Federal Circuit Clarifies Venue in Hatch-Waxman Actions in Celgene v. Mylan
Fish & Richardson Trademark & Copyright Thoughts
NOVEMBER 9, 2021
The Hatch-Waxman Act provides a cause of action for infringement based on the submission of an abbreviated new drug application (ANDA) to FDA. Bare allegations of cooperation and control are insufficient to state a claim against a would-be Hatch-Waxman defendant who did not sign or submit the ANDA. 35 U.S.C. § Mylan Pharms.
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