Sandoz Inc. v. Amgen Inc.

Sandoz (defendant) applied to the FDA to market a biosimilar referencing Amgen's (plaintiff) biologic product, and rather than turning over its application and manufacturing information to Amgen as the Act contemplated, it told Amgen it did not intend to comply and that Amgen was free to sue for infringement immediately. Amgen sued for patent infringement; while the case was pending, the FDA licensed Sandoz's product and Sandoz gave a further notice of commercial marketing. The Federal Circuit held Sandoz's earlier, pre-licensure notice was ineffective, that the 180-day marketing delay only began after the second, post-licensure notice, and issued an injunction enforcing that 180-day wait.