IP Law Daily, PATENT—D. Mass.: Moderna sues Pfizer/BioNTech for patent infringement in developing COVID vaccine, (Aug 26, 2022)

By Brian Craig, J.D.

Moderna sued Pfizer and its German partner BioNTech alleging they used Moderna’s foundational mRNA technology in the development of the COVID-19 vaccine.

Moderna has filed a patent infringement lawsuit against Pfizer and its German partner BioNTech claiming that Pfizer and BioNTech improperly used Moderna’s foundational mRNA technology in the development of the COVID-19 vaccine. Moderna’s complaint filed in the federal district court in Massachusetts alleges that Pfizer and BioNTech infringed three of Modern’s patents by focusing exclusively on vaccine designs that used Moderna’s foundational mRNA technology. Moderna seeks unspecific damages for infringement occurring after March 8, 2022 and a finding that Pfizer/BioNTech acted willfully. Moderna also stated that it plans to file a separate lawsuit in Germany (ModernaTX, Inc. v. Pfizer Inc., Complaint, August 26, 2022).

Moderna’s technology. Moderna owns three patents relating to mRNA technology: U.S. Patent Nos. 10,898,574, 10,702,600, and 10,933,127. Moderna was founded in 2010 aimed at developing RNA technology to create a new generation of transformative medicines. When the COVID-19 pandemic struck, Moderna claims it already had conducted a decade of foundational research in the area of mRNA medicines, including coronaviruses, and was uniquely positioned to respond to the crisis.

Allegations. Moderna claims that Pfizer and BioNTech infringed its patents with the development of the mRNA COVID-19 vaccine, marketed under the brand name Comirnaty. When COVID-19 emerged, neither Pfizer nor BioNTech had Moderna’s level of experience with developing mRNA vaccines for coronaviruses. Before the emergence of COVID-19, neither Pfizer nor BioNTech had ever developed an mRNA vaccine for a coronavirus. Moderna alleges that Pfizer copied two key features of Moderna’s patented technologies which are critical to the success of mRNA vaccines. First, Pfizer and BioNTech took four different vaccine candidates into clinical testing, which included options that would have steered clear of Moderna's innovative path. Pfizer and BioNTech, however, ultimately decided to proceed with a vaccine that has the same exact mRNA chemical modification to its vaccine. Second, Moderna contends that Pfizer and BioNTech copied Moderna’s approach to encode for the full-length spike protein in a lipid nanoparticle for a coronavirus. Moderna worked on this approach in developing a vaccine for Middle East Respiratory Syndrome (MERS) years before COVID-19 first emerged. Although the MERS vaccine never went to market, its development helped Moderna speed up the time in rolling out the COVID-19 vaccine.

“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. “Our mission to create a new generation of transformative medicines for patients by delivering on the promise of mRNA science cannot be achieved without a patent system that rewards and protects innovation.”

Relief sought. Moderna seeks unspecific money damages against Pfizer/BioNTech for infringement of the three patents for activity occurring on or after March 8, 2022. Moderna also seeks a finding of willfulness along with enhanced damages up to three times the amount of compensatory damage. In addition, Moderna seeks attorney fees and costs, claiming that this is an exceptional case.

Moderna will not seek damages for any activity before March 8, 2022. In October 2020, Moderna pledged not to enforce its COVID-19 related patents while the pandemic continued. In March 2022, when the collective struggle against COVID-19 entered a new phase and the vaccine supply was no longer a barrier in many countries, Moderna updated its pledge. Consistent with federal law, Moderna does not seek damages for any sales to the U.S. government. Furthermore, Moderna is not seeking damages for infringement in 92 low- and middle-income countries because Moderna agreed early in the pandemic that it would not enforce its COVID-19 patents to help those countries. Moderna is not seeking to remove Pfizer’s Comirnaty drug from the market and is not asking for an injunction to prevent its future sale, but the company is asking for a reasonable royalty, lost profits, and other relief.

The case is No. 1:22-cv-11378.

Attorneys: William F. Lee (Wilmer Cutler Pickering Hale and Dorr LLP) for ModernaTX, Inc. and Moderna US, Inc.

Companies: ModernaTX, Inc.; Moderna US, Inc.; Pfizer Inc.; Biontech SE; Biontech Manufacturing GmbH; Biontech US Inc.

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