United States v. Gilead: Two Year Anniversary Letter
CAP is proud to sign on to the attached letter below, which seeks “to urge [The Honorable Merrick Garland and The Honorable Xavier Becerra] to pledge and to act to ensure that the United States v. Gilead lawsuit serves as a mechanism to increase access to PrEP across the country, as quickly as possible. We ask that [The Honorable Merrick Garland and The Honorable Xavier Becerra] provide an update on the litigation to stakeholders and to the public at large. Any decision that DOJ and HHS make regarding United States v. Gilead, including any licensing agreements or other settlement, should be made in communication with the communities that will be directly impacted by that decision for years to come.
The Honorable Merrick Garland
Attorney General of the United States
U.S. Department of Justice
950 Pennsylvania Avenue, NW
Washington, DC 20530-0001
The Honorable Xavier Becerra
Secretary of Health and Human Services
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201
Dear Attorney General Garland and Secretary Becerra,
Two years ago, on November 6, 2019, the Department of Justice (DOJ), on behalf of the Department of Health and Human Services (HHS), filed a complaint against Gilead Sciences (Gilead) seeking damages for Gilead’s infringement of HHS’s patents on pre-exposure prophylaxis (PrEP) for HIV prevention. The lawsuit brought by DOJ and HHS—United States v. Gilead—was a historic move lauded by many in the HIV and access to medicines movements. However, this lawsuit has yet to make any meaningful impact in the lives of patients living with and vulnerable to HIV. As service providers and advocacy groups fighting to end the HIV epidemic domestically and around the world, we urge you to pledge and to ensure that this lawsuit serves that goal.
PrEP is a highly effective medical technology, and it exists thanks to taxpayer-funded research conducted by constituent agencies of HHS. PrEP was invented by scientists at the Centers for Disease Control and Prevention (CDC) in the 2000s. PrEP was then first proven safe and effective in humans in a clinical trial funded by the National Institutes of Health (NIH) and the Bill & Melinda Gates Foundation in the late 2000s and early 2010s. This trial and subsequent trials have shown that PrEP is over 99% effective at preventing sexual transmission of HIV.
Gilead relied on this taxpayer-funded research when it sought and received approval from the Food & Drug Administration (FDA) to market commercial PrEP products. The FDA approved Gilead’s first version of PrEP in 2012, and Gilead has marketed PrEP products continuously since then. Since 2012, Gilead has earned at least $10 billion from PrEP sales in the United States. Gilead’s manufacturing costs on PrEP are low—estimated at less than $6 per bottle—and its profits have been massive. As HHS stated in 2019, when it filed the lawsuit, “Gilead has profited from research funded by hundreds of millions of taxpayer dollars and reaped billions from PrEP through the sale of Truvada® and Descovy®.”
However, while Gilead profited, there was little progress at curtailing the HIV epidemic in the United States, largely because of a lack of access to PrEP. Despite PrEP’s incredible efficacy, U.S. HIV diagnoses have fallen by less than 10% since 2012. Nearly 40,000 Americans become newly infected with HIV every year. This lack of progress is not because PrEP doesn’t work; it is because PrEP is still grossly underutilized by people who would benefit from it. Fewer than 25% of people indicated for PrEP currently use the drug. Hundreds of thousands of Americans who are indicated for PrEP do not get the drug and remain at risk of HIV. A myriad of barriers inhibit its use among the communities most vulnerable to HIV.
It is clear that these access issues were top of mind when DOJ and HHS brought the United States v. Gilead lawsuit in 2019. In the legal complaint it filed in 2019, DOJ highlighted how the very high price of Truvada—a PrEP product sold by Gilead—created one “critical barrier to increasing access to PrEP in the United States.” The complaint also observed that “[m]any AIDS activists and many in the medical community have criticized Truvada’s price in the United States, particularly in light of HHS’s patents, the government’s funding of clinical research on PrEP, and the relatively low cost at which Gilead apparently makes the product.”
As of 2019, Gilead sold Truvada at a price of $21,600/patient/year. Today, Gilead charges even more for Truvada—$22,500/patient/year. It charges the same price for another PrEP product, Descovy. Lower cost generic versions of Truvada have become available in the United States, but there is no generic version of Descovy available to patients in the United States.
Since 2019, the U.S. government’s leverage over the company seems only to have increased. First, Gilead tried to invalidate HHS’s patents outside of the United States v. Gilead litigation, but Gilead’s efforts failed. Second, the judge presiding over United States v. Gilead denied Gilead’s motions to dismiss. Third, the amount of money that Gilead could owe the U.S. government for infringement of HHS’s patents has increased substantially since 2019. In 2019, an analysis published in the New York Times estimated that Gilead’s potential infringement liability could reach $3 billion. In 2020, an independent article published in JAMA found that Gilead’s liability could exceed $4 billion. Since then, Gilead has earned billions more in revenues from PrEP sales within the United States. With each and every new sale, Gilead’s potential liability increases.
Given the urgency of the ongoing HIV epidemic in the United States and the U.S. government’s strong leverage over Gilead, DOJ and HHS must use the United States v. Gilead lawsuit to benefit patients who have been harmed by lack of access to PrEP, and they should do so as quickly as possible. While we applaud DOJ’s and HHS’s decision to bring the United States v. Gilead lawsuit, two years have passed, and the suit has yet to produce any concrete benefits for people with and vulnerable to HIV. United States v. Gilead is not scheduled to go to trial until 2023. At current infection rates, by mid-2023, over 100,000 Americans will have been newly diagnosed with HIV since DOJ and HHS brought the lawsuit.
It is impossible to ignore the fact that earlier and more aggressive action from the U.S. government would likely have benefited hundreds of thousands of Americans diagnosed with HIV since PrEP was approved in 2012. Almost a decade after PrEP’s first FDA approval, still HHS and CDC have yet to develop and implement a national action plan for universal access to PrEP. HHS has committed to end the HIV epidemic by 2030. It cannot do so without universal access to PrEP for all Americans.
We, the undersigned organizations, urge you to pledge and to act to ensure that the United States v. Gilead lawsuit serves as a mechanism to increase access to PrEP across the country, as quickly as possible. We ask that you provide an update on the litigation to stakeholders and to the public at large. Any decision that DOJ and HHS make regarding United States v. Gilead, including any licensing agreements or other settlement, should be made in communication with the communities that will be directly impacted by that decision for years to come.
Specifically, we ask your agencies to:
Publicly commit to investing any and all royalties received from United States v. Gilead to ending the domestic HIV epidemic and increasing access to PrEP. This includes:
Funding organizations that provide support services to people vulnerable to HIV to connect and maintain them in PrEP care;
Covering the cost of drugs, lab visits, and associated clinical care for uninsured patients; and/or
Establishing a federal program aimed at achieving universal PrEP access
Provide relevant updates to the community regarding the status of United States v. Gilead. Namely, we request answers to the following questions:
How do both of your agencies characterize the goals of this litigation? What remedies do you seek?
How much longer should patients expect to wait before this lawsuit increases access to PrEP?
Have U.S. Government attorneys discussed with Gilead potential settlement and licensing terms? If so, what is the status of those discussions?
Meet with representatives from the undersigned organizations to discuss the U.S. government’s strategy in United States v. Gilead, specifically as it pertains to increasing access to PrEP in the United States.
We look forward to your prompt response and answers to the questions outlined above.
Signed,
AIDS Action Baltimore
AIDS Alabama
African American Health Alliance
Alliance of Families for Justice
American Academy of HIV Medicine
AVAC
Callen Lorde Community Health Center
Cascade AIDS Project
Center for Popular Democracy
Doctors for America
Faith for Justice
Freedom, Inc.
Frontline Legal Services
Georgia AIDS Coalition
Health Care Voices
Health Global Access Project
Housing Works
Latinos Salud
Movement for Black Lives
National Black Justice Coalition
People’s Action
PrEP4ALL
SIECUS: Sex Ed for Social Change
Treatment Action Group
Universities Allied for Essential Medicines North America
About Cascade AIDS Project
CAP is a non-profit organization that was founded in 1985 as a grassroots response to the AIDS crisis. As the oldest and largest community-based HIV services provider in Oregon and southwest Washington, we seek to support and empower all people with or affected by HIV, reduce stigma, and provide the LGBTQ+ community with compassionate healthcare. We do so by helping to ensure the health and well-being of our program participants each year through health, housing, and other social services. When the need for affordable, accessible, and culturally affirming primary care services was identified as a community need, we responded by opening Prism Health in 2017. More information can be found at www.capnw.org.
About PrEP4All
Founded in March 2018, PrEP4All is an organization of community members, healthcare professionals, lawyers, and academics all dedicated to increasing access to lifesaving HIV medication. Every member of PrEP4All has been personally affected by the HIV epidemic, and most of us rely on HIV medications every day. As patients ourselves, we have all experienced the shortcomings in the domestic HIV response first hand, whether through arguing with insurance companies refusing to cover our medication, encountering doctors unwilling to refill our prescriptions, or receiving an unexpected bill for $1,800 after our copay assistance has run out. Our biggest strength is our personal experience.
