Two documents dating back to 2015 shed further light on the role the federal government played in discovering remdesivir and its use in treating coronaviruses — work that has taken on new meaning as the Gilead Sciences (GILD) drug has gained global attention and an emergency use authorization from federal regulators to treat patients with Covid-19.
The first document was an application filed in September 2015 in which Gilead sought a U.S. patent for a using the compound for any number of coronavirus infections. Although the code Gilead assigned to the compound – GS-5734 – does not appear in the body of the application, experts who have reviewed the chemical structure say the compound is remdesivir. And Gilead could take that patent, which was issued last year, to the bank if its medicine ever becomes a viable business proposition for treating Covid-19 or any other illness.
One month later, some of the same Gilead employees whose names appeared on the patent application were listed as co-authors on a Nature research paper – along with numerous government scientists – showing remdesivir, specifically, held promise in fighting Ebola and other coronaviruses. The paper also noted testing was conducted at high-risk security labs run by the federal government.
The role played by the federal government in developing remdesivir to combat coronaviruses has, in fact, involved various grants to universities, as well as contributions from government personnel at such agencies as the U.S. Army Medical Research Institute of Infectious Diseases, according to Knowledge Ecology International, an advocacy group that first disclosed these connections.
But while it remains unclear the extent to which federal funds contributed to the R&D, the patent is of particular interest because it is tangible evidence that government work yielded something of potential financial value to the company. Yet government employees are not listed as inventors, which one expert suggested should be corrected, especially in an era when federally financed research might be leveraged to collect royalties or, arguably, lower the price of medicines.
“In this case, all of these scientists were really working together very intimately on research that led to the molecule,” said Arti Rai, a Duke University law professor who specializes in intellectual property and a former U.S. Patent and Trademark Office official, who is researching remdesivir patents and the role played by the federal government.
“Gilead actually had a huge number of patents on the molecules, but had to do a tremendous amount of work to figure out which variations of the various molecules would work against the biological models the government had. This patent illustrates the essence of why collaboration between the public and private sectors is important, not just in terms of money, such as grants, but resources.”
“What really matters is how much money the government has put into research, but if their names were on there, it would help to make the case there was a lot of in-kind contribution from the government,” she explained. “Right now, if Gilead tried to assert rights (in response to a patent challenge), there would be no way to know there was some government right to a license to the patent.”
Generally, one must play connect the dots to find government assistance. For instance, the National Institutes of Health gave grants to several universities whose researchers worked with Gilead scientists. Their efforts appeared in a 2018 paper in the American Society for Microbiology, which found remdesivir can combat coronaviruses, noted Tahir Amin, who heads the Initiative for Medicines, Access, and Knowledge, an advocacy group that challenged various Gilead patents on hepatitis C medicines.
We asked Gilead, which several months ago sought to add claims to the patent, for comment and will update you accordingly.
The issue arises amid intense anticipation over the ability of remdesivir to combat Covid-19. Last week, preliminary clinical trial results indicated the intravenous drug can be used to treat the most serious patients. The disclosure prompted the Food and Drug Administration to quickly grant an emergency use authorization so the medicine can be used by hospitals. The U.S. government is overseeing distribution.
The news also accelerated growing concern over future access to the medicine at a time when there is already worldwide anxiety over the affordability of any Covid-19 medical product. The World Health Organization, for instance, reached out to Gilead and the U.S. government earlier this week to ask about the availability of remdesivir in other countries.
In the U.S., such apprehension has often emerged over costly medicines that were discovered, in part, thanks to backing from the federal government. Numerous consumer advocates, academics, and lawmakers have argued that prescription drugs invented with taxpayer dollars should be affordable to Americans. Public Citizen estimated that U.S. taxpayers contributed $70.5 million to remdesivir R&D overall.
“Since we’re paying for the research, we shouldn’t expect to be at disadvantage,” said Jamie Love of Knowledge Ecology International. “The argument that you have to have a high price because a company made big investments is harder to justify when there was a large public financing role in the R&D. A high company may say a high price is necessary, but the rationale falls apart when we’re paying for the R&D.”
Gilead has often been at the center of such debates. As noted previously, the drug maker and the federal government filed dueling lawsuits over patents that formed the basis of a best-selling HIV prevention pill called Truvada. The government claims Gilead should pay royalties on its patents, which stemmed, in part, from taxpayer funding, while the company has argued the government patents are invalid.
Given the Covid-19 pandemic, Gilead is facing increasingly intense scrutiny over access to remdesivir. Last week, two lawmakers asked the U.S. Department of Health and Human Services to provide information about various ways the agency may have provided funding that contributed to development of the drug and what will be done to ensure that Americans do not later encounter “price gouging.”
Keenly aware of negative publicity, the company agreed to donate 1.5 million doses in the U.S., which can be used for anywhere from 140,000 to 280,000 patients. And Gilead is talking to other companies about licenses so the medicine can be produced and more readily made available in other countries, including low-income nations.
Even so, there are questions about the extent to which remdesivir has the potential to become a moneymaker for the company. Gilead is investing about $1 billion on clinical trials and ramping up production, among other things, leading Wall Street analysts to question whether the medicine has enough legs to yield a long-term return.
“There continues to be a fair amount of debate on this topic. Gilead is being very judicious and careful in trying to balance social responsibility during the pandemic on one side, and shareholder questions on investments on the other side,” wrote Evercore ISI analyst Umer Raffat to investors in which he noted the donations and licensing talks. “But what happens after that?”
Already, though, pricing is being kicked around. Earlier this week, the Institute for Clinical and Economic Review estimated that remdesivir should be priced at about $4,460 to be cost effective. As SVBLeerink analyst Geoff Porges noted, this calculation puts “some bounds” on the pricing. To recover its costs, which ICER estimated $10 a for a 10-day course, the nonprofit suggested remdesivir should be priced at $4,500.
[This post was corrected to note the ICER estimate is $4,500 for a course of remdesivir not $10].