In an opinion that details many intricacies of both the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and related portions of the Patent Act, the US Court of Appeals for the Federal Circuit affirmed a district court’s grant of a preliminary injunction, finding that a biosimilar product applicant must provide a biologic reference product sponsor with 180 days’ post-licensure notice before the applicant’s commercial marketing begins, regardless of whether the applicant provided notice of US Food and Drug Administration (FDA) review under 42 USC § 262(l)(2)(A). Amgen, Inc. v. Apotex, Inc., Case No. 16-1308 (Fed. Cir., July 5, 2015) (Taranto, J).

Apotex filed an application for an FDA license to market a biosimilar version of Amgen’s Neulasta® biologic product, invoking the BPCIA’s abbreviated pathway for regulatory approval of follow-on biological products that are “highly similar” to a previously approved reference product. Amgen sought and obtained a preliminary injunction to enforce BPCIA’s § 262(l)(8)(A), which requires a biosimilar product applicant to give notice to the reference product sponsor 180 days before the applicant begins commercially marketing its FDA-licensed product. The parties stipulated that all of the factors considered in awarding a preliminary injunction favored Amgen as the reference product sponsor, except for the likelihood of success factor, which depended on the parties’ competing interpretations of the BPCIA. Apotex appealed the preliminary injunction to the Federal Circuit.

In a prior case, Amgen v. Sandoz, the Federal Circuit held that the 180-day notice period must follow, not precede, FDA licensure. In that case, the biosimilar product applicant had not engaged in the so-called “patent dance.” As detailed in the multi-part subsection § 262(l) of the BPCIA, the “patent dance” refers to a series of information disclosures made between an applicant and the reference product sponsor, and to the parties’ related duties concerning initiation of patent litigation relating to marketing a licensed biosimilar product. The dance is initiated by the disclosures described in § 262(l)(2)(A). In Sandoz, the Federal Circuit held that a biosimilar product applicant cannot be compelled to provide notice of FDA review under § 262(l)(2)(A), and that an infringement suit under 35 USC § 271(e)(2) is the reference product sponsor’s remedy if the applicant does not voluntarily provide such notice.

In this case, Apotex argued that the 180-day post-licensure notice described in § 262(l)(8)(A) was not mandatory under the BPCIA when the applicant had made its disclosures under § 262(l)(2)(A). In Sandoz, the Court described the 180-day notice as mandatory, but the applicant had not made a § 262(l)(2)(A) disclosure. Apotex argued that § 262(l)(9) establishes that the exclusive remedy for failure to provide the 180-day notice of commercial marketing under § 262(l)(8)(A), where an applicant had also made its § 262(l)(2)(A) disclosure, is a declaratory judgment suit.

BPCIA § 262(l)(9) provides different remedies for a reference product sponsor depending on the status of the § 262(l)(2)(A) and § 262(l)(8)(A) disclosures. The Federal Circuit rejected Apotex’s argument, however, finding that the 180-day notice is mandatory regardless of whether the applicant first provides notice under § 262(l)(2)(A), and is enforceable by injunction. As the Court explained, while § 262(l)(9)(A) bars certain declaratory judgment actions, §§ 262(l)(9)(B) and (C) state only that, in certain circumstances, the reference product sponsor “may bring” such an action. There is no language that excludes other remedies for the conduct described. Indeed, according to the Court, Apotex’s argument conflicts with the Supreme Court of the United States mandate that “equitable jurisdiction is not to be denied or limited in the absence of a clear and valid legislative command.” For these reasons, the Federal Circuit affirmed the grant of the preliminary injunction.