Amgen Opposes Supreme Court Review on Pre-Commercial Notice Provision in Amgen v. Sandoz But Files Cross-Petition on Whether Patent Dance Is Mandatory

 By: Jennifer Giordano-Coltart, Ph.D.

We recently posted on Sandoz Inc.’s petition for writ of certiorari that was filed February 16, 2016 requesting U.S. Supreme Court (Supreme Court) review of the U.S. Court of Appeals for the Federal Circuit’s (Federal Circuit) interpretation of the pre-commercialization notice provision of the Biologics Price Competition and Innovation Act of 2009 (BPCIA).  In that case, the Federal Circuit held that, “under paragraph (l)(8)(A), a subsection (k) [of the BPCIA] applicant may only give effective notice of commercial marketing after the FDA has licensed its product.”[1]

On the March 21, 2016 deadline, Amgen Inc. filed its opposition brief in support of the Federal Circuit’s interpretation, arguing that delaying the 180-day notice until after product approval would confirm that any requested injunction blocking the biosimilar is factually based.  A copy of Amgen’s opposition brief is available here.

Amgen also filed a conditional cross-petition addressing the Federal Circuit’s decision that the patent information exchange provisions of section (l)(2)(A) of the BPCIA (i.e. “the patent dance”) were not mandatory and that, when a biosimilar applicant chose not to provide its abbreviated Biologics License Application and manufacturing information to the reference product Sponsor, the only recourse for the Sponsor is to bring a patent infringement suit under 35 U.S.C. § 271(e)(2)(C)(ii) or a declaratory judgement action under 42 U.S.C. § 262(l)(9)(C) and obtain that information through discovery.  As we previously discussed here, Amgen chose not to file a petition for certiorari on this issue, and it was unclear whether it would file a conditional cross-petition. A copy of Amgen’s cross-petition is available here.

[1] Amgen Inc. v. Sandoz Inc., 794 F.3d 1347, 1351 (Fed. Cir. 2015) (en banc reh’g denied Oct. 16, 2015).  The majority opinion was based on interpreting the phrase “licensed under subsection (k)” to require that notice be given only after the product is licensed by the FDA.

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