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Patricia O'Connell
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Wiley Rein Files Amicus Brief on Behalf of Generic Pharmaceutical Association in AstraZeneca AB v. Mylan Pharmaceuticals Inc.

May 27, 2015

On May 26, 2015, Wiley Rein LLP submitted an amicus brief in AstraZeneca AB v. Mylan Pharmaceuticals Inc. on behalf of The Generic Pharmaceutical Association (GPhA), supporting Mylan’s interlocutory appeal challenging the U.S. District Court for the District of Delaware’s exercise of personal jurisdiction. The issue certified for appeal has far-reaching implications for the pharmaceutical industry.

The Wiley Rein team that authored the brief includes James H. Wallace, Jr., chair emeritus of the firm’s Intellectual Property Group, IP litigation partners Eric H. Weisblatt and Mark A. Pacella, and IP associate A. Claire Frezza.

The Federal Circuit granted Mylan’s appeal by permission on March 17, 2015, and is now poised to decide the merits of whether the District of Delaware was correct in holding Mylan subject to specific personal jurisdiction. The District of Delaware agreed that Mylan, a West Virginia corporation, could not be subject to general personal jurisdiction in light of Daimler v. Bauman AG, the recent Supreme Court of the United States case narrowing the exercise of general jurisdiction over defendants. The District of Delaware instead held that Mylan was subject to specific personal jurisdiction in Delaware based on its mailing of a paragraph IV notice letter into the forum, a statutorily-required action under the Hatch-Waxman Act for any Abbreviated New Drug Application (ANDA) filer seeking approval for generic use prior to the expiration of the brand drug’s listed patents.

GPhA explained to the court that by conferring specific personal jurisdiction based on an ANDA filer’s mailing of the statutorily-required notice letter, the decision would effectively force ANDA filers to litigate in any forum chosen by plaintiffs, because plaintiffs dictate where the notice letters must be mailed through their listed address or chosen representative. GPhA stressed that such a holding is contrary to the balance intended by the Hatch-Waxman Act and contrary to Daimler, which unequivocally narrowed the circumstances under which a court can exercise personal jurisdiction over a non-resident defendant. GPhA further detailed the constitutional concerns of haling an ANDA filer into a given forum based on its compliance with the Hatch-Waxman Act, which violates an ANDA filer’s First Amendment right to petition the government and disregards the due process requirement that an ANDA filer must personally avail itself of a forum in order to be haled there under specific jurisdiction principles.

The case, docketed as No. 15-1460, is one that any company involved in ANDA litigation should follow closely.