HC bins Roche's injunction plea, allows generic version of only drug for SMA

A division bench of Delhi high court Thursday rejected the appeal of pharma giant, Roche , seeking an injunction against Indian pharma company Natco Pharma launching a generic version of Risdiplam , the only available drug to treat a rare genetic disorder, spinal muscular atrophy (SMA). This comes as a major relief for Indian SMA patients.

Govt 's one-time aid of Rs 50 lakh for patients of rare diseases was not enough to cover even a year's treatment using Roche's patented version of Risdiplam, but at Natco's price for the generic version of the drug, treatment cost could be covered for 10-16 years.

In March this year, a single-judge bench of Delhi HC rejected Roche's injunction plea against Hyderabad-based Natco Pharma in a patent infringement dispute related to Risdiplam. Roche's patent expires only in March 2035. However, Natco applied for a patent for an improved process for the preparation of Risdiplam and intermediates in Sept 2022. The court had ruled Natco had prima facie raised credible challenges to the validity of Roche's patent and ruled in favour of Natco.

Several public health groups had opposed Roche seeking a permanent injunction against Natco, arguing that Roche's patent infringement lawsuit against Natco prioritised profits over patients' access to affordable treatment, potentially violating India's National Rare Disease Policy.

Roche's patented medicine costs roughly Rs 6 lakh a bottle. An individual with a body weight of over 20kg needs roughly 2.5-3 bottles per month, or 30-36 bottles per year. Roche gives two bottles for free if you buy one, and so the patient would have to pay about Rs 60-72 lakh per year for treatment, unaffordable for most patients in India. Drug costing experts peg the cost of producing the drug at roughly Rs 3,000 for a year's supply.

In April, Natco revealed in a "legal update regarding Risdiplam launch in India" that the "company has decided to price the product (Risdiplam) at Rs 15,900" per 60mg bottle, reducing the price by as much as 97%. This would bring down the cost to less than Rs 5 lakh per year. Bulk buying by govt could bring down the price to Rs 10,000 per bottle, which could bring the cost down to Rs 3.1 lakh per year, said health activists. The financial assistance for patients with rare diseases was increased to Rs 50 lakh in Sept 2024. At Natco's price, those living with SMA would be able to afford treatment for up to 16 years.

The Working Group on Access to Medicines and Treatment welcomed HC's decision and said it highlighted harmful effects of patent evergreening, which could delay access to affordable medicines and lead to unnecessary litigation. It reaffirmed that access to lifesaving drugs should not depend on one's ability to pay.