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Location Where Hatch-Waxman Notice Letter Received Does Not Establish Venue
The Federal Circuit addresses pleading requirements in Hatch-Waxman actions concerning venue and identification of defendants

On November 5, 2021, the Federal Circuit affirmed a New Jersey district court’s dismissal of Celgene Corporation’s case against Mylan Pharmaceuticals Inc., Mylan Inc., and Mylan N.V. under the Hatch-Waxman Act. The case against MPI and Mylan Inc. was dismissed for improper venue, and the case against Mylan N.V. was dismissed for failure to state a claim.


Venue was improper because MPI and Mylan Inc. were not shown to have committed acts of infringement in New Jersey and not shown to have a regular and established place of business in New Jersey. While MPI served notice of its Hatch-Waxman ANDA filing in New Jersey, that notice was not considered an act of infringement under the Hatch-Waxman Act. Regarding MPI and Mylan Inc.’s places of business, the Federal Circuit held that places associated with Mylan employees and places associated with Mylan affiliates were insufficient to establish that either company had a regular and established place of business in New Jersey.


The case against Mylan N.V. was dismissed for failure to state a claim based on a lack of evidence showing Mylan N.V. involvement in signing the Hatch-Waxman ANDA filing.