Roche Appeals to Supreme Court to Block

NATCOPHARM

's Generic Launch of SMA Drug Risdiplam

Swiss pharmaceutical company Roche has approached the Supreme Court of India seeking to block

from selling the generic version of its life-saving Spinal Muscular Atrophy (SMA) drug, Risdiplam. → Roche's legal action follows a ruling by the Delhi High Court division bench on October 9, which refused to grant an injunction against Natco's generic launch, upholding an earlier single-judge order. → Risdiplam, sold under the brand name Evrysdi, is used to treat SMA, a rare genetic disorder and a leading cause of infant mortality. The government estimates the annual treatment cost for SMA in India is between ₹6,400 crore and ₹34,000 crore. → The Delhi High Court's ruling immediately cleared the way for the generic drug's entry, leading Natco Pharma to announce the launch of its product at a Maximum Retail Price (MRP) of ₹15,900 per bottle. → This generic price represents a massive drop from Roche’s patented drug, which costs over ₹6,00,000 per bottle. → Roche holds an Indian patent for Risdiplam that is valid from May 2015 to May 2035 and claims the molecule is a new chemical entity, distinct from earlier patents, justifying the high cost due to R&D investment. Roche stated its disappointment with the High Court's decision and reaffirmed its commitment to protecting its pharmaceutical innovation within the framework of Indian law. → The company currently attempts to address affordability through patient access and compassionate-use programs, under which 52 patients are reportedly receiving Risdiplam free of cost.