On Monday, January 9, 2017, the U.S. Supreme Court denied, without comment, Mylan Pharmaceuticals’ petition for certiorari to reverse an opinion by the Court of Appeals for the Federal Circuit, which affirmed a broad scope of personal jurisdiction over generic ANDA filers in patent infringement suits under the Hatch-Waxman Act.

The Supreme Court Declines to Revisit the Federal Circuit Holding that Filing an ANDA Satisfies the Minimum Contacts Requirement of Specific Personal Jurisdiction

On Friday, March 18, 2016, the Federal Circuit affirmed a pair of rulings from the U.S. District Court for the District of Delaware that Mylan, a non-resident of Delaware, was subject to personal jurisdiction in the state based on Mylan’s filing an ANDA, seeking approval to market a generic version of Acorda Therapeutics’s multiple sclerosis drug, Ampyra. (For more detailed coverage of the Federal Circuit opinion and the cases below, see our prior blog post.) The Federal Circuit held that, by filing an ANDA, Mylan performed a formal act reliably indicating its intent to engage in the allegedly infringing activity of marketing and selling its generic drug product in the state. Thus, the court held that an ANDA filer such as Mylan satisfies the minimum contacts requirement of specific personal jurisdiction in Delaware, and any other state in which the ANDA filer seeks approval to market its generic product.

The Parties’ Arguments to the Supreme Court

Traditionally, branded drug company plaintiffs in Hatch-Waxman infringement suits successfully demonstrated general personal jurisdiction over generic ANDA filers in states other than those where the generics were residents or incorporated. In its September 19, 2016 petition for writ of certiorari, Mylan argued that the Supreme Court’s 2014 Daimler AG v. Bauman decision, which addressed the availability of general personal jurisdiction over non-resident defendants, also narrowed the scope of specific and general personal jurisdiction in Hatch-Waxman cases. Mylan also claimed that the Federal Circuit’s ruling would have a “substantial chilling effect on generic activity” by subjecting generics to personal jurisdiction in all jurisdictions where they seek approval to market their ANDA products.

Writing in opposition, Acorda, argued that Mylan failed to demonstrate how the Federal Circuit’s recent finding of specific jurisdiction, would suddenly “chill” generic activity. Indeed, Mylan’s argument was particularly puzzling given that the pre-Daimler jurisprudence had apparently never had such an effect and the Federal Circuit’s recent ruling established a similar effective scope of personal jurisdiction. Moreover, as AstraZeneca AB, another of the plaintiffs below, pointed out, the Daimler court expressly addressed general, not specific, jurisdiction. Nor did the Daimler court foreclose the possibility that a patent infringement defendant be subject to personal jurisdiction in every state where infringing sales are made, as is the case in non-Hatch-Waxman patent litigation.

Hatch-Waxman Plaintiffs Will Continue to Find Clear Federal Circuit Support for Personal Jurisdiction Over Non-resident ANDA Filer Defendants

As a result of the Supreme Court’s refusal to grant Mylan’s petition for certiorari, Federal Circuit authority, holding that an ANDA filer is subject to specific personal jurisdiction in every state where it would market or sell its proposed generic product following FDA approval of the ANDA, stands. Indeed numerous Federal District Courts have already applied the Federal Circuit’s ruling to accordingly find personal jurisdiction over out-of-state ANDA filer defendants.