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 the intellectual property litigation described in our 2023 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 2023 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 2023 Form 10-K, we have initiated patent infringement proceedings against Pfizer and BioNTech (and affiliated entities) in the U.S. and Europe. Pfizer and BioNTech have also filed actions seeking revocation of certain of our patents.

There are two patents at issue in the European patent infringement proceedings–EP3590949 (the ‘949 patent), which relates to chemically-modified mRNA and EP3718565 (the ‘565 patent), which relates to coronavirus mRNA vaccines.

In July 2024, the High Court of Justice of England & Wales issued a judgment confirming the validity of the ‘949 patent and finding that Pfizer and BioNTech had infringed the patent. The court further determined that the ‘565 patent was invalid. These decisions are first instance decisions subject to appeal.

In December 2023, the District Court of The Hague issued a first instance decision determining that the ‘949 patent was invalid in the Netherlands. Moderna has appealed this decision to the Court of Appeal of The Hague, with a second instance decision expected in 2025.

In addition, there remain ongoing Opposition Proceedings at the European Patent Office by a number of opponents, including Pfizer and BioNTech related to these two patents.