The federal government accused the drugmaker Gilead in a lawsuit on Wednesday of infringing on government patents for the HIV prevention drugs Truvada and Descovy, fulfilling the wishes of some lawmakers and HIV activists to address the possibility of price gouging.
The government alleges that Gilead is marketing and selling the drugs for use in preexposure prophylaxis, or PrEP, regimens for which the Department of Health and Human Services holds patents, without the proper licensing. Gilead originally had approval for the drugs from the Food and Drug Administration for use in post-infection HIV treatment,
“Communities have put these drugs to use in saving lives and reducing the spread of HIV,” HHS Secretary Alex Azar said. “However, Gilead must respect the U.S. patent system, the groundbreaking work of CDC researchers, and the substantial taxpayer contributions to the development of these drugs.”
Truvada for PrEP can set a patient back about $2,000 for a 30-day supply. Its accessibility is key to fulfilling the president’s promise to eradicate HIV and AIDS by 2030. Truvada and Descovy are the only two drugs approved to prevent HIV. The high cost of the drugs, along with Gilead’s sizable profits from making them, have led some congressional Democrats to demand that the administration look into whether the company is infringing on government patents.
The government maintains that Centers for Disease Control and Prevention researchers developed the PrEP regimen in the mid-2000s. Gilead’s CEO has said that scientists were already researching the use of the drugs for PrEP before then but that the company hasn’t challenged the CDC patents because it partners with the agency.
