In what appears to be a case of first impression, on August 23, 2021 U.S. District Judge John Z. Lee of the United States District Court for the Northern District of Illinois denied a biosimilar applicant’s motion to dismiss a patent infringement suit brought under the Biosimilar Price Competition and Innovation Act (“BPCIA”) against a foreign parent corporation that did not file or sign the relevant abbreviated Biologics License Application (“aBLA”). AbbVie Inc. v. Alvotech hf., No. 21-cv-02258, (N.D. Ill.). In so doing, Judge Lee relied heavily on parallels between the Hatch-Waxman Act and the BPCIA.

Plaintiffs, AbbVie Inc. and AbbVie Biotechnology Ltd. (collectively, “AbbVie”), make the biologic, Humira^® (adalimumab), which is used to treat a variety of autoimmune conditions including rheumatoid arthritis, psoriasis, and Crohn’s disease. Defendant, Alvotech hf., is an Icelandic corporation in the business of developing, manufacturing, marketing, and selling biologic drugs. In May 2018, Alvotech hf. began clinical trials for a biosimilar of Humira^® called AVT02. In January 2019, Alvotech hf. incorporated its “wholly-owned, regulatory affairs, governmental policy and legal subsidiary,” Alvotech USA, in Virginia. And in fall of 2020, Alvotech USA signed and filed an aBLA seeking FDA approval for AVT02. Following the BPCIA’s biosimilar litigation framework, the parties completed the “patent dance” information exchange and, on April 27, 2021, AbbVie sued Alvotech hf., but not Alvotech USA, for infringement of four patents under 35 U.S.C. § 271(e)(2)(C) in the Northern District of Illinois. (For some of Mintz’s prior coverage of the BPCIA and its patent dance information exchange, see 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.)

Alvotech hf. moved to dismiss the complaint for lack of subject matter jurisdiction, lack of personal jurisdiction, failure to state a claim, and failure to join an indispensable party, all largely premised on AbbVie’s suing Alvotech hf. but not the U.S. subsidiary, Alvotech USA. The court first concluded that the primary issue was not one of subject matter jurisdiction under Rule 12(b)(1), but rather involved the merits under Rule 12(b)(6). In so ruling, the court relied on Federal Circuit precedent in the Hatch-Waxman context holding that § 271(e), which provides the infringement cause of action in both Hatch-Waxman and BPCIA infringement suits, is not a jurisdictional statute.

The court then turned to the central questions of whether Alvotech hf. “submitted” the aBLA, despite not signing or filing it, and whether Alvotech USA “submitted” the aBLA and was a necessary party to the suit. The court observed that the same word “submit” appears in the general section of § 271(e)(2) and should therefore be interpreted the same in both the Hatch-Waxman (§ 271(e)(2)(A)) and BPCIA (§ 271(e)(2)(C)) contexts. The court further noted that the additional BPCIA and patent dance provisions, including their references to one who “submits” an aBLA, did not compel departure from ANDA litigation jurisprudence.

As a result, the court applied the Federal Circuit’s In re Rosuvastatin Calcium Patent Litigation, 703 F.3d 511 (Fed. Cir. 2012) holding that an ANDA “submitter” is a party “actively involved in preparing the ANDA,” “includ[ing] marketing and distributing the approved generic drugs in the United States,” and one “participating in the [drug’s] manufacture [or] importation,” “regardless of whether they are the named applicant, especially where the parties involved are in the same corporate family.” Id. at 528; Adverio Pharma GmbH v. Alembic Pharms. Ltd., No. CV 18-73-LPS, 2019 WL 581618, at *4 (D. Del. Feb. 13, 2019). The court observed that according to the complaint, Alvotech hf. created and prepared the information in the aBLA, especially where at least one AVT02 clinical trial began before Alvotech USA existed, and Alvotech hf. will engage in the commercial manufacture and supply of AVT02 and financially benefit in significant manner from the approval of the AVT02 aBLA. The court thus concluded that Alvotech hf. was a “submitter” of the aBLA, and denied the Rule 12(b)(6) motion accordingly.

Next, the court addressed defendant’s motion to dismiss under Rule 12(b)(7) for failure to join Alvotech USA as a necessary and indispensable party. Alvotech hf. argued, and AbbVie did not dispute, that if Alvotech USA were a necessary party to the litigation, it could not be joined to the current suit in the Northern District of Illinois because venue would be improper over the Virginia corporation. (See Mintz’s prior coverage here of the Federal Circuit’s restriction of venue in Hatch-Waxman litigation to districts in which acts related to the ANDA submission occurred, rather than districts where the ANDA product may be distributed once approved.) Nonetheless, the court concluded that the suit could proceed without naming the U.S. subsidiary because, under 7th Circuit law, it is unlikely that a “100 percent subsidiary could ever be an indispensable party,” see Extra Equipamentos E Exportação Ltda. v. Case Corp., 361 F.3d 359, 364 (7th Cir. 2004) (emphasis in original), and a parent corporation is presumed to adequately represent the interests of its wholly-owned subsidiary in the patent context. Where AbbVie sued Alvotech hf. for its own conduct as aBLA “submitter,” the court found Alvotech hf. had not met its burden to show that the case must be dismissed under Rule 12(b)(7) for failure to join Alvotech USA.

Finally, the court concluded that specific personal jurisdiction was appropriate over Alvotech hf. in the Northern District of Illinois, again relying on Federal Circuit holdings in the Hatch-Waxman context. Specifically, in Acorda Therapeutics v. Mylan Pharmaceuticals, the Federal Circuit held that the submission of an ANDA is a “suit-related” and “substantial connection” where the defendant plans to market its proposed drug in the forum state. 817 F.3d 755, 762-63 (Fed. Cir. 2016). Likewise, in the case at hand, AbbVie alleged that Alvotech hf. will engage in commercial manufacture and supply of the aBLA product in the Northern District of Illinois, and defendant submitted no evidence to the contrary. Because Alvotech hf.’s “submission” of the aBLA indicates intent to market and distribute the biosimilar in Illinois, the court ruled, specific jurisdiction exists over it in the district.

Stay tuned for further coverage as this and other BPCIA issues make their way through the courts in this rapidly evolving area of law.