[Ip-health] Health Policy Watch: Moderna Makes Milestone Pledge To “Not Enforce Our Patents” On COVID-19 Vaccine Technologies During Pandemic & Issue Open Licenses Afterward

Thiru Balasubramaniam thiru at keionline.org
Thu Oct 8 21:58:12 PDT 2020


Moderna Makes Milestone Pledge To “Not Enforce Our Patents” On COVID-19
Vaccine Technologies During Pandemic & Issue Open Licenses Afterward
Intellectual Property 08/10/2020 • Raisa Santos & Elaine Ruth Fletcher

Moderna, Inc., developer of one of the four front-running COVID-19 vaccine
candidates, announced on Thursday that the the company would “not enforce”
its COVID-19-related patents against other companies making vaccines to
combat the pandemic – and would also be willing to license intellectual
property for their COVID-19 vaccines for the post pandemic period.

“We feel a special obligation under the current circumstances to use our
resources to bring this pandemic to an end as quickly as possible.” said
the company’s statement, which raises the bar on corporate policies around
patents as the world fights a pandemic. “Accordingly, while the pandemic
continues, Moderna will not enforce our COVID-19 related patents against
those making vaccines intended to combat the pandemic.

“Further, to eliminate any perceived IP barriers to vaccine development
during the pandemic period, upon request we are also willing to license our
intellectual property for COVID-19 vaccines to others for the post-pandemic
period. Moderna is proud that its mRNA technology is poised to be used to
help end the current pandemic.”

Speaking at a webcast of the company’s 8 October update where the
announcement was made public,  Stephen Hoge, president of Moderna told
investors, “It is our responsibility to be upfront and transparent, but
we’re not going to be using those patents and try to enforce them.”

Added Tal Zaks, Moderna Chief Medical Officer at the presentation:  “It is
the right thing to do, to protect the population.”

Leading Medicine Access Advocate Applauds Moderna Announcement – Others
Demand More

The announcement was greeted with applause by one leading medicines access
advocate, Jamie Love of Knowledge Ecology International, who said that the
new Moderna policy offers a model that other pharma companies should

Statement by Moderna on Intellectual Property during COVID-19 Pandemic

“Moderna is the only company manufacturing a drug or vaccine that has made
a pledge to openly share its COVID-19 patents,” Love, generally an
outspoken critic of pharma positions, told Health Policy Watch.  “And the
statement includes both the period during the pandemic, and an offer to
license in the post-pandemic,”

Love added that the commitment, “should be matched by every manufacturer of
a therapeutic, vaccine or diagnostic test…”

Love contrasted the Moderna pledge with the fact that Oxford University had
granted the pharma company AstraZeneca exclusive rights to the IP
associated with the adenovirus vector vaccine technology that they are
co-developing, with backing from the Bill and Melinda Gates Foundation.

“This makes the deal that Oxford and Gates struck with AstraZeneca look
absurd,” Love said, adding that no matter how rights are used during the
pandemic, the framework of the latter also leaves AstraZeneca to “tighten
the screws” when the pandemic is over while, “Moderna will provide licenses
that extend post-pandemic.”

A KEI statement, however, added that Moderna should still go further and
“engage with the WHO COVID-19 Technology Access Pool (C-TAP) and the
Medicines Patent Pool” – which are serving as vehicles for more systematic
pooling of vaccines and their patents. “Every manufacturer of a vaccine,
drug or diagnostic should follow suit and publish the patents relevant to
the technology, waive or license rights in those patents, and  provide
constructive transfer of manufacturing know-how and access to cell lines
and data when necessary”.

Other advocates expressed skepticism about the reasons behind the moves,
saying that the announcement was motivated by pending legal challenges to
Moderna IP claims, as well as rising consumer and political pressures:
 Moderna “should not be lionized for taking baby steps on access when we
are in a race for our lives,” stated an op-ed by Asia Russell, Brook Baker
and Jessica Bassett, published by HealthGap Global Access Project:

“It is no accident that Moderna’s announcement comes less than a week after
South Africa and India filed a petition to the World Trade Organization
calling for waiver or suspension on the granting or enforcement of any
intellectual property protections on COVID-19-related medical technologies
for the duration of the pandemic.

“But Moderna knows that this non-enforcement-of-patents concession is
meaningless without a commitment to share not only the patents, but also
all the information, know-how, data, and biologic resources needed for
other qualified vaccine manufacturers to produce the vaccine economically
and at scale to meet global need. Moderna should fully commit to sharing
all necessary rights and knowledge through the WHO COVID-19 Technology
Access Pool (C-TAP), with no artificial time limitation based on the
severity of the pandemic.”

Moderna To Submit Vaccine Candidate to FDA 25 November for Approval

The Moderna announcement comes just days after Moderna’s chief executive
officer Stéphane Bancel said that the company aims to submit the candidate
vaccine to the FDA for emergency use authorization by 25 November 2020. The
company then intends to submit the vaccine as a candidate for the general
population by late January. If approved, the vaccine would be available for
widespread distribution by spring 2021.

Stéphane Bancel, CEO of Moderna

Based in Cambridge, Massachusetts, Moderna is a biotechnology company
pioneering the development of messenger RNA (mRNA) vaccine and
therapeutics. The mRNA-1273 technology contains the “coding” for a
stabilized form of the Spike (S) protein that is characteristic of the
SARS-CoV2 virus that, which was co-developed by Moderna and investigators
from NIAIDS’s Vaccine Research Center.

Moderna’s vaccine candidate uses novel mRNA technology to prime and boost
the immune response in regards to antibody neutralization across all age
groups. Effectively, the vaccine  “teaches” human cells to induce an immune
response that could build the body’s own defense against COVID-19.

The company’s Phase 3 study of RNA-1273, the vaccine candidate against
COVID-19 began in July, and is close to its target enrollment of around
30,000 US participants.

AstraZeneca and Pfizer are also in late-stage Phase 3 testing; however,
AstraZeneca’s timeline has been stalled after reports of severe side
effects from several trial participants administered its vaccine candidate,
which is based on a different technology. Participants from both Moderna
and Pfizer’s Phase 3 studies have reported symptoms of high fever, body
aches, headache, and exhaustion after receiving the respective candidate
vaccines. The two companies have recognized that there is potential for the
recipients of their vaccines to induce “mild” side effects similar to mild
COVID-19 symptoms.

Tal Zaks, chief medical officer at Moderna

Other Pharma Companies Received Billions in Public Subsidies – But Holding
Patents Close

Only recently, KEI sharply criticized Moderna for failing to disclose
public funding from BARDA [US Biomedical Advanced Research and Development
Authority]as well DARPA, (Defense Advance Research Projects Agency), in its
patent applications, and the two agencies are currently examining the
alledged omissions.

But even if the company made the announcement under burgeoning consumer and
government pressure, its new policy still contrasts sharply with other
firms that have benefited from similar public subsidies for urgent COVID-19
research, but are retaining their patent rights close to their chest.

Among those, BioNTechSE, partner of Pfizer Inc., have been adamant about
their about complete ownership of their vaccine patents – even when they,
too, benefitted from large US government subsidies.

 “Contrasts should be drawn between Moderna and other companies, including
in particularly those that have benefited from massive subsidies from
governments and foundations, that are not even making patent landscapes
transparent, let alone making the inventions widely available,” said Love
in the KEI statement..

“Moderna is also making it clear that government agencies like the NIH
[National Institutes of Health] and BARDA have been too willing to grant or
enable exclusive rights when subsidizing COVID-19 research.”

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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