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March 3, 2020

Expanding Access and Reducing Prices for Drugs to Prevent HIV: Should Government Enforce Its Patent Rights Against the Pharmaceutical Industry?

Author Affiliations
  • 1Georgetown University Law Center, Washington, DC
  • 2Duke University School of Law, Durham, North Carolina
JAMA. 2020;323(9):821-822. doi:10.1001/jama.2019.22357

On November 6, 2019, the Department of Health and Human Services (HHS) filed a lawsuit against Gilead Sciences, claiming Gilead’s highly profitable sale of antiretroviral drugs (estimated at US $4 billion annually)1 infringes on patents held by the Centers for Disease Control and Prevention (CDC). The government rarely enforces its intellectual property rights, instead preferring collaborative relationships with industry. United States v Gilead Sciences comes in the wake of the campaign by HHS to end the HIV epidemic by 20302 and intense public concern over rising drug prices.3 Drugs used for preexposure prophylaxis (PrEP)—Truvada (emtricitabine and tenofovir disoproxil fumarate) and Descovy (emtricitabine and tenofovir alafenamide)—form the lynchpin of HHS’ campaign. Consistent daily use of PrEP is highly effective and has been shown to reduce HIV transmission through sex by 99% and through drug injection by 74%.4 Yet a yearly regimen of Truvada costs $20 000, rendering it unaffordable for many.