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Our Take: U.S. government sues Gilead Sciences in dispute over PrEP patents

Nov 18, 2019

The Trump administration has filed a lawsuit in a federal district court on behalf of the Department of Health and Human Services (HHS) against Gilead Sciences, seeking damages for alleged infringement of HHS patents related to the use of Truvada and Descovy for pre-exposure prophylaxis (PrEP) for HIV prevention.

Our Take:
At first glance, that doesn’t seem to make much sense — considering that Gilead developed Truvada, a combination of two other drugs that Gilead developed for treating patients with HIV (Viread [tenofovir disoproxil] and Emtriva [emtricitabine]) — so we’ll break it down and provide some context.


When the Food and Drug Administration approved Truvada back in 2004, it was indicated as a treatment for people who were already infected with HIV. Then, in 2012, the FDA approved Truvada for PrEP. In this indication, uninfected people who are at high risk take Truvada every day to lower their risk of infection, should they be exposed to the virus. Incidentally, PrEP also includes other measures, such as practicing safe sex, attending risk reduction counseling, and getting tested for HIV on a regular basis.


Meanwhile, in the mid 2000s, researchers at the Centers for Disease Control and Prevention were investigating the use of HIV drug combinations as a means of preventing HIV infection. Since 2015, HHS has applied for and been granted four patents for this research. In a press statement HHS issued about the lawsuit, the agency states that “[h]undreds of millions of taxpayer dollars funded many of [the CDC’s] trials” and that the patents “entitle HHS to license CDC’s PrEP regimens and receive a reasonable royalty for their use.”


Gilead issued a statement in May in which it said the government “did not invent PrEP, Truvada, or Truvada for PrEP.” The company formally challenged the validity of HHS’ patents in August, stating that published materials “clearly show that well before HHS claims to have invented the concepts of PrEP and PEP [post-exposure prophylaxis] in 2006, others had conceived of using an antiretroviral therapy, including Truvada …, for both forms of prophylaxis.”


In response to the lawsuit, Gilead said it has acted in good faith to come to a resolution with HHS and that the company would be asking the court to stay the litigation until the Patent Office has completed the review Gilead requested in August.


There’s a lot of money at stake, so this “dispute” could get uglier, and it could be a while before it’s settled.


Truvada can cost patients $20,000 or more a year, and Gilead has earned billions annually on sales of the drug. According to Advisory Board, the wholesale price of Truvada has increased about 45% in the last six years.


And yes, as we mentioned above, the government’s lawsuit includes Descovy (emtricitabine/tenofovir alafenamide), another Gilead combination drug originally approved in 2016 as a treatment for HIV infection. The FDA just approved Descovy last month as a PrEP regimen for men and transgender women. (Gilead hasn’t conducted large-scale trials of Descovy as a PrEP regimen in cisgender women yet, which is why the FDA excluded that population from the approval.)


No other drug company sells an FDA-approved PrEP regimen in the U.S., and HIV/AIDS activists have accused Gilead of price gouging. One group, the PrEP4All Collaboration, said, “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.”


In May, HHS touted the fact that the Trump administration had secured a “historic donation of billions of dollars in HIV prevention drugs.” That’s when Gilead agreed to donate up to 2.4 million bottles of Truvada each year to the CDC for uninsured Americans at risk for HIV, through 2030. At the time, the company said it would transition the donation to Descovy if the FDA approved it for use as PrEP.


Gilead said that despite the dispute, it will continue to work with federal agencies, including HHS and CDC, toward ending the HIV epidemic.



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