February 3, 2015
Once a seemingly settled issue, 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 Supreme Court has reined in the application of general jurisdiction that had begun to wander from its traditional foundation. See Goodyear Dunlop Tires Operations, S.A. 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.

For more discussion on the earliest reactions of district courts, to renewed jurisdictional challenges, please click here.