On October 16, 2015, the Federal Circuit declined to rehear en banc its July decision interpreting key provisions of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). Fitzpatrick reported on this earlier decision in detail here. In short, in its July decision, the Federal Circuit found both (i) that the BPCIA’s “patent dance” set out at 42 U.S.C. § 262(l)(2)(A) is not mandatory – that is, a biosimilar applicant does not have to disclose its abbreviated biologics license application (“aBLA”) and manufacturing process information to the reference product sponsor (“RPS”) and (ii) a biosimilar applicant can provide notice of commercial marketing under 42 U.S.C. § 262(l)(8)(A) only after the United States Food and Drug Administration approves the aBLA product, and such notice is mandatory when the biosimilar applicant does not participate in the patent dance.
However, the panel decision was fractured, with Judges Lourie and Chen agreeing that the patent dance provisions were optional, with Judge Newman dissenting; and Judges Lourie and Newman agreeing that notice of commercial marketing cannot be given until product approval, with Judge Chen dissenting.
Amgen sought rehearing of the holding that a RPS’s only remedy is to sue for infringement when a biosimilar applicant opts out of the patent dance and Sandoz sought rehearing of the holding that notice of commercial marketing is ineffective before the aBLA is approved. The Federal Circuit’s denial to grant en banc review may have been unexpected given the panel decision was plainly divided and raised important issues of first impression.
In view of the potential repercussions of this decision for the nascent biosimilars industry, we expect that one or both parties will petition the United States Supreme Court for certiorari by the January 14, 2016 deadline.