What changed in this filing

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Item 1. Legal Proceedings

2025-05-14 compared with 2024-11-06 · 42 added, 70 removed, 50 unchanged (69% of the section changed)

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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.

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.

Subsequently, the claim construction hearing was scheduled for December 18, 2024.

Scheduling of subsequent case dates, including the date for trial, will be set at a later time that is yet to be determined.

Document and written discovery in the action is ongoing.

Patent Infringement Litigation vs.

United States:

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

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

On November 30, 2022, Moderna filed its Answer to the Complaint and Counterclaims.

We and Genevant filed our Answer to Moderna’s Counterclaims on December 21, 2022.

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 Governments’ Statement of Interest on the scheduling of the matter.

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.

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.

On June 9, 2023, the court granted the parties’ request to extend the time for claim construction briefing.

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

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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”.

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, subject to the court’s availability.

Acuitas Declaratory Judgment Lawsuit

On March 18, 2022, Acuitas Therapeutics Inc.

(Acuitas) filed a lawsuit against us and Genevant in the U.S.

District Court for the Southern District of New York, asking the court to enter declaratory judgment that Arbutus patent Nos.

8,058,069, 8,492,359, 8,822,668, 9,006,417, 9,364,435, 9,404,127, 9,504,651, 9,518,272, and 11,141,378 do not infringe Pfizer and BioNTech’s COVID-19 vaccine, COMIRNATY, which uses an mRNA lipid provided, under license, by Acuitas.

seeks a declaration that each of the listed patents is invalid.

On June 24, 2022, we and Genevant sought a pre-motion conference concerning our anticipated motion to dismiss all of Acuitas’ claims due to lack of subject matter jurisdiction.

The request for a pre-motion conference was granted, but the case was subsequently re-assigned to a new judge who entered an order directing:

(i) Acuitas to inform the court whether it intended to file an amended complaint;

(ii) that Acuitas must file any amended complaint by a certain date;

and (iii) that if Acuitas did not file an amended complaint, we and Genevant must file our motion to dismiss by a certain date.

Acuitas filed its amended complaint on September 6, 2022.

On October 4, 2022, we and Genevant filed our motion to dismiss the Acuitas action for lack of subject matter jurisdiction based on the lack of a case or controversy.

Acuitas filed its opposition to the motion to dismiss on November 1, 2022, and we and Genevant filed our reply brief on November 16, 2022 at which point the motion was fully briefed.

A status conference for the action was set for August 9, 2023, however on August 4, 2023, Acuitas voluntarily dismissed its complaint in the Southern District of New York and refiled a virtually identical complaint in the District Court of New Jersey (D.

N.J.) where the Pfizer/BioNTech matter is currently pending, except that the 9,404,127 patent is not at issue in the New Jersey action, and Acuitas also added two additional patents to its New Jersey declaratory judgment action (U.S.

11,298,320 and 11,318,098) that were not at issue in its New York action.

On September 15, 2023, we and Genevant filed a letter with the court seeking a premotion conference for a motion to dismiss and subsequently filed our and Genevant’s motion to dismiss on October 13, 2023.

Acuitas filed its opposition on November 1, 2023 and we and Genevant filed our reply on November 16, 2023.

Acuitas filed a request to commence discovery on November 18, 2023, to which we and Genevant responded on November 20, 2023.

On May 20, 2024, the court granted our and Genevant’s motion to dismiss, so we believe this matter is now concluded.

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

Trial is currently scheduled for September 29, 2025.

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

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.

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:

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.

• Unified Patent Court:

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 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.

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.

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.

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 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.

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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.

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.

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 have given notice of their intent to appeal the Opposition Division’s decision, and the deadline for filing for their respective grounds for appeal is November 25, 2024.

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.

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.

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.

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

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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.

What changed 10-Q

Item 1. Legal Proceedings