180-day post-FDA licensure notice for commercial marketing mandatory for biosimilar product applicants 

Amgen Inc. v. Apotex Inc., No. 2016-1308 (Fed. Cir. July 5, 2016) 

Amgen Inc. brought an action against Apotex Inc. under the Biologics Price Competition and Innovation Act (BPCIA) alleging that Apotex’s marketing of an application-pending drug that was “biosimilar” to Amgen’s FDA-approved Neulasta infringed Amgen’s patent.

Amgen sought a preliminary injunction to enforce a provision of the BPCIA requiring biosimilar-product applicants to give 180 days’ notice before commercially marketing their FDA-licensed products. The parties stipulated that Amgen would be irreparably harmed if Apotex entered the market without the 180 days’ notice, that the balance of the hardships favors Amgen, and that the public interest favored an injunction. “The decision whether to grant the preliminary injunction motion, therefore, turned on Amgen’s likelihood of success on the legal question presented: whether the (8)(A) notice requirement is a mandatory one enforceable by injunction as to an applicant (such as Apotex) that, unlike Sandoz inAmgen v. Sandoz, gave the (2)(A) notice to launch the information-exchange process leading to the paragraph (6) infringement suit.” (Op. at 13-14).

The district court granted the preliminary injunction and enjoined Apotex from entering the market unless it had given Amgen notice after receiving the requested FDA license and then waited 180 days after the notice.

On appeal, Apotex argued the injunction was improper and that the commercial-marketing provision of the BPCIA, along with the 180-day notice period, was not mandatory because Apotex had launched the process for exchanging patent information and channeling patent litigation pursuant to the BPCIA.

Reviewing the question of law de novo, the Federal Circuit affirmed the district court’s injunction order. The Federal Circuit held that Apotex was required under Section 262(l)(8)(A) of the BPCIA to provide 180 days’ post-licensure notice before commercially marketing Apotex’s biosimilar product, and that the mandatory requirement was enforceable by preliminary injunction. The Federal Circuit also reiterated its prior holding in Sandoz that the commercial marketing notice requirements of Paragraph 8(A) of the Act were mandatory and enforceable. The Federal Circuit rejected Apotex’s argument that the 180-day notice period began tolling prior to the FDA license grant simply because Apotex had complied with the Act. The Federal Circuit held that Apotex’s compliance was a factual distinction, not a legal one, and the mandatory requirements under the Act still applied. 

A copy of the opinion can be found here ►