Valeant v. Mylan: Restrictions on Venue in Hatch-Waxman Litigation

For the first time since the U.S. Supreme Court’s TC Heartland decision, the U.S. Court of Appeals for the Federal Circuit addressed the issue of venue specific to Hatch-Waxman litigation, pursuant to which branded pharmaceutical companies sue generic applicants for patent infringement prior to approval of the generic applicant’s Abbreviated New Drug Application (ANDA). TC Heartland held that under 28 U.S.C. § 1400(b), a domestic corporation “resides” only in its state of incorporation for purposes of venue in patent cases. Venue is therefore proper only in the state of incorporation or in a place in which a company maintains a regular and established place of business and an act of infringement has occurred. Subsequent to TC Heartland, the Federal Circuit has further clarified the meaning of a “regular and established place of business.” See In re Cray Inc., 871 F.3d 1355 (Fed. Cir. 2017); In re Google LLC, 949 F.3d 1338 (Fed. Cir. 2020). Valeant v. Mylan presented the Federal Circuit its first opportunity to consider where an “act of infringement has occurred” in cases brought pursuant to the Hatch-Waxman Act.

Under the Hatch-Waxman Act, it is “an act of infringement to submit [an ANDA] for a drug claimed in a patent . . . if the purpose of such submission is to obtain approval . . . to engage in the commercial manufacture, use, or sale of a drug . . . claimed in a patent . . . before the expiration of such patent.” 35 U.S.C. § 271(e)(2).

The central question in Valeant was whether, in Hatch-Waxman litigation, venue must be predicated on past acts of infringement, or if future acts of infringement could be contemplated, thus extending venue to all places of future sales of the generic product. Faced with this question, the Federal Circuit held that “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.”

Beginning in September 2018, Valeant filed a number of Hatch-Waxman suits in the District of New Jersey against defendants, including Mylan, who sought to make generic versions of its drug Jublia^®. Valeant named three entities in its complaint against Mylan: Mylan Pharmaceuticals Inc. (MPI), which is incorporated and principally based in West Virginia; Mylan Inc., which is incorporated and principally based in Pennsylvania; and Mylan Laboratories Ltd...