New Delhi: The Delhi High Court has dismissed an appeal filed by Swiss drug major F. Hoffmann-La Roche AG and its Indian arm, challenging the order of a Single Judge that refused to restrain Natco Pharma Limited from manufacturing and selling Risdiplam, a drug used to treat Spinal Muscular Atrophy (SMA).

The Division Bench of Justice C. Hari Shankar and Justice Ajay Digpaul held that Roche’s species patent (IN 334397) for Risdiplam was prima facie vulnerable to invalidation under Section 64(1)(f) of the Patents Act, 1970, as being obvious in view of prior art disclosed in Roche’s own genus patent (WO 2013/119916 / US 9586955).

Risdiplam is admittedly manufactured and marketed by the appellants in various countries, including India, under the brand name EVRYSDI Risdiplam is an oral presc

See Full Page