Delhi High Court restrains generic pharmaceutical companies from making Novartis patented drug News
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Delhi High Court restrains generic pharmaceutical companies from making Novartis patented drug

The Delhi High Court Tuesday issued an injunction against various generic pharmaceutical companies, preventing them from manufacturing or selling Valsartan and Sacubitril tablets used to treat cardiovascular diseases. The court said that the generic companies’ manufacturing or selling of these tablets may amount to infringement of a patent owned by major pharmaceutical company Novartis AG.

The order has been passed against Natco Pharma, Torrent Pharmaceuticals, Eris Lifesciences and Windlas Biotech. These all are generic pharmaceutical companies manufacturing or selling Valsartan and Sacubitril.

Novartis, the patent-holder, has been selling Valsartan and Sacubitril tablets in India under the brand name “Vymada” since 2016. The company had filed a plea in the Delhi High Court, seeking to restrain other pharma companies from manufacturing or selling the patented combination of Valsartan and Sacubitril tablets.

The injunction order restrains all the generic pharmaceutical companies and their agents from manufacturing, importing, selling, or offering for sale any pharmaceutical composition comprising a combination of Valsartan or a pharmaceutically acceptable salt. This also includes Sacubitril or a pharmaceutically acceptable salt, and a pharmaceutically acceptable carrier. More specifically, this includes a pharmaceutical composition comprising combination of Sacubitril and Valsartan as a sodium salt complex, or in any other form which may amount to infringement of the Indian Patent of Novartis AG.

The plaintiff claimed it learned about the generic companies’ acts through defendant’s press release in January 2019. The generic pharmaceutical companies, in a 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 statement further said that the invention is nothing but a physical combination of Valsartan and Sacubitril, and that the defendant’s product is a supra molecular complex comprising of Valsartan and Sacubitril anions with sodium cations and water molecules. Therefore, defendants claimed that the product does not fall within the scope of the suit patent.

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