Locke Lord Obtains Federal Circuit Ruling in Favor of Zydus Pharmaceuticals (USA) Inc.

A Chicago-based Locke Lord team represented Zydus Pharmaceuticals (USA) Inc. before the U.S. Court of Appeals for the Federal Circuit. The Federal Circuit affirmed the ruling from the U.S. District Court for the District of Delaware that Zydus’ Abbreviated New Drug Application (ANDA) for vortioxetine hydrobromide tablets did not infringe two patents owned by H. Lundbeck A/S. The decision permits entry of Zydus’ approved ANDA product five and a half years before patents on the brand name antidepressant, Trintellix®, expire. Lundbeck and its marketing partner Takeda reported Trintellix®’s 2022 annual U.S. sales to be greater than $700 million. Important for the industry as a whole, the ruling solidifies that a generic pharmaceutical manufacturer may avoid patent infringement liability by excluding from product labeling any patented uses for which the company does not seek approval by the FDA. The Locke Lord team representing Zydus included David Abramowitz (argued), Michael Gaertner, Carolyn Blessing, Hugh Balsam, Timothy Peterson, Jonathan Turpin and Leah Brackensick (all of Chicago).
Posted on December 15, 2023