AbbVie’s Humira protection strategy has made headlines almost daily as critics multiply—and so do legal threats. More plaintiffs are piling into court claiming the company illegally quashed competition with a "patent thicket" and a “pay-for-delay" deal.
Since a grocery workers’ union in New York filed its lawsuit March 18, several other organizations have joined the fight. Police officers in Miami, the mayor and city council in Baltimore, plus groups representing pipefitters and electrical workers in Minnesota have filed class actions with similar complaints, according to court filings. A union representing heavy machine operators in New York also sued.
The lawsuits allege AbbVie blocked competition to Humira by creating a “patent thicket” that effectively prevents biosimilar makers from reaching the market. Backed by the “thicket,” the company sued biosim makers and settled on 2023 launch dates, delaying the entry of low-cost copycats. Humira’s main patent expired in 2016.
The recent lawsuits also list Amgen as a defendant. In those cases, plaintiffs say Amgen will get a payout by being the first to reach a settlement with AbbVie. Under its settlement, Amgen can launch its biosimilar in January 2023, while other competitors won’t hit the market until June that year at the earliest.
An AbbVie representative said the allegations are "factually inaccurate and legally baseless."
"AbbVie’s settlement agreements resolved complex intellectual property issues and provide biosimilar access more than 10 years before our last Humira patent expires," she added. "They do not involve any payments or other incentives from AbbVie to induce resolution."
A spokeswoman for Amgen said the company is "reviewing the complaints and will vigorously defend our actions."
She said the company's settlement was "procompetitive and not anticompetitive because it allows Amgen’s product to come to the US market years before the expiration of all of AbbVie’s asserted patents." Amgen will pay a royalty to AbbVie under the deal, she added. AbbVie won't pay Amgen.
At a recent Congressional hearing, AbbVie CEO Richard Gonzalez acknowledged the biosim deals may not be “popular,” but he said AbbVie sought to strike a “reasonable balance” with the moves. Some of Humira’s patents don’t expire until long after 2023, he pointed out.
One biosim maker has opted not to settle. Boehringer Ingelheim has leveled similar allegations in court, alleging AbbVie pursued overlapping and non-inventive patents to protect Humira.
Meanwhile, in Europe, biosims have already rolled. There, they’re hurting AbbVie’s pricing power and stealing market share. In fact, a publication in the Netherlands recently reported that the company is aggressively discounting there in order to keep business. Some biosim companies have pulled back from the market in response, according to the report.
AbbVie’s Humira is the world’s best-selling drug, generating nearly $20 billion last year. The company hopes it can protect sales for the med in the coming years as its new launches pick up steam. Skyrizi, a new immunology med, recently won its first global approval in Japan. AbbVie is also counting on upadacitinib to post strong sales growth upon a launch, expected this year.