Paper No. ___
`Filed: April 1, 2020
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`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.
`_____________________________
`
`Case IPR2019-00554
`Patent No. 8,058,069
`_____________________________
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`PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE PURSUANT
`TO 37. C.F.R. § 42.64(c)
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`Filed: April 1, 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 MOTION TO EXCLUDE EVIDENCE PURSUANT
`TO 37. C.F.R. § 42.64(c)
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`I. STATEMENT OF PRECISE RELIEF REQUESTED
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`Pursuant to 37 C.F.R. §§ 42.62 and 42.64(c) and the Federal Rules of
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`Evidence, Patent Owner respectfully moves to exclude exhibit 1020, as well as
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`portions of exhibit 2033, pursuant to 37 C.F.R. § 42.64(c).
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`Patent Owner timely objected to exhibits 1020 and 2033 and reliance
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`thereon. Paper 22, EX2033.
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`II. STATEMENT OF REASONS FOR THE RELIEF REQUESTED
`A. Exhibit 1020 should be excluded
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`Exhibit 1020 is the declaration of Petitioner’s proffered new expert, Dr.
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`Anchordoquy, and it should be excluded in its entirety under at least F.R.E. 401,
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`402 (Irrelevant Evidence Inadmissible), 403 (Excluding Evidence for Prejudice,
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`Confusion, Waste of Time, Duplication, or Other Reasons), F.R.E. 702, 703
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`(Expert Foundation and Opinions).
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`First, Dr. Anchordoquy is a zoologist, not a lipid chemist with formal
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`training in the subject matter at hand. EX1020, ¶9. As such, Dr. Anchordoquy
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`fails to qualify as a person of ordinary skill as defined by Petitioner and the Board.
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`That is, Petitioner and Dr. Anchordoquy define the ordinary artisan as someone
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`who “would have specific experience with lipid particle formation and use in the
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`context of delivering therapeutic nucleic acid payloads.” EX1020, ¶25; see also
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`-1-
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`Decision on Institution, 11-12 (discussing the level of ordinary skill in the art). Dr.
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`Anchordoquy lacks the qualifications necessary to meet this minimal threshold.
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`Dr. Anchordoquy, as support for his expertise in the field, specifically
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`discusses his first issued patent, U.S. Patent No. 7,914,714, which he asserts
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`“described a process by which lipid bilayers could be formed around a solution of
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`nucleic acids, effectively surrounding the nucleic acids to achieve complete
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`encapsulation within a lipid vesicle.” EX1020, ¶14. That patent, however, claims
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`a “method for making an encapsulated droplet … of an agent to be
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`encapsulated…through electrostatic atomization….” This technology is neither the
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`same nor similar to the technology at issue. Indeed, it does not seem that Dr.
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`Anchordoquy has any relevant patents or patent applications at all. Petitioner does
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`not demonstrate that Dr. Anchordoquy has any significant expertise in the
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`technology at issue through his publications or academic studies.
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`Clearly concerned by this new witness’ thin resume, Petitioner staged an
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`unprompted and rehearsed questioning on redirect during Dr. Anchordoquy’s
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`recent deposition. EX2043, 77:4-79:25. But that testimony is hardly reassuring.
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`Dr. Anchordoquy attempted to spin his zoology training as broadly encompassing
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`“everything related to animals.” Id., 77:22-23. He testified that while his graduate
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`school offered a program in biophysics and the zoology department offered an
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`emphasis in biophysics, he was not in either program. Id., 78:6-14. He testified he
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`was aware of other individuals (“we had a guy down the hall who did muscle
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`contraction”) and lab equipment (“we had a calorimeter, a differential scanning
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`calorimeter. Oh boy.”) fitting under the broad umbrella of “biophysics,” but
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`unrelated to the technology at hand in this proceeding. Id., 78:13-21; 79:10-11.
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`His prepared remarks during redirect may shed further light on his lack of
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`qualifications but offer no reassurance that his declaration testimony is relevant or
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`otherwise admissible in this proceeding.
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`Accordingly, Dr. Anchordoquy does not have the requisite experience with
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`delivering therapeutic nucleic acids as required by Petitioner’s definition of the
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`ordinary artisan and as adopted by Dr. Anchordoquy. His testimony should be
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`excluded at least on this basis.
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`Second, even if the Board does not exclude the testimony of Dr.
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`Anchordoquy on the basis that he lacks the requisite qualifications to serve as an
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`expert in this case, his declaration is irrelevant for the purposes proffered by
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`Petitioner. Dr. Anchordoquy’s declaration is used as a means to belatedly
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`introduce argument that should have been presented with the petition, but was not.
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`As is appreciated by the Board, bare notice pleading tactics—where critical
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`evidence is missing from the petition materials and belatedly sought entry for the
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`first time in Reply—is strictly prohibited in inter partes review proceedings.
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`Consolidated Trial Practice Guide, 73 (“Petitioner may not submit new evidence in
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`reply that it could have presented earlier, e.g. to make out a prima facie case of
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`unpatentability.”); Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d
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`1359, 1369 (Fed. Cir. 2016) (“Unlike district court litigation — where parties have
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`greater freedom to revise and develop their arguments over time and in response to
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`newly discovered material — the expedited nature of IPRs bring with it an
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`obligation for petitioners to make their case in their petition to institute.”)
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`(emphasis added); 35 U.S.C. §312(a)(3) (requiring particularity in the petition
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`materials).
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`Belated entry of evidence critically required of the petition materials is
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`precisely what Petitioner now attempts at the reply stage of the proceeding. The
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`petition cited caselaw and a legal theory which required a showing of routine
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`optimization, but the petition materials critically lacked evidence to support such
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`an obviousness charge. The Patent Owner Response (e.g., POR, 11-24) explains in
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`detail the disconnect between the invoked legal theory and the utter lack of
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`evidence or argument in the petition to support this theory.
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`In fact, up until the Reply, Petitioner and its expert, Dr. Janoff, agreed on the
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`inapplicability of routine optimization. The petition materials embraced the
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`complexity of the technology and argued wild unpredictability. During cross-
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`examination, Petitioner’s expert witness repeatedly testified the prior art lipid
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`ranges are “immense” and “would require undue experimentation, not simple
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`optimization.” EX2033, 60:5-16; 42:7-10; 19:25-20:15; POR 4, 19-27. As
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`explained in the POR, Dr. Janoff was correct in this regard, undermining the ill-
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`conceived obviousness case in the petition.
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`With the deficiencies in the petition case laid bare, Petitioner belatedly
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`attempts to cure them at the reply stage, including submission of Dr.
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`Anchordoquy’s declaration (EX1020)—ignoring the evidence and testimony of its
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`own witness entirely and now asserting “routine optimization.”
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`In Reply, Petitioner now attempts to submit evidence that is required to have
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`been submitted with the petition materials. 37 CFR § 42.23(b). Petitioner did not
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`do so, but instead, now attempts to abandon arguments and explanation proffered
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`by its previous expert in order to advance different and new obviousness
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`arguments, and also improperly attempts to incorporate huge swaths of Dr.
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`Anchordoquy’ s declaration by reference. E.g., Reply, 4 (citing EX1020, ¶¶36-41,
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`87-91), 6 (citing EX1020, ¶¶51-55), 7 (same); 8 (citing EX1020, ¶¶56-69), 12
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`(citing EX1020, ¶¶73-76), 15 (citing EX1020, ¶¶85-88), 17 (citing EX1020, ¶¶36-
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`41).
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`Third, Dr. Anchordoquy fails to describe the underlying facts or data on
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`which his opinions are based, thereby failing to provide a proper foundation for his
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`opinions. For example, as to the introduced N/P ratio, Dr. Anchordoquy did not
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`provide any of the underlying calculations for the N/P ratios he provided in his
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`declaration. E.g., EX1020, ¶¶62, 72, 73, 88, 89. But as Dr. Anchordoquy
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`conceded during cross-examination, there are a number of variables involved,
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`some of which he did not know, requiring him to make certain (unexplained and
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`undisclosed) assumptions. EX2043, 36:8-40:17, 44:20-45:16. He further
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`conceded that he made “approximations” rather than precise calculations. Id.,
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`44:24-45:13. Moreover, Dr. Anchordoquy’s (EX1020, ¶89) assertion that both Lin
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`and Ahmad demonstrate that the testing in those references establish that
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`increasing the N/P ratio by elevating cationic lipid concentrations above 50%
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`enhanced transfection efficiency is not supported by the references, as both
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`references (EX1006, 3314; EX1007, 743) expressly state that ratio was kept
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`constant. Dr. Anchordoquy also ignored the fact that the N/P ratio for the
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`optimized commercial product, patisiran, is 3.4 (EX2041). When probed during
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`deposition, Dr. Anchordoquy conceded that he had calculated the N/P ratio but
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`chose to exclude it from his declaration. EX2043, 65:13-66:2; 66:19-67:13. Such
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`information is clearly probative as to the lack of credibility to this argument and
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`should not have been withheld.
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`Dr. Anchordoquy also falsely asserts a trend of increasing cationic lipid
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`levels, while conceding he conducted no meaningful investigation—rather, he
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`relied on an admittedly erroneous figure generated by the lawyers. He concedes
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`this “trend” was fabricated by cherry picking only three data points—an analysis
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`no credible scientist would embrace. EX2043, 61:13-22. He concedes he did not
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`investigate patent owner’s publications at the time (there were more than 30 patent
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`publications alone). Id., 30:25-31:7. He concedes there were hundreds to
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`thousands of publications that were not omitted from this analysis entirely. Id.,
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`29:25-30:4, 62:1-9. He concedes the lawyer generated plot omits the ’910
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`publication, which focuses on formulations with 30% cationic lipid or less. Id.,
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`52:9-16 (confirming he did not construct the “trend”), 12:18-20 (discussing Figure
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`23 of the ’910 publication), 16:6-19:24 (discussing in vivo experiments of the ’910
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`publication using 30% cationic lipid). He further concedes that plotting even a
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`single data point from the ’910 publication would destroy the purported trend.
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`EX2043, 59:7-61:7.
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`There is no basis in the Board’s rules or opinions, nor in the case law of the
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`Court of Appeals for the Federal Circuit, that requires a fact finder to credit the
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`unsupported assertions of an expert witness. Furthermore, as illustrated above, the
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`identified testimony is simply not credible and, therefore, would do little more than
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`add confusion and waste of time and resources.
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`Accordingly, what little (if any) probative weight to which the declaration
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`may be entitled is outweighed by its prejudicial effect. The declaration should be
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`excluded.
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`-7-
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`B.
`Exhibit 2033 should be excluded-in-part
`The redirect of Dr. Janoff should be excluded under F.R.E. 402 as beyond
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`the scope of the cross-examination, and thus irrelevant and prejudicial. Patent
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`Owner objected to the questions of counsel for Petitioner not only during the
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`deposition, but also in a phone call to the Board. E.g., EX2033, 148:10-12,
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`148:18-22, 149:4-21, 153:3-162:21
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`The Patent Owner Preliminary Response (e.g., 3, 12, 16, 27) discussed the
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`lack of motivation and the lack of a discussion of a reasonable expectation of
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`success in the petition’s obviousness analysis. Counsel for Petitioner improperly
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`used his opportunity for redirect to fill the gaping holes in Petitioner’s obviousness
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`challenge. For example, as counsel for Patent Owner noted, one of the questions
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`asked by counsel for Petitioner asked on redirect is “[w]hat is the purpose for
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`including cholesterol in the nucleic acid particle?” But cholesterol was not asked
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`about during cross-examination. As Patent Owner’s counsel noted during the
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`conference call with the Board:
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`-8-
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`EX2033, 160:4-15.
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`Counsel for Petitioner responded that “they are directly responsive in
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`establishing the technical analysis supporting the determination that the expert
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`made.” Id., 160:19-24. The only question regarding a technical analysis however,
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`elicited a concession that the requisite technical analysis was absent from the
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`petition materials:
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`EX2033, 145:12-22. Moreover, the “technical analysis” for which counsel for
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`Petitioner was asking was never made in Dr. Janoff’s declaration in the first place,
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`thus the re-direct was a blatant attempt to get such testimony into the record.
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`Thus, Dr. Janoff’s redirect should be excluded in its entirety.
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`III. CONCLUSION
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`For the reasons discussed above, the above-identified evidence should be
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`excluded from consideration by the Board in this proceeding.
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`-10-
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`Date: April 1, 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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`-11-
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`CERTIFICATE OF SERVICE
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`I certify that the foregoing Patent Owner’s Motion to Exclude Evidence was
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`served on April 1, 2020, on the Petitioner at the electronic service addresses of the
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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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`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 1, 2020
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