- The U.S. government made a significant research investment in Gilead’s COVID-19 treatment remdesivir, but never had cause to pursue a patent on the work, the Government Accountability Office concluded in a report released Wednesday.
- Between 2013 and 2020, U.S. agencies spent $162 million to study the drug for various viruses, including clinical trials for Ebola and COVID-19, the congressional watchdog found. The National Institutes of Health, Centers for Disease Control and Prevention and the Defense Department all contributed to the research.
- By the time the government work began, Gilead had already begun registering patents on remdesivir. U.S. officials told the GAO that none of the work conducted by agencies resulted in new inventions that would have warranted patents on the drug.
The GAO report highlights an issue that has dogged Gilead over the past year, as the company raked in profits for remdesivir, sold under the brand name Veklury. Sales of the drug reached $1.9 billion in the fourth quarter alone, and Gilead estimates about half of all patients hospitalized with COVID-19 are treated with it.
Doctors began using the medication early in the pandemic after a study funded by the NIH found remdesivir could speed the recovery of hospitalized patients. An emergency clearance from the Food and Drug Administration quickly followed in May 2020, and then the drug became the first COVID-19 drug to win a full FDA approval in October.
Gilead initially donated its entire stock of remdesivir as the pandemic gripped the world. Then in June, the company announced it would charge between $2,340 and $3,120 for a typical course of treatment, drawing fire from groups such as Public Citizen, which said remdesivir could be sold for $1 a day and still generate a reasonable profit for Gilead.
Public Citizen and another advocacy group, PrEP4All, said the U.S. government should step in because of the taxpayer investment that helped bring remdesivir to market. PrEP4All, which has feuded with Gilead in the past over patents covering the company's HIV drugs, said it believed the U.S. likely co-owned key patents on remdesivir.
But in its new report, the GAO claims that’s not the case. Agreements with Gilead would have allowed U.S. agencies to seek patents, but the GAO doesn't believe that any of the agencies contributed innovations that would have warranted such patents.
U.S. Department of Defense and NIH officials told the GAO that even though the government didn’t secure patent rights, the spending "helped deliver a needed drug to the public."
Gilead, meanwhile, told the GAO that it didn’t rely on any government help in inventing remdesivir and invested $786 million of its own funds in research and development, plus over $500 million more on manufacturing, distribution and supply for research.
The company spent more than $1 billion last year alone, and its overall investment "far outweighed any limited contributions by federal agencies," Gilead said in a statement Wednesday. "Gilead is proud of the benefits Veklury provides to patients, physicians and healthcare systems in the U.S. as a standard of care treatment for COVID-19."