Natco Gets SC Nod to Launch Generic Risdiplam at 80% Lower Price, Roche Appeal Dismissed
Supreme Court of India
New Delhi: The Supreme Court has given the go-ahead to Natco Pharma for launching its generic version of Risdiplam in India, dismissing the appeal filed by Swiss drugmaker F. Hoffmann-La Roche that sought to restrain the Hyderabad-based company.
Risdiplam, an oral therapy prescribed for spinal muscular atrophy (SMA) in patients aged two months and above, is covered under Roche’s patent titled “compounds for treating spinal muscular atrophy.” The company claims a valid “species patent” for Risdiplam, the active pharmaceutical ingredient (API) in its branded product Evrysdi, which is marketed globally, including in India.
A Bench led by Justice P.S. Narasimha declined to interfere with last week’s Delhi High Court order, which had refused to impose any restraint on Natco. The apex court further directed that Roche’s pending plea before the High Court, seeking a permanent injunction against Natco over the Risdiplam formulation, be decided expeditiously. It also clarified that the single-judge proceedings shall continue uninfluenced by interim observations.
Earlier, in March, the High Court’s single-judge bench had rejected Roche’s interim injunction plea, observing that “a drug which is the only one available for treatment in India, for a rare disease, its availability to the public at large at very economical and competitive prices, is a material factor which a court will consider at the time of dealing with an application for interim injunction.”
Appearing for Roche, senior counsel N.K. Kaul argued before the Supreme Court that public interest considerations cannot override statutory patent rights merely because a rival product is cheaper. He maintained that Risdiplam, the API in Roche’s commercial product Evrysdi, was developed after years of research and was “neither disclosed nor rendered obvious by its earlier genus patent.” Kaul added that Roche holds valid patents in over sixty countries.
Roche currently imports and sells Evrysdi in India at a maximum retail price of around ₹6 lakh per 750 microgram/mL bottle.
Following the High Court ruling, Natco Pharma announced its decision to launch the product immediately at ₹15,900 per bottle, consistent with its submissions before the court that it would manufacture locally and offer the medicine at 80–90% lower price than Roche. The company also stated that it plans to extend discounts to eligible patients under a patient access programme.
Roche, in response, was quoted as saying by ET that since Evrysdi’s India launch in 2021—the first SMA therapy available in the country—it has been working with authorities to ensure equitable access through tailored pricing models. “In 2020, Roche initiated a Compassionate Use Program (CUP) for SMA patients under which 52 patients across India are benefitting free of cost,” the company said, adding that about 300 SMA patients have received Evrysdi since its introduction in India.
