Law Street Media

Novartis Files ANDA Suit Against Dr. Reddy’s Over Heart Treatment

Analyzing samples in test tube backgrounds at laboratory.

On Tuesday a case was filed in the District of Delaware by Novartis Pharmaceuticals Corporation against Dr. Reddy’s Laboratories Inc. regarding patent infringement for Entresto tablets.

Entresto is a medication designed to treat heart failure and is indicated to reduce 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 defendants have submitted an Abbreviated New Drug Application (ANDA) intending to create and sell a generic version of the medication prior to the expiration of the patents held by the plaintiffs. The plaintiffs specifically note that the patent and label instructions for Entresto specifically include “instructions for titration for human patients who are not taking an ACE inhibitor or an ARB or taking a low dose of an ACE inhibitor or an ARB before treatment with ENTRESTO® is initiated.” The information included in the ANDA from the defendants specifically tracks those titration instructions and in the process directly recites part of a claim in the original patents, the plaintiffs argue.

The plaintiffs are suing for patent infringement and seek declaratory judgment, permanent injunctive relief restricting the defendants from acting prior to the expiration of the patents, and damages. Plaintiff is represented by McCarter & English LLP.

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