Gilead loses two more patent challenges on HIV pill, setting up courtroom fight in Delaware

Gilead sustained two more losses in their efforts to rid themselves of an activist-backed patent lawsuit from the US government over a best-selling HIV pill.

Urged on by activists seeking to divert a portion of Gilead?s revenue to clinics and prevention programs, the Department of Health and Human Services made a claim to some of the patents for the best-selling HIV prevention drug, Truvada, also known as PrEP. Gilead responded by arguing in court that HHS?s patents were invalid.

Today, the US Patent and Trademark Office ruled that Gilead was likely to lose the last two of those challenges as well. The USPTO ruled against Gilead on the first two patents earlier this month.

The ruling is a significant win for HHS and activists in their efforts to collect on Gilead?s revenue. ?It means that the case will now be decided in federal court in Delaware where, three months ago, the HHS filed a suit against Gilead for infringing on its patents and refusing to sign a licensing deal.

It is highly unusual for the federal government to sue pharma companies over intellectual property, although it routinely licenses out patents that came out of government-backed research. HHS said they tried to work out such a deal with Gilead for over a year, but Gilead maintained the government didn?t have rights to the patent.

HHS has pointed in part to the nearly $50 million of federal grants that backed HIV prevention work by San Francisco AIDS foundation researcher Robert Grant and CDC researcher Thomas Folks. Gilead said others had already formulated the idea of using an HIV drug for pre-exposure prophylaxis, pointing to guidelines published in 2005 by the Center for HIV Identification, Prevention, and Treatment Services and AIDS Partnership California.

The federal government?s unusual pursuit has been fueled in part by AIDS activists, who have criticized the $21,100 price tag Gilead placed on PrEP. They say government royalties could be used to fund treatment and education programs that will expand access to the drug.

The high price Gilead has charged, along with educational and other barriers, has helped lead?to wide racial, geographic and economic disparities in who has access to the drug and where the HIV epidemic still reaches crisis levels.

Truvada, a pill, ?is more than 90% effective in preventing HIV if taken properly. Gilead has raised the price by more than $10,000 since it was introduced in 2004, when they charged $650 per month, or $7,800 per year.

The company has noted that its assistance programs curb costs for many patients and last year it donated enough of PrEP to cover 200,000 patients for 11 years.

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