HIV Drug Class Action Lawsuit Filed Over Withholding Safer Options to Keep Prices Higher

Gilead and other drug manufacturers face a class action lawsuit over HIV “cocktail” drugs, alleging that anti-consumer tactics were used to drive up prices consumers paid for the medications, at the same time Gilead is being accursed of conspiring to keep safer alternatives off the market, to generate maximum profits from formulations they were already selling.

On May 14, a group of plaintiffs filed a complaint (PDF) in the U.S. District Court for the Northern District of California against Gilead Sciences, Inc. Bristol-Myers Squibb, Japan Tobacco Inc., Akros Pharma, Johnson & Johnson, and it’s subsidiary Janssen, which seeks class action status against the HIV drug manufacturers.

“Gilead and its coconspirators have engaged in a long-running scheme to restrain competition with respect to some of the most important drugs used to treat Human Immunodeficiency Virus (‘HIV’) infection – a disease which, if left untreated, destroys the immune system, leading to Acquired Immunodeficiency Syndrome (‘AIDS’) and eventual death,” the lawsuit explains. “Through an array of anticompetitive practices… Gilead has acquired and maintained a monopoly in the market for drugs that comprise the modern HIV treatment regimen known as ‘combination antiretroviral therapy’ (‘cART’). The scheme has enabled Gilead and its coconspirators to unlawfully extend patent protection for their drugs, impair entry by would-be generic competitors, and charge exorbitant, supracompetitive prices for the drugs that people living with HIV need to survive.”

The lawsuit notes that today, more than 80% of individuals starting HIV drug treatment have to take one of Gilead’s products on a daily basis, resulting in the company pulling in annual sales of more than $11 billion.

Gilead manufactures, markets and sells HIV “cocktail” drugs under the brand names Viread, Truvada, Atripla, Complera, Stribild and others; all of which contain the active ingredient tenofovir disoproxil fumarate (TDF) combined with other treatments.

The lawsuit indicates that Gilead conspired with the other drug manufacturers to make sure its medications did not face early generic competition, thus ensuring its ability to charge high prices for the drugs.

Additionally, the company faces complaints that side effects of those HIV drugs are highly toxic, and that it withheld a safer ingredient, tenofovir alafenamide fumarate (TAF), in order to milk profits from the more toxic medications for as long as possible.

The lawsuit lays out a series of joint development schemes and what it says are unlawful agreements between the drug manufacturers.

“In a relentless effort to reap ever-more monopoly profits, Gilead engaged in further anticompetitive conduct to reinforce the exclusionary effects of these illegal exclusion agreements,” the lawsuit states. “When generic competition to TDF became imminent, Gilead amended the No-Generics pacts to preclude its coconspirators from competing not only against Gilead’s then-marketed TDF but also against a new formulation of the compound, tenofovir alafenamide (‘TAF’), and further extended the term of the NoGenerics Restraints. Gilead had been holding TAF in reserve for more than a decade to roll out later as part of its scheme to impair competition once generic entry was imminent.”

The lawsuit seeks class action status for all patients who used the HIV drugs and seeks reimbursement for what they calculate members of the class were overcharged as well as other forms of relief.

In addition, Gilead now faces a growing number of individual HIV drug lawsuits. The lawsuits claim Gilead knew TAF was less toxic than TDF because it could be administered at a lower dose with the same effectiveness. The company shelved TAF in 2004, and did not begin to sell TAF-designed drugs until 2015, plaintiffs point out, which gives them patent protection until 2032. TDF drug patents began expiring last year.