What changed in this filing

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Item 1. Legal Proceedings

2025-08-06 compared with 2025-05-14 · 29 added, 33 removed, 59 unchanged (51% of the section changed)

7 unchanged sentences

The patents relate to nucleic acid-lipid particles and lipid vesicles, as well as compositions and methods for their use.

The lawsuit does not seek an injunction or otherwise seek to impede the sale, manufacture or distribution of MRNA-1273.

However, we seek fair compensation for Moderna’s use of our patented technology that was developed with great effort and at great expense, without which Moderna’s COVID-19 vaccine would not have been successful.

On May 6, 2022, Moderna filed a partial motion to dismiss the claims “relating to Moderna’s sale and provision of COVID-19 vaccine doses to the U.S.

Government.” On November 2, 2022, the court issued an Order denying Moderna’s motion.

On February 14, 2023, the U.S.

In the lawsuit, we seek fair compensation for Moderna’s use of our patented technology that was developed with great effort and at great expense, without which Moderna’s COVID-19 vaccine would not have been successful.

In May 2022, Moderna filed a partial motion to dismiss the claims “relating to Moderna’s sale and provision of COVID-19 vaccine doses to the U.S.

Government” and argued that U.S.

taxpayers, not Moderna, are financially liable for any infringement by Moderna of our patents.

In November 2022, the court issued an Order denying Moderna’s motion.

In February 2023, the U.S.

Department of Justice filed a Statement of Interest in the action.

On February 16, 2023, the court held an Initial Pretrial Conference after which it issued an Order directing the parties and the U.S.

Government to submit letters regarding the impact of the Government’s Statement of Interest.

On March 10, 2023, the court reaffirmed its denial of Moderna’s motion to dismiss.

The claim construction hearing was held on February 8, 2024.

On April 3, 2024, the court issued its opinion regarding the claims construction.

Subsequently in February 2023, the court held a hearing and directed the parties and the U.S.

Government to submit letters regarding the impact of the Government’s Statement of Interest on Moderna’s motion to dismiss.

In March 2023, the court reaffirmed its denial of Moderna’s motion to dismiss.

The claim construction hearing was held in February 2024, and in April 2024, the court issued its opinion regarding the claims construction.

The court agreed with both of our positions regarding the Composition of Total Lipid (’069) Patent that:

6 unchanged sentences

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”.

Trial is currently scheduled for September 29, 2025.

Expert discovery has concluded and the case is entering the summary judgement stage.

Fact discovery has been completed, and expert discovery is concluding.

The summary judgment phase of the case began in July 2025 and a jury trial is scheduled to be held in March 2026.

Additionally, in July 2025, the case was reassigned to a different judge in the same court.

International:

On March 3, 2025, we and Genevant filed five international lawsuits against Moderna seeking to enforce patents protecting our patented lipid nanoparticle technology.

These five lawsuits target alleged infringing activities by Moderna in 30 countries, including Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Monaco, Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Spain, Sweden, Switzerland, and Turkey.

We and Genevant are seeking monetary relief and injunctions against 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.

These five lawsuits target alleged infringing activities by Moderna in 30 countries, including Austria, Belgium, Bulgaria, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Japan, Latvia, Lithuania, Luxembourg, Malta, Monaco, Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Spain, Sweden, Switzerland/Liechtenstein, and Turkey.

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.

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.

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The five complaints have been or are being served on Moderna pursuant to the service of process rules of the respective courts.

In the Unified Patent Court, Moderna’s Statement of Defense is due on July 8, 2025.

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.

Patent Infringement Litigation vs.

5 unchanged sentences

The patents relate to nucleic acid-lipid particles and their composition, manufacture, delivery and methods of use.

The lawsuit does not seek an injunction or otherwise seek to impede the sale, manufacture or distribution of any COVID-19 mRNA-LNP vaccines.

However, 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.

The claim construction hearing occurred in December 2024.

The court is expected to provide its ruling on the claim construction and issue a further scheduling order, including the date for trial, in 2025.

Fact discovery in the action is ongoing.

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.

The claim construction hearing occurred in December 2024, and fact discovery is ongoing.

The court has not provided guidance for the timing of its ruling in the claim construction hearing, which could potentially come in 2025.

Moderna and Merck European Oppositions

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.

We filed a response to Moderna and Merck’s oppositions on September 3, 2018.

A hearing was conducted before the Opposition Division of the EPO on October 10, 2019.

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.

At the conclusion of the hearing, the EPO upheld an auxiliary request adopting the amendment, as put forth by us, of certain claims of the ’254 Patent.

In February 2020, Moderna and Merck filed Notices of Appeal challenging the EPO’s grant of the auxiliary request.

Merck filed its notice of appeal on February 24, 2020 and Moderna on February 27, 2020.

Both Merck and Moderna perfected their appeals by filing Grounds of Appeal on April 30, 2020.

We filed our responses to the appeals on September 18, 2020.

On March 22, 2022, Moderna filed further written submissions to which we and Genevant responded in August 2022.

On April 18, 2023, we and Genevant withdrew our auxiliary request, however, the original (main) request remains in the action.

We filed our responses to the appeals in September 2020.

In March 2022, Moderna filed further written submissions to which we and Genevant responded in August 2022.

In April 2023, we and Genevant withdrew our auxiliary request, however, the original (main) request remains in the action.

We and Moderna informed the Board of Appeals that we would not object to a remittance of the matter without a hearing to the Opposition Division of the EPO.

The hearing in this matter before the Board of Appeals was subsequently cancelled and resubmitted to the Opposition Division (i.e., lower board) of the EPO.

On October 31, 2023, the Opposition Division issued a summons for oral proceedings and provided its preliminary and non-binding opinion on the subject matter to be discussed at the hearing.

On November 3, 2023, we responded to the summons and on January 15, 2024, Moderna and Merck filed their reply to the written opinion of the Opposition Division, as well as to our written submission of November 3, 2023.

We responded to Moderna and Merck’s reply on April 5, 2024.

Oral proceedings were held on June 6, 2024, and the Opposition Division upheld the ’254 Patent but declined our and Genevant’s request to broaden certain claims in the ’254 Patent.

Both parties appealed the Opposition Division’s decision and on March 21, 2025, the Board of Appeals scheduled oral proceedings for January 15 and 16, 2026.

In October 2023, the Opposition Division issued a summons for oral proceedings and provided its preliminary and non-binding opinion on the subject matter to be discussed at the hearing.

In November 2023, we responded to the summons and in January 2024, Moderna and Merck filed their reply to the written opinion of the Opposition Division, as well as to our written submission from November 2023.

We responded to Moderna and Merck’s reply in April 2024.

Oral proceedings were held in June 2024, and the Opposition Division upheld the ’254 Patent but declined our and Genevant’s request to broaden certain claims in the ’254 Patent.

Both parties appealed the Opposition Division’s decision and in March 2025, the Board of Appeals scheduled oral proceedings for January 2026.

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.

Moderna’s deadline to provide facts, arguments, and evidence in support of invalidity is July 23, 2025.

Moderna submitted its opposition brief in July 2025 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.

11 unchanged sentences

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.

What changed 10-Q

Item 1. Legal Proceedings