It was reported this morning by The Advocate that the Department of Health and Human Services is suing Gilead Sciences, the makers of Truvada and Descovy, for patent infringement.
The lawsuit argues that the pharmaceutical company has made billions in profits from these drugs due to price gauging, despite the fact that the United States government (via American tax dollars) not only conceived and funded the research into the HIV prevention technology, but it also owns the patent to these drugs for which Gilead allegedly never paid royalties.
A report in The Washington Post, published in March, detailed that the federal government issued $50 million in grants to researchers developing PrEP. The government then patented the use of Truvada, a drug that was previously used for HIV treatment before the FDA approved it to be used as PrEP in 2012.
However, activists claim that Gilead has reaped all of the profits, earning $3 billion from sales of the drug last year alone.
PrEP4All, a collaboration of PrEP activists, alleges that the entire concept of PrEP was discovered by scientists at the Centers for Disease Control and Prevention nearly 20 years ago — not Gilead. Furthermore, they allege that the company hasn’t contributed any money during Truvada for PrEP's entire development. They further allege that despite successful innovation by the CDC, the government has been stagnant in delivering these treatments to the public.
James Krellenstein, co-founder of PrEP4All and #BreakThePatent campaign, specifically alleges that Dr. Jonathan Mermin, the director of the CDC's National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention since 2013, has failed to make a dent in these public health concerns.
“We believe, in particular, that the conduct of Dr. Jonathan Mermin should be carefully scrutinized,” Krellenstein tells Plus. “Dr. Mermin has headed over the division of the CDC that is in charge of both HIV and hepatitis, and despite monumental technology transformation in those fields, Dr. Mermin has failed to ensure that these technologies are able to be accessible to those who need it.”
The consequences of these failures are manifested in the CDC’s own data, Krellenstein alleges.
“We have seen no progress in the reduction of the number of new HIV diagnoses in [Dr. Mermin's] tenure and we’ve seen a dramatic increase in the number of new hepatitis C cases, despite the fact that we have easily available and easily usable cures for hep C.”
Since the introduction of these new hep C cures in 2011, the number of new cases has nearly tripled, skyrocketing from an estimated 17,000 new cases in 2010 to more than 41,200 in 2016.
“Dr. Mermin’s conduct in particular with these patents exemplifies his incompetence,” Krellenstein alleges. “Despite the fact that HIV activists have been struggling since the FDA approval of PrEP back in 2012, Dr. Mermin did not ever think it was necessary to disclose the existence of these patents to anyone in the community, and in fact actively mislead and lied to the PreP4All collaboration last year when we met with him in New York. He falsely stated that the CDC has no control over these very patents that are now being enforced by the Department of Health and Human Services in this lawsuit.”
Truvada is sold on the market for nearly $2,000 per month, though it costs Gilead only $6 to make. As Congresswoman Alexandria Ocasio-Cortez pointed out in an oversight hearing in May examining Gilead’s price gauging, countries like Australia sell generic versions of Truvada for only $8.
“We think there has been too much of a revolving door relationship, particularly with the CDC and Gilead Sciences,” Krellenstein notes. “But what the data shows is that if advocates do their job and be a steadfast watchdog on the federal government, we can force the government to stand up for our own interests.”
Gilead announced earlier this year it would allow competitor Teva to make a generic version of Truvada. Soon after the oversight hearing, the company announced it would be donating up to 2.4 million bottles of Truvada each year for up to 11 years, which would reach approximately 200,000 Americans who are uninsured or at high-risk of transmission.
“What we hope is that this [lawsuit] represents a step in the right direction of the federal government standing up for the American people’s investment in research and development of pharmaceutical trust,” Krellenstein says on behalf of the PrEP4All collaborators, whose research helped spearhead the Washington Post report.
“In the case of Truvada as PrEP, we have an example of where every step — from the invention of the concept to the commercialization of the drug, to the Phase 2 and Phase 3 trials — were paid for by the U.S. taxpayers or by the Gates Foundation, with Gilead not contributing a single cent,” he explains. “We hope this move represents a new commitment by the federal government to stand up for taxpayers and prevent companies like Gilead from price gauging technology they did not even invest in.”
Krellenstein continues, “Our advocacy priorities and priorities in the HIV and LGBTQ community need to now be focused on HHS and the CDC and the Department of Justice to ensure that these patents are used not just to get monetary royalties back from Gilead, but also to make sure they are used to increase access to Truvada and Descovy as PrEP for anyone who needs it.”
“We need to ensure that any monetary damages that are recovered are ultimately redistributed back into the communities that need it most through a comprehensive national HIV prevention program that will guarantee access to HIV prevention technology to every single person who needs it, whether they’re living with HIV or vulnerable to HIV.”