U.S. Government Sues Gilead Sciences Over Patent on HIV Drug Truvada

Earlier this month, the Trump administration sued drug maker Gilead Sciences in federal court, alleging that the company made billions of dollars on Truvada for HIV prevention while ignoring government patents. According to the lawsuit, filed by the U.S. Department of Justice, “Gilead has repeatedly refused to obtain a license from CDC to use the patented regimens. Meanwhile, Gilead has profited from research funded by hundreds of millions of taxpayer dollars.” Truvada for PrEP (Pre-exposure Prophylaxis) has been shown to reduce the risk of HIV by up to 99% and the CDC estimated in 2015 that there were more than one million people who could benefit from PrEP. However, like any pharmaceutical drug, Truvada comes with potential risks. In fact, Truvada and other similar tenofovir-based medications have been linked to serious and potentially life-threatening kidney and bone injuries in users, which has led to a surge of lawsuits against Gilead Sciences. If you or someone you know has taken Truvada for HIV treatment or prevention and you have suffered one or more serious side effects, contact an experienced Truvada injury lawyer today to discuss your legal options.

What is Truvada?

Truvada is an emtricitabine/tenofovir disoproxil fumarate (TDF) combination tablet that was sold by Gilead beginning in 2004 as a treatment for people already infected by HIV, the virus that causes AIDS. As a prevention or treatment for HIV, Truvada has been prescribed to hundreds of thousands of people at risk for or already infected by the virus, and since garnering approval for the drug in 2004, Gilead has earned $36.2 billion on Truvada sales, according to the company’s annual reports. In recent years though, Gilead has faced a great deal of criticism for allegedly failing to provide accurate warnings about the potential risk of kidney disease and bone damage from Truvada treatment and for deliberately withholding from the market a safer and more effective alternative known as tenofovir alafenamide fumarate (TAF) in order to increase profits by extending patent protection.

Truvada for HIV Prevention

Around the same time that Truvada was approved by the FDA to treat HIV, the U.S. Centers for Disease Control and Prevention (CDC) was looking for a drug that could curb or even end the HIV/AIDS epidemic in the United States, and discovered during testing that Truvada could also be used to prevent the HIV virus. The government was ultimately awarded the patent in 2015, nine years after originally applying for the patent in 2006. In the meantime, based on human clinical trials conducted by the government, Gilead had won approval for Truvada as a PrEP medication in 2012 and reportedly made billions of dollars off the drug treatment, which costs about $20,000 per year for a single patient. According to the government’s lawsuit, the high cost of Truvada “is a major reason that many at risk for HIV infection in the United States are not currently taking Truvada for PrEP.”

In March 2019, the Washington Post published an article detailing the standoff between the U.S. government and Gilead Sciences over the patent for Truvada for HIV prevention. According to the article, Gilead, which has a monopoly on Truvada, charges between $1,600 and $2,000 for one month’s supply of Truvada, which can be manufactured for a fraction of that cost. Says HIV/AIDS activist and co-founder of the PrEP4All Collaboration, James Krellenstein, “The CDC has all these patents and is allowing Gilead to rip off the American people at the expense of public health.” For its part, Gilead maintains that the government improperly claimed to have invented the use of Truvada for HIV prevention, when the drug was already being used for that purpose “off-label” by the time the CDC applied for the patent.

Potential Side Effects of Truvada

Gilead’s Truvada patent expires in 2021 and Gilead has prepared for that fact by winning approval for a new-generation HIV prevention drug called Descovy, though the government says that its patents apply to Descovy as well. In the meantime, HIV activists say that the government’s latest move against Gilead is the first step towards making Truvada for PrEP more widely available to those engaging in risky sex, but that too poses a potential problem, given the serious side effects that have been linked to Truvada treatment. Gilead Sciences currently faces a growing number of lawsuits filed on behalf of individuals across the country who used Truvada and other similar HIV drugs like Viread, Atripla, Stribild and Complera, and subsequently suffered severe kidney- and bone-related injuries, including bone fractures, kidney failure, chronic kidney disease and tooth loss.