Under the Patents Act, 1970, where invention uses biological material from India or the source and/or the origin of the biological material is from India as per disclosure in the specification, the applicant is required to disclose the source and geographical origin and obtain approval from the National Biodiversity Authority (NBA) under Section 10(4)(ii)(D), read with Section 6(1A) of the Biological Diversity Act, 2002. However, the statutory scheme does not mandate that such approval must accompany the patent application at the time of filing or that the application must be rejected merely because NBA approval is pending. The consistent position, also reflected in the Patent Office Guidelines, is that a patent cannot be granted without NBA approval, but not that it must be refused in its absence where the applicant has already applied and is awaiting a decision.

This position was recently clarified by the Delhi High Court in Manu Chaudhary vs Controller of Patents and Designs [C.A.(COMM.IPD-PAT) 36/2024].

The appeal arose from the refusal of patent application number 201711047431 relating to an oral herbal pain killer composition and the process of preparation of the same. The application was refused on the grounds that the Appellant failed take approval from NBA within the prescribed period of 15 days, non-patentability under Section 3(p) and non-compliance of Sections 128 and 132 which provide that only authorized Patent Agents and Advocates are entitled to represent their clients in hearings/proceedings before the Controller of Patents (unlike proceedings before the Registrar of Trade Marks, where authorized representatives are permitted to appear).

Before the Court, the Appellant demonstrated that an application for NBA approval had been filed and that the Controller had been informed (via email dated December 28, 2023) that acknowledgment from the NBA had been received. However, the impugned order was passed on February 22, 2024, without awaiting the outcome in the NBA process. The approval was subsequently granted on July 4, 2024.

The Court held that the Controller ought to have deferred the decision once it was clear that the applicant had applied for NBA approval and that the delay was beyond the Appellant’s control. The Court emphasized:

• Section 6(1A) of the Biological Diversity Act only mandates registration with the NBA before grant of patent.
• The Guidelines for Processing of Patent Applications relating to Traditional Knowledge and Biological Material merely require that patents shall not be granted without NBA approval.
• There is no statutory provision mandating outright rejection of a patent application solely because the approval is not placed with the application and/or during the hearing.
• The Controller’s discretion under Section 15 should have been exercised to defer the decision rather than refuse the application.

Accordingly, without entering into the merits, the Court set aside the refusal and remanded the matter for fresh consideration, directing the Controller to re-examine the application after taking into account the subsequently granted NBA approval.