Six Lawsuits Target AbbVie’s Humira and its Patent Thicket

Regulatory NewsRegulatory News | 02 April 2019 |  By 

The city of Baltimore, the largest grocery-worker union in New York and at least four other health plans have filed lawsuits against AbbVie over the past several weeks, alleging the Chicago-based company’s blockbuster Humira (adalimumab) should already have biosimilar competition in the US.

One of the lawsuits, brought on by UFCW Local 1500 Welfare Fund, the New York grocery-worker union, argues that AbbVie should be held accountable for its thicket of patents and recent deals to allow Humira biosimilars to launch in Europe, but not in the US.

“Had AbbVie not engaged in anticompetitive conduct, the plaintiffs would have been able to purchase Humira biosimilars in the U.S. as early as January 1, 2017, the expiration of Humira’s primary patent, at significantly lower prices,” Labaton Sucharow LLP said, after filing a class action lawsuit on the fund’s behalf.

The suit also alleges that AbbVie used its patents to enter into agreements with eight other drug companies “in a concerted effort to delay biosimilar entry in the U.S. until at least 2023,” while permitting entry of biosimilar versions of Humira in Europe this year. These agreements operated as an “anticompetitive scheme to restrain competition in the market for Humira.”


Similarly, Baltimore’s suit (from which the chart above is contained) claims that AbbVie’s anticompetitive conduct began as early as 2012 in the form of a citizen petition to stall biosimilar competition. AbbVie executives have also made clear their intentions to use the more than 100 patents to deter competition.

AbbVie’s EVP of finance and administration Bill Chase said at the Goldman Sachs Healthcare Conference in 2014: “The bulk of that IP strategy, although there’s a lot of strategies in there, is designed to make it more difficult for a biosimilar to follow behind you and come up with a very, very similar biosimilar.”

AbbVie amassed this patent thicket, according to Baltimore’s suit, by filing continuation applications for certain patents. “The continuation applications are substantially similar to the parent applications with minor variations, and timed to maintain original application’s priority date and seek even more duplicative patents,” the suit says.

But was AbbVie illegally gaming the patent system, or merely using the system to its advantage?

Michael Carrier, distinguished professor at Rutgers Law School, told Focus: “Typically, it’s not an antitrust violation to obtain a patent. But what about 100? And when the patents seem to be obtained just to keep competitors off the market?

“Patents are supposed to promote innovation, and in doing so, they often harm competitors. But can the plaintiffs here show that the patents AbbVie obtained after the patent on the active ingredient expired had nothing to do with innovation and everything to do with harming competitors? That’s an important part of their case,” he said.

The other lawsuits were filed by the Fraternal Order of Police, Miami Lodge 20; Trades Services MN Welfare Fund; St. Paul Electrical Workers' Health Plan and the Welfare Plan of the International Union of Operating Engineers Locals 137, 137A, 137B, 137C, and 137R. All the lawsuits were filed in the US District Court for the Northern District of Illinois.


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