Health groups join patent war over spinal muscular atrophy drug

Several public health groups are opposing Roche seeking a permanent injunction against Natco Pharma to prevent the introduction of a generic version of Risdiplam, a Spinal Muscular Atrophy (SMA) drug, citing patent infringement. They argued that Roche's legal action to block generic supply would jeopardise public interest by limiting access to affordable medication.

Roche's patent for Risdiplam, which is effective until May 2035, allows them to charge approximately Rs 72 lakh per year, while production costs suggest the drug could be made available for as low as Rs 3,024 annually. Patient representatives and treatment activists urged govt, courts, and lawmakers to take urgent action to address the abuse of patent monopolies in rare diseases by incentivising generic production.

"Roche's action against Natco isn't just about a single drug or one company's right to profits, it's about our right to life. By blocking access to a generic version, Roche effectively decides who among us gets to hope and who doesn't," said Saifullah Khalidi, a 30-year-old living with SMA.

"How can Roche seek such a high price on the plea of high R&D costs when it has not submitted the cost incurred on R&D?" asked Leena Menghaney, a lawyer working on the issue of access to medicines.

National Rare Disease Policy (NRDP) 2017, among other recommendations, included (a) measures, legislative or otherwise, for encouraging local manufacturing of drugs for rare diseases and (b) taking legal and other measures to control the prices of drugs for rare diseases to ensure its affordability and health system sustainability.