National Biodiversity Authority Approval Has No Bearing On Patentability: Delhi High Court

The Delhi High Court has held that approval granted by the National Biodiversity Authority under biodiversity laws for pursuing intellectual property rights does not determine whether an invention qualifies for patent protection.

The court dismissed Shaafi Naturcure LLP's challenge to the rejection of its patent application for a six-herb asthma treatment.

Justice Tushar Rao Gedela dismissed the firm's appeal against a 2020 order of the Assistant Controller of Patents and Designs. The order had refused a patent application for an herbal powder composition claimed to treat asthma.

The company had argued that it had obtained approval from the National Biodiversity Authority in relation to the patent application. According to the company, this rendered the patent objection unsustainable.

“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,” the court held.

The patent application was filed in November 2019. It was titled “A Herbal Powder Composition for the Treatment of Asthma”. The claimed composition contained six herbs: Tephrosia Purpura, Cuscuta Reflexa, Morinda Citrifolia, Terminalia Arjuna, Piper Longum and Piper Nigrum.

The Patent Office had rejected the application after finding that the claimed invention lacked an inventive step, was based on traditional knowledge.

Before the High Court, Shaafi Naturcure argued that the invention lay in selecting six herbs from a larger pool of medicinal plants traditionally associated with asthma treatment and determining the proportions in which they should be combined. The company also relied on an agreement executed with the National Biodiversity Authority.

The company further claimed that the composition was capable of treating five different types of asthma. The court, however, noted that the complete specification filed with the patent application contained no disclosure regarding five variants of asthma.

The judgment recorded that the classification was introduced through an affidavit filed later by the inventor. The court noted that no evidence or documentary proof supporting those different variants of asthma had been submitted.

The court also examined additional material filed by the company to show that altering the ratios of ingredients reduced efficacy or produced side effects. It held that such information could not be relied upon because it was not disclosed, even implicitly, in the original specification.

Referring to an earlier decision, the court observed that post-filing evidence may be used only to confirm a technical effect already embedded in a patent specification. It cannot be used to establish that effect for the first time.

Another difficulty for the applicant arose from examples contained in the specification itself. The court noted that one of the examples described a formulation comprising only four ingredients.

“The composition (f.) under Example 6, has 4 ingredients only and it still results in significant relief from asthma,” the court observed.

The court held that this was inconsistent with the claim that the six-herb composition produced the asserted synergistic effect. It therefore found that the claimed invention lacked an inventive step.

The judgment also referred to prior-art documents cited by the Patent Office. Those documents disclosed the use of the individual herbs, or compositions containing them, for treating asthma and related respiratory ailments.

Rejecting the company's reliance on the National Biodiversity Authority's approval, the court held that the Biological Diversity Act and the Patents Act operate in separate fields. The biodiversity law regulates access to biological resources and benefit sharing. Questions of patentability are governed exclusively by the Patents Act.

Finding no error in the Patent Office's decision, the court upheld the refusal of the patent application and dismissed the appeal.