“We believe that Pfizer and BioNTech unlawfully copied Moderna’s inventions, and they have continued to use them without permission,” Moderna Chief Legal Officer Shannon Thyme Klinger said in a company news release. The company said it filed suits in U.S. District Court 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 the competition between Pfizer, a global pharmaceutical giant, and Moderna, a start-up biotechnology company based in Massachusetts that had never before sold a product before it won emergency authorization from the Food and Drug Administration for its coronavirus vaccine in late 2020.
Patent lawsuits, common in the biotech industry, typically play out over years and often wind up in federal appeals courts. It could be three to five years before Moderna’s dispute with Pfizer-BioNTech is resolved.
Pfizer said Friday it had not received a copy of the suit and did not yet have a response. Last month, in response to a patent suit brought against it by CureVac, a German company that attempted to produce a coronavirus vaccine, BioNTech stated that its “work is original, and we will vigorously defend it against all allegations of patent infringement.”
Moderna and Pfizer have made tens of billions of dollars in coronavirus vaccine sales. But Moderna said it is 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 medicines.”
Rather, the outcome of the dispute could prove to be more relevant for future uses of the mRNA technology. The mRNA platform holds the promise of future vaccines against influenza, 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 during the decade preceding the COVID-19 pandemic,” Moderna chief executive Stéphane Bancel said in the company’s release.
Moderna has been working on RNA vaccines since its founding in 2010. Pfizer partnered with BioNTech, another pioneer in the technology, at the beginning of the pandemic. 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.
The two shots work in 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 distinctive feature on the surface of every coronavirus particle. The spike protein triggers an immune response in the human body that inoculates against infection.
Moderna’s lawsuit alleges Pfizer-BioNTech appropriated two of Moderna’s inventions.
Moderna contends Pfizer and BioNTech’s shot “has the same exact mRNA chemical modifications” as Moderna’s, according to its news release. Those modifications to mRNA, which Moderna said were validated in 2015, are designed to avoid an undesirable 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. It described the invention as a patented approach to “encode for the full-length spike protein in a lipid nanoparticle formulation for a coronavirus.”
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Read More: Moderna sues Pfizer and BioNTech over covid vaccine patent
