Delhi High Court’s cleared NATCO launch affordable Risdiplam generic, disrupting Roche’s monopoly and improving SMA treatment accessibility in India.

The Delhi High Court has cleared NATCO Pharma LTD to launch its generic version of Risdiplam, a critical treatment for an uncommon genetic disorder that causes severe muscle weakness and leads cause of infant death.

The Delhi court dismissed Swiss pharmaceutical giant Roche’s appeal on Thursday, October 9, eliminating the legal difficulty for NATCO to make the drug available in India.

Risdiplam is a drug used to treat Spinal Muscular Atrophy (SMA), an uncommon and debilitating genetic illness that is one of the leading causes of infant mortality due to neuron degeneration.

The single judge of the Delhi High Court had earlier, on March 24, denied Roche’s plea for a prohibition against NATCO, citing the inaccuracy of Roche’s patent and emphasizing public interest, the drug largely inaccessible as the original pricing to Indian patients. 

According to a leading expert on patents and intellectual property rights, ET that in India, Roche had not filed for a patent that covered the broad goods claims(#9586955) while its existing patent (#9969754) covered only the specific compound patent for the drug, due to the peculiar error, NATCO could get a favorable decision from the court.

The court’s decision paves the way for NATCO to launch the generic version of Evrysdi, which is used to treat spinal muscular atrophy (SMA-1) at the lower price of Rs 15,900 per bottle against the label price of roughly Rs 6 lakh charged by Roche. The company drug is available at a high discount for needy patients, but the cost is still prohibitively high.

According to the exchange filing that NATCO's strategy is to introduce Risdiplam directly at an MRP of ₹15,900, while also providing discounts for the authorized patients through its patient access program.