Gilead challenges Government over patents on preventative HIV drug Truvada

pharmafile | August 22, 2019 | News story | Research and Development, Sales and Marketing AIDS, CDC, Gilead, HIV, IP, PrEP, Truvada, government, patents 

Gilead is challenging the US Government’s patents on PrEP drug Truvada.

The Foster City firm has submitted a challenge to the US Patents and Trademark Office (PTO) over the Department of Health and Human Service (HHS) patent on preventative HIV drug Truvada.

In a statement from August 21, Gilead said: “We strongly believe that the patents granted to HHS since 2015 for PrEP and PEP are not valid.”

The challenge comes after Gilead CEO Daniel O’Day was questioned over the price of Truvada at a US congressional hearing in May 2019. Truvada currently costs more than $21,000 a year in the United States.

While Gilead developed Truvada as a treatment for HIV, the CDC have a patent on the drug’s use as a pre-exposure prophylaxis after its ability to prevent transmission of HIV was discovered in a government funded study in a CDC primate research lab in Atlanta. As of yet, Gilead has not come to an agreement with the Government over royalties on Truvada.

The researchers who discovered Truvada’s use as PrEP, Dr Robert Grant, from the University of California and Dr Thomas Folks from the CDC, also received $50 million in federal funding for their research. Gilead provided the researchers with free samples of Truvada.

Now, the challenge to the CDC’s patent comes as Gilead claim that “Published materials clearly show that well before HHS claims to have invented the concepts of PrEP and PEP in 2006, others had conceived of using an antiretroviral therapy, including Truvada… for both forms of prophylaxis.”

The statement claims that “guidelines published in 2004 recommended administering combination antiretrovirals — including Truvada — to certain categories of “high risk” individuals before an HIV exposure, while the Center for Disease Control and Prevention’s (CDC) own 2005 guidelines recommended Truvada for prophylaxis immediately after exposure.”

Louis Goss

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