Big Molecule Watch
April 12, 2023

Update on Arbutus mRNA Vaccine Patent Litigations

Last week, Arbutus Biopharma Corp. and Genevant Sciences GmbH (collectively, Arbutus) filed a complaint for patent infringement in the District of New Jersey against Pfizer, Inc. and BioNTech SE.

Arbutus/Genevant allege that Pfizer/BioNTech’s COVID-19 vaccine and any COVID-19 mRNA LNP vaccine products infringe five Arbutus/Genevant patents “relating to nucleic acid-lipid particles, compositions thereof, their manufacture, and/or their use to deliver mRNA and/or other nucleic acid-based medicines.”  The patents-in-suit are U.S. Patent Nos. 9,504,651; 8,492,359; 11,141,378; 11,298,230; and 11,318,098.

Arbutus/Genevant allege that Pfizer and BioNTech “are and have been operating jointly and as agents of one another as to Defendants’ vaccine and share equally in profits from sales of the vaccine.”  Arbutus/Genevant allege that Pfizer and BioNTech have been on actual notice of the patents but nonetheless used the “technology in nucleic acid-based products and product candidates…without permission.”

The Complaint seeks judgment in favor of Arbutus and Genevant against Pfizer and BioNTech, and seeks reasonable royalty damages, a judgment of willful infringement, enhancement of damages, and attorneys’ fees.

Arbutus/Genevant has also sued Moderna in the District of Delaware where Arbutus/Genevant asserts six patents “relating to nucleic acid-liquid particles, compositions thereof, and their use to deliver nucleic acid-based medicines.”  Those six patents are U.S. Patent Nos. 8,058,069; 8,492,359; 8,822,668; 9,364,435; 9,504,651; and 11,141378.  In a related proceeding before the Patent Trial and Appeal Board, Moderna convinced the PTAB to invalidate Arbutus’s U.S. Patent No. 9,404,127.

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