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

The court order came in the wake of Novartis' guilty plea.

New Delhi:

The Delhi High Court has prevented several generic pharmaceutical companies from making or selling valsartan and sacubitril tablets, a combination to treat cardiovascular diseases, as it may constitute an infringement of the patent of the major pharmaceutical company Novartis AG.

The court order was approved against Natco Pharma, Torrent Pharmaceuticals, Eris Lifesciences and Windlas Biotech, generic pharmaceutical companies that make or sell Valsartan and Sacubitril.

Novartis, as the patent holder, has been selling Valsartan and Sacubitril tablets in India under the brand name "Vymada" since 2016.

The court order came in the wake of Novartis' guilty plea, represented through attorney Mamta Jha, who seeks to prevent other pharmaceutical companies from making or selling the proprietary combination of sacubitril and valsartan tablets.

Judge Jayant Nath said: "A court order is issued in favor of the plaintiffs and against all defendants preventing 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 a combination of sacubitril + valsartan as a sodium salt complex or in any other form that may constitute an infringement of the Indian patent ... of Claimant No. 1 (Novartis AG) ".

The statement said that the plaintiff, through a press release dated January 28, 2019 issued by the defendant, learned of his act by launching a pharmaceutical composition comprising the proprietary combination of Sacubitril and Valsartan in tablet under the brand name VALSAC as a combination medicine.

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

Therefore, the invention is nothing more than a physical combination of Valsartan and Sacubitril and the defendant's product is a "supra-molecular complex comprising Valsartan and Sacubitril anions with sodium cations and water molecules and does not fall within the scope of the patent for the lawsuit, "he said. .

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