[Ip-health] Acknowledging the public role in private drug development: lessons from remdesivir

kathryn ardizzone kathryn.ardizzone at keionline.org
Fri May 8 08:31:05 PDT 2020


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


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.

Kathryn Ardizzone, Esq.
Knowledge Ecology International
1621 Connecticut Avenue NW, Suite 500
Washington, DC 20009
kathryn.ardizzone at keionline.org
(202) 332-2670

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