Updated: October 2020

UFCW Local 1500 Welfare Fund v. AbbVie, Inc.

The maker of Humira, the world's best-selling drug, faces a legal challenge over alleged anticompetitive tactics (UFCW Local 1500 Welfare Fund v. AbbVie, Inc.). On Oct. 12, 2020, Consumer Action and the U.S. Public Interest Research Group (U.S. PIRG) filed an amicus brief in the 7th Circuit Court of Appeals arguing that AbbVie’s strategies to reverse payment settlements and create “patent thickets” have delayed the entry of biologically similar generic drugs (biosimilars) onto the market, costing Americans billions of dollars. AbbVie first started selling Humira in 2002.

The groups are concerned about the growing number of strategies used by major pharmaceutical companies to increase the cost of generic and biosimilar drugs. The availability of generic and biosimilar drugs increases competition and sharply lowers the cost of prescription drugs for consumers.

The brief argues that the appeals court should overturn the district court’s decision to dismiss the case, stating in part: “As the records demonstrate, most of Humira’s U.S. patents were set to expire in 2016, but AbbVie engaged in a patent thicket strategy that allowed the company to prolong its Humira monopoly for years beyond what Congress intended. And while biosimilar manufacturers challenged AbbVie’s patent estate, they all eventually agreed to delay their entry into the U.S. market until 2023 in exchange for entering the European market much sooner. ”Reverse payment settlements, or “pay-for-delay,” occur when the patent-holding manufacturer pays a settlement to a company to keep it from selling a competing biosimilar for a period of time. This delay allows the brand manufacturer to retain its exclusivity in the marketplace. Patent holders sometimes create “patent thickets” by continuing to create multiple overlapping patents on the original drug which are difficult to challenge in court. These tactics work to extend the patent for the drug beyond the expected timeframe, reducing any benefits for consumers who would have saved money by substituting a generic for Humira.

The brief supporting UFCW Local 1500 Welfare Fund v. AbbVie, Inc. alleges that these anticompetitive practices have allowed Humira’s price to rise in the United States. The list price of the drug, which is primarily used to treat rheumatoid arthritis, more than tripled from 2006 to 2017, and is even higher now at $72,000 for a one-year supply. Yet in Europe, where biosimilars are competing without barriers, AbbVie’s branded Humira is discounted as much as 80 percent.