Sandoz Inc. v. Amgen Inc.

The Biologics Price Competition and Innovation Act (the act) was passed by Congress in 2009. The act governed a type of drug called a biosimilar, which was a biologic product that was highly similar to a biologic product that has already been approved by the Food and Drug Administration (FDA). Under the act, an applicant that sought FDA approval of a biosimilar had to provide its application materials and manufacturing information to the manufacturer of the corresponding biologic. The applicant then was required to give notice to the manufacturer at least 180 days before marketing the biosimilar commercially. Amgen Inc. (plaintiff) marketed a biologic product and claimed to hold patents on methods of manufacturing and using the biologic. Sandoz (defendant) filed an application with the FDA seeking approval to market a biosimilar, with Amgen’s product as the reference product. The FDA informed Sandoz that it had accepted the application for review. One day later, Sandoz notified Amgen both that it had submitted an application and that it intended to begin marketing its product immediately upon receiving FDA approval. Sandoz later confirmed that it did not intend to provide the requisite application and manufacturing information under the act and informed Amgen that Amgen could sue for infringement immediately under the act. Amgen then sued Sandoz for patent infringement. While the case was pending, the FDA licensed Sandoz’s product, and Sandoz provided Amgen a further notice of commercial marketing. The trial court granted judgment in favor of Sandoz. Amgen then appealed to the Federal Circuit. The Federal Circuit held that Sandoz did not violate the act in failing to disclose its application and manufacturing information. The court further held that the remedies contained in the act are the exclusive remedies for an applicant’s failure to comply with the act. The court also held that an applicant may provide effective notice of commercial marketing only after the FDA has licensed the biosimilar. Thus, the 180-day clock began after Sandoz’s second, post-licensure notice. The Federal Circuit further concluded that the notice requirement was mandatory and issued an injunction barring Sandoz from marketing its product until 180 days after the date it provided its second notice. The Supreme Court granted certiorari.