Gilead Sciences Inc. filed for a review of patents held by the U.S. Department of Health and Human Services for HIV drug Truvada.
The Foster City, Calif.-based company filed petitions asking the U.S. Patent and Trademark Office to conduct an inter partes review reexamining the validity of patents granted to the HHS for Truvada's use as a pre-exposure prophylaxis, or PrEP, and post-exposure prophylaxis, or PEP.
Truvada is a combination of two medicines — emtricitabine and tenofovir disoproxil fumarate — and was initially approved in 2004 by the U.S. Food and Drug Administration to treat HIV, the virus that causes AIDS. In 2012, the FDA approved the use of Truvada as a PrEP treatment to prevent HIV transmission.
The concept of using a combination antiretroviral therapy as PrEP and PEP treatments was already being discussed in published materials as early as 2004 before the U.S. health agency patented its claims in 2006, Gilead said in a news release.
On Aug. 19, the Financial Times reported that Gilead did not seek exclusivity when it applied for the FDA's approval to use Truvada as PrEP treatment in 2012. This could mean that the company owes the U.S. government at least $1 billion in royalties and damages, the report added.
Currently the only FDA-approved medicine for PrEP, Truvada is at the heart of the U.S. government's new effort to end HIV/AIDS in the nation.
Gilead is facing scrutiny over the high price of the drug, which costs nearly $1,800 per month, despite the medicine not undergoing any changes, from its list price of about $800 per month in 2004. For the first half of 2019, Truvada generated $1.32 billion in sales.
In May, Gilead CEO Daniel O'Day was on Capitol Hill to defend the price of Truvada and disputed allegations that anyone other than the company had invented the medicine.
Four generic versions of Truvada have been approved by the FDA but will only enter the U.S. market by Sept. 30, 2020. Previously, a Truvada generic was expected in 2021.
