Delhi HC Clarifies NBA Approval Timing in Patent–Biodiversity Interface

I. Introduction

The grant of a patent for an invention derived from biological material sourced from India is conditional on compliance with the Biological Diversity Act, 2002 (BD Act). Section 10(4)(ii)(D) of the Patents Act, 1970 mandates disclosure of the source of biological material, and NBA approval must be obtained before any IP right is granted. The timing of this requirement had generated considerable uncertainty in prosecution practice — this appeal directly addressed when, exactly, approval must be placed on record.

II. Background Facts

The patent application related to an oral herbal pain-killer composition targeting peripheral pain, disclosing synergistic herbal compositions in specific predefined ratios and a reproducible preparation process. After FER objections (including on inventive step, Sections 3(d), 3(e), 3(p), and NBA approval), the applicant filed a substantive response and amended claims. The Controller narrowed objections to two at the hearing: (a) NBA approval; and (b) Section 3(p) non-patentability — signalling persuasion on inventive step and novelty.

At the hearing, the applicant informed the Controller that an email had been sent enclosing the NBA acknowledgement, demonstrating that approval was pending. The Controller nonetheless refused the application on 22 February 2024 on three grounds: NBA approval not obtained within 15 days; Section 3(p) non-patentability; and unauthorised representation (the attendee was not a registered patent agent). The NBA approval was eventually received on 4 July 2024.

III. The Court's Holding: NBA Approval Timing

The Court decisively rejected the Controller's interpretation. Anchoring its analysis in Section 6(1A) of the BD Act, the Court held that the obligation is to register with the NBA before IP rights are granted — not before the hearing or the order. This reading was fortified by the official BD Act Guidelines:

• Paragraph 19: The patent shall not be 'granted' unless NBA permission has been submitted.
• Paragraph 22: No patent shall be 'granted' without necessary permission where the invention uses biological material from India.

Both provisions operate as conditions precedent to 'grant', not to the hearing. The Court also noted a structural reason why flexibility is required: the timing of NBA approval is not within the applicant's control. An applicant cannot 'insist' that the authority grant approval within any particular timeframe. It would be fundamentally unjust to penalise an applicant for administrative delay over which they bear no responsibility.

IV. The Deferred-Order Doctrine

The Court found that since: (i) the applicant had informed the Controller that NBA approval was awaited; (ii) the Controller was satisfied that the invention was novel; and (iii) the sole outstanding matter was regulatory clearance from a third body — the proper course was plainly to defer the order. The Court held that Section 15 of the Patents Act grants the Controller wide powers, including the power to defer where a pending approval lies outside the applicant's control. Refusal is a remedy of last resort under Section 15.

V. Questions Left Open

The Court expressly refrained from deciding: (a) Section 3(p) non-patentability — whether the herbal composition amounts to a patentable invention or merely a 'new use' of known materials without technical advancement; and (b) Representation issues — whether the earlier hearing was vitiated by the unauthorised representative. Both issues are remanded to the Controller.

VI. Operative Directions

The respondent (Controller) shall re-examine the patent application after granting a fresh opportunity of hearing, taking the NBA approval into account alongside all prior oral and written arguments. No fresh material shall be placed by the applicant except the NBA approval. The Controller shall take a decision within two months of receiving the order.

VII. Practical Implications for Patent Practitioners

• File the NBA application concurrently with or as early as possible after the patent application, and document the filing date carefully.
• Notify the Controller at the FER response stage if NBA approval is still outstanding, and request deferment in writing.
• Before any hearing, submit a written request to defer the final order if approval is still pending — attach the NBA acknowledgement.
• Ensure all hearings are attended only by a registered patent agent and/or an enrolled advocate (Sections 128 and 132 of the Patents Act).
• On Section 3(p): Prepare detailed technical evidence establishing specific part-based selection, defined chemical-constituent ratios, and demonstrated synergistic pharmacodynamic efficacy.
• If a refusal order is passed before NBA approval is received, file a Section 117A(2) appeal promptly and annex the approval when available.

VIII. Significance

This decision establishes a 'deferred-order doctrine' in Indian patent prosecution: where a pending regulatory approval from a third authority is the sole remaining obstacle to grant and the applicant has communicated the pendency, the Controller must defer — not refuse. It is particularly significant for the ayurvedic, herbal pharmaceuticals, and biotechnology sectors, where the boundary between traditional knowledge and patentable innovation continues to generate litigation.