The Delhi High Court has dismissed Roche's appeal seeking an injunction against Natco Pharma, clearing the way for the Indian pharmaceutical company to launch a significantly more affordable generic version of risdiplam, a critical treatment for spinal muscular atrophy (SMA). The decision represents a landmark ruling that prioritizes patient access over patent protection for rare disease medications.
Court Upholds Public Health Priority
A division bench led by Justice Hari Shankar vacated its March order that had maintained status quo on Natco Pharma's launch plans. The ruling upholds an earlier single bench decision by Justice Mini Pushkarna, who rejected Roche's plea for interim injunction, stating 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."
The court emphasized that public health must take precedence over monopolistic practices, while noting that Roche can seek damages if it succeeds in the main trial.
Dramatic Price Reduction for Life-Saving Treatment
The price differential between the two versions is striking. Roche currently imports and sells its branded version Evrysdi at a maximum retail price of approximately ₹6.2 lakh ($6,982) per bottle containing 750 microgram/mL of risdiplam. In contrast, Natco Pharma announced it will launch its generic version at ₹15,900 ($179) per bottle, representing a 97% price reduction.
"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," said Seba PK, one of two SMA patients who intervened in the case opposing the injunction.
Impact on Rare Disease Treatment Access
Risdiplam is used to treat spinal muscular atrophy, a rare and life-threatening genetic condition. The Working Group on Access to Medicines and Treatment noted that the decision is particularly significant given that the medication must be taken lifelong, making Roche's pricing unaffordable for most families.
The ruling is expected to enable more SMA patients to benefit from government support under the National Policy for Rare Diseases. The Working Group has urged the Centre to procure the generic version under the Rare Diseases policy "to facilitate timely and equitable access to this life saving medicine."
Company Responses and Market Impact
Natco Pharma stated it would launch the product "with immediate effect" and also intends to offer additional discounts to deserving patients through its patient access programme. The Hyderabad-based company had consistently maintained before the court that it would manufacture the drug locally and make it available at 80-90% less than Roche's price.
Roche expressed strong disappointment with the decision. "We are extremely disappointed with this development and are considering our options within the scope of the Indian law," a Roche Pharma India spokesperson said. The company emphasized that "IP protection is a cornerstone for any pharmaceutical innovation" and is "essential for innovation to thrive in India."
Roche's Patient Access Initiatives
Despite the legal setback, Roche highlighted its existing patient support programs. Since launching Evrysdi in 2021 as the first SMA drug in India, the company has implemented tailored pricing solutions and initiated a Compassionate Use Programme in 2020, under which 52 patients across India receive the medication free of cost. Approximately 300 SMA patients have benefited from Evrysdi since its launch.
The company also operates the Blue Tree patient assistance programme, providing comprehensive support including physiotherapy, diet counselling, psychological counselling, and nutrition support alongside medication access.
Patent Protection Debate
The case centers on Roche's registered "species patent" for risdiplam, the active pharmaceutical ingredient in Evrysdi. The ruling reflects ongoing tensions between patent protection for pharmaceutical innovation and ensuring affordable access to essential medications for rare diseases in emerging markets.
The decision sets a significant precedent for how Indian courts balance intellectual property rights against public health imperatives, particularly for treatments addressing rare diseases where patient populations are small but medical needs are critical.
