Delhi High Court refuses to restrain Natco from manufacturing spinal muscular atrophy drug

The Court dismissed Swiss drugmaker Roche’s plea for interim injunction

The Delhi High Court has refused to restrain Natco Pharma from manufacturing a generic version of risdiplam, a drug used to treat spinal muscular atrophy (SMA), dismissing a plea by Swiss pharmaceutical giant Roche. The decision allows Natco to continue selling a significantly more affordable version of the drug, which is sold by Roche under the brand name Evrysdi.

On October 9, 2025, a division bench of the High Court rejected an appeal by Roche against a previous single-judge order from March 2025. This decision paves the way for Natco's generic drug to remain on the market.

The court found that public interest, particularly the need for affordable access to a life-saving drug for a rare disease, outweighs Roche's patent claims. The single-judge order had noted that Roche's high pricing made the drug largely inaccessible to most Indian patients.

The court held that Natco had presented a credible challenge to the validity of Roche's patent for risdiplam. Natco argued that Roche's patent was an instance of "evergreening," a practice of extending a patent monopoly by filing new patents on minor modifications of an existing drug. The court noted that Roche had taken different positions on the patent's scope in India and other countries, which weakened its claim.

Natco has priced its generic version of risdiplam at ₹15,900 per bottle. This is in stark contrast to Roche's Evrysdi, which costs around ₹6.2 lakh per bottle. The dramatic price difference makes the treatment accessible to a much wider patient population in India.

Roche expressed disappointment with the ruling and indicated it is considering its legal options. The company emphasized the importance of patent protection for pharmaceutical innovation.