Fitzpatrick Case Update
July 21, 2015
On July 21, 2015, the Federal Circuit issued an opinion addressing two issues of first impression relating to the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). First, the Court held that 42 U.S.C. § 262(l)(2)(A) 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 42 U.S.C. § 262(l)(8)(A) requires the biosimilar applicant to provide notice of commercial marketing to the RPS, but that effective notice under that section of the statute can only be given after the United States Food & Drug Administration (“FDA”) licenses the aBLA product.