Risdiplam Patent Infringement Case In India

Date:19-10-2025 | By Afzal Hasan, Vatsala Singh Hasan, Shardul Chouhan

F. Hoffmann-La Roche AG vs NATCO Pharma Limited

On October 16, 2025, the Supreme Court of India delivered a decisive blow to Swiss pharmaceutical giant F. Hoffmann-La Roche AG's last-ditch effort to block Natco Pharma's generic version of Risdiplam, cementing what may become one of the most significant pharmaceutical patent rulings of the decade. 

A two-judge bench comprising Justice PS Narasimha and Justice Atul S Chandurkar dis missed Roche's Special Leave Petition challenging the Delhi High Court's concurrent orders that had refused to grant interim injunctions against Natco. The Court's terse yet definitive order stated:

"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." 

F. Hoffmann-La Roche AG & Anr. (Appellants) had moved the appeal against Natco Pharma Limited (Respondent) and had challenged an order granted by a Single Judge of the said court. The case is about a patent infringement action in relation to the drug Risdiplam, which is commercially sold by the Appellants with the brand name EVRYSDI® for the treatment of Spinal Muscular Atrophy (SMA). 

Appellants/Plaintiffs: F. Hoffmann-La Roche AG & Anr. (Owner of the suit patent). 
Respondent/ Defendant: Natco Pharma Limited (Manufacturing and selling Risdiplam admittedly). 
Suit Patent (Species Patent): Indian Patent IN 334397 (IN '397). 
Prior Art (Genus Patent): PCT application WO 2013/119916 (WO '916) and respective US Patent US 9586955 (US '955). 

Code of Civil Procedure, 1908 (CPC): 

• Order 43, Rule 1: Governs appeals from orders, including interim injunction orders under Order 39 
• Section 104: Enumerates appealable orders 
• Order 39, Rules 1 & 2: Temporary injunctions and interlocutory orders

Patents Act, 1970: 

• Section 107(1): Statutory defense allowing validity challenges as grounds for non-infringement 
• Section 64(1)(e) & (f): Grounds for patent revocation based on anticipation and obviousness 
• Section 48: Rights conferred by patent grant

The appeal questions the Single Judge's rejection of the Appellants' application for interim injunction against the Respondent's production and sale of Risdiplam. The Division Bench confirmed the rejection of the injunction by the Single Judge and, in turn, rejected the appeal. The crux of the ruling lies in deciding whether the Respondent (Natco Pharma) made a serious challenge to the validity of Appellants' (Roche's) patent, IN '397, a valid defense under Section 107(1) read with Section 64(1) of the Patents Act. The Division Bench agreed with the Single Judge's conclusion that the claim in the suit patent (Risdiplam) is susceptible to invalidity in terms of obviousness or absence of inventive step under Section 64(1)(f) of the Patents Act, over prior art. The Single Judge held the claim of Risdiplam to be obvious in comparison with Compound 809 disclosed in the prior art genus patents WO '916/US '955.The molecular structure of Risdiplam and Compound 809 are reported to be the same except for a single position where the Compound 809 contains a -CH radical and Risdiplam contains a Nitrogen (-N) atom. The Division Bench held that the Single Judge gave "cogent and well-considered reasons" to hold that the teachings and disclosures in the prior art genus patent, along with other considerations, would lead a person skilled in the art to arrive at Risdiplam, thus making it obvious. The Division Bench was concerned with the Single Judge's conclusion that Risdiplam was susceptible to invalidity on the ground of absence of novelty under Section 64(1)(e) (i.e., it was disclosed in the genus patent). The court dealt with the divergent opinions on whether mere inclusion of a compound (such as Risdiplam) in a wide Markush framework of a genus patent (WO '916/US '955) constitutes disclosure for novelty. The Bench expressed its preliminary opinion that coverage by itself does not always mean disclosure, as disclosure has to be "enabling in nature" so that one familiar with the art can synthesize the product. But since the obviousness finding (Section 64(1)(f)) was enough to affirm the Single Judge's rejection of the injunction, the court did not feel the need to finally hold on the question of novelty (Section 64(1)(e)). The High Court, invoking the doctrine of appellate restraint in interfering with discretionary orders (the dictum in Wander Ltd. v. Antox India), saw no grounds for interference into the Single Judge's discretion since the Single Judge had applied the principles of law well, and specifically regarding the prima facie case of obviousness of the suit patent. The appeal was thus dismissed. 

Disclaimer- Above article is author’s view and interpretation of the subject. This is not a legal opinion or legal advice in any manner whatsoever. Reach us at- hasan@hasanandsingh.com