Delhi HC dismisses Roche's plea, allows Natco to sell generic Risdiplam

The Delhi High Court on Thursday allowed Natco Pharma to continue selling the generic version of its medicine, Risdiplam, dismissing a plea by Swiss pharmaceutical giant F. Hoffmann-La Roche AG (Roche). A division bench comprising Justices C Hari Shankar and Ajay Digpaul upheld a March 2025 single-judge bench order that had denied Roche an injunction. A detailed judgment copy is awaited.

 

Risdiplam is an oral medicine for the treatment of spinal muscular atrophy (SMA) in patients two months of age or older. SMA is a rare, progressive, and genetic disease that affects the motor neurons in the spinal cord, causing muscle weakness and wasting.

 

 

The single-judge order had refused to stop Natco Pharma from manufacturing a generic version of Risdiplam, citing public interest. It noted that SMA is a rare disease and that wider access to an affordable drug would benefit patients who cannot otherwise afford treatment.

 

While delivering the verdict, the single-judge bench of Justice Mini Pushkarna had said that when dealing with an interim injunction, the court must consider the fact that the drug, the only one available for treatment in India for a rare disease, should be made available to the public at a very economical and competitive price.

 

Roche has a registered patent for Risdiplam, an active pharmaceutical ingredient in its worldwide commercial product under the brand name Evrysdi. It had sought an injunction against Natco Pharma to restrain infringement of its patent titled ‘compounds for treating spinal muscular atrophy’.

 

It argued that Risdiplam is a new chemical entity, distinct from earlier broader patents, and highlighted the high cost of research and development. Roche also alleged that Natco Pharma was planning to commercially manufacture Risdiplam, and that this would infringe Roche's Indian patent for Risdiplam, set to expire in May 2035.

 

Natco, on the other hand, argued that Roche was “evergreening” its monopoly by filing a species patent that added little to the original broader patent. It argued that it could manufacture the drug at a lower cost, which would make the drug accessible to millions of patients in India who cannot afford Roche’s high-priced version.

 

Natco had said in April this year it would price its rare disease drug, Risdiplam, used to treat SMA, at ₹15,900 per bottle, against Rs 6.2 lakh per bottle charged by Roche under the brand Evrysdi.

 

Reacting to the judgment, Roche Pharma India Spokesperson said, "We are extremely disappointed with this development and are considering our options within the scope of the Indian law. Roche is committed to protecting its innovation.IP protection is a cornerstone for any pharmaceutical innovation. We believe that strong IP protection, including patents, is essential for innovation to thrive in India, drive access to innovative treatments that address the healthcare challenges we face today, and a critical lever for Viksit Bharat".