Natco Pharma has won a significant legal victory in India, enabling it to launch a generic version of risdiplam, a treatment for spinal muscular atrophy (SMA). In a ruling by an appellate bench of the Delhi High Court, the court dismissed a plea by Roche seeking to block Natco’s launch, thereby allowing the Indian company to proceed with its version.

Under the court’s decision, Natco can manufacture and market the generic risdiplam, potentially making this critical therapy far more affordable and accessible. The ruling affirmed a prior judgment that had refused Roche’s request for an injunction, emphasising public health interests in enabling access to a lower-cost version of the drug.

Roche holds a “species” patent in India covering risdiplam, under which it markets the product as Evrysdi. Despite the patent, the court found that Roche had not met the threshold to justify restraining Natco’s entry, particularly for a medicine for a rare but serious disease with limited therapeutic alternatives.

This outcome may reshape the landscape of rare disease treatment access in India, particularly for SMA patients who have faced prohibitive costs to access the branded therapy. Natco has indicated it plans to launch the generic version immediately.