Update On Personal Jurisdiction For BPCIA Litigants After The Supreme Court's Decision In Daimler

Under 35 U.S.C. § 271(e), filing an Abbreviated Biologics License Application (aBLA)—like filing an Abbreviated New Drug Application (ANDA)— can be an act of patent infringement resulting in 'artificial' injury to a patentee. The artificial nature of the injury challenges traditional understandings of personal jurisdiction. As Judge Sleet of the District of Delaware put it, in ANDA cases it's "difficult to point to a location out of which the injury 'arises' for jurisdictional purposes...[and] a lawsuit is often inevitable, but it is not clear where it should be held." Astrazeneca AB v. Mylan Pharms, Inc., 72 F. Supp. 3d 549, 558 (D. Del. Nov. 5, 2014).

Prior to the Supreme Court's 2014 decision in Daimler AG v. Bauman, 134 S. Ct. 746 (2014) (discussed in detail in an earlier post), plaintiffs in ANDA cases regularly relied on concepts of general jurisdiction to bring suit against corporations in any state for products sold nationally. However, since Daimler effectively limits general jurisdiction over corporations to their "home" state—their state of incorporation or principal place of business—plaintiffs in ANDA cases have faced a slew of motions to dismiss for lack of personal jurisdiction over defendants outside their home states. Id. at 760.

In post-Daimler ANDA cases, patentees have relied on two theories of personal jurisdiction. The first theory involves consent jurisdiction, i.e., that a defendant who registers to do business in a state has consented to general jurisdiction there. The second theory involves specific jurisdiction, i.e., that a defendant who files an ANDA and a paragraph IV certification directs its activities at the plaintiff in its home forum, and the harm of that filing is felt by the plaintiff there.

Both theories are at play in Mylan's interlocutory appeal to the Federal Circuit of the district court's decisions in Astrazeneca AB v. Mylan Pharms, Inc., 72 F. Supp. 3d 549, 558 (D. Del. Nov. 5, 2014)., Fed. Cir. Docket No. 15-1460 and in Acorda Therapeutics v. Mylan Pharms. Inc., 78 F. Supp. 3d 572 (D. Del. Jan. 14, 2015), Fed. Cir. Docket No. 15-1456. Briefing is complete, and the cases are likely to be argued before the Federal Circuit early in 2016.

While the appeal is pending, decisions by district courts in Delaware, New Jersey, the Eastern District of Texas, and the Southern District of Indiana have addressed these issues. The table below summarizes the courts' findings on personal jurisdiction in twelve...