Moderna's patent suit for Covid-19 vaccine points to different virus to drive infringement suit against Pfizer - MedCity News

When a new respiratory virus emerged and caused global concern, Moderna responded with a new infectious disease department. Biotechnology scientists have developed a messenger RNA vaccine that encodes the entire length of the spike protein characteristic of this new coronavirus. Animal tests of mRNA encapsulated in lipid nanoparticles have shown that the technology works.

This vaccine is not for SARS-CoV-2. Rather, Moderna is referring to an outbreak caused by a different coronavirus, Middle East Respiratory Syndrome (MERS). This research began in 2014 – five years before the emergence of Covid-19. Moderna claims that this MERS work and the intellectual property derived from it was the basis for its mRNA-based Covid-19 vaccine. The vaccine developer is now judicial partners Pfizer and BioNTech, claiming that these companies copied his work and infringed on the 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.

Although the mRNA vaccines now available for Covid-19 have validated this approach to vaccine development, it is easy to forget that uncertainty surrounded the entire field of mRNA research before the pandemic. One of the hurdles for mRNA continues to be a challenge for genetic medicine: the body can perceive the vaccine and therapeutic components as foreign, triggering an immune response. Another challenge is ensuring the delivery of mRNA to its cellular destination.

The 39-page US complaint alleges that Pfizer and BioNTech followed in Moderna’s footsteps and copied its innovations without licensing the technology used to develop their vaccine, called Spikevax. Moderna points to two technologies in particular. The first is a chemical modification of the mRNA that protects it, avoiding an immune response to the mRNA. In the suit, Moderna says its scientists began this work in 2010.

The second innovation that Moderna claims Pfizer infringed concerns the delivery of mRNA into cells. In 2011, scientists at Moderna tested the delivery of mRNA encapsulated by lipid nanoparticles, according to the suit. Following the success of these experiments, Moderna said that mRNA protected from chemical modification and encapsulated in a lipid nanoparticle became the basis of its mRNA platform. Moderna further claimed that its MERS research made the company the first to discover that using mRNA to encode a full-length spike protein in a lipid nanoparticle formulation could be effective in producing neutralizing antibodies against the coronavirus.

“Through this work on MERS, Moderna has demonstrated the effectiveness of mRNA vaccines in preventing coronavirus infection and has developed a template that can be used against future coronaviruses,” Moderna said in the complaint.

When Covid-19 hit, Moderna’s pipeline already included six clinical-stage mRNA candidates for infectious diseases such as influenza, respiratory syncytial virus and Zika virus. In comparison, neither Pfizer nor BioNTech had mRNA candidates for infectious diseases. BioNTech’s initial focus on mRNA was cancer. The spread of the pandemic has prompted the developers of various types of vaccines to turn their attention to Covid-19. Moderna, Pfizer and BioNTech were among them.

The suit alleges that Pfizer and BioNTech had multiple opportunities to avoid taking the same mRNA pathway as Moderna. The partners started with more than 20 mRNA vaccine candidates taken for animal testing. These vaccines were limited to four selected for human testing. The vaccine candidate that Pfizer and BioNTech ultimately chose for later-stage testing was one that encapsulated the entire length of the spike protein—the same approach as Moderna’s. This vaccine, now known as Comirnaty, was the first to receive emergency approval from the FDA and the first to receive full agency approval.

Moderna said in 2020 that it would not enforce its Covid-19 patents while the pandemic continues. As vaccine supplies have improved in many parts of the world, Moderna updates his promise last March. The company reiterated that it will not enforce its Covid-19 vaccine patents in places covered by the Gavi Covid-19 Vaccines Advance Market Commitment (COVAX AMC), which provides access to vaccines 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 expects other companies to respect its intellectual property and license its Covid-19 vaccine technology “on commercially reasonable terms”. Moderna said in the lawsuit that Pfizer and BioNTech have not yet sought such a license. Pfizer provided a brief email response to the lawsuit.

“Pfizer/BioNTech have not yet fully reviewed the complaint, but we are surprised by the litigation given that Pfizer/BioNTech’s COVID-19 vaccine is based on BioNTech’s proprietary mRNA technology and was developed by both BioNTech and and by Pfizer,” the company said. “We remain confident in our intellectual property in support of the Pfizer/BioNTech vaccine and will vigorously defend against the allegations in the lawsuit.”

IN separate statement, BioNTech said its work is original and the company will “vigorously defend against all allegations of patent infringement.” The company added that it would not comment on its legal strategy.

Moderna is not seeking Comirnaty’s removal from the market, nor will it seek an injunction to prevent future sales of the photo. The suit seeks unspecified monetary damages “including reasonable remuneration and/or lost profits” for the infringement of three patents.

Moderna’s lawsuit places limits on the scope of the infringement it alleges. The company said none of the patent rights it wants to enforce relate to intellectual property created during its Covid-19 collaboration with the National Institutes of Health. This 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. Moderna also said it is not seeking compensation 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 US government, a major buyer of Comirnaty, liable. Regarding the alleged infringement by Pfizer and BioNTech, Moderna said it was limiting its claim for damages to activity subsequent to the March 7 patent promise.

Litigation surrounding mRNA technologies is growing this year. In March, Alnylam Pharmaceuticals filed patent infringement lawsuits against Moderna and Pfizer. Cambridge-based Alnylam claims that the mRNA vaccines from the two pharmaceutical giants violate their patented technology to protect the mRNA as it is delivered into the cell. Last month, mRNA vaccine developer CureVac is suing BioNTech, claiming the other German company is infringing its patents covering the engineering and formulation of mRNA vaccines.

Photo: Michael Sohn – Pool/Getty Images

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