AbbVie reaps billions of dollars annually from its big-selling immunology medicine Humira, and, under deals with biosimilar makers, the drug is likely free from U.S. competition until 2023. A class of purchasers had sued over the company's defense strategy—including its so-called "patent thicket"—but a judge has now sided with AbbVie.
While AbbVie’s deals with biosimilar companies preserve high prices in the U.S. for several years, the company's strategy doesn't amount to an antitrust violation, U.S. District Judge Manish Shah wrote in an order Monday.
As AbbVie’s initial patent on Humira approached expiration, the company applied for dozens of follow-up patents. The plaintiffs—among them the City of Baltimore, an insurance trust fund for Miami police officers and a benefit plan for pipe trade workers in Minnesota—alleged AbbVie illegally blocked competition for Humira by obtaining a “patent thicket" and deploying it on would-be competitors.
With that thicket, the company sued companies seeking to market biosimilars and then inked deals to keep competing products off the U.S. market until 2023. As part of those deals, AbbVie gave biosim companies permission to launch in Europe despite existing patents there, the plaintiffs alleged.
But after hearing arguments from both sides, the judge found the company’s strategy to be legal.
“AbbVie has exploited advantages conferred on it through lawful practices and to the extent this has kept prices high for Humira, existing antitrust doctrine does not prohibit it,” he wrote in an order dismissing the lawsuit.
The plaintiffs outlined a “disparate set of aggressive but mostly protected actions” that “even when considered broadly and together for their potential to restrain trade—fall short of alleging the kind of competitive harm remedied by antitrust law,” the judge added.
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Back in 2017, AbbVie began inking a series of patent settlements with biosimilar companies allowing them to launch U.S. Humira copycats in 2023. Already, biosims are chipping away at the company’s market share in Europe. In 2019, the first full year after European biosimilars launched, the company’s international sales for the drug fell by 28% to $4.3 billion.
As AbbVie struck more and more biosimilar patent settlements, scrutiny increased. At a congressional hearing last year on drug pricing, Sen. Debbie Stabenow, D-Michigan, asked AbbVie CEO Richard Gonzalez why prices remained high in the U.S. while European patients had access to cheaper biosimilars.
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Gonzalez responded that he believed AbbVie had struck a “reasonable balance” with the deals, although he knew they might not be “popular.” The company’s first patent expiration comes in 2022, and biosims will launch less than a year later, he said.
But AbbVie knows U.S. competition to Humira is eventually coming, and last year it snagged a $63 billion buyout of Botox maker Allergan. The deal closed last month. Meanwhile, the company is also marketing Humira follow-ups Rinvoq and Skyrizi.