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Commentary

    * [27]COVID-19
    * [28]Health Care

  [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

  X

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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

  <h1>Why Moderna won’t share rights to the COVID-19 vaccine__
  <p class="byline">by Ana Santos Rutschman, <a href="https://
   <p>A quiet <a target="_blank" href="https://www.thedenverch
  <p><a target="_blank" href="https://www.slu.edu/law/faculty/
  <p>Moderna recently <a target="_blank" href="https://www.cbs
  <h2>    <h4 class="editorialSubhed">U.S. was a major funder
  ____________________________________________________________
       </h2>______________________________________________________
  <p>Vaccines have <a target="_blank" href="https://www.who.in
  <p>In December 2020, Moderna became the second pharmaceutica
  <p>Unlike many of the other pharmaceutical companies involve
  <p>Throughout the 2010s, Moderna focused on the development
  <p>Even <a target="_blank" href="https://direct.mit.edu/qss/
  <p>In addition, after the COVID-19 outbreak began Moderna al
  <p>Researchers have calculated that, collectively, the U.S.
  <h2>    <h4 class="editorialSubhed">U.S., Moderna scientists
  ____________________________________________________________
       </h2>______________________________________________________
  <p>In addition to providing financial support, the federal g
  <p>These contributions included <a target="_blank" href="htt
  <p>The importance of the role played by federal scientists i
  <p>While the U.S. government has spent money on <a target="_
  <h2>    <h4 class="editorialSubhed">How it became a patent d
  ____________________________________________________________
       </h2>______________________________________________________
  <p>As development of the vaccine progressed, Moderna applied
  <p>In applying for some patents related to its vaccine, Mode
  <p>However, in July 2021, Moderna made it clear that it woul
  <p>Moderna’s position was that <a target="_blank" href="ht__
  <p>In November 2021, government officials publicly challenge
  <p>“Just because someone is an inventor on one patent appl__
  <p>By contrast, the National Institutes of Health <a target=
  <p>But this dispute is not merely about scientific principle
  <p>From a practical perspective, excluding federal scientist
  <p>This is especially relevant in cases of product scarcity
  <h2>    <h4 class="editorialSubhed">Broader implications</h4
  ____________________________________________________________
       </h2>______________________________________________________
  <figure class="align-right zoomable">    <div class="halfwid
          <img loading="lazy" src="https://images.theconversat
  <span class="attribution"><a target="_blank" class="source"
  ____________________________________________________________
       </figure>__________________________________________________
  <figure class="align-right zoomable">The ongoing battle betw
  <p>On the one hand, the federal government <a target="_blank
  <p>The pharmaceutical industry thus plays an important and n
  <p>If the NIH is correct about co-ownership of the vaccine,
  <p>However, even if the NIH prevails in the patent dispute,
  <p>But co-ownership would not enable the government to fix a
  <p>In my view, the dispute is a reminder of the <a target="_
  <p>This article is republished from <a target="_blank" href=
  ____________________________________________________________
  ____________________________________________________________
   <p><a href="https://iowacapitaldispatch.com">Iowa Capital D
  (BUTTON) Copy to clipboard
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  [88]Creative Commons License
  (BUTTON) Republish

  Our stories may be republished online or in print under Creative
  Commons license CC BY-NC-ND 4.0. We ask that you edit only for style or
  to shorten, provide proper attribution and link to our web site. Please
  see our republishing guidelines for use of photos and graphics.
  Ana Santos Rutschman
  [89]

Ana Santos Rutschman

  Ana Santos Rutschman is an assistant professor of law at Saint Louis
  University School of Law, where she teaches courses in health law,
  intellectual property, and regulation in the life sciences. She has
  advised the Biden campaign on issues related to intellectual property
  and health technologies. She researches and writes on topics related to
  emerging health technologies, with a particular focus on vaccines and
  other forms of biotechnology. She has also published on topics related
  to e-health, global public health and artificial intelligence.
  [90]MORE FROM AUTHOR

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104. https://iowacapitaldispatch.com/ethics-policy
105. https://iowacapitaldispatch.com/privacy-policy
106. https://iowacapitaldispatch.com/ethics-policy
107. https://iowacapitaldispatch.com/privacy-policy

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