Gilead loses key patent challenge over best-selling HIV drug
Gilead won’t easily rid of itself of this HIV patent challenge.
Last year, the Department of Health and Human Services said that it owned some of the patents for Gilead’s best-selling HIV prevention drug, Truvada, also known as PrEP. Gilead responded by arguing in court that HHS’s patents were invalid.
Today, a US Patent and Trademark Office panel ruled that Gilead was likely to lose its challenge.
The ruling won’t decide the larger issue and Gilead still has two patent challenges pending before the USPTO. But it offers a significant win for both HHS and AIDS activists in their efforts to force Gilead to pay the federal government royalties on a drug that earned the company $2.6 billion last year.
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.