AbbVie Suppressed Competition for Humira Biosimilars Antitrust Class Action

Humira is the best-selling drug in the US, which means significant profits for its makers AbbVie, Inc. and AbbVie Biotechnology, Ltd. The complaint for this class action alleges that the companies have sought to keep their monopoly on the drug by unfair methods, even after its patent has expired, by bogus patents and deals with would-be competitors. 

Two classes have been defined for this action.

  • The Injunctive Class is all entities in the US, including Puerto Rico, who indirectly bought or provided reimbursement for Humira, other than for resale, between December 31, 2016 and the present.
  • The Damages Class is all entities who indirectly bought or provided reimbursement for Humira, other than for resale, between December 31, 2016 and the present, in Arizona, California, Connecticut, the District of Columbia, Florida, Georgia, Hawaii, Illinois, Iowa, Kansas, Maine, Maryland, Michigan, Minnesota, Mississippi, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Carolina, North Dakota, Oregon, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, Vermont, West Virginia, and Wisconsin, for use by their members, employees, insureds, participants, or beneficiaries.

Humira brings its makers more than $13.6 billion in US sales and almost $20 billion around the world. The patent on Humira expired in 2016, which means that any company can begin the process of putting out a biosimilar version of Humira. This would cause brand sales to fall, as biosimilars offered lower prices, and more competitors would cause prices to fall even further.

However, Humira currently earn about half of AbbVie’s revenues, and none of the drugs it has in its pipeline are ready to bring to market yet. The complaint alleges that AbbVie therefore decided to take two measures. 

First, it “created a virtually impenetrable thick” of patents: “AbbVie now has filed more than 240 patent applications and obtained well over 100 patents ostensibly covering Humira.” These expire much later than the original Humira patent, giving the drug additional years of protection. The complaint contends they are not all valid and that some have already been invalidated. Still, it can tie up competitors in litigation for a long time. 

Second, AbbVie has entered into deals with competitors to delay their entry into the market. One of them, Amgen, Inc., even received FDA approval for a biosimilar. AbbVie offered to give it a period of exclusivity, the complaint says: Amgen agreed to drop its challenges to AbbVie’s patents and not to launch its biosimilar product until January 2023, then AbbVie made deals with other companies to keep them out of the market for five months after Amgen’s entry. 

The complaint says that without this “unlawful scheme and monopolization of the market” and without the “patent thicket,” competition would have begun in 2016. This means that, since then, consumers have had to pay higher prices for the drug than they would have in a competitive market. 

The complaint brings suit under the Sherman Act, and under state laws forbidding pay-for-delay agreements, monopolization, and unfair conduct.

Article Type: Lawsuit
Topic: Antitrust

Most Recent Case Event

AbbVie Suppressed Competition for Humira Biosimilars Antitrust Complaint

April 9, 2019

Humira is the best-selling drug in the US, which means significant profits for its makers AbbVie, Inc. and AbbVie Biotechnology, Ltd. The complaint for this class action alleges that the companies sought to keep their monopoly on the drug by unfair methods, even after its patent has expired, by bogus patents and deals with would-be competitors. The complaint brings suit under the Sherman Act, and under state laws forbidding pay-for-delay agreements, monopolization, and unfair conduct.

abbvie_humira_anticompetitive_behavior_compl.pdf

Case Event History

AbbVie Suppressed Competition for Humira Biosimilars Antitrust Complaint

April 9, 2019

Humira is the best-selling drug in the US, which means significant profits for its makers AbbVie, Inc. and AbbVie Biotechnology, Ltd. The complaint for this class action alleges that the companies sought to keep their monopoly on the drug by unfair methods, even after its patent has expired, by bogus patents and deals with would-be competitors. The complaint brings suit under the Sherman Act, and under state laws forbidding pay-for-delay agreements, monopolization, and unfair conduct.

abbvie_humira_anticompetitive_behavior_compl.pdf
Tags: Antitrust, Pharmaceuticals