Once a seemingly settled question, personal jurisdiction has become a significant issue in Hatch-Waxman cases. New drug application sponsors typically do business throughout the country. Consequently, district courts usually exercised personal jurisdiction over Hatch-Waxman litigants under the theory of general jurisdiction. Notwithstanding a few holding companies or foreign-based sponsors, for most Hatch-Waxman litigants, this was the end of the story.
In the past few years, however, the U.S. Supreme Court has reined in the application of general jurisdiction that had begun to wander from its traditional foundation. See Goodyear Dunlop Tires Operations SA v. Brown
, 564 U.S. ‐ ‐ ‐, 131 S. Ct. 2846 (2011) and Daimler AG v. Bauman
, 571 U.S. ‐ ‐ ‐, 134 S. Ct. 746 (2014). Even domestic Hatch‐Waxman litigants may now have colorable arguments that they are not subject to personal jurisdiction in some of the popular forums for these cases.
The first wave of post‐Daimler decisions suggests district courts will rely on new theories of general and specific jurisdiction to exercise personal jurisdiction in Hatch‐Waxman cases. Traditionally, district courts exercised personal jurisdiction in such cases based on theories of general jurisdiction because there was no “real” act of infringement in any district (infringement under 35 U.S.C. § 271(e)(2) being “imaginary” or “artificial”). Tending to find that such “acts” of infringement did not really “occur” anywhere, courts instead relied on general jurisdiction to exercise power over a party. See, e.g., Eli Lilly v. Sicor Pharmaceuticals Inc.
, No. 06‐cv‐238, (S.D. Ind. Apr. 27, 2007).
The applicability of general jurisdiction came into doubt in recent years following the Supreme Court’s decisions in Goodyear
, which held that general jurisdiction requires contact with a state that is so pervasive it makes the defendant “essentially at home” or “comparable to a domestic enterprise.” Although many Hatch‐Waxman litigants may do business throughout the country, they are not subject to general jurisdiction wherever they have substantial sales. To hold otherwise would be to essentially subject them to jurisdiction everywhere, a conclusion the majority in Daimler found “unacceptably grasping.”
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