The U.S. Patent Trial and Appeal Board (PTAB) denied Gilead’s request to review two HHS patents for the use of Truvada (emtricitabine/tenofovir) for prevention of HIV infection.
The board previously turned down Gilead’s request for a review of two related patents for the pre-exposure prophylactic (PrEP) regimens on the same grounds.
The HIV drugmaker has been at odds with HHS over the validity of four patents that the Center for Disease Control and Prevention (CDC) holds on the two-drug PrEP regimen. Gilead said it challenged the patents as “the first step” in resolving the ongoing dispute.
PTAB found that Gilead would not prevail in its argument that the patents are invalid because a skilled person would have known to combine the two medicines to prevent HIV.
The latest decision ends the drugmakers’ Truvada patent challenges before the board. The matter is now in the hands of the U.S. District Court for the District of Delaware, where HHS has sued the drugmaker for patent infringement.