Moderna sues Pfizer and BioNTech for covid vaccine patent


Moderna sued Pfizer and its German partner BioNTech on Friday, alleging that the rival firms misused their basic technology in the development of a coronavirus vaccine. The case sets up a legal battle between the most prominent companies that helped curb the coronavirus pandemic in the United States by developing highly effective shots in record time.

“We believe that Pfizer and BioNTech illegally copied Moderna’s inventions and have continued to use them without permission,” Moderna Chief Legal Officer Shannon Thyme Klinger said in a press release. The company said it filed lawsuits in US 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 Massachusetts-based biotech startup that had never sold a product before it won the emergency. authorization from the Food and Drug Administration for its coronavirus vaccine in late 2020.

Moderna ends coronavirus vaccine patent battle with federal authorities

Patent lawsuits, common in the biotech industry, typically play out over years and often end up in federal appeals courts. It may take three to five years before Moderna’s dispute with Pfizer-BioNTech is resolved.

Pfizer said Friday it had not fully reviewed the complaint.

“We are surprised by the lawsuits 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 will vigorously defend against the allegations in the lawsuit.”

Moderna and Pfizer have earned tens of billions of dollars from the sale of vaccines against the coronavirus. But Moderna said it is not seeking an injunction against Pfizer’s sale of the vaccine or its removal from the market, recognizing the need “to ensure continued access to these life-saving medicines.”

Rather, the outcome of the dispute may prove more relevant to the future use 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 in the decade before the COVID-19 pandemic,” Moderna CEO St├ęphane 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 start of the pandemic. Both companies produced vaccines in record time when 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 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 distinctive 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 has appropriated two of Moderna’s inventions.

Moderna claims that Pfizer and BioNTech’s shots “have the same exact chemical mRNA modifications” as Moderna’s, according to its press 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 other invention in question was developed in response to Middle East respiratory syndrome (MERS), Moderna said. It 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 were supported by the National Institutes of Health and developed by NIH researchers. Moderna last year sparked an intellectual property dispute with the government over elements of its vaccine when it left NIH researchers off a draft patent application; Moderna subsequently backtracked, saying it is in discussions with the government to resolve the dispute.

In its press release on Friday, Moderna said that none of the patent rights in the lawsuit against Pfizer and BioNTech are related to intellectual property generated during the collaboration with the NIH. It added that it is not seeking monetary damages for Pfizer sales of vaccine to impoverished foreign countries or in any cases where the U.S. government would be liable.

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