Gilead Stock – US government does not own any remdesivir patents, GAO report finds – Endpoints News
The US federal government’s contributions to research on Gilead’s Covid-19 antiviral drug remdesivir did not result in any patent rights because the research did not create new inventions, the Government Accountability Office said in a report on Wednesday afternoon.
The report settles a longstanding dispute over whether the government might be co-inventors of remdesivir, which has lingered since before former California attorney general Xavier Becerra (who’s now Biden’s HHS secretary) led a group of other AGs last summer in calling on the government to intervene and lower the more than $3,000 price tag for remdesivir because of the government’s significant contributions to remdesivir.
The GAO report acknowledges that between 2013 and 2020, the government pumped $162 million into the development of remdesivir, with the Centers for Disease Control and Prevention (CDC), the Department of Defense (DOD), and the National Institutes of Health (NIH) conducting and funding preclinical research. In addition, NIH funded three remdesivir clinical trials, including the one showing that the antiviral shortened the recovery time for hospitalized patients with severe Covid-19.
Gilead, however, also conducted its own research that led to the invention of remdesivir and the company said it invested $786 million in remdesivir R&D from 2000 through December 2020, GAO says. Gilead added in a statement that its investment in remdesivir exceeded $1 billion in 2020 alone and that currently about half of all hospitalized patients with Covid-19 in the US are treated with the drug.
DOD, NIH and other scientists at Vanderbilt and the University of North Carolina at Chapel Hill acknowledged to GAO that their scientists were not co-inventors of patented remdesivir discoveries. For instance, NIH officials told the GAO that Gilead began patenting methods of using remdesivir to treat coronavirus infections in 2015, while NIH scientists began their remdesivir research focusing on coronaviruses in 2016.
“The principal investigators of NIH-funded coronavirus research projects told us that they did not consider filing invention disclosures because their research did not involve making any modifications to remdesivir or its parent compounds. The principal investigators stated that they viewed such modifications as the threshold for filing such disclosures,” GAO said.
And even if the government had filed for a remdesivir method-of-use patent, DOD and NIH officials said that would be of low economic value because the federal government did not own the compound patents and would have had to license those patents from Gilead if it wanted to commercialize the method of use or license it to another company.
According to CDC officials, as of last month, they said it was “unlikely that CDC would conduct an inventorship analysis or pursue intellectual property rights given Gilead’s background intellectual property and the limited potential for CDC to license any such rights.”
Chris Morten, a lawyer who currently teaches at New York University School of Law, noted that the report did not clarify if a CDC scientist, Michael Lo, co-invented Gilead’s remdesivir compound patents, and if so, “CDC would, under the default rules of patent law, have a claim to co-ownership. But CDC appears uninterested in pursuing its legal rights.”