The US Court of Appeals for the Federal Circuit found that in cases brought under the Hatch-Waxman Act, for purposes of determining venue, infringement occurs only in districts where actions related to the submission of an abbreviated new drug application (ANDA) occur, and not in all locations where future distribution of the generic products specified in the ANDA is contemplated. Valeant Pharmaceuticals North American LLC v. Mylan Pharmaceuticals Inc., Case No. 19-2402 (Fed. Cir. Nov. 5, 2020) (O'Malley, J.). Valeant holds a new drug application for the brand name drug Jublia®, which is used to treat toenail fungal infections. In 2018, Mylan Pharmaceuticals Inc. (MPI) executed an ANDA seeking approval to market a generic version of Jublia®. MPI sent the ANDA from its West Virginia corporate office to the US Food and Drug Administration, located in White Oak, Maryland. The ANDA included a Paragraph IV certification that the Orange-Book-listed patents for...

Continue Reading