Background of the Case
The In Re: Humira (Adalimumab) Antitrust Litigation (Case No. 1:19-cv-01873) is a significant antitrust case that involves AbbVie Inc., the manufacturer of Humira (adalimumab), a monoclonal antibody used to treat various inflammatory conditions, including rheumatoid arthritis. Humira is the world's best-selling prescription drug, generating $19.7 billion in revenue in 2019 alone[2][4].
Plaintiffs and Their Allegations
The plaintiffs in this case are two classes of indirect purchasers of Humira, including union benefit funds, health insurers, and local governments. They filed a class-action lawsuit against AbbVie, alleging violations of Sections 1 and 2 of the Sherman Antitrust Act.
Monopolization Claims (Section 2)
The plaintiffs argued that AbbVie engaged in anticompetitive conduct by creating a "patent thicket" – a strategy involving the aggressive pursuit and assertion of numerous patents to block competitors from entering the market. This allegedly delayed or foreclosed the entry of biosimilar products, thereby maintaining AbbVie's monopoly over the U.S. market for adalimumab[1][4].
Conspiracy and Restraint of Trade Claims (Section 1)
The plaintiffs also alleged that AbbVie entered into settlement agreements with biosimilar manufacturers (Amgen, Samsung Bioepis, and Sandoz) that constituted an unlawful "pay-for-delay" scheme and geographic market allocation. These agreements allowed the biosimilar companies to sell their products in Europe in 2018 but prohibited them from entering the U.S. market until January 2023[1][4].
Court Decision
On June 10, 2020, Judge Manish Shah of the United States District Court for the Northern District of Illinois granted AbbVie's motion to dismiss the plaintiffs' claims.
Noerr-Pennington Doctrine
The court applied the Noerr-Pennington doctrine, which grants First Amendment protection against antitrust liability for good-faith petitioning of government entities, including the pursuit and assertion of patents. The court found that AbbVie's patent petitions and litigation were not objectively baseless and therefore immunized from antitrust scrutiny[1][4].
Lack of Reverse Payments
The court rejected the plaintiffs' claims of a "pay-for-delay" scheme because the settlement agreements did not involve reverse payments, which are cash payments from the brand-name drug manufacturer to the generic or biosimilar manufacturer to delay market entry. The agreements allowed biosimilar entry into both European and U.S. markets before the expiration of AbbVie's last-expiring patents, which did not trigger antitrust scrutiny under the Supreme Court's FTC v. Actavis decision[1][4].
No Antitrust Injury
The court also held that the plaintiffs failed to plead an actionable antitrust injury. The plaintiffs could not demonstrate that AbbVie's conduct caused harm to consumers or that competitors could have entered the market and lowered prices any sooner than the dates set in the settlement agreements[1][4].
Analysis and Implications
Interplay Between Antitrust and Patent Law
The case highlights the complex interplay between antitrust law and patent law. The decision suggests that patent "evergreening" practices, such as those alleged by the plaintiffs, may still be available to innovators seeking to extend their patent terms and maintain market dominance[4].
Consumer Welfare Standard
The consumer welfare standard, a key criterion in antitrust claims, was not met in this case. The plaintiffs could not show that AbbVie's conduct resulted in higher prices for consumers or other harm to consumer welfare[2].
Market Impact
The decision allows AbbVie to continue its dominance in the U.S. market for adalimumab, enabling the company to maintain high prices for Humira. This has significant implications for the biologics industry, as it sets a precedent for how patent strategies and settlement agreements can be used to delay competition[2][4].
Key Takeaways
- Patent Thicket Strategy: AbbVie's aggressive pursuit of patents was protected under the Noerr-Pennington doctrine.
- Settlement Agreements: The court found that the settlement agreements did not constitute reverse payments or unlawful geographic market allocation.
- Lack of Antitrust Injury: Plaintiffs failed to demonstrate actionable antitrust injury to consumers.
- Interplay Between Antitrust and Patent Law: The decision clarifies the application of antitrust law in the context of patent strategies.
- Consumer Welfare: The case underscores the importance of the consumer welfare standard in antitrust claims.
FAQs
Q: What is the main drug at the center of the In Re: Humira (Adalimumab) Antitrust Litigation?
A: The main drug is Humira (adalimumab), a monoclonal antibody used to treat various inflammatory conditions.
Q: What were the primary allegations made by the plaintiffs against AbbVie?
A: The plaintiffs alleged that AbbVie created a "patent thicket" to block competitors and entered into settlement agreements that constituted an unlawful "pay-for-delay" scheme and geographic market allocation.
Q: What doctrine protected AbbVie's patent petitions and litigation from antitrust scrutiny?
A: The Noerr-Pennington doctrine granted First Amendment protection for good-faith petitioning of government entities, including the pursuit and assertion of patents.
Q: Why did the court reject the "pay-for-delay" claims?
A: The court rejected these claims because the settlement agreements did not involve reverse payments and allowed biosimilar entry into both European and U.S. markets before the expiration of AbbVie's last-expiring patents.
Q: What was the outcome of the case regarding antitrust injury to consumers?
A: The court found that the plaintiffs failed to demonstrate an actionable antitrust injury to consumers, as they could not show that competitors could have entered the market and lowered prices any sooner than the dates set in the settlement agreements.
Sources
- Northern District Of Illinois Dismisses Antitrust Claims Relating To Worlds Most Profitable Drug - A&O Shearman Antitrust Blog
- AbbVie Wins First Round in Humira Antitrust Lawsuit - Bill of Health, Harvard Law School
- In re Humira (Adalimumab) Antitrust Litigation - A&O Shearman Antitrust Blog
- Unqualified Antitrust Immunity: the In re Humira Decision - Wolf Greenfield
- Case: 1:19-cv-01873 Document #: 124 Filed - Kramer Levin Naftalis & Frankel LLP
