Moderna sues Pfizer and BioNTech over COVID vaccine patents
Moderna sues Pfizer and BioNTech over COVID vaccine patents The Boston Globe
Moderna said Friday that is filing lawsuits against its biggest competitors, Pfizer and BioNTech, for infringing patented mRNA technology used in its COVID-19 vaccines. All three companies are facing separate lawsuits over patents related to the technology, but the action by Cambridge-based Moderna is the highest profile suit yet in an increasingly tangled web over who owns the rights to key inventions for mRNA vaccines.
Global sales of the two mRNA COVID-19 vaccines, one made by Moderna, the other jointly developed by Pfizer and BioNTech, are expected to reach more than $107 billion by the end of the year. Nearly $69 billion of that comes from sales of the Pfizer and BioNTech vaccine. If Moderna wins the lawsuit, even a small royalty percentage could reap the firm immense profits.
“We believe that Pfizer and BioNTech unlawfully copied Moderna’s inventions, and they have continued to use them without permission,” said Moderna Chief Legal Officer Shannon Thyme Klinger in a press release.
A spokesperson for Pfizer said that Pfizer and BioNTech have not had time to fully review the lawsuit, but that the companies “are surprised by the litigation” and that their vaccine “was based on BioNTech’s proprietary mRNA technology and developed by both BioNTech and Pfizer.”
Moderna said it is not seeking to have its competitors’ vaccine removed from the market.
In October 2020, Moderna pledged that it would not enforce its patents related to the COVID-19 vaccine during the pandemic. But in March of this year, the company said that “the collective fight against COVID-19 [has] entered a new phase and vaccine supply was no longer a barrier to access in many parts of the world,” opening the door for legal action against Pfizer and BioNTech for any sales of its vaccine after March 8, 2022.
“We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in creating, and patented during the decade preceding the COVID-19 pandemic,” Moderna CEO Stéphane Bancel said in a press release.
Moderna was founded in 2010 on the belief that scientists could use synthetic mRNA molecules to encode instructions for temporarily making any protein in cells. The idea stretches back decades, and although sound in principle many scientists and investors doubted whether it would ever work reliably and safely in humans.
When the pandemic began, there were no approved therapies or vaccines based on the technology, although Moderna had several early stage clinical trials underway. In January 2020, the firm rapidly pivoted to develop a vaccine for COVID-19 based on its previous work on an experimental vaccine for another coronavirus that causes Middle East Respiratory Syndrome, or MERS.
At the time, Pfizer was working with BioNTech on an mRNA vaccine for flu, but the companies did not disclose their plans for a COVID vaccine until that March. Moderna claims that Pfizer and BioNTech “copied two key features” used in its COVID vaccine.
The first alleged infringement focuses on a chemical modification that Moderna made to its mRNA to help it escape detection by the immune system. Without these modifications, the immune system can attack and destroy the mRNA molecule itself, thus preventing the vaccine from teaching our immune system to attack the coronavirus.
The second alleged infringement is related to the overall design of the COVID vaccine. Pfizer and BioNTech’s vaccine is similar to Moderna’s in that they both encode a full-length spike protein from the coronavirus in an mRNA molecule, and they both used bubble-like molecular wrappers called lipid nanoparticles to protect and deliver the mRNA into human cells. Moderna said it first developed this approach for its MERS vaccine.
Lipid nanoparticles are the subject of several additional lawsuits. In March, Cambridge based Alnylam Pharmaceuticals sued Moderna and Pfizer over the key ingredient used in the companies’ lipid nanoparticles. The Pennsylvanian firm Arbutus Biopharma and its affiliate Genevant Sciences are also suing Moderna over a lipid nanoparticle patent. And the small Canadian firm Acuitas Therapeutics, which licensed its lipid nanoparticle technology to Pfizer, recently sued Arbutus and Genevant.
Moderna has also quarreled with the National Institutes of Health, whose scientists were involved in the early development of the the COVID vaccine, including tests in animals. The NIH said that its researchers were not included in a key patent application for the COVID vaccine. Moderna contended that its own scientists were responsible for the patented work. The firm’s lawsuit against Pfizer and BioNTech focuses on earlier patents filed between 2010 and 2016.
Ryan Cross can be reached at ryan.cross@globe.com. Follow him on Twitter @RLCscienceboss.
