AIBRIEF
Natco told the Delhi High Court that Novartis's second patent on breast cancer drug Kisqali (ribociclib) would push Indian generic entry from 2027 to 2029. Next hearing: 16 September.
Natco Pharma, a Hyderabad-based generic drugmaker, has asked the Delhi High Court to overturn the Indian Patent Office's 10 July 2026 order directing grant of a new patent on ribociclib, the breast cancer drug Kisqali. Justice Anup Jairam Bhambhani issued notice and listed the case for 16 September.
The patent office's order had rejected four pre-grant oppositions to Novartis's application, titled "Pyrrolopyrimidine Compounds as CDK Inhibitors" and filed in February 2011, and approved grant with a single amended claim. Astex Therapeutics, the UK co-applicant, was named alongside Novartis.
Natco argues the second patent would extend Novartis's hold on ribociclib past the 24 May 2027 expiry of Indian Patent No. 283133, which the Swiss company has already used to stop Natco from selling the drug. Generic entry in India would slip toward 2029 if the new patent stands. In the petition, Natco says the controller "perpetuates an unlawful monopoly" and "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."
Novartis and Natco didn't respond to email queries. The 16 September hearing will test whether India's pre-grant opposition system can block a second patent on a drug whose first has roughly 18 months left.