Delhi High Court Upholds Natco’s Risdiplam Launch, Prioritizing Public Interest Over Roche’s Patent

NEW DELHI – In a landmark decision with significant implications for pharmaceutical patent litigation in India, a Division Bench of the Delhi High Court has affirmed a single-judge order, refusing to grant an interim injunction to Swiss pharmaceutical giant F. Hoffmann-La Roche AG. The ruling effectively permits Indian generic drugmaker Natco Pharma to continue manufacturing and selling its affordable version of Risdiplam, a life-saving drug for Spinal Muscular Atrophy (SMA), a debilitating rare genetic disorder.

The judgment, delivered by a bench comprising Justices C. Hari Shankar and Ajay Digpaul, solidifies the growing influence of the public interest doctrine in Indian patent jurisprudence. It underscores the judiciary's willingness to weigh the imperative of affordable access to medicine against the enforcement of patent rights, particularly at the interim stage of litigation.

The decision is a major setback for Roche, which markets the drug under the brand name Evrysdi at over ₹6,00,000 per bottle. In stark contrast, Natco has launched its generic version at a maximum retail price of ₹15,900, a move set to radically alter the treatment landscape for SMA patients in India.

The Legal Fulcrum: Public Interest vs. Patent Rights

The core of the dispute revolves around Roche's Indian Patent (IN334397) for Risdiplam, a "species patent" which the company asserted was a novel chemical entity deserving of monopoly protection. Roche initiated the lawsuit in early 2024 upon learning of Natco’s plans to launch a generic competitor, seeking an injunction to prevent patent infringement.

However, in a detailed order in March 2025, a single-judge bench had refused to grant the injunction. The court's reasoning was heavily predicated on the "public interest" element, a crucial consideration in discretionary remedies like interim injunctions. The single judge noted that SMA is a rare but severe condition and the prohibitive cost of Roche's drug made it inaccessible to the vast majority of Indian patients. The court concluded that the immense public benefit of having a widely available, affordable treatment outweighed the potential harm to the patent holder.

The Division Bench, in upholding this view, reinforced that when a defendant presents a credible challenge to a patent's validity, and the balance of convenience and public interest tilt heavily in their favour, an injunction should not be granted. "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,” the single-judge had observed, a sentiment echoed by the appellate bench.

Natco’s ‘Evergreening’ Challenge Casts a Shadow on Patent Validity

A key factor in the court's decision was Natco’s "credible challenge" to the validity of Roche's patent itself. Natco argued that the Risdiplam patent was a classic case of "evergreening"—a strategy where innovator companies attempt to extend their monopoly by filing for new patents on minor modifications or specific forms of an existing, previously disclosed invention.

Natco contended that Roche's earlier, broader patents already encompassed compounds similar to Risdiplam. The court found that Roche had not sufficiently demonstrated a significant technical advancement or inventive step in the specific Risdiplam patent over its prior art. This challenge effectively weakened Roche's prima facie case, a foundational requirement for securing an interim injunction. The court noted that Roche had allegedly taken inconsistent positions regarding the patent's scope in different jurisdictions, further eroding the strength of its claim at this preliminary stage.

This aspect of the ruling is likely to embolden other generic manufacturers to vigorously challenge follow-on patents, scrutinizing them for any hint of attempting to unmeritoriously prolong market exclusivity.

Broader Implications for Pharmaceutical Litigation in India

While a victory for patient access, the decision raises complex questions for the future of patent enforcement and pharmaceutical innovation in India. Legal experts are closely watching the case for the precedent it may set.

A notable point of discussion is the court’s decision to allow market entry without recourse to the statutory mechanism of compulsory licensing. The Indian Patents Act, 1970, contains specific provisions (like Section 84) for granting a compulsory license when a patented invention is not available to the public at a reasonably affordable price. This is a structured process involving the Controller of Patents.

Ashwin Sapra, Partner at Cyril Amarchand Mangaldas, commented on this procedural nuance, stating, "Patent rights granted under the Indian Patents Act can be modified or diluted under the extant provisions of the same Act - in this case, the public interest issue could very well be addressed by using statutory compulsory licensing provisions in the Patents Act itself."

The court's approach, effectively permitting an at-risk launch by denying an injunction, bypasses this formal route. This could be interpreted as the judiciary carving out a more direct path to address public health crises, but it also introduces uncertainty for patent holders who rely on the statutory framework. Innovator companies may now face a dual threat: the formal compulsory licensing regime and the judiciary’s application of public interest principles to deny injunctions.

The Industry Responds

Roche expressed profound disappointment with the outcome. In an emailed statement, a spokesperson for Roche Pharma India emphasized the company's commitment to protecting its innovation. "IP protection is a cornerstone for any pharmaceutical innovation. We believe that strong IP protection, including patents, is essential for medical innovation in India, patient well-being, and for access to new and innovative treatment to address the healthcare challenges we face today," the statement read. Roche has highlighted its patient assistance programs, which provide Evrysdi free of cost to 52 patients, and stated it is evaluating its next legal steps, which could include an appeal to the Supreme Court of India.

For Natco Pharma, the ruling is consistent with its long-standing business strategy. The company has a history of challenging innovator patents in India, famously securing the country's first-ever compulsory license in 2012 for Bayer's cancer drug, Nexavar. This latest victory further cements its reputation as a formidable challenger in the generic pharmaceutical space.

For patients, the impact is immediate and life-altering. Seba PK, an individual with SMA who intervened in the case, expressed immense relief: "This decision could make a huge difference in the affordability of Risdiplam... It’s a huge relief for me and my friends living with SMA."

The case of F Hoffman- LA Roche Vs Natco Pharma is far from over, as the trial on the merits of patent infringement and validity will continue. However, this interim ruling serves as a powerful testament to the evolving dynamics of patent law in India, where the constitutional right to health and the public good are increasingly becoming decisive factors in the courtroom.