Moderna sues Pfizer/BioNTech for patent infringement on COVID vaccine

Moderna’s logo is reflected in a drop on a syringe needle in this illustration taken November 9, 2020. REUTERS/Dado Ruvic/Illustration

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Aug 26 (Reuters) – Moderna sued Pfizer and its German partner BioNTech on Friday for patent infringement in the development of the first COVID-19 vaccine approved in the United States, alleging they copied technology Moderna had developed years before the pandemic.

Shares of Pfizer fell nearly 1%, while U.S.-listed shares of BioNTech fell about 1.5% in early trading on Friday.

The lawsuit, which seeks indeterminate damages, was filed in the US District Court in Massachusetts. In a press release on Friday, Moderna said the lawsuit would also be filed in the Düsseldorf Regional Court in Germany.

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Contacted by Reuters, a spokesman for the Düsseldorf court said: “I cannot currently confirm receipt of such a claim.”

“We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in creating, and patented in the decade before the COVID-19 pandemic,” the CEO said. of Moderna, Stéphane Bancel, in the press release.

Moderna said her lawsuit was not intended to stop people from getting vaccinated.

Modern Inc. (ARNM.O)alone, and the partnership of Pfizer Inc (PFE.N) and BioNTech SE (22UAy.DE) were two of the first groups to develop a vaccine against the novel coronavirus.

Pfizer said the company has not been served and was unable to comment at this time. BioNTech did not immediately respond to requests for comment.

Just ten years old, Cambridge, Massachusetts-based Moderna had been an innovator in messenger RNA (mRNA) vaccine technology that enabled the unprecedented speed of COVID-19 vaccine development.

An approval process that previously took years was completed in months, thanks in large part to the breakthrough in mRNA vaccines, which teach human cells how to make a protein that will trigger an immune response.

The German company BioNTech was also working in this field when it joined forces with the American pharmaceutical giant Pfizer.

The United States Food and Drug Administration granted emergency use authorization for the COVID-19 vaccine first to Pfizer/BioNTech in December 2020, then a week later to Moderna.

Moderna’s COVID vaccine — its only commercial product — brought in $10.4 billion in revenue this year while Pfizer’s vaccine brought in about $22 billion.

The lawsuit will likely take years to unfold, according to Cowen & Co analyst Tyler Van Buren.

Moderna alleges that Pfizer/BioNTech, without permission, copied mRNA technology that Moderna patented between 2010 and 2016, long before COVID-19 emerged in 2019 and exploded into global consciousness in early 2020.

At the start of the pandemic, Moderna said it would not enforce its COVID-19 patents to help others develop their own vaccines, especially for low- and middle-income countries. But in March 2022, Moderna said it expected companies such as Pfizer and BioNTech to respect its intellectual property rights. He said he would not seek damages for any activity until March 8, 2022.

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

Pfizer and BioNTech already face multiple lawsuits from other companies that claim the partnership’s vaccine infringes their patents. Pfizer/BioNTech said they would vigorously defend their patents.

Germany’s CureVac, for example, 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 US and has an ongoing dispute with the US National Institutes of Health over mRNA technology rights.

In Friday’s statement, Moderna said Pfizer/BioNTech had 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 tested four different vaccine candidates in clinical trials, which included options that would have avoided Moderna’s innovative path. Pfizer and BioNTech, however, ultimately decided to proceed with a vaccine that has the exact same chemical modification of mRNA from its vaccine,” Moderna said.

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

Although the MERS vaccine was never commercialized, its development helped Moderna rapidly deploy its COVID-19 vaccine.

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Reporting by Daniel Trotta, additional reporting by Mrinalika Roy and Amruta Khandekar in Bengaluru and Zuzanna Szymanska in Berlin and Jonathan Stempel in New York; Editing by Caroline Humer, Edwina Gibbs and Howard Goller

Our standards: The Thomson Reuters Trust Principles.

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