Federal Circuit Limits Venue Options For Hatch-Waxman Litigation

Nearly three and a half years after the Supreme Court's landmark patent venue decision in TC Heartland, the Court of Appeals for the Federal Circuit continues to grapple with the fallout. The latest iteration came on Thursday, November 5, when the Federal Circuit confronted the question of where "acts of infringement" under 28 U.S.C. § 1400(b) occur with respect to patent infringement claims brought pursuant to the Hatch-Waxman Act.

In what may be seen as a win for generic drug manufacturers, the court (in an opinion by Judge O'Malley, joined by Judges Newman and Taranto) held that, for cases brought under 35 U.S.C. § 271(e)(2), infringement occurs for venue purposes only in districts where "actions related to the submission of an Abbreviated New Drug Application ('ANDA')" occur. The court rejected a broader interpretation of the statute, refusing to read "acts of infringement" as referring to future, contemplated distribution of the generic product specified in