April 7, 2016
Case Name: Acorda Therapeutics Inc. v. Mylan Pharms. Inc., 2015-1456, 2015-1460, 2016 U.S. App. LEXIS 4942 (Fed. Cir. Mar. 18, 2016) (Circuit Judges Newman, O’Malley, and Taranto presiding; Opinion by Taranto, J.; Concurring Opinion by O’Malley, J.) (Appeal from D. Del., Stark, C.J.)
Drug Product and Patent(s)-in-Suit: Ampyra® (dalfampridine); Onglyza® (saxagliptin); Kombiglyze™ (saxagliptin and metformin HCl)
Nature of the Case and Issue(s) Presented: This appeal involved two separate district court actions against Mylan in the District of Delaware. Chief Judge Stark (in the Acorda case) and Judge Sleet (in the AstraZeneca case) denied Mylan’s motions to dismiss, concluding that Delaware had sufficient contacts related to the subject of these cases that it could exercise specific personal jurisdiction over Mylan. The two judges disagreed about whether Delaware could exercise general personal jurisdiction (independent of suit-related contacts) on the ground that Mylan consented to such jurisdiction in registering to do business: they took different views of the status of Supreme Court decisions supporting such jurisdiction, e.g., Pa. Fire Ins. Co. v. Gold Issue Mining & Milling Co., 243 U.S. 93, (1917), in light of later decisions such as Daimler AG v. Bauman, 134 S. Ct. 746, (2014). But the latter disagreement did not alter the finding of personal jurisdiction in these cases. In each case the district court certified its decision for interlocutory review, and the Federal Circuit granted permission to appeal, ultimately siding with Chief Judge Stark that there was specific personal jurisdiction over Mylan in Delaware.
Why Plaintiffs Prevailed: Mylan is incorporated and has its principal place of business in West Virginia, but is registered to do business in Delaware with an appointed in-state agent to accept service of process. More importantly, Mylan filed an ANDA with the FDA to market its generic drugs throughout the United States, including Delaware. The Federal Circuit characterized the ANDA as “tightly tied, in purpose and effect, to the deliberate making of sales in Delaware” such that filing the ANDA served as a “formal act” indicating intent to engage in marketing of the proposed generic drugs. Accordingly, the Federal Circuit held that filing an ANDA meant that Mylan had sufficient minimum contacts with Delaware such that Mylan was subject to specific personal jurisdiction in the District of Delaware.
The Federal Circuit looked to the purpose of the 35 U.S.C. § 271(e)(2) to support its holding. In drafting § 271(e)(2), Congress provided a means by which a generic drug manufacturer could assert that it intended to “commit real world acts that would make it liable for infringement.” This provision distinguished ANDA filers from other would-be infringers. Further, due the expense and effort required to prepare an ANDA, the filing of an ANDA realistically establishes a plan to market the generic drug. Additionally, because states are not forbidden from exercising their judicial power to prevent planned future conduct (for example, by issuing injunctions), exerting jurisdiction over an ANDA filer did not offend the traditional notions of fair play and substantial justice. Thus, the Federal Circuit affirmed the Acorda court’s rulings, and held that the District of Delaware properly had jurisdiction over Mylan.
Judge O’Malley agreed with the result, but contended that general jurisdiction provided a more straightforward analysis. Judge O’Malley reasoned that Mylan was subject to general jurisdiction in Delaware because it registered to do business in the state and appointed an in-state agent to accept service of process. In other words, Mylan had voluntarily elected to conduct business in the Delaware. According to Judge O’Malley, this was sufficient to establish general jurisdiction. Judge O’Malley also noted that he would find that Mylan was also specific jurisdiction based on the effects test of Calder v. Jones, rather than based on future intent. In so doing, Judge O’Malley concluded that the effect of the ANDA was to harm the intellectual property rights of Delaware corporations.