Alnylam commenced proceedings in the US District Court of Delaware on 26 May 2023 against both Moderna and Pfizer alleging patent infringement over Alnylam’s RNA Lipid Particle Technology encompassed in United States Patent Nos. 11,590,229, 11,633,479, 11,633,480 and 11,612,657. Alnylam claims that its patented technology is ‘foundational to the success of the recently-developed messenger RNA (mRNA) based COVID vaccines’.
Alnylam alleges that Moderna:
- infringes Alnylam’s ’479 patent and ’480 patent by using SM102, a protonatable biodegradable lipid formulated into lipid particles that protect and deliver the vaccine’s mRNA;
- infringes Alnylam’s ’229 patent by using Alnylam’s patented lipid particles that protect and deliver Moderna’s COVID-19 Vaccine’s mRNA (comprising four lipids: SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3- phosphocholine [DSPC]); and
- used confidential information presented to it in discussions between Alnylam and Moderna in 2013/2014 about a potential license Alnylam’s IP along with a potential business relationship or a collaboration.
Alnylam alleges that Pfizer infringes:
- Alnylam’s ’479 patent through the use of ALC-0315, a lipid compound used in Pfizer’s COVID-19 Vaccine;
- the ’480 patent through the use of ALC-0315, which is formulated into a lipid particle that protects and delivers the vaccine’s mRNA; and
- Alnylam’s ’657 and ’229 patents through the use of Alnylam’s patented lipid particles that protect and deliver Pfizer’s COVID-19 Vaccine’s mRNA (comprising four lipids: ALC-0315 (a protonatable biodegradable lipid), 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide (a PEG-modified lipid), 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and cholesterol).
Alnylam is seeking to recovery monetary compensation for Moderna and Pfizer’s unlicensed use of Alnylam’s patents. Alnylam is not seeking injunctive relief.