In November, we wrote about Mylan’s attempt to dismiss an infringement action for lack of personal jurisdiction.  U.S. District of Delaware Judge Gregory M. Sleet denied that motion, finding specific jurisdiction because Mylan sent its paragraph IV certification to the NDA holder who was located in Delaware.  AstraZeneca AB v. Mylan Pharms., Inc., 2014 U.S. Dist. LEXIS 156660 (D. Del. Nov. 5, 2014).  Yesterday, another Delaware judge, Judge Leonard P. Stark, weighed in on the issue.  Acorda Therapeutics Inc. et al v. Mylan Inc. et al., 1-14-cv-00935 (E.D. Del. January 14, 2015, Order).  Judge Stark agreed with Judge Sleet that under Daimler AG v. Bauman, 134 S.Ct. 2846 (2014), the court lacks general jurisdiction over Mylan.  But, unlike Judge Sleet, Judge Stark found Mylan consented to personal jurisdiction in Delaware by registering to do business and appointing an agent for service of process in Delaware.  Judge Stark also found the court may exercise specific jurisdiction over Mylan for similar reasons to Judge Sleet.

The Federal Circuit has disfavored courts using specific jurisdiction as a basis to exercise jurisdiction over generic drug company defendants in ANDA cases.  In 1999, the Federal Circuit ruled that Maryland, the location of the FDA, where ANDAs are filed, could not exercise specific jurisdiction over ANDA filers simply because of that filing.  Zeneca Ltd. v. Mylan Pharm., Inc., 173 F.3d 829 (Fed. Cir. 1999) (which was not considered by the Supreme Court in Daimler).

This begs the question, if filing in Maryland, as required by law, is not enough to support specific jurisdiction, how then is sending a copy of the paragraph IV certification to the patent holder enough to establish specific jurisdiction, especially since the Hatch-Waxman Act makes the filing of the ANDA, not the mailing of the notice letter, the “highly artificial” act of infringement which triggers the patent holder’s ability to sue the infringer?  See Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 678 (1990)).  Judge Sleet acknowledged Zeneca, but worried that if he agreed with Mylan, it might “create the untenable position that [Mylan’s] conduct is not directed to any jurisdiction” and the defendant could only be sued in its general jurisdiction state.  Faced with this dilemma, Judge Sleet chose to assert the court’s jurisdiction based on specific jurisdiction.

Mylan requested an interlocutory appeal from Judge Sleet’s decision.  Since it was required by law to send AstraZeneca a copy of its paragraph IV certification in Delaware, Mylan argues that this notification cannot be considered an injury sufficient for establishing specific jurisdiction.  At the end of December, Judge Sleet agreed that the question needed further analysis by the Federal Circuit.  He approved the appeal to ask the Federal Circuit how district courts are to analyze personal jurisdiction in ANDA actions in the wake of the Supreme Court’s ruling in Daimler.  On January 12, 2015, AstraZeneca filed with the Federal Circuit its opposition to Mylan’s petition for permission to appeal.  Now the Federal Circuit will need to decide if it wants to tackle this thorny issue.

Some clarity from the Federal Circuit would be helpful.  It is probably unrealistic to hope that the Federal Circuit will only permit ANDA suits in defendants’ home districts, but it also appears logically untenable to allow Judge Sleet’s opinion to stand in the face of Zeneca.  If the Federal Circuit wants to continue to allow patent holders freedom to choose to sue ANDA filers outside of their home state, it will either have to perform some legal gymnastics to allow for specific jurisdiction notwithstanding Zeneca, or overturn Zeneca, or find a way to interpret Daimler in a way that revives a broader understanding of general jurisdiction in ANDA cases.