The Biologic Price Competition and Innovation Act (“BPCIA”) was enacted in 2010 to provide an abbreviated pathway for FDA approval of biologic products (“biosimilars”) deemed sufficiently similar to products already on the market. In July 2014, Sandoz filed the first-ever biosimilar application under the BPCIA for filgrastim (a biosimilar to Amgen’s NEUPOGEN product). Sandoz’s biosimilar application was approved by the FDA on March 6, 2015.
Despite the approval, Sandoz did not immediately bring its biosimilar to market in the U.S. due to a pending litigation filed by Amgen against Sandoz relating to the biosimilar application. Shortly before the FDA’s approval of Sandoz’s biosimilar application, Amgen filed a motion seeking a preliminary injunction to stop Sandoz from marketing the biosimilar in the U.S. upon approval. On Thursday, March 19, 2015, the court denied Amgen’s motion, thereby clearing the path for Sandoz to bring its biosimilar to market in the U.S. The court’s decision can be found here.
The court’s decision is significant because it reflects the first time a court has interpreted two key provisions in the BPCIA. First, the court ruled that the BPCIA does not require a biosimilar applicant to disclose its biosimilar application to the reference product sponsor or otherwise engage in the exchange of patent-related information concerning the application (which some commentators have referred to as the “patent dance”). Instead, a biosimilar applicant can opt out of these exchanges and face the possibility of an immediate patent infringement action. Second, the court ruled that a biosimilar applicant does not need to wait until FDA approval of its biosimilar application to first give a reference product sponsor the required 180-day notice of commercial marketing. Rather, the biosimilar applicant can provide notice prior to FDA approval such that commercial marketing can start upon FDA approval.