Acorda Therapeutics Inc. et al. v. Mylan Pharmaceuticals Inc. et al. / Astrazeneca AB v. v. Mylan Pharmaceuticals Inc. et al.

Docket No. 2015-1456 and -1460

March 18, 2016

Brief Summary: DC decisions denying Mylan’s motions to dismiss actions based on its ANDA filing affirmed because, e.g., Mylan’s ANDA confirms “a plan to engage in real-world marketing” (“injury-causing and allegedly wrongful marketing conduct”) in DE.

Summary: Acorda et al. and Astrazeneca each brought actions in DE (assigned to two different judges) against Mylan under § 271(e)(2) regarding Mylan’s ANDAs (Acorda markets Ampyra® and AZ markets Onglyza®). Mylan moved to dismiss, arguing that DE “could not (and so the federal court may not) exercise personal jurisdiction-either general or specific personal jurisdiction-over Mylan in these cases” (FRCP 12(b)(2)), and the motions were denied. Each judge concluded DE could exercise specific personal jurisdiction “based on Mylan’s suit-related contacts with” DE but disagreed about whether DE could exersice PJ on the ground that Mylan consented to such jurisdiction in registering to do business”, taking “different views of the status of Surpeme Court decisions supporting such jurisdiction” (Pa. Fire Ins., US 1917; Daimler, US 2014). The FC panel opinion explains that Mylan has registered to do business and appointed an agent to accept service in” DE and “intends to direct sales of its drugs into” DE (taking “the costly, significant setp of applying to the FDA to engage in future activities…that will be purposefully directed at” DE), Acorda is incorporated in DE, and AZ’s US subsidiary has its principle place of business in DE. It concluded “the minimum-contacts standard is satisfied by the particular actions Mylan has already taken-its ANDA filings-for the purpose or engaging in injury-causing and allegedly wrongful marketing conduct in” DE (an ANDA confirms “a plan to engage in real-world marketing” (“We have pointed to future real-world market acts as sufficiently connected to the ANDA that triggers the litigation.” Apotex, FC 2015; Caraco, FC 2008). It explained that “[a] State’s exercise of jurisdiction over a defendant planning such conduct can hardly come as a surprise to the defendant and does nothing to ‘offend ‘traditional notions of fair play and substantial justice’’” (Int’l Shoe, US 1945). It also noted that Zeneca (FC 1999) did not address this issue. After minimum contacts is shown, however, PJ may be defeated by sufficiently demonstrating that other considerations render jurisdiction unreasonable” (Burger King, US 1985); “the burden on the defendant,” “the forum State’s interest in adjudicating the dispute,”, “the plaintiff’s interest in obtaining convenient and effective relief,” and “the interstate judicial system’s interest in obtaining the most efficient resolution of controversies” (World-Wide Volkswagon, US 1980)). And it found that “Mylan cannot show that those due-process factors weigh against ligitating the present cases in” DE. The DC decisions were therefore affirmed. Judge O’Malley’s concurring opinion argued that the question of general jurisdiction should have been reached and that PJ could be found “under a different legal theory” (Calder, US 1984 (defendant engages in intentional acts expressly aimed at the forum state, knowing that those acts will harm a potential plaintiff that resides in that state)).

This entry was posted in Appeal, Article III disputes, Generics / ANDA, Jurisdiction. Bookmark the permalink.

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