DMFs (Drug Master File) filed in July 2025 and Risdiplam : F. Hoffmann-La Roche AG vs Natco Pharma Limited, Delhi High Court
Contents
DMFs filed in July 2025
General information
Xspray Pharma: FDA accepts New Drug Application for XS003 (nilotinib) for the treatment of CML – PDUFA date set for June 18, 2026
Novo Nordisk and D Young defend crucial patent for tablet form of semaglutide
Intellectual Property
Risdiplam : F. Hoffmann-La Roche AG vs Natco Pharma Limited, Delhi High Court
DMFs filed in July 2025
The FDA publishes a list of DMF filings each quarter. The list for the third quarter was recently released. A total of 322 DMFs were filed during that period. Below is the list of companies that submitted more than three DMFs in the quarter.
General information
Xspray Pharma: FDA accepts New Drug Application for XS003 (nilotinib) for the treatment of CML – PDUFA date set for June 18, 2026
XS003 is an improved formulation of nilotinib (Tasigna®) for the treatment of chronic myeloid leukemia (CML), developed using Xspray’s proprietary HyNap™ technology. Data demonstrate bioequivalence to the reference product at less than half the dose, as well as a significantly reduced food effect (29% compared to 82% for Tasigna). News hereNovo Nordisk and D Young defend crucial patent for tablet form of semaglutide
The European Patent Office has upheld a patent owned by Novo Nordisk. The patent is one of several intellectual property rights related to the diabetes and weight loss drug semaglutide, which the Danish patent holder is defending News hereIntellectual Property
Risdiplam : F. Hoffmann-La Roche AG vs Natco Pharma Limited, Delhi High Court
Overview This write-up presents the judgment in the case of F. Hoffmann-La Roche AG vs Natco Pharma Limited delivered by the High Court of Delhi on October 9, 2025. The case concerns an appeal against a decision by a Single Judge, who dismissed an application by F. Hoffmann-La Roche AG (the appellants) seeking an injunction against Natco Pharma Limited (the respondent) from manufacturing and selling the drug Risdiplam. The appellants (Roche) argued that the respondent's actions infringed their Indian Patent IN 3343971. Background The core issue is whether Natco Pharma's production and sale of Risdiplam infringes upon Roche's patent for compounds treating spinal muscular atrophy. The patent in question covers a Markush structure that covers a group of compounds with similar structures. Risdiplam is classified within this structure as one of the compounds. Key question in litigation A key point of contention is whether Risdiplam, claimed in the suit patent, is vulnerable to invalidity based on Section 64(1)(e) (lack of novelty) and Section 64(1)(f) (obviousness and lack of inventive step). Arguments The appellants (Roche) argued that Natco Pharma's manufacture and sale of Risdiplam infringed their patent. Natco Pharma defended its actions, arguing that the patent was not novel and was obvious based on prior art, explicitly referencing the Markush formulation disclosed in patents WO'916 and US'955. (WO2013119916) Single Judge's Decision The Single Judge ruled in favour of Natco Pharma, concluding that the suit patent was susceptible to invalidity under both Section 64(1)(e) and Section 64(1)(f) of the Patents Act. The judge reasoned that the broad Markush formulation in WO'916/US'955 disclosed Risdiplam and that Risdiplam would have been obvious to a person skilled in the art based on the teachings in those prior patents. We previously covered the decision by the Single Judge bench, which can be accessed here. All technical details were outlined in our previous post. Although we are not reiterating the technical details discussed earlier, for the readers' benefit, the closest prior art (WO'916/US'955 ) reported structure is shown on the left, and Risdiplam is on the right.
Appellate Court's Analysis The appellate court acknowledged the Single Judge's findings and the need to adhere to the limited parameters of judicial review as outlined in Wander Ltd v Antox India (P) Ltd. The court expresses reservations regarding the Single Judge's finding that Risdiplam lacks novelty under Section 64(1)(e). It questions whether mere coverage within a Markush formulation in a genus patent is sufficient to establish disclosure, which is necessary for a finding of lack of novelty. However, the appellate court ultimately concurred with the Single Judge's determination that the Risdiplam was obvious, thus validating the conclusion that the patent would not be upheld. The court examines the facts, pointing out there are differences between Risdiplam and compound 809 in WO'916/US'955; the difference being that the compounds are merely a Nitrogen atom and a Carbon-Hydrogen radical. The court stated that an expert knowledgeable in medicinal chemistry would find the compounds obvious. Key Considerations The appellate court notes the significance of the inventors of the genus patent (WO'916/US'955) and the species patent (the suit patent) being the same. The court finds this legitimate to assume that the inventors possessed the knowledge to be able to select compound 809 from the 835 compounds exemplified. Conclusion The appellate court dismisses the appeal. While the court raises some concerns about the Single Judge's reasoning regarding the lack of novelty, it upholds the decision based on the finding that Risdiplam would be obvious. The court concluded that the respondent (Natco) effectively challenged the validity of the suit patent, and it does not need to consider any other aspects of the matter. Next actions Roche has moved to the Supreme Court (SC) against the Division Bench (DB) order. The CJI has allowed the matter to be listed urgently. The case was heard on 16 October. The Supreme Court said that the Court is not inclined to interfere with the High Court's findings, as they were made in an interim matter, and the findings are consistent in both the Single Judge and Division Bench orders. The Court also refused to impose an embargo on the export of Natco’s generics but directed that the High Court shall endeavor to dispose of the suit promptly. The Supreme Court’s order is not yet posted on the website, and details about the SC’s order from 16 October are based on reports in national newspapers. Details here
