Moderna sues Pfizer-BioNTech, alleging COVID-19 vaccine patent infringement

Moderna has sued Pfizer and its German partner BioNTech, alleging the rival firms improperly used its foundational technology in developing their coronavirus vaccine. The suit sets up a legal battle between the most prominent companies that helped curb the coronavirus pandemic in the US by developing highly effective shots in record time.

“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 on Friday (US time). The company said it filed suits in US District Court in Massachusetts and in Germany, where BioNTech is headquartered.

Vials of the Pfizer and Moderna COVID-19 vaccine.Credit: AP

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 authorisation 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”.

Crucial elements of the science behind both vaccines was supported by the National Institutes of Health and developed by NIH scientists. Moderna last year triggered an intellectual property dispute with the government over elements of its vaccine when it left NIH scientists off a draft patent filing; Moderna subsequently backed off and said it is in discussions with the government to resolve the disagreement.

In its news release, Moderna said none of the patent rights in its suit against Pfizer and BioNTech relate to intellectual property generated during its collaborations with NIH. It added that it is not seeking financial damage awards for Pfizer sales of vaccine to impoverished foreign countries or in any instance where the US government would be responsible.

The Washington Post

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