Patent Holders May Not Use Federal Law To Issue Injunctions Against Applicants For Biosimilar Products

The Biologics Price Competition and Innovation Act of 2009 provides an abbreviated process for the FDA to approve drugs that are biosimilar to already licensed biological products. The Act, in part, requires an applicant for a biosimilar product to provide its application and manufacturing information to the patent holder within 20 days of the date the FDA notifies the applicant that it has accepted the application for review. If the applicant fails to so act, the Act allows the patent holder to immediately bring an infringement action. Also, The Act requires the applicant to give the patent holder notice before marketing the biosimilar product, which, if not done, permits the patent holder to file a declaratory judgment action. In Sandoz Inc. v. Amgen Inc., Sandoz sought FDA approval to market a biosimilar product to one that Amgen claimed patents over. Sandoz told Amgen it would not provide its application or manufacturing information, and invited Amgen to file suit. Sandoz also told Amgen of its intention to market the product before getting licensure from the FDA. Amgen sued, and requested injunctions to enforce both requirements. The Court, in an 8-0 decision by Justice Thomas, held that the Act did not allow for such injunctions, but that the courts below should consider whether such injunctions were available under state law. The Court also held that providing notice to market a product prior to obtaining licensure was permissible under the Act. Justice Breyer, in a concurrence, suggested that the FDA might be permitted to come to a different interpretation of these requirements. A link to the opinion is here.