The United Food and Commercial Workers Local 1500 (UFCW Local 1500) filed a class action lawsuit against AbbVie for allegedly using a group of patents to maintain a monopoly on its blockbuster Humira (adalimumab). The lawsuit also alleges that AbbVie and several of its biosimilar competitors colluded to split the Humira market between the U.S. and Europe.
UFCW Local 1500 is the largest grocery-worker union in New York State. The lawsuit was filed in U.S. District Court for the Northern District of Illinois.
The suit argues that the union membership and others in similar situations paid artificially high prices for the branded version of Humira, which deprived them of the benefits of significant competition from biosimilars.
The complaint states, in part, that AbbVie’s patents are “designed solely to insulate Humira from any biosimilar competition in the U.S. for years to come.” It also argues that many of the patents are overlapping and noninventive and were filed as a way to prevent U.S. biosimilar competition by forcing protracted litigation.
The lawsuit also claims that AbbVie entered into “illegal market-division agreements,” according to The Center for Biosimilars, and seven other drug manufacturers are co-defendants in the case. They are Amgen, Samsung Bioepis, Mylan, Sandoz, Fresenius Kabi, Pfizer, and Momenta.
The suit claims, “AbbVie has cooked up a monopoly scheme that has U.S. patients paying higher monopoly prices while patients in Europe benefit from competition.”
AbbVie holds approximately 136 patents for Humira. Because of a variety of deals and what the lawsuit dubs a “patent thicket,” the first biosimilar competitor won’t hit the U.S. market until 2023, which will be 20 years after the drug first launched. Humira, an anti-inflammatory used to treat rheumatoid arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, psoriatic arthritis, hidradenitis suppurativa, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis and non-infectious intermediate, posterior, and panuveitis, has raked in about $130 billion since it launched in 2003.
Not content to just fight for the union workers, the lawsuit cites the entire U.S. healthcare system, stating, “AbbVie’s scheme to keep out biosimilar competition has cost the U.S. healthcare system billions of dollars. For example, Wells Fargo analyst Davis Maris calculated that AbbVie’s 9.7 percent price hike on Humira in 2018 cost the country’s healthcare system approximately $1.2 billion.”
Amgen, Bioepsis, Mylan and Pfizer have previously settled patent disputes with AbbVie over Humira. The complaint argues these settlements were “illegal market division agreements.”
In Europe, where biosimilars have a higher penetration than in the U.S., there is biosimilar competition for Humira, with the lawsuit claiming that the lower prices in the European Union have been subsidized by the higher prices in the U.S. The suit alleges that annual costs for patient on the drug increased from $19,000 in 2012 to more than $38,000 with rebates in 2018 and before rebates, about $50,000.
Although AbbVie has not responded to Modern Healthcare’s request for comment, Pfizer stated it 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.”
Apparently, the use of the phrase “patent thickets” has the biopharma industry on edge. As Modern Healthcare notes, a biopharma intellectual property (IP) expert told them “he is concerned that lawmakers are using the term too loosely without broader context for how multiple patents protect a company’s significant changes to a drug.”
At the February 2019 U.S. Senate Finance Committee hearing with biopharma executives, AbbVie’s chief executive officer Richard Gonazalez responded to lawmakers about the company’s IP strategy concerning Humira, and he indicated that its Humira patents evolved as the company discovered new applications in various disease states, saying, “Humira is like nine different drugs.” He also argued that the settlements with biosimilar developers was a “reasonable balance” that allows for market entry after Humira patents expire. “We don’t block any biosimilars,” he told the senators. “We’ve given license to every biosimilar player but one.”
It will be interesting to see if this class action lawsuit gains traction. It will also be interesting to see if it opens a floodgate of similar class action lawsuits by unions and other healthcare consumers looking for a piece of the action.