An emerging issue in Hatch-Waxman litigation – and potentially under the Biologics Price Competition and Innovation Act (BPCIA) – is the impact of the Supreme Court’s decision in Daimler AG v. Bauman, 134 S. Ct.746 (2014), on where suit may be brought for infringement. Prior to Daimler, personal jurisdiction was largely a non-issue in ANDA cases, and plaintiffs could rely on broad concepts of general jurisdiction that allowed suit against corporation in all states for products that are sold nationally. Daimler cut back on general jurisdiction. It is widely understood to limit general jurisdiction over corporations to their “home” state, which generally would be their state of incorporation or principal place of business. Id. at 760.
Several manufacturers of generic drugs have relied on Daimler in moving to dismiss ANDA cases brought outside of their home forums for lack of personal jurisdiction. But they have yet to succeed. In eight opinions on the subject, district courts in Delaware, New Jersey, the Eastern District of Texas and the Southern District of Indiana have asserted jurisdiction over ANDA defendants outside their home forums.
Rather than relying on general jurisdiction post-Daimler, these courts based jurisdiction on one, or both, of two other theories. The first theory is that a defendant who registers to do business in a forum has consented to jurisdiction there. The second is specific jurisdiction: a defendant who files an ANDA directs its activities at the plaintiff in its home forum, and the harm of the ANDA filing is felt by plaintiff at its home. As Judge Sleet explained in Astrazeneca v. Mylan Pharmaceuticals, even though the tortious act of submitting an ANDA is artificial, it is a real act with actual consequences, and those consequences are suffered in the home forum of the patent holder. No. 14-696-GMS, 2014 U.S. Dist. LEXIS 156660, at *20 (D. Del. Nov. 5, 2014). Judge Sleet concluded that the defendant’s ANDA filing was necessarily directed at the patent owner’s residence because otherwise the result was the “untenable position that [defendant’s] conduct is not directed at any jurisdiction.” Id.
The table below summarizes the courts’ findings on personal jurisdiction in eight recent ANDA cases.
Please click here to view the table.
These district court decisions will not be the last word on the subject. The Federal Circuit has given Mylan permission to take an interlocutory appeal from the decisions in Astrazeneca, Fed. Cir. Docket No. 15-1460 and in Acorda, Fed. Cir. Docket No. 15-1456. Briefing in these appeals should be complete this summer and the cases are likely to be argued in the Federal Circuit decision this Fall.
So far, personal jurisdiction has not been an issue in BPCIA litigation. But theories of consent and specific jurisdiction should be equally applicable to such cases. Consent jurisdiction isn’t limited to any particular cause of action. And the courts’ specific jurisdiction theory in ANDA litigation is relevant to BPCIA patent litigation which also arises from an ‘artificial’ injury. The BPCIA provides for patent litigation pursuant to 42 U.S.C. § 262(l) and 35 U.S.C. § 271(e) was amended to reflect the technical injury caused by filing an aBLA. As with ANDA filings, the patent owner will suffer the consequences of an aBLA filing in its home forum.
The Federal Circuit’s upcoming decisions in Astrazeneca and Acorda will shape the personal jurisdiction landscape in ANDA cases, and provide lessons for future BPCIA litigation.