The U.S. government claims Gilead Sciences has made billions of dollars by capitalizing on an anti-HIV regimen patented by the CDC, while the drugmaker argues the patents are invalid.
, or PrEP, and the CDC contends that its researchers paved the way for the approach at a time others were skeptical it could work.Gilead donated its drug, Truvada, for the CDC’s research at no cost. After results proved promising, the agency urged the company to seek approval from the Food and Drug Administration to use Truvada for PrEP. The FDA granted it in 2012, partially relying on the CDC’s research, and the discovery kicked off a new use for Truvada. Then the partnership soured.
Gilead went on to make $6.7 billion from selling Truvada in the United States over about four years, according to the government’s lawsuit, with PrEP accounting for more than 60 percent of the demand in the first three months of 2019. The CDC had patents for PrEP over those years, but Gilead didn’t pay any royalties to the government.
“Gilead has repeatedly refused to obtain a license from the CDC to use the patented regimens” and “has profited from research funded by hundreds of millions of taxpayer dollars,” the government claims in its lawsuit.The company counters that its research agreements with the CDC required the government to “promptly notify” it of any inventions from the research.
Gilead argues that the CDC’s delay in providing notice denied it the chance to “negotiate a relatively low-cost or royalty-free license” when government researchers first thought they had come up with an invention.. In February 2020, the Patent Trial and Appeal Board declined to review Gilead’s dispute, saying it hadn’t shown a “reasonable likelihood of prevailing.”
The trial over the government’s patent claim will be heard in the U.S. District Court in Delaware and is expected to last six days.
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