The Covid-19 pandemic saw a proliferation in novel vaccine technologies being produced rapidly. With the emergence of vaccines came accusations of technology encroachment amongst biotech companies. The result was a plethora of patient infringement lawsuits, with several cases being filed that included Moderna, Pfizer/BioNTech, Alnylam Pharmaceuticals, Arbutus Biopharma, and Genevant Sciences on different sides of the court.
In July 2022, CureVac entered this list when it filed a patent infringement lawsuit in Germany against BioNTech, alleging that a protected portfolio of crucial elements necessary for the production of mRNA vaccines was used to produce and sell Pfizer and BioNTech’s mRNA Covid-19 vaccine, Comirnaty.
Pfizer/BioNTech responded by filing a nullity action at the federal district court of Massachusetts in July 2022 seeking confirmation that no patents were infringed upon. But the case will now be investigated by the Eastern District of Virginia.
The motion to transfer the case is part of a counterclaim by CureVac that includes the expansion of infringement to nine US patents. CureVac said this expands upon the three patents originally named by Pfizer/BioNTech.
CureVac’s lawsuits add to a complex legal landscape for Pfizer/BioNTech that already includes ones from Moderna. In an August 2022 statement, Moderna stated its technology contained within patents filed between 2010 and 2016 was copied without permission. Pfizer/BioNTech then countersued in December 2022.
In a statement, CureVac pointed to a preliminary opinion issued in April 2023 by the German Federal Patent Court that “supports the validity of one of the CureVac patents at issue, which was challenged by BioNTech in September 2022.” CureVac is seeking fair compensation for Comirnaty revenue. If successful, the biotech company could be in line for a share of $80bn – Comirnaty’s approximate revenue to date as per CureVac, based on Pfizer/BioNTech’s financial reports.
“The progress of this litigation to date, in both Europe and the United States, gives us confidence in both the validity of our intellectual property portfolio and its relevance to the mRNA field,” said CureVac CEO Dr. Alexander Zehnder.
The news follows Sanofi’s high-profile patent hearing in mid-May – the Supreme Court backing the French biotech giant in its anti-cholesterol drug patent infringement case filed by Amgen after nearly a decade of legal battles.