US District Court Expands Definition of aBLA Submitter, Impacting Biosimilar Patent Litigation

Under the Biosimilar Price Competition and Innovation Act of 2009, filing an abbreviated Biologics License Application (aBLA) for a biosimilar can constitute an artificial act of infringement. The recent AbbVie Inc. v. Alvotech hf. decision expands what it means to submit an aBLA and allows patent‑infringement claims to target the foreign parent company listed in the application. This ruling has far‑reaching consequences for biosimilar makers outside the United States.

Background

In 2018, Iceland‑based Alvotech hf. began clinical trials for a biosimilar version of AbbVie’s Humira®, a drug used to treat rheumatoid arthritis, psoriasis, and Crohn’s disease. The company formed a wholly‑owned U.S. subsidiary, Alvotech USA, in 2019. In fall 2020, Alvotech USA filed an aBLA seeking U.S. approval. As required by the BPCIA, the application was notified to AbbVie, who promptly sued AbbVie in the Northern District of Illinois for patent infringement based on the submission.

AbbVie named Alvotech hf. as the defendant—rather than the U.S. subsidiary. The complaint alleged that Alvotech hf. created and prepared the aBLA data, and that, if approved, it would manufacture, commercialise and sell the biosimilar. Alvotech hf. moved to dismiss the suit.

District Court’s Interpretation of "Submit"

U.S. patent law defines an act of infringement as "submit" of an ANDA or an aBLA when the purpose is to obtain approval for commercial manufacture, use or sale before the patent expires. Alvotech hf. argued that only Alvotech USA was the actual submitter.

The court rejected that argument, citing Hatch‑Waxman precedent that adopts an expansive meaning of "submitter" for ANDA products. In In re Rosuvastatin Calcium Patent Litigation, the Federal Circuit held that an entity "submits" an ANDA if it intends to benefit directly from the approval by participating in manufacture, importation, distribution or sale.

Applying the same reasoning, the court held that §271(e)(2) applies equally to the BPCIA, making the Icelandic parent an eligible submitter. The court found that AbbVie had adequately alleged that Alvotech hf. created and prepared the aBLA information and would participate in manufacture, supply, development and registration of the Humira® biosimilar. These allegations were sufficient to deny the motion to dismiss.

Implications for Biosimilars Litigation

Because the Hatch‑Waxman Act predates the BPCIA by 25 years, there is substantially more case law governing ANDA submissions than aBLA submissions. Future courts are likely to draw on Hatch‑Waxman principles when adjudicating BPCIA cases.

Importantly, biosimilar developers should recognise that non‑U.S. entities may be named as defendants under the court’s broadened definition of "submitter." Companies that create or prepare aBLA data—or that will engage in manufacture, distribution, marketing or importation of a biosimilar—may face patent‑infringement litigation, even if they are not listed in the aBLA. For U.S. brand‑name holders, the decision could open a more favourable venue for suits. Foreign corporations with arm‑sized U.S. subsidiaries should consider potential liabilities and litigation control in their contracts and licensing agreements.

References:

1. 35 U.S.C. § 271(e)(2)(C).
2. AbbVie Inc. v. Alvotech hf., No. 1:21‑cv‑02258, Doc. 51 (N.D. Ill. Aug. 23, 2021) ("Alvotech").
3. Alvotech at *5–6.
4. 42 U.S.C. § 262(k).
5. Alvotech at *6–7.
6. Id.
7. Id. at *11–12.
8. 35 U.S.C. § 271(e)(2).
9. Id. at *14, 17–19.
10. Alvotech at *18–19 (citing In re Rosuvastatin Calcium Patent Litigation, 703 F.3d 511, 528 (Fed. Cir. 2012); Adverio Pharma GmbH v. Alembic Pharms. Ltd., No. CV-18-73-LPS, 2019 WL 581618, at *4 (D. Del. Feb. 13, 2019)).
11. Alvotech at *15, 18.
12. Id. at *15–18.
13. Id. at *19.
14. Id.
15. Id. at *19–20.