“We are pleased with today’s favorable jury verdict,” Deb Telman, Gilead’s general counsel, said in a statement. “The jury determined that Gilead has not infringed the U.S. government’s patents and that the patents are invalid.” The Justice Department declined to comment Tuesday.
The verdict amounts to a big blow to the department, which sued Gilead in 2019 in one of its most muscular efforts in recent years to enforce its patent rights. The government accused Gilead of infringing on patents obtained by the U.S. Centers for Disease Control and Prevention, raking in a multibillion-dollar windfall enabled by the agency’s pioneering research.
Gilead, however, contended that the CDC’s patents were invalid and won a separate federal court ruling that the government breached contracts over research.
The dispute goes back to the mid-2000s, when CDC scientists discovered that combining two drugs used to treat HIV could effectively prevent the spread of the virus that causes AIDS. The regimen is called pre-exposure prophylaxis, 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, to 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 that approval in 2012, partially relying on the CDC’s research, and the discovery kicked off a new use for Truvada.
That collaboration frayed as the CDC tried to license its patents to Gilead, and the drugmaker balked. Gilead went on to make billions selling Truvada, and paid no royalties to the government.
Gilead had previously challenged the CDC’s patents, but the Patent Trial and Appeal Board declined to review Gilead’s dispute in February 2020, saying it hadn’t shown a “reasonable likelihood of prevailing.”
The jury in Delaware federal court, however, found that specific claims in three patents at issue were invalid because they could have been anticipated or were obvious, according to the verdict sheet.
Organizations advocating for expanding access to PrEP had closely followed the litigation, hoping that a government victory could create a revenue stream to make the treatment more available. One group, PrEP4ALL, expressed disappointment Tuesday, saying “American taxpayers have been robbed once again.”
If the verdict stands, the group said, “it will not only perpetuate harm to the American people but also threaten to set a dangerous precedent, encouraging other drug companies to privatize and profit from publicly developed technology with impunity.”
