The Trump administration sued Gilead Sciences late Wednesday, alleging patent infringement over its crucial drugs to prevent the spread of HIV.
In a rare move, the administration accused the company of reaping profits from Truvada and Descovy when in fact the patents are owned by the government, after scientists at the Centers for Disease Control and Prevention (CDC) developed the breakthrough drugs.
{mosads}The Department of Health and Human Services (HHS) said Gilead had refused to obtain licenses for use of the government patents.
Gilead has come under criticism for the price of the drugs — around $20,000 — that are crucial for efforts to prevent the spread of HIV.
“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,” HHS Secretary Alex Azar said in a statement.
“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,” he added. “The complaint filed today seeks to ensure that they do.”
President Trump in his State of the Union address earlier this year set a goal of ending the HIV epidemic in 10 years. Trump has also railed against high drug prices.
The decision regarding the drugs, also known as PrEP, drew some rare praise from Democrats for the Trump administration on Wednesday night.
The group PrEP4All, which has pressured HHS for action, also praised the decision.
“For nearly a decade, Gilead’s price gouging on PrEP has prevented hundreds of thousands of Americans from accessing this life saving medication, despite it being a taxpayer funded invention,” the group said in a statement. “If HHS is truly invested in ending the HIV epidemic, it will use these patents as leverage to ensure that everyone who needs PrEP can get it.”
Gilead responded in a statement on Thursday that the government patents are “invalid” and argued that Gilead deserves the credit for inventing the drugs. The company said it will ask the court to stay the lawsuit until claims Gilead has already filed in the dispute in the Patent Office are resolved.
“The fact remains that Gilead invented Truvada and funded the clinical trials that led to its 2004 FDA approval for use in combination with other antiretroviral agents to treat HIV,” the company said. “The company has spent an estimated $1.1 billion on R&D related to Truvada — to develop the two individual drugs that make up Truvada, invent the combination product that is Truvada, invent its use for HIV treatment and support the clinical trials that led to the approval of Truvada for PrEP.”
Updated at 1:46 p.m.