Supreme Court Dismisses Roche's Plea To Restrain Natco From Making Generic Drug For SMA; Asks Delhi HC To Decide Patent Suit Soon

The Supreme Court on Friday dismissed the petition filed by Swiss pharmaceutical giant F Hoffmann-La Roche AG against the Delhi High Court's order allowing Natco Pharma to manufacture and sell a generic drug of Risdiplam, a drug used to treat Spinal Muscular Atrophy (SMA).A bench comprising Justice PS Narasimha and Justice AS Chandurkar declined to interfere with the High Court's order, observing that it was only an interim order. The bench also noted that both the single bench and the division bench of the High Court have entered concurrent findings.The bench however urged the High Court to dispose of the suit filed by Roche against Natco expeditiously."We are not inclined to interfere for the reason that it is interim in nature and also because the findings are concurrent. We have not expressed anything on merits. Needless to say, the observations made in the civil applications are intended only to dispose of the appeals and will have no bearing on the final decision. The High Court shall endeavour to dispose of the suit expeditiously," the bench observed in the order.Senior Advocate Neeraj Kishan Kaul for Roche argued that they hold the patent for the drug, and Natco was claiming rights after doing "reverse engineering." He argued that Roche developed the drug after investing millions of dollars and years of research."To use the public interest argument to defeat a right I have under the Patent Act is unfair. The issue requires consideration," Kaul urged. He added that Roche has also been helping the public and said that the Supreme Court itself has noted this fact in an earlier proceeding.Saying that the drug has protection in over sixty countries and that Natco has not yet launched the drug, Kaul argued that the balance of convenience was in Roche's favour as regards interim relief.However, the bench expressed reluctance to entertain the matter, pointing out that the High Court's findings have been concurrent, both at the single bench and division bench levels.Kaul persuaded the bench to at least admit the matter, if not inclined to grant interim relief, saying that the matter required consideration on the point of law. He argued that the High Court applied the wrong test, since the right test for inventiveness and obviousness must be from the point of view of a person ordinarily skilled in the art.Kaul urged the bench to at least direct Natco to maintain the accounts of profit from the sale of the drug and to restrain them from exporting it. However, the bench did not express any view on this. Ultimately, at Kaul's persuasion, the bench agreed to ask the High Court to expeditiously decide the main suit.Senior Advocates Kapil Sibal and Gopal Subramanium appeared for Natco.On October 9, a division bench of the Delhi High Court had refused to pass an injunction against Natco Pharma in a patent dispute. A Division Bench of Justice C Hari Shankar and Justice Ajay Digpaul dismissed Roche's appeal against a Single Judge's decision, which had allowed Natco to continue manufacturing and selling the drug in India. Roche had argued that Natco's product infringed its suit patent IN'397, valid until 2035, which claimed compounds for treating spinal muscular atrophy.The case arose out of Roche's claim that Natco's manufacture and sale of Risdiplam infringed its Indian patent containing compounds for treating SMA.Natco invoked the statutory defence under Section 107(1) of the Patents Act, 1970, claiming that the patent was invalid under Section 64(1)(e) (lack of novelty) and Section 64(1)(f) (obviousness).The High Court division bench found “no reason to interfere with the findings of the learned Single Judge that Risdiplam is vulnerable to invalidity in terms of Section 64(1)(f) of the Patents Act, as being obvious vis-à-vis prior art in the form of the claimed Compound 809 in WO'916/US'955,” and held that “no case for interference with the said decision, within the parameters of Wander, can be said to have been made out.”Case Details : F. HOFFMANNLA ROCHE AG Vs NATCO PHARMA LIMITED | SLP(C) No. 29664/2025

Supreme Court Dismisses Roche's Plea To Restrain Natco From Making Generic Drug For SMA; Asks Delhi HC To Decide Patent Suit Soon

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