Novartis Sues Pharmaceutical Companies for Patent Infringement Over Generic ENTRESTO Tablets

Novartis Pharmaceuticals Corporation filed suit against Torrent Pharma, Inc., and Torrent Pharmaceuticals, LTD on Wednesday in the District of Delaware. The complaint alleges that Torrent engaged in patent infringement when they sought FDA approval to engage in the manufacture, production, and marketing of a generic version of the plaintiff’s Entresto tablets.

The complaint explained that Novartis owns a patent protecting their Entresto tablets, issued in July, meaning the patent will not expire until May 2036. Entresto tablets are intended to “reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure, and for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older.” The patent-in-suit claims a specific regimen for treating heart failure with “reduced ejection fraction,” something that is unique to Entresto tablets.

Torrent recently submitted an ANDA, or abbreviated new drug application, to the FDA seeking approval to manufacture, produce, and market a generic version of Entresto tablets. Novartis’ complaint asserts that if the proposed products are approved by the FDA, it will directly infringe on one or more claims of the patent-in-suit.

If Torrent is to move forward with the production of the generic Entresto pending FDA approval, the plaintiffs argue they will be doing so with full knowledge that their actions constitute infringement. Novartis contends that the production of generic Entresto will be “substantially and irreparably” damaging to them.

The complaint cites one count of infringement of the ‘667 patent, which has led Novartis to seek favorable judgement regarding the infringement, an injunction preventing them from engaging in further infringement, damages and monetary relief for the infringement, litigation fees, and any other relief deemed just by the Court.

Novartis has filed a similar patent infringement suit against Crystal Pharmaceutical Co., LTD., who have also filed an ANDA in hopes of producing generic versions of Entresto.The plaintiff is represented by McCarter & English LLP in the litigation.