Before 2014, personal jurisdiction in Hatch Waxman cases was commonly established through general jurisdiction.1 Drug companies being sued were subject to general jurisdiction in any state where they distributed any of their products, including products not at issue in the litigation. For most drug companies, this essentially established personal jurisdiction for Hatch Waxman cases in any state in the United States. But in 2014, the Supreme Court changed the landscape for establishing general jurisdiction in a non-Hatch Waxman case, Daimler AG v. Bauman, holding that a corporation is subject to general jurisdiction where its contacts with a particular state render it “essentially at home.”2 This means that post-Daimler, absent “exceptional circumstances,” a corporation may be subject to general jurisdiction only in the state in which it incorporated or the state encompassing its principal place of business.3

Defendants Mylan Pharmaceuticals, Inc. and Mylan, Inc. (collectively, “Mylan”) filed motions to dismiss relying heavily on Daimler in two Hatch Waxman cases filed in the District of Delaware,4 which were assigned to different Judges. In both cases, Mylan argued Delaware could not exercise general jurisdiction over it because Mylan is not incorporated and does not have a principal place of business in Delaware.5 Additionally, Mylan asserted that specific jurisdiction was improper because its only suit-related acts were preparation and filing of its abbreviated new drug application (“ANDA”), which occurred in West Virginia and Maryland, respectively.6

Both District Judges denied Mylan’s respective motions, finding personal jurisdiction by means of slightly different analyses. One Judge held that the act of delivering a paragraph IV notice letter to the plaintiff in Delaware supported a finding of specific jurisdiction.7 The other Judge held that the act of sending a paragraph IV notice letter to a company incorporated—and therefore “at home”—in Delaware supported specific jurisdiction.8 The Judges also came to opposite conclusions regarding the impact of Daimler on the general jurisdiction analysis, one finding basis, and the other finding no basis, for general jurisdiction.9 Both opinions were certified for interlocutory appeal, and Mylan filed corresponding appeals with the Federal Circuit.

On March 18, 2016, the Federal Circuit affirmed the establishment of personal jurisdiction for Mylan on specific jurisdiction grounds.10 However, its reasoning differed from that offered by either of the District Judges. The Federal Circuit majority found that specific jurisdiction was sustained by Mylan’s future intent to sell its ANDA products in Delaware.11 The majority opinion did not address general jurisdiction, despite the parties briefing the topic, and discussing at oral argument.12 Notably, Judge O’Malley filed a concurrence stating she would find personal jurisdiction on both general and specific jurisdiction grounds, but under yet another legal theory.13 Judge O’Malley warned that the majority’s rule on specific jurisdiction involves “a host of factual questions” regarding an ANDA filer’s future marketing intent.14 Accordingly, Judge O’Malley would have found specific jurisdiction on the basis that filing the ANDA was directed at and caused injury to Delaware residents.15

Mylan’s petition for rehearing en banc was denied on June 20, 2016.16

On September 19, 2016, Mylan filed a petition for writ of certiorari with the Supreme Court.17 In its petition, Mylan postures the question presented as whether the act of filing an ANDA is sufficient to subject the filer to specific jurisdiction in “any state where it might someday market the drug.”18 Mylan also reiterates the argument that its only suit-related activities occurred where the ANDA was prepared and filed, and accordingly, specific jurisdiction is only proper in those jurisdictions.19 Mylan further asserts that the Federal Circuit holding, permitting jurisdiction where an ANDA applicant will market its proposed product, “re-creates the pre-Daimler status quo” by permitting broad specific jurisdiction in the wake of tightened general jurisdiction.20

With so many competing theories of jurisdiction—or lack thereof—among these litigants, the District Judges and Federal Circuit Judges,21 this is a murky area of the law that may be ripe for clarification. It remains to be seen whether the Supreme Court will leave the Federal Circuit majority holding in place, rule in favor of an alternate legal theory on general jurisdiction, clarify or change the specific jurisdiction analysis in Hatch Waxman cases, or even comment more broadly on the impact of Daimler, if any, on the specific or general jurisdiction inquiries within or even beyond Hatch Waxman cases. Interested parties await the Supreme Court’s next move.