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The makers of the blockbuster HIV drug Truvada has filed a lawsuit against the U.S. government, claiming that the U.S. Centers for Disease Control and Prevention (CDC) breached a contract with Gilead, when it secured patents on the lucrative use of the drug to prevent the development of HIV.
Gilead announced the Truvada lawsuit in an April 24 press release, indicating that the U.S. government violated four Material Transfer Agreements (MTAs) and a Clinical Trial Agreement entered into by the company and the CDC.
The contracts were used to govern a collaboration that resulted in Truvada being used for pre-exposure prophylaxix (PrEP), and Gilead claims the contracts included provisions with a promise by the CDC not to seek patent protection on any inventions that came from the 15-year collaboration with the drug maker.
The Gilead lawsuit claims the government violated that agreement when the U.S. Department of Health and Human Services filed for Truvada patent protection in 2006.
The case is the latest salvo between the federal government and Gilead, over who actually owns the patent for the HIV drug. In November 2019, the U.S. Department of Justice announced the filing of its own patent lawsuit against Gilead, indicating that the government spent hundreds of millions of dollars on clinical studies, and now Gilead is profiting by selling the drugs at highly inflated prices to the taxpayers who helped created it.
Gilead is allegedly infringing on four patents owned by the U.S. Department of Health and Human Services (HHS) through its sale of Truvada and Descovy as pre-exposure prophylaxix (PrEP), according to the lawsuit. The two HIV drugs are believed to be 99% effective at preventing the transmission of HIV when taken daily by those without the disease.
According to the lawsuit, Gilead originally obtained FDA approval for the drugs to be used in combination with other treatments. However, in the early 2000’s, researchers at the U.S. Centers for Disease Control and Prevention (CDC) created new regimens to prevent the spread of HIV. Those regimens were patented by the U.S. government.
Gilead then began to sell the drugs, emtricitabine and tenofovir, which had previously only been for treatment of already infected persons, as Trudava for PrEP, and has generated billions of dollars in sales among individuals who are at high risk of developing HIV.
Gilead’s response with this latest lawsuit claims the federal government’s lawsuit is invalid, because it should not have gotten the patents in the first place. The company’s attorneys claim it has suffered reputational harm and unnecessary legal fees due to the federal lawsuit and seeks a declaration of contract breach and compensatory damages.
In addition to the legal battle with the Justice Department, Gilead faces a growing number of individual Truvada lawsuits filed by users of the HIV drug who have experienced bone and kidney problems caused by tenofovir disoproxil fumarate (TDF) contained in the medication.
Those plaintiffs claim that Gilead knew about a safer alternative in 2004, known as tenofovir alafenamide (TAF), which is used in Descovy and other drugs introduced in recent years, yet held off on development of the newer drugs until Truvada and other TDF-based drugs started facing generic competition.