`Filed: August 7, 2019
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________
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`MODERNA THERAPEUTICS, INC.,
`Petitioner,
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`v.
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`ARBUTUS BIOPHARMA CORPORATION,
`Patent Owner.
`_____________________________
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`Case IPR2019-00554
`Patent No. 8,058,069
`_____________________________
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`PATENT OWNER’S OBJECTIONS TO EXHIBITS SUBMITTED BEFORE
`INSTITUTION PURSUANT TO 37 C.F.R. § 42.64(b)(1)
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`I.
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`INTRODUCTION
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`Pursuant to 37 C.F.R. § 42.64(b)(1), Arbutus Biopharma Corporation
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`(“Patent Owner”) submits the following objections to Moderna Therapeutics, Inc.’s
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`(“Petitioner”) Exhibit 1008, and any reference to or reliance on the foregoing
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`Exhibit in the Petition or future filings by Petitioner. Patent Owner’s objections are
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`made pursuant to the Code of Federal Regulations (“C.F.R.”) governing this
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`proceeding, including without limitation 37 C.F.R. §§ 42.61-42.65 and § 42.6(a)(3).
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`As required by 37 C.F.R. § 42.62, Patent Owner’s objections below apply the
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`Federal Rules of Evidence (“F.R.E.”).
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`II. OBJECTIONS.
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`1. Objections to Exhibit 1008, and any Reference to/Reliance Thereon
`Grounds for Objection: F.R.E. 401, 402 (Irrelevant Evidence Inadmissible);
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`F.R.E. 403 (Excluding Evidence for Prejudice, Confusion, Waste of Time,
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`Duplication, or Other Reasons); F.R.E. 701, 702, 703 (Expert Foundation and
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`Opinions); F.R. E. 802, 803, 805 (Inadmissible Hearsay).
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`EX1008 is the declaration of Dr. Janoff and is objected to in its entirety. Dr.
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`Janoff fails to describe the underlying facts or data on which his opinions are based.
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`Similar to Dr. Janoff’s declarations in prior proceedings, Dr. Janoff merely parrots
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`word-for-word the attorney argument presented in the petition. In prior
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`proceedings, Dr. Janoff expressly stated in his direct and cross-examination
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`testimony that his declaration was based on studying the petition, confirmed that
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`the lawyers drafted the petition without his assistance, and that his declaration was
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`later prepared after the petition was completed. As was the case in prior
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`proceedings, the Janoff declaration in this proceeding is a virtual word-for-word
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`copy of that argument offered in the present petition. Indeed, in EX1008 Dr. Janoff
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`similarly confirms that his direct testimony is “based on studying the petition.” See,
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`e.g., ¶¶ 5, 6 and 7.
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`While the present IPR involves a different patent from the prior proceedings,
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`the content of this petition, and of Dr. Janoff’s declaration, is nearly identical to the
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`petition and Janoff Declaration in IPR2018-00739. Moreover, in nearly every
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`instance the content of Dr. Janoff’s Declaration, besides parroting the attorney
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`argument found in the petition, lacks evidentiary support. Nothing in the Board’s
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`rules or cases, nor in Federal Circuit case law, requires a fact finder to credit the
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`unsupported assertions of an expert witness. As a result, what little (if any)
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`probative weight the declaration is entitled to is outweighed by the prejudicial
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`effect of the unsupported testimony in this proceeding.
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`III. CONCLUSION
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`The aforementioned exhibit was filed with the petition, prior to institution.
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`Trial was instituted on July 24, 2019. These objections are made within 10
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`business days of institution pursuant to 37 C.F.R. § 42.64.
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`Dated: August 7, 2019
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`Respectfully submitted,
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`/ Michael T. Rosato /
`Michael T. Rosato, Lead Counsel
`Reg. No. 52,182
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`CERTIFICATE OF SERVICE
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`The undersigned certifies that the foregoing Patent Owner’s Objections to
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`Exhibits Submitted Before Institution Pursuant to 37 C.F.R. § 42.64(b)(1) was
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`served on August 7, 2019, at the following electronic service addresses:
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`Michael Fleming
`C. Maclain Wells
`IRELL & MANELLA LLP
`mfleming@irell.com
`mwells@irell.com
`ModernaIPR@irell.com
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`Dated: August 7, 2019
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`Respectfully submitted,
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`/ Michael T. Rosato /
`Michael T. Rosato, Lead Counsel
`Reg. No. 52,182
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