The Indian Patent Office has annulled the patent granted to Novartis for its heart failure drug Vymada, also sold internationally as Entresto.
The Controller General of Patents, Designs and Trademarks cited lack of novelty, insufficient inventive step, and inadequate disclosure of advantages in the patent application as reasons for its move.
Vymada, a combination of sacubitril and valsartan, is prescribed for hypertension and heart failure.
While cancelling the patent for the “supramolecular complex” of sacubitril and valsartan, the active ingredients in Vymada, the controller said Novartis failed to show any clear therapeutic advantage of its claimed “supramolecular complex” over existing formulations.
The order followed a post-grant opposition filed by the Indian Pharmaceutical Alliance (IPA), an industry group representing major domestic drugmakers.
Two companies, IPCA and Micro Labs, also opposed the patent at the post‑grant stage.
Novartis’ patent on another form of the same drug expired in 2023, and this led to the entry of dozens of copycats into the market.
The Swiss drug maker then claimed that a specific crystalline form, for which it got the patent, was necessary for Entresto to work.
Generic drugmakers were later barred from copying the Swiss company’s crystalline form, Times of India reports.
IPA challenged the patent in December 2023, alleging a lack of novelty.
Vymada is among Novartis’ top-selling drugs, generating $7.8 billion globally in 2024.
With the drug going off-patent, many companies, including Torrent Pharma, Sun Pharma, Cipla, Lupin, USV have expressed interest in marketing generic versions of the drug.
