In its recent Amgen Inc. v. Sandoz Inc. decision, the Federal Circuit decided two issues of first impression relating to the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). First, the Court held that the BPCIA does not require a biosimilar applicant to disclose its abbreviated biologics license application (“aBLA”) and manufacturing information to the reference product sponsor (“RPS”). Second, the Court concluded that the BPCIA does require the biosimilar applicant to provide notice of commercial marketing to the RPS. However, effective notice of commercial marketing can only be given after the United States Food & Drug Administration (“FDA”) licenses the aBLA product. This decision provides some of the first insight into how the Federal Circuit will, to quote Judge Lourie, “unravel the riddle, solve the mystery, and comprehend the enigma” that is the BPCIA.
