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 that they copied technology developed by Moderna years before the pandemic.
The lawsuit, which seeks unspecified monetary damages, was filed in U.S. District Court in Massachusetts and the Regional Court of Düsseldorf in Germany, Moderna said in a news release on Friday.
“We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in developing, and patented during the decade preceding the Covid-19 pandemic,” Moderna Chief Executive Stephane Bancel said in a statement.
Moderna and the collaboration of Pfizer and BioNTech were the first to develop a vaccine for the novel coronavirus.
Moderna, based in Cambridge, Massachusetts, was a pioneer in messenger RNA (mRNA) vaccine technology, which enabled the Covid-19 vaccine to be developed at an unprecedented speed.
An approval process that used to take years was reduced to months, thanks in large part to advances in mRNA vaccines, which teach human cells how to make a protein that will trigger an immune response.
BioNTech, based in Germany, had also been working in this field before partnering with Pfizer, the world’s largest pharmaceutical company.
The US Food and Drug Administration granted Pfizer/BioNTech emergency use authorization for the Covid-19 vaccine in December 2020, followed by Moderna one week later.
Pfizer/BioNTech allegedly copied mRNA technology that Moderna had patented between 2010 and 2016, well before Covid-19 emerged in 2019 and exploded into global consciousness in early 2020, without permission, according to Moderna.
Early in the pandemic, Moderna stated that it would not enforce its Covid-19 patents in order to assist others in developing their own vaccines, especially in low- and middle-income countries. However, Moderna stated in March 2022 that it expected companies such as Pfizer and BioNTech to respect its intellectual property rights. It stated that it would not seek damages for any activity occurring before March 8, 2022.
Patent infringement is common in the early stages of new technology.
Other companies have already sued Pfizer and BioNTech, claiming that the partnership’s vaccine infringes on their patents. Pfizer/BioNTech have stated that they will vigorously defend their patents.
CureVac, for example, filed a lawsuit against BioNTech in Germany in July. BioNTech responded with a statement claiming that its work was unique.
Moderna has also been sued for patent infringement in the United States, and it is in a legal dispute with the National Institutes of Health over mRNA technology rights.
Pfizer/BioNTech appropriated two types of intellectual property, according to Moderna’s statement on Friday.
One involved an mRNA structure that Moderna scientists developed in 2010 and were the first to validate in human trials in 2015.
“Pfizer and BioNTech tested four different vaccine candidates in clinical trials, including options that would have avoided Moderna’s innovative path.” Pfizer and BioNTech, on the other hand, ultimately decided to proceed with a vaccine that contains the same exact mRNA chemical modification,” Moderna said in a statement.
The second alleged infringement involves the coding of a full-length spike protein developed by Moderna scientists while developing a vaccine for the coronavirus that causes Middle East Respiratory Syndrome (MERS).
Although the MERS vaccine was never commercialized, its development aided Moderna in the rapid rollout of its Covid-19 vaccine.
