Comment Moderna sued Pfizer and German partner BioNTech on Friday, alleging the rival companies improperly used its core technology to develop their coronavirus vaccine. The lawsuit sets up a legal battle between the most prominent companies that helped contain the coronavirus pandemic in the United States by developing highly effective plans in record time. “We believe that Pfizer and BioNTech illegally copied Moderna’s inventions and continued to use them without permission,” Moderna Chief Legal Officer Shannon Thyme Klinger said in a company press release. The company said it filed lawsuits in U.S. District Court in Massachusetts and in Germany, where BioNTech is based. The prospect of a legal battle between mRNA vaccine makers shows the high stakes in the competition between Pfizer, a global pharmaceutical giant, and Moderna, a Massachusetts-based biotech startup that had never sold a product before winning emergency authorization from the Food and Drug Administration for this coronavirus vaccine in late 2020. Moderna ends coronavirus vaccine patent battle with federal government Patent lawsuits, common in the biotech industry, typically play out over years and often end 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 lawsuit and had yet to respond. Last month, in response to a patent lawsuit brought against it by CureVac, a German company that tried to produce a vaccine against the coronavirus, BioNTech said that “its work is original and we will vigorously defend it against all claims of patent infringement’. Moderna and Pfizer have made tens of billions of dollars from sales of coronavirus vaccines. However, Moderna said it is not seeking an injunction against Pfizer selling its vaccine or removing it from the market, recognizing the need “to ensure continued access to these life-saving medicines.” Instead, the outcome of the controversy could prove more relevant for future uses of mRNA technology. The mRNA platform holds promise for 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 in the decade leading up to the COVID-19 pandemic,” Moderna CEO Stéphane Bancel said in the statement the company’s. Moderna has been working on RNA vaccines since it was founded in 2010. Pfizer partnered with BioNTech, another pioneer in the technology, at the start 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. 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 make 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 the infection. Moderna’s lawsuit alleges that Pfizer-BioNTech misappropriated two of Moderna’s inventions. Moderna claims that Pfizer and BioNTech’s take “has the exact same mRNA chemical modifications” as Moderna’s, according to its news release. These modifications to the mRNA, which Moderna said 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 “encoding the full-length spike protein in a lipid nanoparticle formulation for a coronavirus.” The critical elements of the science behind the two vaccines were supported by the National Institutes of Health and developed by NIH scientists. Moderna sparked an intellectual property dispute with the government last year over elements of its vaccine when it left NIH scientists from filing a patent plan. Moderna later backed down and said it was in talks with the government to resolve the dispute. In its press release Friday, Moderna said none of the patent rights in its lawsuit against Pfizer and BioNTech relate to intellectual property created during its collaborations with the NIH. It added that it is not seeking economic damage awards for Pfizer’s vaccine sales in poor foreign countries or in any case where the US government is liable.
