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In February 2023, the U.S.
−Removed: Department of Justice filed a Statement of Interest in the action.
−Removed: Subsequently in February 2023, the court held a hearing and directed the parties and the U.S.
−Removed: Government to submit letters regarding the impact of the Government’s Statement of Interest on Moderna’s motion to dismiss.
−Removed: In March 2023, the court reaffirmed its denial of Moderna’s motion to dismiss.
−Removed: The claim construction hearing was held in February 2024, and in April 2024, the court issued its opinion regarding the claims construction.
+Added: Department of Justice filed a Statement of Interest in the action, and in March 2023, the court reaffirmed its denial of Moderna’s motion to dismiss.
+Added: The claim construction hearing was held in February 2024, and in April 2024, the court issued its claim construction order.
The court agreed with both of our positions regarding the Composition of Total Lipid (’069) Patent that:
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Regarding the Encapsulation of mRNA (’651) Patent, the court held that “wherein at least 70% / at least 80% / about 90% of the mRNA in the formulation is fully encapsulated in the lipid vesicles” means “wherein at least 70% / at least 80% / about 90% of the mRNA is fully, as distinct from partially, contained inside the lipid vesicles”.
−Removed: Fact discovery has been completed, and expert discovery is concluding.
−Removed: The summary judgment phase of the case began in July 2025 and a jury trial is scheduled to be held in March 2026.
+Added: Fact discovery, expert discovery and summary judgment briefing have been completed, and a jury trial is scheduled for March 2026.
Additionally, in July 2025, the case was reassigned to a different judge in the same court.
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We and Genevant are seeking monetary relief and injunctions against the continued manufacture and sale of Moderna’s COVID-19 vaccine and, in the Unified Patent Court, additional Moderna products which Moderna has represented use the same lipid nanoparticle technology as the COVID-19 vaccine, including its RSV vaccine.
−Removed: Where permitted to do so at this stage, we and Genevant submitted evidence from testing of commercial Moderna product samples sourced from the U.S.
−Removed: and European Union indicating the samples contain lipid nanoparticles falling under the protective scope of the claims of our lipid composition patents.
The five international lawsuits are as follows:
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Case 10280/2025, seeking permanent and provisional injunctions, as well as monetary damages, which can include recovery of Moderna’s unfair profits, from infringement of EP 4 241 767.
−Removed: The five complaints have been or are being served on Moderna pursuant to the service of process rules of the respective courts.
−Removed: Moderna and/or its affiliates have responded to the lawsuits in Japan, Switzerland and the Unified Patent Court, and the first major hearings are expected to occur in the first half of calendar year 2026.
+Added: Where permitted to do so in the initial pleadings, we and Genevant submitted evidence from testing of commercial Moderna product samples sourced from the U.S.
+Added: and European Union indicating the samples contain lipid nanoparticles falling under the protective scope of the claims of our lipid composition patents.
+Added: In October 2025, where permitted to do so, we submitted additional testing evidence from the U.S.
+Added: case that indicates samples produced by Moderna in the U.S.
+Added: proceedings also contain lipid nanoparticles falling under the protective scope of the claims of our lipid composition patents.
+Added: Public oral hearings for the Unified Patent Court cases are scheduled for May 2026, and the trial in the Canadian case is set to begin in September 2027.
Patent Infringement Litigation vs.
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In the lawsuit, we seek fair compensation for Pfizer’s and BioNTech’s use of our patented technology that was developed with great effort and at great expense, without which their COVID-19 mRNA-LNP vaccines would not have been successful.
−Removed: The claim construction hearing occurred in December 2024, and fact discovery is ongoing.
−Removed: The court has not provided guidance for the timing of its ruling in the claim construction hearing, which could potentially come in 2025.
+Added: The claim construction hearing occurred in December 2024, and in September 2025, the court issued a claim construction ruling, which construed the disputed claim terms in a manner we generally consider to be favorable.
Moderna and Merck European Oppositions
−Removed: On April 5, 2018, Moderna and Merck, Sharp & Dohme Corporation (Merck) filed Notices of Opposition to Arbutus’ European patent EP 2279254 (the ’254 Patent) with the European Patent Office (EPO), requesting that the ’254 Patent be revoked in its entirety for all contracting states.
+Added: On April 5, 2018, Moderna and Merck, Sharp & Dohme Corporation (Merck) filed Notices of Opposition to our European patent EP 2279254 (the ’254 Patent) with the European Patent Office (EPO), requesting that the ’254 Patent be revoked in its entirety for all contracting states.
We filed a response to Moderna and Merck’s oppositions in September 2018 and a hearing was conducted before the Opposition Division of the EPO in October 2019.
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On April 29, 2025, Moderna filed a revocation action on EPO patent EP 4 241 767 (the ’767 patent) with the EPO, requesting that the patent be revoked in its entirety for all contracting states.
−Removed: Moderna submitted its opposition brief in July 2025 and we are currently preparing our response.
+Added: In July 2025, Merck, Arrowhouse GmbH and Keltie LLP filed three additional revocation actions against the ‘767 patent.
+Added: All opponents have submitted their opposition briefs and we are currently preparing our response.
While we are the patent owner, the ’254 Patent, the ’767 Patent, and the other patents in our LNP portfolio have been licensed to Genevant under the Genevant License.
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.