Hyderabad-based Natco Pharma has moved the Delhi High Court against the Indian Patent Office's decision to grant a patent for the breast cancer drug ribociclib (Kisqali) to Swiss drugmaker Novartis AG and UK-based Astex Therapeutics. According to reports from Mint, Justice Anup Jairam Bhambhani briefly heard the matter on Wednesday and issued notice to all parties, listing the case for further hearing on 16 September. The patent application was originally filed in 2011 and the patent office rejected four pre-grant oppositions in July 2026, directing the grant of the ribociclib patent with a single amended claim.
Natco argued in its petition that the fresh patent would unfairly extend Novartis' monopoly over the medicine. As reported by Mint, the company challenged the patent office's order dated 10 July 2026, which rejected four pre-grant oppositions and directed the grant of the ribociclib patent. Natco alleged that the patent controller failed to recognise that ribociclib was already covered under Novartis' earlier patent and ignored previous court rulings while deciding to grant the new patent. The company argued that Novartis already owns Indian Patent No. 283133, which covers ribociclib and is valid until 24 May 2027.
According to the petition reviewed by Mint, Natco alleged that the patent controller "gravely errs by failing to appreciate that the applicants, by securing two patents for the same invention, are unlawfully extending the term of protection of the genus patent through the impugned patent application." The company argued that Novartis cannot claim ribociclib is already protected under its existing patent while also obtaining a fresh patent that could keep generic competitors out of the market until 2029. Natco also referred to a 7 September 2022 Delhi High Court order in an earlier patent dispute, under which it agreed not to launch ribociclib until the earlier patent expired in 2027.
The dispute dates back to February 2011, when Novartis and Astex filed a patent application titled 'Pyrrolopyrimidine Compounds as CDK Inhibitors', covering ribociclib. As reported by Mint, Natco filed its pre-grant opposition in November 2018, while three other parties also opposed the application in subsequent years. After several rounds of hearings, expert opinions and written submissions, the patent office rejected all four oppositions in July 2026. Natco had previously settled a patent infringement suit by Novartis and Astex over Kisqali in a US court in 2025, as both parties stipulated to a dismissal with prejudice. Last year, the company won a landmark suit in the Delhi High Court against Roche over risdiplam, a drug used to treat spinal muscular atrophy.
