24 Sep 2025
In a ruling that could reshape India’s heart drug market, the Indian Patent Office has revoked Novartis’ patent for its blockbuster therapy Vymada (sold internationally as Entresto). The decision, issued on September 12, found that Novartis’ claims lacked novelty, inventive step, and sufficient proof of enhanced efficacy.
Vymada, a combination of sacubitril and valsartan, is prescribed worldwide for hypertension and heart failure. It generated nearly $7.8 billion in global sales last year, making it one of Novartis’ most profitable products. But in India, the patent has been fiercely contested since it was granted in 2022, with local companies eager to launch more affordable versions.
At the heart of the dispute was Section 3(d) of India’s Patents Act, which blocks “evergreening” — the practice of extending patent life through minor modifications without genuine therapeutic benefit. This same provision famously came into play when Novartis lost its Glivec cancer drug case in 2013. In the Vymada ruling, the Patent Office concluded that no clinical data or comparative studies demonstrated real improvements over existing treatments.
For Indian patients, the outcome could be significant. Domestic manufacturers including Natco, Torrent Pharma, MSN Labs, and Eris Lifesciences are now free to sell generic versions without the shadow of litigation. More competition is expected to push prices down, expanding access to life-saving cardiac therapy for thousands.
Novartis did not attend the final hearing and has yet to issue a response, though legal experts anticipate an appeal. Regardless, the case underscores the ongoing tension between multinational pharmaceutical firms seeking to protect their innovations and India’s long-standing policy of prioritising affordable access to essential medicines.
Patent disputes like this show how complex the balance between innovation and access can be. At IP Solved, we help businesses navigate patent challenges, manage risk, and protect IP strategies across global markets. Contact us today to safeguard your innovations.
