MRNA IP 2022 Year In Review: Pioneers Clash In Major Patent Litigations

• Jurisdiction: United States,Federal,Delaware,New York
• Law Firm: Rothwell, Figg, Ernst & Manbeck, P.C.
• Subject Matter: Intellectual Property, Patent
• Author: Mr Daniel L. Shores
• Published date: 06 January 2023

Substantial patent litigation activity occurred in the mRNA space in 2022, involving nearly all of the major mRNA and lipid nanoparticle (LNP) pioneers. Since this is the most significant happening in this space with respect to IP in 2022, this post will provide an overview of that activity as well as a summary exposure analysis.

Summary of 2022 Litigation Activity

On February 28, lipid pioneer Arbutus and its exclusive licensee Genevant sued mRNA pioneer Moderna in the U.S. District Court for the District of Delaware. The complaint contains allegations that Moderna infringed U.S. Patent Nos. 8,058,069, 8,492,359, 8,822,668, 9,364,435, 9,504,651, and 11,141,378 through, inter alia, Moderna's sales of its Spikevax' vaccine product. The key patents-in-suit relate to four-lipid delivery systems designed to protect fragile mRNA "payloads" post-injection and release them once inside a recipient's cells. Moderna moved to dismiss certain claims relating to Spikevax' made and sold to the U.S. government (the motion was based on 28 U.S.C. ' 1498, which requires patent-holders to seek redress from the U.S. government in the U.S. Court of Federal Claims whenever an invention covered its patent "is used or manufactured by or for the United States without a license"). The court denied the motion, Moderna answered the complaint on November 30, and discovery has not yet commenced.

On March 17, lipid and SiRNA pioneer Alnylam sued Moderna and Pfizer separately in the District of Delaware. The respective complaints contain allegations that of Moderna and Pfizer each infringed U.S. Patent No. 11,246,933 by using Alnylam's claimed cationic lipids in their vaccine products. On July 12, 2022, Alnylam filed new separate suits against Moderna and Pfizer (and this time including Pfizer's collaborator and mRNA pioneer BioNTech) also in the District of Delaware, for infringement of U.S. Patent No. 11,382,979, which issued the same day the suit was filed and has claims directed to lipid nanoparticles and related methods of preparation. The March and July Moderna and Pfizer/BioNTech cases were each separately consolidated and discovery has commenced in each case. Similar to the Arbutus case, in the Alnylam v. Moderna case, Moderna moved to dismiss certain claims under 28 U.S.C. ' 1498 but the court has not ruled on that motion to date.

On March 18, a day after the initial Alnylam lawsuits were filed, lipid pioneer Acuitas sued Arbutus and Genevant in the U.S. District Court for the Southern District of New York seeking a declaratory judgment that the BioNTech and Pfizer vaccine product Comirnaty' does not infringe the six Arbutus patents asserted in the Moderna case plus three other Arbutus-owned patents directed to LNPs (U.S. Patent Nos. 9,006,417, 9,404,127, and 9,518,272) and that the subject Arbutus patents are invalid. Acuitas alleged that Comirnaty' contains "the lipids and lipid nanoparticles...