Washington, DC - The Department of Justice announced Thursday that the United States has filed a complaint alleging infringement by Gilead Sciences Inc. and Gilead Sciences Ireland UC (collectively, Gilead) of four U.S. patents awarded to and owned by the United States, Department of Health and Human Services (HHS). These patents cover specific drug regimens used for pre-exposure prophylaxis (commonly referred to as PrEP) that prevents HIV transmission. The complaint alleges infringement in connection with two of Gilead’s drugs, Truvada® and Descovy®, which Gilead markets for use to prevent HIV as part of the PrEP regimen.
“Gilead has received billions of dollars in revenue from HIV prevention regimens invented by HHS researchers and patented by the United States,” said Assistant Attorney General Jody Hunt of the Department of Justice’s Civil Division. “This lawsuit demonstrates the Department’s commitment to protect the government’s intellectual property and hold accountable those who seek to unfairly gain from the government’s research without paying reasonable royalties as the law requires.”
“HHS recognizes Gilead’s role in selling Truvada® and Descovy® to patients for prevention of HIV. Communities have put these drugs to use in saving lives and reducing the spread of HIV,” said HHS Secretary Alex Azar II. “However, Gilead must respect the U.S. patent system, the groundbreaking work by CDC researchers, and the substantial taxpayer contributions to the development of these drugs. The complaint filed today seeks to ensure that they do.”
Starting in the early 2000’s, researchers at the Centers for Disease Control and Prevention’s (CDC) Division of HIV/AIDS Prevention invented an innovative two-drug regimens that could, for the first time, prevent people from becoming infected with HIV. These breakthrough inventions, now covered by four United States patents, demonstrated that regular prophylactic doses of a combination of two antiretroviral drugs could prevent the transmission and reproduction of the virus that causes 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 have ushered in a new era in HIV prevention and are currently a critical component of the government’s efforts to end the HIV epidemic. During the 2019 State of the Union address, President Donald J. Trump announced a new initiative entitled “Ending the HIV Epidemic: A Plan for America,” with the goal of reducing new HIV infections by 90 percent by 2030. PrEP drug regimens are an appropriate centerpiece of this initiative as clinical trials based on the patented research have shown that approximately 99 percent of at-risk persons who adhere to a once-daily PrEP regimen are protected from HIV transmission. Expanding the use of PrEP drug regimens will be a key component for preventing the spread of HIV across the United States.
Gilead manufactures, markets, and sells Truvada® and Descovy®. Gilead had originally obtained FDA approvals for those products to be used solely for treating HIV in combination with other drugs. It was only after CDC’s innovative PrEP work and subsequent human trials that Gilead sought FDA approvals for Truvada®, and more recently Descovy®, to be used as part of PrEP drug regimens to prevent HIV. Gilead now markets and sells Truvada® and Descovy® for PrEP regimens that CDC developed and patented.
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. This move contradicts the testimony of Gilead’s CEO, Daniel O’Day, before the Oversight Committee of the U.S. House of Representatives that Gilead had “chosen not to challenge [the United States’] patents because we value our collaborative relationship with the agency.” The United States maintains that all four patents were validly issued and will respond as appropriate.
This matter is being handled by the Commercial Litigation Branch, Intellectual Property Staff, of the Department of Justice’s Civil Division, with assistance from the U.S. Attorney’s Office for the District of Delaware. The claims asserted against the defendants are allegations only, and there has been no determination of liability.