India Supreme Court: Novartis's Glivec patent not novel

Managing IP is part of Legal Benchmarking Limited, 1-2 Paris Gardens, London, SE1 8ND

Copyright © Legal Benchmarking Limited and its affiliated companies 2025

Accessibility | Terms of Use | Privacy Policy | Modern Slavery Statement

India Supreme Court: Novartis's Glivec patent not novel

The India Supreme Court has upheld the Intellectual Property Appellate Board's (IPAB) denial of Novartis's patent application for anti-cancer drug Glivec

Domestic generic manufacturers Ranbaxy and Cipla brought the opposition, with both represented by Singh & Singh. Anand & Anand acted for Novartis. You can read the Court's ruling here.

The comptroller of patents rejected the Glivec application for lack of novelty. Specifically at issue was section 3(d) of the Patents Act, which states that new formulations of existing drugs are not novel unless they “differ significantly in properties with regard to efficacy”. The act specifically refers to alternative forms such as salts and ethers. Glivec is a salt formulation of the known molecule imatinib.

The IPAB agreed with the patent controller, finding that Glivec was not patentable.

Novartis claims that Glivec is a major improvement over the original molecule, stating that “without further development, [imatinib] could not safely be administered to patients and represented only the first step in the process to develop Glivec as a viable treatment for cancer” (emphasis in original).

The Glivec saga has been ongoing for over six years, with Novartis going so far as challenging the constitutionality of section 3(d). On the other side of the dispute, generics and activists claimed that the application was an attempt at evergreening, where a rights holder patents a minor variation of a drug to extend the protection period.

The Glivec case is just the latest development raising concerns among international pharmaceutical companies about IP protection in India. India has denied patent protection to a number of drugs developed by multinationals, including Pfizer’s sutent and Roche’s Pegasys. Observers around the world have also been discussing the country’s increasingly aggressive compulsory licensing programme, whether it improves access to medicines as intended and whether it is in violation of TRIPs.

more from across site and SHARED ros bottom lb

More from across our site

EasyGroup, the owner of the easyJet airline, said in a press release that UK-based first-instance judges are “less experienced”, bringing a long-running debate back to the fore
A cross-practice team from Mayer Brown, which included members of the firm’s IP practice, advised on the deal
María Cecilia Romoleroux discusses the challenges she has faced in her career in IP and how she hopes to improve things for the next generation of women
Value-added services give in-house counsel the satisfaction that they are getting more value for money, while law firms get the opportunity to win more work
A team at Boies Schiller Flexner is advising shoe company Kizik and parent company HandsFree Labs in the dispute
Nokia’s latest enforcement actions against Geely and Transsion joining Via LA’s AAC pool were also among the top talking points
Benjamin Kelly, the firm’s fifth IP partner hire in a little over one year, has experience in patent and trade secret disputes involving complex technologies
Half-year Talent Tracker data shows Pierson Ferdinand was among the most prolific hirers in the US, while in Europe, there has been a notable UPC swing
Exclusive data reveals in-house counsel want external legal advisers to build better client relationships and add value beyond routine work
Brett Sandford acted for Perplexity AI, which fended off the threat of a preliminary injunction to launch an AI-powered web browser
Gift this article