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Federal Circuit: District Court Did Not Err In Declining to Find Infringement By Moderna’s Activities Involving COVID-19 Vaccine
On June 4, 2025, a Federal Circuit panel consisting of Judges Taranto, Chen, and Hughes issued a unanimous opinion, authored by Judge Taranto, in Alnylam Pharmaceuticals, Inc. v. Moderna, Inc., Case No. 2023-2357. The panel affirmed the U.S. District Court for the District of Delaware’s decision that appellee’s activities involving its mRNA-based COVID-19 vaccine SPIKEVAX® did not infringe appellant’s U.S. Patent Nos. 11,246,933 (’933 patent) or 11,382,979 (’979 patent). Slip Op. at 2–3.
Alnylam Pharmaceuticals, Inc., (Alnylam) owns the ’933 and ’979 patents. Id. at 2. The ’979 patent is the child of the ’933 patent. Id. Both patents are directed to biodegradable lipids and their use for the delivery of active agents, such as nucleic acids. Id. at 3. Specifically, the ’933 and ’979 patents disclosed a cationic lipid with at least a branched alkyl terminal hydrophobic chain in at least one biodegradable hydrophobic tail. Id. at 5. In March 2022, Alnylam sued Defendants Moderna, Inc., ModernaTX, Inc., and Moderna US, Inc. (collectively Moderna) in the U.S. District Court for the District of Delaware, alleging that Moderna infringed the ’933 patent through activities involving the SM-102 lipid in SPIKEVAX®. Id. at 6. In July 2022, after the ’979 patent issued, Alnylam sued Moderna in the same forum for alleged infringement of the ’979 patent through activities involving SPIKEVAX®. Id. The two pending actions were consolidated. Id.
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