Delhi High Court Sets Aside Patent Rejection Of Biotyx Medical, Slams Hindsight Analysis

The Delhi High Court on 19 May set aside an order of the Assistant Controller of Patents and Designs that had refused to grant a patent to Biotyx Medical Shenzhen Co. Ltd for its invention titled “Absorbable Stent.”

A Bench of Justice Jyoti Singh held that the rejection relied on hindsight analysis and failed to follow settled principles of patent law, and remanded the matter to the Controller for fresh consideration within four months.

She noted that the Controller recorded Biotyx's submissions but did not address them in the reasoning section of the order. “Strangely, while these submissions on D1 are taken note of, but Respondent does not deal with them in the 'Reasons for decision',” she observed, calling it “a glaring error and violation of principles of natural justice.”

Biotyx Medical Shenzhen Co. Ltd filed the Indian Patent Application in July 2019 as a national phase entry, claiming priority from 31 December 2016. The invention concerned an absorbable metallic stent designed to balance two competing clinical requirements: a shorter corrosion and absorption cycle and enhanced radial supporting strength.

The Controller rejected the application in April 2024, finding that the claimed invention lacked inventive step in view of two prior art documents. Biotyx challenged the rejection before the High Court, arguing that the Controller ignored key submissions and relied on an impermissible hindsight analysis.

Justice Singh held that the Controller referred to Biotyx's submissions but failed to engage with them in the reasoning portion of the order. She also found that the Controller drew unsupported assumptions while linking prior art D2, which amounted to conjecture.

The Court observed that the Controller, in its zeal to build a connection with prior art D2, had “conjectured into presuming that if D2 disclosed a cylindrical shape, its properties will be the same as of the proposed device of the claimed invention,” and held that such reasoning reflected an impermissible hindsight approach.

Relying on its earlier ruling in Agriboard International LLC v. Deputy Controller of Patents and Designs, the Court reiterated that authorities must assess inventive step by considering the prior art, the claimed invention, and whether the invention would have been obvious to a person skilled in the art.

Accordingly, the High Court held that the impugned order violated legal principles more than it complied with them, set it aside, and directed the Controller to reconsider the application after granting Biotyx a fresh hearing.