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Item 3. Legal Proceedings

2026-03-23 compared with 2025-03-27 · 37 added, 101 removed, 13 unchanged (91% of the section changed)

1 unchanged sentence

Patent Infringement Litigation vs.

United States:

On February 28, 2022, we and Genevant filed a lawsuit in the U.S.

District Court for the District of Delaware against Moderna, Inc.

and a Moderna affiliate (collectively, Moderna) seeking damages for infringement of U.S.

8,058,069, 8,492,359, 8,822,668, 9,364,435, 9,504,651, and 11,141,378 in the manufacture and sale of MRNA-1273, Moderna’s vaccine for COVID-19.

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.

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, dated February 16, 2023, ordering that within 14 days of the issuance of the Order, the parties and the U.S.

Government were to submit letters regarding the impact of the Government’s Statement of Interest on the scheduling of the matter.

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

On March 16, 2023, the court held a Rule 16 scheduling conference, and on March 21, 2023, the court issued a scheduling order in the matter without setting a trial date.

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

On April 3, 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:

(i) the claimed molar percentage (mol.

%) ranges can be met by any particle and is not limited to “finished” particles that are not subjected to further process steps;

and (ii) that the claimed mol.

% ranges include standard variation based on the number of significant figures recited in the claim.

The court also agreed with our position regarding the Cationic Lipid with Protonatable Tertiary Amine (‘378) Patent that there is no limitation as to the mol.

% of the claimed cationic lipid.

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”.

On August 5, 2024, we and Genevant, along with Moderna, filed the Stipulation with the court that requested an amended case schedule to accommodate certain outstanding discovery from Moderna and third parties.

The court approved the amended case schedule and the start of the trial was moved from April 21, 2025 to September 24, 2025.

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, where applicable, additional Moderna products, which Moderna has represented use the same lipid nanoparticle technology as the COVID-19 vaccine, including its RSV vaccine, which recently received regulatory approval in the U.S.

and European Union.

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.

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:

Federal Court of Canada File No.

T-704-25, seeking a permanent injunction and damages or, if Genevant so elects, an accounting of Moderna’s profits, attributable to infringement of Canadian Patent No.

Tokyo District Court Case No.

2025 (Wa) 70079, seeking a permanent injunction and reasonable royalty for infringement of Japanese Patent No.

• Switzerland:

a case seeking a permanent injunction and monetary relief, which upon later choice of Genevant and Arbutus can include surrender of profits, damages or a reasonable royalty, for infringement of EP 2 279 254.

• Unified Patent Court (UPC):

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 2 279 254.

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.

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

To date, Moderna has not responded to any of the five international lawsuits.

Patent Infringement Litigation vs.

Pfizer and BioNTech

On April 4, 2023, we and Genevant filed a lawsuit in the U.S.

District Court for the District of New Jersey against Pfizer Inc.

(Pfizer) and BioNTech SE (BioNTech) seeking damages for infringement of U.S.

On April 4, 2023, we and Genevant filed a lawsuit in the United States District Court for the District of New Jersey against Pfizer/BioNTech seeking damages for infringement of United States Patent Nos.

and 11,318,098 in the manufacture and sale of any COVID-19 mRNA-LNP vaccines.

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.

On July 10, 2023, Pfizer and BioNTech filed their answer to the complaint, affirmative defenses and counterclaims.

We and Genevant filed our answer to these counterclaims on August 14, 2023.

A scheduling conference was held on August 28, 2023 and the court issued a Letter Order on September 7, 2023 setting certain court dates.

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.

Moderna Inter Partes Review Petition

On February 21, 2018, Moderna Therapeutics, Inc.

(Moderna) filed a petition requesting the United States Patent and Trademark Office to institute an Inter Partes Review of Arbutus United States Patent 9,404,127 (the ’127 Patent).

In its petition, Moderna sought to invalidate all claims of the patent based on Moderna’s allegation that the claims are anticipated and/or obvious.

We filed a response to Moderna’s petition on June 14, 2018.

On September 12, 2018, the Patent Trial and Appeal Board (the PTAB) rendered its decision to institute Inter Partes Review of the ‘127 Patent.

The ‘127 Patent represents only a fraction of our extensive LNP patent portfolio.

With respect to the ‘127 Patent, the PTAB held all claims as invalid on September 10, 2019, by reason of anticipatory prior art.

However, this decision was vacated and sent back (remanded) to the PTAB for a rehearing, pending the U.S.

Supreme Court’s (Supreme Court) decision whether to grant certiorari in a different case, United States v.

Athrex), the holding of which could impact the findings in the ‘127 Patent matter.

The Supreme Court granted certiorari in US v.

Athrex on October 13, 2020 (i.e., agreed to review the decision appealed from a lower court).

Until the Supreme Court rendered its opinion in US v.

Athrex, the ‘127 Patent hearing remained in abeyance, with no decision reached as to the validity of its claims.

The Supreme Court decided on the US v.

Athrex case on June 21, 2021, following which the Federal Circuit reinstated the appeal sua sponte, requiring the parties to brief how the case should proceed in light of the Supreme Court’s opinion or for the Appellant to waive the challenge.

We elected to waive the challenge and proceed with the appeal at the Federal Circuit.

The opening brief was filed on October 25, 2021.

Moderna’s responsive brief was filed on February 24, 2022 and our reply brief was filed on April 26, 2022.

An oral hearing for this matter was held on November 4, 2022.

On April 11, 2023, the Federal Circuit rendered its opinion, affirming the PTAB’s finding that all claims of the ‘127 Patent are invalid by reason of anticipation.

Moderna and Merck European Opposition

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.

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 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.

While we are the patent holder, the ‘127 Patent, the ‘254 Patent, the other patents in our LNP portfolio have been licensed to Genevant and are included in the rights licensed by us to Genevant under the Genevant License.

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 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.

The parties are awaiting further scheduling in the litigation.

Patent Infringement Litigation vs.

On February 28, 2022, we and Genevant filed a lawsuit in the United States District Court for the District of Delaware against Moderna seeking damages for infringement of United States Patent Nos.

8,058,069, 8,492,359, 8,822,668, 9,364,435, 9,504,651, and 11,141,378 in the manufacture and sale of MRNA-1273, Moderna’s vaccine for COVID-19.

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

Together, these lawsuits comprise the Moderna LNP Litigation.

On March 3, 2026, we, Genevant, and, solely for specified purposes, Genevant Sciences Ltd., and Moderna entered into the Moderna Settlement Agreement to resolve the Moderna LNP Litigation.

Pursuant to the Moderna Settlement Agreement, all parties filed stipulated judgments and stipulations of dismissal for the respective courts or tribunals to enter judgment, dismiss with prejudice or withdraw (as the case may be) all claims in the Moderna LNP Litigation, except that Moderna may file the Moderna §1498 Appeal.

The Moderna §1498 Appeal is an appeal of the consent judgment entered in the District Court solely with respect to whether §1498 bars our and Genevant’s claims for direct infringement and indirect infringement against Moderna for vaccine doses that were sold to the United States Government under a particular contract and characterized by the District Court as “vaccines that did not go directly to United States Government employees.”

Under the terms of the Moderna Settlement Agreement, Moderna will make an aggregate $950.0 million Noncontingent Settlement Payment to us and Genevant on or before July 8, 2026.

In addition, as described in more detail in, and subject to the terms of, the Moderna Settlement Agreement, Moderna will make an additional Contingent Settlement Payment of an aggregate $1.3 billion to us and Genevant (i) if the Court of Appeals for the Federal Circuit (whether by the initial panel, upon panel rehearing or en banc ) affirms, or if there is a final non-appealable judgment that affirms, the rejection of Moderna’s affirmative defense pursuant to §1498 by the District Court in its entirety or otherwise holds that §1498 does not bar our and Genevant’s claim against Moderna as to either or both of direct infringement and indirect infringement with respect to all of the doses subject to the Moderna §1498 Appeal, or (ii) upon a failure to timely file, or voluntary dismissal of, the Moderna §1498 Appeal (any of the foregoing (clause (i) or (ii) above), an Arbutus/Genevant §1498 Victory).

If an appellate ruling were to hold that §1498 bars our and Genevant’s infringement claims as to some, but not all, of the doses subject to the Moderna §1498 Appeal, the Moderna Settlement Agreement provides that Moderna will pay us and Genevant a prorated amount of the Contingent Settlement Payment, calculated based on the number of doses for which §1498 bars our and Genevant’s infringement claims as clearly articulated by the Federal Circuit or, if not clearly articulated by the Federal Circuit, as mutually agreed by the parties or determined in an accelerated binding arbitration process.

Under certain circumstances, as described in more detail in, and subject to the terms of, the Moderna Settlement Agreement, if the Arbutus/Genevant §1498 Victory is subsequently overturned in Moderna’s favor in a final nonappealable decision, we and Genevant are required to return any Contingent Settlement Payment to Moderna, plus interest.

If, following an Arbutus/Genevant §1498 Victory, either (i) Moderna does not timely appeal such Arbutus/Genevant §1498 Victory or (ii) such Arbutus/Genevant §1498 Victory is subsequently affirmed in a final nonappealable decision, Moderna will have no further right to a potential repayment of the Contingent Settlement Payment.

The Moderna Settlement Agreement includes mutual financial covenants to protect the payment or repayment of the Contingent Settlement Payment, as described above.

The Moderna Settlement Agreement also contains customary mutual releases in favor of each of us/Genevant and Moderna in respect of the Moderna LNP Litigation.

In addition, the Moderna Settlement Agreement includes a fully paid-up, royalty free, irrevocable, non-exclusive, worldwide license and covenant not to sue granted to Moderna under any patents and patent applications owned or licensable by us or Genevant or our respective direct and indirect wholly owned subsidiaries that exist, or that claim priority to patents or patent applications that exist, as of the effective date of the Moderna Settlement Agreement, to make, sell and generally otherwise exploit Moderna’s SPIKEVAX™, mNEXSPIKE™ and mRESVIA™ vaccines and any other mRNA vaccines that include a lipid SM-102-based LNP formulation against an infectious disease and meet certain conditions, as well as a covenant not to sue with respect to certain other of our and Genevant’s patents and Moderna products.

On March 19, 2026, we and Genevant filed a complaint against the United States in the United States Court of Federal Claims, seeking to recover compensation for Moderna’s infringement for vaccine doses that were sold to the United States Government under a particular contract and were deemed by the District Court to be doses that were provided directly to United States Government employees.

The complaint also includes a protective request to recover compensation from the United States for any other vaccine doses where, as a result of the Moderna §1498 Appeal, §1498 is deemed to bar our and Genevant’s claims for direct infringement and indirect infringement against Moderna.

Moderna and Merck European Oppositions

On April 5, 2018, Moderna and Merck filed Notices of Opposition to the ’254 Patent with the EPO, requesting that the ’254 Patent be revoked in its entirety for all contracting states.

From 2018 until 2024, various hearings were held by different divisions of the EPO regarding requests submitted by all parties.

Oral proceedings were held in June 2024, and the Opposition Division of the EPO 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 January 15, 2026, in a verbal decision, the Board of Appeal of the EPO revoked the ’254 Patent.

A written decision is expected in the next few months.

We disagree with the outcome, and upon receipt of the written decision, we plan to file a petition for review by the Enlarged Board of Appeal of the EPO.

The revocation was based on an EPO standard of “added matter” that does not apply in the United States.

In March 2026, pursuant to the Moderna Settlement Agreement, Moderna withdrew from this revocation proceeding.

We do not expect the EPO revocation decision to have an impact on the potential outcome, or timing, of our patent infringement litigation pending against Pfizer/BioNTech in the United States.

On April 29, 2025, Moderna filed a revocation action on the ’767 patent with the EPO, requesting that the patent be revoked in its entirety for all contracting states.

In July 2025, Merck, Arrowhouse GmbH and Keltie LLP filed three additional revocation actions against the ’767 patent.

Initial briefing has been completed and we are currently awaiting an initial hearing date.

In March 2026, pursuant to the Moderna Settlement Agreement, Moderna withdrew from this revocation proceeding.

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.

Other Matters

7 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-K

Item 3. Legal Proceedings