Arbutus Biopharma and Genevant Sciences have recently brought a patent lawsuit against Pfizer and BioNTech in the US federal courts, surrounding the use of the lipid nanoparticle (LNP) technology used in the latter’s COVID-19 vaccines. The claim follows positive developments for the plaintiffs in their very similar lawsuit brought against Moderna last year. This latest case reflects the highly litigious environment within the mRNA space, says GlobalData, a leading data and analytics company.

Jay Patel, Pharma Analyst at GlobalData, comments: “The move reflects a desire by these companies to strengthen their competitive position within the mRNA space, as well as take advantage of the tremendous cash windfall that COVID-19 vaccine developers have accumulated. For example, according to GlobalData, Pfizer, made over $43 billion in sales of its Comirnaty vaccine in 2022. In addition, GlobalData estimates that Comirnaty is set to remain the best-selling COVID-19 vaccine over the next five years. Given Pfizer’s immense financial resources, and its past willingness to reach out-of-court settlements with smaller biotech companies, a strong case against them could result in a lucrative financial payout for Arbutus and Genevant.”

Genevant signed a strategic collaboration with BioNTech in 2018 to combine Genevant’s LNP drug delivery technology with BioNTech’s drug discovery platform to pursue therapies for rare diseases with high unmet clinical need. At the time, BioNTech CEO Ugur Sahin described it Genevant’s technology as “highly potent” and “clinically validated”. Arbutus and Genevant cited this previous deal in their lawsuit as evidence of BioNTech’s knowledge of their technology.

Patel concludes: “This is the second major patent suit brought by Arbutus and Genevant. Their lawsuit against Moderna has already seen some success in the courts, following Moderna’s unsuccessful bid to shift liability to the U.S. government to dismiss the case. This success may be the rationale for pursuing litigation against Pfizer, owing to the similarities between the mRNA vaccines produced by Pfizer and Moderna, and suggests that there may be a strong prospect for success in this case as well.”

In addition to these lawsuits, Pfizer and Moderna are also engaged in patent litigation against one another, over the LNP formulations used in their respective COVID-19 vaccines.