Pfizer Files Rebuttal of Moderna’s Patent Claim

08.12.2022 - Faced with a lawsuit from US rival Moderna, alleging that Pfizer and its German partner BioNTech infringed one of its patent for their top-selling Covid-19 vaccine Comirnaty, the New York US drugs giant said in a court filing that Comirnaty was based on independent research and wasn’t a Moderna copy.

Moderna filed suit against Pfizer in August this year without saying how much it is seeking in "compensatory damages," only that it expects royalties and lost profits to be compensated, retroactive to March of this year

In a rebuttal filing, Pfizer had harsh words for the Maryland-headquartered biotech. It accused Moderna of not only discrediting the work of the Comirnaty makers and decades of research done by pioneering mRNA scientists, in particular Katalin Karikó and Drew Weissman of the University of Pennsylvania, but also effectively undermining the contributions of its own research partners.

Moderna, Pfizer wrote, should also credit the US National Institutes of Health (NIH), which collaborated on and funded the development of the biotech’s Spikevax vaccine, adding that, "in its complaint against BioNTech and Pfizer, Moderna rewrites that story to eliminate the contributions of many brilliant and dedicated scientists and place itself in the single, starring role.”

The Spikevax maker is also embroiled in a dispute with the NIH over its refusal to acknowledge the preliminary and parallel work done by US government scientists.

The litigation against Pfizer/BioNTEch focuses on three patents Moderna filed between 2010, the year it was founded, and 2016. The company alleges that those patents cover two particular components of the Pfizer-BioNTech vaccine: the exact chemical modification the American-German duo made to the RNA molecules in the vaccine and the exact target of the vaccine, the full-length spike protein.

While both Comirnaty and Spikevax use modified mRNA to direct the body's cells to make copies of the spike protein and prompt the immune system to create antibodies to attack and both wrap their RNA molecules in lipid nanoparticles (LNP), there are significant differences, Pfizer said.

First, it notes, Comirnaty's RNA has a different sequence from that of the Moderna vaccine. Moreover, the makeup of the LNP is not exactly the same, as its rival claims, because Comirnaty and Spikevax employ different lipids.

Moderna itself is a defendant in two other intellectual property enforcement cases. One was filed by Pennsylvania-based Arbutus Biopharma and its affiliate Genevant Sciences, the other by Cambridge, Massachusetts-based Alnylam Pharmaceuticals. Alnylam has also sued Pfizer, as has CureVac. For their part, Pfizer and BioNTech have countersued CureVac.

Author: Dede Williams, Freelance Journalist