IPR2017-01489
`Patent Owner’s Motion to Exclude
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`
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`Adam R. Brausa (Reg No. 60,287)
`Daralyn J. Durie (Pro Hac Vice)
`DURIE TANGRI LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
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`Filed on behalf of Patent Owner Genentech, Inc. by:
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`David L. Cavanaugh (Reg. No. 36,476)
`Lauren V. Blakely (Reg. No. 70,247)
`Robert J. Gunther, Jr. (Pro Hac Vice)
`Lisa J. Pirozzolo (Pro Hac Vice)
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`Kevin S. Prussia (Pro Hac Vice)
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`Andrew J. Danford (Pro Hac Vice)
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`WILMER CUTLER PICKERING
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` HALE AND DORR LLP
`1875 Pennsylvania Ave., NW
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`Washington, DC 20006
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________________________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________________________
`PFIZER, INC. AND
`SAMSUNG BIOEPIS CO., LTD.;
`Petitioners,
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`v.
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`GENENTECH, INC.,
`Patent Owner.
`____________________________________________
`Case IPR2017-014891
`U.S. Patent No. 6,407,213
`____________________________________________
`PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64
`
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`1 Case IPR2017-02140 has been joined with this proceeding.
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`Patent Owner’s Motion to Exclude
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`
`
`Adam R. Brausa (Reg No. 60,287)
`Daralyn J. Durie (Pro Hac Vice)
`DURIE TANGRI LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
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`Filed on behalf of Patent Owner Genentech, Inc. by:
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`David L. Cavanaugh (Reg. No. 36,476)
`Lauren V. Blakely (Reg. No. 70,247)
`Robert J. Gunther, Jr. (Pro Hac Vice)
`Lisa J. Pirozzolo (Pro Hac Vice)
`
`Kevin S. Prussia (Pro Hac Vice)
`
`Andrew J. Danford (Pro Hac Vice)
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`WILMER CUTLER PICKERING
`
` HALE AND DORR LLP
`1875 Pennsylvania Ave., NW
`
`Washington, DC 20006
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________________________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________________________
`PFIZER, INC. AND
`SAMSUNG BIOEPIS CO., LTD.;
`Petitioners,
`
`v.
`
`GENENTECH, INC.,
`Patent Owner.
`____________________________________________
`Case IPR2017-014891
`U.S. Patent No. 6,407,213
`____________________________________________
`PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64
`
`
`1 Case IPR2017-02140 has been joined with this proceeding.
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`IPR2017-01489
`Patent Owner’s Motion to Exclude
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`Pursuant to 37 C.F.R. § 42.64 Patent Owner moves to exclude the Buss
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`Declaration (Ex. 1504); Exhibit 1693 and the argument and testimony pertaining to
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`it; and the evidence and testimony regarding Petitioners’ new obviousness theory
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`regarding Kurrle.
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`I.
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`THE DECLARATION OF MR. BUSS (EX. 1504) SHOULD BE
`EXCLUDED.
`The opinions provided by Mr. Timothy Buss at Ex. 1504, ¶¶ 15-16, 18, 30-
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`33, 43-45, 53-55, 63, 67, 69-70 (“Buss Opinions”) are inadmissible in this
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`proceeding at least because Petitioners have not shown that Mr. Buss, a lab
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`technician, meets the level of ordinary skill in the art or that his opinions are the
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`product of reliable principles and methods.2 Because Petitioners cannot meet their
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`burden of demonstrating the admissibility of the Buss Opinions, the Board should
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`exclude them. See Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 592 n.10
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`2 Patent Owner objected to Ex. 1504 as lacking a disclosed basis of sufficient facts
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`or data (FRE 705; 37 C.F.R. § 42.65), not being based on sufficient facts or data,
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`the product of reliable principles and methods, and/or a reliable application of the
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`principles and methods to the facts (FRE 702, 703), and being misleading and/or
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`confusing (FRE 403). (Paper 31 at 1-2; see also Paper 42 at 63-64.)
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`1
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`(1993) (“The proponent of expert testimony must demonstrate admissibility by a
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`IPR2017-01489
`Patent Owner’s Motion to Exclude
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`preponderance of the evidence.”).
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`A. Mr. Buss’s Opinions Should be Excluded Because They Are Not
`the Product of Reliable Principles and Methods, and They Do Not
`Assist the Trier of Fact to Understand Any Facts at Issue.
`It is undisputed that the Buss Declaration’s analysis of the grounds of
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`unpatentability are nearly identical to the analysis presented by Dr. Edward Ball
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`submitted in Mylan Pharms. v. Genentech, Inc., IPR2016-01694. (See, e.g., Ex.
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`2058 (Redline of Ball/Buss Declarations); Ex. 2040 at 12:10-14:9.) Despite
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`lacking the credentials of Dr. Ball, a medical doctor with “more than 35 years of
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`practical and research experience specializing in oncology and hematology with an
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`emphasis on treating patients with antibody therapeutics” (Ex. 2056 at ¶23), Mr.
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`Buss copied nearly verbatim the substantive analysis provided by Dr. Ball and he
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`did so while performing no independent research or analysis regarding the subject
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`matter of the ’213 patent. (See, e.g., Ex. 2040 at 14:22-15:7.) He testified that he
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`only gave the ’213 patent “a quick read” and he “read through it briefly,” but he
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`could not recall whether he read the patent before or after he read the Ball
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`declaration. (Id. at 84:6-25.)
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`Mr. Buss also conceded during his deposition that he copied the substance of
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`Dr. Ball’s opinion without knowing who Dr. Ball was; without performing any
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`diligence to determine Dr. Ball’s reputation in the field; and without doing any
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`2
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`research of his own regarding the literature involved in this matter. (Ex. 2040 at
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`IPR2017-01489
`Patent Owner’s Motion to Exclude
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`14:10-15:7.) Further, he testified that for nearly every reference cited in his
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`declaration—including Hudziak, which forms the basis of grounds 8-10—he
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`included it in his declaration only because Dr. Ball had cited them. (Ex. 2040 at
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`95:1-8, 125:8-126:21, 127:21-128:3; see generally id. at 96:18-125:7 (discussing
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`over 25 references).) And as of 1991, Mr. Buss had not even heard of HER2-
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`positive breast cancer. (Ex. 2040 at 51:7-11.)
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`The only expertise contributed by Mr. Buss is the ability to “read[] papers on
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`molecular biology antibodies.” (See, e.g., Ex. 2040 at 145:22-146:13.) But simply
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`copying the work of another expert and reading the documents cited therein is not
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`a reliable method under Federal Rule of Evidence 702. Bouygues Telecom, S.A. v.
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`Tekelec, 472 F. Supp. 2d 722, 729 (E.D.N.C. 2007) (“[T]he wholesale adoption of
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`the opinion of another expert verbatim cannot be within the intent of Fed. R. Evid.
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`702.”). The inherent problems with a “read and copy” methodology are
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`exacerbated here, where the only major substantive difference between the
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`declarations of Mr. Buss and Dr. Ball is Mr. Buss’s use of a more relaxed
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`definition of a person having ordinary skill in the art—a definition that Mr. Buss
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`did not himself write or independently assess. (See, e.g., Ex. 1504 at 22:23-27:13.)
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`As a result, the entirety of the Buss Opinions should be excluded under Federal
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`Rules of Evidence 702, 703.
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`3
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`IPR2017-01489
`Patent Owner’s Motion to Exclude
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`B. Mr. Buss’s Testimony Regarding the Use of Humanized
`Antibodies as Therapeutic Agents Should be Excluded.
`Petitioners rely on Mr. Buss to provide opinions related to the use of
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`humanized antibodies as therapeutic agents. For example, Mr. Buss opines that the
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`murine 4D5 antibody would have been “a prime candidate for further development
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`as a therapy for breast cancer.” (Ex. 1504 ¶18; see also id. at ¶63 (opining that “the
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`mouse monoclonal the mouse monoclonal antibody 4D5 was identified as a
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`promising new antibody therapeutic for breast cancer treatment”), ¶67 (opining
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`that a reference “called for [4D5] humanization for further development as a
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`therapeutic”), ¶¶69-70 (section titled “Humanization of 4D5 to Enable Therapeutic
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`Use”). Mr. Buss, however, is not an oncologist; his background is as laboratory
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`technician. (Ex. 2040 at 34:15-18, 42:12-13.)
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`In its Institution Decision, the Board found that a person having ordinary
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`skill in the art would have had either (1) “a Ph.D. or equivalent in chemistry,
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`biochemistry, structural biology, or a closely related field, and experience with
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`antibody structural characterization, engineering, and/or biological testing;” or (2)
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`“an M.D. with practical academic or industrial experience in antibody
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`development.” (Paper 27 at 8.) Mr. Buss does not hold a Ph.D.; his purported
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`expertise derives entirely from the on-the-job experience as a lab technician. (See,
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`e.g., Ex. 2040 at 35:1-10, 40:3-12, 45:14-48:18.) But even if that were
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`4
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`“equivalent” to a Ph.D., his limited “experience with antibody structural
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`IPR2017-01489
`Patent Owner’s Motion to Exclude
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`characterization, engineering, and/or biological testing” does not qualify him to
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`opine on the therapeutic value of an anti-cancer molecule. That is the purview of
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`the second prong of the POSA definition. (Ex. 2040 at 46:2-14 (“[I]f you are
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`developing … a therapeutic, say it’s for breast cancer, you could have an …
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`oncologist on board in a team to advise on breast cancer.”).)
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`As such, Mr. Buss lacks the knowledge, skill, experience, training, and
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`education to opine as to the use of humanized antibodies as therapeutic agents.
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`Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1363-64 (Fed. Cir.
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`2008) (“[W]here an issue calls for consideration of evidence from the perspective
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`of one of ordinary skill in the art, it is contradictory to Rule 702 to allow a witness
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`to testify on the issue who is not qualified as a technical expert in that art.”) As a
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`result, Mr. Buss’s opinions regarding the therapeutic use of antibodies, Ex. 1504 at
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`¶¶15-16, 18, 43-45, 53-55, 63, 67, 69-70, should be excluded. See, e.g., Flex-Rest,
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`LLC v. Steelcase, Inc., 455 F.3d 1351, 1360 (Fed. Cir. 2006) (affirming exclusion
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`of testimony from unqualified expert).
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`C. Exclusion is the Proper Remedy.
`The absence of a jury does not absolve the Board of its responsibility to
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`police the admission of unreliable and misleading expert testimony. (See, e.g., 37
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`C.F.R. § 42.62(a) (the Federal Rules of Evidence apply to a proceeding).) Indeed,
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`5
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`even in bench trials where the presiding judge is capable of teasing out what is and
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`IPR2017-01489
`Patent Owner’s Motion to Exclude
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`is not proper, “the Daubert standards of relevance and reliability for scientific
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`evidence must nevertheless be met.” Seaboard Lumber Co. v. United States, 308
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`F.3d 1283, 1302 (Fed. Cir. 2002); see also Honeywell Int'l Inc. v. Universal
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`Avionics Sys. Corp., 488 F.3d 982, 994 (Fed. Cir. 2007) (affirming exclusion of
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`evidence in a bench trial).
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`To be sure, the Board has found that criticism as to the qualifications of an
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`expert witness may go to weight, rather than admissibility. (See, e.g., Paper 53 at
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`23 (citing Nat’l Oilwell Varco, LP v. Tech. Indus. Inc., IPR2017-00860, Paper 34
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`at 2 (PTAB Apr. 23, 2018).) But the facts here are different from the mine-run
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`case of an almost-qualified expert. Here, the declarant copied nearly word for
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`word the analysis of an expert from another proceeding who presumably drafted
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`the opinion from the perspective of someone having his particular skill set: i.e., a
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`medical doctor. And now that declarant claims that the very same analysis reflects
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`a “protein engineering … view,” (Ex. 2040 at 47:14-23). But under Daubert, a
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`“scientist, however well credentialed he may be, is not permitted to be the
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`mouthpiece of a scientist in a different specialty.” Dura Auto. Sys. of Indiana, Inc.
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`v. CTS Corp., 285 F.3d 609, 614 (7th Cir. 2002). “That would not be responsible
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`science.” Id. Accordingly, at least ¶¶ 15-16, 18, 30-33, 43-45, 53-55, 63, 67, 69-
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`70 of the Buss Declaration should be excluded.
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`6
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`II.
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`IPR2017-01489
`Patent Owner’s Motion to Exclude
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`PETITIONERS’ NEW EVIDENCE AND ARGUMENTS
`INTRODUCED IN REPLY SHOULD BE EXCLUDED
`Patent Owner has moved to strike Exhibit 1193 and the associated
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`arguments and testimony that rely on this exhibit, including the paragraph
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`spanning pages 26-27 of the Reply; Ex. 1702, ¶¶ 12, 41-43, 79, 82, 119, 162, and
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`187; Ex. 1697, 176:25-178:23; Ex. 2039, 327:12-331:11. Patent Owner has also
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`moved to strike the first full paragraph of page 18 of the Reply and the testimony
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`relying on Petitioners’ new theory including: Ex. 1702, ¶¶7, 12, 82, 104-106, 119,
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`160-162, 187; Ex. 1697, 258:3-263:21; 264:9-267:18; 267:24-268:12; Ex. 2039,
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`313:7-320:11.3
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`3 Patent Owner objected to Ex. 1693 as improper new evidence and irrelevant and
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`misleading under Fed. R. Evid. 401, 402, 403 and 37 C.F.R. § 42.23(b). (Paper 53
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`at 1.) Patent Owner objected to the above listed paragraphs in Ex. 1702 as
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`improper for raising new arguments in reply, and under Fed. R. Evid. 702, 703,
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`705, 403; 77 Fed. Reg. at 48,763; 37 C.F.R. § 42.65, and as being misleading
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`and/or confusing under Fed. R. Evid. 403. (Id. at 9). Patent Owner objected to the
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`above listed paragraphs in Ex. 1697 as misleading, confusing, unfairly prejudicial,
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`and irrelevant under Fed. R. Evid. 401, 402, 403. (Id. at 9-10; see also Ex. 1697 at
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`177:4-6 (objecting to questions pertaining to Ex. 1193).)
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`7
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`IPR2017-01489
`Patent Owner’s Motion to Exclude
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`As explained in Patent Owner’s contemporaneously filed Motion to Strike,
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`this evidence and argument is new and improper. To the extent the Board agrees,
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`it should also exclude these new arguments and evidence under Federal Rules of
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`Evidence 401 and 402 because they are not relevant to any of the instituted
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`grounds, for which Petitioner was obligated to identify all of the supporting
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`evidence with particularity in the Petition. See 35 U.S.C. § 312(a); see also 37
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`C.F.R. § 42.23(b). Moreover, because Patent Owner has been denied any
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`meaningful opportunity to substantively respond to Petitioners’ positions any
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`alleged relevance is substantially outweighed by unfair prejudice to Patent Owner,
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`and the evidence and argument should be excluded under Federal Rule of Evidence
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`403.
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`III. CONCLUSION
`For the foregoing reasons, Patent Owner Requests that the Board exclude the
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`above described evidence and argument.
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`Date: June 22, 2018
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`Respectfully submitted,
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`/David L. Cavanaugh/
`By:
`David L. Cavanaugh
`Reg. No. 36,476
`Wilmer Cutler Pickering Hale and Dorr LLP
`1875 Pennsylvania Avenue NW
`Washington, DC 20006
`202-663-6025
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`8
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