Moderna Inc

Item 1. Legal Proceedings

We are involved in various claims and legal proceedings of a nature considered ordinary course in our business, including those described in our 2024 Form 10-K under the heading “Legal Proceedings.” Most of the issues raised by these claims are highly complex and subject to substantial uncertainties. For a description of risks relating to these and other legal proceedings we face, see Part I, Item 1A., “Risk Factors,” of our 2024 Form 10-K, including the discussion under the headings entitled “Risks related to our intellectual property” and “Risks related to the manufacturing of our commercial products and product candidates.” The outcome of any such proceedings, regardless of the merits, is inherently uncertain; therefore, assessing the likelihood of loss and any estimated damages is difficult and subject to considerable judgment.

Pfizer/BioNTech Patent Litigation

As more fully described in our 2024 Form 10-K, we have initiated patent infringement proceedings against Pfizer Inc. (Pfizer) and BioNTech SE (and affiliated entities, together BioNTech) in the U.S. and Europe. The U.S. litigation has been stayed pending the outcome of two Inter Partes Proceedings (IPRs) before the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) regarding the validity of two of the three asserted Moderna patents in the lawsuit. In March 2025, the PTAB found all challenged claims unpatentable in those two patents. The decision is subject to appeal.

Also in March 2025, the Dusseldorf Regional Court in Germany ruled that Pfizer and BioNTech violated one of our European patents related to our COVID vaccine technology and that they owe us damages related to the sale of their COVID vaccine. Pfizer and BioNTech have appealed this decision. The court has not ruled on the amount of damages to be paid, which will depend on further legal proceedings.

Proceedings Related to Patents Owned by Arbutus

In March 2025, Arbutus Biopharma Corporation (Arbutus) and Genevant Sciences GmbH (Genevant) filed five international lawsuits asserting that our manufacture and sale of Spikevax and/or mRESVIA infringes certain patents concerning lipid nanoparticles. The companies filed lawsuits in the Canadian Federal Court, Tokyo District Court in Japan and Swiss Federal Patent Court, and submitted two lawsuits to the Unified Patent Court (UPC). The two UPC actions seek relief in all UPC member states and in ten additional European Patent Convention contracting states. Each proceeding identifies Spikevax and mRESVIA as accused products except for the Canadian proceeding, which only identifies Spikevax. The complaints seek monetary relief and injunctive relief.

Proceedings Related to Patents Owned by GSK

As more fully described in our 2024 Form 10-K, GlaxoSmithKline Biologicals SA (GSK) has filed two complaints against us in the U.S. District Court for the District of Delaware, asserting that either Spikevax or mRESVIA infringe certain patents owned by GSK. Trial dates have been set for both cases, with the trial related to Spikevax to begin July 19, 2027, and the trial related to mRESVIA to begin August 23, 2027.