Gilead and Other HIV Treatment-Making Companies Face Class Action Lawsuit
While Gilead Sciences gained praise from the White House for agreeing to donate 2.4 million annual doses of an HIV treatment, the California-based company still faces legal allegations over the pricing and patents of those medications.
The company has been under fire from some HIV/AIDS activists over its HIV drug patents. The company has been accused of withholding safer formulations of its HIV drugs in order to maximize profits on those medications that had already been approved, such as Truvada. Earlier this week, Gilead, along with other HIV drugmakers such as Bristol-Myers Squibb and Johnson & Johnson became the target of a class-action lawsuit filed in San Francisco that claims the companies used anticompetitive tactics to keep prices artificially high for their respective HIV treatments. Drugs singled out in the complaint include Truvada, Descovy, Atripla, Genvoya and Odefsey. Also, the lawsuit named Viread, Emtriva, Complera, Stribild, Vemlidy, Reyataz, Evotaz, Prezista, Prezcobix, Edurant, Symtuza, and Tybost.
The plaintiffs in the case, which includes AIDS activists Gregg Gonsalves, Brenda Goodrow, Andrew Spieldenner, Peter Staley, Robert Vázquez and Jason Walker, allege that the drugmakers agreed to not make fixed-dose combination treatments with generic versions of the components. By doing this, the companies have been able to keep prices high, the complaint said. As an example, the plaintiffs pointed to Gilead’s Complera, which has a list price of $35,000 per year. The plaintiffs noted that a generic version of Complera, combined with Janssen’s still-on-patent rilpivirine would sell for no more than half that amount. The plaintiffs have argued that agreements between the two companies prohibit Janssen from making that generic-containing version of the drug or from licensing rilpivirine to generic manufacturers that would make it.
The companies, the plaintiffs argue, have a “no-generics” policy, which keeps the price of the drugs high. That policy covers more than 75% of Nucleoside Reverse Transcriptase Inhibitors (NRTIs), which are the backbones of many HIV treatments. Additionally, the plaintiffs argued that the prices of more than 50 percent of core agents, such as protease inhibitors, integrase inhibitors and 75% of booster drugs are also artificially inflated due to these agreements. The complaint alleges that the defendants used these pervasive no-generics restraints to keep their HIV-drug prices at the sky-high $35,000-per-year level even though three principal NRTIs are now available as generics.
“The anticompetitive actions alleged in this case are shocking and help explain why the prices we pay for our antiviral pills just keep going up and up. This gross profiteering explains why less than half of people living with HIV in the U.S. are virally suppressed, one of the lowest rates among the world's high-income countries,” Goodrow, one of the plaintiffs, said in a statement through the legal firm Hilliard & Shadowen, LLP.
Jason Walker, another plaintiff, said the “no-generics restraints crafted by Gilead and its co-conspirators” are detrimental to innovation in HIV treatment. The complaint identified 28 specific fixed-dose combination products that could be made available if the “no-generics” restrictions were not in place, he said.
A generic version of Gilead’s Truvada could be available in the United States next year, due to a legal decision regarding the company’s patents. Teva Pharmaceuticals is expected to begin marketing its Truvada generic next year.
The HIV market is expected to grow to $22.5 billion by 2025. Gilead Sciences has three of the top four best-selling HIV drugs on the market. Gilead is not the only player in the HIV market. In addition to Teva’s generic, Gilead also must contend with medications developed by ViiV Healthcare, a subsidiary of GlaxoSmithKline. Last month, ViiV Healthcare submitted a New Drug Application to the US Food and Drug Administration for potential approval of its investigational combination treatment for HIV-1.