Patent Litigation over COVID-19 Vaccine
The U.S. company Modela has filed a patent infringement lawsuit against Pfizer Inc. of the U.S. and Biontec AG of Germany based on a patent for mRNA-related technology developed by Modela for COVID-19 vaccine.
I spoke a little about this at the following clubhouse the other day, and I would like to briefly summarize the details of this lawsuit here on this blog.
American Intellectual Property and Legal on Clubhouse
First, Modela claims that its rights under three U.S. patents are infringed by Comirnaty®, a coronavirus vaccine marketed by Pfizer, Inc. and others.
- 10,898,574 (the “‘574 patent”): Delivery and formulation of engineered nucleic acids
- 10,702,600 (the “‘600 patent”) : Betacolonavirus mRNA vaccine
- 10,933,127 (the “‘127 patent”) : Betacolonavirus mRNA vaccine
A summary of claim 1 of each patent is as follows
A method of producing a polypeptide of interest in a cell in a subject in need thereof, comprising administering to the subject a pharmaceutical composition comprising a modified messenger RNA (mmRNA) such that the mmRNA is introduced into the cell, wherein the mmRNA comprises a translatable region encoding the polypeptide of interest and comprises the modified nucleoside 1-methyl-pseudouridine, and wherein the pharmaceutical composition comprises an effective amount of the mmRNA providing for increased polypeptide production and substantially reduced innate immune response in the cell, as compared to a composition comprising a corresponding unmodified mRNA.
Japanese translation of claim 1 of ‘574 patent
A composition, comprising: a messenger ribonucleic acid (mRNA) comprising an open reading frame encoding a betacoronavirus (BetaCoV) S protein or S protein subunit formulated in a lipid nanoparticle.
Japanese translation of claim 1 of ‘600 patent
A method comprising administering to a subject a messenger ribonucleic acid (mRNA) comprising an open reading frame encoding a betacoronavirus (BetaCoV) S protein or S protein subunit formulated in a lipid nanoparticle in an effective amount to induce in the subject an immune response to the BetaCoV S protein or S protein subunit, wherein the lipid nanoparticle comprises 20-60 mol % ionizable cationic lipid, 5-25 mol % neutral lipid, 25-55 mol % cholesterol, and 0.5-15 mol % PEG-modified lipid.
Japanese translation of claim1 of ‘127 patent
The complaint can be read below.
Moderna v. Pfizer, 22-cv-11378, US District Court, District of Massachusetts.
In its complaint, Modela states that it only seeks damages for patent infringement after March 8, 2022, and also states that it does not cover vaccine sales from low-income countries made by Pfizer of the U.S. and Biontec of Germany. Both companies have been accused of willfully infringing Moderna’s patent rights, and Moderna is seeking a jury trial.
In addition, we would like to continue to follow the information regarding this lawsuit, and we would also like to update you on this lawsuit to the extent that we are able.
