Biotech giants BioNTech and Pfizer Monday filed a complaint for declaratory judgment of noninfringement in the US District Court of Massachusetts. The companies seek to quell claims by CureVac of intellectual property violations.

BioNTech and Pfizer collaborated in the development and distribution of their COVID-19 vaccine. The Pfizer-BioNTech vaccine, trademarked as COMIRNATY®, was the first successful mRNA drug product approved in the United States and was expedited on an emergency basis by the Food and Drug Administration (FDA). The vaccine was distributed to adults over 16 years of age in December 2020. Pfizer developed over 3 million doses in 2021 and expects 4 million in 2022.

CureVac, a separate biotechnology company, also began development on a COVID-19 vaccine. By June 2021, clinical trials showed the vaccine to be only 47 percent effective, and the company stopped development. CureVac now faces over $1 billion in debt. In January, CureVac began discussions with BioNTech and Pfizer over intellectual property rights. Attempts to resolve differences were unsuccessful, and CureVac filed a lawsuit against BioNTech in the German Regional Court in Dusseldorf on June 29.

In a statement, CureVac said it had “accumulated over more than two decades of pioneering work in mRNA technology, which contributed to COVID-19 vaccine development.” 

BioNTech and Pfizer now seek a declaratory judgment in US federal court that the COMIRNATY® vaccine does not infringe on U.S. Patent No. 11,135,312, U.S. Patent No. 11,241,493, and U.S. Patent No. 11,149,278. They argue that the techniques and methods used to manufacture the vaccine do not infringe upon any of CureVac’s patents.