Background
The litigation between Alvotech USA Inc. and AbbVie Inc. revolves around Alvotech's biosimilar version of AbbVie's blockbuster drug Humira (adalimumab). Here is a detailed summary and analysis of the key events and legal arguments in this case.
Filing of the Biosimilar Application
In September 2020, Alvotech USA filed a Biologics License Application (BLA) with the FDA for AVT02, a biosimilar of AbbVie's 100 mg/mL citrate-free Humira formulation[2][4].
AbbVie's Patent Infringement Suit
In March 2021, AbbVie filed a patent infringement lawsuit against Alvotech hf. (the Icelandic parent company of Alvotech USA) in the Northern District of Illinois (N.D. Ill.) under the Biosimilar Price Competition and Innovation Act (BPCIA). AbbVie alleged that Alvotech hf.'s filing of the BLA infringed 62 of AbbVie's patents related to Humira[2][4].
Alvotech's Declaratory Judgment Suit
On May 11, 2021, Alvotech USA and Alvotech hf. filed a complaint in the Eastern District of Virginia (E.D. Va.) seeking a declaratory judgment of non-infringement and invalidity of AbbVie's patents. Alvotech argued that AbbVie incorrectly sued Alvotech hf. instead of Alvotech USA, which was the actual BLA applicant. Alvotech also alleged that AbbVie's actions constituted misconduct aimed at avoiding litigation in the E.D. Va.[2][3].
Key Allegations by Alvotech
- Incorrect Defendant: Alvotech argued that AbbVie should have sued Alvotech USA, the entity that filed the BLA, rather than Alvotech hf.[2][4].
- Misconduct: Alvotech claimed that AbbVie's refusal to sue Alvotech USA was a deliberate strategy to avoid litigating in the E.D. Va. and to shield its patent portfolio from legal scrutiny[2].
- Patent Misuse: Alvotech alleged that AbbVie engaged in patent misuse by asserting a large number of "dubious patents" to deter competition and avoid legal scrutiny of its patents[2].
AbbVie's Motions
In June 2021, AbbVie moved to dismiss or transfer Alvotech's lawsuit in E.D. Va., arguing that it was duplicative of AbbVie's suit in N.D. Ill. AbbVie also claimed that the action should be dismissed or transferred under the first-to-file rule, or alternatively, for lack of personal jurisdiction, or transferred to Illinois[1][3].
Court Decision
On October 22, 2021, Judge Raymond A. Jackson of the E.D. Va. granted AbbVie's motion to transfer the case to the Northern District of Illinois and dismissed AbbVie's pending motion to dismiss as moot. Following this transfer, Alvotech voluntarily dismissed the case without prejudice on November 5, 2021[1][3].
Settlement and Licensing Agreement
In a subsequent development, AbbVie and Alvotech settled the case, with AbbVie granting Alvotech a non-exclusive license to all Humira-related patents in the United States, effective July 1, 2023. This settlement opened the door for more Humira biosimilars to be manufactured by other companies in the future[5].
Analysis
Jurisdiction and Venue
The dispute over the proper defendant and jurisdiction highlights the complexities of BPCIA litigation. Alvotech's argument that AbbVie should have sued Alvotech USA, which is domiciled in Virginia, was central to its claim of misconduct and improper venue. However, the court ultimately transferred the case to Illinois, aligning with AbbVie's motion[1][4].
Patent Strategy
AbbVie's strategy of asserting a large number of patents was a key point of contention. Alvotech alleged that this was a tactic to intimidate competitors and avoid legal scrutiny of the patents. This approach is often seen in biosimilar litigation, where the patent holder seeks to protect its market dominance through extensive patent portfolios[2].
Impact on Biosimilar Market
The settlement and licensing agreement have significant implications for the biosimilar market. By granting Alvotech a non-exclusive license, AbbVie has paved the way for other biosimilar manufacturers to enter the market, potentially increasing competition and reducing prices for Humira[5].
Key Takeaways
- Proper Defendant: The case highlights the importance of identifying the correct defendant in BPCIA litigation.
- Jurisdiction and Venue: The transfer of the case from E.D. Va. to N.D. Ill. underscores the complexities of venue selection in biosimilar disputes.
- Patent Strategy: The assertion of a large number of patents can be a powerful tool for patent holders but may also be challenged as misconduct.
- Settlement and Licensing: The settlement between AbbVie and Alvotech demonstrates how licensing agreements can facilitate market entry for biosimilars.
Frequently Asked Questions
1. What was the basis of Alvotech's declaratory judgment suit against AbbVie?
Alvotech filed a declaratory judgment suit alleging that AbbVie incorrectly sued Alvotech hf. instead of Alvotech USA, the actual BLA applicant, and that AbbVie's actions constituted misconduct to avoid litigation in the E.D. Va.[2].
2. Why did AbbVie file a patent infringement suit against Alvotech hf.?
AbbVie filed the suit alleging that Alvotech hf.'s filing of the BLA for AVT02 infringed 62 of AbbVie's patents related to Humira. AbbVie argued that Alvotech hf. was the entity responsible for the manufacture, commercialization, and sale of AVT02[2][4].
3. What was the outcome of the court decision regarding the transfer of the case?
The court granted AbbVie's motion to transfer the case from E.D. Va. to N.D. Ill. and dismissed AbbVie's pending motion to dismiss as moot[1][3].
4. What was the result of the settlement between AbbVie and Alvotech?
The settlement granted Alvotech a non-exclusive license to all Humira-related patents in the United States, effective July 1, 2023, allowing for the potential entry of more Humira biosimilars into the market[5].
5. How does this case impact the biosimilar market?
The settlement and licensing agreement open the door for increased competition in the biosimilar market, potentially reducing prices for Humira and allowing other biosimilar manufacturers to enter the market[5].
Sources:
- JDSupra: Alvotech's E.D. Va. Declaratory Judgment Action Against AbbVie Transferred to N.D. Ill.[1]
- Goodwin Law: Alvotech Files Suit Against AbbVie to Invalidate Humira Patent Portfolio[2]
- Fish & Richardson: Biosimilars 2021 Year in Review[3]
- Casetext: AbbVie Inc. v. Alvotech HF., 21 C 2258[4]
- BioSpace: Settlement Opens Doors for Biosimilars of Abbvie's Most Profitable Drug[5]
