Last week, the U.S. Court of Appeals for the Federal Circuit issued an opinion in Celgene Corp. v. Mylan Pharmaceuticals Inc., et al., No. 2021-1154 (November 5, 2021), affirming the trial court’s dismissal of Celgene’s patent lawsuit under the Hatch-Waxman Act based, in part, on improper venue where the infringing act, the ANDA, was not filed in New Jersey and the residence of Mylan employees there was not enough.
Celgene owns patents that protect its drug Pomalyst. Celgene is headquartered in New Jersey and filed its lawsuit there against the Mylan defendants, who had applied to the FDA for approval of a generic version of Pomalyst. Mylan moved to dismiss for improper venue. After nearly two years of venue-related discovery, the trial court granted the motion.
The Federal Circuit affirmed. Under 28 U.S.C. § 1400(b), a plaintiff in a patent infringement suit must show “either that the defendant ‘resides’ in a particular district or that it ‘has committed acts of infringement and has a regular and established place of business there.’” Because none of the Mylan defendants reside in New Jersey, the Court analyzed the second prong of 1400(b).
First, the Court considered whether Mylan had “committed acts of infringement” in New Jersey and concluded that it had not. Under the Hatch-Waxman Act, the submission of the Abbreviated New Drug Application (ANDA) to the FDA is the infringing act. That did not occur in New Jersey. The Court rejected Celgene’s argument that the sending of Mylan’s notice letter, required under Hatch-Waxman procedure, to Celgene’s New Jersey headquarters was an infringing act. The notice letter cannot be sent until the FDA has received the ANDA and, for venue purposes, the Court held only the submission of the ANDA is the triggering event for infringement.
Despite finding no acts of infringement in New Jersey, the Court nevertheless went on to consider whether Mylan had a “regular and established place of business” in New Jersey and concluded it did not. Specifically, the Court rejected Celgene’s argument that the existence of several Mylan employees who worked from their homes in New Jersey was enough, explaining that for venue purposes “it is not enough ‘that there exists within the district a physical location where an employee of the defendant carries on certain work for his employer.’”