AbbVie’s efforts to protect its megablockbuster Humira have been well documented and much maligned, and now New York’s largest grocery union is taking the drugmaker to task over its “patent thicket” and “market division” agreements.
New York’s UFCW Local 1500 Welfare Fund, which provides health and welfare benefits to nearly 23,000 plan participants, filed a proposed class action lawsuit against the drugmaker over its defense of Humira, which generated nearly $20 billion in sales last year.
UFCW Local 1500 says AbbVie “created and employed an exclusionary ‘patent thicket’—an unlawful scheme whereby it secured over 100 patents designed solely to insulate Humira from any biosimilar competition in the U.S. for years to come.” The company's efforts to protect the drug have violated antitrust and consumer protection laws, the union argues.
If not for the conduct, union members could have accessed cheaper copies of the drug as early as Jan. 1, 2017, the suit says. Humira's primary patent expired in December 2016. Including rebates, costs for the drug have grown to more than $38,000 per patient last year, up from $19,000 in 2012. But without rebates, prices can reach more than $50,000 per patient per year, according to the suit. Humira has generated more than $130 billion since launch, the union said.
The thicket has been effective, the suit notes. Rather than litigating 100 patents, biosim makers have chosen to ink agreements allowing for 2023 launch dates. Some of Humira’s patents stretch out to 2034, more than three decades after the drug launched.
As the plaintiffs point out, cheaper biosims have been available in Europe since last fall. U.S. patients are in effect “subsidizing” those lower prices in Europe, they argue.
AbbVie, for its part, believes that "patents are essential to encourage and protect the investment required to develop advances in healthcare," a company spokeswoman said, adding that Humira's patents “have repeatedly withstood challenges in legal proceedings.”
“Our patent settlements, which do not include any payments by AbbVie, balance protecting our investment in innovation with access to biosimilars 10 years before our last Humira patent expires, and the allegations in the lawsuit are without merit,” she said.
Many biosim makers are listed as co-defendants in the proposed lawsuit for the alleged “market division” agreements. AbbVie has struck 7 biosimilar patent settlements allowing for staggered rollouts throughout 2023. In a statement, a spokeswoman from Pfizer, which struck one of those settlements, said the company believes the lawsuit is “without merit.”
"Pfizer stands by the lawfulness of its patent settlement with AbbVie, which will allow Pfizer’s lower cost alternative adalimumab biosimilar to enter well before expiration of the patents AbbVie asserted against Pfizer, thereby offering patients expanded access sooner," she added.
Humira was one drug in focus last month when pharma execs, including AbbVie CEO Richard Gonzalez, testified about prices before Congress. While Gonzalez acknowledged the biosim deals may not be “popular,” he said AbbVie sought to strike a “reasonable balance” with the moves.
If the union’s arguments sound familiar, that’s because Boehringer Ingelheim is pushing many of the same points in its own legal fight with AbbVie. The company won FDA approval for its Humira biosimilar Cytelzo in 2017 but hasn’t yet been able to launch. The company is asking a court to toss AbbVie’s patent infringement lawsuit by arguing AbbVie acted inequitably by pursing so many overlapping and non-inventive patents.
UFCW Local 1500’s proposed suit says Boehringer’s “litigation has no resolution in sight, just as AbbVie intended through the creation of its patent thicket.”
In the Boehringer case, the sides have been stuck fighting over which documents are relevant to the case. Recently, Boehringer scored a win when the judge told AbbVie to hand over documents it sought to protect, and AbbVie secured a favorable ruling when the judge ruled Boehringer must release its biosimilar launch plans.