Settling the PrEP Patent Disputes

Gilead Sciences and the outgoing Biden Administration have settled a significant patent dispute concerning Gilead’s HIV prevention medications, Truvada and Descovy. The dispute originates from collaborations between Gilead and the Centers for Disease Control and Prevention (CDC) to investigate whether Truvada could prevent HIV transmission, which led to the development of the pre-exposure prophylaxis (PrEP) regimen. 

However, the US alleges that Gilead failed to adequately compensate the CDC for its contributions to the PrEP research and refused to license the CDC’s patents related to the PrEP regimen.

In 2019, the Department of Health and Human Services claimed Gilead profited from publicly funded research without properly licensing the patents. Gilead countered by challenging the validity of the patents, asserting its rights to produce Truvada and Descovy for PrEP. However, a 2023 jury verdict sided with Gilead, finding that the company did not infringe on government-held patents and also declared those patents invalid. 

Further complicating the matter, a series of legal decisions across 2022, 2023, and 2024 found that the government had breached contracts with Gilead. The CDC (under President George W. Bush) had requested free PrEP drugs from Gilead for research purposes. Gilead provided the drugs under the condition that any resulting innovations would be reported, and the company would be granted a licence to use them.

In 2006, CDC scientists filed a patent application claiming the use of drugs such as Truvada for PrEP. However, Gilead was not notified of the patent filing until 2016, in direct violation of the material transfer agreements between the two parties. 

The 2023 verdict, described as a “precedent-setting patent infringement trial” by Gilead’s legal team at WilmerHale, reverberated across the pharmaceutical industry, and dealt a significant blow to both the US Department of Justice and the Department of Health and Human Services. Ron Machen, WilmerHale’s Litigation and Controversy Chair, said, “The verdict was especially gratifying because Gilead trusted the CDC scientists and honestly believed they were in a collaborative partnership to end the fight against HIV. Gilead never dreamed that trust would be violated by these scientists filing for patent protection on Gilead’s crown jewel drug, Truvada, behind their back … I was ecstatic our firm was able to bring a fair and just result for Gilead, which has worked incredibly hard to end the HIV epidemic.”

In July 2024, the US government appealed the 2023 verdict, but this was unsuccessful.

Gilead's General Counsel, Deborah Telman, said, “Today’s settlement ends this litigation, and this final resolution allows Gilead to continue to focus its resources on its mission to discover, develop, and deliver innovative therapeutics to people with life-threatening diseases. Gilead is proud to have invented and developed Truvada and Descovy, and to have brought these life-changing innovations to people in need. Gilead continues to champion collaborations, including our efforts with HHS that span more than 15 years, as we all work together toward our common goal to end the HIV epidemic for everyone, everywhere."

The settlement concludes a prolonged legal battle and Biden’s tenure as US President. Gilead will continue to make progress in HIV prevention, but patent disputes are as commonplace in the pharmaceutical industry as stars and stripes. Another will likely come along sooner rather than later.