In Valeant Pharmaceuticals North America v. Mylan Pharmaceuticals, the Federal Circuit clarified venue for Hatch-Waxman cases and addressed a split among district courts on where Abbreviated New Drug Application (ANDA) filers could be sued after TC Heartland. The Supreme Court in TC Heartland held that venue in patent infringement is only available where (1) the defendant is incorporated or (2) where it has a regular and established place of business and committed acts of infringement.

In the wake of TC Heartland, some district courts held that an ANDA filer commits acts of infringement under 28 U.S.C. §1400 only where it prepares its ANDA, whereas others reasoned that an ANDA filer commits acts of infringement in any jurisdiction where it intends to distribute the ANDA product. In Valeant, the Federal Circuit took the narrower view of “acts of infringement,” and held that infringement occurs only where the ANDA filer took actions related to its ANDA submission.