`
`
`David L. Cavanaugh (Reg. No. 36,476)
`Robert J. Gunther, Jr. (Pro Hac Vice)
`Lisa J. Pirozzolo (Pro Hac Vice)
`Kevin S. Prussia (Pro Hac Vice)
`Andrew J. Danford (Pro Hac Vice)
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`1875 Pennsylvania Ave., NW
`Washington, DC 20006
`
`Adam R. Brausa (Reg. No.
`60,287)
`Daralyn J. Durie (Pro Hac
`Vice)
`DURIE TANGRI LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________________________
`
`CELLTRION, INC.,
`Petitioner,
`
`v.
`
`GENENTECH, INC.,
`Patent Owner.
`____________________________________________
`
`Case IPR2017-01374
`Patent 6,407,213
`____________________________________________
`
`PATENT OWNER’S RENEWED MOTION TO SEAL
`
`
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`
`
`IPR2017-01374
`
` Patent Owner’s Renewed Motion to Seal
`
`
`STATEMENT OF PRECISE RELIEF REQUESTED
`
`Pursuant to 37 C.F.R. §§ 42.14 and 42.54, and the Board’s Final Written
`
`Decision, Paper 85, Patent Owner Genentech, Inc. respectfully submits this
`
`renewed motion to seal certain parts of Exhibits 2001 (Laboratory Notebook 10098
`
`(Leonard Presta)), 2002 (Laboratory Notebook 10823 (Leonard Presta)), 2005
`
`(Laboratory Notebook 10840 (John Brady)), and 2006 (Laboratory Notebook
`
`11162 (John Brady)) that describe confidential research unrelated to the issues in
`
`this proceeding. Patent Owner files concurrently with this motion redacted
`
`versions of these exhibits.
`
`As discussed below, Patent Owner is only seeking to seal certain portions of
`
`Exhibits 2001, 2002, 2005, and 2006 that are not relevant to any issue in this
`
`proceeding and that were not relied upon in the Final Written Decision. Given the
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`public disclosure of Genentech’s work humanizing the 4D5 antibody at the oral
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`hearing and the Board’s reliance on that work in its Final Written Decision, see
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`Paper 85 at 17-25, Patent Owner does not request the sealing of the Final Written
`
`Decision, any paper previously filed in this proceeding, or any other exhibit
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`submitted in this proceeding.
`
`REASONS FOR RELIEF REQUESTED
`
`Although “the default rule is that all papers filed in an inter partes review
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`are open and available for access by the public,” a party may file a motion with the
`1
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`IPR2017-01374
`
` Patent Owner’s Renewed Motion to Seal
`
`Board to seal confidential information that is protected from disclosure. Garmin v.
`
`Cuozzo, IPR2012-00001, Paper No. 36. “The standard for granting a motion to
`
`seal is ‘for good cause.’” Id. (quoting 37 C.F.R § 42.54); see Argentum Pharms.
`
`LLC v. Alcon Research, Ltd., IPR2017-01053, Paper 27 at 3-4 (Jan. 19, 2018)
`
`(informative). The Office Patent Trial Practice Guide, 77 Fed. Reg. 48756, 48760
`
`(Aug. 14, 2012), states that the “rules identify confidential information in a manner
`
`consistent with Federal Rule of Civil Procedure (“FRCP”) 26(c)(1)(G), which
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`provides for protective orders for trade secret or other confidential research,
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`development, or commercial information.”
`
`The parties have conferred and agreed to the provisions of the Modified
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`Default Standing Protective Order set forth in Exhibit 2030, and have stipulated to
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`be bound to the terms set forth therein. Exhibit 2031 shows the proposed
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`modifications from the Default Standing Protective Order, to which the parties
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`have stipulated, in redline. The Modified Default Standing Protective Order
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`provides:
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`Where confidentiality is alleged as to some but not all of the
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`information submitted to the Board, the submitting party shall file
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`confidential and non-confidential versions of its submission, together
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`with a Motion to Seal the confidential version setting forth the reasons
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`why the information redacted from the non-confidential version is
`2
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`
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`confidential and should not be made available to the public. The
`
`IPR2017-01374
`
` Patent Owner’s Renewed Motion to Seal
`
`
`nonconfidential version of the submission shall clearly indicate the
`
`locations of information that has been redacted. The confidential
`
`version of the submission shall be filed under seal. The redacted
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`information shall remain under seal unless, upon motion of a party
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`and after a hearing on the issue, or sua sponte, the Board determines
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`that some or all of the redacted information does not qualify for
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`confidential treatment.
`
`(Ex. 2030, Modified Default Standing Protective Order and Patent Owner’s
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`Certification of Agreement to Terms, at 3-4.)
`
`Exhibits 2001 and 2002 are laboratory notebooks authored by Dr. Leonard
`
`Presta, who is an inventor of U.S. Patent No. 6,407,213 (“the ’213 patent”).
`
`Exhibits 2001 and 2002 describe Dr. Presta’s work humanizing the 4D5 antibody,
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`which is described in the ’213 patent. But Exhibits 2001 and 2002 also describe
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`Dr. Presta’s confidential research on other projects that are unrelated to the issues
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`in this proceeding and that occurred after his work humanizing the 4D5 antibody.
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`Patent Owner requests to seal the description of these unrelated experiments in the
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`table of contents on page 5 of Exhibit 2001, as well as the detailed experimental
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`description on pages 42-90 of Exhibit 2001 and pages 40-68 of Exhibit 2002.
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`3
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`Exhibits 2005 and 2006 are laboratory notebooks authored by Mr. John
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`IPR2017-01374
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` Patent Owner’s Renewed Motion to Seal
`
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`Ridgeway Brady, which corroborate the inventors’ work relating to the ’213
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`patent. Patent Owner does not request to seal any portion of Mr. Brady’s
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`notebooks cited or discussed in these proceedings. However, there are certain
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`experiments in the beginning of Exhibits 2005 and 2006 that do not relate to
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`humanized 4D5 antibodies and therefore are not relevant to the issue of
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`corroboration or any other issue in these proceedings. Patent Owner requests to
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`seal the details of this confidential research that does not involve humanized 4D5
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`antibodies on pages 13-72 of Exhibit 2005 and pages 13-46 of Exhibit 2006.
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`The material that Patent Owner requests to seal is maintained confidentially
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`at Genentech, and the public disclosure of such confidential research and
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`development materials would place Genentech at a competitive disadvantage.
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`Patent Owner is submitting concurrently herewith redacted versions of Exhibits
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`2001, 2002, 2005, and 2006, and attests that the materials sought to be protected is
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`not directly or indirectly relied on in the Board’s Final Written Decision. Rather,
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`the only information that Patent Owner is seeking to redact in Exhibits 2001, 2002,
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`2005, and 2006 are the details of confidential experiments unrelated to the issues in
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`4
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`this proceeding.1 There is therefore good cause for sealing these confidential
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`IPR2017-01374
`
` Patent Owner’s Renewed Motion to Seal
`
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`research materials, and no countervailing public interest that would warrant
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`unsealing the portions of these exhibits that are unrelated to the issues in this
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`proceeding. Indeed, in related IPR2017-01373 and IPR2017-01489, the Board
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`granted Patent Owner’s motion to seal these materials where, as here, the material
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`sought to be sealed was not relied upon the Final Written Decision. See IPR2017-
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`01373, Paper 84, at 54-55 (sealing, inter alia, Exhibits 2001, 2002, 2005, and
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`2006); IPR2017-01489, Paper 86, at 53 (same).
`
`
`1
`The Board referred to the dates and signatures on pages 43-63, 65, 68-71,
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`73, 74, 77-84, and 90 of Exhibit 2001 and pages 40-43, 46, 51, 59-61, and 64-68 of
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`Exhibit 2002 in related IPR2017-01488 to refute “Petitioner’s suggestion that [the
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`notebooks] are substantially unsigned and undated.” See IPR2017-01488, Paper
`
`87 at 25 n.14. The Board did not rely upon or discuss the experimental details
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`described on those pages, which do not relate to the inventors’ work humanizing
`
`the 4D5 antibody at issue in this proceeding. Patent Owner does not request that
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`the dates and signatures referred to in the Final Written Decision in IPR2017-
`
`01488 be sealed; Patent Owner only requests to seal the details of the unrelated
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`research described on those pages.
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`
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`5
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`Patent Owner therefore respectfully requests that the Board grant this
`
`IPR2017-01374
`
` Patent Owner’s Renewed Motion to Seal
`
`
`renewed motion to seal portions of Exhibits 2001, 2002, 2005, and 2006 as
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`reflected in Patent Owner’s redacted versions of these exhibits submitted herewith.
`
`
`
`Date: December 13, 2018
`
`
`
`
`
`
`
`Respectfully submitted,
`
`/David L. Cavanaugh/
`David L. Cavanaugh
`Registration No. 36,476
`
`Counsel for Patent Owner
`
`
`
`
`
`
`
`WILMER CUTLER PICKERING HALE AND DORR LLP
`1875 PENNSYLVANIA AVENUE NW
`WASHINGTON, DC 20006
`TEL: 202-663-6000
`FAX: 202-663-6363
`EMAIL: david.cavanaugh@wilmerhale.com
`
`
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`6
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`IPR2017-01374
`Patent Owner’s Updated Exhibit List
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`
`IPR2017-01374
`Patent Owner’s Updated Exhibit List
`
`Patent Owner’s
`Exhibit Number
`2001
`
`
`2002
`
`2003
`2004
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
`
`2011
`
`2012
`2013
`2014
`2015
`
`2016
`2017
`2018
`2019
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`Exhibit Name
`
`Genentech, Inc. Laboratory Notebook No. 10098 (Leonard
`Presta)
`PROTECTIVE ORDER MATERIAL
`Genentech, Inc. Laboratory Notebook No. 10823 (Leonard
`Presta)
`PROTECTIVE ORDER MATERIAL
`Genentech, Inc. Laboratory Notebook No. 11268 (Paul Carter)
`Genentech, Inc. Laboratory Notebook No. 11643 (Paul Carter)
`Genentech, Inc. Laboratory Notebook No. 10840 (John Brady)
`PROTECTIVE ORDER MATERIAL
`Genentech, Inc. Laboratory Notebook No. 11162 (John Brady)
`PROTECTIVE ORDER MATERIAL
`Excerpts from Genentech, Inc. Laboratory Notebook No. 11008
`(Ann Rowland)
`Excerpts from Genentech, Inc. Laboratory Notebook No. 11297
`(Tim Hotaling)
`Excerpts from Genentech, Inc. Laboratory Notebook No. 11568
`(Monique Carver)
`Genentech, Inc. Interoffice Memorandum from Paul Carter to
`Leonard Presta and Dennis Henner
`Genentech, Inc. Interoffice Memorandum from Paul Carter to
`Leonard Presta
`Genentech, Inc. Synthetic DNA Requests
`Genentech, Inc. Synthetic DNA Requests
`Genentech, Inc. Protein Engineering of 4D5 Status Report
`Genentech, Inc. Interoffice Memorandum re: RCC Minutes and
`Recommendations
`Declaration of Dr. Leonard G. Presta
`Declaration of Dr. Paul J. Carter
`Declaration of John Ridgway Brady
`Declaration of Irene Loeffler
`
`7
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`Patent Owner’s
`Exhibit Number
`2020
`
`
`2021
`
`2022
`
`2023
`
`2024
`
`2025
`
`2026
`
`2027
`
`2028
`
`2029
`2030
`
`2031
`2032
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`2033
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`2034
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`IPR2017-01374
`Patent Owner’s Updated Exhibit List
`
`
`Exhibit Name
`
`Paul Carter, et al., Humanization of the Anti-p185 Antibody for
`Human Cancer Therapy, 89 PROC. NATL. ACAD. SCI. 4285-
`4289 (1992)
`Leonard Presta, et al., Humanization of an Anti-Vascular
`Endothelial Growth Factor Monoclonal Antibody for the
`Therapy of Solid Tumors and Other Disorders, 57 CANCER
`RESEARCH 4593-4599 (1997)
`Marianne Brüggerman, et al., The Immunogenicity of Chimeric
`Antibodies, 170 J. EXP. MED. 2153-2157 (1989)
`Jatinderpal Kalsi, et al., Structure-function Analysis and the
`Molecular Origins of Anti-DNA Antibodies in Systemic Lupus
`Erythematosus, EXPERT REVIEWS IN MOLECULAR MEDICINE 1-
`28 (1999)
`Scott Gorman, et al., Reshaping a Therapeutic CD4 Antibody,
`88 PROC. NATL. ACAD. SCI. 4181-4185 (1991)
`John Isaacs, et al., Humanised Monoclonal Antibody Therapy
`for Rheumatoid Arthritis, 340 THE LANCET 748-752 (1992)
`Elvin Kabat, et al., Sequences of Proteins of Immunological
`Interest 1-23 (4th ed. 1987)
`Anna Tramontano, et al., Framework Residue 71 Is a Major
`Determinant of the Position and Conformation of the Second
`Hypervariable Region in the VH Domains of Immunoglobulins,
`215 J. MOL. BIOL. 175-182 (1990)
`H.M. Shepard, et al., Herceptin, in THERAPEUTIC ANTIBODIES.
`HANDBOOK OF EXPERIMENTAL PHARMACOLOGY 183-219 (Y.
`Chernajovsky & A. Nissim, eds. 2008)
`Excerpt from Roche Finance Report 2016
`Modified Default Standing Protective Order and Patent
`Owner’s Certification of Agreement to Terms
`Modified Default Standing Protective Order – Redline
`Declaration of Robert J. Gunther, Jr. in support of Motion for
`Admission Pro Hac Vice
`Declaration of Daralyn J. Durie in support of Motion for
`Admission Pro Hac Vice
`Declaration of Lisa J. Pirozzolo in support of Motion for
`Admission Pro Hac Vice
`
`8
`
`
`
`Patent Owner’s
`Exhibit Number
`2035
`
`
`2036
`
`2037
`
`2038
`2039
`
`2040
`
`2041
`2042
`2043
`2044
`
`2045
`
`2046
`2047
`2048
`2049
`2050
`2051
`2052
`2053
`
`2054
`
`2055
`
`2056
`2057
`2058
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`
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`IPR2017-01374
`Patent Owner’s Updated Exhibit List
`
`
`Exhibit Name
`
`Declaration of Kevin S. Prussia in support of Motion for
`Admission Pro Hac Vice
`Declaration of Andrew J. Danford in support of Motion for
`Admission Pro Hac Vice
`File History for U.S. Patent Application No. 07/715,272
`Immunoglobulin Variants (filed June 14, 1991).
`Reserved
`Deposition Transcript of Lutz Riechmann, Celltrion, Inc. v.
`Genentech, Inc. (PTAB), Feb. 14, 2018
`Deposition Transcript of Robert Leonard, Celltrion, Inc. v.
`Genentech, Inc. (PTAB), Feb. 16, 2018
`Expert Declaration of Dr. Ian A. Wilson
`U.S. Patent No. 7,375,193
`U.S. Patent No. 7,560,111
`Leonard Presta, et al., Humanization of an Antibody Directed
`Against IgE, 151 J. IMMUNOLOGY 2623-2632 (1993)
`A. Bondi, van de Waals Volumes and Radii, 68 J. PHYSICAL
`CHEMISTRY 441-451 (1964)
`Reserved
`Reserved
`Reserved
`Reserved
`Reserved
`Reserved
`Reserved
`Ole Brekke, et al., Therapeutic Antibodies for Human Diseases
`at the Dawn of the Twenty-First Century, 2 NATURE REVIEWS |
`DRUG DISCOVERY 52- 62 (2003)
`Thomas A. Waldmann, Monoclonal Antibodies in Diagnosis
`and Therapy, 252 SCIENCE 1657-1662 (1991)
`Greg Winter, et al., Antibody-Based Therapy: Humanized
`Antibodies, 14 TIPS 139-143 (1993)
`Reserved
`Reserved
`Reserved
`
`9
`
`
`
`Patent Owner’s
`Exhibit Number
`2059
`
`
`2060
`
`2061
`
`2062
`
`2063
`
`2064
`
`2065
`
`
`
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`
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`IPR2017-01374
`Patent Owner’s Updated Exhibit List
`
`
`Exhibit Name
`
`Gert Riethmüller, et al., Monoclonal Antibodies in the
`Detection and Therapy of Micrometastic Epthelial Cancers, 4
`CURRENT OP. IMMUNOLOGY 647-655 (1992)
`Gert Riethmüller, et al., Monoclonal Antibodies in Cancer
`Therapy, 5 CURRENT OP. IMMUNOLOGY 732-739 (1993)
`Mark D. Pegram, et al., Phase II Study of Receptor-Enhanced
`Chemosensitivity Using Recombinant Humanized Anti-
`pl85HER2/neu Monoclonal Antibody Plus Cisplatin in Patients
`with HER2/neu-Overexpressing Metastatic Breast Cancer
`Refractory to Chemotherapy Treatment, 16 J. CLINICAL
`ONCOLOGY 2659-2671 (1998)
`Redline of IPR2016-01694 Expert Declaration of Dr. Eduardo
`A. Padlan in Support of Petition for Inter Partes Review of
`Patent No. 6,407,213 and IPR2017-01373 Expert Declaration
`of Lutz Riechmann, Ph.D., in Support of Petition for Inter
`Partes Review of Patent No. 6,407,213
`Corrected Exhibit P of Expert Declaration of Lutz Riechmann,
`Ph.D., in Support of Petition for Inter Partes Review of Patent
`No. 6,407,213
`Deposition Transcript of Lutz Riechmann, Celltrion, Inc. v.
`Genentech, Inc. (PTAB), June 19, 2018
`Transcript of Conference Call, Celltrion, Inc. v. Genentech,
`Inc., June 18, 2018
`
`
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`
`10
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`CERTIFICATE OF SERVICE
`
`I hereby certify that, on December 13, 2018, I caused a true and correct copy of the
`
`following materials:
`
` Patent Owner’s Renewed Motion to Seal
`
` Patent Owner’s Updated Exhibit List
`
` Exhibits 2001, 2002, 2005, and 2006
`
`to be served via electronic mail on the following attorneys of record:
`
`Cynthia Lambert Hardman
`GOODWIN PROCTER LLP
`chardman@goodwinlaw.com
`620 Eighth Avenue New York, NY 10018
`
`Robert V. Cerwinski
`GOODWIN PROCTER LLP
`rcerwinski@goodwinlaw.com
`620 Eighth Avenue New York, NY 10018
`
`Elizabeth Holland
`GOODWIN PROCTER LLP
`eholland@goodwinlaw.com
`620 Eighth Avenue New York, NY 10018
`
`Linnea P. Cipriano
`GOODWIN PROCTER LLP
`lcipriano@goodwinlaw.com
`620 Eighth Avenue New York, NY 10018
`
`Sarah J. Fischer
`GOODWIN PROCTER LLP
`sfischer@goodwinlaw.com
`100 Northern Avenue, Boston, MA 02110
`11
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`
`
`/ Jennifer Graber/
`Jennifer Graber
`
`
`WILMER CUTLER PICKERING HALE AND DORR LLP
`7 WORLD TRADE CENTER
`250 GREENWICH STREET
`NEW YORK, NY 10007
`TEL: 212-295-6446
`FAX: 212-230-8888
`EMAIL: jennifer.graber@wilmerhale.com
`
`
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`12
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