Press Release

Wiley Rein Files Amicus Brief on Behalf of GPhA in Critical Hatch-Waxman Act Litigation Before the Federal Circuit

May 5, 2016

Washington, DC—Wiley Rein LLP filed an amicus brief this week on behalf of the Generic Pharmaceutical Association (GPhA), urging the Federal Circuit to rehear en banc two important cases involving the scope of personal jurisdiction in Hatch-Waxman Act litigation: Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc. and AstraZeneca AB v. Mylan Pharmaceuticals Inc. (Acorda).

The brief, filed May 2, was authored by James H. Wallace, Jr., partner and chair emeritus of the Wiley Rein’s Intellectual Property Group, along with partner Mark A. Pacella and associate Wesley E. Weeks.

Historically, Hatch-Waxman Act plaintiffs have filed suit against generic defendants wherever they pleased under a liberal interpretation of the scope of general personal jurisdiction. But in the recent Daimler A.G. v. Bauman case, the Supreme Court of the United States dramatically cut back on the availability of general personal jurisdiction, describing the assertion of nationwide jurisdiction in that case as “exorbitant” and “unacceptably grasping” because it did not “permit out-of-state defendants to structure their primary conduct with some minimum assurance as to where that conduct will and will not render them liable to suit.”

In Acorda, a panel of the Federal Circuit held that, notwithstanding Daimler, the West Virginia-based company Mylan is subject to specific personal jurisdiction in Delaware based on a mistaken assumption that the filing of an Abbreviated New Drug Application (ANDA) shows that Mylan “intends to direct sales of its drugs into Delaware.” The panel’s opinion set forth a new standard for specific jurisdiction based on “planned, non-speculative harmful conduct,” i.e., infringing future sales. Wiley Rein’s brief points out that the panel’s reasoning overlooks a key point about Hatch-Waxman Act litigation: “The Hatch-Waxman Act’s carefully balanced framework, chosen by Congress, ensures that in the vast majority of cases there will never be an infringing sale.” The Hatch-Waxman Act provides for a 30-month stay of U.S. Food and Drug Administration approval while the patent infringement case is litigated, which ensures that the most likely outcome in ANDA litigation will be either an adjudication of non-infringement or invalidity prior to any sales or an injunction against sales.

Moreover, as Wiley Rein’s brief points out, “the panel’s decision, in effect, subjects every ANDA filer to nationwide jurisdiction for Hatch-Waxman Act litigation”—exactly the result the Supreme Court found unacceptable in Daimler. The brief also shows that the panel’s opinion conflicts with other prior opinions of both the Supreme Court and the Federal Circuit.

Wiley Rein offers comprehensive intellectual property services for owners and users of patents, copyrights, trademarks, and trade secrets, with a strategic focus on new technologies and dedicated specialists in each of these areas. In particular, the firm counsels clients on patent strategies in connection with biologics and biosimilars ANDA patent litigation arising under the Hatch-Waxman Act.

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