On October 16, 2015, the Federal Circuit declined to rehear en banc the July 21, 2015, decision in Amgen Inc. v. Sandoz Inc.1 Accordingly, the first Federal Circuit decision interpreting certain provisions of the Biologics Price Competition and Innovation Act (BPCIA) remains undisturbed.
In July, Judge Lourie wrote the decision for a split panel that also included Judges Newman and Chen. The decision resolved two main issues of first impression related to the BPCIA: (1) whether a biosimilar applicant must provide the reference product sponsor with a copy of its application to the FDA for licensure of its biosimilar product (aBLA), and (2) whether the biosimilar applicant must wait until it receives FDA approval before providing the reference product sponsor with its 180-day notice of commercial marketing.
With regard to the first issue, Judges Lourie and Chen agreed that the aBLA disclosure provision set forth in §262(l)(2) of the BPCIA is optional.2 The decision rejected Amgen’s argument that use of the word “shall” in § 262(l)(2) indicated that disclosure of the aBLA was mandatory, finding instead that when read in context with other provisions of the BPCIA, the aBLA disclosure provision was optional.3 Judge Newman dissented.
With regard to the second issue, Judges Lourie and Newman agreed that a biosimilar applicant could not provide its 180-day notice of commercial marketing until after the FDA approves the biosimilar application, rejecting Sandoz’s argument to the contrary. Judge Lourie explained that before FDA approval, the therapeutic uses and manufacturing processes of a potential biosimilar are not fixed, and thus a biosimilar applicant cannot give effective notice until after the FDA has granted approved.4,5 Judge Chen dissented.
Having each lost on one issue, both Amgen and Sandoz filed petitions for rehearing. Based on the fractured nature of the panel decision, many watching the case anticipated en banc review. By denying the petitions, the court’s July decision remains intact. Either side may appeal the decision to the United States Supreme Court, and given the significant implications stemming from the Federal Circuit’s decision, petitions seeking certiorari can be expected.