Enough hubbub about HHS Truvada patents, Gilead says. We are challenging them at the PTO

Drugmakers have often lambasted the U.S. Patent and Trademark Offices (PTOs) inter partes review system, but now Gilead Sciences is hoping to use it to its advantage. The drugmaker is taking on the U.S. government, arguing the Department of Health and Human Services patents covering preventive uses of its HIV drug Truvada are invalid. Gilead says it stronglybelieves HHS pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) patents for Truvada granted since 2015 are invalid. It's asking the PTO to review and invalidate them accordingly. The company hasn't acted on that belief until now, but Gilead says that “well before” HHS claims to have invented PrEP and PEP, “others had conceived of using an antiretroviral therapy” such as Truvada for “both forms of prophylaxis.” The company pointed to unspecified 2004 guidelines recommending combo antitretrovirals for “high risk” individuals before HIV exposure. Centers for Disease Control and Prevention guidelines in 2005 recommended Truvada for prophylaxis immediately after exposure, the company says. Government patents covering Gilead’s Truvada have made the rounds in the press lately, and the company figures the ongoing debate is “a distraction from the important work being done by Gilead and its many community partners to reduce barriers to PrEP."

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