Tensions erupted between Gilead Sciences and the Centers for Disease Control and Prevention (CDC) recently when the pharmaceutical giant was sued in U.S. District Court by the Trump administration for the billions of dollars raked in from HIV prevention therapy, while overtly ignoring government patents.

The patent infringement case comes as political anger has risen over skyrocketing drug prices, and it signals there has been a shift in a relationship that was once mostly collaborative. Gilead Sciences, based in San Francisco, has worked with the CDC for years to fight HIV and has even provided free medication for government experiments. The company has also worked to enlarge the reach of hepatitis C treatment.

The new lawsuit, however, describes how Gilead began in 2015 to repeatedly ignore CDC patents already in place for Truvada for PrEP, an HIV prevention drug. The suit was filed on behalf of the Department of Health and Human Services.

Gilead Defied Patent

The lawsuit claims: “Gilead has repeatedly refused to obtain a license from CDC to use the patented regimens.” Filed in Delaware federal court by the Justice Department, the lawsuit further states, “Meanwhile, Gilead has profited from research funded by hundreds of millions of taxpayer dollars. Indeed, Gilead has reaped billions from PrEP … but has not paid any royalties to CDC.”

This unusual case has been filed by the Trump administration as it readies an initiative to wipe out new cases of AIDS and HIV by the year 2030. The plan hinges on a wider distribution of the preventative medication.

Back in 2004, Gilead sold Truvada as a combination tablet to treat individuals already infected with the HIV virus. In the meantime, though, the CDC had proven in its Atlanta government labs that Truvada is effective as a preventative against HIV in monkeys. The CDC then filed applications for patents that were granted to the government during 2015.

However, back in 2012, the Food and Drug Administration approved the preventative regimen, and Gilead began taking in billions of dollars by marketing Truvada for PrEP, shown to be over 96 percent effective at blocking HIV. The high price tag the manufacturer puts on the medication has drawn outrage from activists and congressional members. Currently, an individual pays an astronomical $20,000 for one year’s treatment. In its suit, the government notes that the high cost “is a major reason that many at risk of HIV infection in the United States are not currently taking Truvada for PrEP.”

Recently, Gilead gained approval to market a similar new medication for HIV prevention, Descovy. The approval comes as Gilead faces the opening of generic competition for Truvada next year. The government claims that the same patents it holds applying to Truvada also apply to Descovy.

The Washington Post highlighted the standoff between Gilead and the National Institutes of Health and the CDC over the Truvada for PrEP patent. A March article reported on the frustration circling among researchers and HIV/AIDS activists due to the government’s failure to take legal action against Gilead’s defiance, even though the government was clearly given patents in 2015.

Gilead’s CEO Says Government Patent Invalid

An article in April saw the Washington Post reporting on the Justice Department’s newly opened review of the patent. HHS Secretary Alex Azar released news that the government has filed this lawsuit to guard the public’s investment in HIV prevention. “Gilead must respect the U.S. patent system, the groundbreaking work by CDC researchers, and the substantial taxpayer contributions to the development of these drugs,” said Azar. “The complaint filed today seeks to ensure that they do.”

Gilead expressed surprise at the lawsuit. The company’s stock fell 2.2 percent by the stock market’s closing time on November 7. The manufacturer said, “Gilead has acted above board and in good faith to come to a resolution with HHS on the issue of the validity and ownership of the … PrEP patents. We strongly believe that the patents granted to HHS since 2015 for PrEP … are not valid and reject any notion of willful infringement.” Continuing, “HHS improperly filed for patents without alerting Gilead, despite its obligation to do so.”

A formal challenge was filed in August by Gilead at the U.S. Patents and Trademark Office. Per Gilead’s filing, the idea of using the drug Truvada for the prevention of HIV had already been discussed before the CDC made its application for a patent.

According to Chad Landmon, an attorney who handles pharmaceutical patent issues in his role at the firm Axinn, Veltrop and Harkrider, the lawsuit will likely take several years unless a settlement is reached.

“This is very rare. The government is sort of planting a flag on this one. Obviously, the Trump administration has, at times, taken new and unique approaches to problems, and this is a new and unique strategy,” Landmon said. HIV activists expressed approval at the move, saying it is a “first step” on the way to making Truvada for PrEP widely available.

Pharmaceutical Giant Profits from Taxpayer-Funded HIV Treatment

According to PrEP4All Collaboration, “For nearly a decade, Gilead’s price gouging on PrEP has prevented hundreds of thousands of Americans from accessing this technology, despite it being a taxpayer-funded invention. If HHS is truly invested in ending the HIV epidemic, it will use these patents as leverage to ensure that everyone who needs PrEP can get it.”

HHS Secretary Azar’s action has garnered support from Capitol Hill where Senator Debbie Stabenow of Michigan responded by saying, “This is an important step in expanding access to HIV prevention medication.” She wrote to Azar back in April questioning the lack of enforcement of the patent. Stabenow added, “Drug companies should not be able to charge patients tens of thousands of dollars for lifesaving treatments discovered through taxpayer-funded research. Nor should they be allowed to infringe on government-owned intellectual property with impunity.”

Gilead pledged it would provide Truvada at no cost to help the Trump administration meet its goal of eradicating HIV. Gilead and HHS say the patent dispute will not affect the company’s pledge. Gilead will be donating 2.4 million bottles of Truvada for PrEP each year.  

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