Federal Circuit Patent Updates - July 2016

Amgen Inc. v. Apotex Inc. (No. 2016-1308, 7/5/16) (Wallach, Bryson, Taranto)

July 5, 2016 12:05 PM

Taranto, J. In a suit under the Biologics Price Competition and Innovation Act, affirming the grant of a preliminary injunction against the biologics license applicant entering the market unless it has given the patentee notice after receiving the requested FDA license and then waiting 180 days. "We hold that the commercial marketing provision is mandatory and enforceable by injunction even for an applicant" who "did launch the statutory process for exchanging patent information and channeling patent litigation." "We conclude that an applicant must provide a reference product sponsor with 180 days' post-licensure notice before commercial marketing begins, regardless of whether the applicant provided the (2)(A) notice of FDA review."