Moderna is suing Pfizer and its German partner company BioNTech, claiming that they inappropriately used its technology in developing the coronavirus vaccine.
“We believe that Pfizer and BioNTech unlawfully copied Moderna’s inventions, and they have continued to use them without permission,” the chief legal officer for Moderna, Shannon Thyme Klinger, said in a press release.
Moderna said they filed the lawsuit in Massachusetts US District Court as well as in Germany.
The legal filing could lead to a court fight between an international pharmaceutical behemoth – Pfizer, and a biotechnology start-up – Moderna, which had never sold a product before receiving emergency authorization from the Food and Drug Administration (FDA) in the United States to produce its coronavirus vaccine about a year into the spread of Covid-19 in late 2020, The Washington Post noted.
While lawsuits over patents are a common occurrence in the field of biotech, they tend to take years to resolve and usually go all the way to federal appeals courts. The dispute could last between three and five years, The Post reported.
On Friday, Pfizer announced that it had yet to review the lawsuit and didn’t have a response at this time.
BioNTech said last month in response to a patent lawsuit from fellow German company CureVac that its “work is original, and we will vigorously defend it against all allegations of patent infringement”.
Moderna said it’s not seeking to remove the Pfizer-BioNTech vaccine from the market because “continued access to these lifesaving medicines” need to be ensured.
In the press release, Moderna CEO Stephane Bancel said that “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”.
Both companies made tens of billions of dollars selling vaccines during the pandemic.
Since it was created in 2010, Moderna has been developing RNA vaccines. Fellow RNA developer BioNTech entered a partnership with Pfizer at the start of the pandemic.
The vaccines from the two makers work in a similar fashion by sending a strand of messenger RNA into a person’s cells, forwarding instructions to create a spike protein that can be found on the surface of coronavirus particles. This prompts the immune system to respond and creates protection against infection and disease.
Moderna claims that the vaccine made by Pfizer-BioNTech “has the same exact mRNA chemical modifications”.
Moderna states that the modifications were validated in 2015.
The modifications are designed to prevent an unwanted immune response when the mRNA enters the human system, The Post noted.
The second invention that Moderna claims its rival inappropriately copied was developed in response to the Middle East respiratory syndrome (MERS).
Moderna said it was a way to “encode for the full-length spike protein in a lipid nanoparticle formulation for a coronavirus”.
Support for the development of the vaccines was provided by the US’ National Institutes of Health (NIH), and its scientists made vital contributions to the science the vaccines are based on.
Last year, Moderna left NIH scientists off a draft filing for a patent, leading to an intellectual property disagreement. Moderna has said it’s in talks with the government to find a resolution.
In its Friday press release, Moderna said none of the patents at issue in its dispute with Pfizer-BioNTech were developed in partnership with NIH.
Moderna also said that it’s not looking to get financial damages for the sales of the Pfizer-BioNTech vaccine to struggling foreign nations or concerning any situation involving the US government.
The companies Arbutus Biopharma and Genevant Sciences have sued Moderna for patent infringement, alleging that it used their technology in the invention of its lipid nanoparticle.
Both Moderna and Pfizer were sued last month by Alnylam Pharmaceuticals, which claims that they used its nanoparticle technology, according to The Post.
