Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc., No. 19-2402 (Fed. Cir. 2020)Annotate this Case
The Valeant plaintiffs reside in Japan, Ireland, and Delaware. The defendants are incorporated and have principal places of business in West Virginia, Pennsylvania, and India. The brand-name FDA-approved drug Jublia® has nine patents listed in the Orange Book. Defendant, a generic drug company, executed an Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Jublia®, sending the ANDA from its West Virginia office to the FDA in Maryland. Valeant sued for infringement in the District of New Jersey, alleging that the district is a likely destination for the generic solution; each defendant does business in New Jersey and is registered to do so; each defendant has previously submitted to the court's jurisdiction and has a place of business in New Jersey; the generic drug will be “purposefully directed at … New Jersey. The district court dismissed for improper venue, finding that the ANDA was submitted from West Virginia, rendering venue proper there, while acknowledging that MLL, a foreign entity, was subject to venue in every judicial district.
The Federal Circuit affirmed in part, citing the 2017 Supreme Court “TC Heartland” holding: the general venue provision in 28 U.S.C. 1391, which provides that a corporation is deemed to “reside” in any judicial district in which it is subject to personal jurisdiction, does not modify the term “resides” in 28 U.S.C. 1400, the specific patent venue statute; “resides” refers only to a corporation’s state of incorporation. A corporation may be sued for patent infringement in districts in the state of its incorporation and those in which it has a regular and established place of business and an act of infringement has occurred. In Hatch-Waxman Act, 35 U.S.C. 271(e)(2)(A) infringement cases, section 1400 “acts of infringement” occur only in districts where actions related to the ANDA submission occur, not in all locations where future distributions of the products specified in the ANDA is contemplated. The court remanded the dismissal of the foreign defendant.
The court issued a subsequent related opinion or order on November 6, 2020.