Humira manufacturer’s efforts to block generic options challenged in court

U.S. PIRG files amicus brief trying to allow cheaper versions of world’s best-selling drug

U.S. PIRG

CHICAGO — The maker of Humira, the world’s best-selling drug, faces a new legal challenge over alleged anticompetitive tactics. Monday, 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 of reverse payment settlements and creating “patent thickets” have delayed the entry of biologically similar generic drugs (biosimilars) onto the market, costing Americans billions of dollars. 

“The decision in this case is critical to putting an end to illegal abuses of our patent system so that patients can get the medication they need without emptying their bank accounts,” said Patricia Kelmar, U.S. PIRG’s Health Care Campaigns Director. “Other brand name drug manufacturers are hovering about, hoping they too can get away with anticompetitive patent tricks that keep lower cost biosimilars out of the market and out of the hands of hard-working Americans.”    

Reverse payment settlements, also known as pay-for-delay, occur when the patent-holding manufacturer pays a settlement to a company to refrain 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 and work to  extend the patent for the drug beyond the expected timeframe. 

The brief supporting UFCW Local 1500 Welfare Fund v. AbbVie, Inc. alleges that these anticompetitive practices have kept Humira’s price rising 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. 

AbbVie first started selling Humira in 2002, and the brief states:

“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.”

The brief, joined by Consumer Action, argues that the appeals court should overturn the district court’s decision to dismiss the case.