A federal jury in Delaware found on Tuesday that the federal government has no claim of ownership of the lucrative HIV-prevention drugs sold by drugmaker Gilead Sciences.
The ruling in an extraordinary patent infringement case was a defeat for the government and the activists who pushed it to assert more forcefully its financial and legal rights to medicines developed with the help of public funding. Trump administration The lawsuit was filed in 2019 In part, this was due to concern about the high price Gilead was charging.
The legal dispute centered on who originated the idea of using Gilead’s drug for people at risk of contracting HIV, or the human immunodeficiency virus, which causes AIDS. The drug’s two versions — Truvada and the more recent Descovy — have made Gilead huge profits.
Federal government attorneys have argued that Gilead violated three state patents protecting the concept of using Truvada to prevent HIV through what is known as PrEP, or pre-exposure prophylaxis. Patents were granted to researchers at the Centers for Disease Control and Prevention for inventions resulting from experiments they conducted on monkeys in the mid-2000s.
But the jury found that none of these patents had been infringed by Gilead and that they were invalid. The government was seeking more than $1 billion in damages from Gilead, the equivalent of the Centers for Disease Control Annual budget for HIV prevention in the United States of America.
Patent law experts said the government’s defeat could embolden pharmaceutical companies to refuse to enter into licensing agreements with the government to share profits from taxpayer-supported research.
Jeremiah Johnson, executive director of advocacy organization PrEP4All, urged the government on Tuesday to appeal the ruling, saying it risked “encouraging other pharmaceutical companies to privatize and profit from publicly developed technology with impunity”.
The United States does collect royalty payments for some inventions made by government scientists, but companies sometimes don’t pay, claiming that the final product was the result of private research and development.
In Truvada’s case, officials at the Department of Health and Human Services tried to get Gilead to license rights to CDC’s patents, but the two sides never reached an agreement.
Deb Tillman, Gilead’s general counsel, said in a statement that the jury’s verdict confirmed the company’s “firm belief” that it always has a right to PrEP. The company said it has spent $1.1 billion on research and development related to Truvada.
The six jurors reached their verdict after a week of listening to thick science detail and testimony from leading HIV experts. Experts said that while drug companies usually sue each other over patent disputes, the case appears to be the first of its kind brought by the government.
And Gilead represented WilmerHale, a high-end corporate law firm. In his closing argument Monday, David Bassett, Gilead’s chief attorney, said the government had exaggerated the importance of an inexpensive “monkey study.”
“The government has acted like an adversary, a sharp-elbowed competitor who wants to claim the right to use Gilead’s proprietary drugs for the treatment of PrEP,” he said.
Walter Brown, the federal government’s lead attorney, told the jury that the company had spent years “benefiting greatly” from the CDC’s inventions, without paying its fair share. Since 2017, the point at which the government said Gilead began violating Centers for Disease Control and Prevention patents, the company has collected $10 billion in revenue from the sale of its PrEP drugs in the United States.
In addition to the CDC’s patented research, the government also spent about $143 million to fund major clinical trials and other studies that paved the way for Truvada’s approval for HIV prevention use, according to Modern analysis.
HIV activists said the public paid multiple times for PrEP, first by contributing to its development and later by shelling out on the drug as Gilead repeatedly raised prices.
“The billions of dollars in revenue that Gilead was making each year on Truvada came from deductibles, health insurance premiums, and tax dollars paid by every American,” said James Krelenstein, a longtime HIV activist.
More than 30,000 people in the United States are newly diagnosed with HIV each year. PrEP, taken daily as a pill, reduces the risk of infection by 99 percent and is seen as crucial to ending the HIV epidemic.
One of the main reasons for the low turnout was that Gilead’s label price for Truvada had soared to $22,000 a year, according to Elsevier Health, the data provider. From 2012 through 2020, Gilead held a monopoly on HIV PrEP in the United States.
Then, in 2021, a wave of competition from generic versions of Truvada brought the price of the drug down to less than $400 a year.
A Truvada product can be manufactured and distributed to one person, at a modest profit, for approx $72 per yearaccording to A.N appreciation From Dr. Robert Grant, a UCLA researcher who helped launch PrEP and testified on behalf of the government in the trial.
Gilead first won approval for Truvada to treat HIV—not prevent transmission—in 2004. At the time, scientists suspected the drug could also protect people from infection in the first place, and the company didn’t plan to develop it for that purpose.
In 2005, CDC researchers began trials in macaques to see if Truvada could prevent transmission of a version of HIV Gilead given free doses of Truvada tablets and placebo pills, but not otherwise involved in the research.
Centers for Disease Control studies showed that Truvada can prevent infection, a discovery that changed the direction of several human studies on HIV prevention
The government has successfully applied for many patents related to research. Government monkey experiments and patent applications cost about $10 million, according to Gilead’s attorneys.
In 2012, Gilead began marketing Truvada as a drug to prevent HIV.
Between 2014 and 2018, officials with the Department of Health and Human Services repeatedly informed Gilead of the CDC researchers’ inventions and urged the company to obtain a license, which likely involved paying royalties on Truvada to the government, according to correspondence filed in court. Gilead never did.
in Congressional hearing In 2019, Gilead CEO Daniel O’Day told lawmakers that “Gilead invented Truvada, no one else.” Soon after, Gilead no avail He sought to have the CDC patents revoked, arguing that other researchers had already considered using Truvada for HIV prevention.
A few months later, the Trump administration filed a lawsuit.