Issues before the Court

The Delhi High Court was called upon to determine:

• Whether the patent application could be rejected merely because NBA approval had not been granted at the time of the hearing.

• Whether the Controller ought to have deferred the final decision pending receipt of NBA approval.

• Whether the rejection under Section 15 of the Patents Act was procedurally justified.

• Whether procedural irregularities relating to representation before the Controller warranted rejection of the application.

Court’s Analysis of the Legal Framework

The Court examined the interplay between:

• Section 10(4)(ii)(D) of the Patents Act, 1970;

• Section 6(1A) of the Biological Diversity Act, 2002; and

• The Guidelines for Processing Patent Applications relating to Traditional Knowledge and Biological Material.

While examining the matter, the Court analysed the provisions of the Patents Act, 1970 and the Biological Diversity Act, 2002. The Court referred to Section 6(1A) of the Biological Diversity Act, which requires that approval from the National Biodiversity Authority must be obtained before the grant of intellectual property rights involving biological material sourced from India. The Court also examined the Guidelines for Processing Patent Applications relating to Traditional Knowledge and Biological Material. Particular reliance was placed upon paragraphs 19 and 22 of the Guidelines, which state that patents should not be granted without NBA approval. However, the Court noted that neither the statutory provisions nor the Guidelines mandate automatic rejection of a patent application merely because such approval is pending during examination. The Court further analysed Section 15 of the Patents Act and observed that the provision grants broad discretionary powers to the Controller. The purpose of the provision is to allow applicants an opportunity to address deficiencies, amend documents, and ensure compliance before an application is refused.

Detailed Analysis and Findings of the Court

• Recognition of Applicant’s Bona Fide Conduct: The Delhi High Court observed that the appellant had already applied for approval from the National Biodiversity Authority (“NBA”) and had also informed the Patent Office about the same before the rejection order was passed. The Court accepted that the delay in receiving approval was beyond the control of the applicant and therefore, could not be penalized for delays beyond her control.

• Patent Office Should Have Deferred the Matter: The Court held that once the Patent Office was aware that the NBA approval process was pending, the proper course would have been to defer the final order instead of rejecting the application outright. The Court emphasized that an applicant cannot force a statutory authority like the NBA to grant approval within a fixed timeline.

• NBA Approval Required Only Before Grant of Patent: The Court clarified that the law only requires NBA approval before the actual grant of the patent and not necessarily during every stage of examination. Therefore, rejection of the patent application merely because the approval was pending was found to be unjustified.

• Improper Exercise of Powers under Section 15: While interpreting Section 15 of the Patents Act, the Court observed that the Controller has wide discretionary powers and must exercise them fairly. Since the applicant had responded to objections, amended claims, and actively pursued NBA approval, the Court held that the discretion under Section 15 had not been exercised properly.

• Procedural Defect Regarding Representation: The Patent Office had also objected that the hearing was attended by an authorized representative instead of a patent agent or advocate. On this issue, the Court observed that if there was any procedural defect, the applicant should have been given an opportunity to rectify it rather than facing outright rejection.Issue of Patentability Left Open: The Court clarified that it was not deciding the substantive issue relating to patentability under Section 3(p) of the Patents Act. The matter was remanded back to the Patent Office for fresh consideration in accordance with law.

Pending NBA Approval Is No Ground for Patent Rejection: Delhi High Court

The Delhi High Court, in Manu Chaudhary v. Controller of Patents and Designs, delivered a significant ruling on procedural fairness in patent prosecution and the requirement of approvals from the National Biodiversity Authority (hereinafter “NBA”). The judgment clarifies that a patent application cannot be rejected merely because a statutory approval is pending, particularly when the applicant has already taken all necessary steps to obtain such approval. The decision is an important development in Indian patent jurisprudence as it highlights the need for a practical and balanced approach while dealing with procedural requirements under intellectual property law.

Background

The dispute arose from the rejection of Patent Application No. IN 201711047431 filed by Ms. Manu Chaudhary before the Patent Office. The invention related to an oral herbal pain killer composition intended for peripheral pain relief. The application claimed that the composition consisted of selected herbal ingredients used in predefined ratios to produce synergistic pharmacodynamic efficacy. The invention also covered the process for preparation of the composition while maintaining its safety, stability, and reproducibility.

According to the applicant, the invention aimed to provide a safer and more effective alternative to conventional pain relief medications, particularly for patients who suffer side effects from existing formulations. The appellant, who is a pharmaceutical researcher with extensive experience in antimicrobial resistance research and natural product development, asserted that the invention represented a substantial improvement in herbal pharmaceutical formulations.

Following examination of the application, the Patent Office issued a First Examination Report (“FER”) raising objections relating to inventive step, obviousness, and non-patentability under Sections 3(d), 3(e), and 3(p) of the Patents Act, 1970. The Patent Office also raised an objection regarding the absence of approval from the National Biodiversity Authority under Section 10(4)(ii)(D) of the Act, since the invention involved biological materials sourced from India.

The applicant subsequently filed detailed responses addressing the objections and also amended the claims to expedite the examination process. After considering the response, the objections were narrowed primarily to the issue of NBA approval and the objection under Section 3(p). Although the applicant informed the Patent Office that the NBA approval had already been applied for and was pending, the Controller proceeded to reject the application under Section 15 of the Patents Act.

Aggrieved by the rejection order, the appellant approached the Delhi High Court seeking revival of the patent application.

Conclusion

The Delhi High Court ultimately set aside the impugned order and directed the Controller of Patents to re-examine the patent application after considering the NBA approval and after granting a fresh hearing to the applicant. The Court also directed that the matter be decided expeditiously.

This judgment is an important precedent in the field of patent law, particularly for inventions involving biological materials and regulatory approvals. The ruling reinforces the principle that procedural requirements should not be interpreted in an excessively rigid or technical manner, especially where the applicant has acted diligently and in good faith. By emphasizing fairness, proportionality, and proper exercise of discretion, the Delhi High Court has reiterated that intellectual property administration must balance statutory compliance with practical realities. The decision will likely guide future cases involving pending approvals and procedural objections during patent prosecution in India.

This article has been authored by Ms. Bhumi Patel, Intern at Intellect Goodwill LLP, as part of our ongoing IP Awareness Series - Intellect Insights, aimed at simplifying complex intellectual property concepts for entrepreneurs, creators, and businesses.

The views expressed in this article are for informational purposes only and do not constitute legal advice. The content reflects the personal analysis of the author and not necessarily the views of Intellect Goodwill LLP.

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