Supreme Court Clarifies Biosimilar Drug Notice and Disclosure Requirements: Biosimilar Manufacturers May Provide Notice of Commercial Marketing Before FDA Approval

Sullivan & Cromwell LLP - June 13, 2017

In Sandoz Inc. v. Amgen Inc., the U.S. Supreme Court held that, under the Biologics Price Competition and Innovation Act of 2009, a biosimilar manufacturer need not wait until FDA approval to provide patentees with notice of a plan to commercially market a biosimilar product. The Supreme Court also ruled that a patent owner’s exclusive federal remedy for a biosimilar manufacturer’s failure to provide its FDA application and manufacturing information is a suit for declaratory judgment of patent infringement.