On October 16 2015 the Federal Circuit declined to rehear en banc its July 2015 decision interpreting key provisions of the Biologics Price Competition and Innovation Act 2009 (for further details please see "FDA opens door to the US biosimilars market"). In the July decision the Federal Circuit found that:
- the act's "patent dance" set out at 42 USC § 262(l)(2)(A) is not mandatory – that is, a biosimilar applicant need not disclose its abbreviated biologics licence application (aBLA) and manufacturing process information to the reference product sponsor; and
- a biosimilar applicant can provide notice of commercial marketing under 42 USC § 262(l)(8)(A) only after the 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 are optional, with Judge Newman dissenting; and Lourie and Newman agreeing that notice of commercial marketing cannot be given until product approval, with Chen dissenting.
Amgen sought rehearing of the holding that a reference product sponsor'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 that 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, one or both parties are expected to petition the Supreme Court for certiorari by the January 14 2016 deadline.
For further information on this topic please contact Lawrence S Perry or H Rachael Million-Perez at Fitzpatrick, Cella, Harper & Scinto by telephone (+1 212 218 2100) or email (firstname.lastname@example.org or email@example.com). The Fitzpatrick, Cella, Harper & Scinto website can be accessed at www.fitzpatrickcella.com.
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