The U.S. Patent Trial and Appeal Board (PTAB) has decided not to review Gilead’s challenge of two HHS patents on the preventative pre-exposure prophylaxis (PrEP) regimen for HIV.
Gilead and HHS are currently in dispute over four patents that the Centers for Disease Control and Prevention (CDC) holds on the two-dose PrEP regimen.
The board found that Gilead would likely not prevail with its claim that the patents were invalid because a skilled person would have known that administering the two-dose regimen would prevent HIV.
The PTAB decision puts the validity of the patents in the hands of the U.S. District Court for Delaware, where HHS has sued the drugmaker for patent infringement. PTAB still has to decide whether to launch reviews for two remaining patents in the dispute.