March 14, 2016 Articles

Analysis of the Five Amicus Briefs in Amgen v. Sandoz

They address whether the patent dance is mandatory and whether notice of pre-FDA-approved commercial marketing is effective

By Christopher VanDeusen

Five amicus briefs were filed at the Federal Circuit before the court's recent decision in Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015). Three briefs supported the plaintiff-appellant, Amgen, in seeking to overturn the district court's conclusions, while two amici supported the defendant-appellee, Sandoz, in requesting that the district court be affirmed. This analysis will summarize the arguments made by each amicus on the two issues presented under the Biologics Price Competition and Innovation Act (BPCIA).

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