N.D. Ill. Finds That A Foreign Parent Corp. May Be Sued Under BPCIA Without The U.S. Subsidiary That Signed And Filed ABLA

Published date22 September 2021
Subject MatterIntellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent, Food and Drugs Law, Biotechnology & Nanotechnology
Law FirmMintz
AuthorMr Thomas Wintner, Adam P. Samansky and Joseph D. Rutkowski

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...

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