Delhi High Court Allows Natco Pharma to Sell Generic Risdiplam, Dismisses Roche Plea

The Delhi High Court has refused to restrain Natco Pharma from marketing its generic version of Risdiplam, rejecting a plea filed by Swiss pharmaceutical company F. Hoffmann-La Roche.

A division bench comprising Justices C. Hari Shankar and Ajay Digpaul upheld a March 2025 single-judge order that had denied Roche’s request for an injunction. The single bench had emphasised public interest, noting that wider access to an affordable SMA treatment outweighed Roche’s commercial concerns. The court also observed that patients suffering from the condition often find the original drug prohibitively expensive.

Roche markets Risdiplam in India under the brand name Evrysdi, a medicine used to treat Spinal Muscular Atrophy (SMA)—a rare genetic disorder that leads to progressive muscle weakness. The company approached the court in early 2024 after learning of Natco’s plan to launch a lower-cost version of the drug.

Roche holds Indian Patent IN334397 for Risdiplam, valid from May 2015 to May 2035, and claimed that the compound represents a new chemical entity distinct from earlier patents. The company argued that it had invested heavily in research and development and pointed to patient assistance programmes offering discounted medicine, although these benefit only a limited number of patients.

Natco Pharma challenged the validity of Roche’s patent, alleging that the company was “evergreening” its monopoly by seeking protection for a variant that did not represent a significant innovation over earlier compounds. Natco argued that it could manufacture the medicine locally at a fraction of Roche’s price, thereby improving access for patients across India.

In its earlier ruling, the single bench had agreed with Natco’s position, finding that Roche’s earlier patents already covered similar compounds and that no substantial technical advancement had been demonstrated. Testimonies from SMA patients describing the crippling cost of treatment were also taken into account. The court held that ensuring affordable access to a life-saving medicine was a matter of public interest.

The division bench’s latest ruling reaffirms that decision, once again favouring Natco Pharma. Roche, however, retains the option to appeal to the Supreme Court of India. The detailed written judgment is expected to be released soon.

The Working Group on Access to Medicines and Treatment welcomed the verdict, calling it a landmark step towards improving access to essential treatments. “Risdiplam is a vital medicine for those living with SMA, a rare and life-threatening genetic disorder,” the group stated. “This decision enables the introduction of an affordable generic version, significantly improving access for patients across India.”

The difference in price between the two versions is substantial. Roche’s Evrysdi is priced at around ₹6.2 lakh (USD 6,982) per bottle, while Natco’s generic version is expected to cost approximately ₹15,900 (USD 179)—a reduction of about 97 per cent. Given that Risdiplam is a lifelong treatment, the lower price is expected to make it far more affordable and enhance government support under the National Policy for Rare Diseases (NPRD).

Seba PK, one of two individuals with SMA who intervened in the case, expressed relief at the outcome. “This decision could make a huge difference in the affordability of Risdiplam,” she said. “With the reduced price, the government can now procure and provide the medicine for several years under the ₹50-lakh fund available through the NPRD. It’s a huge relief for me and my friends living with SMA.”

Another intervener, Purva Mital, added: “This victory belongs to the SMA community and all the parents who have fought for affordable treatment. The court’s verdict upholds compassion, justice and the right to life, giving hope to countless SMA patients across the country.”