`
`IPR2017-01357
`U.S. Patent 7,332,289
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`PFIZER, INC.,
`Petitioner
`
`v.
`
`CHUGAI PHARMACEUTICAL CO. LTD.,
`Patent Owner
`______________________
`
`Case IPR2017-01357
`Patent 7,332,289
`______________________
`
`
`
`PATENT OWNER’S OPPOSITION TO
`PETITIONER’S MOTION TO EXCLUDE
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`Page
`The Objected-To Exhibits Were Properly Presented at Deposition ............... 3
`A. Articles Describing Ways for Making Citrate Buffer
`(EX2201-EX2205) ............................................................................... 3
`Dr. Przybycien’s Articles Describing a Solution as Being
`“Clouded” (EX2206-EX2207) ............................................................. 8
`A Motion to Exclude Is Not the Proper Vehicle for Striking the
`Challenged Exhibits on the Basis of Scope or Timeliness ........................... 11
`Pfizer’s Relevance Arguments Are Misplaced ............................................. 12
`III.
`IV. Conclusion .................................................................................................... 14
`
`
`
`B.
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`I.
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`II.
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`IPR2017-01357
`U.S. Patent 7,332,289
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`TABLE OF CONTENTS
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`i
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`IPR2017-01357
`U.S. Patent 7,332,289
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`
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`TABLE OF AUTHORITIES
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`Page(s)
`
`
`CASES
`ABB, Inc. v. Roy-G-Biv Corp.,
`IPR2013-00063, Pap. 71 (May 16, 2014) ........................................................... 11
`Argentum Pharm. LLC v. Research Corp. Techs., Inc.,
`IPR2016-00204, Pap. 85 (Mar. 22, 2017) ............................................................ 2
`Arris Int’l PLC v. Sony Corp.,
`IPR2016-00834, Pap. 54 (Sept. 28, 2017) .......................................................... 13
`Corning Inc. v. DSM IP Assets B.V.,
`IPR2013-00047, Pap. 84 (May 1, 2014) ............................................................. 11
`Elbit Sys. of Am., LLC v. Thales Visionix, Inc.,
`881 F.3d 1354 (Fed. Cir. 2018) .......................................................................... 13
`Ericsson Inc. v. Intellectual Ventures I LLC,
`IPR2014-00527, Pap. 41 (May 18, 2015) ........................................................... 10
`Facebook, Inc. v. Software Rights Archive, LLC,
`IPR2013-00478, Pap. 58 (Feb. 2, 2015) ............................................................. 11
`Fox Factory, Inc. v. SRAM, LLC,
`IPR2017-00472, Pap. 64 (Apr. 18, 2018) ........................................................... 13
`Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd.,
`821 F.3d 1359 (Fed. Cir. 2016) ............................................................................ 2
`Juniper Networks, Inc. v. Chrimar Sys., Inc.,
`IPR2016-01389, Pap. 69 (Jan. 23, 2018) ............................................................ 13
`Mastercard Int’l Inc. v. Grecia,
`IPR2017-00791, Pap. 11 (July 27, 2017) ........................................................... 11
`Microsoft Corp. v. Bradium Techs. LLC,
`IPR2015-01432, Pap. 51 (Dec. 21, 2016) ............................................................. 7
`
`ii
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`IPR2017-01357
`U.S. Patent 7,332,289
`
`Palo Alto Networks, Inc. v. Finjan, Inc.,
`IPR2015-02001, Pap. 41 (Mar. 17, 2017) .......................................................... 12
`Reactive Surfaces Ltd. v. Toyota Motor Corp.,
`IPR2016-01462, Pap. 30 (May 31, 2017) ............................................................. 9
`Samsung Elecs. Co. v. Affinity Labs of Tex., LLC,
`IPR2014-00407, Pap. 48 (July 20, 2015) ..................................................... 11, 12
`Toyota Motor Corp. v. Blitzsafe Tex., LLC,
`IPR2016-00418, Pap. 16 (Aug. 2, 2016) ............................................................ 11
`STATUTES
`35 U.S.C. § 312(a)(3) ................................................................................................. 2
`OTHER AUTHORITIES
`37 C.F.R. § 42.23(b) .................................................................................................. 2
`37 C.F.R. § 42.53(d)(5)(ii) ......................................................................................... 1
`37 C.F.R. § 42.53(f)(3) .............................................................................................. 1
`37 C.F.R. §42.64 ...................................................................................................... 14
`37 C.F.R. § 42.104(b)(3) ............................................................................................ 8
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`iii
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`Patent Owner’s
`Exhibits
`2001
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`2002
`2003
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`2004
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`2005
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`2006
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`2007
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`2008
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`2009
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`2010
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`IPR2017-01357
`U.S. Patent 7,332,289
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`PATENT OWNER’S EXHIBITS
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`
`
`Description
`
`Excerpt of European Prosecution History of
`Application No. 03795400.5
`Declaration of Megan Raymond dated August 31, 2017
`Todd M Przybycien et al., Alternative Bioseparation
`Operation: Life Beyond Packed-bed Chromatography,
`Current Opinion in Biotechnology, Vol. 15, pp. 469-
`478 (Sept. 11, 2004)
`Mili Pathak et al., Re-use of Protein A Resin: Fouling
`and Economics, BioPharm Int’l, Vol. 28, No. 3 (Mar.
`1, 2015)
`M. Roth, Automated Amino Acid Analysis with
`Sensitive Fluorescence Detection, Journal of Clinical
`Chemistry and Clinical Biochemistry, Vol. 14, No. 7,
`pp. 361-364 (1976)
`Leslie A. Khawli et al., Charge Variants in IgG1:
`Isolation, Characterization, In Vitro Binding
`Properties and Pharmacokinetics in Rats, MAbs, Vol.
`2, No. 6, pp. 613-624 (Nov. 2010)
`A. Singla et al., Aggregation Kinetics for IgG1-Based
`Monoclonal Antibody Therapeutics, American
`Association of Pharmaceutical Scientists, Vol. 18, No.
`3, pp.689-702 (May 2016).
`Paolo Arosio et al., Aggregation Mechanism of an
`IgG2 and two IgG1 Monoclonal Antibodies at low pH:
`From Oligomers to Larger Aggregates, Pharmaceutical
`Research, Vol. 30, No. 3 (Oct. 9, 2012)
`CRC Handbook of Chemistry and Physics, 5-72
`(Electrical Conductivity of Aqueous Solutions) (W. M.
`Hayes ed., CRC Press 96th ed., 2015)
`Yinges Yigzaw et al., Exploitation of the Adsorptive
`Properties of Depth Filters for Host Cell Protein
`Removal during Monoclonal Antibody Purification,
`Biotechnology Progress, Vol. 22, No. 1, pp.288-296
`(Jan. 6, 2006)
`
`iv
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`
`
`2011
`
`2012
`
`2013
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`2014
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`2015
`2016
`2017
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`2018
`2019
`2020
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`2021-2200, 2208-
`2300
`2301
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`2302
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`2303
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`2304
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`
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`IPR2017-01357
`U.S. Patent 7,332,289
`Ying Hou et al., Improved Process Analytical
`Technology for Protein A Chromatography Using
`Predictive Principal Component Analysis Tools,
`Biotechnology and Bioengineering, Vol. 108, No. 1,
`pp.59-68 (July 29, 2010)
`Thomas Skamris et al., Monoclonal Antibodies Follow
`Distinct Aggregation Pathways During Production-
`Relevant Acidic Incubation and Neutralization,
`Pharmaceutical Research, Vol. 33, No. 3, pp.716-728
`(Nov. 12, 2015)
`Maria Vazquez-Rey et al., Aggregates in Monoclonal
`Antibody Manufacturing Processes, Biotechnology and
`Bioengineering, Vol. 108, No. 7, pp.1494-1508 (Apr.
`7, 2011)
`Deposition Transcript of Todd M. Przybycien dated
`January 30, 2018
`Declaration of Dr. Steven M. Cramer
`Declaration of Dr. Kirston Koths
`Declaration of Megan Raymond dated February 26,
`2018
`Experimental Notebook Pages of Dr. Harry G. Brittain
`Declaration of Dr. Harry G. Brittain
`Deposition Transcript of Todd M. Przybycien dated
`June 12, 2018
`Intentionally Omitted
`
`Ching-Erh Lin et al., Migration Behavior and
`Separation of Sulfonamides in Capillary
`Electrophoresis III. Citrate Buffer as a Background
`Electrolyte, Journal of Chromatography A, Vol. 768,
`pp.105-112 (1997)
`Heinrich Wieland & Dietrich Seidel, A Simple Specific
`Method for Precipitation of Low Density Lipoproteins,
`Journal of Lipid Research, Vol. 24, pp.904-09 (1983)
`Jan Markussen et al., Immobilized Insulin for High
`Capacity Affinity Chromatography of Insulin
`Receptors, The Journal of Biological Chemistry, Vol.
`266, No. 28, pp.18814-18 (1991)
`Steven A. Fuller et al., Purification of Monoclonal
`
`v
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`IPR2017-01357
`U.S. Patent 7,332,289
`Antibodies, in CURRENT PROTOCOLS IN MOLECULAR
`BIOLOGY, 11.11.1-11.11.5 (John Wiley & Sons, Inc.)
`(1997)
`Johannes Schiebel et al., Staphylococcus aureus Fabl:
`Inhibition, Substrate Recognition, and Potential
`Implications for In Vivo Essentiality, Structure, Vol.
`20, No. 5 (Supp. 2012)
`Ganesh Vedantham et al., A Holistic Approach for
`Protein Secondary Structure Estimation from Infrared
`Spectra in H20 Solutions, Analytical Biochemistry,
`Vol. 285, pp.33-49 (2000)
`Michael A. Winters et al., Precipitation of Proteins in
`Supercritical Carbon Dioxide, Journal of
`Pharmaceutical Sciences, Vol. 85, No. 6, pp.586-94
`(June 1996)
`Declaration of Saurabh Gupta
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`2305
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`2306
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`2307
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`2308
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`vi
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`IPR2017-01357
`U.S. Patent 7,332,289
`Patent Owner Chugai Pharmaceutical Co. Ltd. (“PO” or “Chugai”)
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`
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`respectfully opposes Petitioner Pfizer, Inc.’s (“Pfizer”) Motion to Exclude, which
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`would effectively insulate Pfizer’s expert, Dr. Przybycien, from being challenged
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`at deposition about his new Reply testimony with publications—including Dr.
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`Przybycien’s own articles—that squarely contradict his newly-minted Reply
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`positions. There is, of course, no rule limiting PO to confronting Dr. Przybycien
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`only with documents already of record Cf., e.g., § 42.53(f)(3) (discussing handling
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`of new exhibits at deposition). Moreover, Pfizer’s complaints about the scope of
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`these exhibits (EX2201-EX2207) are entirely of Pfizer’s own making.1 While
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`Pfizer complains they were first introduced during deposition and its expert could
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`thus not respond, this is simply not the case: Pfizer quotes Dr. Przybycien’s
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`testimony responding to these documents and redirected him about all of them
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`other than his own publications. Br. 4-11; EX2020, 269:11-278:9. And while
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`Pfizer argues the exhibits should have been presented at its expert’s earlier
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`deposition regarding his first declaration in the case or in some other earlier paper
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`(Br. 4-11), the proper scope of that first deposition was limited to the scope of Dr.
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`Przybycien’s opening declaration (§ 42.53(d)(5)(ii)), and the objected-to exhibits
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`1 As detailed below (infra §II), this Motion is also an improper vehicle for Pfizer’s
`
`objections. Unless noted, emphasis is added and section cites are to 35 U.S.C. or
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`37 C.F.R.
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`1
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`IPR2017-01357
`U.S. Patent 7,332,289
`were used in questioning Dr. Przybycien about his new Reply opinions that were,
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`
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`themselves, well beyond the proper scope of Reply. See, e.g., Pap. 40; § 312(a)(3)
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`(petition must identify, “in writing and with particularity, each claim challenged,
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`the grounds on which the challenge to each claim is based, and the evidence that
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`supports the grounds”); § 42.23(b) (“reply may only respond to arguments
`
`raised”); Trial Practice Guide, 77 Fed. Reg. 48,756, 48,767 (Aug. 14, 2012)
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`(“Examples of indications that a new issue has been raised in a reply include new
`
`evidence necessary to make out a prima facie case for the patentability or
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`unpatentability of an original or proposed substitute claim, and new evidence that
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`could have been presented in a prior filing.”); Intelligent Bio-Sys., Inc. v. Illumina
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`Cambridge Ltd., 821 F.3d 1359, 1369-70 (Fed. Cir. 2016) (“[T]he expedited nature
`
`of IPRs bring with it an obligation for petitioners to make their case in their
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`petition to institute.”); Argentum Pharm. LLC v. Research Corp. Techs., Inc.,
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`IPR2016-00204, Pap. 85, 5-6 (Mar. 22, 2017) (disallowing Petitioner “to advance
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`[in Reply] additional evidence to supplement its original contentions of
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`unpatentability”). Pfizer’s Reply and associated declaration are rife with new
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`positions belatedly attempting to backfill holes in its Petition and meet Pfizer’s
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`burden of establishing a prima facie case of unpatentability. See, e.g., Pap. 40.
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`Because Pfizer first raised these issues at the end of the proceeding, PO could not
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`have questioned its expert about them earlier.
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`IPR2017-01357
`U.S. Patent 7,332,289
`Moreover, the challenged exhibits (and associated testimony) are clearly
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`
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`relevant: they illuminate contradictions and gaps in Dr. Przybycien’s new Reply
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`testimony and in Pfizer’s new Reply arguments on a range of substantive issues,
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`including molarity, conductivity, and particle formation. They further demonstrate
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`how little weight Dr. Przybycien’s opinions should be given, and are highly
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`relevant to the veracity and completeness (or, more precisely, the lack thereof) of
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`Pfizer’s Reply arguments and Dr. Przybycien’s Reply opinions.
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`To the extent Pfizer’s arguments and evidence beyond the proper scope of
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`Reply are considered at all (and they should not be, see Pap. 40), PO respectfully
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`submits that PO’s questioning of Pfizer’s expert regarding those opinions,
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`including questioning about exhibits shown to Pfizer’s expert, must be considered.
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`The purpose for deposing an expert in the first place is to test that expert’s
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`testimony. It cannot be that Pfizer can provide new Reply opinions and testimony
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`beyond the proper scope, as it has done here, and then insist these new positions
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`cannot be questioned and challenged at deposition.
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`I.
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`The Objected-To Exhibits Were Properly Presented at Deposition
`A. Articles Describing Ways for Making Citrate Buffer (EX2201-
`EX2205)
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`The first collection of exhibits (EX2201-EX2205) to which Pfizer objects
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`comprises journal articles and other publications addressing how to make a citrate
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`buffer. See Br. 4-11. In its Petition, Pfizer presented no arguments or evidence
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`IPR2017-01357
`U.S. Patent 7,332,289
`regarding the methods by which Shadle’s citrate buffer was made, and offered no
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`
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`explanation of how such methods would impact its analysis of the prior art.
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`Instead, Pfizer simply offered the summary conclusion that Shadle’s citrate buffer
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`met the molarity limitations of the challenged claims, and that the particle
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`formation conditions in Shadle and the ’289 patent were the same. See, e.g., Pet.,
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`29, 30, 33-37; EX1002, ¶¶72-85.
`
`In its Response, PO explained that at least one well-known way of making
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`Shadle’s citrate buffer (involving the combination of trisodium citrate and
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`hydrochloric acid (HCl)) would result in the molarity limitations of the claims
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`being exceeded, and thus the particle formation conditions in Shadle would be
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`different from those in the ’289 patent (including due to the molarity and
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`conductivity of citrate buffer when made with trisodium citrate and hydrochloric
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`acid). POR, 31-32, 38-40; EX2015, ¶¶59-64, 74-80; EX2019, ¶¶2, 18-24.
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`In its Reply, Pfizer did not challenge PO’s calculations, but instead argued
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`for the first time that there were only “four conventional preparations” for making
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`Shadle’s ProSep A elution buffer, and that the method identified by PO was not
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`among them. See, e.g., Reply, 10 (identifying “the four conventional methods”
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`and denying existence of a “fifth”). Pfizer also made new arguments about why the
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`citrate buffer in Shadle would have been prepared using one of the four methods
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`Pfizer proposed. Reply, 9-15; EX1036, ¶¶23-28; EX1026, 1-3; EX1027, 1-3. For
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`IPR2017-01357
`U.S. Patent 7,332,289
`instance, Pfizer asserted Shadle’s disclosures would have “directed a POSA to
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`
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`prepare the Shadle citrate buffer according to one of the four conventional
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`preparations” Pfizer identified. Reply, 13. However, in criticizing the method
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`identified by PO, Pfizer also argued that the conductivity of the citrate buffer must
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`be made as low as possible, ignoring the fact that certain of Pfizer’s four different
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`methods result in a citrate buffer with different conductivities and molarities (e.g.,
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`Pfizer’s buffer number 3 has a lower molarity and conductivity than its buffer
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`number 2). EX1053, 1-2; EX1027, 1-2. Pfizer further asserted for the first time
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`that the applicability of a disclosed method of making citrate buffer depends on the
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`disclosure’s field of study, even though Pfizer in its Petition materials cited no
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`disclosures at all to support the “four” methods it now argues. Reply, 13; EX1036,
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`¶29. Pfizer also presented new calculations of molarity and conductivity based on
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`its “four” methods. Reply, 9; see EX1036, ¶¶37-38, 41, 57 (citing new exhibit
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`EX1053 and improperly citing to conductivity calculations absent from EX1007
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`and the Petition); EX1026, 1-3; EX1027, 1-3. And Pfizer made the new argument
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`that it “showed that all four conventional buffers” meet the “neutralized eluate
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`limitations.” Reply, 9, 10 (citing EX1026; EX1027), 11, 12-13 (citing new Reply
`
`exhibits EX1028-EX1033, EX1037-EX1041, EX1045, EX1046), 14 (citing
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`EX1043), 15 (citing EX1047). Pfizer and Dr. Przybycien also criticized PO’s
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`IPR2017-01357
`U.S. Patent 7,332,289
`position as depending on a single reference showing citrate buffer being made
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`
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`using trisodium citrate and hydrochloric acid. Reply, 13; EX1036 ¶ 29.
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`In view of these new opinions, Dr. Przybycien was asked questions at the
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`deposition challenging his new testimony, including that there are only four
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`conventional ways of making Shadle’s citrate buffer, and his criticism of PO’s
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`proposed way of making citrate buffer. For instance, Dr. Przybycien was asked a
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`series of questions about the support for the four buffer formulations he proposed,
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`and his testimony reflects that none of the references he cited in support of his
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`“four conventional” buffer preparations actually provided any disclosure of three
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`of the four methods he argued were the only “conventional” choices. EX2020,
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`161:15-165:20, 168:19-171:16; see also id. at 189:24-190:14. Dr. Przybycien also
`
`acknowledged that, while he testified he had searched the literature for ways to
`
`make citrate buffer and allegedly found none reflecting the use of trisodium citrate
`
`and hydrochloric acid, in fact he had looked only for “handbooks or reference
`
`materials” and not, for example, journal articles that would be known to POSITA.
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`See, e.g., id. at 157:8-158:2, 166:22-168:8, 158:2-161:5, 195-21-198:22.
`
`In PO’s process of testing this new Reply declaration and deposition
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`testimony, Dr. Przybycien was shown EX2201-EX2205, which Pfizer seeks to
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`exclude. These journal articles and other publications reflect ways of making a
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`citrate buffer other than what Dr. Przybycien testified were the only four
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`IPR2017-01357
`U.S. Patent 7,332,289
`conventional methods. When asked about them, Dr. Przybycien acknowledged
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`
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`there were additional methods to make citrate buffer beyond the “four” he
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`identified, admitting that some of those additional methods resulted in a citrate
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`buffer used as an elution buffer (EX2203, EX2204, EX2205), and that some are
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`used in the bioprocessing field (EX2204, EX2205)—including to elute
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`chromatography columns such as a Protein A column (EX2204). EX2020, 174:14-
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`179:21, 181:11-185:7, 186:10-189:17, 276:11-25.
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`Dr. Przybycien’s testimony about these additional ways of making a citrate
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`buffer (responding to questions concerning the documents Pfizer seeks to exclude)
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`is relevant to, inter alia, Dr. Przybycien’s and Pfizer’s assertion that only one of
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`“the four” methods of preparing citrate proposed by Dr. Przybycien—and no
`
`others, including using trisodium citrate and hydrochloric acid—would necessarily
`
`have been used by Shadle. See Reply, 9-13; EX1036, ¶¶25-31. This testimony is
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`also relevant because it contradicts Dr. Przybycien’s Reply testimony that a
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`POSITA would not have prepared Shadle’s ProSep A citrate buffer using trisodium
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`citrate and hydrochloric acid (as shown by PO) and would, instead, have prepared
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`this buffer only using (a) citric acid and sodium hydroxide (NaOH), (b)
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`monosodium citrate and hydrochloric acid, (c) citric acid and monosodium citrate,
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`or (d) trisodium citrate and citric acid. See EX1036 ¶¶25-31; Microsoft Corp. v.
`
`Bradium Techs. LLC, IPR2015-01432, Pap. 51, 24-25 (Dec. 21, 2016) (finding
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`7
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`motion to exclude was moot, but noting as procedural matter that it could have
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`
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`been proper and timely for Patent Owner to “cross-examin[e expert], introduc[e]
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`exhibits on which to conduct the cross-examination, and [make] corresponding
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`Motion for Observations” to address issue Petitioner “first raised…after Patent
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`Owner filed its last paper on the merits”) (citing Trial Practice Guide, 77 Fed. Reg.
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`at 48767-8).
`
`In sum, PO’s use of these documents was entirely appropriate, the exhibits
`
`and the testimony concerning them are entirely relevant, and Pfizer has shown no
`
`basis for excluding any of them.
`
`B. Dr. Przybycien’s Articles Describing a Solution as Being
`“Clouded” (EX2206-EX2207)
`
`The second category of exhibits to which Pfizer objects are journal articles
`
`by Pfizer’s own expert that use the term “cloudy.” In its Petition materials, despite
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`§ 42.104(b)(3)’s requirement that Pfizer identify how each challenged claim is to
`
`be construed, Pfizer declined to construe “to form particles”—but Pfizer quoted the
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`patent’s description of “produces particles (i.e., becomes clouded).” Pet., 10, 36
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`(arguing particle formation results from satisfying the ’289 patent’s stated
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`conditions, and quoting EX1001 6:4-7 (“[T]he solution neutralized to a neutral pH
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`level in the above stage, in turn, produces particles (i.e., becomes clouded).”));
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`EX1002, ¶¶41, 83 (citing same). In its Response, PO affirmatively construed “to
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`form particles” as “becomes clouded.” POR, 17.
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`8
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`IPR2017-01357
`U.S. Patent 7,332,289
`Pfizer’s Reply materials asserted for the first time that “to form particles”
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`
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`does not require clouding, and that “clouded” in Pfizer’s construction was
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`indefinite and unclear. Reply, 15-16; EX1036, ¶¶11, 12. Pfizer’s expert was
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`accordingly asked at his Reply deposition about this new testimony, and in
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`particular what “clouding” or “clouded” means. EX2020, 236:6-242:18. When
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`asked whether he had used such words in his own papers, Dr. Przybycien
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`responded he was not sure. Id. at 237:10-13. He was then presented with and
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`asked about his own publications that use the word “cloudy” (EX2206, EX2207).
`
`EX2020, 238:23-242:18. Dr. Przybycien testified that he used the word “cloudy”
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`in those publications to mean “visible to the eye.” Id. at 240:17-19.
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`Dr. Przybycien’s own articles, his testimony about them, and his own use of
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`the word “cloudy” are relevant to his and Pfizer’s attacks on PO’s use of “clouded”
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`in construing “to form particles,” and contradict his and Pfizer’s arguments that it
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`is unclear how cloudiness would be determined. Reply, 16; EX1036, ¶¶11, 12.
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`This highly relevant testimony confirms that little to no weight should be given to
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`these criticisms of PO’s construction, which uses the specification’s term
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`“clouded,” and it was certainly appropriate cross-examination: questions
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`challenging the completeness, veracity, or weight that should be given to an
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`expert’s opinions are within the proper scope of deposition, as are the use and
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`reliance on exhibits to elicit such testimony. See, e.g., Reactive Surfaces Ltd. v.
`
`9
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`IPR2017-01357
`U.S. Patent 7,332,289
`Toyota Motor Corp., IPR2016-01462, Pap. 30, 3 (May 31, 2017) (“[C]ross-
`
`
`
`examination also may include ‘matters affecting the witness’s credibility.’”)
`
`(quoting Fed. R. Evid. 611(b)); Ericsson Inc. v. Intellectual Ventures I LLC,
`
`IPR2014-00527, Pap. 41, 14 (May 18, 2015) (“Courts are admonished to exercise
`
`caution in limiting the cross-examination of a witness whose credibility could have
`
`an important influence on the outcome of the trial.”).
`
`Dr. Przybycien’s understanding of “clouded” or “cloudy” is also relevant
`
`because Pfizer’s Reply submissions asserted that the alleged particle formation in
`
`Shadle may not result in “clouding” (Reply, 15-16; EX1036 ¶12), while the ’289
`
`patent describes clouding of the adjusted eluate (EX1001, 6:4-6) in the same
`
`discussion Dr. Przybycien relies on to opine about how he believes Shadle must
`
`necessarily behave. See, e.g., EX2014, 15:3-10, 18:24-19:13, 19:18-20:5, 22:14-
`
`24, 23:15-24:5; EX1002 ¶¶41, 83 (testifying that particles form in Shadle because
`
`particles form in the patent); EX1036 ¶64. Dr. Przybycien’s entire opinion about
`
`why particles necessarily form in Shadle is based on his assumption that particles
`
`necessarily form under the conditions described in the ’289 patent, and that the
`
`conditions in Shadle and the ’289 patent are the same. Pet., 35-37; Reply, 15-19;
`
`EX1002, ¶¶83-85; EX1036, ¶¶55-61; EX2014, 13:14-15:10, 18:24-19:13, 21:4-
`
`25:14, 70:6-17, 74:11-75:18; EX2020, 145:6-18, 234:15-236:5. However, Dr.
`
`Przybycien’s new opinion that the solution may not cloud is inconsistent with this
`
`10
`
`
`
`IPR2017-01357
`U.S. Patent 7,332,289
`assumption. Again, Pfizer has shown no basis for excluding these exhibits or Dr.
`
`
`
`Przybycien’s testimony about them.
`
`II. A Motion to Exclude Is Not the Proper Vehicle for Striking the
`Challenged Exhibits on the Basis of Scope or Timeliness
`
`The PTAB has repeatedly stated that motions to exclude are only to address
`
`evidentiary deficiencies, not complaints about the timing or scope of evidence.
`
`E.g., Toyota Motor Corp. v. Blitzsafe Tex., LLC, IPR2016-00418, Pap. 16, 5 (Aug.
`
`2, 2016) (“[A] Motion to Exclude should not be used to raise anything other than
`
`admissibility issues under the Federal Rules of Evidence. If an issue with regard to
`
`whether a reply contains arguments or evidence in excess of the proper scope of a
`
`reply, the parties should arrange a conference call with the Board.”); Mastercard
`
`Int’l Inc. v. Grecia, IPR2017-00791, Pap. 11, 2 (July 27, 2017) (same); Facebook,
`
`Inc. v. Software Rights Archive, LLC, IPR2013-00478, Pap. 58, 37-38 (Feb. 2,
`
`2015) (“A motion to exclude . . . normally is not the proper vehicle for resolution
`
`of a dispute regarding reply arguments and evidence exceeding the proper scope”
`
`(internal quotations omitted)); ABB, Inc. v. Roy-G-Biv Corp., IPR2013-00063, Pap.
`
`71, 13-14 (May 16, 2014); Corning Inc. v. DSM IP Assets B.V., IPR2013-00047,
`
`Pap. 84, 7 n.3 (May 1, 2014); see also Samsung Elecs. Co. v. Affinity Labs of Tex.,
`
`LLC, IPR2014-00407, Pap. 48, 21 (July 20, 2015) (“A motion to exclude ‘must
`
`explain why the evidence is not admissible (e.g., relevance or hearsay) but may not
`
`be used to challenge the sufficiency of the evidence to prove a particular fact.”
`
`11
`
`
`
`IPR2017-01357
`U.S. Patent 7,332,289
`(internal quotations omitted)). This is why PO sought permission for a separate
`
`
`
`submission identifying Reply materials that were outside the proper scope. See
`
`Pap. 40. PO thus respectfully submits that Pfizer’s arguments here about
`
`excluding evidence based on scope and timing are improper, and should not be
`
`considered in the context of this motion. Samsung, IPR2014-00407, Pap. 48, 20-
`
`21 (denying exclusion based on complaints about timeliness).
`
`III. Pfizer’s Relevance Arguments Are Misplaced
`
`Pfizer’s only clearly-articulated evidentiary objection is one of relevance
`
`(Br. 1), but its arguments here (including, e.g., Pfizer’s arguments that certain
`
`buffer preparations are irrelevant as purportedly found in publications relating to a
`
`field other than bioprocessing (Br. 7), or that Dr. Przybycien’s use of “cloudy” in
`
`EX2207 does not inform how a POSITA would understand the term (Br. 13)) are
`
`substantive, and thus not appropriate for a motion to exclude. See Pap. 41, ¶¶4-11,
`
`13-23, 25, 26, 28; Samsung, IPR2014-00407, Pap. 48, 20-21. Such disputes about
`
`the exhibits and Dr. Przybycien’s testimony concerning them go to the weight of
`
`the evidence, not its admissibility. E.g., Palo Alto Networks, Inc. v. Finjan, Inc.,
`
`IPR2015-02001, Pap. 41, 25-26 (Mar. 17, 2017) (“express[ing] surprise that a
`
`party would seek to exclude the cross-examination testimony of its own expert
`
`witness” and determining arguments go “to the weight that should be given to the
`
`cross-examination testimony and related deposition exhibit, not
`
`12
`
`
`
`IPR2017-01357
`U.S. Patent 7,332,289
`to…admissibility”); Juniper Networks, Inc. v. Chrimar Sys., Inc., IPR2016-01389,
`
`
`
`Pap. 69, 96-99 (Jan. 23, 2018) (denying motion to exclude because movant’s
`
`relevance arguments were pertinent to weight to be accorded to expert testimony,
`
`not admissibility). And in any case, as the Board and the Federal Circuit have
`
`recognized, the Board is well-situated to deal with such disputes and determine
`
`how much weight to give the evidence, rather than exclude it entirely. E.g., Fox
`
`Factory, Inc. v. SRAM, LLC, IPR2017-00472, Pap. 64, 60 (Apr. 18, 2018) (“As the
`
`factfinder, we are able to consider this evidence, in light of the parties’ arguments,
`
`and give it the appropriate weight.”); see also Elbit Sys. of Am., LLC v. Thales
`
`Visionix, Inc., 881 F.3d 1354, 1358 (Fed. Cir. 2018) (“Determining the weight and
`
`credibility of the evidence is the special province of the trier of fact.”) (quoting
`
`Inwood Labs., Inc. v. Ives Labs., Inc., 456 U.S. 844, 856 (1982)); Arris Int’l PLC v.
`
`Sony Corp., IPR2016-00834, Pap. 54, 46 (Sept. 28, 2017) (“Petitioner’s arguments
`
`concerning the relevance of Exhibits 2003 and 2004 concern the weight that we
`
`should accord to those exhibits, rather than their admissibility.”). Not surprisingly,
`
`Pfizer fails to cite a single case where the Board excluded evidence based on
`
`relevance objections.2
`
`2 While Pfizer’s Motion further argues each of the challenged exhibits only
`
`“purports to be” an article, protocol or supplemental information (e.g., Br. 4-13;
`
`Pap. 35), the exhibits are all from regularly published journals and are self-
`
`13
`
`
`
`IV. Conclusion
`
`For the foregoing reasons, Petitioner’s Motion to Exclude be denied.
`
`
`
`IPR2017-01357
`U.S. Patent 7,332,289
`
`
`
`
`
`
`
`Respectfully submitted by:
`
`/J. Steven Baughman/
`J. Steven Baughman (Reg. No. 47,414)
`Paul, Weiss, Rifkind, Wharton &
`Garrison LLP
`2001 K Street, NW
`Washington, D.C. 20006-1047
`Tel: (202) 223-7340
`Fax: (202) 403-3740
`sbaughman@paulweiss.com
`
`Megan Raymond (Reg. No. 72,997)
`Paul, Weiss, Rifkind, Wharton &
`Garrison LLP
`2001 K Street, NW
`Washington, D.C. 20006-1047
`Tel: (202) 223-7300
`Fax: (202) 403-3777
`mraymond@paulweiss.com
`
`Attorneys For Patent Owner
`
`
`
`Dated: July 5, 2018
`
`
`
`
`
`
`
`
`
`authenticating. See EX2201-EX2207; EX2301-EX2308 (timely served on June 22,
`
`2018, pursuant to §42.64). Further, Petitioner’s expert himself recognized EX2206
`
`and EX2207 as being copies of his own publications. EX2020, 238:23-239:16,
`
`240:20-241:13.
`
`14
`
`
`
`CERTIFICATE OF SERVICE
`
`
`
`IPR2017-01357
`U.S. Patent 7,332,289
`
`The undersigned hereby certifies that a copy of PATENT OWNER’S
`
`OPPOSITION TO PETITIONER’S MOTION TO EXCLUDE has been served in
`
`its entirety by causing the aforementioned document to be electronically mailed to
`
`the following attorneys of record for the Petitioner listed below:
`
`Petitioner’s Counsel of Record:
`
`Jovial Wong (Reg. No. 60,115)
`Charles B. Klein
`Eimeric Reig-Plessis
`Matthew J. Mezger
`WINSTON & STRAWN, LLP
`1700 K Street, NW
`Washington, DC 20006
`jwong@winston.com
`cklein@winston.com
`ereigplessis@winston.com
`mmezger@winston.com
`rituximabIPR@winston.com
`
`
`Dated: July 5, 2018
`
`
`
`
`
`
`
`
`/Sayem Osman/
`By:
`Sayem Osman
`
`15
`
`
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