Journal of Intellectual Property Law & Practice, 2023, Vol. 00, No.
00 ARTICLE 1
When mRNA technology meets patent law:
innovation, barriers and public health
Tolulope Anthony Adekola
1. Introduction
The messenger ribonucleic acid (mRNA) technology has
been hailed as a major scientific breakthrough and a
versatile technology platform in terms of what it can
deliver to human health across different therapeutic areas,
including vaccines, oncology, rare diseases, cancer treat-
ments and inflammatory conditions.1 Although the swift
delivery of the world’s first mRNA-based COVID-19
vaccine put a big spotlight on the promise of mRNA
technology, the technology is not new to the scien-
tific community. For decades, scientists have stud-
ied mRNA, looking for ways to unlock its poten-
tial for preventing and treating disease.2 Following
the COVID-19 pandemic, however, empirical studies
have shown that the mRNA-related patent landscape is
The author
• Dr Tolulope Anthony Adekola is a Research Fel-
low at the T.C. Beirne School of Law, University of
Queensland, Australia. Prior to joining UQ Law
School, he has held research positions at the Max
Planck Institute for Innovation and Competition,
Munich, Germany and the Chinese University of
Hong Kong. His research focuses on the role of
intellectual property law in facilitating access to
pharmaceuticals.
*
Email: t.adekola@uq.edu.au. T.C. Beirne School of Law, University of
Queensland, St Lucia, Queensland 4072, Australia.
I would like to express my sincere thanks and appreciation to Olapoju
Samuel of the Max Planck Institute for Heart and Lung Research,Frankfurt
am Main, Germany for his valuable comments on the technical aspects of
draft. Any mistakes in the analysis are solely the author’s.
1 Pardi, Norbert, et al. ‘mRNA vaccines—a new era in vaccinology’ (2018)
17 Nature reviews Drug discovery 261–279.
2 Dolgin, Elie, ‘The tangled history of mRNA vaccines’ (2021) 597 Nature
318–324.
© The Author(s) 2023. Published by Oxford University Press. All rights reserved.
For permissions, please e-mail: journals.permissions@oup.com
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*
Abstract
• The success of messenger ribonucleic acid
(mRNA) technology during the Coronavirus
disease (COVID-19) pandemic has ushered in a
new era of vaccine and therapeutic development.
In this rapidly evolving field, top biotech and bio-
pharma companies are constantly searching for
new opportunities to create innovative treatments
and vaccines.
• However, the landscape of mRNA patents is get-
ting complicated and dense, with an accumulation
of partially overlapping patent rights that require
multiple rights holders’ permission for use and
commercialization. Additionally, there are sev-
eral pending patent lawsuits related to key com-
ponents of mRNA platform technologies, with
strong implications for follow-on innovation and
technology diffusion within the field.
• The case of mRNA technology—as often hap-
pens with emerging technologies—is therefore
emblematic of the policy dilemma faced by patent
law of how to balance economic incentives in a set-
ting of cumulative innovation. This article maps
out relevant legal factors that, under different con-
ditions, might aggravate or mitigate the potential
negative effects of patents in the field. Further, it
sets a framework for more targeted examination
of the identified issues.
rapidly expanding and becoming increasingly complex.3
It has beencharacterized by multifaceted networks of
3 See Gaviria, Mario, and Burcu Kilic, ‘A network analysis of COVID-19
mRNA vaccine patents’ (2021) 39 Nature Biotechnology 546–548. For
more discussions on the Mrna patent landscape see Li, Mengyao et al. ‘The
global mRNA vaccine patent landscape’ (2022) 18 Human Vaccines &
Immunotherapeutics 2095837). See also Beyerer Chris, ‘The Long History
of mRNA Vaccines’ Published 6 October 2021. Available at https://
publichealth.jhu.edu/2021/the-long-history-of-mrna-vaccines (accessed
14 April 2023).
doi:https://doi.org/10.1093/jiplp/jpad086
2 ARTICLE
overlapping and follow-on technologies owned by differ-
ent patent holders. The past few years have also witnessed
the emergence of university spin-offs, raising millions of
dollars in funding for mRNA research.4
While it is arguable that having more patents leads to
better innovation, it is likely that a high concentration of
patents within the field will discourage the diffusion of
technology and follow-on innovation.5 Furthermore, the
complexity and density of the mRNA patent landscape
suggest the emergence of a patent thicket—an aggre-
gation of partially overlapping patent rights, requiring
those seeking to commercialize the technology to obtain
permission from multiple rights holders.
The policy dilemma regarding the appropriate design
of the patent system in this field stems from the dual
implications of patents for innovation. On the one hand,
patents help secure the investments necessary to develop
inventions and bring technological applications to the
market. On the other hand, patent law vests patent hold-
ers with considerable power, affecting the direction and
cost of subsequent research and innovation.
Given that the unfeasibility of measuring and deter-
mining empirically the ‘net effect’ of patents on innova-
tion is a well-known problem of normative patent law
analysis, this article does not attempt to make any, even
speculative, judgment regarding the ultimate impact of
patents on either research in the field of mRNA vac-
cine nor innovation enabled through mRNA technology.
Instead, it acknowledges that, in practice, patent rights
can impact innovation in multiple ways and maps out rel-
evant legal factors that, under different conditions, might
aggravate or mitigate the potential negative effects of
patents.
The analysis is structured as follows. Section 2 exam-
ines what makes the mRNA technology peculiar and
the types of patents that protect key aspects of mRNA
technology. This section also considers recent patent lit-
igation revolving around lipid nanoparticles (LNPs) and
their implications for innovation in the field. Section 3
examines access to mRNA technologies in the context of
cumulative innovation and the effects of the bourgeoning
mRNA patent landscape on licencing practises and fol-
lows on innovation. Section 4 examines the mRNA tech-
nology transfer hub—a global initiative aimed at facilitat-
ing the production and manufacturing of mRNA-based
vaccines and therapeutics in low and middle-income
countries—against the mRNA patent landscape. This
4 Ibid.
5 Robert P Merges, ‘Philosophical foundations of IP law: the law and
economics paradigm’ in P S Menell, B Depoorter and D Schwartz, (eds)
Research handbook on the economics of intellectual property law (Edward
Elgar Publishing 2019), 72–97.
Journal of Intellectual Property Law & Practice, 2023, Vol. 00, No. 00
section also discusses ways in which the patent system can
be positioned strategically to harness the revolutionary
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potentials of mRNA technology.
2. The mRNA patent landscape
2.1. The emergence of mRNA platforms
The platform nature of mRNA vaccines is one of the
reasons why the technology has generated so much atten-
tion.6 mRNA vaccines have been described as ‘plug
and play’; a reference to the fact that, in theory, only
the mRNA coding region needs to be changed for an
mRNA vaccine to target a different indication.7 For pub-
lic health reasons, this is desirable because it would
allow for vaccines to be developed quickly in response
to new viral threats and updated rapidly to address new
variants.
Despite the attention-grabbing stories detailing
the remarkable rapid development of Moderna
and Pfizer/BioNTech mRNA-based COVID-19 vaccines,
both vaccines are based on decades of mRNA and deliv-
ery platform research.8 Worthy of note is the fact that
there are existing patents for mRNA vaccine platforms
that even predate the COVID-19 pandemic, which is sig-
nificant from an intellectual property (IP) perspective.
Although mRNA was discovered in 1961, its potential
as a drug or vaccine was not explored until the 1990s.9
Even then, researchers encountered numerous obstacles
while conducting synthetic mRNA research. These chal-
lenges include ensuring that, first, mRNA does not trigger
an adverse immune response; second, the mRNA can be
delivered into host cells without being degraded; third,
the mRNA can be correctly read by ribosomes inside a
patient’s cells; and fourth, host cells express enough of
the encoded antigen to have a therapeutic effect.10 Over
the years, researchers working on mRNA technology have
focused heavily on finding solutions to each of these
issues, which has resulted in significant investment in
mRNA sequence engineering and chemistry, delivery sys-
tems, including the composition and chemistry of LNP
delivery systems and manufacturing processes.11
A significant breakthrough in the mRNA field
occurred in 2005, when Katalin Karikó and Drew
6 Barbier, Ann J. et al. ‘The clinical progress of mRNA vaccines and
immunotherapies’ (2022) 40 Nature biotechnology 840–854.
7 Burrows, R. and Lambrix, E., ‘mRNA Vaccines: a growing and complex IP
landscape’ (2022) 1 Vaccine Insights 191–199.
8 See Gaviria, M. and Kilic, B., (n 3).
9 Cobb, Matthew. ‘Who discovered messenger RNA?’ (2015) 25 Current
Biology R526–R532.
10 See Burrows, R. and Lambrix, E., 2022. (n 7) 193.
11 Martin, Cecilia, and Drew Lowery. ‘mRNA vaccines: intellectual property
landscape’ (2020) 19 Nature Reviews Drug Discovery578–579.
Tolulope Anthony ADEKOLA ⋅ when mRNA technology meets patent law
Weissman of the University of Pennsylvania discovered
that incorporating pseudouridine, a naturally modified
mRNA nucleoside, could circumvent the body’s inflam-
matory immune response to synthetic mRNA.12 This
discovery solved the issue of synthetic mRNA trigger-
ing an uncontrolled immune response in patients. The
University of Pennsylvania owns several patents related
to nucleoside-modified mRNAs and their applications.13
Both Moderna and Pfizer/BioNTech’s COVID-19 vac-
cines use a modified nucleoside approach, and both
companies have taken the non-exclusive sub-licences of
mRNA patents owned by the University of Pennsylva-
nia through mRNA RiboTherapeutics and Cellscript.14
However, these sub-licences are subject to time restric-
tions on granting additional sublicences for in vivo
uses in humans.15 Although not all mRNA vaccines in
development have used the same nucleoside-modified
approach, CureVac’s disappointing trial results with their
first-generation mRNA COVID-19 vaccine, which used
normal uridine instead of pseudouridine, has led to
speculation that the modified nucleoside approach is
crucial to the high efficacy seen in the Moderna and
Pfizer/BioNTech vaccines.16 The success of Moderna and
Pfizer/BioNTech vaccines support the case for modified
mRNA and underscores the value of the University of
Pennsylvania’s patents licenced to mRNA RiboTherapeu-
tics and Cellscript.
Turning to mRNA delivery systems, mRNA is ‘inher-
ently unstable and, to function in vivo, it needs to be pack-
aged inside a delivery system to ensure that it can be safely
delivered into target cells without being degraded’.17 The
delivery of RNA-based technologies, including mRNA,
into target cells without degradation has been a major
challenge for researchers, and overcoming this delivery
challenge has been a key factor in the recent success of
mRNA vaccines. Phillip Sharp, a Nobel Prize-winning
researcher and co-founder of Alnylam, stated as early as
2003 that the biggest challenge for RNA-based technolo-
gies is delivering them effectively to their target cells.18 He
emphasized the importance of successful delivery multi-
ple times, using the phrase ‘delivery, delivery, delivery’.19
12 Stuart, Lynda M., ‘In gratitude for mRNA vaccines’ (2021) 385 New
England Journal of Medicine 1436–1438).
13 Ibid.
14 Shapiro, Lucy, and Richard Losick, ‘Delivering the message: How a novel
technology enabled the rapid development of effective vaccines’ (2021)
184 Cell 5271–5274.
15 Burrows, R. and Lambrix, E., 2022. (n 7) 195.
16 Dolgin, Elie, ‘Covid Vaccine Flop Spotlights Mrna Design Challenges’
(2021) 594 Nature 483–483.
17 Burrows, R. and Lambrix, E., 2022. (n 7) 193.
18 Check, Erika, ‘Gene regulation: RNA to the rescue?’ (2003) 425 Nature
10–13.
19 Ibid.
ARTICLE 3
To address the delivery conundrum, several delivery
systems have been developed, including lipids, lipid-like
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materials, polymers, protein derivatives and LNPs How-
ever, LNPs are currently the only delivery technology
that is approved for use in mRNA vaccines (used by
both the Pfizer/BioNTech and Moderna COVID-19 vac-
cines). LNPs have a long history of development, with
early work carried out by Pieter Cullis and his labo-
ratory at the University of British Columbia, and the
technology further developed by companies associated
with Cullis, such as Arbutus Biopharma Corporation
and Acuitas Therapeutics, Inc.20 Given the revolution-
ary potentials of mRNA technology in the health sector,
biotech companies (including Moderna and BioNTech)
have been investing significant time and efforts into opti-
mizing the chemistry and safety of LNPs and develop-
ing their proprietary systems With research underway to
address the remaining challenges associated with LNPs
(such as shelf-life and stability, targeting, optimal load-
ing and manufacturing challenges), it seems likely that
the number of patents relating to the use of LNPs in the
delivery of mRNA vaccines will continue to grow.
2.2. mRNA vaccine patent portfolios
Apart from patents that cover nucleoside modification
and delivery technology, several other types of patents
may apply to an mRNA vaccine candidate. These could
include patents for mRNA vaccine compositions that
encode specific antigens for targeted indications, patents
for mRNA sequence engineering and chemistry, patents
for engineered protein sequences and patents covering
various aspects of mRNA manufacturing.21
Based on the U.S. Security and Exchange Commission
(SEC) filings, as of 31 December 2021, Moderna held
over 170 U.S. patents or patent applications that had been
issued or allowed, as well as more than 110 granted or
allowed patents in non-U.S. jurisdictions, and an addi-
tional 430 patent applications that were still pending.22
Moderna’s filings indicate that the company generally
seeks patent protection for both product and method of
use claims Moderna possesses a wide-ranging prophylac-
tic vaccine patent portfolio that encompasses claims to
LNP-encapsulated mRNAs that encode infectious disease
antigens for various indications, including COVID-19.23
The patent family also includes methods utilizing those
compositions for vaccination.
20 Chen, Sam Lipid nanoparticles for delivery of nucleic acid therapeutics
(Diss. University of British Columbia (2016).
21 Burrows, R. and Lambrix, E., 2022. (n 7) 195.
22 Ibid at 175.
23 Moch, F., et al. ‘What the Moderna–NIH COVID vaccine patent fight
means for research’ (2021) 600 Nature 200–201.
4 ARTICLE
BioNTech has also disclosed that it possesses a wide-
ranging patent estate consisting of over 100 patent fami-
lies that are either exclusively or jointly owned by BioN-
Tech, all of which include at least one filing in either
the European Union or the United States.24 BioNTech’s
SEC filings suggest that its patent portfolio encompasses
patents relating to various features of therapeutic mRNA
structures, mRNA formulations (including lipoplex for-
mulations and LNPs), mRNA manufacturing and uses
of mRNA therapeutics.25 In addition to Moderna and
BioNTech, numerous other companies such as Cure-
Vac, GlaxoSmithKline, Sanofi (which acquired Trans-
late Bio in 2021) and Arcturus Therapeutics are actively
engaged in the development of mRNA vaccines and are
concurrently constructing patent portfolios concerning
mRNA vaccines.26
2.3. Patent litigation: the start of an LNP patent
war
The growing number of companies involved in the devel-
opment of mRNA vaccines and related technology makes
patent litigation in this field almost inevitable in the first
place. There have been reports in several biotech publica-
tions and the press of several patent infringement cases.
Interestingly, three of the five major cases reported in
2022 related to patents covering the LNPs, suggesting a
potential trend in future litigation.27 In all these cases, the
claimants are seeking damages for alleged patent infringe-
ment, but none are seeking an injunction to prevent sales
of the vaccines. This is unusual in patent infringement
cases but understandable given the very low chance of
obtaining such an injunction due to the pandemic. Some
of the major cases will be reviewed further.
In the US District Court of Delaware, Arbutus and
Genevant initiated a patent infringement case against
Moderna in February 2022.28 The crux of their claim
is that Moderna’s COVID-19 vaccine’s production and
sale infringe six US patents associated with LNPs and
their use.29 Arbutus asserts that the relevant patents are
under its ownership and licenced to Genevant. Moderna
has refuted any claims of infringing the aforementioned
patents.
24 Burrows, R. and Lambrix, E., 2022. (n 7) 193.
25 Ibid.
26 Scheibner, J., Nielsen, J. and Nicol, D., ‘An ethical-legal assessment of
intellectual property rights and their effect on COVID-19 vaccine
distribution: an Australian case study’ (2022) 9 Journal of Law and the
Biosciences lsac020.
27 Shores, D.L. ‘COVID-19 Patent Wars: mRNA and Lipid Nanoparticle
Pioneers Clash over Vaccine Delivery Patents, published in Landslide’
(2022) 15 The American Bar Association.
28 Burrows, R. and Lambrix, E., 2022. (n 7) 193.
29 Ibid.
Journal of Intellectual Property Law & Practice, 2023, Vol. 00, No. 00
In March 2022, Alnylam instituted individual patent
infringement lawsuits against Moderna and Pfizer in the
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US District Court of Delaware.30 Alnylam asserts that
the Moderna and Pfizer/BioNTech COVID-19 vaccines
infringe one of its US patents, which covers a category of
cationic biodegradable lipids that can be employed in the
development of LNPs for delivering an active agent, such
as mRNA.31 Both Moderna and Pfizer have denied any
infringement.
Subsequently, in June 2022, Alnylam initiated
new patent infringement lawsuits against Moderna and
Pfizer/BioNTech (in separate actions) in the US Dis-
trict Court of Delaware.32 The latest cases allege that
‘both infringed its patent concerning one of the four
lipid components encapsulating an mRNA payload in
commercialized LNPs’.33
In June 2022, CureVac filed a lawsuit against BioN-
Tech and two of its subsidiaries in the German Regional
Court in Düsseldorf, alleging that the Pfizer/BioNTech
COVID-19 vaccine infringes four of CureVac’s Ger-
man patents pertaining to the engineering of mRNA
molecules.34 The press release issued by CureVac stated
that the patents relate to sequence modifications intended
to increase stability and enhance protein expression, as
well as mRNA vaccine formulations specific to COVID-
19 vaccines.35 BioNTech has responded to the law-
suit without mentioning CureVac, stating on its web-
site that ‘BioNTech’s work is original, and we will
vigorously defend it against all allegations of patent
infringement’.36
In what has been called the ‘clash of the titans’, on
26 August 2022 Moderna initiated a patent infringe-
ment lawsuit against Pfizer and BioNTech in both the
United States District Court for the District of Mas-
sachusetts and the Regional Court of Düsseldorf in
30 See Dunleavy K ‘Alnylam sues Pfizer and Moderna claiming infringement
on its delivery technology for COVID shots’ Available at https://www.
fiercepharma.com/pharma/alnylam-files-lawsuits-vs-pfizer-moderna-
claiming-infringement-its-delivery-technology-covid.accessed (accessed
19 January 2023).
31 Ibid.
32 Kevin Dunleavy, ‘Alnylam ratchets up Pfizer, Moderna infringement fight
on the same day it scored a new patent’ Available at https://www.fiercep
harma.com/pharma/same-day-patent-was-granted-alnylam-claims-pfi
zer-moderna-infringed-it-making-covid-19 (accessed 19 January 2023).
33 Aquino-Jarquin, Guillermo, ‘The patent dispute over the breakthrough
mRNA technology.’(2022) 10 Frontiers in Bioengineering and Biotechnology
1–4.
34 Nature News in Brief, ‘CureVac sues BioNTech over mRNA technology’
(2022).40 Nat Biotechnology 1160.
35 Press Release, ‘5 July 2022, CureVac Files Patent Infringement Lawsuit in
Germany Against BioNTech 5 July 2022’ Available at https://www.curevac.
com/en/curevac-files-patent-infringement-lawsuit-in-germany-against-
biontech/ (accssed 15 March 2023).
36 Nature News in Brief (n 34).
Tolulope Anthony ADEKOLA ⋅ when mRNA technology meets patent law
Germany.37 The lawsuit relates to three patents that
cover Moderna’s foundational IP, with priority applica-
tions filed between 2010 and 2016. Moderna alleges
that Pfizer and BioNTech unlawfully copied two key
components of its patented mRNA technology plat-
form, specifically the mRNA chemical modification N1-
methyl pseudouridine (m1ψ) and the design of encoding
complete spike protein.38 Moderna claims to have evi-
dence to support these allegations, as these components
are critical for enhancing immune evasion and protein
production.
A close look at the claims reveals that there are indeed
several similarities between the Pfizer/BioNTech and
Moderna COVID-19 vaccines. Both vaccines use mRNA
technology encoding for the spike protein of SARS-CoV-
2 and are encapsulated in LNPs for delivery. They also
both require two doses administered intramuscularly and
have shown high efficacy rates in preventing symptomatic
COVID-19 disease in clinical trials. Additionally, both
vaccines have generally presented mild side effects. Mod-
erna has pointed out these similarities in their recent
patent infringement lawsuit against Pfizer and BioN-
Tech, claiming that the companies unlawfully copied
their patented mRNA technology platform. Pfizer and
BioNTech denied each of Moderna’s claims, noting that
Moderna is stretching its ‘already overbroad’ and arguably
‘invalid’ patents and is trying to ‘claim credit for oth-
ers’ work.’39 The companies argue that Moderna, in its
original lawsuit, tried to rewrite the well-known story of
the COVID-19 pandemic to put itself in the ‘single, star-
ring role’ by ignoring the contributions of other players,
including scientists at Pfizer and the National Institute of
Health (NIH).40
An analysis of the crux of these cases reveals two crit-
ical motives of the parties. The first is to seek damages,
which are typically calculated based on a ‘reasonable roy-
alty’ applied to the sales of infringing products. Given
that vaccine products have generated billions of dollars in
revenue in recent years, potential damages awards could
be significant. The second is to seek control over the
foundational mRNA technology. The party that would
be eventually declared by the court as holding the valid
patent over foundational mRNA technology (LNP, for
instance) would have a dominant position in the mRNA
37 See Case 1:22-cv-11 378 Document 1 Filed 08/26/22 Page 1 of 39 Available
at https://htv-prod-media.s3.amazonaws.com/files/01-main-1661517480.
pdf (accsessed 23 April 2023). See also Moderna v, ‘Pfizer: What the Patent
Infringement Suit Means for Biotech by Scott Berinato’ Available at
https://hbr.org/2022/09/moderna-v-pfizer-what-the-patent-infringement-
suit-means-for-biotech (accessed 23 April 2023).
38 Ibid.
39 Ibid.
40 Ibid.
ARTICLE 5
market, with the exclusive rights to use and licence the
technology. Beyond the United States, the uncertainties of
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the pending litigations would likely have a global effect on
innovation in the mRNA field including delays in com-
mercialization, uncertainty for investors, increased costs
reduced collaboration and equitable access. For instance,
if any of the early LNP patents are invalidated, other
mRNA competitors may have more freedom to use the
delivery formulations without obtaining a licence. Con-
versely, if the patents survive validity challenges dur-
ing litigation, they would be considered stronger, hav-
ing withstood legal battles, and rights holders may be
more inclined to enforce them in the future. Overall,
the uncertainties generated by these cases make it dif-
ficult for stakeholders to use the technology without
fear and also present a barrier to entry for researchers
and technology developers wishing to explore the
technology.
3. Navigating the balance
3.1. Overly broad patent claims and sufficiency
of disclosure
Having examined the nature of the mRNA technol-
ogy and the ongoing patent wars, we now exam-
ine the concerns regarding the underutilization of
mRNA technology or the otherwise negative impact
of patents on technology dissemination and follow-on
innovation.
For clarity, the inventions protected by patents can
be broadly categorized as products or processes. How-
ever, multiple different claim types can be granted, which
set out the boundaries of the protected invention. With
regard to mRNA vaccines, and by way of example, such
claims could cover the mRNA sequence itself, the deliv-
ery system for the mRNA vaccine, the dosage regimen for
the mRNA vaccine, the medical use(s) for the mRNA vac-
cine, processes for producing mRNA vaccines generally
and processes for the manufacture of a particular mRNA
vaccine.41
The first concern revolves around overly broad patent
claims in the field. In the ongoing legal battles surround-
ing mRNA technology, there are arguments criticizing
the perceived overly broad scope of patent protection
granted. In particular, some litigants argue that ‘extremely
broad claims’ related to the mRNA sequence, the delivery
system used for mRNA vaccines, and the dosage regimen
for such vaccines could impede innovation in the field
41 Gaviria, Mario, and Burcu Kilic, ‘A network analysis of COVID-19 mRNA
vaccine patents’ (2021) 39 Nature Biotechnology 546–548.
6 ARTICLE
and act as a barrier for researchers and technology devel-
opers looking to experiment with the technology in their
preferred systems.42
In any case, patent law stipulates that an invention
must be disclosed ‘in a manner sufficiently clear and com-
plete for it to be carried out by a person skilled in the
art’.43 In cases where a broad subject matter is claimed, the
European Patent Office for instance requires the applicant
to provide a range of examples of alternative embodi-
ments that ‘extend over the area protected by the claims’
to meet this requirement.44 It is worth noting that even if
a broad claim is ‘sufficiently exemplified’, the patent appli-
cation must nonetheless include sufficient information to
enable a person skilled in the art, using common general
knowledge, execute the invention across the entire area
claimed without undue difficulty or the need for inventive
skill.45 Whether mRNA’s patent fulfils this requirement is
disputable. There are questions of whether mRNA’s basic
patents can fulfil the standard of the sufficiency of dis-
closure, according to which the skilled person should not
experience ‘undue burden’, even if it concedes that a lim-
ited amount of trial and error may be permissible, e.g. in
an unexplored field or when there are many technical
difficulties.46
In the context of mRNA technology, Morderna’s
mRNA vaccines to protect against betacoronaviruses—
the genus that includes SARS-CoV-2—can be viewed as
claiming a ‘genus’.47 The discrepancy between the scope
of a genus claim and its disclosure is not a novel issue in
patent law and has been regarded as generally character-
istic of chemical inventions. In patent law, genus claims
refer to claims that cover a wide range of variations or
species of an invention, as opposed to a narrow or spe-
cific invention.48 Although they may seem advantageous
for providing broader protection for an invention, they
are generally disfavoured in patent law for several reasons.
First, the genus claims may encompass numerous poten-
tial embodiments or variations that are not all enabled by
42 Ibid.
43 Kim, Daria, et al. ‘CRISPR/Cas Technology and Innovation: Mapping
patent law issues’ Max Planck Institute for Innovation & Competition
Research Paper 22–06 (2022).
44 EPO Guidelines for Examination, F-III-1 https://www.epo.org/law-
practice/legaltexts/html/guidelines/e/f_iii_1.htm (accessed 22 March
2022).
45 Marco, Alan C., Joshua D. Sarnoff, and A. W. Charles, ‘Patent claims and
patent scope’ (2019) 48 Research Policy 103790.
46 Kim, D., Hilty, R., Hofmeister, E., Slowinski, P.R. and Steinhart, M.,(n 43).
47 Cohen Jon, ‘Scientists question Moderna invention claim in COVID-19
vaccine dispute Company sues rivals Pfizer and BioNTech over mRNA
technology’ Available at https://www.science.org/content/article/
scientists-question-moderna-invention-claim-covid-19-vaccine-
dispute(accessed 23 April 2023).
48 Karshtedt, Dmitry, Mark A. Lemley, and Sean B. Seymore. ‘The death of
the genus claim’ (2021) 35 Harvard Journal of Law & Technology 1–72.
Journal of Intellectual Property Law & Practice, 2023, Vol. 00, No. 00
the disclosure provided in the patent specification, mak-
ing it difficult for others to determine what is actually cov-
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ered by the patent and may potentially lead to confusion
and disputes.49 Second, the genus claims may be exces-
sively broad and cover many variations that lack novelty
or inventiveness, allowing a patent owner to unfairly
monopolize a large area of technology.50 Third, the genus
claims may be ambiguous, making it challenging for com-
petitors to determine what falls within the scope of the
patent and creating uncertainty in the marketplace. As
a result, disputes and litigation may arise, which can
be costly, time-consuming and detract from resources
that could be used for innovation.51 Interestingly, argu-
ments challenging the patent on a functional genus claim
on the grounds of insufficient disclosure and the lack of
enablement are currently before the US Supreme Court in
Amgen Inc v Sanofi.52 The question carved out by the US
Supreme Court is: ‘should the enablement requirement
of a patent claim focus on whether the disclosures sim-
ply enable skilled people in the field to “make and use”
the claimed invention or whether the disclosures accu-
rately enable the “full scope” of the invention—all vari-
ations of the invention that fall within the patent claim’s
description of the invention; and, would a relatively easy
trial-and-error procedure equate to undue experimenta-
tion?’53 This is a case that could have profound impacts
both on the invention enablement issues that have been
plaguing life science patenting, but also more broadly on
defining the contemporary role that the patent system
will play in the biotechnology innovation economy going
forward.
In the context of mRNA, Moderna’s claim to have
invented the specific use of mRNA vaccines to pro-
tect against betacoronaviruses has been characterized as
‘incredibly broad’.54 Genus claims could be problem-
atic because mRNA molecules can be highly variable in
terms of their structure, function and specificity. A genus
claim that covers a large group of mRNA molecules could
make it difficult for other researchers to develop and
49 Holman, Christopher M. ‘Is the Chemical Genus Claim Really “Dead” at
the Federal Circuit?: Part I’ (2022) 41 Biotechnology Law Report 4–22.
50 Ibid.
51 Ibid.
52 Tu, S. Sean, Sarosh Nagar, and Victor L. Van de Wiele, ‘Broad Patent
Claims Come Before the Supreme Court in Amgen v Sanofi’ (2023) JAMA
1641–1642.
53 Holman, Christopher M, ‘Amgen v. Sanofi: The Supreme Court Takes up
the Enablement Requirement in the Context of Therapeutic Monoclonal
Antibodies’ (2022) 41 Biotechnology Law Report 269–282.
54 Pmbyjon Cohen, ‘Scientists question Moderna invention claim in
COVID-19 vaccine dispute Company sues rivals Pfizer and BioNTech
over mRNA technology’ 29 August 2022 Available at https://www.science.
org/content/article/scientists-question-moderna-invention-claim-covid-
19-vaccine-dispute (accessed 1 May 2023).
Tolulope Anthony ADEKOLA ⋅ when mRNA technology meets patent law
patent specific mRNA sequences or applications, even
if those sequences or applications are distinct from the
ones covered by the genus claim.55 Furthermore, mRNA
technology is a rapidly evolving field, with discoveries
and applications emerging all the time. Allowing genus
claims could potentially stifle innovation by granting
broad patents that cover a wide range of mRNA molecules
and applications, without necessarily providing a clear
incentive for researchers to develop new and specific
mRNA-based therapies or technologies.
3.2. Access to mRNA technologies in the
context of cumulative innovation
The landscape of mRNA patents has been described as a
complex and dense ‘jungle’.56 This complexity and density
can create what is known as a ‘patent thicket’ – a collection
of partially overlapping patent rights that require those
seeking to commercialize the technology to obtain per-
mission from multiple rights holders.57 This situation is
similar to the concept of the ‘anticommons’, where owner-
ship rights are fragmented and dispersed among multiple
parties, making it difficult to coordinate usage rights that
are collectively necessary to utilize a resource.58
Patent thickets and anticommons have long been on
the policy radar. A patent thicket creates uncertainty
regarding freedom to operate and increases the costs of
follow-on innovation. The social cost at stake is associated
with technology underutilization, ‘unrealized economic
value’, and ‘opportunity loss’. Where patents cover plat-
form technologies, the welfare loss can take the form
of undeveloped or delayed knowledge and innovation.
Even though different technological fields can be prone
to anticommons or patent thickets, the issue of under-
utilization of ‘upstream’ knowledge resources has been
subject to scrutiny, especially regarding biotechnologi-
cal research tools. In the case of mRNA technology tools
(delivery systems, sequence engineering and chemistry,
etc), this means that their application—be it basic or
applied research, the development of human vaccines or
therapeutics—might be foregone or substantially delayed.
It is important to note that the presence of patents
in platform technology, even if they are divided among
55 Larsson, Chatarina, et al. ‘In situ detection and genotyping of individual
mRNA molecules’ (2010) 7 Nature methods 395–397.
56 Li, Mengyao, et al. ‘The global mRNA vaccine patent landscape’ (2022) 18
Human Vaccines & Immunotherapeutics 2095837.
57 Heller, Michael A., and Rebecca S. Eisenberg, ‘Can patents deter
innovation? The anticommons in biomedical research’ (1998) 280 Science
698–701.
58 Depoorter, Ben, Peter Menell, and David Schwartz, eds. Research
Handbook on the Economics of Intellectual Property Law: Vol 1: Theory Vol
2: Analytical Methods (Edward Elgar Publishing 2019).
ARTICLE 7
different owners, does not necessarily mean that the tech-
nology is being underutilized. The key factor is how the
Downloaded from https://academic.oup.com/jiplp/advance-article/doi/10.1093/jiplp/jpad086/7335474 by Rajiv Gandhi National University of Law user on 04 November 2023
rights to use the technology are distributed. Previous
studies have identified certain factors that can lead to
a ‘bargaining failure’ and, as a result, the underutiliza-
tion of technology. These factors include high transaction
costs due to the fragmentation of patent ownership and
stacking licences, as well as information asymmetries and
uncertainties regarding the extent of patent protection
and the value of patents.
3.2.1. High transaction costs
There are some instances of overlapping patent claims
related to mRNA technology. One perspective suggests
that researchers using the patented foundational mRNA
technologies would have to obtain licences from Mod-
erna and/or Pfizer, depending on how the patent cases
unfold, in regions where patent protection is applica-
ble.59 Additionally, other rights holders may be involved,
depending on the specific purpose for which a licence is
being sought. The situation may become more complex
as patent rights for auxiliary tools would also have to be
cleared to utilize mRNA systems.
This all suggests that negotiating and creating con-
tracts for developing and selling a commercial prod-
uct involves significant transaction costs, making costs
high due to the existence of multiple rights holders, as
well as the complicated procedures required for carry-
ing out freedom-to-operate searches and clearing rights.
Licensing mRNA patents could be particularly challeng-
ing due to the complexity of the patent landscape and
there are also concerns that the terms of licensing agree-
ments, including ‘reach-through’ provisions, could affect
the incentives for innovation of institutions interested in
commercializing products that use mRNA technology.
3.2.2. Stacking licences
The term ‘reach-through’ licensing agreements, also
known as ‘stacking licences’, describes situations in which
the owner of a patent for an ‘upstream’ technology
requires a share of the economic benefits generated
through the downstream use of the licenced technology.
This exercise of bargaining power makes licensing unap-
pealing to potential licencees. Enabling technologies,
59 Florio, Massimo. ‘To what extent patents for Covid-19 mRNA vaccines are
based on public research and taxpayers’ funding? A case study on the
privatization of knowledge’ (2022) 31 Industrial and Corporate Change
1137–1151.
8 ARTICLE
being applied as tools in research and product develop-
ment, are susceptible to’ stacking licences’ by definition,
as they are not end products themselves.60
It is essential to distinguish ‘reach-through’ licensing
provisions from ‘reach-through’ patent claims61 Even if
the products developed through a patented mRNA-based
technique do not fall under the patent protection for the
technique itself, the patent owner could still claim a share
in the economic benefits generated downstream under
contractual terms. These conditions can make it difficult
for potential licencees, and even if they agree to them,
it would likely lead to higher prices for the final prod-
ucts. In summary, licensing mRNA technology could be
subject to both high transaction costs and contractual
reach-through claims.
3.3. Compulsory licences for mRNA
technologies
The use of mRNA technologies often requires addi-
tional technologies, like delivery systems, which means
that patent dependencies are likely to occur frequently.
In cases where a later invention cannot be used with-
out infringing an ‘upstream’ mRNA patent, the user
would need to obtain a licence from the relevant patent
holder(s).62 If voluntary licensing fails and the parties
cannot come to an agreement on reasonable licens-
ing terms within a reasonable period, the legal option
of compulsory licensing for dependent patents may be
considered. As a precondition for obtaining a compul-
sory licence in a case of patent dependency, the TRIPS
Agreement requires that the later invention constitute ‘an
important technical advance of considerable economic
significance in relation to the invention claimed in the
first patent’.63 Overall, the effectiveness of this type of
compulsory licence as an instrument of access does not
appear straightforward, as it depends on several factors
such as the interpretation of the standard for an important
technical advance and the willingness of patent holders
to grant voluntary licences. While the lack of its practi-
cal use suggests that the provision has not been applied,
one might hypothesize that the very existence of the pro-
vision might be a factor contributing to the patent holder’s
willingness to grant a voluntary licence.
60 Lemley, Mark A., and Carl Shapiro. ‘Patent holdup and royalty stacking’
(2006) 85 Texas law review 1991.
61 For discussions on this see Kock, Michael A. ‘Open Intellectual Property
Models for Plant Innovations in the Context of New Breeding
Technologies’ (2021) 11 Agronomy 1218.
62 A dependent invention refers to a situation where a patented invention
cannot be exploited without infringing a patent with an earlier filing or
priority date.
63 See Article 31(l) of the TRIPS Agreement.
Journal of Intellectual Property Law & Practice, 2023, Vol. 00, No. 00
In addition, as mRNA technology has great potential
to address basic societal needs such as public health, there
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is a possibility of implementing a compulsory licence
based on public interest, particularly in low- and middle-
income countries. However, the effectiveness of such a
licence would depend on how it is implemented under
national law, the availability of local manufacturing tech-
nology and the accessibility of technical know-how. As
important as compulsory licences may seem, they will
not suffice without a comprehensive and effective transfer
of know-how, which is essential to make use of patented
technology. Accordingly, for ‘medicinal products based
on known methods, such as the use of small-molecule
drugs or traditional vaccines using particles of a virus, a
compulsory licence can provide a ready-to-deploy mech-
anism for production and distribution’.64 In contrast, in
the case of vector-based or mRNA-based vaccines, ‘repli-
cating the technical teaching underlying a patent without
access to the related know-how is by no means trivial’.65
Therefore, compulsory licensing cannot be viewed as an
immediate solution to address large-scale patent hold-ups
due to its exceptional nature and case-by-case assess-
ment.66 Instead, other measures, such as additional access
instruments and private ordering initiatives like patent
pools, should be explored based on a more comprehen-
sive understanding of current and emerging practices,
especially in the context of mRNA patents.
While this article focuses on patents, it is essential
to acknowledge that patents are not the only means of
protecting innovations. Confidentiality restrictions and
trade secrets law can also protect unpatented know-how,
which is particularly useful for protecting aspects of
a product’s development or manufacture that are diffi-
cult to patent, such as drug discovery and development
methods.
4. Potential solutions and the role of
patents
4.1. The mRNA technology transfer hub
Born out of the vaccine inequality experienced during
the COVID-19 pandemic, the global initiative known as
the mRNA technology transfer program was established
64 Hilty, Reto, et al. ‘Covid-19 and the role of intellectual property: position
statement of the Max Planck Institute for innovation and competition of 7
May 2021’ (2021) Max Planck Institute for Innovation & Competition
Research Paper 21–13.
65 Ibid.
66 Hilty, R., Batista, P., Carls, S., Kim, D., Lamping, M. and Slowinski, P.R., (n
64).
Tolulope Anthony ADEKOLA ⋅ when mRNA technology meets patent law
in 2021 to enhance health security in low- and middle-
income countries by establishing sustainable, locally-
owned mRNA manufacturing capabilities.67 The pro-
gram is centred around a technology transfer ‘hub’,
Afrigen, located in South Africa, which is to provide
technology development, training and transfer services
to 15 manufacturers called ‘spokes’.68 While the COVID-
19 vaccine is a crucial test for the hub and a potential
first step to unlocking research and development capac-
ity for other mRNA vaccines, it may not be the goal for
all the spokes. Martin Friede, the coordinator for the Ini-
tiative for Vaccines Research at the WHO, suggests that
while the spokes are interconnected and committed to
sharing knowledge, each one has the autonomy to plot its
own course forward.69 An example of such deviation is
Sinergium Biotech and Bio-Manguinhos, the two South
American spokes, who are considering what other vac-
cines they might develop—identifying what the needs of
the region are and making the most of the mRNA tech-
nology for other classes of vaccines and therapeutics for
diseases.70 The plan is that the Hub at Afrigen will share
technology and technical know-how with local producers
while WHO and partners will bring training and financial
support to build the necessary human capital for produc-
tion know-how, quality control and product regulation,
while also assisting, where needed with the necessary
licences.71
Turning to the mRNA patent landscape, the Medicines
Patent Pool (MPP)—which co-leads the hub’s initiative
with the WHO—is expected to assist in IP management
by providing IP analysis and defining and negotiating
terms and conditions of eventual agreements.72 Accord-
ing to Charles Gore, executive director of the MPP, this
task is expected to be complex and challenging.73 While
Moderna has pledged not to enforce its patents when it
comes to COVID-19 vaccines, it has not made the same
commitment if that technology is used to develop other
immunizations. That may eventually require Afrigen to
67 WHO. ‘mRNA Technology Transfer Hub’ Available at https://www.who.
int/initiatives/the-mrna-vaccine-technology-transfer-hub (accessed 26
April 2023).
68 Ibid.
69 Kerry Cullinan. ‘Even if Moderna Declines—Other Pharma Partners Now
Poised to Join South African mRNA Vaccine Hub Initiative’ of 9 February
2022. Available at https://healthpolicy-watch.news/has-south-africa-
made-modernas-vaccine-scientists-are-not-yet-sure-because-there-has-
been-no-tech-transfer/ (accessed 4 May 2023).
70 Green Andrew Inside Development Global health. ‘South Africa’s mRNA
hub confronts old problems and new directions of 10 November 2022’
Available at https://www.devex.com/news/south-africa-s-mrna-hub-
confronts-old-problems-and-new-directions-104398 (accseed 4 May
2023).
71 WHO (n 67).
72 Ibid.
73 Green A. (n 70).
ARTICLE 9
pursue a different formula that minimizes the risk of
patents becoming a barrier.
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Also, Afrigen started by using publicly available infor-
mation about Moderna’s existing vaccine—but without
any cooperation from the company. Moderna’s technol-
ogy was only chosen because the company had publicly
stated that it would not enforce patent rights during the
pandemic.74 In a rather surprising move, however, Mod-
erna has gone ahead to set up a manufacturing facility
in Kenya, its first in Africa, to produce messenger RNA
(mRNA) vaccines, including COVID-19 shots. Accord-
ing to Moderna, it expects to invest about $500 million
in the Kenyan facility and supply as many as 500 mil-
lion doses of mRNA vaccines to the African continent
each year.75 This move suggests there could be compet-
ing interests between the mRNA technology transfer hub
and Moderna.
Against the background of the earlier discussions, the
mRNA technology transfer hub may face various IP issues
due to the proprietary nature of the mRNA technology
and the patents held by biotech companies, as previously
discussed. One potential issue is licensing, which would
require the hub to negotiate licences with the owners
of relevant patents to use the technology and manufac-
ture vaccines. This is a complex and time-consuming
process, particularly for mRNA technology, where mul-
tiple patents are involved. In addition, issues are likely to
arise if the hub develops modifications or improvements
to the existing mRNA technologies, leading to disputes
with the original patent holders over new patents. This
is particularly important given that the WHO has hinted
that IP resulting from the activity of the hub will be held
by the inventors but will be made freely available to the
spokes.76 Ensuring that the transfer of technology and
knowledge from Afrigen to other ‘spokes’ does not vio-
late existing IP agreements or lead to infringement claims
will no doubt pose a challenge, given the growing mRNA
patent landscape and the complex international IP laws
and regulations.
4.2. Is patenting a problem or a solution?
Having identified some of the barriers that patents might
pose to realizing the revolutionary potentials of mRNA
technology, we now discuss how to mitigate the barriers
and leverage the benefits of patents.
74 WHO (n 67).
75 Pharmaceutical Technology News. ‘Moderna to set up new mRNA
manufacturing facility in Kenya’ Available at https://www.pharmaceutical-
technology.com/news/moderna-mrna-manufacturing-facility/ (accessed 4
May 2023).
76 See WHO (n 67).
10 ARTICLE
Whether patent law is viewed as a problem or a solu-
tion depends on the perspective taken, either an informed
and strategic view or a reactive one. The effectiveness
of the patent system relies on its utilization with a posi-
tive outlook, and ensuring that it functions as intended
and fulfils its considerable potential, while mitigating its
harm. The IP system was certainly not devised as a ‘means
of blocking access to technologies or denying the public
the benefits of new technologies. It was created “not only
to stimulate the creation of new technologies, but also to
provide an efficient means of widely disseminating this
new technological information, and to build structures to
transfer the technology and to put it to work”’.77
That being said, the patent system is often described
as a delicate balance between protecting the interests of
private investors who finance the development of new
technologies and promoting the public interest in ensur-
ing that these technologies are not just abstract concepts
but are disseminated to the public for their benefit.78
Achieving this balance is a complex task, which can be
divided into two sets of issues: pre-grant and post-grant
questions.
In the pre-grant phase of the patent system, the pri-
mary concern is to ensure that the patents granted are in
the public interest, as defined by the ‘patentability’ cri-
teria. These would ensure that patents should only be
granted for technologies that are genuine additions to
existing technological knowledge (i.e., ‘novel’), involve
a significant advancement in their technical field (i.e.,
‘inventive’ or ‘non-obvious’), and are practically useful
(i.e., have ‘utility’ or ‘industrial applicability’). For mRNA
technologies, the patent system must ensure that the
patent applications in this field describe the invention in
enough detail for someone skilled in the field to repli-
cate it, which is what makes patent information systems
valuable for disseminating new technology. The scope of
the patent rights claimed should not exceed the new tech-
nology disclosed in the patent, and patent offices should
narrow claims during the application phase to ensure that
patent rights are limited to their proper scope.79 While
these criteria are generally known in patent law, the key to
an effective patent system is ensuring that issued patents
77 See Taubman, Antony Scott ‘TRIPS jurisprudence in the balance: between
the realist defense of policy space and a shared utilitarian ethic’ in Lenk,
Hoppe and Andorno (eds) SCIENCE AND TECHNOLOGY(Ashgate,
2007) 08–10.
78 Guan, Wenwei, WTO jurisprudence: governments, private rights, and
international trade (Routledge 2020).
79 See Taubman A ‘Climate Change and The Intellectual Property System:
What Challenges, What Options, What Solutions?’ (2018) available on
WIPO website at. Available at https://www.wipo.int/export/sites/www/
policy/en/climate_change/pdf/ip_climate.pdf (accessed 3 May 2023).
Journal of Intellectual Property Law & Practice, 2023, Vol. 00, No. 00
conform to them in practice, which requires maintaining
high standards of ‘patent quality’.
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After a patent is granted for a technology, post-
grant considerations become important as the technol-
ogy, in this case, mRNA technology enters into a broader
legal and regulatory environment. The focus should shift
toward how the patent owners can appropriately exer-
cise their exclusive patent rights, and what remedies can
be implemented to serve the public interest. Given that
technologies have to be typically packaged together from
several sources and licenced through a range of arrange-
ments and structures, regulators may scrutinize how a
patent holder licences technology, particularly for pub-
licly funded or public sector institutions that hold key
patents on valuable technologies with a strong public
interest. Post-grant questions that must be answered with
regard to mRNA technologies for instance should include
determining appropriate licensing structures and IP man-
agement strategies to promote the dissemination of the
technologies, establishing exceptions and limitations to
patent law to safeguard the public interest and interven-
tions that override exclusive patent rights to address anti-
competitive practices and other abuses of patent rights.
Furthermore, given that the current market-based
innovation ecosystem for the R&D of mRNA technolo-
gies seems to pose many challenges and uncertainties, it
would be important to explore how non-IP incentives and
initiatives can complement the current IP market-based
incentives sustainably. The time is ripe for such inquiry
as the culture of collaboration and inclusivity exhibited
during the early days of the COVID-19 pandemic could
unleash a genuinely new competing model for the dis-
covery of new medicines. For instance, researchers in
countries such as China, Germany, the United Kingdom
and the US shared information on the genome sequence
for COVID-19 paving the way for researchers and labo-
ratories around the world to jointly decode the structures
of key coronavirus proteins.80 Efforts through COVAX, a
jointly led initiative by the WHO, Gavi, Coalition for Epi-
demic Preparedness Innovation and UNICEF, have also
been very helpful in facilitating access to vaccines. Sev-
eral platforms have also been designed to facilitate the free
exchange of pharmaceutical technologies and epidemio-
logical research data on COVID-19 (such as the WHO
COVID-19 Technology Access Pool). Moreover, alterna-
tives to the current R&D pathways—such as prizes and
the Health Impact Fund—have been posed for some time
but failed to gain traction; such alternatives should be
80 Editorials Coronavirus: everyone wins when patents are pooled 5 Nature
581(2020).
Tolulope Anthony ADEKOLA ⋅ when mRNA technology meets patent law
studied and revised in light of the lessons learned from
the COVID-19 pandemic.81
5. Outlook and conclusion
The field of biopharmaceuticals is witnessing a surge
in interest in mRNA technology, owing to its superior
flexibility, safety and precision as compared to tradi-
tional methods. The growing interest is evident from the
increasing number of clinical trials being conducted for
cancer therapies and infectious diseases, signalling the
industry’s inclination toward launching these novel vac-
cines in the market. Several studies have examined the
mRNA patent landscape, but there is little evidence of
licensing practices for this technology. The complexity of
the patent landscape is generally considered unfavourable
to the business environment and may discourage poten-
tial licencees. In the case of mRNA technology, there are
three scenarios where usage rights need to be licenced:
(i) non-commercial research, (ii) toolkits and deliv-
ery systems development and (iii) downstream product
development and commercialization, such as vaccines
and therapeutics. Non-commercial research and toolkit
development are typically granted non-exclusive licences
81 Hollis, Aidan, and Colin Busby ‘International fund could drive equitable
development of COVID-19 vaccine’ Policy Options (2020). Available at
https://policyoptions.irpp.org/magazines/april-2020/international-fund-
could-drive-equitable-development-of-covid-19-vaccine/ (accessed 3 May
2023).
ARTICLE 11
while licensing terms for commercial research can be
onerous and impose various restrictions. While existing
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evidence provides some insights, a more comprehensive
understanding of access to mRNA technology through
voluntary contracts, particularly about the scope of exclu-
sive licences, is needed.
As the patent landscape surrounding mRNA vaccines
becomes more complex and fragmented, freedom to
operate issues and the possibility of litigation are almost
inevitable. However, this situation should also encourage
the formation of new collaborations and partnerships for
cross-licensing, especially between mRNA vaccine devel-
opers and companies specializing in delivery technology
like LNPs in the interest of the public. In summary, while
patents can play a crucial role in protecting innovation
and incentivizing investment, they can also create obsta-
cles to market entry and limit access to medicines if not
managed properly. As the field of mRNA vaccines con-
tinues to grow and evolve, it will be important for com-
panies to navigate the patent landscape carefully, seeking
out collaboration opportunities and cross-licensing part-
nerships where possible, while also considering broader
issues of public interest related to access, pricing and
funding.