WASHINGTON DC, November 11, 2019 – The Fair Pricing Coalition (FPC), a national group advocating for reasonable costs for HIV and hepatitis drugs, today expressed solidarity with the Treatment Action Group, AIDS Action Baltimore, Health GAP, Housing Works, the SERO Project, and amfAR, who have filed an amicus curiae brief in the case of Peter Staley, et al., v. Gilead Sciences, Inc. et al. opposing a motion by Gilead for dismissal.
 

The Staley et al. class action lawsuit, filed in May 2019, charges that Gilead, in allowing its widely used antiretroviral drugs to be compounded with those of other companies into single tablets, prohibited Bristol-Myers Squibb, Janssen Pharmaceuticals, and Japan Tobacco from using less expensive generic components, even after patents expire.  

These arrangements, plaintiffs assert, are anti-competitive and will maintain excessive prices for HIV/AIDS drugs well into the future, potentially limiting access to cheaper treatments and diverting scarce dollars needed to ensure the expansion and sustainability of medical and support services and to fulfill the U.S. Department of Health and Human Services goal to “End the HIV Epidemic” by 2030.

Wholesale acquisition costs for preferred regimens made by these companies and recommended in the U.S. Department of Health and Human Services’ Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV range from $35,000 to $42,000 per year.  Manufacturers claim that discounts, rebates, and indigent patient assistance and copay programs compensate for these inflated rates. Plaintiffs and the FPC contend that prices based on actual costs, or utilizing generic equivalents, could be far lower and still provide the companies with generous profits. 

The suit also asserts Gilead delayed developing Descovy (tenofovir alafenamide fumarate/emtricitabine) for eight years so that the company could prolong its significant market share for Truvada (tenofovir disoproxil fumarate/emtricitabine), now approaching the end of its patent protections.  

Gilead has sought to have the lawsuit dismissed, claiming the companies’ restrictive collaborations encourage innovation, are lawful and legitimate business practices, and that the charges are “pejorative.”  In response, the amicus brief filed by the HIV groups argues – and the Fair Pricing Coalition agrees – that “the court will benefit from a fuller discussion” of these issues, as excessive drug prices have generated increasing national alarm.

In a separate amicus brief filed with the U.S. District Court for the Northern District of California, the Federal Trade Commission (FTC) argued that Gilead’s motion to dismiss contains claims that are inconsistent with core legal principles governing market definition in antitrust cases. The FTC brief does not take a position on the underlying factual assertions of the case.