Gilead loses again in PrEP patent fight with HHS, sending dispute to federal court

Gilead
Following a similar decision earlier this month, Gilead has lost a patent challenge at the U.S. Patent & Trademark Office. (Gilead China)

In its high-profile patent feud with the U.S. government over HIV prevention medicines, Gilead Sciences has suffered its second consecutive loss. 

Following a similar decision earlier this month, the U.S. Patent & Trademark Office’s Patent Trial and Appeal Board decided not to strike up inter partes reviews (IPR) of patents held by the U.S. government. Gilead had challenged the patents in August, but for the second time this month, the board decided Gilead wouldn’t be likely to succeed.

Gilead “has not demonstrated a reasonable likelihood that it would prevail with respect to at least one of the claims,” the PTAB said in a Thursday ruling. Gilead markets Truvada and Descovy for HIV prevention, or PrEP. 

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Last year, the company argued that “well before” the U.S. Department of Health and Human Services claims to claims to have invented pre-exposure prophylaxis, “others had conceived of using an antiretroviral therapy” such as Truvada to prevent against HIV transmission. The company challenged 4 HHS patents on Truvada, and the PTAB decided against taking up a review for each.

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

Following the loss earlier this month, Gilead argued the decision didn’t mean the patents are valid. The company maintained 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.” 

The drugmaker and U.S. government have been locked in the public patent dispute since at least last year. After Gilead filed its patent challenges at the PTO, HHS sued the company for patent infringement in federal court. HHS tried to license the patents to the drugmaker, the agency said, but Gilead refused multiple times. In the suit, HHS alleges Gilead has reaped profits off of taxpayer-funded research in PrEP. 

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

After the loss earlier this month, the company said it still plans to defend against HHS’ lawsuit. The drugmaker has “additional defenses to the government’s lawsuit, beyond those contained in the IPRs, and will vigorously defend itself,” it said in a statement. 

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. Gilead's Truvada will face generics later this year, and the company is working to switch patients to the newer Descovy.

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