The Trump administration on Wednesday filed a lawsuit against Gilead Sciences claiming the drugmaker's sales of the HIV-prevention drugs Truvada and Descovy violate HHS patents.

Your cheat sheets for understanding health care's legal landscape

The announcement comes after the administration and Gilead earlier this year reached a deal under which Gilead agreed to donate Truvada to millions of U.S. residents as part of the administration's goal to eliminate new transmissions of HIV/AIDS in the United States within the next 10 years.

Background

Truvada is a brand-name pre-exposure prophylaxis (PrEP), which can be more than 90% effective at preventing HIV infection when the medication is taken daily. Truvada and Descovy, a separate PrEP drug manufactured and sold by Gilead that received FDA's approval last month, are the only forms of PrEP available in the U.S. market. FDA last year approved a generic version of Truvada, manufactured by Teva Pharmaceuticals, but it is not yet available in the United States.

Advocates have argued that rising prices for Truvada, as well as insurance changes that have shifted more costs onto patients, have inhibited public health officials' efforts to increase use of PrEP. The wholesale price for Truvada has increased by about 45% since FDA approved the drug six years ago. Truvada's list price as of July 2018 was nearly $2,000 for a 30-day supply, and the drug generates billions of dollars in annual revenue for Gilead.

According to the Washington Post, Gilead originally developed Truvada to treat HIV, not to prevent it. HHS claims that CDC researchers discovered the drug could be used for HIV prevention in the mid-2000s, and HHS consequently filed and received four patents covering the PrEP prevention regimens for which Truvada and Descovy are used today. HHS said the patents entitle the department "to license CDC's PrEP regimens and receive a reasonable royalty for their use."

But Gilead has argued that independent researchers had discussed the idea of using Truvada as an HIV prevention drug before HHS applied for the patents. As such, Gilead has disputed HHS' patents, and in August filed a formal challenge to the patents.

Lawsuit details

HHS in a release said it filed the lawsuit because Gilead had "willfully and deliberatively induced infringement of the HHS patents" for Truvada's and Descovy's PrEP prevention regimens, which HHS said was developed by CDC researchers. As a result of the alleged patent infringement, "Gilead has profited from research funded by hundreds of millions of taxpayer dollars and reaped billions from PrEP through the sale[s] of Truvada and Descovy," HHS said.

HHS said it has tried to reach an agreement with Gilead regarding the patent issue, but "Gilead has repeatedly refused to obtain licenses for the use of the HHS patents." The department noted that "two other companies that manufacture generic equivalents of Truvada for PrEP in foreign countries have agreed to licenses with HHS."

Comments

HHS Secretary Alex Azar said, "Gilead must respect the U.S. patent system, the groundbreaking work by CDC researchers, and the substantial taxpayer contributions to the development of these drugs. The complaint filed today seeks to ensure that they do."

HIV/AIDS activists said the lawsuit marks the "first step" toward expanding access to Truvada, the Post reports. The PrEP4All Collaboration said, "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 group added, "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."

According to Modern Healthcare, Gilead on Thursday said it would continue donating its PrEP drugs to U.S. residents despite the lawsuit."Despite this patent dispute, Gilead will continue to work collaboratively with federal agencies, including HHS and CDC, on efforts to end the HIV epidemic in the United States," the company said in a statement. It continued, "We remain committed to supporting the government's efforts to substantially increase the number of people at risk for HIV who have access to PrEP through our historic donation and through our own ongoing efforts to address the social and structural barriers to care" (Victor, New York Times, 11/7; Rowland, Washington Post, 11/7; HHS release, 11/6; Morrison, Washington Examiner, 11/6; Ross Johnson, Modern Healthcare, 11/7).