COVID-19 Patent Wars: mRNA and Lipid Nanoparticle Pioneers Clash over Vaccine Delivery Patents

• Date: 01 September 2022
• Author: Daniel L. Shores

Published in Landslide, Volume 15, Number 1, 2022. © 2022 by the American Bar Association. Reproduced with permission. All rights reserved. This information or any portion

thereof may not be copied or disseminated in any form or by any means or stored in an electronic database or retrieval system without the express written consent of the

American Bar Association.

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Image: Getty Images

W

hile the COVID-19 pandemic has caused widespread

tragedy for millions of families worldwide, it has also

spurred concomitant advancements in health care,

not the least of which include the rst-ever regulatory approv-

als of therapies based on messenger ribonucleic acid (mRNA)

technology. The two leading COVID-19 vaccines on the market,

introduced by Moderna Inc. and BioNTech SE (in collaboration

with Pzer Inc.), are based on this technology and are currently

the subject of major patent litigations relating to how those thera-

pies are delivered. This article provides an overview of these cases

and the current patent litigation landscape in the mRNA space.

Background on mRNA Technology

Our cells naturally produce mRNA to facilitate the production

of proteins. During the “transcription” process, enzymes within

our cells use segments of DNA as templates to form mRNA in cell

nuclei.1 Then, during the “translation” process, different enzymes

use the produced mRNA as templates to form proteins in cell cyto-

plasm.2 The primary structure of each protein produced by our

cells corresponds to the primary structure of the mRNA molecules

from which the protein was derived.3

BY DANIEL L. SHORES

COVID-19 Patent Wars

mRNA and Lipid Nanoparticle Pioneers Clash

over Vaccine Delivery Patents

Pioneers have developed therapies where the applicable mRNA

sequences are synthesized in the lab and introduced into the cyto-

plasm of cells for translation into proteins.4 Importantly, in these

therapies, the synthesized mRNA sequence can encode for proteins

not derived from a recipient’s genome, which may facilitate cells’

production of specic proteins applicable to a variety of therapies

including, but not limited to, vaccines.5

In the case of the COVID-19 vaccines, pioneers BioNTech and

Moderna developed mRNA congured to encode for the charac-

teristic spike protein appearing on the surface of the COVID-19

virus.

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In these therapies, the mRNA are introduced into the recipi-

ent’s cells, and copies of the unique spike protein are created and

expressed. This allows the recipient’s immune system to identify

the spike protein as an antigen without exposure to the COVID-19

virus and build its defenses against it, in preparation for potential

actual exposure.7

But introducing the mRNA “payload” into cells is no easy

task. These molecules are inherently unstable—if introduced into

the recipient’s body without any protective layer, they may tend to

degrade or otherwise be destroyed by the recipient’s biochemistry,

rather than being taken into cells for translation into the desired

Published in Landslide, Volume 15, Number 1, 2022. © 2022 by the American Bar Association. Reproduced with permission. All rights reserved. This information or any portion

thereof may not be copied or disseminated in any form or by any means or stored in an electronic database or retrieval system without the express written consent of the

American Bar Association.

30