that approval of the National Biodiversity Authority (NBA) must be obtained before the grant of any intellectual property right (IPR) based on biological resources obtained from India.
While the legal requirement itself is well settled, a recurring practical issue arises when an applicant has applied for NBA approval but the approval remains pending for reasons beyond the applicant's control. The Delhi High Court recently addressed this issue in Manu Chaudhary v. Controller of Patents and Designs (C.A.(COMM.IPD-PAT) 36/2024, decision dated 7 February 2026), holding that a patent application should not be refused merely because NBA approval is awaited, particularly where the applicant has already taken steps to obtain such approval.
Background
The appeal arose from the refusal of an Indian patent application relating to herbal pain-relief compositions comprising selected herbal ingredients in specific ratios. The First Examination Report (FER) raised objections on grounds of inventive step; patentability under Sections 3(d), 3(e), and 3(p) of the Act; and absence of NBA approval.
In response, the applicant amended the claims and filed detailed submissions. At the hearing stage, the Indian Patent Office (IPO) accepted the applicant’s arguments on inventive step and patentability under Section 3(d) and 3(e), but retained objections under Section 3(p) and absence of NBA approval.
On the remaining latter objection, the applicant informed the IPO that a request for approval had already been sought, and was under consideration by the NBA. Despite being informed thus, the Controller proceeded to refuse the application under Section 15 of the Act on three grounds, including that NBA approval had not been obtained. The applicant challenged this decision in court.
Main Issues
The Court had to deal primarily with two issues, as follows:
1. Can a patent application be refused solely because NBA approval has not been
granted, even though such approval has already been sought?
The Court noted that Section 6, BDA, merely requires that the applicant obtain NBA
approval before IPR is granted. Similarly, the IPO’s Guidelines for Processing Patent
Applications Relating to Traditional Knowledge and Biological Material state that patents
should not be granted without NBA approval. Neither the BDA nor the guidelines
contemplate automatic refusal merely because NBA approval is pending.
According to the Court, this distinction is important because the process of obtaining NBA approval often involves considerable delays. An applicant may diligently file all requests and comply with requirements, yet remain dependent on the timelines of a statutory authority over which it has no control.
Recognising this, the Court observed that once the applicant had demonstrated that an
application for approval had been filed, the Controller ought to have deferred the final
decision rather than reject the patent application outright.
2. What is the scope of the Controller’s discretion under Section 15 of the Act?
The Court held that Section 15 permits the Controller to require amendments or
compliance before proceeding with an application. It also empowers the Controller to
refuse an application only where the applicant fails to comply. The Court emphasized that this provision confers discretion and should not be applied mechanically.
According to the Court, once the Controller was aware that NBA approval had been
applied for and was pending, discretion should have been exercised in favour of granting
additional time rather than refusing the application.
Key Takeaways
This decision provides valuable guidance for applicants of inventions involving biological
resources from India:
– NBA approval remains mandatory before grant of a patent. The judgment does not
dilute this statutory requirement in any way.
– The absence of NBA approval at the examination or hearing stage does not
automatically justify refusal where the applicant has already initiated the approval
process.
– Applicants must maintain a clear record before the IPO, including placing on record
(as soon as possible) evidence of NBA filings, acknowledgements, and
correspondence.
– Controllers must exercise statutory discretion reasonably and in a manner consistent
with the objectives of both the Patents Act, 1970 and the Biological Diversity Act,
2002.
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