Last week the Federal Circuit handed down one of its more anticipated decisions regarding jurisdiction in cases brought under 35 U.S.C. § 271(e)(2) (aka Hatch-Waxman or ANDA litigation). In its holding, the Federal Circuit stated that a “[defendant’s] ANDA filings and its distribution channels” are enough to “establish that [the defendant’s] plans to market its proposed [ANDA product in the forum state]” are enough to meet the minimum-contacts requirement to establish jurisdiction. It further held “there is no substantial argument that considerations of unfairness override the minimum-contacts basis for [the forum state’s] exercise of specific personal jurisdiction over” the defendants. This holding is much broader than the underlying district court rulings and limited the analysis to specific jurisdiction without addressing the underlying general jurisdictional questions.
Stemming from the Supreme Court’s 2014 decision in Daimler AG v. Bauman in which held that “minimum contacts” and thus, general jurisdiction, required not merely “continuous and systematic” in-forum contacts, but “continuous and systematic” in-forum contacts so as to “render [it] essentially at home in the forum state,” generic drug manufacturers began challenging jurisdiction in Hatch-Waxman cases. The two underlying cases involved the same defendant, Mylan Pharmaceuticals, Inc. (“Mylan”), a West Virginia incorporated worldwide producer of generic pharmaceuticals, in the same District Court, Delaware. Chief Judge Stark, in Acorda Therapeutics, Inc. v. Mylan Pharm. Inc., 78 F. Supp. 3d 572, 583-92 (D. Del. 2015) held that compliance with a state’s registration statute and appointment of a registered agent for service of process constitutes consent to general personal jurisdiction. Judge Sleet, in AstraZeneca AB v. Mylan Pharm., Inc., 72 F. Supp. 3d 549, 558-60 (D. Del. 2014) found jurisdiction on the bases that Mylan sent its paragraph IV certification to the plaintiff in the forum state, Delaware. The panel’s decision did not rely on either of these bases to establish jurisdiction, but instead, found specific jurisdiction on the basis that “Mylan’s ANDA filings constitute formal acts that reliably indicate plans to engage in marketing of the proposed generic drugs.”