Merck Files Patent Infringement Suit Over Prescription Drug Januvia

A patent suit was filed on Thursday in the District of Delaware by Merck Sharp & Dohme Corp. against Laurus Labs Limited and Laurus Generics Inc.. Merck is seeking declaratory judgement of patent infringement after the defendants submitted an Abbreviated New Drug Application (ANDA) to the Food and Drug Administration (FDA) to produce a generic version of the plaintiff’s diabetes treatment.

Januvia, according to the filing, is a prescription drug designed for adults diagnosed with type 2 diabetes. The once-daily prescription aids in lowering a patient’s blood sugar. Januvia is a form of sitagliptin phosphate oral tablets, and the defendants are seeking to produce and market a generic form of sitagliptin phosphate oral tablets. The patent Merck holds to protect Januvia, or the ‘708 patent, protects phosphoric acid salt of a dipeptidyl peptidase IV inhibitor. The patent, which was issued in 2008, covers a vital component of what is used to create Januvia.

Laurus Labs Limited notified the plaintiff of their intent to produce a generic version of Januvia through a notice letter which was dated July 8, 2021. In the notice letter, Merck detailed their belief that certain claims of the ‘708 patent were “invalid, unenforceable, and/or will not be infringed by the manufacture, use, offer for sale, and/or importation of Laurus’s ANDA Product.” The complaint asserts that if the defendant is to gain FDA approval and take the necessary steps towards manufacturing their product, their actions will constitute infringement of the ‘708 patent.

The complaint details counts of infringement of the ‘708 patent as well as declaratory judgement of that infringement. The plaintiff is seeking favorable judgement on all counts, a request that FDA approval of the ANDA not be made prior to the expiration of the ‘708 patent, an order enjoining Laurus Labs Limited from producing the infringing product, attorney’s fees, and any other relief deemed proper by the court.

The plaintiff is represented by McCarter & English LLP.