Gilead and Others HIV Drug Anticompetitive Agreements Class Action

Anticompetitive efforts in the field of pharmaceuticals have become more sophisticated in recent years. This antitrust class action concerns combination antiretroviral therapy (cART) regimen drugs used by patients with human immunodeficiency virus (HIV), a condition that can lead to Acquired Immunodeficiency Syndrome (AIDS) and death. The complaint alleges that a number of companies have conspired to maintain a monopoly in the market for cART regimen drugs by extending patent protection, delaying the entry of generics, and charging “anticompetitive prices” for the drugs.

The class for this action is all persons in the US and its territories who directly purchased cART regimen drugs from May 14, 2015 until the anticompetitive effects of the defendants’ conduct ends.

The many defendants who are accused of participating in the conspiracy in this case include Gilead Sciences, Inc., Gilead Holdings, LLC, Gilead Sciences, LLC, Gilead Sciences Ireland UC (here jointly called Gilead), Bristol-Myers Squibb Company, E.R. Squibb & Sons, LLC (here jointly called BMS), Japan Tobacco, Inc., Janssen R&D Ireland, and Johnson & Johnson, Inc. 

The cART regimens involve a “cocktail” of drugs taken in combination. A principal ingredient in such regimens is the drug Tenofovir, discovered some thirty years ago and made by Gilead. The complaint says, “More than 80% of patients starting an HIV regimen in the United States and more than 80% of continuing patients take one or more of Gilead’s products every day.” 

Its HIV drugs have been profitable for the company: The complaint claims that in 2017 it earned $14 billion from them. It charges between $1600 and $2000 for a month’s worth of Truvada, even though an Indian pharmaceutical company sells generic Truvada in Africa for $60 per year

When its monopoly on Tenofovir was schedule to expire, the complaint says, Gilead entered agreements with its competitors, BMS, Janssen, and Japan Tobacco, under which the competitors agreed not to compete with Tenofovir.

Gilead had a Tenofovir compound known as TDF. According to the complaint, “Gilead and its coconspirators coformulated TDF with the coconspirators’ third agents into single pills known as fixed-dose-combination drugs…” The coconspirators agreed they would not make their combinations with generic versions of TDF after the patents expired. “Through its anticompetitive conduct,” the complaint alleges, “Gilead switched the market from its standalone version of TDF to the fixed dose combination.” The complaint says this allowed all of the companies “to artificially inflate prices.”

Another, more complicated anticompetitive agreement involved a Gilead booster drug, Cobicistat. 

Later, Gilead amended its anticompetitive agreements with another tenofovir drug combination so that it would not face competition in that area until 2032.

According to the complaint, “Gilead also degraded some of its key products and held back innovative products.” When Teva Pharmaceuticals challenged some of its patents, the complaint claims, Gilead made an anticompetitive agreement with Teva.

Article Type: Lawsuit
Topic: Antitrust

Most Recent Case Event

Gilead and Others HIV Drug Anticompetitive Agreements Complaint

February 5, 2020

Anticompetitive efforts in the field of pharmaceuticals have become more sophisticated in recent years. This antitrust class action concerns combination antiretroviral therapy (cART) regimen drugs used by patients with human immunodeficiency virus (HIV), a condition that can lead to Acquired Immunodeficiency Syndrome (AIDS) and death. The complaint alleges that a number of companies have conspired to maintain a monopoly in the market for cART regimen drugs by extending patent protection, delaying the entry of generics, and charging “anticompetitive prices” for the drugs.

cart_regimen_drugs_antitrust_complaint.pdf

Case Event History

Gilead and Others HIV Drug Anticompetitive Agreements Complaint

February 5, 2020

Anticompetitive efforts in the field of pharmaceuticals have become more sophisticated in recent years. This antitrust class action concerns combination antiretroviral therapy (cART) regimen drugs used by patients with human immunodeficiency virus (HIV), a condition that can lead to Acquired Immunodeficiency Syndrome (AIDS) and death. The complaint alleges that a number of companies have conspired to maintain a monopoly in the market for cART regimen drugs by extending patent protection, delaying the entry of generics, and charging “anticompetitive prices” for the drugs.

cart_regimen_drugs_antitrust_complaint.pdf
Tags: Antitrust, Pharmaceuticals