Drug maker AbbVie is facing federal antitrust lawsuits accusing it of using patents to stifle competition and boost the price of its drug, Humira.
The United Food and Commercial Workers International Union Local 1500 Welfare Fund filed a federal class action against North Chicago-based AbbVie Monday in Chicago, and a similar complaint followed Wednesday from the Fraternal Order of Police, Miami Lodge 20, Insurance Trust Fund.
At issue are patents for the drug Humira, an anti-inflammatory used to treat conditions like rheumatoid arthritis, plaque psoriasis, ulcerative colitis and Crohn’s disease.
In addition to AbbVie, UFCW named as defendants Amgen, Samsung Bioepis, Mylan Pharmaceuticals, Sandoz, Fresenius Kabi USA, Pfizer and Momenta Pharmaceuticals. Amgen also is a named defendant in the Miami FOP action.
According to the complaints, Humira is the best-selling drug in the world, with more than $130 billion in total sales since being introduced more than 15 years ago, and nearly $20 billion in 2018 alone, worth 61 percent of AbbVie’s global revenues. The plaintiffs said Humira cost patients $19,000 per year in 2012 and more than $38,000 in 2018 after rebates, with a list price of nearly $50,000 per year.
Although eight companies have developed generic versions, three of which earned U.S. Food and Drug Administration approval, “AbbVie has successfully prevented all (generics) from launching in the U.S. market through widespread anticompetitive conduct that has allowed it to maintain its monopoly and supracompetitive prices,” according to UFCW.
The plaintiffs say AbbVie used a “patent thicket” by unlawfully securing more than 100 patents specifically preventing generic versions of Humira from entering the U.S. market. UFCW accused the other named defendants of participating in illegal market division agreements to keep generics out of American pharmacies until at least 2023, although generics are already available in Europe.
“This trade-off meant that the lower price for Humira in Europe was subsidized by the much higher price in the United States where AbbVie unlawfully maintained its monopoly,” the UFCW said.
The Miami FOP said the vast majority of the patents in question were issued in 2014, although Humira had already been on the market for 12 years at that point.
“Many of AbbVie’s patents have clear deficiencies,” the union said. “For example, some of AbbVie’s patents have been invalidated by the U.S. Patent and Trademark Office. But the patents served AbbVie’s purpose: creating a thicket so dense that competitors would have to engage in costly and time-consuming litigation over dozens upon dozens of patents before they could launch competing products.”
The FOP singled out Amgen — the first to get FDA approval for a Humira generic — by accusing it of agreeing to drop patent challenges and keep its product off shelves until January 2023 in exchange for AbbVie giving it de facto exclusivity for five months. UFCW said Bioepsis can introduce its product in June 2023, and by that November, the other five companies will have theirs on the market. It also said Boehringer Ingelheim International is the only drug maker carrying forward independent litigation in an attempt to fairly launch its generic version of Humira.
In addition to class and subclass certification and jury trials, the plaintiffs want a court to force the companies to end the market division agreements, to disgorge profits and mandate restitution through a constructive trust and award damages where applicable, including punitive damages.
Representing UFCW in the matter is Freed Kanner London & Millen LLC, of Bannockburn; Labaton Sucharow LLP, of New York; and Fine, Kaplan and Black RPC, of Philadelphia.
Representing the Miami FOP are Hagens Berman Sobol Shapiro LLP, of Chicago, Seattle and Cambridge, Mass.; Girard Sharp LLP, of San Francisco; and Shepherd, Finkelman, Miller & Shah LLP, of Fort Lauderdale, Fla.