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 recent ANDA cases.
Click here to view the Table
Of the post-Daimler district courts that have considered consent to jurisdiction by registration in ANDA cases, only Judge Sleet in Astrazeneca rejected the theory.
As for specific jurisdiction, in none of these cases was the specific jurisdiction theory rejected. Judge Sleet, in Astrazeneca, concluded that the defendants had established minimum contacts with the plaintiff’s home forum by sending a paragraph IV notice letter to plaintiffs in Delaware, and could reasonably anticipate being haled into the forum to which the paragraph IV letter was sent. This begs the question—if the defendant had sent the paragraph IV notice letter to one of the plaintiff’s subsidiaries or to the plaintiff at a different location, could the plaintiff still sue the defendant in its home forum?
In Acorda Therapeutics v. Mylan Pharms. Inc., Judge Stark concluded that mailing a paragraph IV notice letter into the forum was not a prerequisite for finding specific jurisdiction in that forum. 78 F. Supp. 3d 572 (D. Del. Jan. 14, 2015). Judge Stark recognized that the plaintiff, a Delaware corporation, was injured in Delaware by the ANDA filing and that it was fair to exercise personal jurisdiction in Delaware given defendants’ other contacts with the forum including registration to do business, registration with the Board of Pharmacy, and litigation history in Delaware.
Only two district court decisions, both in Delaware, granted a defendant’s motion to dismiss for lack of personal jurisdiction: Purdue v. Collegium Pharm., 2015 U.S. Dist. LEXIS 102899 (D. Del. Aug. 6, 2015) and Novartis Pharms. Corp. v. Zydus Noveltech, Inc. 2015 U.S. Dist. LEXIS 103708 (D. Del. Aug. 7, 2015). In both cases, defendants were not registered to do business in Delaware, and defendants had not sent a paragraph IV certification into Delaware. In Purdue, Judge Robinson found that defendants had not sent a paragraph IV notice letter to Delaware, and that the defendants had no additional contacts with the forum—no business registration, no preparation of the ANDA, no research or relevant manufacturing. Id. at *13-14. Similarly, in Novartis Pharms. Corp. v. Zydus Noveltech, Inc., Judge Andrews concluded that asserting personal jurisdiction over Defendants for sending a paragraph IV notice letter to a Delaware corporation in New Jersey would not pass constitutional muster absent any other contacts with the forum. Judge Andrews agreed with Judge Stark that mailing a paragraph IV notice letter into the forum was not a prerequisite to finding specific jurisdiction in that forum, but found that defendants had no additional contacts with the forum. Id. at *12. Defendants were not registered to do business in Delaware, had never litigated a case in Delaware in any context, had no property or staff in Delaware, and in fact conducted no business in the forum at all. Id.
Under these cases, plaintiffs in ANDA and BPCIA cases will continue to rely on both theories of personal jurisdiction.