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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`PFIZER, INC., and
`SAMSUNG BIOEPIS CO., LTD.,1
`Petitioners,
`
`v.
`
`GENENTECH, INC.,
`Patent Owner.
`____________
`
`Case IPR2017-01488
`Patent 6,407,213
`____________
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`
`
`PETITIONERS’ OPPOSITION TO PATENT OWNER’S MOTION
`TO EXCLUDE EVIDENCE PURSUANT TO 37 C.F.R. § 42.642
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`
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`1 Samsung Bioepis Co. Ltd.’s IPR2017-02139 has been joined with this
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`proceeding. (IPR2017-02139, Paper 42.)
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`2 All emphases within are added.
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`i
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`IPR2017-01488: Petitioners’ Opposition to PO’s Motion to Exclude Evidence
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`TABLE OF CONTENTS
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`Page
`INTRODUCTION ........................................................................................... 1
`ARGUMENT ................................................................................................... 2
`A. Mr. Buss’s Declaration Should Not Be Excluded ................................. 2
`1.
`Factual background ..................................................................... 2
`2. Mr. Buss’s uncontroverted opinions are the product of
`reliable principles and methods, and will assist the Board ......... 5
`3. Mr. Buss’s testimony regarding the use of humanized
`antibodies as therapeutic agents should not be excluded ............ 9
`PO’s criticisms at most go to weight not admissibility,
`and anyway are moot as Mr. Buss’s opinions are
`uncontroverted .......................................................................... 12
`A Motion To Exclude Is Not A Proper Vehicle For PO’s
`Improper Reply Evidence Argument .................................................. 15
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`B.
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`4.
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`
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`ii
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`I.
`II.
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`IPR2017-01488: Petitioners’ Opposition to PO’s Motion to Exclude Evidence
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`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`1964 Ears, LLC v. Jerry Harvey Audio Holding, LLC,
`IPR2016-00494, Paper 56 (July 19, 2017) ......................................................... 12
`Apple Inc. v. DSS Tech. Mgmt., Inc.,
`IPR2015-00369, Paper 40 (June 17, 2016) ......................................................... 12
`Blackberry Corp. v. Zipit Wireless, Inc.,
`IPR2014-01508, Paper 49 (Mar. 29, 2016) ........................................................ 15
`Bouygues Telecom, S.A. v. Tekelec,
`472 F. Supp. 2d 722 (E.D.N.C. 2007) .................................................................. 8
`Camelbak Prods. v. Ignite USA, LLC,
`IPR2015-01034, Paper 37 (June 7, 2016) ........................................................... 12
`Dura Auto. Sys. of Indiana, Inc. v. CTS Corp.,
`285 F.3d 609 (7th Cir. 2002) ........................................................................ 12, 13
`Flex-Rest, LLC v. Steelcase, Inc.,
`455 F.3d 1351 (Fed. Cir. 2006) .......................................................................... 11
`Frontier Therapeutics v. Medac Gesellschaft Für Klinische,
`IPR2016-00649, Paper 10 (September 1, 2016) ................................................... 6
`Helios Software, LLC v. Awareness Techs., Inc.,
`CV 11-1259-LPS, 2015 WL 12806482 (D. Del. Apr. 13, 2015) ......................... 6
`Honeywell Int’l Inc. v. Universal Avionics Sys. Corp.,
`488 F.3d 982 (Fed. Cir. 2007) ............................................................................ 14
`Nat’l Oilwell Varco, LP v. Tech. Indus. Inc.,
`IPR2017-00860, Paper 34 (April 23, 2018) ....................................................... 12
`Primera Tech. v. Auto Mfg. Sys. Inc.,
`IPR2013-00196, Paper 50 (July 17, 2014) ......................................................... 11
`Seaboard Lumber Co. v. U.S.,
`308 F.3d 1283 (Fed. Cir. 2002) .......................................................................... 14
`iii
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`IPR2017-01488: Petitioners’ Opposition to PO’s Motion to Exclude Evidence
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`Sundance, Inc. v. DeMonte Fabricating Ltd.,
`550 F.3d 1356 (Fed. Cir. 2008) .......................................................................... 11
`U.S. Gypsum Co. v. Lafarge N.A. Inc.,
`670 F. Supp. 2d 737 (N.D. Ill. 2009) .................................................................... 6
`Rules
`Fed. R. Civ. P. 26 ..................................................................................................... 14
`Fed. R. Evid. 401 ..................................................................................................... 15
`Fed. R. Evid. 402 ..................................................................................................... 15
`Fed. R. Evid. 702 ............................................................................................... 12, 14
`Fed. R. Evid. 703 ..................................................................................................... 13
`Regulations
`37 C.F.R. § 42.64 ....................................................................................................... 1
`
`
`
`iv
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`IPR2017-01488: Petitioners’ Opposition to PO’s Motion to Exclude
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`I.
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`INTRODUCTION
`Pursuant to the Joint Notice of Stipulation to Revise Schedule (Paper 53),
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`Petitioners submit the following Opposition to PO’s Motion to Exclude Evidence
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`Pursuant to 37 C.F.R. § 42.64 (Paper 63). PO’s motion should be denied.
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`First, PO has identified no basis to exclude Mr. Buss’s declaration. As an
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`initial matter, there is nothing improper in an expert serving a declaration mirroring
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`that of another expert, particularly when supporting a copycat IPR petition. Mr.
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`Buss did not merely “adopt” Dr. Ball’s opinions; rather he carefully considered the
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`same evidence and reached the same conclusions. Nor has PO identified any flaw
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`in Mr. Buss’s qualifications or analysis. As established by his declaration and
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`testimony, Mr. Buss does meet the Board’s definition of the person skilled in the art.
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`And significantly, Mr. Buss’s opinions remain uncontroverted—PO has not
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`submitted evidence from any expert, much less one meeting the qualifications it says
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`Mr. Buss must possess, disagreeing in any way with Mr. Buss’s opinions. At base,
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`to the extent not moot in the absence of any evidence refuting Mr. Buss’s opinions,
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`PO’s complaints at most go to the weight to be given to those opinions.
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`Second, a motion to exclude is not the proper vehicle to raise “improper reply”
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`arguments. It follows that PO’s “relevance” and “prejudice” arguments on the same
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`basis also are not properly raised here. Petitioners will address PO’s assertions in
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`this regard in its forthcoming opposition to PO’s Motion to Strike (Paper 61).
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`1
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`IPR2017-01488: Petitioners’ Opposition to PO’s Motion to Exclude
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`II. ARGUMENT
`A. Mr. Buss’s Declaration Should Not Be Excluded
`1.
`Factual background
`As described in his Declaration, Mr. Buss is an “independent consultant in the
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`antibody engineering field,” who “help[s] clients with a variety [of] antibody
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`discovery development issues,” including “choosing the best methods to immunize
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`and screen monoclonal antibodies, humanize antibodies by CDR grafting onto
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`human frameworks and develop methods for expression and purification of
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`recombinant proteins.” Ex. 1004, ¶2. He has “more than 25 years of practical and
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`research experience specializing in antibody design, humanization, and expression.”
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`Id., ¶3. At the ’213 patent priority date in 1991, Mr. Buss was a Higher Scientific
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`Officer under Sir Gregory Winter at the Cambridge Centre for Protein Engineering,
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`Laboratory of Molecular Biology, at the forefront of antibody humanization. Id., ¶6;
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`Exs. 2039 at 50:12–51:8; 61:1–9; 1202, ¶31; 2040 at 15:8–20. Before that, Mr. Buss
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`obtained a Higher National Certificate (equivalent to a four-year Bachelor of
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`Sciences) in 1986, and worked for several years at the Medical Research Council on
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`recombinant protein development, including polyclonal antibody production. Exs.
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`1004, ¶¶4–5; 2040 at 27:25-29:12, 39:24-40:15, 41:21-43:20, 138:6-140:18, 149:21-
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`150:7. As Mr. Buss testified, he thus had the equivalent of a Ph.D. in molecular
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`biology by 1991. Id. at 34:19-25, 39:1-40:6.
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`In his declaration, Mr. Buss surveys the prior art literature, including Hudziak
`2
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`IPR2017-01488: Petitioners’ Opposition to PO’s Motion to Exclude
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`1999, and explains why, at that time, “one of ordinary skill in the art would have
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`acknowledged and recognized the … promising properties of the mouse monoclonal
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`antibody 4D5 in vitro and in vivo and have strong motivation to select this antibody
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`as a prime candidate for further development as a therapy for breast cancer” and
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`“would logically proceed to develop the monoclonal 4D5 antibody as a breast cancer
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`therapeutic via well-established humanization techniques, thereby reducing the
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`antibody’s
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`immunogenicity and restoring antibody-dependent cell-mediated
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`cytotoxicity (ADCC) and effector cell binding.” Ex. 1004, ¶18. Although he based
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`the language in his declaration on that of the declaration of Dr. Edward Ball
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`submitted with the initial petition challenging the ’213 patent filed by Mylan, Mr.
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`Buss conducted his own review and performed his own analysis:
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`I understand a third-party, Mylan, previously filed IPR petitions
`challenging claims of the ’213 patent. I have reviewed and considered
`Mylan’s IPR petitions and the declarations filed in support of Mylan’s
`IPR petitions. Applying my independent judgement and expertise,
`after having independently reviewed and analyzed all of the materials
`in Mylan expert Dr. Edward Ball’s materials considered lists, and after
`having done the additional work of fact checking and considering
`whether potential counterarguments may exist, I have come to the
`same conclusions as Dr. Ball and I agree with the analysis in his
`declaration as set forth below. Readers of this declaration may note the
`language and organization is similar to that of Dr. Ball’s declaration
`because it did not seem a necessary expenditure of resources to rewrite
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`3
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`IPR2017-01488: Petitioners’ Opposition to PO’s Motion to Exclude
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`the material which I independently confirmed as acceptable and
`correct. The opinions in this declaration should be considered mine.
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`Id., ¶ 13; Ex. 2040 at 95:23–96:5, 145:17–148:4.
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`Notably, although they criticized Mr. Buss’s qualifications, PO and its expert
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`Dr. Wilson did not criticize any of Mr. Buss’s opinions, or the bases therefor. For
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`example, PO and Dr. Wilson do not dispute any of Mr. Buss’s discussion of the state
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`of the art of monoclonal antibody therapies and cancer, including early antibody
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`therapy, efforts to reduce immunogenicity (chimerization and humanization), breast
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`cancer and HER2, or identification and characterization of 4D5 as a potential
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`therapeutic mouse monoclonal antibody to HER-2/neu. Ex. 1004, ¶¶ 35–70. Nor do
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`PO or Dr. Wilson dispute Mr. Buss’s opinions regarding the motivation to humanize
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`4D5 to enable therapeutic use. Id., ¶¶ 68–70. On the contrary, Dr. Wilson admitted
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`that there was a known “correlation” between overexpression of HER2 and “a
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`particularly poor prognosis in breast cancer,” that “work had been done to identify
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`murine antibodies that would target the HER2 receptor,” that in Hudziak 1999 “the
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`authors described the generation of a number of antibodies, mouse antibodies,
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`against the HER2 receptor,” and that “the 4D5 antibody was shown to have the …
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`greatest effect of relative cell proliferation.” Ex. 1197 at 19:7-20:1; 21:25-22:12.
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`And Dr. Wilson also admitted that, “[p]rior to the ’213 patent invention … based on
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`Hudziak’s data, there was a motivation to investigate the 4D5 antibody as a human
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`4
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`IPR2017-01488: Petitioners’ Opposition to PO’s Motion to Exclude
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`therapeutic agent against HER2 overexpressing breast cancer,” and that there would
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`have been a “concern” that “as a murine antibody, it would be likely to be ineffective
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`as a human therapeutic agent due to the immunogenic potential.” Id. at 24:22-25:16.
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`At most PO and Dr. Wilson assert that the prior art does not suggest an anti-
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`HER2 antibody with the framework substitutions recited in the relevant challenged
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`claims. POR at 61-64; Ex. 2041, ¶¶259-262. But responding to such assertions is
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`within the purview of Dr. Foote, whose qualifications and analysis remain
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`unchallenged. Exs. 1003, ¶¶39-40; 1202 at ¶33; 1004, ¶¶15-18.
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`2. Mr. Buss’s uncontroverted opinions are the product of
`reliable principles and methods, and will assist the Board
`Given that Mr. Buss’s opinions are undisputed and establish the motivation to
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`humanize anti-HER2 antibodies, including 4D5, there is no legitimate basis for
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`concluding they are not the product of reliable principles or methods, or that they
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`will not assist the Board in making its patentability determinations.
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`PO’s primary criticism is that Mr. Buss’ analysis is “nearly identical” to the
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`analysis presented by Dr. Ball in IPR2016-01694. Mot. at 2–3. But this is nothing
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`more than a red herring, given that PO has not moved to exclude another expert’s
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`near-identical declaration in Celltrion’s related ’213 patent IPR. IPR2017-01373,
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`Paper 61 (not moving to exclude Ex. 1004). And in any event. PO does not identify
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`any regulation or precedent that prohibits experts from submitting opinions that
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`mirror the previously-submitted opinions of another expert. Indeed, such practice is
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`5
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`IPR2017-01488: Petitioners’ Opposition to PO’s Motion to Exclude
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`common with copycat petitions. Frontier Therapeutics v. Medac Gesellschaft Für
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`Klinische, IPR2016-00649, Paper 10 at 10-11, (Sept. 1, 2016) (declining to accord
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`no weight to copycat declarations, finding expert credentials and testimony
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`sufficient to permit consideration); Helios Software, LLC v. Awareness Techs., Inc.,
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`CV 11-1259-LPS, 2015 WL 12806482, at *2 (D. Del. Apr. 13, 2015) (expert report
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`relying on another expert’s analysis in related case admissible where expert testified
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`he “conducted his own analysis of the prior art … identified by [another expert]
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`before independently reaching the same conclusions”); see also, U.S. Gypsum Co.
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`v. Lafarge N.A. Inc., 670 F. Supp. 2d 737, 744 (N.D. Ill. 2009) (denying motion to
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`preclude expert testimony that adopted opinions of previous expert, finding that the
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`expert undertook adequate independent review based on her reports and testimony,
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`and party seeking exclusion did not object to the substance of the analysis). PO also
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`does not identify any policy that would require an expert supporting a copycat
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`declaration to unnecessarily expend resources in rewriting the declaration supporting
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`the original petition.
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`PO’s other criticisms also are unavailing. First, PO criticizes Mr. Buss for the
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`amount of time he spent reading the ’213 patent. Mot. at 2. But PO identifies
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`nothing requiring an expert to read the patent-in-suit at all, much less for any given
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`duration, before opining on the relevant state of the art. Mr. Buss’s opinions are
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`based on the prior art, not the patent’s teachings. Exs. 1004, ¶¶15-18; 2040 at 95:23–
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`6
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`IPR2017-01488: Petitioners’ Opposition to PO’s Motion to Exclude
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`96:5. Nor was it necessary for Mr. Buss to know who Dr. Ball was, or determine his
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`reputation, before reaching agreement with his opinions. Mot. at 2–3. As described
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`in Mr. Buss’s declaration, he applied his own “independent judgment and expertise,”
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`after having “independently reviewed and analyzed all of the materials” in Dr. Ball’s
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`declaration, and after having done “the additional work of fact checking and
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`considering whether potential counterarguments may exist.” Ex. 1004, ¶ 13. Thus,
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`because Mr. Buss did not merely rely on Dr. Ball’s expertise, Dr. Ball’s
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`qualifications and reputation were irrelevant to Mr. Buss’s opinions. Notably,
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`neither PO nor its expert assert that Dr. Ball was not qualified to provide the opinions
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`he provided in his own declaration, so PO’s criticisms of Mr. Buss are moot.
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`Nor is the fact that Mr. Buss relied on the literature cited by Dr. Ball, including
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`the Hudziak reference, basis for exclusion of his opinion. Mot. at 3. PO identifies no
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`rule requiring an expert to conduct a completely new literature search to establish
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`the state of the art, rather than relying on literature identified by others. And PO does
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`not identify any additional literature that Mr. Buss should have considered, much
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`less literature that might have contradicted his opinions.
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`PO’s assertion that “[t]he only expertise contributed by Mr. Buss is the ability
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`to ‘read[] papers on molecular biology antibodies,’” Mot. at 3, is not well taken. Mr.
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`Buss’s expertise goes well beyond that dismissive description—he has consulted in
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`the antibody engineering field for over 25 years, and as of the priority date of the
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`7
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`IPR2017-01488: Petitioners’ Opposition to PO’s Motion to Exclude
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`’213 patent had years of experience in protein engineering, including antibody
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`development, and was employed in the renowned Winter laboratory at Cambridge.
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`Exs. 2039 at 50:12–51:8; 61:1–9; 1202, ¶31; 2040 at 15:8–20. PO’s criticisms are
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`particularly disingenuous given that neither its own expert Dr. Wilson, nor its
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`inventors Dr. Carter and Dr. Presta, have the medical expertise PO would require of
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`Mr. Buss. Exs. 1185 at 9–10; 2016, ¶2; 2017, ¶2; 2041, ¶7. Indeed, both Dr. Carter
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`and Dr. Presta—the only inventors named on the ’213 patent—testified that the
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`decision to humanize the 4D5 antibody was made by others before they began their
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`work on the alleged invention. Exs. 1199 at 22:19–23:16; 1198 at 23:22–24:20. This
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`confirms that that decision is not part of the claimed invention and that, like Mr.
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`Buss is accused of doing, the inventors simply relied on the work of others.
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`At base, PO does not identify anything improper or unreliable in Mr. Buss’s
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`independent analysis of the literature identified in Dr. Ball’s declaration, and use of
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`the language in that declaration for his own declaration. Exclusion is not warranted.3
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`In Bouygues Telecom, S.A. v. Tekelec, 472 F. Supp. 2d 722, 729 (E.D.N.C. 2007),
`3
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`the court rejected the plaintiff’s attempt to make an end-run around the court’s
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`order limiting experts by withdrawing two experts’ reports and having another
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`expert incorporate them by reference. Id. at *729–30. The court noted that if the
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`withdrawn opinions were the same as those of the adopting expert, they would
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`8
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`IPR2017-01488: Petitioners’ Opposition to PO’s Motion to Exclude
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`3. Mr. Buss’s testimony regarding the use of humanized
`antibodies as therapeutic agents should not be excluded
`PO next argues that Mr. Buss’s testimony regarding the use of humanized
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`antibodies as therapeutic agents should be excluded because Mr. Buss is “not an
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`oncologist; his background is as a laboratory technician.” Mot. at 4–5. But PO again
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`understates Mr. Buss’s expertise. Nowhere did Mr. Buss state that his “background
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`is as a laboratory technician,” only that his work “initially” after receiving his Higher
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`National Certificate was as a lab technician. Ex. 2040 at 34:15–17. By 1987 when
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`he joined the Medical Research Council Group, Mr. Buss was a Scientific Officer, a
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`“semi-independent” role that would “not be considered a lab-technician.” Id. at 38:6-
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`20. And when Mr. Buss joined Dr. Winter’s laboratory, he was employed as a
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`Higher Scientific Officer, also not a laboratory technician position. Exs. 1004, ¶ 6;
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`2040 at 56:18–57:6. As of the date of his Declaration, Mr. Buss had 25 years of
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`experience in antibody development, including advising clients on all aspects of
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`humanization projects. Ex. 1004, ¶ 2. Thus, PO’s denigrating attempts to dismiss
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`Mr. Buss as a “laboratory technician” are misplaced.
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`Nor is the fact that Mr. Buss is not an oncologist basis to dismiss his opinions
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`regarding the choice of the 4D5 antibody for humanization. As Mr. Buss testified,
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`be “cumulative and inadmissible.” No such gamesmanship is alleged here, nor
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`is there any assertion that Mr. Buss’s opinions are “cumulative.”
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`9
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`IPR2017-01488: Petitioners’ Opposition to PO’s Motion to Exclude
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`the role of the clinician (e.g., oncologist) on a team making up the person of ordinary
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`skill in the art would be to provide input as to what might be “good targets” to
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`generate antibodies against. Ex. 2040 at 63:13–23 (“It was the clinicians that were
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`the ones who would say, hey, we think we have an interesting target”), Id. at 73:5–
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`74:3. The molecular biologists, like Mr. Buss, would then “do the work,” i.e.,
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`generate antibodies, determine which ones were appropriate for humanization, and
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`humanize them. Id. at 63:13–64:5. In the case of HER2, by the ’213 patent invention
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`date, the HER2 receptor already had been identified as a target, and mouse antibodies
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`had been generated against it, as described in the prior art reviewed by Mr. Buss.
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`Exs. 1001 at 3:56–4:4; 1004, ¶¶46-67; 1021 at 14. The decision to humanize the
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`antibody then would have been made by a molecular biologist like Mr. Buss, rather
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`than a clinician. Indeed, the named inventors testified that the decision to humanize
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`4D5 was made by Genentech scientist Dr. Michael Shepard. Exs. 1199 at 22:19–
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`23:16; 1198 at 23:22–24:20. Sure enough, Dr. Shepard is a molecular biologist, not
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`a clinician. Id. at 24:9–25:1; Ex. 2020 at 1 (denoting Dr. Shepard with “Cell Biology,
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`Genentech Inc.”).
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`In this regard, Mr. Buss does not “opine on the therapeutic value of an anti-
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`cancer molecule” (Mot. at 5) but rather relies on the already-known expected value
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`of murine anti-HER2 antibodies as therapeutic agents reported in prior art, such as
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`Hudziak, to opine that skilled artisans would have been motivated to humanize those
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`10
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`IPR2017-01488: Petitioners’ Opposition to PO’s Motion to Exclude
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`antibodies to avoid immunogenic response. Exs. 1021 at 14 (“Monoclonal antibodies
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`specific for p185HER2 may therefore be useful therapeutic agents for the treatment of
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`human neoplasias, including certain mammary carcinomas, which are characterized
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`by the overexpressing of p185HER2”); 1004, ¶¶68-70. That is well within Mr. Buss’
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`“purview” based on his “knowledge, skill, experience, training and education” and
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`PO does not establish otherwise.4 To the extent Mr. Buss presents evidence
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`regarding identification of the HER2 target and any other clinical aspects, that
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`merely constitutes undisputed background state of the art underlying Mr. Buss’s
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`opinions, and thus should not be excluded. Primera Tech. v. Auto Mfg. Sys. Inc.,
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`IPR2013-00196, Paper 50 at 27-30 (July 17, 2014) (denying motion to exclude state
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`4 The cases cited by PO are thus inapposite. See Sundance, Inc. v. DeMonte
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`Fabricating Ltd., 550 F.3d 1356, 1363-64 (Fed. Cir. 2008) (excluding opinions
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`of “patent law expert” on matters of infringement and validity that required
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`“technical background in the field of the invention,” (Id. at 1361) such as “how
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`the disclosed invention, accused system, and prior art operate” Id. at 1362); Flex-
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`Rest, LLC v. Steelcase, Inc., 455 F.3d 1351, 1360 (Fed. Cir. 2006) (where art of
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`invention was “keyboard design,” and after a full hearing on expert’s
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`qualifications, excluding opinions of “ergonomics” expert with no relevant
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`knowledge of keyboard design principles).
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`11
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`IPR2017-01488: Petitioners’ Opposition to PO’s Motion to Exclude
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`of the art testimony, finding expert sufficiently qualified in field).
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`4.
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`PO’s criticisms at most go to weight not admissibility, and
`anyway are moot as Mr. Buss’s opinions are uncontroverted
`Finally, even if PO’s criticisms of Mr. Buss’s declaration had merit—which
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`they do not—they at most go to its weight not its admissibility. 1964 Ears, LLC v.
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`Jerry Harvey Audio Holding, LLC, IPR2016-00494, Paper 56 at 13–16 (July 19,
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`2017) (qualifications arguments went to weight not admissibility). Indeed, PO
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`concedes that “the Board has found that criticism as to the qualifications of an expert
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`witness may go to weight, rather than admissibility.” Mot. at 6 (citing Nat’l Oilwell
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`Varco, LP v. Tech. Indus. Inc., IPR2017-00860, Paper 34 at 2 (April 23, 2018); see
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`also, Apple Inc. v. DSS Tech. Mgmt., Inc., IPR2015-00369, Paper 40, at 36–37 (June
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`17, 2016), (“[a] motion to exclude…is not an appropriate mechanism for challenging
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`the sufficiency of evidence or the proper weight that should be afforded an
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`argument.”); Camelbak Prods. v. Ignite USA, LLC, IPR2015-01034, Paper 37 at 37-
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`40, (June 7, 2016) (refusing to exclude expert testimony under FRE 702, holding
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`that the Board “need not find a complete overlap between the witness’s technical
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`qualifications and the problem confronting the inventor”). And PO does not cite a
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`single Board decision excluding an expert’s opinions on this basis.
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`The decisions outside of the IPR context cited by PO are inapposite. In Dura
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`Auto. Sys. of Indiana, Inc. v. CTS Corp., 285 F.3d 609, 614 (7th Cir. 2002), the court
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`excluded opinions of hydrologist which relied on mathematical models drawn up by
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`12
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`IPR2017-01488: Petitioners’ Opposition to PO’s Motion to Exclude
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`other employees of his consulting firm who had not been timely disclosed as experts,
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`where the hydrologist admitted he did not have sufficient expertise to determine if
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`the models were reliable and appropriate. Id. at 612. Critical to the court’s decision
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`was its finding that the underlying models were considered to be “controversial in
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`the relevant community of experts,” where the affidavits from the employees who
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`put together the models “show[ed] the breadth of the expert discretion that they
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`exercised,” without “explaining and justifying the discretionary choices that they
`
`made”. Id. at 614–15. Here in contrast, Mr. Buss is not merely relying on Dr. Ball’s
`
`opinions wholesale but rather applying his own expertise in the choice of antibodies
`
`for humanization, based on review of the literature available at the relevant time. As
`
`discussed above, Mr. Buss is qualified to provide such opinions.
`
`Moreover, even were Mr. Buss to be relying on Mr. Ball’s expertise as a
`
`medical doctor that would not be improper. As the Dura court noted, “it is common
`
`in technical fields for an expert to base an opinion in part on what a different expert
`
`believes on the basis of expert knowledge not possessed by the first expert; and it is
`
`apparent from the wording of Rule 703 that there is no general requirement that the
`
`other expert testify as well. Id. at 613. Concerns only arise where “the soundness of
`
`the underlying expert judgment is in issue.” Id. In this case, the soundness of Dr.
`
`Ball’s judgment is not in issue. On the contrary, PO has not presented testimony
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`from any expert, much less one with the qualifications it contends are required to
`
`
`
`13
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`
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`IPR2017-01488: Petitioners’ Opposition to PO’s Motion to Exclude
`
`opine on therapeutic use of antibodies, disagreeing with anything in Mr. Buss’s (or
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`Dr. Ball’s) declaration. Ex. 1004, ¶¶18, 62-63. And with good reason. The ’213
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`patent itself acknowledges the knowledge in the field before the patent regarding the
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`HER2 receptor target and generation of murine antibodies targeting them, as
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`admitted by PO’s expert Dr. Wilson and inventors Drs. Presta and Carter, none of
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`whom are medical doctors. Exs. 1185 at 9–10; 2016, ¶2; 2017, ¶2; 2041, ¶7.
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`The other cases cited by PO also do not support exclusion. In Seaboard
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`Lumber Co. v. U.S., 308 F.3d 1283, 1303 (Fed. Cir. 2002), the court found concerns
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`regarding “relevance and reliability for scientific evidence” are “of lesser import in
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`a bench trial,” and declined to exclude the challenged testimony because both
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`parties’ analyses had a “common premise” and any weaknesses were merely “fine
`
`tuning.” Id. at 1302. Here, not only do the parties’ experts proceed from a “common
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`premise”—that there was motivation to humanize anti-HER2 antibodies—but there
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`are no differences in their analyses as related to Mr. Buss’s opinions.
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`Finally, in Honeywell Int’l Inc. v. Universal Avionics Sys. Corp., 488 F.3d
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`982, 994 (Fed. Cir. 2007), the Federal Circuit affirmed the district court’s exclusion
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`of expert deposition testimony regarding the doctrine of equivalents—under Fed. R.
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`Civ. P. 26 rather than FRE 702 and Daubert—because it was not contained in the
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`expert’s report, which “made no mention of the doctrine of equivalents.” Id. at 994.
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`PO does not assert that any of Mr. Buss’s opinions were not timely disclosed here.
`
`
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`14
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`IPR2017-01488: Petitioners’ Opposition to PO’s Motion to Exclude
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`At base, any objection to Mr. Buss’s qualifications not only does not warrant
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`exclusion, but also is moot, given Mr. Buss’s opinions set forth in his declaration are
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`uncontroverted. PO has not cited any case, in the IPR context or otherwise, where
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`opinions of an expert that were not even disputed by the other party or its own
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`experts were excluded for unreliability. PO’s motion should be denied.
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`B. A Motion To Exclude Is Not A Proper Vehicle For PO’s Improper
`Reply Evidence Argument
`PO argues that certain evidence and argument submitted by Petitioners in
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`reply are “new and improper.” Mot. at 7–8. But “a motion to exclude is not a proper
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`vehicle for a party to raise the issue of arguments exceeding the permissible scope
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`of a reply.” See Blackberry Corp. v. Zipit Wireless, Inc., IPR2014-01508, Paper 49
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`at 40 (Mar. 29, 2016). Further, PO acknowledges that its “relevance” arguments
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`under FRE 401 and 402 are only applicable “[t]o the extent the Board agrees” with
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`its arguments on PO’s Motion to Strike (Paper 61). Mot. at 8. And PO’s “prejudice”
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`arguments similarly rely on an assertion that it “has been denied any meaningful
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`opportunity to substantively respond to Petitioners’ positions,” which again rely on
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`the Board agreeing with PO’s positions on its Motion to Strike. Petitioners will
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`respond to PO’s Motion to Strike on the date ordered by the Board (see Paper 60).
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` Date: July 3, 2018
`
`
`
`
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`Respectfully submitted,
`
` /Amanda Hollis/
`Attorney For Petitioner Pfizer, Inc.
`
`15
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`
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`IPR2017-01488: Petitioners’ Opposition to PO’s Motion to Exclude
`
`CERTIFICATE OF SERVICE
`The undersigned hereby certifies that a copy of the foregoing Opposition to
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`Motion to Exclude Evidence was served on July 3, 2018, via electronic service on
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`lead and back-up counsel:
`
`For Genentech:
`david.cavanaugh@wilmerhale.com
`lauren.blakely@wilmerhale.com
`robert.gunther@wilmerhale.com
`abrausa@durietangri.com
`ddurie@durietangri.com
`andrew.danford@wilmerhale.com
`kevin.prussia@wilmerhale.com
`lisa.pirozzolo@wilmerhale.com
`
`For Samsung Bioepis Co., Ltd.:
`ddrivas@whitecase.com
`sweingaertner@whitecase.com
`eric.majchrzak@whitecase.com
`athakore@whitecase.com
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` /Amanda Hollis/
`Amanda Hollis
`
`
`
`
`
`
`
`16
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`
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