The Indian Patent Office (IPO) has revoked the patent for Novartis’ cardiac drug Vymada—known globally as Entresto—on the grounds of lack of novelty and inventive step. The decision was issued by Deputy Controller D. Usha Rao on September 12, stating that Novartis did not provide sufficient evidence that its claimed “supramolecular complex” offered therapeutic advantages over existing formulations.

Vymada combines two active ingredients, sacubitril and valsartan, and is used in the treatment of heart failure and hypertension. In 2024, global sales of the medicine were approximately 7.8 billion USD. However, until now, courts had blocked generic versions from companies including Natco, Torrent Pharma, MSN Labs, and Eris Lifesciences due to active patent protection.

The patent revocation follows a post-grant opposition led by the Indian Pharmaceutical Alliance and several generics makers. They argued that the formulation did not meet legal standards for patentability, including novelty and inventive step. The IPO’s ruling agreed, finding that Novartis failed to demonstrate any clear therapeutic benefit from the specific patented complex beyond what was already known.

With the patent revoked, Indian pharmaceutical companies are now free to produce generic versions of Vymada, which could bring more affordable treatment options to patients. This development is expected to significantly reduce costs for heart disease treatments and improve access.

Industry analysts say the move is likely to reshape the cardiovascular drugs landscape in India. It also reinforces India’s commitment to balancing intellectual property rights with public health needs.