Moderna filed lawsuits on Friday against its biggest competitors, Pfizer and BioNTech, alleging they infringed patented mRNA technology used in the Cambridge company’s COVID-19 vaccines.
All three companies are facing separate lawsuits over patents related to the technology, but the action by Moderna is the highest profile suit yet in an increasingly tangled web over who owns the rights to key inventions for mRNA vaccines. A resolution is likely many years away.
“It’s David versus Goliath, and Moderna is the David,” said Kevin Noonan, a biotechnology patent lawyer for the Chicago law firm McDonnell Boehnen Hulbert & Berghoff, who isn’t involved in the litigation.
Moderna was founded in 2010 based on the belief that messenger RNA, or mRNA, could be used to deliver genetic instructions to cells for making proteins. The COVID vaccines used mRNA to coax cells into temporarily making coronavirus proteins, and the genetic technology proved faster to design and manufacture than traditional vaccines.
Global sales of the two mRNA COVID-19 vaccines are expected to reach more than $107 billion by the end of the year, with nearly two-thirds going to Pfizer and BioNTech. If Moderna eventually prevails, even a small royalty percentage could add to the billions of dollars in profits it already has reaped from vaccine sales.
“We believe that Pfizer and BioNTech unlawfully copied Moderna’s inventions, and they have continued to use them without permission,” Moderna’s chief legal officer, Shannon Thyme Klinger, said in a statement.
A spokesperson for Pfizer said that the New York-based company and BioNTech, its German development partner on the COVID vaccine, have not had time to fully review the lawsuit, but that the companies “are surprised by the litigation.” Their vaccine “was based on BioNTech’s proprietary mRNA technology and developed by both BioNTech and Pfizer,” the spokesperson said.
Experts who closely follow the mRNA field said that the clash was bound to happen.
“We’re seeing a lot of lawsuits related to mRNA vaccines right now, so I wasn’t surprised about this particular lawsuit,” said Mansoor Amiji, a professor of pharmaceutical sciences and chemical engineering at Northeastern University.
Moderna said it is not seeking to have its competitors’ vaccine removed from the market.
In October 2020, the company pledged that it would not enforce its patents related to the COVID-19 vaccine during the pandemic. But on Friday the company said that in March “the collective fight against COVID-19 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.
“I think the repercussions are going to be pretty small” for COVID vaccines, said Jacob Sherkow, a professor of law and expert on biotechnology patents at the University of Illinois. “This is going to be about booster shots going forward.” But Sherkow added that the lawsuit could have broader implications for other mRNA vaccines and therapies.
“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 the company’s statement.
When the pandemic began, there were no approved therapies or vaccines based on mRNA technology, although Moderna had several early stage clinical trials underway. In January 2020, the firm rapidly moved 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 the immune system to block the coronavirus.
The chemical modification trick was discovered by Katalin Karikó — who now works at BioNTech — and Drew Weissman at the University of Pennsylvania in 2005. Moderna asserts that it invented and owns the patent for a specific chemical modification used in the COVID vaccines. Noonan, the Chicago lawyer, said that Moderna is making a bold move by putting the patent on the line, but that if it wins, it could pay off handsomely “not just for the COVID vaccine, but for pretty much any RNA vaccine.”
The second alleged infringement centers on two patents 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 use 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 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.