The Trump Administration’s Suing Gilead Over PrEP

Single pills (brand name Truvada) containing two antiretroviral drugs, emtricitabine and tenofovir disoproxyl fumarate. Truvada is used for pre-exposure prophylaxis, or PrEP, a strategy in which healthy people routinely take antiretrovirals to reduce the risk of becoming infected with HIV. / Image via NIAID (CC)

The United States Government is suing Truvada and Descovy manufacturer Gilead over PrEP patents. The Trump administration announced this legal step last Wednesday night.

“Today, the United States, on behalf of [the Department of Health and Human Services,] filed a complaint in federal district court against Gilead seeking damages for Gilead’s infringement of HHS patents related to pre-exposure prophylaxis (or PrEP) for HIV prevention,” HHS Secretary Alex M. Azar II tweeted while sharing the official department press release. “Gilead must respect the U.S. patent system, the groundbreaking work by [Center of Disease Control] researchers, and the substantial taxpayer contributions to the development of [Truvada and Descovy.] The complaint filed today seeks to ensure that they do.”

The HHS says that Gilead has “willfully and deliberatively induced infringement of the HHS patents.”

The department said as a result, “Gilead has profited from research funded by hundreds of millions of taxpayer dollars and reaped billions from PrEP” through the sale of Truvada and a newer Gilead drug, Descovy. Despite efforts by the government to reach an agreement, the department said, “Gilead has repeatedly refused to obtain licenses for the use of the HHS patents.”

This scenario is a follow-up to several months of discussions around how Gilead has marked up prices for Truvada in the US. In the U.S., Gilead currently charges roughly $2,000 per month for Truvada, which is used for pre-exposure prophylaxis or PrEP. This price is alarming considering the stark contrast to prices abroad. In other countries, the prices can go as little as $210 a month, and that’s before health/medical insurance kicks in. Due to this suspicious pricing, Gilead has garnered ridicule from government officials and LGBTQ, AIDs, and health advocates alike.

The Committee on Oversight and Reform, made up of Chairman Elijah Cummings, Alexandria Oscasio-Cortez, Ayanna S. Pressley, and Ro Khanna, released a letter to Gilead CEO Daniel O’Day in June. The Oversight Committee requested documents and emails between the CDC and Gilead to see if there were some shady business and backdoor dealings causing the CDC to not question this expensive cost to Truvada.

So now, it seems the executive branch is joining the legislative branch in this fight against the expense of Truvada. And given the fact that the government and taxpayers paid to support the creation of PrEP, it’s only right that we don’t get swindled by Gilead in order to use it.

“PrEP is not Gilead’s invention, it’s the American taxpayer’s invention and because [the CDC] invented it and owns four patents protecting that invention, Gilead needs to in some way pay back the American taxpayers,” PrEP4All co-founder James Krellenstein told Out. “That can be in monetary royalties — the Financial Times estimates that Gilead owes at least a billion dollars back to the American taxpayer — but it can also be other things. Like commitments to increase access and make sure PrEP is universally available.” 

“For nearly a decade, Gilead’s price gouging on PrEP has prevented hundreds of thousands of Americans from accessing this technology, despite it being a taxpayer funded invention,” the PrEP4All Collaboration then said in an official statmeent. “If HHS is truly invested in ending the HIV epidemic, it will use these patents as leverage to ensure that everyone who needs PrEP can get it.”

Source: The Washington Post, The New York Times

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