When a novel respiratory virus emerged and sparked global worries, Moderna responded with a new infectious disease division. The biotech’s scientists developed a messenger RNA vaccine that encoded the full length of the spike protein characteristic of this novel coronavirus. Animal tests of the lipid nanoparticle-encapsulated mRNA showed that the technology worked.
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This vaccine was not for SARS-CoV-2. Rather, Moderna is referring to an outbreak sparked by a different coronavirus, Middle East Respiratory Syndrome (MERS). That research began in 2014—five years before Covid-19’s emergence. Moderna contends that this MERS work, and the intellectual property that stemmed from it, was the foundation for its mRNA-based Covid-19 vaccine. The vaccine developer is now suing partners Pfizer and BioNTech, claiming that those companies copied its work and are infringing patented mRNA technology.
Separate lawsuits were filed Friday in the U.S. District Court for the District of Massachusetts and the Regional Court of Düsseldorf Germany.
Though the mRNA vaccines now available for Covid-19 have validated this approach to vaccine development, it’s easy to forget that uncertainty surrounded the entire field of mRNA research prior to the pandemic. One of hurdles for mRNA continues to be a challenge for genetic medicines: The body can see vaccine and therapeutic components as foreign, prompting an immune response. Another challenge is ensuring delivery of mRNA to its cellular destination.
The 39-page U.S. complaint claims that Pfizer and BioNTech followed Moderna’s trail and copied its innovations without licensing the technology used to develop its vaccine, named Spikevax. Moderna specifically points to two technologies. The first is a chemical modification to mRNA that protects it, avoiding an immune response to the mRNA. In the suit, Moderna says its scientists began this work in 2010.
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The second innovation that Moderna claims Pfizer infringed relates to mRNA delivery into cells. In 2011, Moderna scientists tested the delivery of mRNA encapsulated by lipid nanoparticles, according to the suit. Following the success of these experiments, Moderna said that mRNA protected by the chemical modification and encapsulated in a lipid nanoparticle became the foundation of of its mRNA platform. Moderna further asserts its MERS research made the company the first to discover that using mRNA to encode for a full-length spike protein in a lipid nanoparticle formulation could be effective at producing neutralizing antibodies to the coronavirus.
“Through that work on MERS, Moderna demonstrated the effectiveness of the mRNA vaccines to prevent coronavirus infection and developed a template that could be used against future coronaviruses,” Moderna states in the complaint.
When Covid-19 emerged, the Moderna pipeline already included six clinical-stage mRNA candidates for infectious diseases such as influenza, respiratory syncytial virus, and Zika virus. By comparison, neither Pfizer nor BioNTech had any mRNA candidates for infectious disease. BioNTech’s initial mRNA focus was cancer. The pandemic’s spread prompted developers of various types of vaccines to turn their attention to Covid-19. Moderna, Pfizer, and BioNTech were among them.
The suit contends that Pfizer and BioNTech had multiple opportunities to avoid taking the same mRNA path as Moderna. The partners started with more than 20 mRNA vaccine candidates taken into animal testing. Those vaccines were narrowed to four chosen for human testing. The vaccine candidate that Pfizer and BioNTech ultimately selected for later-stage testing was the one that encapsulated the full-length of the spike protein—the same approach as Moderna’s. That vaccine, now known as Comirnaty, was the first one to receive FDA emergency authorization and the first one to receive the agency’s full approval.
Moderna said in 2020 that it would not enforce its Covid-19 patents while the pandemic continued. As vaccine supply improved in many parts of the world, Moderna updated its pledge this past March. The company reiterated that it wouldn’t enforce its Covid-19 vaccine patents in places covered by the Gavi Covid-19 Vaccines Advance Market Commitment (COVAX AMC), which is providing vaccine access in 92 low- and middle-income countries.
However, the mRNA vaccine developer also said that in countries where vaccine supply is no longer a barrier to access, it expected other companies to respect its intellectual property and license its Covid-19 vaccines technology “on commercially reasonable terms.” Moderna stated in the suit that Pfizer and BioNTech have yet to seek such a license. Pfizer provided a brief emailed response to the lawsuit.
“Pfizer/BioNTech has not yet fully reviewed the complaint but we are surprised by the litigation given the Pfizer/BioNTech COVID-19 Vaccine was based on BioNTech’s proprietary mRNA technology and developed by both BioNTech and Pfizer,” the company said. “We remain confident in our intellectual property supporting the Pfizer/BioNTech vaccine and will vigorously defend against the allegations of the lawsuit.”
In a separate statement, BioNTech asserted that its work is original and the company will “vigorously defend against all allegations of patent infringement.” The company added that it will not comment on its legal strategy.
Moderna isn’t seeking removal of Comirnaty from the market, nor will it ask for an injunction to prevent future sales of the shot. The suit seeks unspecified monetary damages, “including reasonable royalties and/or lost profits” for the infringement of three patents.
Moderna’s suit places limits on the scope of infringement it asserts. The company said none of the patent rights it is seeking to enforce relate to intellectual property created during its Covid-19 collaboration with the National Institutes of Health. That collaboration began after the patented technologies that are part of the complaint were successfully tested in clinical trials in 2015 and 2016, the company said. Furthermore, Moderna said it is not seeking damages related to Pfizer’s sales of the drug in the 92 countries covered by the Gavi initiative. Moderna is also not seeking to recover any damages that would make the U.S. government, a large purchaser of Comirnaty, responsible. With respect to the alleged infringement by Pfizer and BioNTech, Moderna said it is limiting its damages claim to activity that followed its March 7 patent pledge.
Litigation surrounding mRNA technologies has been growing this year. In March, Alnylam Pharmaceuticals filed patent infringement suits against both Moderna and Pfizer. Cambridge-based Alnylam claims that the mRNA vaccines from both pharmaceutical giants infringe its patented technology for protecting mRNA as it is delivered into a cell. Last month, mRNA vaccine developer CureVac sued BioNTech, claiming that the fellow German company is infringing its patents covering the engineering and formulation of mRNA vaccines.
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