Class Action Lawsuit Filed Against AbbVie, Biosimilar Manufacturers

A class action lawsuit has been filed by United Food and Commercial Workers Local 1500 (UFCW Local 1500) against AbbVie for alleged use of a patent thicket to maintain a monopoly for its brand-name adalimumab, Humira. The complaint also alleges that AbbVie and a number of its biosimilar competitors colluded to divide the market for adalimumab between Europe and the United States.

The lawsuit, brought on behalf of UFCW Local 1500, the largest grocery-worker union in New York State, and filed in the US District Court for the Northern District of Illinois, claims that UFCW Local 1500’s membership and others who are similarly situated paid artificially high prices for brand-name Humira, and that they were deprived of the benefits of early, robust competition from biosimilars as a result of wrongful conduct.

The complaint alleges that AbbVie’s patent estate for Humira is “designed solely to insulate Humira from any biosimilar competition in the US for years to come,” and that the company secured patents, many of them overlapping and noninventive, in advance of the expiry of its primary patent in 2016 as a means by which to ensure that protracted litigation would prevent a US biosimilar launch.

The suit also alleges that AbbVie entered into illegal market-division agreements with biosimilar developers Amgen, Samsung Bioepis, Mylan, Sandoz, Fresenius Kabi, Pfizer, and Momenta, all of whom are named as codefendants in the suit. Each of the biosimilar developers named has entered into its own settlement with AbbVie that does not allow for US marketing of a biosimilar adalimumab product prior to 2023, though the biosimilar developers’ products were eligible to be launched as early as October 2018 in the European market. According to the suit, “AbbVie has cooked up a monopoly scheme that has US patients paying higher monopoly prices while patients in Europe benefit from competition.”

Gregory Asciolla, cochair of the antitrust and competition litigation practice at Labaton Sucharow, which is representing UFCW Local 1500 in the suit, said in a statement that “AbbVie has used its patents as leverage with the other drug manufacturers to delay their entry into the US market. With this lawsuit, AbbVie will have to open the doors to competition and compensate those who have paid exorbitant prices for their medication. AbbVie’s unlawful scheme to keep out biosimilar competition has cost the healthcare system billions of dollars.”

In an email to The Center for Biosimilars^®, a representative of Pfizer said the company "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. We believe the lawsuit is without merit and that there are multiple grounds supporting dismissal of the plaintiffs' claims."

The lawsuit’s filing comes amid renewed questions about AbbVie’s use of its patents in the US context. In a February 2019 hearing before the US Senate Committee on Finance, AbbVie’s chief executive officer, Richard Gonzalez, faced questions from lawmakers about AbbVie’s intellectual property strategy related to Humira, and responded that AbbVie’s portfolio of patents evolved as the company discovered Humira’s applications in various disease states. Given its broad range of therapeutic applications, “Humira is like 9 different drugs,” he said.

Gonzalez also called the settlements struck with biosimilar developers a “reasonable balance” that will allow for market entry after patents on adalimumab expire. “We don’t block any biosimilars…. We’ve given license to every biosimilar player but 1,” Gonzalez told senators.

This article was originally published by The Center for Biosimilars.