Moderna v. Pfizer

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Moderna v. Pfizer and BioNTech is a patent infringement lawsuit filed in late August 2022,[1] in both federal court in Massachusetts (typically Boston) and the Germany Regional Court of Düsseldorf.[2] BioNTech is a vaccine partner of Pfizer.

As explained by the Wall Street Journal:

“ Moderna Inc. sued rival Covid-19 vaccine makers Pfizer Inc. and BioNTech SE, alleging that the companies’ shot infringes on key intellectual property owned by Moderna.

Pfizer and BioNTech’s vaccine relies on messenger RNA technology that Moderna had developed and patented years ago, including a chemical modification that avoids prompting an undesirable immune response, Moderna said in lawsuits filed [on August 26, 2022].

”

Moderna alleges two central infringements on its patents by defendants: first, that Pfizer copied the same Moderna modification to mRNA that stabilizes the molecule "long enough to program human cells to produce the crucial spike protein that triggers an immune response against Covid."[3] Second, Moderna alleges that defendants use "the same full-length spike protein in its Covid shots. Moderna says it demonstrated a full spike produced an immune response in 2015 when it developed an mRNA vaccine against the Middle East Respiratory Syndrome. That vaccine never went to market."[3]

Pfizer and BioNTech countersued when they filed their answer to Moderna's lawsuit. Moderna alleged that the rival mRNA vaccines are so similar that it constitutes a patent infringement due to mRNA and lipid nanoparticles in both of the vaccines. Pfizer and BioNTech deny this and assert that their vaccine is “undeniably different” from Moderna's, by using a different mRNA structure and different lipids from Moderna's patented mRNA vaccine.

Pfizer also complains that Moderna was violating its pledge in 2020 that it refrain from enforcing any of its COVID vaccine patents while the pandemic continued.

Moderna's Allegations

Long before COVID-19 first emerged, Moderna recognized that mRNA had the potential to revolutionize the field of medicine. mRNA is a molecule that instructs cells to make particular proteins. Unlike traditional vaccines and therapeutics, mRNA medicines harness the body’s own cellular machinery to make proteins themselves that can treat or prevent disease. mRNA medicines use a specific nucleotide sequence to encode instructions to make the exact protein needed for a particular disease. This makes mRNA medicines a powerful tool that can be programmed to target specific diseases. However, before Moderna began its research, nobody had figured out how to make or use mRNA medicines successfully. ...[4]

Along the way, Moderna encountered many technical challenges as it attempted to develop an entirely new way to treat and prevent disease. The problems that Moderna faced started with the mRNA itself. mRNA is an unstable molecule that is quickly destroyed inside the body. Moderna scientists had to develop novel ways to stabilize mRNA by modifying its chemical structure so that it could be used in vaccines and therapeutics. Moderna also optimized its mRNA platform to make it more effective at producing the proteins needed to fight and prevent disease.[5]

...

48. The genomic sequence for SARS-CoV-2 was first published on January 11, 2020, and, within a matter of days, Moderna took that information to create an mRNA sequence encoding for the virus’s spike protein. The first clinical batch of Moderna’s COVID-19 vaccine was manufactured on February 7, 2020—just four weeks after the genome sequence for SARS-CoV-2 was published. Moderna provided clinical samples to its partners at the NIH. Moderna and the NIH then worked together to conduct clinical trials of Moderna’s vaccine on an expedited basis. 49. Moderna’s new mRNA technology dramatically changed the pace of vaccine development. While other leading pharmaceutical companies thought that it could take “several years” or more before a vaccine would be ready, Moderna’s CEO, Stéphane Bancel, predicted in March 2020 that Moderna could have its vaccine in Phase II and III clinical trials in just a “few months.”[6]

Vaccines compared

A study published in the British medical journal Lancet on March 4, 2022, concluded that the Moderna (mRNA-1273) vaccine was more effective in the long term than the Pfizer-BioNTech (BNT162b2) vaccine:

“ our findings suggest that vaccination with mRNA-1273 results in significantly lower rates of SARS-CoV-2-infection and SARS-CoV-2-related hospitalization than vaccination with BNT162b2, and these differences become more pronounced as time from vaccination accrues[7] ”

See also

References