NextFin news, On Friday, October 10, 2025, the Delhi High Court delivered a significant ruling allowing Indian pharmaceutical company Natco Pharma to manufacture and sell a generic version of Roche’s rare disease drug, Risdiplam, used to treat spinal muscular atrophy (SMA). The court rejected Roche’s appeal to restrain Natco, emphasizing the public interest in affordable access to life-saving medication.
Risdiplam is an oral therapy for SMA, a genetic disorder that causes muscle weakness and wasting, often leading to death in severe cases by age two if untreated. Roche’s patented version of the drug is priced at approximately Rs 6.2 lakh (about USD 6,982) per bottle, making it unaffordable for most patients in India. Natco’s generic version is expected to be priced around Rs 15,900 (approximately USD 179) per bottle, representing a nearly 97% reduction in cost.
The case has been closely watched as a test of balancing patent rights with public health needs. In March 2025, the Delhi High Court had questioned the validity of Roche’s patents on Evrysdi (Risdiplam), noting credible technical arguments by Natco for invalidation and signaling the benefit of a generic alternative to the public. However, the patents themselves, expiring in 2033 and 2035, were not revoked at that time.
Patient advocates and members of the SMA community welcomed the ruling, describing it as a major relief that could improve access to essential treatment. Seba PK, an SMA patient who intervened in the case, highlighted that the decision enables the government to procure the drug under the National Policy for Rare Diseases, potentially providing treatment to many more patients.
Purva Mittal, another intervener representing SMA patients, called the verdict a collective victory prioritizing life and justice over monopolistic practices. The Working Group on Access to Medicines and Treatment also urged the Indian government to proactively procure the generic drug to ensure equitable access.
Roche had sought to prevent Natco from proceeding with the generic version, citing patent protections. The court’s decision underscores the judiciary’s stance that public health considerations can take precedence over pharmaceutical patent monopolies, especially for rare and life-threatening diseases.
This ruling marks a pivotal moment in India’s ongoing efforts to improve access to affordable medicines for rare diseases, balancing innovation incentives with public health imperatives.
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