US loses key case over rights to HIV prevention drugs
A federal jury in Delaware found Tuesday that the federal government has no proprietary claim to lucrative HIV prevention drugs sold by the pharmaceutical company Gilead Sciences.
The verdict in an unusual patent infringement case has defeated the government and activists who have pushed it to more aggressively assert its financial and legal rights to drugs developed using government money. The Trump administration filed the lawsuit in 2019 in part over concerns about the high price Gilead was charging.
The legal dispute centered on who came up with the idea of using Gilead medication for people at high risk of contracting HIV, or the human immunodeficiency virus, which causes AIDS. The two versions of the drug — Truvada and the newer Descovy — have brought huge profits to Gilead.
Federal government lawyers had argued that Gilead had violated three government patents protecting the concept of using Truvada to prevent HIV through what is known as PrEP, or pre-exposure prophylaxis. The patents were issued to researchers at the Centers for Disease Control and Prevention for inventions that resulted from experiments they conducted on monkeys in the mid-2000s.
But the jury ruled that Gilead had not infringed any of those patents and that they were invalid. The government had sought more than $1 billion in damages from Gilead, equal to that of the CDC annual budget for HIV prevention in the United States.
Patent law experts said the government’s defeat could encourage drug companies to refuse to enter into licensing deals with the government to share in the profits generated from taxpayer-backed research.
Jeremiah Johnson, executive director of the advocacy organization PrEP4All, urged the government on Tuesday to appeal the verdict, saying it risked “encouraging other pharmaceutical companies to privatize with impunity and take advantage of publicly developed technology”.
The United States already collects royalty payments for some government scientist inventions, but sometimes companies won’t pay because they claim the end product is the result of private sector research and development.
In Truvada’s case, officials from the Department of Health and Human Services tried to get Gilead to license the rights to the CDC patents, but the two sides never reached an agreement.
Gilead general counsel Deb Telman said in a statement that the jury’s verdict reaffirmed the company’s “longstanding belief” that it has always held the rights to the drugs for PrEP. The company has 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 dense scientific detail and testimony from leading HIV experts. While drug companies usually sue each other over patent litigation, the case appeared to be the first of its kind brought by the government, experts said.
Gilead was represented by WilmerHale, an elite corporate law firm. In his closing argument Monday, Gilead’s chief attorney, David Bassett, said the government had exaggerated the importance of a cheap “monkey study.”
“The government has acted as an adversary, a sharp-elbowed competitor seeking to claim for itself the right to use Gilead’s proprietary drugs for PrEP,” he said.
Walter Brown, the federal government’s lead attorney, told the jury that the company had “benefited lavishly” from the CDC’s inventions for years without paying back its fair share. Since 2017, when the government said Gilead had begun infringing CDC patents, the company has collected $10 billion in revenue from sales of its PrEP drugs in the United States.
In addition to the patented CDC study, the government also spent approximately $143 million funding key clinical trials and other studies that led to Truvada’s approval for HIV prevention use, according to a recent analysis.
HIV activists said the public paid for PrEP multiple times, first by contributing to its development and later by paying for the drug when Gilead repeatedly raised prices.
“Those billions of dollars in revenue that Gilead earned each year on Truvada came from the deductibles and health insurance premiums and tax dollars that every American pays,” said James Krellenstein, a longtime HIV activist.
Each year, more than 30,000 people in the United States are newly diagnosed with HIV. PrEP, taken daily as a pill, reduces the risk of infection by 99 percent and is seen as crucial to ending the HIV epidemic.
About 1.2 million people in the United States are at increased risk of contracting HIV through sex or shared needles. But only about a quarter of those who could benefit from PrEP use it.
A major reason for the low adoption was that Gilead’s sticker price for Truvada rose to as much as $22,000 a year, according to Elsevier Health, a data provider. From 2012 through 2020, Gilead had a monopoly on PrEP for HIV in the United States.
Then in 2021, a wave of competition from generic versions of Truvada pushed the price of the drug down to less than $400 a year.
A single person’s supply of Truvada can be produced for a modest profit and distributed for approx $72 per yearsaid one estimation from dr. Robert Grant, a University of California researcher who helped pioneer PrEP and testified on behalf of the government at the trial.
Gilead first received approval for Truvada in 2004 for the treatment of HIV – not to prevent transmission. At the time, scientists doubted that the drug could even protect humans against infection, and the company had no plans to develop it for that purpose. usage.
In 2005, CDC researchers began experiments in macaque monkeys to see if Truvada could block the transmission of one version of HIV. Gilead provided free doses of Truvada and placebo pills but was otherwise not involved in the study.
The CDCs studies showed that Truvada could prevent infections, a discovery that changed the direction of several human studies on HIV prevention
The government has successfully applied for several patents related to the research. The government’s monkey experiments and patent filings cost about $10 million, according to Gilead’s lawyers.
In 2012, Gilead began marketing Truvada as a drug to prevent HIV
Between 2014 and 2018, officials from the Department of Health and Human Services repeatedly informed Gilead of the CDC researchers’ inventions and urged the company to acquire a license, likely involving royalties from Truvada to the government must be paid, according to correspondence filed in court. Gilead never did.
At one congressional hearing in 2019, Daniel O’Day, Gilead’s CEO, told lawmakers that “Gilead invented Truvada, nobody else.” Soon after, Gilead in vain tried to get the CDC patents canceled, arguing that other researchers had already considered using Truvada to prevent HIV
A few months later, the Trump administration sued.