The Delhi High Court has cleared the way for Natco Pharma to sell a generic version of Risdiplam, a life-saving drug for spinal muscular atrophy (SMA) despite objections from Swiss drugmaker Roche.
The court dismissed Roche’s plea for an injunction, citing public interest and the need for affordable access to the drug, which currently retails at over ₹600,000 per bottle under Roche’s brand name Evrysdi. Natco’s version is expected to cost just ₹15,900 — a staggering 97% price cut.
“I'm greatly relieved to hear this news,” said Seba PK, one of two SMA patients who intervened in the case. “With the reduced price, the government will now be able to purchase and provide the medicine for several years using the ₹50 lakh fund under the National Policy for Rare Diseases.”
The division bench of Justices C. Hari Shankar and Ajay Digpaul upheld a March 2025 single-judge order that had denied Roche’s injunction request. The court emphasized that public health must take precedence over monopolistic practices, especially in the case of rare diseases like SMA, which causes progressive muscle weakness and can be fatal without treatment.
“This victory belongs to all the parents of SMA patients and the angels of the SMA community,” said Purva Mital, another intervener. “It marks a pivotal moment in our collective journey.”
Roche expresses disappointment
Roche, which holds an Indian patent for Risdiplam valid until 2035, expressed disappointment with the ruling.
“We are disheartened with this development and are considering our options within the scope of Indian law,” the company said in a statement. “IP protection is a cornerstone for any pharmaceutical innovation.”
Roche defended its record on access, pointing to its Blue Tree patient assistance program, which offers physiotherapy, diet and psychological counselling, and free drugs to select patients. The company also highlighted a Compassionate Use Program launched in 2020, which provided free Risdiplam to 52 patients before the drug’s commercial launch.
“Our focus remains on discovering and developing innovative medicines and diagnostics that will change standards of care,” Roche said. “We remain committed to ensuring that as many patients as possible have access to our products.”
Patient support group welcomes court decision
Natco Pharma challenged Roche’s patent, accusing the company of “evergreening” — a controversial practice where pharmaceutical firms file new patents on minor modifications of existing drugs to extend monopolies.
The Working Group on Access to Medicines and Treatment welcomed the court’s decision, calling it a blow to evergreening and a win for equitable healthcare.
“Access to life-saving medicines should not depend on people’s ability to pay,” the group said. “This ruling highlights the harmful effects of patent evergreening, which can delay access and lead to unnecessary litigation.”
The ruling could have far-reaching implications for India’s National Policy for Rare Diseases, which has struggled with funding constraints and limited access to high-cost treatments.
The Working Group urged the Central Government to proactively procure Natco’s generic Risdiplam, enabling broader access for SMA patients.
“This decision significantly improves access to this life-saving treatment for patients across India,” the group said.
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