Litigation Details for AbbVie Inc. v. Alvotech hf. (N.D. Ill. 2021)

AbbVie Inc. v. Alvotech hf. (N.D. Ill. 2021)

Docket		Date Filed	2021-05-28
Court	District Court, N.D. Illinois	Date Terminated	2022-03-09
Cause	35:271 Patent Infringement	Assigned To	John Zihun Lee
Jury Demand	Defendant	Referred To
Patents	8,231,876; 8,420,081; 8,663,945; 8,715,664; 8,808,700; 8,883,156; 8,889,136; 8,895,009; 8,906,372; 8,906,373; 8,906,646; 8,911,964; 8,916,153; 8,926,975; 8,961,973; 8,961,974; 8,986,693; 8,999,337; 9,061,005; 9,062,106; 9,067,992; 9,085,618; 9,085,619; 9,085,620; 9,090,688; 9,090,689; 9,090,867; 9,096,666; 9,102,723; 9,150,645; 9,181,337; 9,181,572; 9,187,559; 9,234,032; 9,266,949; 9,273,132; 9,284,370; 9,284,371; 9,290,568; 9,315,574; 9,328,165; 9,334,319; 9,346,879; 9,359,434; 9,499,614; 9,499,616; 9,505,834; 9,512,216; 9,522,953; 9,550,826; 9,624,295; 9,669,093; 9,683,033; 9,708,400; 9,957,318
Link to Docket	External link to docket

Biologic Drugs cited in AbbVie Inc. v. Alvotech hf.

Details for AbbVie Inc. v. Alvotech hf. (N.D. Ill. 2021)

Date Filed	Document No.	Description	Snippet	Link To Document
2021-05-28				External link to document
2021-05-28	130	amended complaint	U.S. Patent No. 8,231,876 72. U.S. Patent No. 8,231,876 (the “’876 patent”), titled …will constitute infringement of U.S. Patent Nos. 6,805,686, 8,231,876, 8,420,081, 8,663,945, 8,708,968, … INFRINGEMENT OF U.S. PATENT NO. 8,231,876 224. AbbVie incorporates by …DECLARATORY JUDGMENT OF INFRINGEMENT OF U.S. PATENT NO. 8,231,876 237. AbbVie incorporates by … Protector Shroud 2. 8,231,876 Wan Purified Antibody	External link to document
2021-05-28	247	status report	deadlines for the Ten Patents are as follows: 1 U.S. Patent Nos. 6,805,686, 8,926,975, 8,961,973, 8,999,337…with respect to ten patents that will be subject to a first trial1 (“Ten Patents”). Dkt. 63 (2258); Dkt…the ’559 and ’216 patents based on the allegations previously pled for the ’973 patent. [AbbVie…Defenses of Inequitable Conduct, Unclean Hands, and Patent Misuse in 2258 (Dkt. 69 (2258)). On January…Defenses of Inequitable Conduct, Unclean Hands, and Patent Misuse in 2899 (Dkt. 214 (2899)). The Court has	External link to document
2021-05-28	79	stipulation	Requests for Production related to U.S. Patent Nos. 6,805,686; 8,999,337; 9,067,992; 9,187,559; 9,512,216;…9,512,216; 11,083,792; and 11,167,030 (the patent issuing from U.S. Patent Application No. 17/137,201) (collectively…collectively, the “Remaining Patents”) by treating the term “Patents- in-Suit” as used in those Requests…served on August 25, 2021, to reflect all ten patents that will be tried in the August 2022 trial; and…Requests as including the Remaining Patents. AbbVie shall substantially complete this production on or before	External link to document
2021-05-28	80	other	proceeding involving the ’619 patent’s parent, U.S. Patent No. 8,420,081, lends further support to “water…indefinite, with terms in the ’792 patent being the most egregious. That patent, which AbbVie asserts covers…’s so-called “bufferless” patents, one of which, in violation of the Patent Dance confidentiality provisions… ARGUMENT The ’792 Patent The ’792 patent relates to methods for purifying … The ’619 and ’030 Patents The ’619 and ’030 patents share a common specification2	External link to document

Litigation Summary and Analysis for AbbVie Inc. v. Alvotech hf.

Introduction

The litigation between AbbVie Inc. and Alvotech hf. revolves around patent disputes related to adalimumab, a biologic drug marketed by AbbVie under the brand name Humira. This article delves into the key aspects of the litigation, including the claims, counterclaims, and the legal maneuvers employed by both parties.

Background of the Dispute

In the early fall of 2020, Alvotech USA submitted an Abbreviated Biologics License Application (aBLA) to the FDA seeking approval for AVT02, a biosimilar of adalimumab. As part of the Biologics Price Competition and Innovation Act (BPCIA) process, Alvotech USA notified AbbVie of its application, and the parties engaged in the "patent dance" to identify the patents that would be litigated[5].

AbbVie's Initial Lawsuit

AbbVie filed a patent infringement suit against Alvotech hf. in the Northern District of Illinois, alleging that Alvotech hf.'s filing of the aBLA infringed four of AbbVie's patents: US 8,420,081; US 9,085,619; US 8,926,975; and US 8,961,973. These patents pertain to various formulations and methods of treating diseases using adalimumab[1][5].

Alvotech's Counterclaims and Declaratory Judgment Action

In response, Alvotech filed a complaint in the Eastern District of Virginia seeking a declaratory judgment of non-infringement and invalidity of the same four patents. Alvotech argued that AbbVie's refusal to sue Alvotech USA, the actual applicant for the aBLA, was a strategic move to avoid litigating in the Eastern District of Virginia, which Alvotech considered misconduct[1][3].

Claims of Inequitable Conduct and Unclean Hands

Alvotech's complaint also alleged that the '973 patent was unenforceable due to inequitable conduct. It claimed that AbbVie had misrepresented safety data to the patent office. Additionally, Alvotech alleged that AbbVie's assertion of over 60 patents was part of a broader strategy to maintain a monopoly by creating a "patent minefield" that would deter meaningful litigation[1].

Jurisdictional and Procedural Disputes

Alvotech hf. moved to dismiss AbbVie's complaint in the Northern District of Illinois, arguing that the court lacked subject matter jurisdiction, personal jurisdiction, and that AbbVie had failed to state a claim. Alvotech hf. also contended that Alvotech USA, domiciled in Virginia, was the real party in interest and should have been named as a defendant[5].

Court Decisions and Transfers

Judge Raymond A. Jackson of the Eastern District of Virginia transferred Alvotech's declaratory judgment suit to the Northern District of Illinois and dismissed AbbVie's pending motion to dismiss as moot. This decision aligned the litigation with AbbVie's existing suits in the Northern District of Illinois[3].

Second Wave of Litigation

AbbVie filed a second BPCIA action in the Northern District of Illinois, alleging infringement of an additional 58 patents. Alvotech hf. renewed its motion to dismiss this second complaint, arguing that the court had not yet ruled on its original motion to dismiss[2].

AbbVie's Motions to Dismiss

AbbVie moved to dismiss Alvotech's counterclaims and affirmative defenses of inequitable conduct, unclean hands, and patent misuse. Alvotech opposed this motion, and AbbVie filed a reply. The motion remains pending before the court[2].

Analysis of Legal Arguments

The court denied Alvotech hf.'s motion to dismiss under Rule 12(b)(1) for lack of subject matter jurisdiction, finding that the argument was more properly analyzed under Rule 12(b)(6). The court also rejected Alvotech hf.'s claim that the proper defendant was Alvotech USA, as the evidence suggested that Alvotech hf. was the entity responsible for the manufacture, commercialization, and sale of AVT02[5].

Strategic Implications

The litigation highlights the complex and strategic nature of patent disputes in the biologics industry. AbbVie's extensive patent portfolio and its litigation strategy aim to protect its market dominance for Humira. Alvotech's counterclaims and declaratory judgment action reflect its efforts to challenge AbbVie's patents and pave the way for market entry of its biosimilar, AVT02[1][2].

Key Takeaways

• Patent Disputes: The litigation centers around four key patents related to adalimumab formulations and treatment methods.
• Jurisdictional Issues: The case involves disputes over the proper jurisdiction and the correct defendant to be named.
• Inequitable Conduct: Alvotech alleges AbbVie engaged in inequitable conduct and unclean hands to maintain its patent monopoly.
• Strategic Litigation: Both parties employ strategic legal maneuvers to protect or challenge the patents.
• Market Impact: The outcome of this litigation could significantly impact the market entry of biosimilars and the pricing of biologic drugs.

FAQs

Q: What is the main issue in the AbbVie v. Alvotech hf. litigation? A: The main issue is the patent infringement dispute related to adalimumab, with AbbVie alleging that Alvotech's biosimilar infringes several of its patents.

Q: Why did Alvotech file a declaratory judgment action in the Eastern District of Virginia? A: Alvotech filed the action to seek a declaratory judgment of non-infringement and invalidity of AbbVie's patents and to challenge AbbVie's decision not to sue Alvotech USA.

Q: What are the four patents at the center of the dispute? A: The patents are US 8,420,081; US 9,085,619; US 8,926,975; and US 8,961,973, which pertain to various formulations and treatment methods using adalimumab.

Q: What is the significance of the "patent dance" in this litigation? A: The "patent dance" is a process under the BPCIA where the biosimilar applicant and the reference product sponsor identify the patents to be litigated, which in this case led to the identification of the four key patents.

Q: How has the court ruled on the jurisdictional disputes so far? A: The court has transferred Alvotech's declaratory judgment suit to the Northern District of Illinois and denied Alvotech hf.'s motion to dismiss under Rule 12(b)(1) for lack of subject matter jurisdiction.

Sources

1. Goodwin Law: Alvotech Files Suit Against AbbVie to Invalidate Humira Patent
2. Goodwin Law: Litigation Update: AbbVie v. Alvotech hf (Adalimumab)
3. JDSupra: Alvotech's E.D. Va. Declaratory Judgment Action Against AbbVie
4. GovInfo: AbbVie Inc. et al v. Alvotech hf.
5. Casetext: AbbVie Inc. v. Alvotech HF.

Last updated: 2025-01-17