ARTICLE
15 January 2025

Acuitas Sues GSK Seeking Declaratory Judgment Of Invalidity And Non-Infringement Of MRNA Vaccine Patents

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Goodwin Procter LLP

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As we previously reported, in April of last year, GlaxoSmithKline Biologicals SA and GlaxoSmithKline LLC brought a lawsuit against Pfizer and BioNTech in the District Court for the District of Delaware.
United States Intellectual Property

As we previously reported, in April of last year, GlaxoSmithKline Biologicals SA and GlaxoSmithKline LLC brought a lawsuit against Pfizer and BioNTech in the District Court for the District of Delaware, alleging that the COVID-19 vaccine, Comirnaty®, infringed five of their U.S. patents directed to mRNA vaccine technology—specifically, U.S. Patent Nos. 11,638,693; 11,638,694; 11,666,534; 11,766,401; and 11,786,467.

In response to this lawsuit, late last week, Acuitas Therapeutics Inc brought an action in the District Court for the District of Delaware against GSK, seeking declaratory judgment of invalidity and non-infringement of the same five patents. As a co-developer of Comirnaty®, Acuitas contends that without declaratory judgment they face possible indemnity obligations to BioNTech and potential monetary and reputational damage with respect to its partner's ability to use its technology free from the threat of patent infringement accusations from GSK.

Acuitas alleges that the "development of the lipids and co-development of the mRNA-LNP in Comirnaty® is a result of a decade of research and development efforts by Acuitas scientists." They argue their business partners now "must contend with the risk of opportunistic litigation by GSK, which did not invent and had nothing to do with the success of Acuitas's lipids, Acuitas's LNPs, or the vaccines that include them."

Acuitas seeks a judgment declaring non-infringement and invalidity of the five patents GSK has asserted against Pfizer and BioNTech, attorneys' fees, costs and expenses in the action, and such other relief that the Court deems just and proper.

Both cases are assigned to Judge Gregory Williams.

Stay tuned to the Big Molecule Watch for further updates on these cases.

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