Item 3. 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 below. 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,” 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. We describe below those legal matters for which a material loss is either (i) possible but not probable, and/or (ii) not reasonably estimable at this time.

Pfizer/BioNTech Patent Litigation

U.S. Proceedings

In August 2022, we filed a lawsuit in the U.S. District Court for the District of Massachusetts against Pfizer Inc. (Pfizer) and BioNTech SE, BioNTech Manufacturing GmbH and BioNTech US Inc. (collectively, BioNTech), asserting infringement of certain U.S. patents concerning our mRNA platform technology and disease-specific vaccine designs in Pfizer and BioNTech’s manufacture and sale of their mRNA COVID vaccines. The complaint seeks a judgment of infringement of the asserted patents and monetary damages. The case has been stayed pending the outcome of two Inter Partes Review 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 patents. In March 2025, the PTAB found the patents invalid and we appealed to the U.S. Court of Appeals for the Federal Circuit (Federal Circuit).

European Proceedings

Also in August 2022, we initiated patent infringement proceedings in the UK (in the High Court of Justice of England & Wales), the Netherlands (in the District Court of The Hague) and Germany (in the Dusseldorf Regional Court), against Pfizer, BioNTech and related entities with respect to certain European patents that also concern our mRNA platform technology and disease-specific vaccine designs, including coronaviruses. In May 2023, we initiated patent infringement proceedings in Ireland (in the High Court) and Belgium (in the Brussels Business Court) against Pfizer, BioNTech and related entities with respect to the same European patents. As in the U.S. action, we seek a judgment of infringement of the asserted patents and monetary damages.

In July 2024, the High Court of Justice of England & Wales ruled that EP3590949 (the ‘949 patent), which relates to chemically-modified mRNA, was valid and infringed by Pfizer and BioNTech. The court further ruled that EP3718565 (the ‘565 patent), which relates to coronavirus mRNA vaccines, was invalid. In August 2025, the UK Court of Appeal upheld the High Court’s decision that the ‘949 patent is valid and infringed by Pfizer and BioNTech. In December 2025, the UK Supreme Court denied permission for appeal by Pfizer and BioNTech.

In December 2023, the District Court of The Hague ruled that the ‘949 patent was invalid. We appealed to the Court of Appeal of The Hague, which held a hearing on September 22, 2025, and is expected to issue its decision on March 31, 2026.

In March 2025, the Dusseldorf Regional Court in Germany ruled that Pfizer and BioNTech infringed the ‘949 patent. Pfizer and BioNTech have appealed to the Higher Regional Court of Dusseldorf, which will hold a hearing November 26, 2026.

Pfizer Inc. and BioNTech SE have filed oppositions seeking revocation of the ‘949 and ‘565 patents at the European Patent Office. In May 2024, the Opposition Division (OD) ruled that the ‘949 patent was valid, and Pfizer and BioNTech appealed to the Technical Appeal Board (TBA), which will hold a hearing on September 8-10, 2026. In November 2023, the OD ruled that the ‘565 patent was invalid and we appealed to the TBA, which confirmed the invalidity on January 27, 2026.

Arbutus Patent Litigation

In February 2022, Arbutus Biopharma Corporation (Arbutus) and Genevant Sciences GmbH (Genevant) filed a complaint against us in the U.S. District Court for the District of Delaware asserting that our manufacture and sale of our COVID vaccine willfully infringes certain U.S. patents concerning lipid nanoparticles but does not seek to prevent or stop the marketing or sales of our COVID vaccines. The complaint seeks a judgment of infringement of the asserted patents and monetary damages. The Court has set trial to begin March 9, 2026.

In March 2025, Arbutus and 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, the Tokyo District Court in Japan and the Swiss Federal Patent Court and submitted two lawsuits to the Unified Patent Court (UPC). The 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 after a trial decision and before any appeals are decided. Hearings for the UPC actions are set for May 19 and 20, 2026. The Canadian lawsuit is scheduled for trial beginning in September 2027.

GSK Patent Litigation

In October 2024, GlaxoSmithKline Biologicals SA (GSK) filed two separate complaints against us in the U.S. District Court for the District of Delaware asserting that our manufacture and sale of our COVID and RSV vaccines willfully infringe certain U.S. patents directed to lipid-mRNA vaccine formulation technology. Each complaint seeks a judgment of infringement of the asserted patents and unspecified damages, and injunctive relief related to RSV after any appeals are decided. The Court has set trial to begin on July 19, 2027 with respect to our COVID vaccines, and on August 23, 2027 with respect to our RSV vaccine.

In July 2025, GSK submitted two lawsuits to the UPC asserting that our manufacture and sale of our COVID and RSV vaccines infringe three European patents related to liposomes with specified characteristics for RNA delivery. The complaints seek monetary and injunctive relief after appeal. Hearings are set for September 2026.

In December 2025, GSK served us with two separate complaints in the Barcelona Commercial Court and the Madrid Commercial Court (the Spanish Courts) asserting that our manufacture and sale of our COVID and RSV vaccines infringe the same patents asserted in the UPC actions. The complaints seek monetary and injunctive relief after an appeal decision.

Northwestern University Patent Litigation

In October 2024, Northwestern University filed a complaint against us in the U.S. District Court for the District of Delaware asserting that our COVID and RSV vaccines infringe several U.S. patents concerning lipid nanoparticle technology. The complaint seeks a judgment of infringement of the asserted patents and unspecified damages.

Alnylam Patent Litigation

In March 2022 and July 2022, Alnylam Pharmaceuticals, Inc. (Alnylam) filed two complaints against us in the U.S. District Court for the District of Delaware asserting that our manufacture and sale of our COVID vaccine infringed certain U.S. patents concerning cationic lipids. On August 25, 2023, the Court entered a Final Judgment of non-infringement of all asserted patents in these lawsuits. In the first case, Alnylam appealed and the Federal Circuit decided the appeal in our favor in June 2025.

Relatedly, in May 2023, Alnylam filed a third complaint against us in the U.S. District Court for the District of Delaware asserting three additional U.S. patents concerning cationic lipids. The complaint sought judgments of infringement of the asserted patents and monetary damages. In November 2023, the District Court entered an order of partial dismissal with respect to two of the patents at issue. Subsequently, in October 2024, the District Court entered a final judgment of non-infringement in our favor with respect to the third patent at issue.

Following the June 2025 Federal Circuit decision in our favor, we and Alnylam entered into an agreement in September 2025 to settle all disputes between the parties, including filing a stipulated dismissal of Alnylam’s claims with prejudice. The settlement did not include payments of any kind by us.

Bayer CropSciences Patent Litigation

In January 2026, Bayer CropScience LLC, Monsanto Company and Monsanto Technology, LLC (collectively, Bayer) filed a complaint against us in the U.S. District Court for the District of Delaware asserting that our manufacture and sale of our COVID vaccines infringe a U.S. patent directed to methods of modifying gene sequences. The complaint seeks a judgment of infringement of the asserted patent and unspecified damages.

mNG Bio Patent Litigation

In January 2026, mNG Bio, LLC (mNG) filed a complaint against us in the U.S. District Court for the District of Massachusetts asserting that certain tests of our COVID vaccines willfully infringe a U.S. patent directed to a yellow-green fluorescent protein. The complaint seeks a judgment of infringement of the asserted patent and unspecified damages.

BioNTech Patent Litigation

In February 2026, BioNTech SE filed a complaint against us in the U.S. District Court for the District of Delaware asserting that our manufacture and sale of mNEXSPIKE willfully infringes a U.S. patent directed to modified mRNA compositions encoding a spike protein fragment. The complaint seeks a judgment of infringement of the asserted patent and unspecified damages.

Securities Class Action Litigation

In August 2024, a putative shareholder class action complaint was filed against us and certain officers in the U.S. District Court for the District of Massachusetts. The action was purportedly brought on behalf of a class of shareholders who purchased Moderna common stock between January 18, 2023 and June 25, 2024. The complaint asserts claims under the Securities Exchange Act of 1934 regarding statements about our RSV vaccine (mRNA-1345) and seeks unspecified damages. On August 25, 2025, plaintiff filed an amended complaint, which, among other things, narrowed the asserted class period to February 15, 2024 to May 31, 2024. On October 24, 2025, the Company filed a motion to dismiss, which remains pending.

Derivative Litigation

Between September and November 2024, purported shareholder derivative complaints were filed in the U.S. District Court for the District of Massachusetts against certain of our officers and directors and against us as a nominal defendant. The complaints allege breaches of fiduciary duty and claims under the Securities Exchange Act of 1934 regarding statements about mRNA-1345 and seek declaratory and injunctive relief and unspecified damages payable to us. The cases were stayed pending a decision on defendants’ motion to dismiss the putative securities class action described above.