Acknowledging the public role in private drug development: lessons from remdesivir

The quest for vaccines and therapeutic treatments against Covid-19 shouldn’t be complicated or delayed by charged debates over patent rights, the respective public and private roles in biopharmaceutical innovation, and whether the U.S. government should use its legal powers to “break” patents in order to promote access to medicines. But it may be.

Gilead’s antiviral drug remdesivir, for which the FDA recently granted emergency use authorization for Covid-19, is currently caught in the crosshairs of the debate. We suggest a path forward that could be useful in the remdesivir case and in others.

Remdesivir provides a classic example of how public/private collaboration produces biopharmaceutical innovations — and the complexities that follow. As detailed by the nonprofit Knowledge Ecology International, the public role in the development of remdesivir is undeniable. Our own review of the drug’s development indicates that one or more government researchers should probably have been listed as inventors on key patents for remdesivir.

On Sept. 16, 2015, Gilead filed a patent application entitled “Methods for treating arenaviridae and coronaviridae virus infections.” The claims of this application plainly encompass a molecule with a structure that is now called remdesivir. Not long after that, on Oct. 26, 2015, a group of scientists largely drawn from the U.S. military, the Centers for Disease Control and Prevention, and Gilead submitted a paper to the journal Nature. The paper announces the “discovery of a novel small molecule GS-5734” with potential “broad spectrum antiviral activity” against the Ebola virus as well as “other pathogenic RNA viruses, including filoviruses, arenaviruses, and coronaviruses” (the emphasis is ours).

Remdesivir and GS-5734 are one and the same. Yet Gilead’s patent application lists only inventors from Gilead. The same is true for the two patents that have now emerged from the application, including one specifically directed to coronaviruses for which an issuance payment was made on April 30, 2020.

One of us (A.K.R.) has written about the accountability issues raised when patented drugs that emerge from public funding fail to document the public role played in their development. And there seems to be just such an omission here. Lining up the two patents that emerged from the September 2015 application and the research paper submitted to Nature in October 2015 (it was published on March 2, 2016), the evidence suggests that several U.S. government scientists contributed to the patented invention.

For many years, policymakers have legitimately been concerned about return on investment from taxpayer dollars used to fund research. Omitting the role played by the public should not occur as it misleadingly suggests no such return.

We are not writing to criticize Gilead. Promptly correcting the record is an appropriate remedy for a good-faith omission of inventors on a patent. And given Gilead’s public-minded stances on Covid-19 to date, we think one should assume a good-faith omission.

More broadly, we applaud Gilead’s decision to persist in the field of infectious diseases, developing drugs for HIV, hepatitis C, and now Covid-19. It is an underserved area and one that puts the company under constant public scrutiny. The company’s important role in researching RNA viruses is apparent from a round of patents the firm has filed since 2008 on a collection of molecules it had synthesized with the potential to inhibit a polymerase upon which RNA viruses rely. This collection includes precursors to remdesivir.

Gilead, the U.S. government, and academic researchers then collaborated intensively on screening, testing, and refining that collection of molecules. Private-sector skills in identifying potentially useful and safe molecules were combined with public-sector strengths in developing biological models. When the paper submitted to Nature in 2015 announced the “discovery of … small molecule GS-5734,” that was a victory for both public science and private science.

Going forward, policymakers considering what to do about the patents on remdesivir need to think carefully about the precedents they may establish. Our system of collaborative public/private biopharmaceutical research is messy, and perhaps far from optimal, but it produces a steady stream of innovations like remdesivir. And we need that system to continue churning out drugs that may someday work against viruses we cannot yet imagine but we know will threaten millions.

In its response to the Covid-19 pandemic, Gilead has been a reasonably good corporate citizen. It has pledged its existing stockpile of remdesivir to patients acutely ill with Covid-19 and is working to scale up production of the drug on three continents.

If remdesivir truly is an effective therapy against Covid-19, production may need to be scaled up even further. If Gilead cannot meet production demands, it should allow others to step in. But pragmatic approaches to ensuring that patents don’t block necessary manufacturing are not the same as precedents that eliminate patent rights altogether.

As long as the public role is properly accounted for, the current emergency does not need to set fundamentally new rules for patents.

Justin Hughes is a professor of law at Loyola Law School in Los Angeles and a former a senior policy advisor to the director of the U.S. Patent and Trademark Office. Arti K. Rai is a professor of law at Duke University School of Law and the former administrator for external affairs for the U.S. Patent and Trademark Office.