Filed on behalf of Patent Owner Genentech, Inc. by:
`
`
`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
`
`____________________________________________
`
`PFIZER, INC., and
`SAMSUNG BIOEPIS CO., LTD.,
`Petitioners,
`
`v.
`
`GENENTECH, INC.,
`Patent Owner.
`____________________________________________
`
`Case IPR2017-014881
`Patent 6,407,213
`____________________________________________
`
`PATENT OWNER’S RENEWED MOTION TO SEAL
`
`
`1 Case IPR2017-02139 has been joined with this proceeding.
`
`

`

`
`
`
`IPR2017-01488
`
` 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
`
`public disclosure of Genentech’s work humanizing the 4D5 antibody at the oral
`
`hearing and the Board’s reliance on that work in its Final Written Decision, see
`
`Paper 87 at 21-28, Patent Owner does not request the sealing of the Final Written
`
`Decision, any paper previously filed in this proceeding, or any other exhibit
`
`submitted in this proceeding.
`
`REASONS FOR RELIEF REQUESTED
`
`Although “the default rule is that all papers filed in an inter partes review
`
`are open and available for access by the public,” a party may file a motion with the
`1
`
`
`
`

`

`
`
`
`IPR2017-01488
`
` 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
`
`provides for protective orders for trade secret or other confidential research,
`
`development, or commercial information.”
`
`The parties have conferred and agreed to the provisions of the Modified
`
`Default Standing Protective Order set forth in Exhibit 2030, and have stipulated to
`
`be bound to the terms set forth therein. Exhibit 2031 shows the proposed
`
`modifications from the Default Standing Protective Order, to which the parties
`
`have stipulated, in redline. The Modified Default Standing Protective Order
`
`provides:
`
`Where confidentiality is alleged as to some but not all of the
`
`information submitted to the Board, the submitting party shall file
`
`confidential and non-confidential versions of its submission, together
`
`with a Motion to Seal the confidential version setting forth the reasons
`
`why the information redacted from the non-confidential version is
`2
`
`
`
`

`

`
`
`
`confidential and should not be made available to the public. The
`
`IPR2017-01488
`
` 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
`
`information shall remain under seal unless, upon motion of a party
`
`and after a hearing on the issue, or sua sponte, the Board determines
`
`that some or all of the redacted information does not qualify for
`
`confidential treatment.
`
`(Ex. 2030, Modified Default Standing Protective Order and Patent Owner’s
`
`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,
`
`which is described in the ’213 patent. But Exhibits 2001 and 2002 also describe
`
`Dr. Presta’s confidential research on other projects that are unrelated to the issues
`
`in this proceeding and that occurred after his work humanizing the 4D5 antibody.
`
`Patent Owner requests to seal the description of these unrelated experiments in the
`
`table of contents on page 5 of Exhibit 2001, as well as the detailed experimental
`
`description on pages 42-90 of Exhibit 2001 and pages 40-68 of Exhibit 2002.
`
`
`
`3
`
`

`

`
`
`
`Exhibits 2005 and 2006 are laboratory notebooks authored by Mr. John
`
`IPR2017-01488
`
` Patent Owner’s Renewed Motion to Seal
`
`
`Ridgeway Brady, which corroborate the inventors’ work relating to the ’213
`
`patent. Patent Owner does not request to seal any portion of Mr. Brady’s
`
`notebooks cited or discussed in these proceedings. However, there are certain
`
`experiments in the beginning of Exhibits 2005 and 2006 that do not relate to
`
`humanized 4D5 antibodies and therefore are not relevant to the issue of
`
`corroboration or any other issue in these proceedings. Patent Owner requests to
`
`seal the details of this confidential research that does not involve humanized 4D5
`
`antibodies on pages 13-72 of Exhibit 2005 and pages 13-46 of Exhibit 2006.
`
`The material that Patent Owner requests to seal is maintained confidentially
`
`at Genentech, and the public disclosure of such confidential research and
`
`development materials would place Genentech at a competitive disadvantage.
`
`Patent Owner is submitting concurrently herewith redacted versions of Exhibits
`
`2001, 2002, 2005, and 2006, and attests that the materials sought to be protected is
`
`not directly or indirectly relied on in the Board’s Final Written Decision. Rather,
`
`the only information that Patent Owner is seeking to redact in Exhibits 2001, 2002,
`
`2005, and 2006 are the details of confidential experiments unrelated to the issues in
`
`
`
`4
`
`

`

`
`
`
`this proceeding.2 There is therefore good cause for sealing these confidential
`
`IPR2017-01488
`
` Patent Owner’s Renewed Motion to Seal
`
`
`research materials, and no countervailing public interest that would warrant
`
`unsealing the portions of these exhibits that are unrelated to the issues in this
`
`proceeding. Indeed, in related IPR2017-01373 and IPR2017-01489, the Board
`
`granted Patent Owner’s motion to seal these materials where, as here, the material
`
`sought to be sealed was not relied upon the Final Written Decision. See IPR2017-
`
`01373, Paper 84, at 54-55 (sealing, inter alia, Exhibits 2001, 2002, 2005, and
`
`2006); IPR2017-01489, Paper 86, at 53 (same).
`
`
`2
`The Board referred to the dates and signatures on pages 43-63, 65, 68-71,
`
`73, 74, 77-84, and 90 of Exhibit 2001 and pages 40-43, 46, 51, 59-61, and 64-68 of
`
`Exhibit 2002 to refute “Petitioner’s suggestion that [the notebooks] are
`
`substantially unsigned and undated.” See Paper 87 at 25 n.14. The Board did not
`
`rely upon or discuss the experimental details 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 the dates and signatures referred to
`
`in the Final Written Decision be sealed; Patent Owner only requests to seal the
`
`details of the unrelated research described on those pages.
`
`
`
`5
`
`

`

`
`
`
`IPR2017-01488
`
` Patent Owner’s Renewed Motion to Seal
`
`Patent Owner has conferred with Petitioners regarding this renewed motion
`
`to seal, and Petitioners have indicated that it does not oppose the relief requested
`
`herein.
`
`Patent Owner therefore respectfully requests that the Board grant this
`
`renewed motion to seal portions of Exhibits 2001, 2002, 2005, and 2006 as
`
`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
`
`
`
`6
`
`

`

`
`
`
`
`IPR2017-01488
`Patent Owner’s Updated Exhibit List
`
`
`IPR2017-01488
`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
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`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
`
`
`
`
`
`
`
`

`

`Patent Owner’s
`Exhibit Number
`2020
`
`
`2021
`
`2022
`
`2023
`
`2024
`
`2025
`
`2026
`
`2027
`
`2028
`
`2029
`2030
`
`2031
`2032
`
`2033
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2017-01488
`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
`File History for U.S. Patent Application No. 07/715,272
`Immunoglobulin Variants (filed June 14, 1991).
`Shearman, et al. Construction, expression and characterization
`of humanized antibodies directed against the human a/b T cell
`receptor. J. Immunol. 147(12):4366-4373, (December 15,
`1991)
`
`8
`
`

`

`Patent Owner’s
`Exhibit Number
`2034
`
`
`2035
`
`2036
`
`2037
`
`2038
`
`2039
`
`2040
`
`2041
`2042
`2043
`2044
`
`2045
`
`2046
`2047
`2048
`2049
`2050
`2051
`
`2052
`
`2053
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2017-01488
`Patent Owner’s Updated Exhibit List
`
`
`Exhibit Name
`
`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
`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
`Deposition Transcript of Jefferson Foote, Pfizer, Inc. v.
`Genentech, Inc. (PTAB), Feb. 4, 2018
`Deposition Transcript of Timothy Buss, Pfizer, Inc. v.
`Genentech, Inc. (PTAB), Feb. 8, 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
`Man Sung Co, et al., Chimeric and Humanized Antibodies with
`Specificity for The CD33 Antigen, 148 J. IMMUNOLOGY 1149-
`1154 (1992)
`Trial Transcript – Vol. II, Sinomab Bioscience Ltd. v.
`Immunomedics, Inc., No. 2417-VCS (Del. Ch. Nov. 13, 2008)
`(Excerpted)
`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)
`
`9
`
`

`

`Patent Owner’s
`Exhibit Number
`2054
`
`
`2055
`
`2056
`
`2057
`
`2058
`
`2059
`
`2060
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2017-01488
`Patent Owner’s Updated Exhibit List
`
`
`Exhibit Name
`
`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)
`IPR2016-01694 Expert Declaration of Edward Ball, M.D. In
`Support of Petition for Inter Partes Review of Patent No.
`6,407,213
`About HNCs and HNDs, SCOTTISH QUALIFICATIONS AUTH.,
`https://www.sqa.org.uk/sqa/168.2432.html (last visited Feb. 6,
`2018)
`Redline of IPR2016-01694 Expert Declaration of Edward Ball,
`M.D. in Support of Petition for Inter Partes Review of Patent
`No. 6,407,213 and IPR2017-01488 Declaration of Timothy
`Buss
`Deposition Transcript of Jefferson Foote, Pfizer, Inc. v.
`Genentech, Inc. (PTAB), June 14, 2018
`Transcript of Conference Call, Pfizer, Inc. v. Genentech, Inc.,
`June 19, 2018
`
`
`
`10
`
`
`
`
`
`

`

`
`
`
`
`
`
`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:
`
`Amanda Hollis
`KIRKLAND & ELLIS LLP
`amanda.hollis@kirkland.com
`300 North LaSalle, Chicago, IL 60654
`
`Stefan M. Miller, Ph.D.
`Stefan.miller@kirkland.com
`601 Lexington Avenue, New York, NY 10022
`
`Benjamin A. Lasky
`benjamin.lasky@kirkland.com
`601 Lexington Avenue, New York, NY 10022
`
`Sarah K. Tsou
`sarah.tsou@kirkland.com
`601 Lexington Avenue, New York, NY 10022
`
`Mark C. McLennan
`mark.mclennan@kirkland.com
`601 Lexington Avenue, New York, NY 10022
`
`
`
`
`11
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`

`
`
`
`
`
`
`
`
`
`
`
`
`
`Christopher J. Citro
`christopher.citro@kirkland.com
`601 Lexington Avenue, New York, NY 10022
`
`Micah Rappazzo
`micah.rappazzo@kirkland.com
`601 Lexington Avenue, New York, NY 10022
`
`Sharick Naqi
`sharick.naqi@kirkland.com
`300 North LaSalle, Chicago, IL 60654
`
`Pfizer_Genentech_IPRs@kirkland.com
`
`Dimitrios T. Drivas
`WHITE & CASE LLP
`ddrivas@whitecase.com
`1221 Avenue of the Americas, New York, NY 10020
`
`Scott T. Weingaertner
`WHITE & CASE LLP
`scott.weingaertner@whitecase.com
`1221 Avenue of the Americas, New York, NY 10020
`
`Amit H. Thakore
`WHITE & CASE LLP
`athakore@whitecase.com
`1221 Avenue of the Americas, New York, NY 10020
`
`Eric Majchrzak
`WHITE & CASE LLP
`eric.majchrzak@whitecase.com
`1221 Avenue of the Americas, New York, NY 10020
`
`
`
`
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`
`12
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`

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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
`
`
`
`
`
`13
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`