NBA Approval Under Biological Diversity Act Does Not Determine Patentability Of Inventions Under Patents Act: Delhi High Court
The High Court held that approval granted by the National Biodiversity Authority (NBA) under the Biological Diversity Act, 2002, is merely a statutory regulatory requirement governing access to and utilisation of biological resources and has no bearing on the patentability of an invention under the Patents Act, 1970.
Justice Tushar Rao Gedela, Delhi High Court
The Delhi High Court has ruled that the grant of approval by the National Biodiversity Authority (NBA) under the Biological Diversity Act, 2002, cannot be construed as satisfaction of the patentability requirements under the Patents Act, 1970.
The Court held that the scheme of the Biological Diversity Act is confined to regulating access to biological resources and ensuring equitable benefit sharing, and does not empower the NBA to examine whether an invention is patentable.
A Bench of Justice Tushar Rao Gedela, while rejecting the contention that execution of an agreement with the NBA under the Biological Diversity Act rendered objections under Section 3(p) of the Patents Act unsustainable, observed: "A fortiori, the aspect of patentability of a claimed invention being met with, once NBA grants approval under the provisions of BDA, is legally unfounded and is unsustainable. Ergo, the argument of the learned counsel for the appellant in this context is unmerited."
Advocate Kapil Kumar represented the appellant, while Sumit Nagpal, SPC, represented the respondents.
Background
The appeal arose from an order of the Assistant Controller of Patents and Designs refusing a patent application titled "A Herbal Powder Composition for the Treatment of Asthma" on the ground that the claimed invention failed to satisfy the requirements of Sections 2(1)(j), 3(p), 10(4)(a) and 10(4)(b) of the Patents Act, 1970.
One of the principal arguments advanced by the appellant was that since the National Biodiversity Authority had granted approval under Section 19 of the Biological Diversity Act and entered into an agreement with the appellant under Section 6 of the Act, the objection under Section 3(p) of the Patents Act stood automatically satisfied. According to the appellant, the Biological Diversity Act and the Patents Act ought to be read harmoniously, and the NBA's approval effectively validated the invention for patent purposes.
Court's Observations
Rejecting the submission, the Court first examined the object and scheme of the Biological Diversity Act.
The Court observed that the legislation was enacted to ensure conservation of biological diversity, sustainable utilisation of biological resources and equitable sharing of benefits arising from their commercial exploitation. The statutory framework was therefore regulatory in nature and intended to prevent unauthorised extraction or commercial utilisation of biological resources.
Examining Sections 6, 7 and 19 of the Biological Diversity Act along with Rule 16 of the Biological Diversity Rules, 2024, the Court held that prior registration with and approval from the NBA is mandatory before an applicant seeks intellectual property protection involving biological resources.
However, the Court made it clear that neither the Act nor the Rules confer any authority upon the NBA to determine whether an invention satisfies the patentability requirements under the Patents Act.
The Bench observed: "A cumulative reading of Sections 6, 7, and 19 of BDA also makes it clear that the right to file an application for intellectual property rights to the appropriate authority is subject to mandatory registration with the NBA before grant of such intellectual property rights. The manner, mode and procedure for registration and obtaining prior approval from the NBA before seeking grant of intellectual property rights is prescribed in Rule 16 of the Rules. Nowhere does the Act or the Rules provide ascertainment of patentability of the subject invention of a patent application. The approval that is granted by the NBA is statutorily reduced into writing in the form of an agreement on mutually agreed terms."
The Court emphasised that the NBA's statutory role is limited to regulating access to biological resources and ensuring compliance with biodiversity laws. Questions relating to novelty, inventive step and patentability fall exclusively within the domain of the Patents Act.
The Court observed: "It appears to this Court that the basic framework of the regime contemplated under the BDA is only for the purposes of ensuring that no person or entity is able to utilise or extract biological resources without obtaining registration and approval from the NBA. It is also manifest from the provisions of the Act and the Rules framed thereunder that it is mandatory to obtain necessary approval from the NBA by an entity or an individual which is desirous of seeking a grant of intellectual property rights in a composition or invention which would involve extraction and utilisation of the biological resources for its invention etc."
Clarifying the limits of the NBA's authority, the Court held: "There is no provision in either the BDA or the Rules which confer any power or authority or even jurisdiction to the NBA to venture into or conduct any inquiry in any manner whatsoever with respect to the patentability or otherwise of any claimed invention. Thus, the mere grant of approval by the NBA has no rationale or remote nexus with the patentability of a claimed invention, which is the exclusive mandate of the Patents Act, 1970."
Consequently, the Court rejected the appellant's contention that NBA approval rendered objections under Section 3(p) of the Patents Act inapplicable.
Having rejected the argument based on the Biological Diversity Act, the Court held that the appellant was still required to independently overcome the objections raised under Section 3(p) of the Patents Act before the patent application could be considered on the merits.
Conclusion
Holding that the complete specification failed to fully and particularly describe the claimed invention and did not disclose the best method of performing the invention as mandated under Sections 10(4)(a) and 10(4)(b) of the Patents Act, 1970, the Delhi High Court upheld the Controller's refusal of the patent application.
The Court concluded: "In view of the issues regarding the CS discussed above, the rejection of the data submitted through the affidavit and considering the abovementioned judgement in AstraZeneca AB (supra), the CS is not fully and particularly disclosing the claimed invention as required under Section10(4)(a) of the Act. Additionally, the present invention also fails to disclose the best method of performing the invention as required under Section 10(4)(b) of the Act."
Accordingly, the Court concluded that the appeal failed and dismissed it along with pending applications.
Cause Title: Shaafi Naturcure LLP v. Assistant Controller of Patents and Designs (Neutral Citation: 2026:DHC:5157)
Appearances
Appellant: Kapil Kumar and Abhishek Jain, Advocates.
Respondent: Sumit Nagpal, SPC with Tanmay Saini and Kunal Khurana, Advocates.