The Indian Patent Office has revoked the patent on Novartis’ blockbuster cardiac drug Vymada on grounds of lack of novelty, potentially opening the door for affordable generics to enter the Indian market.
Generics Poised to Enter Market
Vymada, sold internationally as Entresto (sacubitril + valsartan), has long attracted attention in India. Several domestic firms—including Natco, Torrent Pharma, MSN Labs, and Eris Lifesciences—earlier launched versions “at risk,” but courts restrained them following Novartis’ legal action. With the revocation, these companies can now launch freely, and more players are expected to follow, likely lowering therapy costs further.
Industry Push Against Patent
The Indian Pharmaceutical Alliance—along with IPCA and Micro Labs—formally opposed the patent at the post-grant stage. Their challenge cited Section 3(d) of the Indian Patent Act, a provision designed to prevent ‘evergreening’ of patents by requiring proof of enhanced therapeutic efficacy. Notably, Novartis had earlier lost its patent on cancer drug Glivec in 2013 under the same clause.
IPO’s Ruling
Usha Rao, Deputy Controller of Patents and Designs, stated, “The patentee has failed to disclose any demonstrated advantages or technical advancement of the claimed supramolecular complex over the combination already disclosed in D1 (closest prior art, patentee’s own earlier application). No experimental data, comparative studies or technical rationale have been provided to substantiate any enhanced efficacy. Researchers have not shown any improved therapeutic efficacy.”
High Stakes for Novartis
Vymada is a major revenue driver for Novartis, generating $7.8 billion in global sales last year. As reported by msn.com, the revocation in India is a significant setback for the Swiss drugmaker and a boost for the country’s generic drug industry, which has long argued for wider access to life-saving therapies at affordable prices.
