Gilead Sciences has reached significant settlements in two major patent disputes, resolving years of litigation over its HIV medications portfolio. The pharmaceutical company has agreed to pay ViiV Healthcare $1.25 billion while also settling a separate case with the U.S. government regarding its HIV prevention drugs.
Gilead Pays $1.25 Billion to Settle ViiV Healthcare Patent Dispute
Gilead Sciences has agreed to pay ViiV Healthcare $1.25 billion to resolve a patent dispute dating back to 2018. The settlement also includes a 3% royalty on U.S. sales of Biktarvy and other bictegravir-containing products until October 5, 2027, when ViiV's U.S. patent on dolutegravir expires.
The dispute centered on Gilead's triple-drug regimen Biktarvy, which contains emtricitabine, tenofovir alafenamide, and the integrase inhibitor bictegravir. ViiV Healthcare—a joint venture majority owned by GlaxoSmithKline with Pfizer and Shionogi as partners—had claimed that bictegravir infringed its patents for dolutegravir and related compounds.
Biktarvy is Gilead's top-selling product, generating $8.6 billion in global sales last year, with more than $7 billion coming from the U.S. market alone. Based on these figures, the 3% royalty could amount to approximately $210 million annually for ViiV Healthcare.
As part of the agreement, ViiV will drop related patent litigation outside the United States and grant Gilead a worldwide license to the dolutegravir patents.
U.S. Government Settlement Over HIV Prevention Drugs
In a separate development, Gilead has also settled its long-standing dispute with the U.S. government over patents related to HIV prevention drugs Truvada and Descovy. The settlement follows Gilead's victory in a 2023 jury trial addressing the government's patent infringement allegations.
The U.S. Department of Health and Human Services and Centers for Disease Control and Prevention (CDC) had claimed that Gilead failed to compensate the CDC for discovering that Truvada could be used for pre-exposure prophylaxis (PrEP) to prevent HIV infections. The government had sought up to $691 million in damages from Truvada and $311 million from Descovy.
Deborah Telman, Gilead's General Counsel, stated that the agreement "allows Gilead to continue to focus its resources on its mission to discover, develop, and deliver innovative therapeutics to people with life-threatening diseases."
The dispute originated from Gilead's collaboration with the CDC in the mid-2000s to test whether Truvada could prevent HIV transmission in addition to treating it. The government alleged that Gilead "exaggerated" its role in developing the PrEP regimen and ignored the CDC's contributions.
A Washington, D.C. federal court had previously determined in 2022 that the government breached research agreements with Gilead by applying for patents without giving the company sufficient notice.
Financial Performance Amid Legal Resolutions
These settlements come as Gilead reported a 2% decline in fourth-quarter sales, primarily due to decreased demand for its COVID-19 therapy Veklury (remdesivir). Veklury sales fell 30% to $1.4 billion in the last quarter of 2021 as hospitalizations for severe COVID-19 declined and alternative treatments became available.
Despite this overall decline, Biktarvy continued to perform strongly with a 22% increase to $2.5 billion, driven by robust demand and favorable pricing. Gilead's cell therapy franchise, including Yescarta and Tecartus for various blood cancers, grew by 47% to $239 million.
Daniel O'Day, Gilead's CEO, expressed optimism about the company's future: "Today our cancer therapies, Trodelvy, Yescarta and Tecartus are reaching increasing numbers of cancer patients, Veklury is playing a critical role in the pandemic, and Biktarvy remains the most prescribed HIV treatment in the US. We have all the elements in place for a strong year and a strong decade."
Gilead now projects product sales for 2022 to be between $23.8 billion and $24.3 billion, with Veklury expected to contribute approximately $2 billion.
Impact on HIV Treatment Landscape
These settlements resolve significant uncertainties in Gilead's business operations related to its HIV portfolio, which remains a cornerstone of the company's revenue. Truvada and Descovy generated more than $1.8 billion from U.S. sales in 2023, while Biktarvy continues to dominate as the most prescribed HIV treatment in the United States.
The resolution of these patent disputes allows Gilead to move forward with greater financial clarity while continuing to focus on its expanding oncology portfolio and maintaining its leadership position in HIV treatment and prevention.
