The Federal Circuit answered one of the questions left open by its July 27, 2015, decision in Amgen Inc. v. Sandoz Inc. (Appeal No. 2015-1499): whether the 180-day commercial marketing notice under the Biologics Price Competition and Innovation Act (BPCIA) is mandatory even for a biosimilar applicant that has participated in the so-called patent dance. Yesterday, in a decision that may delay lower-cost competition for biologics, the Federal Circuit ruled in Amgen, Inc. v. Apotex, Inc. (Appeal No. 2016-1308) that all biosimilar applicants must provide their reference-product rivals at least 180 days’ notice before launching a biosimilar.

As was discussed in a July 27, 2015, BakerHostetler Alert, the Federal Circuit had found in the earlier Sandoz case that the 180-day notice was mandatory at least for a biosimilar applicant that had elected not to participate in the BPCIA’s patent dance – an exchange of patent information intended to streamline disputes that starts with the applicant’s providing its application and related information to the reference-product sponsor. That decision did not address the situation of an applicant that did participate in the patent dance. Yesterday’s decision holds that the requirement applies to applicants in both situations, and reiterated that the notice may be effectively given only after the FDA approves the biosimilar application.