(RTTNews) - The United States government has filed a lawsuit against Gilead Sciences, alleging that the biopharmaceutical company's two HIV drugs, Truvada and Descovy, infringe on four patents owned by the Department of Health and Human Services or HHS.
According to the Department of Justice, the four patents owned by the HHS cover specific drug regimens used for pre-exposure prophylaxis or PrEP, to prevent HIV infection.
PrEP is an HIV prevention method in which people who are HIV-negative take the medicine on a daily basis to mitigate the risk of getting HIV if they are exposed to the virus.
Gilead had originally obtained FDA approvals for Truvada and Descovy to be used solely for treating HIV in combination with other drugs.
The company later sought FDA approval for Truvada and more recently, Descovy, to be used as part of PrEP drug regimens after researchers at the Centers for Disease Control and Prevention or CDC developed the two-drug regimens that could, for the first time, prevent people from becoming infected with HIV.
Gilead now markets and sells Truvada and Descovy for PrEP regimens developed as well as patented by CDC. The company has received billions of dollars in revenue from HIV prevention regiments invented by HHS researchers, the Justice Department said.
"Gilead has repeatedly refused to obtain a license for use of the patented drug regimens, while continuing to profit from hundreds of millions of dollars of publicly funded research. Rather than pay royalties owed to the United States, Gilead has challenged the validity of all four patents before the Patent and Trademark Office," the DOJ said.
The CDC's two-drug regiment, now covered by four U.S. patents, demonstrated that regular prophylactic doses of a combination of two antiretroviral drugs could prevent the transmission of AIDS in at-risk populations. To date, the government has spent hundreds of millions of dollars on clinical studies of these treatment regimens.
These regimens are currently a critical component of the U.S. government's efforts to end the HIV epidemic.
In response to the lawsuit, Gilead said it strongly believes that the patents granted to HHS since 2015 for PrEP and PEP are not valid.
The company said it will ask the district court to stay the litigation until the Patent Office has an opportunity to undertake a review it has requested.
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