Delhi HC asks Natco Pharma to pause Risdiplam launch amid patent dispute

Delhi High Court on Wednesday asked Natco Pharma to maintain status quo on the launch of its drug Risdiplam till April 2.

Risdiplam is an oral medicine for spinal muscular atrophy in patients two months of age or older.

A Division Bench led by Justice Hari Shankar asked Hyderabad based generic drug manufacturer to hold on its hands till it heard the case on April 2. Swiss multinational F. Hoffmann-La Roche AG's had appealed against a single judge order that had refused to stop Natco Pharma from manufacturing Risdiplam in India for the rare disease.

Roche has a registered patent, which is a “species patent” for Risdiplam, an active pharmaceutical ingredient in the Swiss firm’s commercial product marketed worldwide under the brand name Evrysdi.

Roche had sought an interim injunction against Natco Pharma to restrain infringement of its patent titled ‘compounds for treating spinal muscular atrophy’. It alleged that Natco Pharma was planning to commercially manufacture Risdiplam and this would infringe its patent for Risdiplam that will expire in May 2035. The Swiss company had said that Natco Pharma’s motive was to only make profits “by imitating” it.

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Justice Mini Pushkarna had on Monday rejected Roche’s petition seeking to temporarily restrain Natco Pharma from infringing its product patent for Risdiplam compound used for treating spinal muscular atrophy.

The court had considered the submissions of some patients that the Roche’s approved drug Risdiplam, which is marketed under the name Evrysdi, was