“We believe that Pfizer and BioNTech illegally copied Moderna’s inventions, and they have continued to use them without permission,” Moderna Chief Legal Officer Shannon Thyme Klinger said in a company press release. The company said it filed a complaint in the US District Court of Massachusetts and in Germany, where BioNTech is headquartered.
The prospect of a legal battle between mRNA vaccine makers underscores the high stakes of competition between Pfizer, a global pharmaceutical giant, and Moderna, a Massachusetts-based biotech startup that had never before sold a produced before he wins the emergency. clearance from the Food and Drug Administration for its coronavirus vaccine end of 2020.
Patent lawsuits, common in the biotechnology industry, typically take years and often end up in federal appellate courts. It could be three to five years before the dispute between Moderna and Pfizer-BioNTech is resolved.
Pfizer said Friday it had not fully investigated the complaint.
“We are surprised by the litigation given that the Pfizer/BioNTech COVID-19 vaccine was based on BioNTech’s proprietary mRNA technology and developed by both BioNTech and Pfizer,” the company said in an email. “We remain confident in our intellectual property supporting the Pfizer/BioNTech vaccine and we will vigorously defend ourselves against the lawsuit allegations.”
Moderna and Pfizer have made tens of billions of dollars in coronavirus vaccine sales. But Moderna said it was not seeking an injunction against Pfizer’s sale of its vaccine or its removal from the market, in recognition of the need “to ensure continued access to these lifesaving drugs.”
On the contrary, the outcome of the dispute may prove more relevant for future uses of mRNA technology. The mRNA platform delivers on the promise of future vaccines against flu, HIV and other diseases.
“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-19 pandemic,” the CEO said. of Moderna, Stéphane Bancel, in the company’s press release.
Moderna has worked on RNA vaccines since its inception in 2010. Pfizer partnered with BioNTech, another technology pioneer, early in the pandemic. The two companies produced vaccines in record time as the coronavirus spread in 2020, infecting hundreds of millions and crippling economies; the virus has now killed 6.4 million people worldwide.
Both injections 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 which inoculates against the infection.
Moderna’s lawsuit alleges that Pfizer-BioNTech appropriated two of Moderna’s inventions.
Moderna contends that the Pfizer and BioNTech shot “has the exact same mRNA chemical modifications” as Moderna’s, according to its press release. These mRNA modifications, which Moderna says were validated in 2015, are designed to avoid an unwanted immune response to the presence of the foreign mRNA in the body.
The second invention at issue was developed in response to Middle East Respiratory Syndrome (MERS), Moderna said. He described the invention as a patented approach to “encode the full-length spike protein in a lipid nanoparticle formulation for a coronavirus.”
Crucial elements of the science behind both vaccines have been backed by the National Institutes of Health and developed by NIH scientists. Last year, Moderna sparked an intellectual property dispute with the government over elements of its vaccine when that left NIH scientists off a patent filing project; Moderna thereafter Backtrack and said he was 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 collaborations with the NIH. He added that he was not seeking financial damages for Pfizer’s vaccine sales to poor foreign countries or in any cases where the US government was responsible.