Item 1. Legal Proceedings
ITEM 1. LEGAL PROCEEDINGS
For other information regarding legal matters, please refer to note 8. Contingencies and Commitments to the condensed consolidated financial statements contained in Part I of this Quarterly Report on Form 10-Q, which is incorporated herein by reference.
Moderna Inter Partes Review Petitions
On February 21, 2018 and on March 5, 2018, Moderna Therapeutics, Inc. (“Moderna”) filed petitions requesting the United States Patent and Trademark Office to institute an Inter Partes Review of Arbutus United States Patents 9,404,127 (“’127 patent”) and 9,364,435 (“’435 patent”), respectively. In its petitions, Moderna sought to invalidate all claims of each Arbutus patent based on Moderna’s allegation that the claims are anticipated and/or obvious. Arbutus filed a response to Moderna’s petitions on June 14, 2018. On September 12, 2018, the Patent Trial and Appeal Board (“PTAB”) rendered its decision to institute Inter Partes Review of both challenged patents. Arbutus’ response was provided December 21, 2018. Oral hearing took place on June 6, 2019. On September 10, 2019, the PTAB rendered its decision on the ‘127 patent, holding all claims invalid as anticipated and on September 11, 2019, the PTAB rendered its decision on the ‘435 patent, holding certain claims invalid and upholding other claims as valid. On February 27, 2020, the Federal Circuit vacated the ‘127 IPR decision and remanded it back to the PTAB for rehearing, where it is presently being held in abeyance until the Supreme Court acts on a petition for writ of certiorari filed July 23, 2020 in a different case. On October 13, 2020, the Supreme Court granted certiorari in United States v. Athrax, Inc. which was the basis of the Federal Circuit’s remand in the ‘127 IPR. On November 27, 2019, Moderna and Arbutus both appealed the ‘435 IPR decision. Moderna filed its opening brief on May 4, 2020. Arbutus’ opening and responsive brief was provided on July 27, 2020. Moderna filed its reply and responsive brief on October 5, 2020.
On January 9, 2019, Moderna filed an additional petition requesting Inter Partes Review of Arbutus United States Patent 8,058,069 (“’069 patent”). The PTAB instituted Inter Partes Review of the ‘069 patent on July 24, 2019, with a hearing held on April 22, 2020. On July 23, 2020, the PTAB rendered its decision on the ‘069 patent, upholding all claims as valid. On September 23, 2020, Moderna appealed the ‘069 IPR decision.
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 (“’254 patent”) with the European Patent Office (“EPO”), requesting that the patent be revoked in its entirety for all contracting states. Arbutus filed a response to Moderna and Merck’s oppositions on September 3, 2018. A hearing was conducted before the Opposition Division on October 10, 2019. At the conclusion of the hearing, the EPO upheld an auxiliary request adopting the amendment, as put forth by Arbutus, 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. Arbutus’ response was filed on September 8, 2020.
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