On January 26, 2022, in what appears to be a case of first impression, U.S. District Court Judge John Z. Lee of the United States District Court for the Northern District of Illinois denied a biosimilar applicant defendant’s motion to dismiss patent infringement claims brought in the second phase of the parties’ Biosimilar Price Competition and Innovation Act (“BPCIA”) litigation. AbbVie Inc. v. Alvotech hf., No. 21-cv-02899 (N.D. Ill. Jan. 26, 2022). In so doing, Judge Lee held that the reference product sponsor (“RPS”) plaintiff is not limited to only declaratory judgment actions in the second phase of litigation under the BPCIA.
As Judge Lee explained, BPCIA litigation consists of two phases: the first phase focuses on certain contested patents disclosed during the parties’ “patent dance,” the BPCIA information exchange, and selected by the RPS for expeditious litigation; while the second phase deals with any remaining patents identified during the patent dance and is not triggered until the biosimilar applicant provides 180-day notice of commercial marketing of its biosimilar product. See 42 U.S.C. § 262(l)(6)-(9). Following the BPCIA framework, AbbVie and Alvotech completed the patent dance and identified four patents to be litigated in the first phase and another sixty-two to be litigated in the second phase. (For more information of the BPCIA litigation framework and its “patent dance” information exchange, see previous Mintz articles regarding the effect of factual statements made during the patent dance and regarding the seminal Supreme Court interpretation of BPCIA patent dance and notice of commercial marketing provisions.)
The first portion of Alvotech’s motion to dismiss related to AbbVie’s naming Icelandic parent corporation, Alvotech hf, but not U.S. subsidiary, Alvotech USA, as a defendant. Judge Lee previously denied Alvotech hf.’s substantially similar motion to dismiss in the related first-phase BPCIA litigation, AbbVie Inc. v. Alvotech hf., No. 21-cv-02258 (N.D. Ill. Aug. 23, 2021), and issued an identical ruling on that similar portion of the instant motion to dismiss. See Mintz’s prior coverage of that order, here.
The remainder of Alvotech’s second motion to dismiss, receiving the bulk of the court’s attention, argued that AbbVie was precluded from asserting infringement claims under 35 U.S.C. § 271(e)(2)(C)(i) or seeking injunctive relief under 35 U.S.C § 271(e)(4)(B) in the second-phase BPCIA litigation.
The court first addressed the argument that infringement claims may not be asserted in the second phase of BPCIA litigation because only § 262(l)(6), which governs the first phase, includes the phrase “an action for patent infringement,” whereas § 262(l)(8)-(9), which govern the second phase, do not. The court clarified that any claims for patent infringement stem not from § 262(l), but from 35 U.S.C. § 271(e)(2)(C)(i). As the Supreme Court held in the seminal case Sandoz v. Amgen, § 271(e)(2)(C)(i) creates an “artificial act of infringement” as to “those [patents] contained in the § 262(l)(3) lists,” which in turn consist of all patents for which the RPS (i.e., AbbVie) believes it could reasonably assert an infringement claim. 137 S. Ct. 1664, 1674 (2017). Thus, the court found an aBLA submission creates an artificial act of infringement as to all patents identified by RPS pursuant to § 262(l)(3), without regard to whether the patents are asserted in the first or second phase.
Judge Lee next examined 35 U.S.C. § 271(e)(4), which sets forth four remedies available to an RPS plaintiff, including “injunctive relief” and “damages or other monetary relief” under § 271(e). Alvotech argued that even if patent infringement assertions are permissible in second-phase BPCIA litigation, injunctive relief is limited to the first phase by § 262(l)(9) of the BPCIA, which describes the second phase as “an action . . . for a declaration of infringement, validity, or enforceability.” The court rejected this argument and did not find that the specific reference to declaratory judgment in § 262(l)(9) indicates an intent to exclude all other remedies. Therefore, the court confirmed that AbbVie can seek, among other remedies, injunctive relief in the second-phase BPCIA litigation for all patents listed during the patent dance pursuant to § 262(l)(3).
Finally, the court explained that the two-phase structure of the BPCIA litigation framework encourages parties to litigate “the most contested and consequential patents immediately” in the first phase, but does not limit assertions and remedies in the second phase. To hold otherwise, the court warned, would incentivize a plaintiff to “include as many of its patents as possible” in the first phase to evade possible limitations in the second phase, thereby “undercutting one of the primary purposes of the [BPCIA].”
Stay tuned for further coverage as this and other BPCIA issues continue to make their way through the courts in this rapidly evolving area of law.