Consumer groups file brief objecting to AbbVie’s strategies to withhold generic drugs

Attempts to extend patent on best-selling drug Humira at issue

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Source: Consumer Action and U.S. PIRG

The maker of Humira, the world's best-selling drug, faces a new legal challenge over alleged anticompetitive tactics. On Oct. 12, 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 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. AbbVie first started selling Humira in 2002.

The groups are concerned at 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.

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.”

“Consumers are harmed greatly by these anticompetitive tactics,” said Linda Sherry, Consumer Action’s director of national priorities. “And it is not only consumers who are harmed—the U.S. government and taxpayers are forced to overpay by billions of dollars. Some consumer are even locked out by high prices of the drugs they need when generics and biosimilars are withheld from the market.”

“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, 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 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 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%.

 

 

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