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Commentary
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[29]
Commentary
Why Moderna won’t share rights to the COVID-19 vaccine with the government
that paid for its development
Ana Santos Rutschman
[30]
Ana Santos Rutschman
November 21, 2021 9:00 am
The U.S. government funded a significant portion of the R&D behind the
Moderna vaccine. (Photo by [31]Peter Endig/picture alliance via Getty
Images)
A quiet [32]monthslong legal fight between the U.S. National Institutes
of Health and drugmaker Moderna over COVID-19 vaccine patents recently
burst into public view. The outcome of the battle has important
implications, not only for efforts to contain the pandemic but more
broadly for drugs and vaccines that could be critical for future public
health crises.
[33]I teach drug regulation and patent law at Saint Louis University’s
[34]Center for Health Law Studies.
Moderna recently [35]offered to share ownership of its main patent with
the government to resolve the dispute. Whether or not this is enough to
satisfy the government’s claims, I believe the dispute points to
serious problems in the ways U.S. companies bring drugs and vaccines to
market.
U.S. was a major funder of the Moderna vaccine
Vaccines have [36]played a crucial role in the response to the
pandemic.
In December 2020, Moderna became the second pharmaceutical company
after Pfizer to [37]obtain authorization from the Food and Drug
Administration to market a COVID-19 vaccine in the United States.
People have since grown so used to talking about the “[38]Moderna
vaccine” that a crucial element in the history of how it was developed
risks being overshadowed: Moderna was [39]not the sole developer of the
vaccine.
Unlike many of the other pharmaceutical companies involved in the
[40]COVID-19 vaccine race, Moderna is a newcomer to drug and vaccine
commercialization. Founded in Massachusetts in 2010, the company had
[41]never brought a product to market until the FDA authorized its
COVID-19 vaccine last year.
Throughout the 2010s, Moderna focused on the development of [42]mRNA
technology, attracting over [43]$2 billion in funding from
pharmaceutical companies and other investors. [44]It went public in
2018.
Even [45]before the pandemic, research on both coronaviruses and
vaccine candidates against emerging pathogens was a priority for
agencies operating in the public health space. In 2015, the
[46]National Institute of Allergy and Infectious Diseases, an institute
within the NIH, [47]signed a cooperative R&D agreement with Moderna on
basic research, including the development of new vaccines. The
agreement resulted in an [48]undisclosed amount of funding and
assistance with research.
In addition, after the COVID-19 outbreak began Moderna also
[49]received almost $1 billion in [50]funding from the [51]Biomedical
Advanced Research and Development Authority, which operates within the
Department of Health and Human Services. This funding was specifically
targeted to the development of a COVID-19 vaccine candidate.
Researchers have calculated that, collectively, the U.S. government
[52]has provided $2.5 billion toward the development and
commercialization of Moderna’s COVID-19 vaccine.
U.S., Moderna scientists working side by side
In addition to providing financial support, the federal government was
instrumental in the development of Moderna’s vaccine for other reasons.
Namely, federal scientists worked alongside Moderna scientists on
different components of the vaccine.
These contributions included [53]working on dosing mechanisms, and the
NIH said federal scientists created the [54]stabilized spike proteins
that are a key component of the vaccine made by Moderna.
The importance of the role played by federal scientists in their work
with Moderna would soon become apparent. A [55]2019 agreement with a
third party explicitly acknowledged this, alluding to mRNA vaccine
candidates “developed and jointly owned by NIAID and Moderna.” And by
late 2020, the U.S. government was calling it the “[56]NIH-Moderna
COVID-19 vaccine.”
While the U.S. government has spent money on [57]COVID-19 vaccines
[58]made by other companies, its close involvement in the R&D stages of
Moderna’s sets it apart.
How it became a patent dispute
As development of the vaccine progressed, Moderna applied for
[59]several patents, each one covering different components of the
vaccine. U.S. law allows inventors to apply for patents on products or
methods that are [60]new, not obvious and useful. While some early
modern vaccines – like the [61]polio vaccine developed by Jonas Salk’s
team – were [62]not covered by patents, from the late 20th century
onward [63]it became very common for one or multiple patents to cover a
newly developed vaccine.
In applying for some patents related to its vaccine, Moderna named
National Institute of Allergy and Infectious Diseases scientists as
co-inventors alongside Moderna scientists. This was the case, for
example, in a [64]patent application dated May 2020 for a relatively
minor component of the vaccine.
However, in July 2021, Moderna made it clear that it would not name
government scientists as co-inventors in a [65]patent application
covering a much more significant component of the vaccine: the mRNA
sequence used to produce the vaccine, known as mRNA-1273.
Moderna’s position was that [66]Moderna scientists alone had selected
the sequence. The [67]company informed the Patent and Trademark Office
of its position in a 2020 statement.
In November 2021, government officials publicly challenged the
company’s decision after months of [68]failed negotiations with the
company. Moderna then [69]took to social media to defend its position,
tweeting:
“Just because someone is an inventor on one patent application relating
to our COVID-19 vaccine does not mean they are an inventor on every
patent application relating to the vaccine.”
By contrast, the National Institutes of Health [70]argued that three
NIAID scientists – Kizzmekia Corbett, Barney Graham and John Mascola –
had meaningfully contributed to the invention, though [71]they’ve
declined to [72]publicly specify how. If true, patent law says they
[73]should be named co-inventors.
But this dispute is not merely about scientific principles or technical
aspects of the law. While patents are also regarded as proxies for
measuring scientific reputation, their most immediate and powerful
effect is to give patent holders a [74]significant amount of control
over the covered technology – in this case, the main component of the
vaccine made by Moderna.
From a practical perspective, excluding federal scientists from the
application means that Moderna alone gets to decide how to use the
vaccine, whether to license it and to whom. If, by contrast, the
government co-owns the vaccine, [75]federal patent law allows each of
the joint owners to engage in a variety of actions – from making and
selling the vaccine to licensing it – without the consent of the other
owners.
This is especially relevant in cases of product scarcity or potential
pricing issues in connection with the commercialization of the vaccine.
For instance, the U.S. [76]would have the ability to allow more
manufacturers to produce vaccines using the mRNA-1273 technology. In
addition, it could direct vaccine doses wherever it likes, including to
[77]lower-income countries that have received few vaccines so far.
Broader implications
A graphic shows how its mRNA technology works Moderna explains its mRNA
technology.
[78]Business Wire
The ongoing battle between the government and an emerging star in the
pharmaceutical industry is yet another episode in a complicated
relationship between actors with complementary yet distinct roles in
the production of drugs and vaccines.
On the one hand, the federal government [79]has long played a critical
role in both performing and funding basic research. On the other, it
does not have the resources and capacity to bring most types of new
drugs and vaccines to market on its own.
The pharmaceutical industry thus plays an important and necessary role
in drug innovation, which I believe should be rewarded – although not
boundlessly.
If the NIH is correct about co-ownership of the vaccine, then Moderna
is unduly using a legal tool to achieve a position of market control –
a reward it does not deserve. This position of sole control becomes
even more problematic in light of the significant amounts of public
money that funded the development of this vaccine. This offset some of
Moderna’s financial risk, even as the [80]company projects to make $15
billion to $18 billion in revenue from vaccine sales in 2021 alone,
with much more expected in 2022.
However, even if the NIH prevails in the patent dispute, it is
important to understand the limitations of such a “win.” The U.S. would
be in a position to license the vaccine, for example, and could do so
by requiring that licensees agree to equitable distribution of vaccine
doses.
But co-ownership would not enable the government to fix any of the
[81]other problems that currently affect the manufacturing and
distribution of COVID-19 vaccines, such as scaling up production or
building infrastructure to deliver vaccine doses.
In my view, the dispute is a reminder of the [82]many [83]problems
embedded in how vaccines are made and delivered in the U.S. And it
shows that when taxpayers fund basic research of a drug, they deserve
more of the control – and rewards – when that drug succeeds. The
Conversation
This article is republished from [84]The Conversation under a Creative
Commons license. Read the [85]original article. The Conversation
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Why Moderna won’t share rights to the COVID-19 vaccine with the government
that paid for its development
by Ana Santos Rutschman, [87]Iowa Capital Dispatch
November 21, 2021
Why Moderna won’t share rights to the COVID-19 vaccine__