ANDA submission can support personal jurisdiction in any state where the drug will be marketed

Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc., No. 2015-1456 (Fed. Cir. Mar. 18, 2016)

The defendant, a drug manufacturer based in West Virginia, filed several Abbreviated New Drug Applications (ANDAs) seeking Federal Drug Administration (FDA) approval to market generic versions of drugs designed to treat individuals with multiple sclerosis and type 2 diabetes. The plaintiffs, the brand name drug manufacturers, sued the defendant in the Delaware federal court for patent infringement. The defendant moved to dismiss both actions for lack of personal jurisdiction under Rule 12(b)(2). These motions were denied, and the defendant appealed.

The Federal Circuit affirmed the district court’s decision finding that, in light of the defendant’s stated intention to market its drugs in Delaware, the defendant’s ANDA filings satisfied the minimum contacts test of International Shoe. The defendant argued that due process forbids a state from exercising its judicial power to prevent the defendant’s planned future conduct in that state. Instead, it was undisputed that the defendant planned to direct sales of its generic drugs to Delaware. Thus, the defendant’s ANDA filings established minimum contacts with Delaware because they reliably and non-speculatively predicted future activities purposefully directed at Delaware. Also, the defendant failed to show that other considerations rendered personal jurisdiction unreasonable. Therefore, the Delaware court was correct to extend specific personal jurisdiction over the defendant.

A copy of the opinion can be found here.