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`IPR2017-01488
`Patent Owner’s Reply ISO 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)
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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
`
` 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,
`
`v.
`
`GENENTECH, INC.,
`Patent Owner.
`____________________________________________
`Case IPR2017-014881
`U.S. Patent No. 6,407,213
`____________________________________________
`PATENT OWNER’S REPLY IN SUPPORT OF ITS MOTION TO
`EXCLUDE EVIDENCE
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`
`1 Case IPR2017-02139 has been joined with this proceeding.
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`I.
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`IPR2017-01488
`Patent Owner’s Reply ISO Motion to Exclude
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`THE DECLARATION OF MR. BUSS (EX. 1004) SHOULD BE
`EXCLUDED.
`A. Mr. Buss’s Copy-and-Paste Methodology is Inherently Unreliable.
`Petitioners have not met their burden of establishing that Mr. Buss’s copy-
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`and-paste declaration is “the product of reliable principles and methods” or that the
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`his “scientific, technical, or other specialized knowledge” will help the Board
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`“understand the evidence” or “determine a fact in issue.” Fed. R. Evid. 702(a), (c);
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`Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 592 n.10 (1993); see also 37
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`C.F.R. § 42.62(a). Petitioners do not contest that (1) Mr. Buss did not perform
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`any independent research or analysis regarding the subject matter of the ’213
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`patent; (2) he only included the references identified in his declaration because the
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`declaration he copied included them; and (3) the only substantive difference
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`between Mr. Buss’s declaration and the declaration he copied is Mr. Buss’s use of
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`a relaxed definition of a skilled artisan. (See Paper 63 at 2-3; Paper 70 at 5-8.)
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`Nevertheless, Petitioners defend Mr. Buss’s declaration by emphasizing one
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`of its few original sentences where he states he applied his “independent judgment
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`and expertise, after having independently reviewed and analyzed” to the materials
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`Dr. Ball selected. (Paper 70 at 3 (quoting Ex. 1003, ¶13).) But this single sentence
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`is insufficient to overcome Mr. Buss’s admissions that he had no prior knowledge
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`of the subject matter and did no independent research of his own. (Ex. 2040 at
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`1
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`IPR2017-01488
`Patent Owner’s Reply ISO Motion to Exclude
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`14:22-15:7, 84:6-25; see also id. at 49:17-51:18, 96:18-125:7.) It strains credulity
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`to suggest that such testimony could be the product of reliable methods or assist
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`the trier of fact where Mr. Buss—without any medical training—copied the
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`analysis of a clinical oncologist and claims the analysis now reflects a “protein
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`engineering” view. (Ex. 2040 at 47:12-23); see Dura Auto Sys. Of Indiana, Inc. v.
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`CTS Corp., 285 F.3d 609, 614 (7th Cir. 2002); Bouygues Telecom, S.A. v. Tekelec,
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`472 F. Supp. 2d 722, 729 (E.D.N.C. 2007).
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`That Patent Owner has not moved to exclude Dr. Leonard, Celltrion’s
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`oncologist in the companion IPRs, (Paper 70 at 5) is not a reason to deny Patent
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`Owner’s motion, but rather highlights the unhelpfulness of Mr. Buss’s testimony.
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`Dr. Leonard—like Dr. Ball—is an experienced oncologist. (See Ex. 2058 at 12; Ex.
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`1004 in IPR2017-01373, ¶2.) And unlike Mr. Buss, Dr. Leonard at least was
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`aware of the subject matter of the patent before reading and copying Mr. Ball’s
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`declaration and performed his own independent research based on his prior
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`knowledge. (Ex. 2040 in IPR2017-01373 at 22:13-24:15, 25:14-22.) In contrast,
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`Mr. Buss brings no such relevant expertise to bear.
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`Likewise, Petitioners’ suggestion that Mr. Buss’s testimony is admissible
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`because Patent Owner allegedly did not challenge the substance of Mr. Buss’s
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`parroted opinions is beside the point. (Paper 70 at 1, 4-5.) The Rules of Evidence
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`exist to keep this testimony away from the factfinder so the opposing side need not
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`2
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`legitimize unreliable testimony by engaging in a debate on the merits. More
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`IPR2017-01488
`Patent Owner’s Reply ISO Motion to Exclude
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`fundamentally, Petitioners bear the burden of producing evidence to support a
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`conclusion of unpatentability. 35 U.S.C. § 316(e); see also In re Magnum Oil
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`Tools Int’l, Ltd., 829 F.3d 1364, 1375-76 (Fed. Cir. 2016). Unreliable or
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`admissible expert testimony cannot be used to meet that burden.
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`In any event, Patent Owner did not concede there was a motivation to
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`combine the prior art. (Paper 70 at 4-5.) At best, the portions of Dr. Wilson’s
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`deposition identified by Petitioners show that Dr. Wilson agreed that that prior to
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`the invention, HER2-positive breast cancer was a serious disease and that Hudziak
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`says that murine 4D5 was shown to have the greatest effect on cell proliferation.
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`(Ex. 1197 at 19:7-25:16.) Dr. Wilson did not “admit” that “based on Hudziak’s
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`data, there was a motivation to investigate the 4D5 antibody as a human
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`therapeutic agent against HER2 overexpressing breast cancer.” (Paper 70 at 4-5.)
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`Rather, when asked if there were such a motivation, Dr. Wilson merely stated that
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`Hudziak identified 4D5 as one of many antibodies with “potential.” (Ex. 1197 at
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`24:22-25:16.) And even if Dr. Wilson had made such a concession (he did not),
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`that does not give Petitioners a free pass to rely on inadmissible testimony.
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`3
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`IPR2017-01488
`Patent Owner’s Reply ISO Motion to Exclude
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`B.
`
`Petitioners’ Attempts to Run From the “Clinical Aspects” of Mr.
`Buss’s Declaration Confirm That His Opinions Are Unreliable.
`Mr. Buss is not a medical doctor and Petitioners have not shown that his
`
`experience as a “Higher Scientific Officer” is relevant to the opinions he offers.
`
`Petitioners now suggest that his opinion is limited to whether a skilled artisan
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`would have been motivated to humanize murine anti-HER2 antibodies. (Paper 70
`
`at 10-11.) However, Mr. Buss plainly offers his opinion that a POSA “would have
`
`recognized the power and potential of monoclonal antibodies” “as therapies for a
`
`number of diseases” and “would have identified 4D5 as a promising candidate for
`
`humanization.” (Ex. 1004, ¶¶15-16; see also id., ¶¶18, 43, 53-55, 63, 67, 69-70.)
`
`These opinions are not limited to “undisputed background state of the art” but, as
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`Petitioners concede, “underl[ie]” the remainder of his opinions. (Paper 70 at 11.).
`
`Indeed, if the scope of Mr. Buss’s declaration were limited to the “humanization of
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`4D5,” there is no reason why it could not have been addressed by Dr. Foote.
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`Petitioners also argue that Mr. Buss need not have any medical training to
`
`offer his opinions because he could have relied on a hypothetical oncologist to fill
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`in the gaps in his knowledge. (Paper 70 at 9-10 (“the role of the clinician (e.g.,
`
`oncologist) on a team making up the person of ordinary skill in the art would be to
`
`provide input as to what might be ‘good targets’ to generate antibodies against”).)
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`But that is not what Mr. Buss purports to do. Mr. Buss—without any medical
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`4
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`training—offers his opinions as to “what might be ‘good targets’ to generate
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`IPR2017-01488
`Patent Owner’s Reply ISO Motion to Exclude
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`antibodies against.” Relying on an uncited, unknown, and undisclosed medical
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`doctor to support a copy-and-pasted declaration originally authored by an
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`oncologist simply is not a reliable method under Rule 702. See also 37 C.F.R.
`
`42.65(a).
`
`II.
`
`Petitioners’ New Evidence Is Properly Excluded
`The exhibits and testimony identified in Patent Owner’s opening motion
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`should be excluded because they represent a new theory of unpatentability not
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`disclosed in the Petition and are therefore not relevant to the instituted grounds.
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`(See Paper 63 at 7-8; Paper 61 at 4-10.) That evidence, including Exhibit 1193, is
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`thus per se irrelevant under Federal Rule of Evidence 401 because it is untimely
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`and in violation of the Board’s rules and its governing statute. 35 U.S.C. § 312(a);
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`37 C.F.R. § 42.23(b). And any relevance is greatly outweighed by the unfair
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`prejudice to Patent Owner because Patent Owner has been denied any meaningful
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`opportunity to substantively respond to Petitioner’s positions. The evidence should
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`therefore be excluded if the Board declines to grant Patent Owner’s motion to
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`strike. See Dexcom, Inc. v. Waveform Techs, Inc., IPR2016-01679, Paper 53 at 50-
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`51 (Feb. 28, 2018) (“Federal Circuit case law indicates that a motion to exclude is
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`a proper vehicle for enforcing our rule and trial practice guide regarding the scope
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`of evidence that may be submitted with a reply brief.”).
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`5
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`Date: July 10, 2018
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`
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`IPR2017-01488
`Patent Owner’s Reply ISO Motion to Exclude
`
`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
`
`6
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`IPR2017-01488
`Patent Owner’s Reply ISO Motion to Exclude
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`CERTIFICATE OF SERVICE
`
`
`
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`
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`I hereby certify that, on July 10, 2018, I caused a true and correct copy of the
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`following materials:
`
` Patent Owner’s Reply in Support of its Motion to Exclude Evidence
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`
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`
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`to be served via electronic mail on the following attorneys of record:
`
`Amanda Hollis
`KIRKLAND & ELLIS LLP
`amanda.hollis@kirkland.com
`300 North LaSalle, Chicago, IL 60654
`
`Stefan M. Miller, Ph.D.
`stefan.miller@kirkland.com
` 601 Lexington Avenue, New York, NY 10022
`
`Benjamin A. Lasky
`benjamin.lasky@kirkland.com
`601 Lexington Avenue, New York, NY 10022
`
`Sarah K. Tsou
`sarah.tsou@kirkland.com
`601 Lexington Avenue, New York, NY 10022
`
`Mark C. McLennan
`mark.mclennan@kirkland.com
`601 Lexington Avenue, New York, NY 10022
`
`Christopher J. Citro
`christopher.citro@kirland.com
`601 Lexington Avenue, New York, NY 10022
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`Pfizer_Genentech_IPRs@kirkland.com
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`1
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`IPR2017-01488
`Patent Owner’s Reply ISO Motion to Exclude
`
`Dimitrios T. Drivas
`White & Case LLP
`ddrivas@whitecase.com
`1221 Avenues of the Americas, New York, NY 10020
`
`Scott T. Weingaertner
`White & Case LLP
`scott.weingaertner@whitecase.com
`1221 Avenues of the Americas, New York, NY 10020
`
`Amit H. Thakore
`White & Case LLP
`athakore@whitecase.com
`1221 Avenue of the Americas, New York, NY 10020
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`Eric Majchrzak
`White & Case LLP
`eric.majchrzak@whitecase.com
`1221 Avenue of the Americas, New York, NY 10020
`
`
`
`
`
`
`/Lauren V. Blakely/
`Lauren V. Blakely
`Reg. No. 70,247
`Wilmer Cutler Pickering Hale and Dorr LLP
`950 Page Mill Road
`Palo Alto, CA 94304
`(650) 600-5039
`
`
`2
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