(Reuters) – Moderna Inc is suing Pfizer Inc and its German partner BioNTech for patent infringement in the development of the first Covid-19 vaccine approved in the United States, alleging they copied technology Moderna developed years before the pandemic.
Pfizer shares fell 1.4% before the bell, while BioNTech was down about 2%.
The suit, which seeks unspecified financial damages, has been filed in the US District Court in Massachusetts and the Regional Court in Düsseldorf, Germany, Moderna said in a press release on Friday.
“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-1
9 pandemic,” Moderna CEO Stephane Bancel said in the statement.Moderna, on its own, and the partnership between Pfizer and BioNTech were two of the first groups to develop a vaccine against the new coronavirus.
Just a decade old, Moderna, based in Cambridge, Massachusetts, had been an innovator in the messenger RNA (mRNA) vaccine technology that enabled the unprecedented speed of the development of the COVID-19 vaccine.
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.
Germany-based BioNTech had also worked in this field when it partnered with American pharmaceutical giant Pfizer.
The US Food and Drug Administration granted emergency authorization for the use of the covid-19 vaccine first to Pfizer/BioNTech in December 2020, then a week later to Moderna.
Moderna’s COVID vaccine — its lone commercial product — has brought in $10.4 billion in revenue this year, while Pfizer’s vaccine brought in about $22 billion.
Moderna alleges that Pfizer/BioNTech, without permission, copied mRNA technology that Moderna had patented between 2010 and 2016, long before COVID-19 emerged in 2019 and exploded into global consciousness in early 2020.
Early in the pandemic, Moderna said it would not enforce its Covid-19 patents to help others develop their own vaccines, particularly 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. It said it would not seek damages for any activity before March 8, 2022.
Patent litigation is not uncommon in the early stages of new technology.
Pfizer and BioNTech are already facing several lawsuits from other companies that say the partnership’s vaccine infringes on their patents. Pfizer/BioNTech has said it will vigorously defend its patents.
For example, Germany’s CureVac 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 the rights to mRNA technology.
In Friday’s statement, Moderna said Pfizer/BioNTech appropriated two types of intellectual property rights.
One involved an mRNA structure that Moderna says its researchers 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 trials, which included options that would have deviated from Moderna’s innovative path. However, Pfizer and BioNTech ultimately decided to proceed with a vaccine that has the same exact mRNA chemical modification of their vaccine.” , says Moderna in its statement.
The second alleged violation involves the coding of a full-length spike protein that Moderna says its researchers developed while creating a vaccine against the coronavirus that causes Middle East Respiratory Syndrome (MERS).
Although the MERS vaccine never made it to market, its development helped Moderna quickly roll out its COVID-19 vaccine.
Pfizer said the company had not been served and could not comment at this time.
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