After a weeklong trial, a federal jury ruled against the federal government, finding that Gilead Sciences Inc. did not infringe upon United States patents with its HIV-prevention drugs Truvada and Descovy. In the case, the United States sued Gilead over its HIV pre-exposure prophylaxis (PrEP) drugs Truvada and Descovy. The United States Food and Drug Administration (FDA) approved Truvada for HIV prevention in 2012 and Descovy for the same purpose in 2019. The United States alleged that Gilead owed millions of dollars in royalties to the Centers for Disease Control and Prevention (CDC) based on patents issued to the agency.
The government alleged that scientists discovered back in the mid-2000s that when two drugs – emtricitabine and tenofovir – were taken together, it was highly effective in preventing HIV infection. Truvada and Descovy both contain emtricitabine and tenofovir and the combined sales for the drugs in 2022 were roughly $2 billion. According to the complaint, “Gilead has repeatedly refused to obtain a license from CDC to use the patented regimens,” collecting “billions from PrEP through the sale of Truvada and Descovy, but has not paid any royalties to CDC.”
However, what the government seemed to largely ignore was that Gilead and the CDC collaborated on research to determine whether the drugs could not only treat the virus, but also prevent transmission of the virus. In its court filings, the federal government said that Gilead “exaggerated” its role in developing PrEP all while ignoring the CDC’s contributions and refusing to license the CDC’s patents.
Gilead stood firm on its position that CDC scientists did not create the PrEP regimen and it does not need to apply for a license with the CDC or pay any royalties from sales of its drugs. Gilead noted that “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.”
Not only did the jury find that Gilead did not owe the royalties to the government, but it also voided three of the patents involved. Going a step further, the jury also concluded that even if the patents were valid, Truvada and Descovy would not have infringed the patents.
With the jury finding in Gilead’s favor, they do not have to pay the more than $1 billion that the government sought as royalties and other penalties.
“Today’s decision confirms our longstanding belief that we have always had the rights to make Truvada and Descovy for PrEP available to all who need it,” said Deb Telman, Gilead’s general counsel and executive vice president of corporate affairs. “Gilead will continue to champion collaborations, including our efforts with the U.S. Health and Human Services Department (HHS) and CDC that span more than 15 years, as we all work together toward our common goal to end the HIV epidemic for everyone, everywhere.”
Government Wants to Continue the Fight
About a week after the jury voided the three patents and ruled that Gilead did not need to pay millions of dollars in royalties to the United States government, the government said it plans to renew several of its issues in the case and seek a new trial. According to Bloomberg, the government wants the new trial to “include the issues of induced infringement, damages, the court’s exclusion of evidence from the jury trial regarding Gilead’s four petitions for administrative validity reviews, and the court’s ‘failure to exclude from the jury trial evidence related to the material transfer agreements and their intellectual property provisions.’”
Related Case
In a separate case last year, the United States Court of Federal Claims found that the government breached research agreements that it had with Gilead by applying for patents without giving sufficient notice. While Gilead was found to have been entitled to monetary damages, the exact number of monetary damages has not yet been determined but could be a significant blow to the government.