Rare Disease

The case, centered on Roche’s high-priced drug risdiplam used to treat Spinal Muscular Atrophy (SMA), brought public health and drug affordability to the forefront of the legal discourse.

Justice Mini Pushkarna, delivering the verdict on March 24, underscored the primacy of public health in patent litigation involving critical medications. “Public health is not something that should be dealt with lightly,” she wrote, adding that when a drug is the only available treatment for a rare disease in India, its affordable availability to the public becomes a “material factor” in deciding whether to grant an injunction. Notably, she emphasized that while pharmaceutical companies can be compensated monetarily, the public “has no such right to compensate itself.”

Roche vs Natco: The Core Dispute
Roche had filed a patent infringement suit seeking to block Natco from manufacturing a generic version of risdiplam, marketed by Roche as Evrysdi. The oral medication is the only approved treatment for SMA in India, a rare and progressive genetic disorder that impairs motor function and eventually leads to loss of movement and breathing capability.

Roche argued that Natco’s generic infringed on its Indian species patent, valid until 2035. Natco, however, challenged the legitimacy of the patent, citing an earlier genus patent filed internationally, claiming Roche was attempting to extend its monopoly illegitimately.

The Affordability Crisis
One of the case’s most compelling elements was the stark reality of Evrysdi’s cost. For an SMA patient weighing over 20 kg, that equates to ₹1.8 crore annually—a prohibitive amount for most Indian families.

Seba P. A., an SMA patient, and Purva Mittal, who is awaiting treatment at Lok Nayak Jai Prakash Hospital in Delhi, both intervened in the suit, highlighting the devastating impact of the drug’s unaffordability.

Roche’s Limited Patient Assistance Programme Rejected
Roche, like many multinational pharmaceutical firms, proposed offering risdiplam at a subsidized rate under a Patient Assistance Programme (PAP). But the court found this insufficient. The judge noted that the programme was too limited in scope, benefiting only a select group of patients, and would still exclude a significant number of SMA sufferers.

Furthermore, Roche’s plan to work with the National Rare Diseases Committee was seen as impractical, given limited funding under the National Policy for Rare Diseases (NPRD). The court referenced a 2024 government release stating that while up to ₹50 lakh is allocated per patient, only 1,118 patients had received support for any rare disease, despite 63 such diseases being recognized.

Court Favors Balance of Convenience
In assessing whether to grant the injunction, the court applied the principle of balance of convenience—weighing which party would suffer more harm from the interim decision. Justice Pushkarna concluded that Natco stood on stronger ground, especially since damages could compensate Roche if it ultimately prevailed, whereas denying access to a life-saving drug could not be reversed for patients.

The judge also drew parallels to a prior case in 2008, where Roche had sought to block Cipla’s generic version of the cancer drug erlotinib (marketed as Tarceva). That case also emphasized affordability, with the court refusing an injunction because Cipla’s generic cost ₹48,000 per month, while Roche’s version was priced at ₹1.4 lakh.

A Global Legal Battle
While Natco has prevailed in India for now, the battle over risdiplam continues elsewhere. In the United States, Roche is pursuing legal action against Natco and other generic makers who have filed Abbreviated New Drug Applications (ANDAs) with the FDA. Despite SMA being a rare condition, Evrysdi’s U.S. sales hit $1.8 billion in 2024, bolstered by its oral formulation, which provides a less invasive option compared to competitor drugs that require spinal injections.

Patent Complexity: Genus vs. Species
At the heart of the legal challenge is the distinction between genus and species patents. Roche holds a species patent for risdiplam in India, valid until 2035, while the earlier genus patent—covering a broader class of compounds—expires in 2033. Natco argues that risdiplam was already disclosed in the genus patent and that Roche is attempting to unfairly extend patent protection through strategic filings. Similar allegations of patent misuse have emerged against Roche in other international jurisdictions.

A Turning Point for Access and IP Law?
Justice Pushkarna’s ruling is being hailed as a significant judicial stance on the issue of drug affordability, especially in the context of rare diseases. While Indian courts have occasionally refused to grant injunctions against generic firms in the past, few have spoken as plainly about the right to health and the public’s interest in affordable medicine.

The case is far from over—trial proceedings will continue to decide the validity of Roche’s patent. However, the court has made it clear: innovation must not come at the cost of accessibility.

As the world grapples with balancing intellectual property rights and public health imperatives, this decision may serve as a legal and moral benchmark—especially for lower-income countries navigating similar dilemmas.