The Delhi High Court dismissed Swiss pharmaceutical giant F. Hoffmann-La Roche AG’s appeal, allowing Indian drugmaker Natco Pharma to manufacture and sell a generic version of Risdiplam, a critical medication for Spinal Muscular Atrophy (SMA).
The Division Bench, upheld a single judge’s March 2025 order, which had rejected Roche’s request for an interim injunction against Natco’s production plans. The ruling effectively removes legal obstacles for Natco to proceed with its generic launch.
Court Highlights Validity Challenge
The court noted that Natco relied on Roche’s own genus patent, which explicitly covered the same drug, strengthening its case. The legal validation underscores that Natco acted within its rights. It also sets a precedent for challenging patents that may hinder access to essential medicines.
Victory for Affordable Healthcare
The judgment is a major win for public health advocacy in India. It emphasizes patient access to affordable medication over strict patent enforcement. By allowing Natco to produce and sell Risdiplam, the court has enabled millions of patients to access life-saving therapy at a fraction of its previous cost.
As reported by theippress.com, Natco immediately announced the launch of its generic Risdiplam at an MRP of ₹15,900 per bottle. The current market price is around ₹6.2 lakh per bottle and can reach up to ₹1 crore for some patients. This price reduction is expected to make treatment far more accessible for SMA patients across India.
