On Monday, June 12, 2017, the United States Supreme Court in a unanimous decision held that manufacturers making biosimilars of biologic drugs did not have to wait until after gaining federal approval of the biosimilar to notify the manufacturer of biologic reference products (Sponsor) that they intend to commercially market a biosimilar drug. The Court’s decision addresses two cases in the same opinion: Sandoz v. Amgen and Amgen v. Sandoz.
The cases involve the Biologics Price Competition and Innovation Act of 2009 (the Act). The Act created an abbreviated path to Food and Drug Administration (FDA) approval for “biosimilars” – products that are “highly similar” biological products previously approved by the FDA. In pertinent part, the Act states that biosimilar manufacturers must provide at least 180 days’ notice to the Sponsors manufacturing the corresponding biologic before commercially marketing a biosimilar. The Act also established a process for resolving patent disputes between manufacturer of biologics and biosimilars.
One question before the Court was whether the biosimilar manufacturer can provide the marketing notice before the biosimilar receives FDA approval, or whether it must delay notification until after its receives FDA approval. Justice Clarence Thomas, delivering the opinion of the Court, stated that the biosimilar manufacturer may provide notice before receiving FDA approval. The decision states that the Act “contains a single timing requirement: The applicant must provide notice at least 180 days prior to marketing its biosimilar.” The Supreme Court’s ruling reversed a Federal Circuit Court of Appeals decision, which held that notice could not take place until after the biosimilar received FDA approval . The ruling also vacated and remanded a second issue regarding whether certain requirements in the patent infringement review sections of the Act can be enforced by an injunction. The case also leaves open questions under California’s unfair competition law.