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`Paper No. ___
`Filed: April 15, 2020
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________________
`
`MODERNA THERAPEUTICS, INC.,
`Petitioner,
`
`v.
`
`ARBUTUS BIOPHARMA CORPORATION,
`Patent Owner.
`_____________________________
`
`Case IPR2019-00554
`Patent No. 8,058,069
`_____________________________
`
`
`PATENT OWNER’S REPLY IN SUPPORT OF
`MOTION TO EXCLUDE EVIDENCE
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`
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`Petitioner fails to show the admissibility of the objected to evidence.
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`I. Exhibit 1020
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`Petitioner (Opp., 1-3) argues the Motion to Exclude (“MTE”) is improper
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`where it seeks exclusion of Dr. Anchordorquy’s declaration on the basis that it
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`presents new and belated argument. The Consolidated Trial Practice Guide
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`(“CTPG”) (79-80) recommends motions to strike directed to briefing (“If a party
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`believes that a brief filed by the opposing party raises new issues….”) and motions
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`to exclude directed towards evidence (“Objections may be preserved only by a
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`motion to exclude the evidence.”). Patent Owner did file a motion to strike the
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`reply brief and the corresponding motion to exclude, as appropriate. As explained
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`in the MTE, this new and belated evidence is more prejudicial than probative as
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`there was insufficient time and opportunity to fully respond, and rebuttal evidence
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`was prohibited. See Paper 25. It is thus a proper target of a motion to exclude.
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`Petitioner (Opp., 3) points to the Institution Decision (“DI”) as somehow
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`excusing its untimely arguments as to routine optimization. See also, Opp. 9-10.
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`The petition materials, however, misapprehended the relevant caselaw and lacked
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`any meaningful argument or evidence to support a routine optimization case. These
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`are not deficiencies that can be cured in Reply. Indeed, the single conclusory
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`sentence about only one lipid component (cationic lipid) identified by the Board
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`(e.g., DI, 26) as “unrebutted” at institution was explored during discovery and
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`-1-
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`thoroughly rebutted in the POR. That single sentence didn’t mention “routine
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`optimization” and lacked a shred of supporting evidence (compare EX1008, ¶109
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`with 37 C.F.R §42.65(a)). When questioned during cross-examination, Dr. Janoff
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`disavowed “routine optimization” in a manner consistent with his direct testimony
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`emphasizing high unpredictability in the field. The testimony of the witnesses
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`(further including Dr. Thompson) and the scientific literature all indicate that
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`routine optimization does not apply here. Petitioner’s attempted 1800 turn in reply
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`not only ignores the overwhelming evidence and admissions of its own witness,
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`but is untimely, highly prejudicial, and lacks underlying evidentiary basis.
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`
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`Petitioner (Opp., 3) attempts to side-step its obligation to provide
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`particularity and corresponding supporting evidence in the petition, asserting that
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`only new theories are prohibited—whereas new evidence is welcome. Petitioner
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`cites Genzyme, but that case is inapposite at least because it did not address the
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`facts presented here, which include 1) petition materials lacking meaningful
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`evidence to support routine optimization even if asserted sub silentio; and 2) the
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`theory was effectively disavowed and described as “undue experimentation” in the
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`direct and deposition testimony of Petitioner’s expert. Under the circumstances
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`presented here, allowing new evidence at this late stage of the proceeding, where
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`Patent Owner cannot adequately respond or provide evidence of its own, is highly
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`prejudicial and conflicts with Board’s rules and Federal Circuit guidance. CTPG,
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`-2-
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`73; Intelligent BioSys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed.
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`Cir. 2016).
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`
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`Petitioner’s (Opp. 4) belated “damage control” efforts to cabin Dr. Janoff’s
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`conflicting testimony to “lipid species” rather than ranges are unsupported attorney
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`spin that can be disregarded. Dr. Janoff did specifically address the “numerical
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`ranges” and “lipid proportions,” and not just the number of different lipid species.
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`E.g., EX2033, 41:4-42:10. Petitioner’s attempted distinction is also of no moment,
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`as the issue is the “immenseness” of the prior art disclosure, which includes
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`“hundreds” of lipids and much broader numerical ranges (i.e., “immense”) than
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`claimed. For example, as to the new phospholipid argument, Dr. Anchordoquy
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`identifies a massive non-cationic range of 5-90%, and a phospholipid (optional) is
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`only one potential sub-genus. EX1020, ¶¶44-45. Cataloguing a broad genus so
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`massive that it is hardly a “range,” the various possible different sub-genera of
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`non-cationic lipids, and the number of lipid species in each sub-genus, and the fact
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`that phospholipid is described in the art as optionally omitted entirely, and the prior
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`art range is truly “immense.” This further underscores the incredible nature of Dr.
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`Anchordoquy’s unsupported “routine optimization” testimony.
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`Petitioner falsely claims the new theory of the 2:40 formulation as a
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`“starting point” was argued in the petition materials. Opp. 3-4, citing Pet. 31,
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`EX1008, ¶108; EX1020, ¶56. This is incorrect, as illustrated by Petitioner’s own
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`-3-
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`citations, which do not even refer to the 2:40 formulation.
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`As to the lack of explanation of N/P ratio “calculations,” this was hardly
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`cured during Dr. Anchordoquy’s deposition. Opp., 5. Dr. Anchordoquy admitted
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`he did not explain the “calculations” in his declaration as required, admitted to
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`variables he didn’t know, and conceded “approximations” based on still
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`unexplained assumptions. MTE 5-6. As to the omitted Patisiran N/P ratio
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`calculation (e.g., EX2041), Dr. Anchordoquy admitted he made the calculation but
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`didn’t include it. Withholding this conflicting evidence undermines the validity of
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`the N/P ratio arguments specifically and the credibility of the witness generally.
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`
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`The Opp. (5-6) asserts the N/P ratio aspects of Lin and Ahmad undermining
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`Petitioner’s arguments, as well as the incomplete and spurious nature of its “trend”
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`argument go to weight, not admissibility. Petitioner’s incredible arguments should
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`be given no weight, and Dr. Anchordoquy’s corresponding testimony excluded as
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`lacking evidentiary foundation and credibility.
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`
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`Finally, as to Dr. Anchordoquy’s qualifications, Petitioner complains about
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`focus on “formal training” and only one patent. Opp. 6-7. But Dr. Anchordoquy
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`emphasized his formal training in zoology in his prepared, but non-reassuring,
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`remarks in redirect. Patent Owner addressed the only published patent/reference
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`Dr. Anchordoquy (EX1020, ¶14) expressly discussed. Those aspects highlighted
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`by Petitioner and its witness simply do not provide the requisite qualifications.
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`-4-
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`II. Exhibit 2033
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`The redirect of Dr. Janoff was outside the scope of the cross-examination
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`and should be excluded. If not excluded, it should be considered only as illustrating
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`the deficiencies of the petition materials. For example, as the alleged hook for the
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`redirect questioning, Petitioner points to Dr. Janoff’s cross-examination testimony
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`explaining his declaration statements of prima facie obviousness were not based on
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`a technical analysis but were based on a purported “legal construct.” Elsewhere,
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`Dr. Janoff actual technical analysis characterized the prior art application as highly
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`unpredictable and requiring “undue experimentation, not simple optimization.”
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`As noted in the MTE (8), the redirect illustrates the recognized deficiencies
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`in the petition case outlined in the POR. That is, the petition challenge rests on
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`mere identification of lipid ranges in the art with no meaningful technical analysis
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`and lacks evidentiary support for the only legal theory implicated at institution.
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`Contrary to the Opp. (7-8), the improper questioning during redirect reflects
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`Petitioner’s scramble to remedy the lack of any meaningful discussion of
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`motivation to combine or reasonable expectation of success. Such scramble began
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`after the filing of the POPR, during redirect of Dr. Janoff, and continues in Reply
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`with the filing of new witness testimony. Such material should be excluded.
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`III. Conclusion
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`The challenged exhibits should be excluded.
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`-5-
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`Date: April 15, 2020
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`Respectfully submitted,
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`
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`/ Michael T. Rosato /
`Michael T. Rosato, Lead Counsel
` Reg. No. 52,182
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`-6-
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`CERTIFICATE OF SERVICE
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`I certify that the foregoing Patent Owner’s Reply in support of Motion to
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`Exclude Evidence was served on April 15, 2020, on the Petitioner at the electronic
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`service addresses of the Petitioner as follows:
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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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`Date: April 15, 2020
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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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`-7-
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