Supreme Court Denies Roche Injunction, Upholds High Court's Refusal to Block Natco's Generic SMA Drug

New Delhi – In a significant decision for India's pharmaceutical and intellectual property landscape, the Supreme Court has dismissed a petition by Swiss pharmaceutical giant F. Hoffmann-La Roche AG, refusing to grant an interim injunction that would have blocked Indian drugmaker Natco Pharma from manufacturing and selling a generic version of Risdiplam, a critical drug for treating Spinal Muscular Atrophy (SMA).

A Bench comprising Justices P.S. Narasimha and A.S. Chandurkar on Friday declined to interfere with the concurrent findings of a Single Judge and a Division Bench of the Delhi High Court, both of which had found that Roche failed to establish a prima facie case for an interim injunction. While the dismissal allows Natco to proceed, the Supreme Court stressed that its decision was based on the interim nature of the High Court's order and should not influence the final outcome of the ongoing patent infringement suit.

“We are not inclined to interfere with the order passed by the High Court for the reason that it is interim in nature and the findings are concurrent,” the Bench observed. Highlighting the procedural posture of the case, the Court added, “The trial court proceedings would continue uninfluenced by any observations made in the interim stage.”

In a crucial directive, the Apex Court urged the Delhi High Court to expedite the trial of the main suit, a move that acknowledges the high stakes involved for both parties and the public.

Background of the High-Stakes Patent Dispute

The legal battle originated from Roche's claim that Natco's generic Risdiplam infringes its Indian Patent IN'397, which covers compounds for treating SMA and is valid until 2035. Roche sought to protect its significant investment in the research and development of the drug, which is marketed globally.

In response, Natco invoked a statutory defence under Section 107(1) of the Patents Act, 1970, mounting a "credible challenge" to the validity of Roche’s patent. Natco argued that the patent was invalid on grounds of lacking novelty (Section 64(1)(e)) and, more pivotally, obviousness (Section 64(1)(f)). This defence strategy is a cornerstone of generic challenges in Indian patent law, where an injunction is typically not granted if the defendant can raise a substantial question about the patent's validity.

The Delhi High Court's Single Judge initially denied Roche's request for an interim injunction, a decision that was subsequently upheld by a Division Bench on October 9. The Division Bench, comprising Justice C. Hari Shankar and Justice Ajay Digpaul, found “no reason to interfere with the findings of the learned Single Judge that Risdiplam is vulnerable to invalidity... as being obvious vis-à-vis prior art.” The appellate bench explicitly referenced the legal standard set in Wander Ltd. v. Antox India P. Ltd. , underscoring that an appellate court should not substitute its discretion for that of the trial court in interim matters unless the decision is perverse or legally unsound.

Arguments Before the Supreme Court

Before the Supreme Court, Senior Advocate Neeraj Kishan Kaul, appearing for Roche, mounted a robust argument emphasizing the sanctity of patent rights. He contended that Natco was attempting to benefit from "reverse engineering" a drug developed after years of research and millions of dollars in investment.

"To use the public interest argument to defeat a right I have under the Patent Act is unfair. The issue requires consideration," Mr. Kaul urged, noting that Risdiplam enjoys patent protection in over sixty countries. He further argued that the balance of convenience favoured Roche, as Natco had not yet launched its product and Roche itself had a history of public-friendly initiatives, a fact he claimed the Supreme Court had previously acknowledged.

A key legal argument advanced by Roche was that the High Court had applied the incorrect test for determining obviousness. Mr. Kaul asserted that the proper standard requires assessing inventiveness from the perspective of a "person ordinarily skilled in the art," suggesting the High Court's analysis was flawed.

Despite these persuasive arguments, the Supreme Court Bench remained reluctant to intervene. The concurrent findings of two tiers of the High Court on the prima facie merits of the injunction application proved to be a formidable barrier. The Bench's stance reiterates the judiciary's deference to lower court discretion in interim orders, especially where complex technical and factual assessments are involved.

When it became clear an injunction was unlikely, Mr. Kaul implored the Bench to at least admit the matter to consider the point of law or, alternatively, to direct Natco to maintain accounts of its profits and refrain from exporting the drug. The Bench, however, did not express a view on these requests, ultimately agreeing only to direct the High Court for an expeditious disposal of the main suit.

Senior Advocates Kapil Sibal and Gopal Subramanium represented Natco Pharma, successfully defending the High Court's orders.

Legal Implications and Industry Impact

The Supreme Court's order carries significant weight for patent litigation in India, particularly within the pharmaceutical sector.

• Reinforcing the "Credible Challenge" Standard: The decision solidifies the principle that an interim injunction in a patent infringement suit is not automatic. If a defendant can present a credible, non-frivolous challenge to the patent's validity, as Natco did on the ground of obviousness, courts will be hesitant to restrain them from entering the market pending a full trial. This places a heavy burden on patentees to demonstrate not just infringement but also the robust validity of their patent at the preliminary stage.

• Deference to Concurrent Interim Findings: The ruling serves as a strong precedent against appealing interim injunction orders to the Supreme Court, especially when a Single Judge and Division Bench have arrived at the same conclusion. The Court has signaled its disinclination to act as a third forum for re-evaluating prima facie evidence, preferring to let the trial court adjudicate the matter on its merits.

• Greenlight for "At-Risk" Launches: For generic manufacturers, this outcome may be seen as an encouragement for "at-risk" launches, where a generic product is introduced to the market while patent litigation is ongoing. While risky, a successful defence against an interim injunction significantly lowers the immediate barriers to market entry.

• Emphasis on Expeditious Trials: The Supreme Court's sole concession—a direction for a speedy trial—is a critical takeaway. It reflects a judicial understanding that while interim relief may be denied, the uncertainty created by protracted litigation is detrimental to both the patent holder and the generic manufacturer. This directive pushes for a final resolution on the merits, which will ultimately determine the patent's validity and whether Natco's product is indeed infringing.

The case, F. Hoffmann-La Roche AG v. Natco Pharma Limited (SLP(C) No. 29664/2025), will now return to the Delhi High Court, where the core questions of patent validity and infringement will be decided in a full trial. While Natco has won the battle for market entry, the war over the Risdiplam patent is far from over.