Risdiplam generic drug case: SC rejects Roche plea against Natco pharma

The Supreme Court upheld Delhi HC's interim order allowing Natco Pharma to manufacture and sell a generic version of Roche's spinal muscular atrophy drug Risdiplam

The Supreme Court on Friday rejected Swiss pharma giant F Hoffmann-La Roche AG's plea against the Delhi High Court's order allowing Natco Pharma to manufacture and sell a generic drug of Risdiplam.

 

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

 

A bench of Justice PS Narasimha and Justice AS Chandurkar declined to interfere with the High Court's order, saying that it was only an interim order. It said that both the single bench and the division bench of the High Court have entered concurrent findings and urged the High Court to dispose of Roche's plea expeditiously.

 

"We are not inclined to interfere for the reason that it is interim in nature and also because the findings are concurrent. We have not expressed anything on merits. Needless to say, the observations made in the civil applications are intended only to dispose of the appeals and will have no bearing on the final decision. The High Court shall endeavour to dispose of the suit expeditiously," the bench observed in the order.  

 

Senior Advocate Neeraj Kishan Kaul, appearing for Roche, argued that they hold the patent for the drug, and Natco was claiming rights after doing 'reverse engineering.' He stressed that Roche developed the drug after investing millions of dollars and years of research. However, the Supreme Court did not entertain this argument. 

 

The Swiss pharmaceutical company moved the apex court this week after the Delhi High Court on October 9 allowed Natco Pharma to continue selling the generic version of its medicine, Risdiplam, dismissing a plea by Roche. The division bench comprising Justices C Hari Shankar and Ajay Digpaul of the Delhi High Court upheld a March 2025 single-judge bench order that had denied Roche an injunction.

 

The single-judge HC 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.

 

"We are extremely disappointed with the Supreme Court’s decision to dismiss our plea concerning the Risdiplam preliminary injunction. As a global healthcare company that invests significantly in research and discovery to bring life changing medicines to patients, we are fully committed to protecting our innovations," Roche Spokesperson said.