July 5, 2016

The Commercial Marketing Provisions of the Biologics Act are Mandatory

By Bryan K. Wheelock, Principal

In Amgen Inc. v. Apotex Inc., [2016-1308] (July 5, 2016), the Federal Circuit affirmed a preliminary injunction against Apotex from entering the market until 180 days after giving Amgen Notice after receiving its FDA license.

The Federal Circuit held that the commercial marketing provision of the Biologics Act was mandatory.