By Hailey Konnath

Law360 (March 31, 2021, 11:04 PM EDT) -- The U.S. government doesn't have the rights to patents covering Gilead Science Inc.'s experimental antiviral drug remdesivir, the Government Accountability Office said Wednesday, noting that although taxpayers spent $162 million on its development, that research didn't lead to any new inventions.

Gilead developed remdesivir, which the U.S. Food and Drug Administration has authorized for emergency use, with the help of the Centers for Disease Control and Prevention, the U.S. Department of Defense and the National Institutes of Health, according to a GAO report. But Gilead already had an existing portfolio of patents and patent applications for the drug when it began collaborating with the federal agencies, the GAO said.

And that "would have left little room for the agencies to generate their own patents," the accountability office said in its summary of the report.

"For example, DOD officials told us that when DOD scientists performed antiviral testing of remdesivir against Ebola virus, they used standard tests and screening methods and did not come up with new tests or methods," the GAO said.

Remdesivir was the first drug to garner an emergency authorization from the FDA to treat COVID-19. It was initially developed to treat Ebola in the wake of the 2014 virus outbreak.

According to Wednesday's report, the CDC, DOD and NIH conducted and funded research on the drug between 2013 and 2020. NIH also footed the bill for three clinical trials, the GAO said. As of December 2020, the federal government spent $39.7 million on the DOD's preclinical research, $11.9 million on preclinical research conducted by NIH and NIH-funded universities and $109 million on the NIH-funded clinical trials.

It also spent about $700,000 on the CDC's preclinical research, per the report.

Gilead said in a statement late Wednesday that GAO's report concluded that it alone funded the research that led to the innovation and initial synthesis of the drug as well as the identification of remdesivir's "antiviral activity against coronaviruses."

Gilead's investment in the drug exceeded $1 billion, and "far outweighed" the contributions by federal agencies, it said. Remdesivir, which Gilead sells under the brand name Veklury, has been approved or has temporary use authorizations in about 50 countries, the company said.

"At this time, approximately half of hospitalized patients with COVID-19 in the U.S. are treated with Veklury," Gilead said. "Gilead continues to invest in antiviral research to improve patient outcomes and help prepare for future pandemics."

Even before its FDA approval in May 2020, its access has been a topic of debate among state officials, consumer advocacy groups and pharmaceutical companies.

Shortly after its approval, activists working to expand access to COVID-19 medications argued that the federal government was the rightful co-owner of the patents and that the feds should harness that ownership to make the medication accessible and affordable.

As co-owner, the government would've been able to make, import, use and sell the drug without Gilead's permission and license it to generic manufacturers, according to the report from the PrEP4All Collaboration and the Technology Law and Policy Clinic of the New York University School of Law.

In August, state officials pushed for the federal government to use so-called march-in rights to force the drugmaker to license its patents for the medication. A group of 34 attorneys general told the U.S. Department of Health and Human Services, NIH and FDA that "Gilead should not profit from the pandemic and it should be pushed to do more to help more people."

In response, Gilead said it's "deeply disappointed that a group of state attorneys general have chosen to misrepresent facts."

Consumer advocacy group Public Citizen also called on the federal government to proceed by itself in developing an alternative to remdesivir if the company continues to sit on its patent holdings for potentially effective drugs to treat COVID-19.

Gilead's alternative to remdesivir — GS-441524 — is simpler and easier to synthesize with considerable advantages over remdesivir, but has been all but ignored by the government and Gilead, Public Citizen said in a letter to the company, the FDA and other agencies.

The CDC, NIH and DOD didn't immediately return requests for comment late Wednesday.

--Additional reporting by Dani Kass. Editing by Jay Jackson Jr.

Update: This story has been updated to include comment from Gilead.

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