[Ip-health] KEI on Moderna’s Oct 8, 2020 Statement on Intellectual Property Matters during the COVID-19 Pandemic

Claire Cassedy claire.cassedy at keionline.org
Thu Oct 8 09:04:38 PDT 2020


https://www.keionline.org/34112

KEI on Moderna’s Oct 8, 2020 Statement on Intellectual Property Matters
during the COVID-19 Pandemic

Posted on October 8, 2020 by James Love

*(More on KEI’s work on coronavirus here:
https://www.keionline.org/coronavirus
<https://www.keionline.org/coronavirus>, and on Moderna, here:
https://www.keionline.org/moderna <https://www.keionline.org/moderna>)*

Moderna’s statement[1] on intellectual property matters during the COVID-19
pandemic is very good, and should be matched by every manufacturer of a
therapeutic, vaccine or diagnostic test. We also encourage Moderna to
engage with the WHO COVID-19 Technology Access Pool (C-TAP)[2] and the
Medicines Patent Pool.[3] 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 also provide
constructive transfer of manufacturing know-how and access to cell lines
and data when necessary.

It is notable that Moderna has addressed both the pandemic and the post
pandemic period, stating “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.”

One nuance about the Moderna announcement is that the company’s list of the
mRNA-1273 COVID-19 vaccine patents is only “representative” of the issued
US patents relevant to the vaccine, which suggests that the list is not
complete and does not extend to patent applications. It includes only one
of the granted patents that KEI cited in our letter to DARPA[4] regarding
failures to disclose federal funding, and both DARPA and BARDA are
investigating several applications and granted patents for failures to
disclose federal funding.

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. Moderna is
also making it clear that government agencies like the NIH and BARDA have
been too willing to grant or enable exclusive rights when subsidizing
COVID-19 research. In the past, KEI has called upon federal agencies to
involve the authorities in the Bayh-Dole Act to condition federal funding
on access to both foreground and background intellectual property rights
and know-how as relates to the pandemic response. Moderna is showing that
is feasible, and government officials in the United States, Europe and
elsewhere need to reflect on this.

James Love, KEI Director

[1]
https://investors.modernatx.com/news-releases/news-release-details/statement-moderna-intellectual-property-matters-during-covid-19
[2]
https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/covid-19-technology-access-pool
[3] https://medicinespatentpool.org/
[4] https://www.keionline.org/rn-2020-3

----------------------------------------

https://investors.modernatx.com/news-releases/news-release-details/statement-moderna-intellectual-property-matters-during-covid-19

Statement by Moderna on Intellectual Property Matters during the COVID-19
Pandemic
October 8, 2020 at 6:39 AM EDT
Moderna is a pioneer in the development of messenger RNA (mRNA) vaccines
and therapeutics. From its inception in 2010, Moderna saw the potential of
this new class of medicines to make a significant difference in patients’
lives. With the support of our investors we have invested billions of
dollars into research and development to make mRNA medicines a reality. One
of the exciting discoveries advanced by Moderna was the combination of mRNA
and lipid nanoparticles (LNPs) to make vaccines, and the demonstration of
this potential in human clinical trials for eleven different infectious
disease vaccines since 2015. Those discoveries and the expertise we
developed have uniquely positioned Moderna to respond to the COVID-19
pandemic quickly. Information on our work toward a COVID-19 vaccine can be
found here.

As a company committed to innovation, Moderna recognizes that intellectual
property rights play an important role in encouraging investment in
research. Our portfolio of intellectual property is an important asset that
will protect and enhance our ability to continue to invest in innovative
medicines. A summary of our intellectual property can be found here. A
selection of representative issued US patents relevant to our mRNA-1273
vaccine against COVID-19 is available here.

Beyond Moderna’s vaccine, there are other COVID-19 vaccines in development
that may use Moderna-patented technologies. We feel a special obligation
under the current circumstances to use our resources to bring this pandemic
to an end as quickly as possible. 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.

Forward-Looking Statements

This statement contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995, as amended, including
regarding Moderna’s stance with respect to enforcement and licensing of its
intellectual property rights during and following the COVID-19 pandemic. In
some cases, forward-looking statements can be identified by terminology
such as “will,” “may,” “should,” “could”, “expects,” “intends,” “plans,”
“aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,”
“continue,” or the negative of these terms or other comparable terminology,
although not all forward-looking statements contain these words. The
forward-looking statements in this statement are neither promises nor
guarantees, and you should not place undue reliance on these
forward-looking statements because they involve known and unknown risks,
uncertainties, and other factors, which could cause actual results to
differ materially from those expressed or implied by these forward-looking
statements. These risks, uncertainties, and other factors include those
risks and uncertainties described under the heading “Risk Factors” in
Moderna’s most recent Quarterly Report on Form 10-Q filed with the U.S.
Securities and Exchange Commission (SEC) and in subsequent filings made by
Moderna with the SEC, which are available on the SEC’s website at
www.sec.gov. Except as required by law, Moderna disclaims any intention or
responsibility for updating or revising any forward-looking statements
contained in this statement in the event of new information, future
developments or otherwise. These forward-looking statements are based on
Moderna’s current expectations and speak only as of the date hereof.

-------------------------------------

https://www.modernatx.com/patents

A selection of representative issued US patents relevant to our mRNA-1273
vaccine against COVID-19 is available here.

Program Patents
The following are protected by patents in the United States and in foreign
jurisdictions for ModernaTx, Inc.

mRNA-1273
COVID-19 VACCINE
US 10,703,789
US 10,702,600
US 10,577,403
US 10,442,756
US 10,266,485
US 10,064,959
US 9,868,692


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