Federal Circuit Reaffirms Valeant Hatch-Waxman Venue Ruling

• Published date: 10 November 2021
• Subject Matter: Intellectual Property, Litigation, Mediation & Arbitration, Patent, Trademark, Trials & Appeals & Compensation
• Law Firm: Panitch Schwarze Belisario & Nadel
• Author: Mr Philip L. Hirschhorn

In a November 5 opinion, the Federal Circuit reaffirmed in Celgene v. Mylan that venue for domestic entities in Hatch-Waxman disputes resides where the act of preparing the ANDA occurred or where it is submitted - neither of which was in New Jersey where the case was filed. Here, Celgene initiated its action against Mylan Inc. and Mylan Pharmaceuticals, both West Virginia corporation, and Mylan N.V., a foreign entity. The domestic Mylan companies asserted improper venue and Mylan N.V. asserted a failure to state a claim, and the district court and ultimately the Federal Circuit agreed.

Starting with venue, the Court articulated the venue standards arising from 28 U.S.C. ' 1400(b) and the burden placed on the plaintiff. Because Celgene did not argue that the Mulan defendants resided in New Jersey, the arguments centered on whether Celgene's evidence sufficiently demonstrated that the domestic entities "committed acts of infringement" in New Jersey. Looking to Valeant v. Mylan, 978 F.3d 1374, 1381-83 (Fed. Cir. 2020), the Court reiterated that "it is the submission of the ANDA and only the submission that constitutes an act of infringement in this context." (Slip Op. at 9). The Court noted that venue could not be shown through reliance on future contemplated conduct.

Celgene offered two primary arguments to support New Jersey venue: (1) the nationwide effect of an ANDA filing and (2) the fact that Mylan sent a notice letter to Celgene's New Jersey office. The Court (like the district court) rejected both. First, the Court held that Valeant put the nationwide effect of ANDA infringement to bed. Second, the panel note that the statutory mandate of the Paragraph IV notice letter. Celgene argued that the notice letter is part and parcel of the ANDA submission and therefore is part of the act of infringement. The Court disagreed. Rather, the infringement required under the Hatch-Waxman statute is complete upon submission, and later acts, like the notice letter, do not change the infringement. The Court...