Gilead HIV Antiretroviral Antitrust

Hagens Berman filed a proposed class-action lawsuit against drug manufacturer Gilead and other players including Johnson & Johnson, Bristol-Meyers Squibb and others for knowingly colluding to raise the price of anti-HIV drugs, illegally raising the price of treatment for the 1 million people in the U.S. living with Human Immunodeficiency Virus-1 (HIV) infection.

The firm’s investigation shows that the anticompetitive conduct allowed Gilead to monopolize the market for all anti-HIV drugs, causing substantial price increases in all of them.

WHICH HIV DRUGS ARE AFFECTED?

The following 17 drugs have been affected by the price-fixing scheme: 

• Truvada
• Descovy
• Atripla
• Genvoya
• Odefsey
• Viread
• Emtriva
• Complera
• Stribild
• Vemlidy
• Reyataz
• Evotaz
• Prezista
• Prezcobix
• Edurant
• Symtuza
• Tybost

THE IMPACT

The cost of the most frequently prescribed HIV treatment regimens in the United States exceeds $40,000 per year, despite equivalent, FDA approved, generic regimens costing less than $100 per year in other countries.

The exorbitant cost of HIV treatment in the United States creates barriers for both individuals living with HIV attempting to access disease-altering treatment, and to public health systems attempting to end the HIV epidemic. The federal government alone spends more than $20 billion on HIV treatment, with the largest programs spending the majority of these funds on purchasing HIV medications.

DRUG PRICE-FIXING EXPLAINED

Hagens Berman’s lawsuit alleges that Gilead knowingly entered into anticompetitive agreements separately with Bristol-Meyers Squibb (BMS) and Johnson & Johnson subsidiary Janssen to thwart generic competition for HIV medications. The plaintiffs allege that Gilead conspired with BMS and Janssen to combine Gilead's tenoforvir (TDF) and emtricitabine (FTC) with BMS’s and Janssen’s HIV drugs, creating various combination pills commonly known as "fixed-dose combinations" (FDCs).  As a part of these FDC deals, Gilead's co-conspirators each agreed to so-called “no generic restraint” (NGR) provisions. The NGRs either prevented each manufacturer from making FDCs with generic HIV drugs when they became available or required that a manufacturer who chose to do so would have to pay large penalties. The complaint alleges that these NGRs prevented the sale of less-expensive generic-based FDCs.

The plaintiffs also allege that Gilead sued manufacturers of generic HIV medications who sought to bring generic versions of Gilead’s HIV drugs to market, including the drugs Viread, Truvada and Atripla. Rather than litigate the allegedly weak patents at issue, Gilead entered into settlement agreements with each generic company. The complaint asserts that in exchange for a promise from the principal generic competition, Teva Pharmaceuticals, to delay the entry of these generic product, Gilead included in the litigation settlement agreements provisions that protected Teva Pharmaceuticals from competition from other generic manufacturers. Teva’s delayed entry and the anticompetitive provisions of the settlement agreements had the effect of delaying entry of every other generic manufacturers’ generic drugs. Without those anticompetitive provisions, attorneys say, generic versions of Viread, Truvada and Atripla would have been available to consumers sooner and at considerable savings.

Per the complaint, Gilead’s ability to delay generic competition for its HIV drugs – through both its anticompetitive NGRs and settlement agreements – bought Gilead time to switch patents from TDF-based products (like Viread, Atripla and Truvada) onto TAF-based products. While Gilead had discovered a safer HIV drug, TAF, years earlier, it had shelved the product and delayed introducing it until it faced generic competition for TDF. These TAF products had longer period of patent protection, which would allow Gilead to charge higher prices and for longer than it could with the TDF-based products.

Once Gilead introduced its TAF-based products, it again entered into NGR provisions with Janssen, preventing Janssen from making TAF-based FDCs with generic TAF.

TOP PHARMA ANTITRUST FIRM

Hagens Berman is one of the most successful litigation law firms in the U.S. and has achieved more than $320 billion in settlements against Big Pharma, tobacco companies, automakers, big banks and others.