In major move, patent of Novartis' blockbuster cardiac drug revoked by India

In a landmark ruling that could reshape the cardiac drug market in India, the Indian Patent Office (IPO) has revoked the patent on Novartis’ blockbuster therapy Vymada, citing lack of novelty and inventive step, The Times of India reported on September 16. The decision is expected to open the door for a wave of generic competition, potentially reducing treatment costs for thousands of patients, the report (by Rupali Mukherjee) said.

Vymada, marketed internationally as Entresto, combines sacubitril and valsartan and is widely prescribed for hypertension and heart failure. For Novartis, the drug is a major revenue driver, generating $7.8 billion in global sales last year.

In India, however, the patent has been the subject of fierce litigation, with domestic pharmaceutical companies pushing for the right to market cheaper versions.


The ruling, issued on September 12 by Deputy Controller of Patents and Designs D Usha Rao, stated that Novartis failed to demonstrate any clear therapeutic advantage of its claimed “supramolecular complex” over existing formulations.

“No experimental data, comparative studies or technical rationale have been provided to substantiate any enhanced efficacy,” the order noted. It further ruled that the application did not sufficiently describe the invention, and revoked Patent No. 414518 under multiple provisions of the Patents Act, 1970.

The outcome brought focus back on the ongoing tension between global pharmaceutical giants and India’s patent regime, which has long prioritised access to affordable medicines.

Novartis’ patent, filed in 2007 and granted in December 2022, came under challenge soon after. Domestic firms, including IPCA and Micro Labs, backed by industry body Indian Pharmaceutical Alliance, opposed the grant at the post-grant stage.

They argued that the claim fell foul of Section 3(d) of the Patents Act, a provision designed to prevent “evergreening” of patents. This clause gained global attention in 2013 when Novartis lost its claim on the cancer drug Glivec.

The revocation marks one of the rare instances where Section 3(d) has been invoked in recent years. For Indian companies that had previously launched versions of the drug at risk — including Natco, Torrent Pharma, MSN Labs, and Eris Lifesciences — the ruling removes a significant legal cloud.

“Companies are now free to launch, with more players expected to follow, bringing down the price of the therapy further,” an industry expert told ToI.

Legal observers noted that Novartis abstained from the final hearing, with the decision based largely on written submissions. The Swiss drugmaker has yet to respond to the ruling, and is widely expected to challenge it in court.