Federal Government Sues Gilead Over PrEP Patents

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Government says taxpayers own HIV prevention drugs

The federal government sued Gilead Sciences earlier this month, claiming the drug company infringed on government patents on the idea of preventing HIV with a daily pill, The New York Times reported

The lawsuit alleges that Gilead exaggerated its role in developing HIV prevention drugs and ignored the part that Centers for Disease Control and Prevention scientists played in the drugs creation. The government says these lifesaving drugs were developed using taxpayer money and that Gilead is ignoring the validity of federal patents

The lawsuit was filed Nov. 6 by the Department of Health and Human Services and marks an important turning point in the fight to make HIV prevention more accessible to those who need it. The current cost of a PrEP prescription is prohibitive to most Americans, coming in at about $20,000 a year. 

At this point, it is unclear whether or not this lawsuit could have an impact on the cost of PrEP treatment, but it is a welcome step in that fight.

Pre-exposure prophylaxis, or PrEP, is a daily treatment to help prevent people from contracting HIV. Truvada for PrEP was the only pill approved by the U.S. Food and Drug Administration until recently when the agency approved a new, potentially safer daily treatment called Descovy for PrEP. Both Truvada and Descovy are manufactured by Gilead.  

Gilead has come under fire not only for the prohibitive costs of PrEP treatments, but also for allegedly choosing to develop Truvada over Descovy first, even though the main ingredient in Descovy was shown to be safer than the main ingredient in Truvada. 

HIV prevention Truvada PrEP

Tenofovir disoproxil, or TDF, is the main chemical in Truvada, Truvada for PrEP and a handful of other Gilead drugs used to treat HIV. TDF drugs have been linked to dangerous kidney issues, including decreased kidney function and kidney failure.  They have also been linked to bone issues, including bone and tooth loss, a potential symptom of decreased kidney function. 

Gilead developed TDF in the 1990s alongside another chemical effective in the treatment of HIV called tenofovir alafenamide, or TAF. According to its own studies, Gilead apparently knew that TDF drugs were more damaging to patients’ kidneys and bones compared to TAF drugs, which were shown to be much safer and just as effective. 

Gilead, however, sought approval for TDF drugs in the early 2000s, and only sought approval for TAF drugs once the patents for TDF—and, therefore, Gilead’s market exclusivity—were set to run out. 

Now, Gilead is facing a lawsuit from the federal government, disputing the role Gilead played in the development of these drugs for HIV prevention. 

Truvada Lawsuits

People who took Truvada and other TDF drugs and later developed kidney or bone problems are now filing lawsuits against Gilead. The lawsuits accuse Gilead of negligently designing a drug it knew could cause serious side effects and that the company had a viable and safer alternative at its 

If you took Truvada, Truvada for PrEP, Viread, Atripla, Complera, or Stribild, and suffered kidney or bone issues, you may be entitled to financial compensation. The experienced Truvada attorneys at Schmidt National Law Group have been in the fight against Gilead since the beginning. 

Call us at 800-631-5656 today to speak with a member of our legal team to see if you qualify for a Truvada Lawsuit.