Novartis Sues Alkem After ANDA for Generic Heart Medicine

On Friday a case was filed in the District of Delaware by Novartis Pharmaceuticals against Alkem Laboratories and their affiliates. The case is regarding an Abbreviated New Drug Application (ANDA) filed by Alkem; Novartis alleges the ANDA violates their patent rights in heart medication Entresto.

Entresto is a drug used to treat chronic heart failure with reduced ejection fraction, the complaint explains. The patent is held by Novartis and is specific to the use of the drug in patients who are also taking an ACE inhibitor as a part of their treatment for chronic heart failure.

The defendant is a manufacturer and importer of drugs and filed the ANDA very close in time to the issuance of the affected patent and without seeking license from Novartis, the complaint said.

The plaintiff is suing for patent infringement and seeks a permanent injunction of Alkems action prior to expiration of the patent as well as declaratory judgment regarding the infringement of the patent. The plaintiff is represented by McCarter & English LLP and Venable LLP