[Ip-health] The U.S. government contributed research to a Gilead remdesivir patent — but didn’t get credit

kathryn ardizzone kathryn.ardizzone at keionline.org
Fri May 8 08:26:24 PDT 2020


https://www.statnews.com/pharmalot/2020/05/08/gilead-remdesivir-covid19-coronavirus-patents/


*The U.S. government contributed research to a Gilead remdesivir patent —
but didn’t get credit*
By ED SILVERMAN @Pharmalot MAY 8, 2020

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.”

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, however, ICER suggested remdesivir should be priced at
just $10 a course.



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


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