Abbvie and Adalimumab Biosimilar Manufacturers Face Class-Action Lawsuit Alleging Antitrust Violations Related to Patent Protection of Humira®

On March 18, 2019, UFCW Local 1500 Welfare Fund, a New-York based grocery union, filed a putative class-action lawsuit against AbbVie and seven adalimumab biosimilar manufacturers alleging misconduct and antitrust violations in connection with AbbVie’s assertion of patents to prevent the sale of biosimilar versions of Humira® in the United States.

The complaint alleges that although the “primary patent for Humira expired” in 2016, Abbvie has applied for hundreds of patents since the original development of Humira, and has used “an unlawful scheme whereby it secured over 100 patents designed solely to insulate Humira from any biosimilar competition in the U.S.”  The complaint further alleges that “AbbVie has abused the patent system” by “collecting dozens and dozens of patents, many of which are overlapping and non-inventive,” such that “biosimilar manufacturers must either engage in years of protracted, expensive patent litigation as they cut their way through AbbVie’s” patents, “or else settle the litigation under terms that significantly delay the launch of their FDA-approved biosimilar products.”

The complaint also names seven biosimilar manufacturers that have “opted to settle” with AbbVie, including Amgen Inc., Samsung Bioepis Co., Mylan Inc., Sandoz Inc., Fresenius Kabi USA, LLC, Pfizer Inc., and Momenta Pharmaceuticals, Inc.  According to the complaint, these companies and AbbVie have “illegally allocated the market for adalimumab,” such that “AbbVie has maintained its adalimumab monopoly in the U.S. market and continues to charge inflated prices… while allowing biosimilars to sell in the European market, where drug prices—and hence profits—are generally much lower.”

The complaint also notes the ongoing litigation between Abbvie and Boehringer Ingelheim concerning Boehringer’s adalimumab biosimilar Cyltezo®, which has received FDA approval.  As we have reported previously, in defending against Abbvie’s allegations of patent infringement, Boehringer has mounted an “unclean hands” defense, alleging that Abbvie improperly used “overlapping and non-inventive patents” to impede competition.

The plaintiffs brought the lawsuit “on behalf of itself and all others similarly situated,” including persons or entities who have purchased or paid for Humira from AbbVie in the United States since January 1, 2017.  The complaint alleges that members of the class paid inflated prices for Humira® as a result of AbbVie’s misconduct.  The plaintiffs are seeking monetary damages as well as injunctions prohibiting defendants “from continuing their unlawful market division agreements.”

Download PDF