Novartis in tight spot as HC stays grant of patent for Entresto amid generics fight

The patents of the Entresto fixed dose combination are set to expire on January 16, 2023. The new patent secured by Novartis on December 14, 2022 prohibits companies from launching the chemically combined complex of the sacubitril and valsartan till 2026.

However, Justice Hari Shankar in his order on January 2023 stayed the patent awarded to Novartis, and has asked the Controller of Patents & Designs to hear the opposition to the patent.

The stay comes in response to a writ petition filed by Natco Pharma against the grant of patent by IPO to the pharmaceutical composition comprising combination of sacubitril + valsartan as a sodium salt complex of the Vymada.

Natco filed writ petition citing procedural irregularities and violation of principles of natural justice by the Assistant Controller of Patents & Designs in awarding patent to Novartis drug on December 14, 2022.

Counsel J Sai Deepak, representing Natco argued that the patent was awarded unilaterally to Novartis by the Assistant Controller without giving Natco an opportunity to submit pre-grant opposition as per the procedure laid down in the Section 25(1) of the Patent Act.

A top executive of Natco Pharma told The Economic Times with the court order "everyone" will be able to launch the generic version of the heart failure drug from January 16.

Medical Dialogues team had earlier reported that various pharma firms have been eyeing to produce the generic version of the top selling drug once its patent expires in 2023. To mention, Novartis' latest patent could potentially put a spanner into Indian drug companies' plans to launch generic versions of the blockbuster drug next week.

Also Read: HC Restrains 4 Pharma Firms From Making, Selling Novartis Sacubitril, Valsartan Tablets

Meanwhile commenting on the latest order, Novartis was quoted as saying in a statement by ET, "Novartis is disappointed with the outcome from the Delhi High Court, India, which stayed the grant of IN 414518," said Novartis in a statement.

"Novartis shall review the order carefully before taking appropriate action to defend its Intellectual property. Novartis has faith in the Indian Judicial system and is committed to protecting its patent rights for Entresto/ Vymada," the company added.