Lawyer Commentary Mondaq United States Federal Circuit Reaffirms Valeant Hatch-Waxman Venue Ruling

Federal Circuit Reaffirms Valeant Hatch-Waxman Venue Ruling

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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...

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