Venue in Hatch-Waxman Cases Tied to Acts of ANDA Submission

| Kendall Loebbaka


Before Newman, O’Malley, and Taranto. Appeal from the District Court of New Jersey

Summary: Venue in Hatch-Waxman cases is proper only in districts where actions related to the Abbreviated New Drug Application (“ANDA”) submission occur.

Mylan Pharmaceuticals Inc. (“MPI”) sought to market a generic version of a drug sold under the brand name Jublia. Valeant Pharmaceuticals North America LLC, Valeant Pharmaceuticals Ireland Ltd., Dow Pharmaceutical Sciences, Inc. (“Dow”), and Kaken Pharmaceuticals Co., Ltd. (collectively “Valeant”) sued MPI and related companies for patent infringement in New Jersey. The defendants included MPI (a West Virginia based corporation), Mylan Inc. (a Pennsylvania corporation with its principle place of business in Canonsburg, PA) and Mylan Laboratories Ltd. (“MLL”) (an Indian corporation based in Hyderabad, India). The Defendants sought dismissal on venue grounds. The District Court found in favor of MPI, dismissing the relevance of planned future acts of infringement in the district. Valeant appealed.

The Federal Circuit affirmed the District Court’s decision that venue was not proper for MPI and Mylan Inc., but reversed and remanded as to foreign defendant MLL. The Federal Circuit held that venue under § 1400(b) requires a past act of infringement and cannot be premised on future acts of infringement, such as where a product is likely to be distributed. The Federal Circuit held that the Hatch-Waxman Act defines one and only one act of infringement—an ANDA submission. As a result, venue is proper only where acts related to the ANDA submission took place. Because the District Court found that no act related to MPI’s ANDA submission took place in New Jersey, the Federal Circuit affirmed the lower court’s decision. With respect to MLL, the Federal Circuit held that venue was proper because MLL was subject to venue in any judicial district as a foreign entity. The Federal Circuit remanded for the lower court to address the substance of MLL’s motion to dismiss under Rule 12(b)(6).

Editor: Paul Stewart