Arbutus Biopharma Announces Claim Construction Ruling in its Ongoing Patent Infringement Lawsuit Against Moderna

WARMINSTER, Pa., April 04, 2024 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop a functional cure for people with chronic hepatitis B virus (cHBV) infection, today issued the following statement regarding the claim construction ruling of the U.S. District Court for the District of Delaware in the lawsuit brought by Arbutus and its licensee Genevant Sciences (Plaintiffs) against Moderna, Inc. and a Moderna affiliate seeking damages for infringement of U.S. 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.

The following summarizes the Court’s Opinion:

• Composition of Total Lipid (‘069)
  • The Court agreed with Plaintiffs’ position that 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.
  • The Court agreed with Plaintiffs’ position that the claimed mol. % ranges include standard variation based on the number of significant figures recited in the claim.
• Cationic Lipid with Protonatable Tertiary Amine (‘378)
  • The Court agreed with Plaintiffs’ position that there is no limitation as to the mol. % of the claimed cationic lipid.
• Encapsulation of mRNA (‘651)
  • 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”.
    

“We are pleased with how the Court construed the disputed claim terms,” said Michael J. McElhaugh, Interim President and Chief Executive Officer of Arbutus Biopharma. “We remain committed to protecting and defending our intellectual property and look forward to the next steps in the litigation.”  

Arbutus and Genevant Sciences are seeking fair compensation for Moderna’s use of its patented LNP technology that was developed with great effort and at great expense, and without which Moderna’s COVID-19 vaccine would not have been successful.

The Court’s claim construction ruling has been posted on the Arbutus website.

About Arbutus

Arbutus Biopharma Corporation (Nasdaq: ABUS) is a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to identify and develop novel therapeutics with distinct mechanisms of action, which can be combined to provide a functional cure for patients with chronic hepatitis B virus (cHBV). We believe the key to success in developing a functional cure involves suppressing HBV DNA, reducing surface antigen, and boosting HBV-specific immune responses. Our pipeline of internally developed, proprietary compounds includes an RNAi therapeutic, imdusiran (AB-729) and an oral PD-L1 inhibitor, AB-101. Imdusiran has generated meaningful clinical data demonstrating an impact on both surface antigen reduction and reawakening of the HBV-specific immune response. Imdusiran is currently in two Phase 2a combination clinical trials. AB-101 is currently being evaluated in a Phase 1a/1b clinical trial. For more information, visit www.arbutusbio.com.