Gilead Wins Key Patent Rights Suit Over HIV Prevention Drug PrEP

A federal jury in Delaware on Tuesday found that the federal government has not claimed ownership of a lucrative drug marketed by drug company Gilead Sciences to prevent HIV.

The extraordinary patent infringement lawsuit ruling is a defeat for governments and activists who have put pressure on them to more aggressively assert their financial and legal rights to drugs developed with the help of public funds. I meant. One of the reasons the Trump administration filed lawsuits in 2019 was concern over the high price Gilead was charging.

The legal battle centered around who devised the idea of ​​using Gilead’s medicines in people at high risk of contracting HIV or the human immunodeficiency virus, which causes AIDS. His two versions of the drug, Truvada and the new Deskovy, made huge profits for Gilead.

Federal attorneys had alleged that Gilead violated three government patents protecting the concept of using Truvada to prevent HIV, known as PrEP (pre-exposure prophylaxis). These patents were granted to researchers at the Centers for Disease Control and Prevention for inventions that resulted from experiments in monkeys in the mid-2000s.

However, a jury found that Gilead did not violate any of these patents and was invalid. Equivalent to. Annual budget for HIV prevention in the United States.

A patent law expert said the government’s defeat could cause pharmaceutical companies to refuse to enter into licensing agreements with the government to share in profits arising from taxpayer-backed research.

Jeremiah Johnson, executive director of advocacy group PrEP4All, told the government Tuesday that the verdict “encourages other drug companies to privatize publicly developed technology and profit from it with impunity.” Yes,” and asked for an appeal.

The U.S. already collects royalty payments for some inventions made by government scientists, but corporations claim that the final product is the result of private sector research and development. We may refuse.

In Truvada’s case, officials from the Department of Health and Human Services tried to get Gilead to license the rights to the CDC patent, but the two sides failed to reach an agreement.

Gilead general counsel Deb Telman said in a statement that the jury’s verdict supports the company’s “long-standing belief” that it will always have the rights to its PrEP drugs. , said it spent $1.1 billion on research and development related to Truvada.

A jury of six reached its verdict after a week of listening to meticulous scientific detail and testimony from leading HIV experts. Pharmaceutical companies typically sue each other over patent disputes, but this appears to be the first time a government has filed a lawsuit of this kind, experts say.

Gilead was represented by Wilmer Hale, an elite corporate law firm. In closing arguments Monday, Gilead’s lead attorney, David Bassett, said the government overstated the importance of cheap “monkey research.”

“The government has acted like an adversary, a sharp competitor who wants to claim the right to use Gilead’s own drug for PrEP for themselves,” he said.

The federal government’s lead attorney, Walter Brown, told jurors that the company had spent years “making a substantial profit” from the CDC’s invention without paying back its fair share. Since 2017, when the government said Gilead began infringing on his CDC patents, the company has generated his $10 billion in revenue selling drugs for his PrEP in the United States.

In addition to the patented CDC study, the government also spent about $143 million in major clinical trials and other research to pave the way for Truvada’s approval for HIV prevention use, he said. Recent analysis.

HIV activists said people have paid for PrEP many times. At first, he contributed to its development, and later, Gilead repeatedly increased the price, so he spent a lot of money on this drug.

“The billions of dollars in revenue that Gilead makes each year in Truvada come from the deductibles and health insurance premiums and taxes that every American pays,” said longtime HIV activist James Cllenstein. Told.

More than 30,000 people are newly diagnosed with HIV each year in the United States. PrEP, taken daily as a pill, reduces the risk of infection by 99% and is considered essential in ending the HIV epidemic.

almost 1.2 million People in the United States are at increased risk of contracting HIV through sex and sharing needles.only about a quarter Among those who may benefit from PrEP are taking PrEP.

According to data provider Elsevier Health, one of the main reasons for the low penetration is that Gilead’s Truvada sticker price has risen to $22,000 a year. From 2012 to 2020, Gilead monopolized his PrEP for her HIV in the US.

Then, in 2021, a wave of competition from generic versions of Truvada pushed the price of the drug below $400 a year.

A single supply of Truvada can be manufactured and distributed for a nominal profit. $72/year,according to estimate From University of California researcher and PrEP pioneer Dr. Robert Grant, who testified on behalf of the government in court.

Gilead first obtained approval in 2004 for Truvada to treat HIV, but not to prevent transmission. use.

In 2005, CDC researchers began experiments on macaques to see if Truvada could block transmission of a version of HIV.

CDC’s the study Showing that Truvada can prevent infections, the findings have changed the direction of several human studies on HIV prevention.

The government has successfully applied for several patents related to this research. According to Gilead’s attorneys, the government’s monkey experiments and patent filings cost about $10 million.

In 2012, Gilead began marketing Truvada for HIV prevention.

From 2014 to 2018, Department of Health and Human Services officials repeatedly notified Gilead of the inventions of CDC researchers and urged the company to obtain a license. This will likely involve paying the government for the use of Truvada, according to correspondence presented in court. Gilead did not.

and congressional hearings In 2019, Gilead CEO Daniel O’Day told lawmakers that “Gilead, no one else, invented Truvada.”Immediately after Gilead We’re screwed The CDC tried to revoke the patent, claiming that other researchers had already considered using Truvada to prevent HIV.

A few months later, the Trump administration filed a lawsuit.

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