Pfizer said the company had not been serviced and was unable to comment at this time.
Pfizer said the company had not been serviced and was unable to comment at this time.
Moderna is suing Pfizer 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 .
Shares of Pfizer fell 1.4% before the bell while BioNTech was down nearly 2%.
The lawsuit, which seeks undetermined monetary damages, was being filed in the US District Court in Massachusetts and the Regional Court of Düsseldorf in Germany, Moderna said in a news release on August 26.
“We are filing these lawsuits to protect the innovative mRNA technology platform we pioneered, invested billions of dollars in building, and built, from the COVID-19 pandemic,” Moderna CEO Stephen Bansell said in the statement. Patented during the first decade.”
Moderna Inc., itself, and the partnership of Pfizer Inc. and BioNTech SE were two of the first groups to develop a vaccine for the novel coronavirus.
Just a decade old, Moderna, based in Cambridge, Massachusetts, was an innovator in messenger RNA (mRNA) vaccine technology that enabled unprecedented speed in developing a COVID-19 vaccine.
An approval process that previously took years was completed in months, largely attributed to breakthroughs in mRNA vaccines, which teach human cells how to make a protein that would trigger an immune response.
Germany-based BioNTech was also working in this area when it partnered with US pharma giant Pfizer.
The US Food and Drug Administration first granted emergency use for a COVID-19 vaccine to Pfizer/BioNtech in December 2020, then to Moderna a week later.
Moderna’s COVID vaccine—its commercial product alone—has brought in $10.4 billion in revenue this year, while Pfizer’s vaccine brought in nearly $22 billion.
Moderna alleges that Pfizer/BioNtech copied the mRNA technology without permission, which Moderna patented between 2010 and 2016, 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 patent to help others develop their own vaccines, specifically for low- and middle-income countries. But in March 2022, Moderna said it expected companies such as Pfizer and BioNtech to respect their 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 have said they will vigorously defend their patents.
For example, Germany’s CureVac also filed suit against BioNTech in Germany in July. BioNTech responded in a statement that its work was original.
Moderna has also been sued in the United States for patent infringement and an ongoing dispute with the US National Institutes of Health over the rights to the mRNA technology.
In Friday’s statement, Moderna said that Pfizer/BioNtech appropriated two types of intellectual property.
One involved an mRNA structure that Moderna says its scientists began developing in 2010 and was the first to be validated in human trials in 2015.
“Pfizer and BioNTech took four different vaccine candidates into clinical trials, including options that clarified Moderna’s innovative path. Pfizer and BioNTech ultimately decided to move forward with a single vaccine, including the vaccine. There is only one exact mRNA chemical modification for . , ” Moderna said in its statement.
The second alleged breach involved 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).
Although the MERS vaccine never hit the market, its development helped Moderna rapidly roll out its COVID-19 vaccine.
Pfizer said the company had not been serviced and was unable to comment at this time.