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Moderna Sues Pfizer and BioNTech for Patent Infringement on COVID-19 Jab

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The mRNA gene therapy manufacturers are going after each other now.

Moderna has accused Pfizer and BioNTech of infringing its patents while working on the first COVID-19 injection to be approved for use in the United States.

“Moderna believes that Pfizer and BioNTech’s COVID-19 vaccine Comirnaty infringes patents Moderna filed between 2010 and 2016 covering Moderna’s foundational mRNA technology,” Moderna said in a news release.

This groundbreaking technology was critical to the development of Moderna’s own mRNA COVID-19 vaccine, Spikevax®. Pfizer and BioNTech copied this technology, without Moderna’s permission, to make Comirnaty®.

“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,” said Moderna Chief Executive Officer Stéphane Bancel.”This foundational platform, which we began building in 2010, along with our patented work on coronaviruses in 2015 and 2016, enabled us to produce a safe and highly effective COVID-19 vaccine in record time after the pandemic struck. As we work to combat health challenges moving forward, Moderna is using our mRNA technology platform to develop medicines that could treat and prevent infectious diseases like influenza and HIV, as well as autoimmune and cardiovascular diseases and rare forms of cancer.”

Consistent with its commitment to equitable global access, in October 2020, Moderna pledged not to enforce its COVID-19 related patents while the pandemic continued. In March 2022, when 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, Moderna updated its pledge. It made clear that while it would never enforce its patents for any COVID-19 vaccine used in the 92 low- and middle-income countries in the GAVI COVAX Advance Market Commitment (AMC 92), Moderna expected companies such as Pfizer and BioNTech to respect its intellectual property rights and would consider a commercially reasonable license should they request one for other markets. Pfizer and BioNTech have failed to do so.

“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. “Outside of AMC 92 countries, where vaccine supply is no longer a barrier to access, Moderna expects Pfizer and BioNTech to compensate Moderna for Comirnaty®’s ongoing use of Moderna’s patented technologies. 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.”

Recognizing the need to ensure continued access to these lifesaving vaccines, Moderna is not seeking to remove Comirnaty® from the market and is not asking for an injunction to prevent its future sale. In addition, Moderna is not seeking damages related to Pfizer’s sales to AMC 92 countries and is not seeking damages for Pfizer’s sales where the U.S. Government would be responsible for any damages. Consistent with Moderna’s patent pledge, the Company is also not seeking damages for activities occurring before March 8, 2022.

From the New York Post:

Patent litigation is not uncommon in the early stages of new technology.

Pfizer and BioNTech are already facing multiple lawsuits from other companies that say the partnership’s vaccine infringes on their patents. Pfizer/BioNTech have said they will defend their patents vigorously.

Germany’s CureVac, for instance, also filed a lawsuit against BioNTech in Germany in July. BioNTech responded in a statement that its work was original.

Moderna has also been sued for patent infringement in the United States and has an ongoing dispute with the US National Institutes of Health over rights to mRNA technology.

In Friday’s statement, Moderna said Pfizer/BioNTech appropriated two types of intellectual property.

One involved an mRNA structure that Moderna says its scientists began developing in 2010 and were the first to validate in human trials in 2015.

“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,” Moderna said in its statement.

The second alleged infringement involves the coding of a full-length spike protein that Moderna says its scientists developed while creating a vaccine for the coronavirus that causes Middle East Respiratory Syndrome (MERS).





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