Delhi High Court Upholds Natco Pharma’s Production of SMA Drug Risdiplam

The Delhi High Court upheld a single-judge order refusing to restrain Natco Pharma from producing ‘Risdiplam,’ a drug for treating Spinal Muscular Atrophy (SMA).

The petitioner, Swiss drugmaker Roche, claimed that Risdiplam was a novel chemical entity distinct from its earlier genus patent and alleged infringement by Natco.

A Division Bench of Justices C Hari Shankar and Ajay Digpaul dismissed the appeal, noting that Natco raised a credible challenge to the patent’s validity.

The Court emphasised that public interest outweighed Roche’s claims, as Natco’s version was significantly cheaper and more accessible to patients in India.

[F Hoffman-La Roche v. Natco Pharma]