Addressing personal jurisdiction in suits under 35 USC § 271(e)(2), the US Court of Appeals for the Federal Circuit held that a state in which an Abbreviated New Drug Application (ANDA) filer plans to sell its generic product has specific personal jurisdiction over the ANDA filer, even where the ANDA was neither prepared nor filed in that state. Acorda Therapeutics Inc. v. Mylan Pharm. Inc., Case Nos. 15-1456; -1460 (Fed. Cir., Mar. 18, 2016) (Taranto, J) (O’Malley, J, concurring).

Mylan filed ANDAs seeking permission from the US Food and Drug Administration (FDA) to manufacture and market generic versions of three drugs owned by two brand-name manufacturers. Mylan prepared the ANDAs at its principal place of business in West Virginia and filed them at FDA headquarters in Maryland. The brand-name manufacturers brought separate suits against Mylan under 35 USC § 271(e)(2) in the District of Delaware. Mylan did not dispute that it planned to sell its product in Delaware or that it was registered to do business in Delaware. Nonetheless, Mylan moved to dismiss the suits for lack of personal jurisdiction. The judges in both suits denied Mylan’s motions, finding that Delaware had specific personal jurisdiction over Mylan. The judges disagreed as to whether general personal jurisdiction existed as a result of Mylan being registered to do business in Delaware. Both judges certified their rulings for interlocutory appeal.

In both cases, the Federal Circuit affirmed the denial of the motion to dismiss on the specific jurisdiction grounds. Although the statute states that “[i]t shall be an act of infringement to submit an application,” the Federal Circuit concluded that § 271(e)(2) was also meant to guard against future infringement, as defined under § 271(a). The Court disagreed with Mylan that a rigid past/future dividing line governs the minimum-contacts standard. The Court explained that Mylan’s uncontested plans to sell its generic product in Delaware supported specific jurisdiction there, even though no sales nor any activity related to submitting the ANDA took place in Delaware.

With the case resolved on specific jurisdiction grounds, the Court did not reach the question of general jurisdiction. Judge O’Malley wrote separately to express that she would have preferred to resolve the case on general jurisdiction grounds as opposed to “planned future conduct in the State.” In her view, a clear line of Supreme Court of the United States precedent supports finding general jurisdiction over Mylan because it registered to do business in Delaware.  

Practice Note: The Federal Circuit declined to disturb a long-standing procedural practice absent a congressional decree. Litigants should recognize the quasi-precedential effect that such long-standing practices have in assessing the likelihood of obtaining relief from the Court.