8-K: Arbutus Patent Revoked by EPO Board of Appeal

Arbutus Biopharma's European patent EP 2279254 was revoked by the EPO Board of Appeal, impacting some ongoing litigation but not others.

Summary

• The European Patent Office (EPO) Board of Appeal revoked Arbutus Biopharma Corporation's European patent EP 2279254 on January 15, 2026.
• This verbal decision, provided without reasons, follows opposition notices originally filed by affiliates of Moderna Therapeutics, Inc. and Merck, Sharp & Dohme Corporation in April 2018.
• Arbutus disagrees with the outcome and plans to file a petition for review by the Enlarged Board of Appeal of the EPO once the written decision is received.
• The decision is likely to affect cases brought by the company and its licensee Genevant Sciences GmbH against Moderna in Switzerland and one Unified Patent Court case (UPC_CFI_191/2025) where the '254 Patent is asserted.
• The company does not expect this decision to impact patent infringement litigation against Moderna in the United States, Japan, or Canada, another UPC case against Moderna (UPC_CFI_192/2025) not involving the '254 Patent, or litigation against Pfizer Inc. and BioNTech SE in the United States.
• The decision was based on an EPO standard of 'added matter' which does not apply in the United States or any other jurisdiction where the company has initiated patent infringement litigation.

Sentiment

Score: 3

Explanation: The revocation of a European patent is a negative development, as it weakens the company's intellectual property position in certain jurisdictions and impacts specific ongoing litigation. However, the company explicitly states it does not expect an impact on its significant US, Japanese, Canadian, and other UPC litigation, and plans to appeal, which mitigates the overall negative sentiment somewhat.

Positives

• The company does not expect the decision to impact its patent infringement litigation against Moderna in the United States, Japan, or Canada.
• The decision is not expected to impact another Unified Patent Court case against Moderna (UPC_CFI_192/2025) that does not involve the '254 Patent.
• The decision is not expected to impact its patent infringement litigation against Pfizer Inc. and BioNTech SE in the United States.
• The company plans to appeal the decision to the Enlarged Board of Appeal of the EPO.

Negatives

• The European patent EP 2279254 has been revoked by the EPO Board of Appeal.
• The decision is likely to affect the case brought by the company and its licensee Genevant Sciences GmbH against Moderna in Switzerland.
• The decision is likely to affect one of two cases brought by the company and Genevant against Moderna in the Unified Patent Court (Case UPC_CFI_191/2025).

Risks

• Uncertainties associated with litigation generally and patent litigation specifically.
• Economic and market conditions may worsen.
• Market shifts may require a change in strategic focus.
• Risks related to the sufficiency of the company's cash resources for its foreseeable and unforeseeable operating expenses and capital expenditures.

Future Outlook

The company plans to file a petition for review by the Enlarged Board of Appeal of the EPO upon receipt of the written decision. It expects the decision to affect certain European patent cases but not its litigation in the United States, Japan, Canada, or other specific UPC cases.

Management Comments

• The Company disagrees with the outcome.
• Upon receipt of the written decision, the Company plans to file a petition for review by the Enlarged Board of Appeal of the EPO.
• The Company does not expect this decision to have an impact on the potential outcome, or timing, of its patent infringement litigation pending against Moderna in the United States, Japan or Canada, its case pending against Moderna before the Unified Patent Court (Case UPC_CFI_192/2025) that does not involve the 254 Patent, or its patent infringement litigation pending against Pfizer Inc. and BioNTech SE in the United States.

Industry Context

This event highlights the ongoing and complex nature of patent disputes within the biotechnology and pharmaceutical industries, particularly concerning foundational intellectual property. Such disputes are common among companies developing novel therapeutic platforms, where patent strength can significantly influence market position and licensing revenues. The involvement of major players like Moderna, Merck, Pfizer, and BioNTech underscores the high stakes in these legal battles, especially in areas like mRNA technology or drug delivery systems.

Legal Proceedings

• Ongoing patent infringement litigation against Moderna in Switzerland.
• Ongoing patent infringement litigation against Moderna in the Unified Patent Court (Case UPC_CFI_191/2025).
• Ongoing patent infringement litigation against Moderna in the United States, Japan, and Canada (not expected to be impacted).
• Ongoing patent infringement litigation against Moderna in the Unified Patent Court (Case UPC_CFI_192/2025) (not expected to be impacted).
• Ongoing patent infringement litigation against Pfizer Inc. and BioNTech SE in the United States (not expected to be impacted).

Stakeholder Impact

• Shareholders: Potential negative impact due to the weakening of intellectual property in Europe and the associated legal costs and uncertainties, though mitigated by the company's assertion of no impact on key US litigation and plans for appeal.
• Competitors (Moderna, Merck): Positive impact as their opposition to the patent was successful, potentially reducing their legal exposure or increasing their freedom to operate in Europe.
• Licensee (Genevant Sciences GmbH): Negative impact as the decision affects cases where Genevant is a co-plaintiff.

Next Steps

• Expectation of a written decision from the EPO in the next few months.
• Upon receipt of the written decision, the company plans to file a petition for review by the Enlarged Board of Appeal of the EPO.

Key Dates

Recommendation

While the patent revocation is a negative development, the company's assertion that it does not impact its significant US litigation against Moderna, Pfizer, and BioNTech, combined with its intent to appeal, suggests that the long-term intellectual property position is not entirely undermined. Investors should hold to observe the outcome of the appeal and the unaffected US litigation, as these are likely more material to the company's valuation. The situation introduces uncertainty but not an immediate reason for a strong sell, nor a strong buy given the negative legal outcome.

Keywords

Arbutus Biopharma, ABUS, EPO, European Patent Office, patent revocation, EP 2279254, Moderna, Merck, Genevant, Pfizer, BioNTech, patent litigation, intellectual property, biotech, pharmaceuticals, 8-K