BPCIA's Pre-Marketing Notice Provision Applies to Biosimilar Applicants Who Have Done the "Patent Dance": Federal Circuit | Practical Law

BPCIA's Pre-Marketing Notice Provision Applies to Biosimilar Applicants Who Have Done the "Patent Dance": Federal Circuit | Practical Law

In Amgen Inc. v. Apotex Inc., the US Court of Appeals for the Federal Circuit held that the Biologics Price Competition and Innovation Act's (BPCIA) 180-day notice of commercial marketing provision is mandatory and enforceable by an injunction against a biosimilar applicant who has disclosed its biologics license application (BLA) to the reference product sponsor (RPS) and participated in the BPCIA's "patent dance" information exchange between the parties.

BPCIA's Pre-Marketing Notice Provision Applies to Biosimilar Applicants Who Have Done the "Patent Dance": Federal Circuit

by Practical Law Intellectual Property & Technology
Published on 06 Jul 2016 • USA (National/Federal)
In Amgen Inc. v. Apotex Inc., the US Court of Appeals for the Federal Circuit held that the Biologics Price Competition and Innovation Act's (BPCIA) 180-day notice of commercial marketing provision is mandatory and enforceable by an injunction against a biosimilar applicant who has disclosed its biologics license application (BLA) to the reference product sponsor (RPS) and participated in the BPCIA's "patent dance" information exchange between the parties.
On July 5, 2016, in Amgen Inc. v. Apotex, Inc., the US Court of Appeals for the Federal Circuit affirmed the US District Court for the Southern District of Florida's grant of a preliminary injunction requiring Apotex to provide 180 days' post-licensure notice to Amgen before marketing a biosimilar version of Amgen's FDA-approved Neulasta product for stimulating white blood cell production ( (Fed. Cir. July 5, 2016)). Expanding on its 2015 Amgen Inc. v. Sandoz, Inc. decision (794 F.3d 1347 (Fed. Cir. 2015)), the court held that:
  • The Biologics Price Competition and Innovation Act's (BPCIA) 180-day pre-commercial marketing notice provision, 42 U.S.C § 262(l)(8)(A), is mandatory even where the biosimilar applicant has disclosed its biologics license application (BLA) to the reference product sponsor (RPS) under 42 U.S.C. § 262(l)(2)(A), triggering the "patent dance" exchange of information between the parties.
  • Section 262(l)(8)(A)'s notice provision is enforceable by an injunction, which the district court appropriately entered against Apotex.
For more background and information on Amgen v. Sandoz, see Legal Update, Generic Biologic Applicant Not Required to Disclose License Application: Federal Circuit.
In October 2014, Apotex filed a BLA with the FDA listing Amgen's Neulasta as the reference product. After the FDA accepted Apotex's application, Apotex provided Amgen a copy of its application and manufacturing process information under 42 U.S.C. § 262(l)(2)(A). Apotex also provided Amgen with a notice of future commercial marketing under 42 U.S.C § 262(l)(8)(A), even though it has not obtained an FDA license to market its biosimilar. The parties then exchanged information under the BPCIA's statutory scheme and agreed to the relevant patents to litigate. Amgen sued for infringement in August 2015.
In October 2015, Amgen moved for a preliminary injunction requiring Apotex to:
  • Provide notice of commercial marketing under 42 U.S.C § 262(l)(8)(A) if and when Apotex actually receives a biologics license.
  • Delay market entry for 180 days after providing post-licensure notice, in accordance with Amgen v. Sandoz.
The district court granted the injunction, ruling in relevant part that:
  • Under Amgen v. Sandoz, Section 262(l)(8)(A)'s notice provision provides a defined statutory window for all biosimilar products that obtain FDA licenses, irrespective of whether the applicant has disclosed its BLA to the RPS.
  • Apotex was wrong in contending that:
    • requiring 180 days' notice from licensure would unfairly extend Amgen's 12-year market exclusivity period under the BPCIA; and
    • the BPCIA's exclusive remedy for breach of the pre-marketing notice provision is a declaratory judgment action under 42 U.S.C. § 262(k)(9).
On appeal, Apotex argued that the Amgen v. Sandoz ruling should not apply because, unlike Sandoz, Apotex disclosed its BLA and participated in the patent dance with Amgen. The court rejected Apotex's argument, reasoning that:
  • The commercial marketing notice provision of 42 U.S.C. § 262(l)(8)(A):
    • expressly states that the applicant "shall" provide notice 180 days before marketing a biosimilar; and
    • stands alone and does not depend on whether the applicant has disclosed its BLA to the RPS under 42 U.S.C. § 262(l)(2)(A).
  • Requiring pre-marketing notice would not unfairly extend the RPS's 12-year market exclusivity under the BPCIA because the statute establishes this time period as the earliest date, not the latest date, on which a biosimilar can go to market.
  • A declaratory judgment action is not the exclusive remedy for breach of the notice provision under 42 U.S.C. § 262(l)(9) because:
    • the statute does not expressly or implicitly make a declaratory judgment action the sole cause of action for a breach of the notice provision; and
    • declaratory judgment of the patent's merits would not be a meaningful remedy for a breach of the notice provision, and would undermine the BPCIA's objective of avoiding rushed and inefficient biosimilar litigation.