US Government files appeal in high-stakes HIV PrEP patent battle against Gilead

Published: Jul 09, 2024

By Tristan Manalac

BioSpace

The Biden administration last week appealed a 2023 jury decision, which found that Gilead did not infringe on key government patents in its HIV prevention regimen consisting of the drugs Truvada (emtricitabine/tenofovir disoproxil fumarate) and Descovy (emtricitabine/tenofovir alafenamide).

In May 2023, a Delaware jury overwhelmingly took Gilead’s side, noting that the U.S. government did not have enough evidence to establish that using the HIV drugs violated three key patents.

The jury also unanimously agreed with the pharma that these patents were invalid in the first place, in part because the technologies they protect were obvious to professionals knowledgeable in the space.

In March 2024, a Delaware court gave the government some breathing room when it granted the state’s motion to “upset the jury’s findings” of direct infringement and the invalidity of these patents. In particular, the court ruled against the jury’s verdict that the patents were not infringed but upheld the view that the patents were invalid.

The government’s appeal last week—filed by the Department of Justice for the Department of Health and Human Services—seeks to reverse the previous rulings on the invalidity of their patent claims over Truvada and Descovy.

First approved in 2004 for the treatment of HIV, Truvada is a combination of two drugs—emtricitabine, a nucleoside reverse transcriptase inhibitor, and a prodrug of tenofovir, which is a nucleotide reverse transcriptase inhibitor. Both of its active ingredients allow Truvada to prevent the HIV virus from infecting a cell and embedding its genetic material into the host’s DNA.

In July 2012, the FDA signed off on the preventative use of Truvada, allowing its administration to reduce the risk of sexually acquired HIV.

Descovy is a newer generation drug that the FDA approved for HIV prevention in October 2019. It also uses emtricitabine, but combines it with tenofovir alafenamide, another tenofovir prodrug.

In November 2019, the Trump administration sued Gilead over the use of Truvada and Descovy, alleging that the combination regimen was first invented by scientists at the Centers for Disease Control and Prevnetion in the early 2000s.

“To date, the government has spent hundreds of millions of dollars on clinical studies of these treatment regimens,” the Justice Department wrote in its announcement at the time, adding that 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.”

Source: BioSpace