Personal Jurisdiction in Hatch-Waxman Actions In View of Daimler

This article appeared in Pharmaceutical Compliance Monitor, May 13, 2015 and is reproduced with permission.

Prior to the Supreme Court's decision in Daimler AG v. Bauman, 134 S. Ct. 746 (2014), concerns over personal jurisdiction in Hatch-Waxman actions were essentially non-existent. General jurisdiction commonly provided the basis to assert jurisdiction over generic drug companies (generics). Resort to state long-arm statutes or specific jurisdiction was rare. If jurisdiction were questionable in the chosen forum and dismissal was possible, a second, so-called protective suit would be filed by the patentee in a district where jurisdiction was certain, e.g., the generic's state of incorporation. This insured that a proper suit was filed within 45-days of the patentee's receipt of a generic's notice letter, a critical benefit to patentees as it prevented the FDA from approving the generic's ANDA for 30 months.

Daimler drastically altered the accepted approach for establishing personal jurisdiction in Hatch-Waxman actions. In Daimler, the Court held that general jurisdiction existed only in those states where the defendant was "at home," i.e., the defendant's state of incorporation or its principal place of business. While the Court left open the possibility that other conduct could establish general jurisdiction, that result would be "exceptional." Apparently no court, including those adjudicating Hatch-Waxman actions, has encountered an "exceptional" case.

Since Daimler, personal jurisdiction has been found in each Hatch-Waxman action where it was challenged; thus, not one action has been dismissed — which may portent the ruling of the Federal Circuit in the appeal pending before it. The basis of jurisdiction, however, has varied and in fact, has been somewhat inconsistent. Many courts have found that the generic defendant consented to jurisdiction by registering to do business in the forum (consent jurisdiction). At least one court rejected this approach, but found specific jurisdiction due to the generic's contacts with forum. Indeed, one court found both consent and specific jurisdiction. As the scorecard indicates, both theories must be adopted by the Federal Circuit to prevent dismissals for lack of jurisdiction. For example, if the defendant is not registered to do business in the forum, a holding of specific jurisdiction is required to avoid dismissal.

Please read “Personal Jurisdiction in Hatch-Waxman Actions in View of Daimler” for the rest of the article.

If you have any questions about this article or would like to discuss this topic further, please contact the authors, Brian Coggio and Ron Vogel.