US Appeals in Crucial HIV PrEP Patent Battle Against Gilead

In a recent development, the Biden administration has filed an appeal against a 2023 jury ruling that favored Gilead Sciences regarding patents related to its HIV prevention drugs, Truvada and Descovy. This appeal challenges the jury's conclusion that Gilead did not infringe on significant government patents with its HIV prevention regimen.

In May 2023, a Delaware jury had sided with Gilead, stating that the U.S. government lacked sufficient evidence to prove that Gilead's use of Truvada and Descovy violated three key patents. Additionally, the jury unanimously deemed these patents invalid, citing that the technologies they protected were evident to professionals in the field.

However, in March 2024, a Delaware court provided some relief to the government by granting a motion to overturn the jury's findings of direct infringement and the invalidity of these patents. The court ruled against the jury’s decision that the patents were not infringed but maintained that the patents were invalid.

The recent appeal, filed by the Department of Justice on behalf of the Department of Health and Human Services, aims to reverse the previous decisions regarding the invalidity of the patent claims over Truvada and Descovy.

Truvada, first approved in 2004 for treating HIV, is a combination of emtricitabine, a nucleoside reverse transcriptase inhibitor, and tenofovir disoproxil fumarate, a nucleotide reverse transcriptase inhibitor. These active ingredients help prevent the HIV virus from infecting a cell and embedding its genetic material into the host's DNA. In July 2012, the FDA approved Truvada for preventative use, allowing it to reduce the risk of sexually acquired HIV.

Descovy, a newer HIV prevention drug, was approved by the FDA in October 2019. Like Truvada, it contains emtricitabine but pairs it with tenofovir alafenamide, another prodrug of tenofovir.

The legal battle between the government and Gilead has been ongoing since November 2019, when the Trump administration sued Gilead, accusing the company of utilizing Truvada and Descovy's regimen without proper authorization. The government claimed that scientists at the Centers for Disease Control and Prevention had initially developed the combination regimen in the early 2000s.

The Justice Department emphasized the significant investment made by the government, noting that it has spent hundreds of millions of dollars on clinical studies for these treatment regimens. The department criticized Gilead for not obtaining a license to use the patented drug regimens while continuing to profit from public research.

The outcome of this appeal could have substantial implications for both Gilead and the government, potentially affecting the availability and cost of these crucial HIV prevention medications.