Recently, District Judge John Z. Lee of the Northern District of Illinois refused to dismiss a patent infringement suit brought under the Biosimilar Price Competition and Innovation Act (“BPCIA”) against a foreign parent company on the grounds that the domestic subsidiary was not a necessary party. See AbbVie Inc. v. Alvotech hf., No. 21-cv-02258 (N.D. Ill. Aug. 23, 2021). In reaching this decision, Judge Lee relied heavily on parallel language in the BPCIA and the Hatch-Waxman Act.
AbbVie, Inc. owns a suite of patents related to the biologic Humira®, used to treat a variety of autoimmune conditions. In late 2020, Alvotech hf.’s recently-incorporated U.S. subsidiary—Alvotech USA—signed and filed an abbreviated Biologics Licensing Application (“aBLA”) for AVT02, a biosimilar of Humira®. Pursuant to the procedure established by the BPCIA, Alvotech USA notified AbbVie of its application and Abbvie filed suit shortly thereafter. Importantly, AbbVie’s Northern District of Illinois litigation named only Alvotech hf., the foreign parent corporation.
Alvotech hf. moved to dismiss, alleging that Alvotech USA was the entity who “submitted” the aBLA within the meaning of 35 U.S.C. § 271 (e)(2), and thus, was the real party in interest. In response, AbbVie argued that Alvotech hf.—not Alvotech USA—would be responsible for the “manufacture, commercialization, marketing, and sale of AVT02,” and that it “created and prepared the information in the aBLA” even if Alvotech USA was the named applicant. Slip op. at 7.
Judge Lee agreed with AbbVie, finding that to “submit” an aBLA covers more than being listed as the applicant on the aBLA form. He premised his holding on In re Rosuvastatin Calcium Patent Litigation, 703 F.3d 511 (Fed. Cir. 2012) from the Hatch Waxman context, which utilizes the same language and which numerous courts have interpreted as broadening the meaning of “submission” of an ANDA beyond the actual filing entity. See Slip op. at 15-16. The Court held that AbbVie’s allegations that Alvotech hf. was “actively involved” in the submission of the aBLA by virtue of its testing and manufacture of AVT02 supported the conclusion that the parent entity was a “submitter” for purposes of the BPCIA. Id. at 19. The court also noted that Alvotech USA was not an indispensable party under 7th Circuit law, and that personal jurisdiction over Alvotech hf. was proper.
This decision suggests that opponents to an aBLA may have some flexibility in filing suit under the BPCIA, at least in the context of wholly-owned subsidiaries.