India revokes Novartis' patent for blockbuster heart drug

Novartis

Indian Patent Office (IPO) has revoked Novartis AG’s patent on its blockbuster heart-failure drug Entresto, sold as Vymada in India, saying the Swiss drug company’s claims lacked novelty.

Vymada 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. The September 12 decision by the deputy controller of patents and designs could pave the way for affordable generics.

While cancelling the patent for the “supramolecular complex” of sacubitril and valsartan, the active ingredients in Vymada, D Usha Rao 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.

“The patentee has failed to disclose any demonstrated advantages or technical advancement of the claimed supramolecular complex over the combination already disclosed…,” the controller wrote in the order.

Moneycontrol has reviewed a copy of the order.

“No experimental data, comparative studies, or technical rationale have been provided to substantiate any enhanced efficacy. Further, no improved therapeutic efficacy has been shown,” Rao said. The patent fell foul of multiple provisions of the Patents Act.

The ruling caps nearly two years of litigation that began in December 2023 when IPA challenged the patent on grounds of lack of novelty, prior claiming, obviousness, and insufficiency of disclosure.

The opposing parties twice recommended revocation and after a Delhi High Court-directed round of rebuttal evidence, the controller held a final hearing on August 20. Novartis’s representatives abstained from the proceedings, the order said.

On February 13, 2009, Novartis was granted a patent for a drug combining valsartan and sacubitril. That patent expired on January 16, 2023, paving the way for dozens of copycats.

Novartis then claimed that a particular crystalline form, for which it was granted patent, was essential to Entresto's function, and blocked generic drugmakers from copying its crystalline form.

Indian firms opposed the patent, questioning whether the crystalline form offered a therapeutic advantage over earlier ones..

The controller sided with the opponents, who argued that the patent was an attempt at “evergreening” — extending monopoly rights without meaningful innovation — a practice India’s patent law seeks to curb.

Novartis spokesperson declined to comment. The drugmaker can appeal the decision in the Delhi High Court.