The defendants also filed a countersuit against the Cambridge, Mass-based biotech, asking the court to dismiss the case and formally invalidate Moderna’s claims.
Moderna sued Pfizer and BioNTech for the first time in August, alleging that the COVID-19 vaccine jointly developed by the latter two infringed Moderna’s mRNA technology patent. Moderna alleges that Pfizer and BioNTech “replicated” the mRNA technology that Moderna patented between 2010 and 2016 “without obtaining a license.”
According to Moderna, Pfizer and BioNTech’s COVID-19 vaccine mainly infringes on two types of technical patents, one involving the mRNA structure and the other involving the full-length spike protein. Regarding the first category of patents, Moderna said that the company developed them in 2010 and put them into clinical trials for the first time in 2015; the second category of patents was developed during the Middle East Respiratory Syndrome (MERS) outbreak. Although the relevant MERS vaccine has not been marketed, such patents It is very helpful for Moderna to quickly develop a vaccine during the COVID-19 epidemic.
In October 2020, Moderna pledged not to enforce its patents during the pandemic. However, the company reversed its decision this year, explaining that it would start enforcing patents in rich countries when the coronavirus entered “a new phase of the epidemic”.
Pfizer and BioNTech said in Monday’s filing that they independently developed the vaccine and that Moderna’s lawsuit is a falsification of history. Moderna’s patents far outweigh its actual contribution to the field, the companies said.
Pfizer and BioNTech argued that Moderna ignored the contributions of their scientists to mRNA technology, as well as those of researchers at the National Institutes of Health.
The companies emphasized that Moderna had de facto waived its right to sue because it had pledged not to sue other vaccine makers during the COVID-19 pandemic, which is not over yet.
Moderna’s lawsuit revolves around two key parts of the mRNA vaccine. First, the company claims that Pfizer and BioNTech make the same chemical modifications to mRNA to help it evade the immune system. Second, it claimed that the defendants infringed the patent by using the full-length spike protein in the vaccine.
Pfizer and BioNTech argued on Monday that their vaccine is “undeniably different” from Moderna’s vaccine, noting that their vaccine uses a different mRNA structure than Moderna’s vax, as well as different lipids.
“Unlike Moderna, Pfizer and BioNTech did not receive a windfall for the work of others,” attorneys for the companies said in the filing. “Moderna’s patent claims far outweighed its actual contributions to the field, its current lawsuit will hinder further development of the remarkable science that initially made possible the accelerated COVID-19 vaccine.”
In addition to denying the plagiarism allegations, Pfizer’s lawsuit is quick to point to Moderna’s pledge in 2020 not to enforce patents related to Covid-19 during the pandemic. But now, Moderna has now been “quietly expanding its patent portfolio,” reneging on its promise to “leverage fundamental research” for financial gain.
All three companies have reaped billions of dollars from their vaccines, but they remain mired in vaccine-related lawsuits, including one from CureVac accusing BioNTech of infringing its intellectual property.