Illinois Federal Court Permits Patent Infringement Claims and Injunctive Relief in Second-Phase BPCIA Litigation

On January 26, 2022, U.S. District Court Judge John Z. Lee of the Northern District of Illinois issued a significant ruling in AbbVie Inc. v. Alvotech hf., No. 21-cv-02899, addressing the scope of patent infringement claims and remedies available in the second phase of Biosimilar Price Competition and Innovation Act (BPCIA) litigation. The court denied a motion to dismiss filed by biosimilar applicant Alvotech hf., holding that the reference product sponsor (RPS), AbbVie, is entitled to assert patent infringement claims and seek injunctive relief beyond declaratory judgments in the second phase of BPCIA litigation.

Judge Lee outlined the BPCIA litigation framework, which consists of two phases. The first phase focuses on patents selected by the RPS for expedited litigation following the “patent dance,” the statutory information exchange between parties. The second phase addresses any remaining patents identified during the patent dance and is triggered only after the biosimilar applicant provides a 180-day notice of commercial marketing, as set forth in 42 U.S.C. § 262(l)(6)-(9). In this case, AbbVie and Alvotech completed the patent dance, identifying four patents for first-phase litigation and sixty-two for the second phase.

Alvotech’s motion to dismiss initially challenged AbbVie’s decision to name the Icelandic parent company, Alvotech hf., as a defendant without naming its U.S. subsidiary, Alvotech USA. Judge Lee had previously rejected a similar challenge in related first-phase litigation (AbbVie Inc. v. Alvotech hf., No. 21-cv-02258), and he reaffirmed that ruling in the current case.

The primary focus of the motion to dismiss was Alvotech’s argument that AbbVie could not assert infringement claims under 35 U.S.C. § 271(e)(2)(C)(i) or seek injunctive relief under 35 U.S.C. § 271(e)(4)(B) during the second phase of BPCIA litigation. Alvotech contended that only the first phase explicitly contemplates an “action for patent infringement” under 42 U.S.C. § 262(l)(6), whereas the second phase, governed by §§ 262(l)(8)-(9), refers solely to declaratory judgment actions.

Judge Lee rejected this interpretation, clarifying that infringement claims arise under 35 U.S.C. § 271(e)(2)(C)(i), which the Supreme Court in Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664 (2017), recognized as creating an “artificial act of infringement” for all patents listed by the RPS pursuant to § 262(l)(3). This statutory provision applies regardless of whether patents are litigated in the first or second phase. Consequently, the court held that the biosimilar applicant’s abbreviated Biologics License Application (aBLA) submission constitutes an artificial act of infringement for all patents identified during the patent dance.

Regarding injunctive relief, the court examined 35 U.S.C. § 271(e)(4), which authorizes remedies including injunctions and monetary damages. Alvotech argued that the second phase’s description as an action “for a declaration of infringement, validity, or enforceability” under § 262(l)(9) limits relief to declaratory judgments only. The court disagreed, finding no legislative intent to exclude other remedies such as injunctions in the second phase. Judge Lee confirmed that AbbVie may seek injunctive relief for all patents listed during the patent dance, consistent with § 271(e).

The court further emphasized that the BPCIA’s two-phase structure aims to prioritize litigation of the most contested patents in the first phase without restricting enforcement options in the second phase. Limiting remedies in the second phase could incentivize plaintiffs to overload the first phase with patents to avoid such constraints, undermining the statute’s purpose.

This ruling marks a critical development in BPCIA jurisprudence, affirming that reference product sponsors retain full enforcement rights, including infringement claims and injunctive relief, throughout the entirety of BPCIA litigation. As biosimilar patent disputes continue to evolve, this decision provides important guidance on the scope of remedies available to patent holders.

Legal practitioners and stakeholders should monitor ongoing developments in this area, as courts further interpret the BPCIA’s complex litigation provisions.

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