Gilead loses first PrEP patent challenge but vows to defend against HHS lawsuit

Gilead Sciences and the U.S. government are locked in a public dispute over an HIV prevention drug, and now Gilead has lost its first attempt to invalidate patents owned by the federal government. 

The U.S. Patent & Trademark Office (PTO) turned away Gilead’s attempt to strike up a review of two patents the government owns protecting the use of Gilead’s Truvada to prevent HIV. Gilead had argued the patents are invalid because the prevention use was obvious when the government filed for patent protections. 

“Well before” the Department of Health and Human Services (HHS) claims to have invented pre-exposure prophylaxis, or PrEP, “others had conceived of using an antiretroviral therapy” such as Truvada to prevent against HIV transmission, the company argued last year. 

The PTO's Patent Trial Appeal Board (PTAB) didn’t buy the argument. 

After reviewing the case, the patent judges concluded that Gilead has “not met its burden to establish a reasonable likelihood of prevailing” in the challenge. The board decided against striking up inter partes reviews. 

This week’s rulings cover two of four patents Gilead challenged, reports. The board’s other rulings are expected yet this month.

RELATED: Enough hubbub about HHS' Truvada patents, Gilead says. We're challenging them at the PTO 

The decision doesn’t mean the patents are valid, Gilead argued in a statement (PDF). Rather, the PTAB “simply did not find the limited evidence we were permitted to introduce in an IPR was sufficient to justify a full hearing on the merits using its expedited procedure.” 

After Gilead filed its patent challenges at the PTO, HHS turned around and sued the company for patent infringement. HHS said it tried to license the patents to the drugmaker but that Gilead refused multiple times. In the suit, HHS alleges Gilead reaped profits off of taxpayer-funded research. 

Despite this week's setback, Gilead maintains it can still prove the patents are invalid in the ongoing litigation. Gilead has “additional defenses to the government’s lawsuit, beyond those contained in the IPRs, and will vigorously defend itself,” the statement says.  

RELATED: Unsuccessful in licensing talks, feds sue Gilead over PrEP-focused HIV patent 

Even as the sides battle over patent rights, they’re also partners in a free drug program for PrEP. Their initiative kicked off in December and is distributing HIV prevention drugs to uninsured patients around the country. Last May, Gilead agreed to a donation of 2.4 million bottles of PrEP drugs annually.