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