A landmark trial between Gilead Sciences and the U.S. government over drug patents began on Tuesday, with the government seeking over $1 billion in compensation.
The California-based pharmaceutical company was sued by the U.S. government in 2019 for allegedly failing to pay royalties to the Centers for Disease Control and Prevention for an HIV prevention drug regimen that has since yielded billions of dollars in profit.
The trial kicked off with jury selection on May 2 and will take place in the Delaware U.S. federal district court. It is expected to run for about six days.
The lawsuit filed in 2019 claims that Gilead is marketing and selling a pre-exposure prophylaxis (PrEP) drug regimen using two antiretroviral drugs — Truvada and Descovy — that were developed and patented by the CDC in the early 2000s, per the Department of Justice.
The U.S. government claims that Gilead only sought FDA approval for Truvada and Descovy after seeing the results of the CDC’s research and trials.
“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,” the Department of Justice alleged.
Gilead reported over $2 billion in profit last year alone from the PrEP drug regimen, which marked a tremendous breakthrough with its 99% efficiency.
In response to the U.S. government’s complaint, Gilead has rejected that its sales of Truvada and Descovy infringe on any CDC patents.
“Not only did Gilead invent Truvada and Descovy, but the concept of using Truvada to prevent HIV was well-known by the time the government tried to obtain its patents,” argued a Gilead spokesperson, according to CNBC.
Furthermore, in 2020, the pharmaceutical firm filed a lawsuit against the U.S. government for breach of contract.
The lawsuit alleges that during the 15-year collaboration between its researchers and those of the government agency, “Gilead agreed to provide the CDC with significant quantities of Gilead compounds free of charge,” per Gilead’s statement.
Not only did the government agree “to promptly notify Gilead of any inventions, discoveries or ideas that resulted from the research,” Gilead argues that it also “promised not to seek patent protection in connection with any alleged inventions” that might result, per Gilead’s statement.
Maryellen Noreika, the U.S. district judge presiding over the case, will be ruling on Gilead’s claims that the government’s patents are not valid due to misconduct in parallel to the jury trial.