The United States Court of Appeals for the Federal Circuit has confirmed that a biosimilar-product applicant must always provide notice to the biologic innovator 180 days before commercially marketing its FDA-licensed product under 42 U.S.C. § 262(l)(8)(A) of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) in Amgen Inc. v. Apotex Inc., No. 2016-1308 (2016). Such (8)(A) notice can only be provided after the FDA issues a license for the biosimilar-product. The decision affirmed that compliance with the notice provision is mandatory and enforceable by injunction regardless of whether the parties had engaged in the patent information exchange pursuant to other sections of § 262(l), also referred to as the “patent dance.” See id. at *15.


In October 2014, Apotex filed a biosimilar application for its pegfilgrastim product under 42 U.S.C. § 262(k), listing Amgen’s Neulasta® as the reference product. Id. at *11. Apotex’s application was accepted for review by the Federal Drug Administration (“FDA”) on December 15, 2014. Id. Two weeks later, Apotex engaged in the patent information exchange process pursuant to § 262(l)(2)(A) by sending Amgen a copy of its application and information detailing its manufacturing process. Id. On February 27, 2015, Amgen sent Apotex its § 262(l)(3)(A) list of patents. Id. On April 17, 2015, Apotex provided its § 262(l)(3)(B) response. Id. On the same day, Apotex also sent Amgen a letter stating it was providing notice of future commercial marketing pursuant to § 262(l)(8)(A). Id. at *11-12. Amgen interpreted this letter as an attempt to initiate the 180 day notice period, even though Apotex’s proposed product had not received an FDA license. Id.

The parties continued to exchange patent information pursuant to other provisions of § 262(l), which culminated in patent infringement litigation filed on August 6, 2015. Id. at *12. In October 2015, Amgen filed a motion for a preliminary injunction requiring Apotex to provide an (8)(A) notice to Amgen only after Apotex receives a license and thereby delay Apotex’s commercial marketing of its pegfilgrastim product for 180 days from that notice. Id. at *13. Resolution of the motion turned on whether the 180 day commercial marketing notice of (8)(A) is mandatory. Id. at *13-14. The District Court held that it was and granted Amgen’s preliminary injunction. Id. at *14. Apotex appealed. Id.

The Federal Circuit Decision

The Federal Circuit agreed with the District Court, noting that (8)(A) notice is mandatory regardless of whether or not a biosimilar applicant chose to comply with the provisions of (2)(A). Id. at *15. The express language of (8)(A) “provides that ‘the subsection (k) applicant shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).’” Id. (emphasis in original). Nothing in (8)(A) turns on whether the applicant provided (2)(A) notice, and no other statutory provisions compelled treatment of (8)(A) as non-mandatory. Id. at *15-16. The Federal Circuit reiterated its previous statement in Amgen v. Sandoz, 794 F.3d 1347, 1359-60 (Fed. Cir. 2015), noting that (8)(A) is a “standalone notice provision not dependent on the information-exchange processes that begin with (2)(A).” Id. It also emphasized the reasoning for (8)(A) notice: giving the parties and the Court time to adjudicate pre-launch issues “without the reliability-reducing rush that would attend requests for relief against immediate market entry that could cause irreparable injury.” Id. at *19; *23-24.

The Federal Circuit also disagreed with Apotex’s argument that reading (8)(A) as mandatory would effectively extend the reference product’s 12 year exclusivity period by six months. Id. at *16. The Court noted that the 12-year date is “an earliest date, not a latest date on which a biosimilar license can take effect.” Id. It further noted that the FDA could issue a license before the 11.5 year mark and “deem the license to take effect on the 12-year date.” Id. at *17. Under such circumstances, the Federal Circuit noted it would read (8)(A) as allowing the notice to be sent when the license issues even if it is not yet effective. Id.

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