Delhi HC Stays Patent Granted to Novartis Drug “Entresto”

The Delhi High Court on 12th January 2023 stayed a patent granted to Novartis last month for its drug “Vymada”, upholding a writ petition filed by Natco Pharma. Vymada, sold internationally as Entresto, is a popular drug for treating hypertension. On 14th December 2022, Novartis was granted a patent from the Indian Patent Office (IPO) for Entresto, a chemical combination of sacubitril and valsartan as a sodium salt complex.

The Swiss multinational pharma Novartis was already holding a patent for a fixed dose combination of Entresto, which expired on 16th January 2023. The latest patent granted for the combination drug Vymada if in force, would have restricted other manufacturers from producing a generic version of drugs using a combination of sacubitril and valsartan till 2026. This, in turn, would have resulted in a monopoly by Novartis and, consequently exorbitant market price for the drug.

Earlier, on 6th September 2016, Natco Pharma, the opponent, had filed a pre-grant opposition against the grant of the patent in accordance with Section 25(1) of the Indian Patent Act, 1970. This opposition aimed to make generic production of the drug possible. Novartis filed a reply statement on 3rd March 2017 without any supporting documentation. IPO has granted a patent to the combination drug Entresto during the pre-grant opposition proceedings.

Subsequently, Natco Pharma filed a writ petition before the Delhi High Court stating procedural irregularities and violation of the principles of natural justice in granting a patent for the combination drug. Natco argued that the patent was awarded without allowing Natco to submit its opposition.

As per section 25(1) of the Patents Act, 1970, “where an application for a patent has been published, but a patent has not been granted, any person may, in writing, represent by way of opposition to the Controller against the grant of a patent on the grounds in the section”. However, this opportunity was allegedly not made available to the opponent in this case. In its order to stay the patent granted to Novartis, the Delhi High Court has further directed the Controller of Patents and Designs to adhere to the pre-grant opposition procedures.