When an invention uses Indian biological material, the patentee must disclose the source and obtain National Biodiversity Authority (NBA) approval. But is a patent doomed if that approval is merely pending? In Manu Chaudhary v. Controller of Patents and Designs [C.A.(COMM.IPD-PAT) 36/2024], the Delhi High Court held that awaiting approval is not the same as failing to obtain it.
Refused while the clock ran at the NBA
The application (no. 201711047431, an oral herbal pain-killer composition and its process) was refused on three grounds: failure to obtain NBA approval within the prescribed period, non-patentability under Section 3(p), and non-compliance with Sections 128 and 132 on authorised representation. Crucially, the applicant had applied to the NBA and had informed the Controller (by email of 28 December 2023) that the NBA’s acknowledgment was received. The refusal nonetheless issued on 22 February 2024, without awaiting the outcome — and the NBA approval was in fact granted on 4 July 2024.
Defer, don’t refuse
The Court read the statutory scheme purposively. Section 6(1A) of the Biological Diversity Act requires NBA registration before grant of a patent — not at filing — and the Patent Office Guidelines for traditional-knowledge and biological-material applications likewise provide that a patent shall not be granted without NBA approval, not that it must be refused in its absence. There is no provision mandating outright rejection merely because approval is pending. The Controller’s discretion under Section 15 should therefore have been exercised to defer the decision once it was clear the applicant had applied and the delay was beyond its control. The refusal was set aside and remanded for fresh consideration in light of the (now granted) NBA approval.
Why it matters
For applicants in the traditional-knowledge, nutraceutical and herbal space — where NBA clearances are routinely slow — this is a sensible and practical ruling: keep the Office informed, file the NBA application early, and a pending approval should buy a deferral rather than a refusal. It also fits a wider pattern in recent appeals: where a deficiency is procedural or timing-related and beyond the applicant’s control, courts prefer deferral and remand to outright rejection — a theme this blog has tracked from Daewoong to the Orissa restoration case. The substantive questions — including Section 3(p) — remain open for the remand.
Sources & further reading: Section 6(1A), Biological Diversity Act; Section 3(p), Patents Act; Section 15.
Educational note: This case summary is general information, not legal advice.