Williams & Connolly’s client Merck won a major trial victory in Hatch-Waxman patent litigation relating to the company’s blockbuster sitagliptin products: Januvia, Janumet, and Janumet XR. On September 22, 2022, the U.S. District Court for the Northern District of West Virginia ruled in favor of Merck following a December 2021 bench trial, holding that the two patents at issue are valid and were infringed.  Merck brought suit against more than a dozen ANDA filers on patents covering sitagliptin salt and polymorphic forms, formulations of sitagliptin and metformin, and processes for making sitagliptin.  The bench trial victory followed a settlement on the eve of trial of related matters that had been coordinated as an MDL proceeding in the District of Delaware.  The ruling also follows Merck’s win before the U.S. Patent Office, which issued a ruling in Merck’s favor in May 2021, finding all challenged claims valid.

The team representing Merck includes Stan Fisher, Bruce Genderson, David Krinsky, Elise Baumgarten, Alexander Zolan, Shaun Mahaffy, Tony Sheh, Sarahi Uribe, Vanessa Omoroghomwan, and Jihad Komis. 

The team was recognized by The American Lawyer as a “Litigator of the Week Runner Up” for their representation of Merck. 

Click here to read Merck’s press release

Click here to read Law360’s coverage of the case.