mRNA-1273 Vaccine Patent Landscape (For NIH-Moderna Vaccine)

 

By Mario Gaviria and Burcu Kilic

November 16, 2020
Safe and effective vaccines are key to combating the Covid-19 pandemic; however, patents and
other intellectual property claims directed at vaccine technologies create legal barriers for
equitable access and fair allocation. No corporation produces at scale to supply the world.
Providing timely global access will depend in significant part on increasing supply, including
by transferring technology to qualified manufacturers. Much of this technology is claimed as
patented, proprietary, or confidential in nature.
The vaccine candidate co-developed by the
U.S. National Institutes of Health (NIH) and
Moderna, mRNA-1273 SARS-CoV-2,
employs the use of lipid nanoparticle (NP)
technology to deliver mRNA to cells. Once
the lipid nanoparticle is injected into a
patient, it travels into the cells and instructs
them to produce the SARS-CoV-2 spike
protein. The presence of this coronavirus
protein is thought to trigger an immune
response leading to the production of
antibodies.
1
If the patient is infected with
coronavirus, the antibodies will identify and
bind to the virus, which triggers a series of
events resulting in the elimination of the
virus. mRNA-1273 is in Phase 3 clinical trials. The NIH and Moderna announced promising but
preliminary trial results on November 16th
.
2

 Public Citizen’s Access to Medicines Program
1 https://www.modernatx.com/mrna-technology/mrna-platform-enabling-drug-discovery-development

2 https://investors.modernatx.com/news-releases/news-release-details/modernas-covid-19-vaccine-candidate-meets-its-primary-
efficacy

PUBLIC CITIZEN mRNA-1273

November 2020 2
We identified several patents claimed by Moderna relating to the pertinent vaccine technologies.
3
We placed them in four groups based on their description and their primary independent claim:
• Patents directed at an mRNA vaccine or RNA
generally
• Patents directed at Lipids/NP + mRNA
• Patents specifically directed at pharmaceutical
compositions involving lipid NP + mRNA.

Below is our non-exhaustive list. In a recent financial statement, Moderna suggested that it
relies to a certain extent on trade secrets, know-how, and technology, which are not protected
by patents, to maintain its competitive position.4 Moderna has announced that it will not
enforce their patent rights against those making vaccines intended to combat the pandemic.

3 Pharmaceutical companies are not the only claimants of key technology. The U.S. government claims a patent on a key technology
which may be relevant for Moderna to stabilize the spike protein. See Public Citizen, Leading COVID-19 Vaccine Candidates
Depend on NIH Technology (Nov. 10, 2020), https://www.citizen.org/article/leading-covid-19-vaccines-depend-on-nih-technology/.
4
If any trade secret, know-how, or other technology not protected by a patent were to be disclosed to or independently developed
by a competitor, our business and financial condition could be materially adversely affected.
Failure to obtain and maintain all available regulatory exclusivities and broad patent scope and to maximize patent term restoration
or extension on patents covering our products may lead to loss of exclusivity and early biosimilar entry resulting in a loss of market
share and/or revenue. Moderna, Quarterly Report, June 30, 2020
https://www.sec.gov/Archives/edgar/data/1682852/000168285220000017/mrna-20200630.htm

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