“We believe that Pfizer and BioNTech have unlawfully copied Moderna’s inventions and continued to use them without permission,” said Shannon Thyme Klinger, Moderna’s chief legal officer in a company press release. The company said it has filed lawsuits in US courts in Massachusetts and in Germany, where BioNTech is headquartered.
The prospect of a legal battle between the mRNA vaccine makers points to the high stakes in competition between Pfizer, a global pharmaceutical giant, and Moderna, a Massachusetts-based biotechnology start-up that had never sold a product before it won the state of emergency. permission from the Food and Drug Administration for its coronavirus vaccine at the end of 2020.
Moderna ends patent battle over coronavirus vaccine with federal government
Patent lawsuits, common in the biotech industry, typically run for years and often end in federal appeals courts. It could take three to five years for Moderna’s dispute with Pfizer-BioNTech to be resolved.
Pfizer said Friday it had not received a copy of the suit and had not yet received a response. Last month, in response to a patent lawsuit filed against the company by CureVac, a German company attempting to produce a coronavirus vaccine, BioNTech stated that its “work is original and that we will vigorously defend it against all allegations of patent infringement.”
Moderna and Pfizer have made tens of billions of dollars selling coronavirus vaccines. But Moderna said it is not seeking a court order against Pfizer’s sale or withdrawal of its vaccine, in recognition of the need “to ensure continued access to these life-saving drugs.”
Instead, the outcome of the dispute could prove more relevant to future uses of the mRNA technology. The mRNA platform holds the promise of future vaccines against flu, HIV and other diseases.
“We are filing these lawsuits to protect the innovative mRNA technology platform we pioneered, invested billions of dollars in creating and patenting during the decade leading up to the COVID-19 pandemic,” said Moderna chief executive Stéphane Bancel in the release of the statement. company.
Moderna has been working on RNA vaccines since its founding in 2010. At the start of the pandemic, Pfizer partnered with BioNTech, another pioneer in the technology. Both companies produced vaccines in record time as the coronavirus spread in 2020, infecting hundreds of millions of people and crippling economies; the virus has now killed 6.4 million people worldwide.
Industry battles over global vaccine patents are just heating up
The two shots work the same way: They deliver a strand of messenger RNA into human cells that instructs the cells to create the unique spike protein that is a distinguishing feature on the surface of each coronavirus particle. The spike protein triggers an immune response in the human body that inoculates against infection.
Moderna’s lawsuit alleges that Pfizer-BioNTech appropriated two of Moderna’s inventions.
Moderna claims that Pfizer and BioNTech’s inclusion “has the same exact chemical mRNA modifications” as Moderna’s, according to the press release. Those modifications to mRNA, which Moderna said were validated in 2015, are designed to prevent an unwanted immune response to the presence of the foreign mRNA in the body.
The second invention in question was developed in response to Middle East Respiratory Syndrome (MERS), Moderna said. It described the invention as a proprietary approach to “encode the full-length spike protein in a lipid nanoparticle formulation for a coronavirus.”
Critical elements of the science behind both vaccines were supported by the National Institutes of Health and developed by NIH scientists. Moderna sparked an intellectual property dispute with the government over elements of its vaccine last year when it withheld NIH scientists from a draft patent application; Moderna subsequently withdrew, saying it is in talks with the government to resolve the disagreement.
In its Friday press release, Moderna said none of the patent rights in its lawsuit against Pfizer and BioNTech relate to intellectual property generated during its partnership with NIH. It added that it will not award financial damages for Pfizer’s sales of vaccines to poor other countries or in any case where the US government would be responsible.