On June 20, 2016, the full Federal Circuit denied Mylan’s petitions for rehearing en banc in Acorda Therapeutics Inc. v. Mylan Pharms. Inc., 817 F.3d 755 (Fed. Cir. 2016), leaving intact the panel’s decision affirming two decisions by the District Court of Delaware to assert personal jurisdiction over West Virginia-based manufacturer Mylan in two ANDA cases: AstraZeneca AB v. Mylan Pharms, Inc., 72 F. Supp. 3d 549, 558 (D. Del. Nov. 5, 2014), Fed. Cir. Docket No. 15-1460 and Acorda Therapeutics v. Mylan Pharms. Inc., 78 F. Supp. 3d 572 (D. Del. Jan. 14, 2015), Fed. Cir. Docket No. 15-1456. The denial of rehearing confirms that ANDA cases as well as cases brought under the Biologics Price Competition and Innovation Act (BPCIA), both of which involve plans to make future sales of proposed products, will continue to be brought in jurisdictions outside the home state of the generic or biosimilar manufacturer.
After the Supreme Court’s decision in Daimler AG v. Bauman, 134 S.Ct. 746 (2014), which narrowed the reach of general jurisdiction, Mylan has argued that it could only be sued in its home state of West Virginia in ANDA cases since future sales of its proposed generic drugs could not confer specific jurisdiction in Delaware. In March, the Federal Circuit rejected Mylan’s argument and affirmed both of the District of Delaware decisions on specific jurisdiction grounds, holding that the formal act of filing an ANDA “reliably indicate[s] plans to engage in marketing of the proposed generic drugs” which is “injury-causing” behavior and satisfies the minimum contacts standard. The Federal Circuit held that the “marketing in Delaware that Mylan plans is suit-related: the suits over patent validity and coverage will directly affect when the ANDA can be approved to allow Mylan’s Delaware marketing and when such marketing can lawfully take place.”
Mylan then requested rehearing en banc, arguing that the Federal Circuit’s decision was factually and legally erroneous. On invitation from the court, plaintiffs Acorda and AstraZeneca filed responses to Mylan’s petitions. On June 20, the Federal Circuit denied Mylan’s petitions in a per curiam order.
Under Acorda, plaintiffs in ANDA and BPCIA cases can continue to bring suit against generic and biosimilar manufacturers respectively in their forum of choice, as plaintiffs did in ANDA cases before the Supreme Court’s decision in Daimler, so long as considerations of fairness do not render jurisdiction in the forum unreasonable. Since the Federal Circuit’s decision in Acorda, district courts in Delaware, New Jersey and Texas have denied out-of-state ANDA filers’ jurisdictional motions to dismiss, asserting specific jurisdiction based on generic manufacturers’ clear intent to sell their proposed generic products in the forum once their ANDAs are approved. See e.g. Pfizer Inc. v. Mylan Inc., 2016 U.S. Dist. LEXIS 45087 (D. Del. Apr. 4, 2016); Allergan, Inc. v. Teva Pharms. USA, Inc., 2016 U.S. Dist. LEXIS 51851 (E.D. Tex. Apr. 19, 2016); Helsinn Healthcare S.A. v. Hospira, Inc., 2016 U.S. Dist. LEXIS 45826 (D.N.J. Apr. 5, 2016); Bayer Healthcare LLC v. Mylan Pharms Inc., 2016 US Dist. LEXIS 41825, (D. Del. Mar. 30, 2016).