Last week, the U.S. Court of Appeals for the Federal Circuit issued an opinion in Valeant Pharmaceuticals v. Mylan Pharmaceuticals, Inc., No. 2019-2402 (Fed. Cir. 2020), answering the question of where “acts of infringement” under 28 U.S.C. § 1400(b) occur for infringement claims brought under the Hatch-Waxman Act.
After the Mylan defendants filed an Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Jublia®, Valeant sued them for patent infringement in the District of New Jersey. The Mylan defendants are incorporated and have principal places of business in West Virginia, Pennsylvania, and India. Valeant alleged venue was proper in New Jersey because it was a likely location for generic Jubila® sales. The district court dismissed the action for improper venue, holding that West Virginia was the proper venue because the ANDA was submitted from there. Valeant appealed.
The Federal Circuit affirmed as to the U.S.-based defendants. As the Court explained, the Supreme Court’s decision in TC Heartland LLC v. Kraft Foods Grp. Brands LLC instructed that a U.S. corporation “may be sued for patent infringement in only two categories of judicial districts: those in the state in which it is incorporated and those in which it has a regular and established place of business and an act of infringement has occurred.” Because the Mylan defendants were not incorporated in New Jersey, the question on appeal with respect to the U.S.-based defendants was the meaning of “act of infringement” in an action brought under the Hatch-Waxman Act. Noting the district courts had reached different conclusions on the matter, the Federal Circuit held “in cases brought under 35 U.S.C. § 271(e)(2)(A), infringement occurs for venue purposes only in districts where actions related to the submission of an [ANDA] occur, not in all locations where future distribution of the generic products specified in the ANDA is contemplated.” The Court based its decision on its conclusion that the plain language of § 271(e)(2)(A) does not identify any act of infringement other than the ANDA submission.
The Federal Circuit vacated and remanded the district court’s dismissal as to the foreign defendant. The Court explained that foreign entities are properly subject to venue in any judicial district. As such, the district court’s dismissal of the case against the foreign defendant was improper.