Business

India Revokes Novartis’ Patent on Major Heart-Drug in Landmark Decision

In a pivotal ruling, India’s Patent Office has annulled the patent held by Novartis for its heart-failure drug Vymada (internationally known as Entresto), citing its failure to meet key criteria of novelty and inventive step under Indian law.

• By Newsdesk
• New Delhi
• Sep 17, 2025

Business

In a pivotal ruling, India’s Patent Office has annulled the patent held by Novartis for its heart-failure drug Vymada (internationally known as Entresto), citing its failure to meet key criteria of novelty and inventive step under Indian law.

The decision opens the door to generic versions of the drug, promising more affordable options for patients in India. Domestic pharmaceutical firms had challenged Novartis’ claim, arguing it contravened Section 3(d) of the Patents Act, which aims to curb the practice of extending patent life through minor modifications.

What’s the Drug and Why It Matters
Vymada, a combination of sacubitril and valsartan, is widely prescribed to treat hypertension and heart failure. Globally, it generated roughly US$7.8 billion in revenue last year.

What the IPO Found
Issued on September 12 by Deputy Controller D. Usha Rao, the revocation order determined that Novartis’ claimed “supramolecular complex” did not provide any observable therapeutic benefit over prior formulations. The patent paperwork lacked comparative studies or technical rationale to support enhanced efficacy, the order noted.

In addition, the application was judged deficient in the description of the invention — a requirement under Indian patent law. Consequently, Patent No. 414518 was revoked under multiple provisions of the Patents Act, 1970.

Aftermath for Generics Players
Several Indian firms that were awaiting this legal clearance — including Natco, Torrent Pharma, MSN Labs, and Eris Lifesciences — now see the removal of significant legal barriers. The ruling is expected to encourage more competition and help lower treatment costs.

Legal and Regulatory Context
The contestation traces back to Novartis filing for the patent in 2007; it was granted in December 2022. Soon after, domestic pharma players, supported by the Indian Pharmaceutical Alliance, challenged it under the post-grant proceedings. Their argument hinged on Section 3(d), historically used in the Glivec case in 2013, to prevent “evergreening” — minor modifications that extend patent life without significant innovation.

Novartis did not attend the final hearing; the IPO decision was conducted based on written submissions alone. The Swiss company has not officially responded yet but is widely expected to appeal.