Delhi High Court Dismisses Roche's Appeal, Allowing Natco Pharma to Launch Affordable Risdiplam for SMA Treatment

In a landmark decision, the Commercial Appellate Division of the Hon’ble Delhi High Court dismissed an appeal filed by F. Hoffmann-La Roche AG, allowing Natco Pharma to launch a generic version of Risdiplam, a drug used for the treatment of Spinal Muscular Atrophy (SMA). The Ld. Single Judge of the Hon’ble Delhi High Court had earlier denied Roche’s plea for an injunction against Natco for the drug. Roche’s appeal before the appellate Bench Delhi Court was announced as appeal refused and consequently, the status quo has been removed. The Ld. Single Judge had factored the challenge of invalidity of Roche’s patent and laid special emphasis on the public interest, considering the Swiss Company’s pricing had rendered the drug inaccessible and unaffordable to the bulk of its patients. Natco has decided to launch the product with immediate effect and price it at INR 15,900 MRP consistent with its stand before the court. The Company also intends to offer some discount to certain deserving patients through its patient access programme.