High Court Restrains Generic Pharma Firms From Making, Selling Patent Drug Of Novartis

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The Delhi High Court has restrained various generic pharmaceutical companies from manufacturing or selling Valsartan and Sacubitril tablets, a combination to treat cardiovascular diseases, as it may amount to infringement of patent of pharma major Novartis AG.
The injunction order has been passed against Natco Pharma, Torrent Pharmaceuticals, Eris Lifesciences and Windlas Biotech, generic pharma firms making or selling Valsartan and Sacubitril.

Novartis, being the patentee, has been selling Valsartan and Sacubitril tablets in India under the brand “Vymada” since 2016.

The court’s order came on the plea by Novartis, represented through advocate Mamta Jha, seeking to restrain other pharma firms from manufacturing or selling the patented combination of Sacubitril and Valsartan tablets.

Justice Jayant Nath said: “An injunction is passed in favour of the plaintiffs and against all the defendants restraining the defendants, their agents etc. from manufacturing, importing, selling, offering for sale, etc. any pharmaceutical composition comprising a combination of Valsartan or a pharmaceutically acceptable salt, and Sacubitril or a pharmaceutically acceptable salt and a pharmaceutically acceptable carrier or more specifically a pharmaceutical composition comprising combination of Sacubitril +Valsartan as a sodium salt complex or in any other form which may amount to infringement of Indian Patent…of plaintiff no.1 (Novartis AG)”.

The plea said the plaintiff through a press release of January 28, 2019 issued by the defendant came to know about its act in launching a pharmaceutical composition comprising of the patented combination of Sacubitril and Valsartan tablet under the brand VALSAC as a combination drug.

The defendants, in the written statement, said that the invention of the suit patent comprises a combination of Valsartan and Sacubitril which together inhibit AT-1 and NEP receptors respectively.

The invention is hence nothing but a physical combination of Valsartan and Sacubitril and the defendant’s product is a “supra molecular complex comprising of Valsartan and Sacubitril anions with sodium cations and water molecules and does not fall within the scope of the suit patent”, it said.

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