Pfizer and BioNTech Counter CureVac Lawsuit

03.08.2022 - Pfizer and BioNTech are fighting back against CureVac’s lawsuit that asserts the makers of the Comirnaty-branded mRNA vaccine for Covid-19 infringed its patent.

In a lawsuit filed with the US District Court for the District of Massachusetts, the American-German partners asked the court to uphold their position that they did not infringe CureVac’s US patents and also bar the company from continuing to pursue such claims.

Pfizer and BioNTech allege there is “an actual, immediate, substantial and justiciable controversy” at play over whether Comirnaty has infringed or will infringe a trio of patents covered in CureVac’s lawsuit.

In early July, CureVac filed charges against BioNTech and two of its subsidiaries in a Düsseldorf, Germany, court. In a German interview, CureVac CEO Franz-Werner Haas said the company believed a piece of its intellectual property had been infringed adding, however, that it didn’t want to shut down Comirnaty’s production but to have its contribution recognized.

In particular, the Tübingen-based biotech asserts that Pfizer and BioNTech violated one of its patents that describes a method for producing a stabilized mRNA molecule encoding a polypeptide. BioNTech argues, however, that Comirnaty is not manufactured using that method.

Comirnaty Makers File with EMA for Omicron-Targeted Shot

Last month, Pfizer and BioNTech filed with the European Medicines Agency (EMA) for approval of an Omicron-adapted bivalent Covid-19 vaccine candidate, based on the BA.1 sub-lineage, for individuals 12 years of age and older.

The companies said the application followed guidance from the EMA and International Coalition of Medicines Regulatory Authorities (ICMRA) to work toward introducing an Omicron-adapted bivalent vaccine candidate to address the continued evolution of SARS-CoV-2, the coronavirus that causes Covid.

Author: Dede Williams, Freelance Journalist