Moderna sues Pfizer, BioNTech over Covid jab technology
Moderna Inc. sued Pfizer Inc. and BioNTech SE, claiming the technology in their Covid-19 shot infringes on its patents, a move that sets the stage for a massive legal clash between the vaccine titans.
Moderna accused Pfizer and BioNTech of violating intellectual property rights on key elements of Moderna’s messenger RNA technology in developing the Comirnaty vaccine. Cambridge, Massachusetts-based Moderna said it had patents from 2010 to 2016 on the mRNA technology that made its Spikevax shot possible but that the other two companies copied the technology without permission.
Pfizer and BioNTech “took four different candidates into clinical testing, including options that would have steered clear of Moderna’s innovative path by using unmodified mRNA,” according a lawsuit filed Friday in the US District Court in Massachusetts. “Ultimately, however, Pfizer and BioNTech discarded those alternatives and copied Moderna’s patented technology.”
Moderna said it is also filing suit in Germany. That complaint could not immediately be verified. Pfizer said it has not been served with a lawsuit and could not comment. Representatives for BioNTech did not immediately respond to a request for comment.
Pfizer shares fell 0.4% at the New York market open, while BioNTech’s American depositary receipts fell 1.6%. Moderna shares fell 0.2%.
Moderna’s lawsuit against Pfizer-BioNTech is unsurprising, given the broad US patents directed toward its mRNA technology, though they may be vulnerable to invalidity under the current case-law trends on written description and enablement. Pfizer-BioNTech could be liable for at least mid-single-digit royalties on past and future Covid vaccine sales if Moderna is successful.
Moderna said it is not asking the courts to pull the Pfizer-BioNTech Covid vaccine from the market nor to block future sales.
The company is seeking damages for the period starting March 8 of this year and says it will not seek damages for Pfizer’s sales to 92 lower- and middle-income countries. Early in the Covid crisis, Moderna promised not to enforce its intellectual property rights during the pandemic, but on March 7 it modified that pledge to apply only to lower-income countries, essentially making this litigation possible.
“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 Officer Stephane Bancel said in a statement.
Pfizer and BioNTech made “the exact same chemical modification to their mRNA that Moderna scientists first developed years earlier, and which the company patented and uses in Spikevax,” the suit said. In addition, “the Pfizer and BioNTech vaccine encoded for the exact same type of coronavirus protein (i.e., the full-length spike protein), which is the coronavirus vaccine design that Moderna had pioneered based off its earlier work on coronaviruses and which the company patented and uses in Spikevax.”
The mRNA vaccines have played a crucial role in the pandemic response, particularly in the US. Pfizer last year recorded almost $37 billion in sales from Comirnaty, while Moderna posted roughly $18 billion of revenue from Spikevax.
Moderna noted that it had pledged not to enforce its patents “while the pandemic continues,” to avoid distracting from efforts to bring an end to the outbreak. Covid entered an endemic phase in many parts of the world in early 2022, the suit said, and Moderna announced in March that it expected companies such as Pfizer and BioNTech to respect its intellectual property.
Intellectual property battles over technology used in both the Moderna and Pfizer-BioNTech vaccines are proliferating. Alnylam Pharmaceuticals Inc. earlier this year sued Moderna, Pfizer and BioNTech over the lipid nanoparticle technology used in both of their Covid vaccines. Moderna has sparred with the National Institutes of Health over whether to list the agency’s scientists as inventors on patents for Moderna’s Covid vaccine.
Moderna said Pfizer and BioNTech had other options but “decided to proceed with a vaccine that has the same exact mRNA chemical modification to its vaccine” as Moderna’s shot. Moderna also accused Pfizer and BioNTech of copying its approach of encoding a full-length spike protein in a lipid nanoparticle.
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