Pfizer, Inc vs Genentech, Inc.

Granting Patent Owner's Unopposed Motion to Expunge

Patent Owner's Unopposed Motion to Expunge

Termination Decision Document

Joint Motion to Terminate IPR2017-02019

Joint Request that Settlement Agreement be Treated as CBI

Patent Owner's Updated Exhibit List

Settlement Agreement

Joint Notice of Stipulation to Modify Due Dates 4-5

PO Updated Exhibits List

Joint Notice Of Scheduling Order Modification

Exhibit 2061 Transcript of Conference Call

PO Objections to Evidence

Notice of Extended Deadline for Petitioner's Reply

EXPUNGED

Petitioner's Reply to Patent Owner's Response [PUBLIC]

Petitioner's Motion to Seal

Declaration of Steve Cattor

Pfizer PFE Belgium SPRL v. Genentech Inc. Decision of Dutch Commercial Court, August 28, 2018, finding EP ¿¿¿455 invalid.

Reply Declaration of Mark C. McLennan

Reply Declaration of Christopher Lowden

Deposition Transcript of Stephanie Mendelsohn

Rodney Pearlman and Y. John Wang, Formulation, Characterization

Cornelia M. Gorman et al., Transient Production of Proteins Using an Adenovirus Transformed Cell Line

Darrell Teh-Yung Liu, Deamidation: A Source of Microheterogeneity in Pharmaceutical Proteins

Certified Translation of Ex-1055 Decision

Declaration of Richard Buick (Dec. 14, 2017) filed in IPR2018-00331

Deposition Transcript of Ruben G. Carbonell, Ph.D.

Deposition Transcript of Holly Prentice, Ph.D.

Deposition Transcript of Gregory S. Blank, Ph.D.

LLOYD R. SNYDER AND JOSEPH J. KIRKLAND, INTRODUCTION TO MODERN LIQUID CHROMATOGRAPH

EXPUNGED

U.S. Patent No. 5,677,171

CHISUM ON PATENTS 3.04

Deposition Transcript of Reed J. Harris

Waterside Binder Vol. 2 (Produced by Genentech Oct. 16, 2018)

Waterside Binder Vol. 3 (Produced by Genentech Oct. 16, 2018)

Waterside Binder Vol. 4 (Produced by Genentech Oct. 16, 2018)

Waterside Binder Vol. 5 (Produced by Genentech Oct. 16, 2018)

Waterside Binder Vol. 6 (Produced by Genentech Oct. 16, 2018)

Waterside Binder Certificate of Service (Oct. 16, 2018)

International PCT Application No. WO 97/04801 to Andya et al. (Highlighted Version)

U.S. Patent 9,489,447 Certified File History Vol. 1

U.S. Patent 9,489,447 Certified File History Vol. 3

U.S. Patent 9,489,447 Certified File History Vol. 4

Library of Congress Record for Exhibit 1065

Waterside Binder Vol. 1 (Produced by Genentech Oct. 16, 2018)

U.S. Patent No. 6,339,142 (Highlighted Version)

Email from M. McBriar to S. Tsou dated Oct. 17, 2018

U.S. Patent 9,489,447 Certified File History Vol. 2

Library of Congress Record for Exhibit 1064

Patent Owner' Request for Oral Hearing

Petitioner's Request for Oral Argument

Petitioner's Notice of Deposition of Reed J. Harris, Ph. D. Under CFR 42.53

Joint Notice of Stipulation to Revise Schedule

Joint Notice of Stipulation to Revise Schedule

Joint Notice of Stipulation to Revise Schedule

Decision Granting-in-Part Petitioner's Motion for Additional Discovery

Patent Owner's Opposition to Motion for Additional Discovery

Petitioner's Updated Mandatory Notices

Patent Owner's Updated Mandatory Notice

Petitioner Motion for Additional Discovery

Joint Notice of Stipulation to Revise Schedule

Petitioners Updated Exhibit List

Transcript of Conference Call September 11, 2018

MODIFYING SCHEDULING ORDER

Exhibit 3001

Petitioners Notice of Deposition of Holly Prentice

Petitioners Notice of Deposition of Gregory S. Blank

Petitioner¿¿¿s Notice of Deposition of Ruben G. Carbonell

Petitioners Notice of Deposition of Stephanie Mendelsohn

Petitioners Updated Mandatory Notices

Decision - 37 C.F.R. 42.10(c)

Granting Petitioners Motion for Pro Hac Vice Recognition of Mr. Mark C. McLennan 37 C.F.R. sec 42.10(c)

PATENT OWNER¿¿¿S UNOPPOSED MOTION FOR ADMISSION PRO HAC VICE OF KEVIN A. GOLDMAN

DECLARATION OF KEVIN A. GOLDMAN IN SUPPORT OF MOTION FOR ADMISSION PRO HAC VICE

Petitioners Motion for the Pro Hac Vice Admission of Mark C. McLennan

Declaration of Mark C. McLennan in Support of Petitioners Motion for the Pro Hac Vice Admission

Petitioners Updated Exhibit List

Petitioners Updated Mandatory Notices

Petitioners Objections to Admissibility of Evidence

Patent Owner's Motion to Seal

EXPUNGED

Patent Owner's Response

EXPUNGED

EXPUNGED

EXPUNGED

Genentech, Inc. Excerpts of Notebook 22722 (Janet Yang)

Genentech, Inc. Excerpts of Notebook 24207 (Janet Yang)

Genentech, Inc. Excerpts of Notebook 24208 (Janet Yang)

Genentech, Inc. Excerpts of Notebook 26196 (Janet Yang)

Curriculum Vitae of Dr. Gregory S. Blank, Ph.D.

Genentech, Inc. Clinical Manufacturing Formula Document Lot No. M21-5 PUBLIC

Genentech, Inc. Clinical Manufacturing Formula Document for Buffer Recipe PUBLIC

Modified Default Standing Protective Order and Patent Owner¿¿¿s Certification of Agreement to Terms

Modified Default Standing Protective Order ¿¿¿ Redline

Declaration of Gregory S. Blank, Ph.D.

Declaration of Holly Prentice, Ph.D.

Declaration of Ruben G. Carbonell, Ph.D.

Rice 1991

Tang 2018

Genentech, Inc. Excerpts of Notebook 22723 (Janet Yang)

Genentech, Inc. Excerpts of Notebook 29916 (Janet Yang)

Genentech, Inc. Clinical Manufacturing Formula Document Lot No. M21-4 PUBLIC

Declaration of Stephanie Mendelsohn

Deposition Transcript of Carl Scandella, Ph.D., May 31, 2018

Deposition Transcript of Richard Buick, Ph.D., June 7, 2018

Horvath 2010

Hossler 2015

Konakovsky 2016

Naciri 2008

Nagashima 2013

Khawli 2010

Genentech, Inc. Excerpts of Notebook 20705 (Carol Basey) PUBLIC

FDA Q6B GUIDANCE 1999

Robinson 2001

Sinha 2009

Xie 2016

Lain 2013

Zhang 2015

Geiger 1987

Stratton 2001

Huang 2005

Spreadsheets Produced by Pfizer on June 25, 2018

Liu 2016

Patent Owner's Updated Mandatory Notice

Buick Deposition Notice

Scandella Deposition Notice

Notice of Stipulation - Modification of Due Dates

Conduct of the Proceeding

Declaration of Keith Carson [Corrected]

Petitioners Updated Mandatory Notices

Order - Conduct of the Proceeding - 37 CFR 42.5

Decision - Granting Petitioner's Motions for Pro Hac Vice Recognition of Ms. Sarah K. Tsou - 37 CFR 42.10(c)

PETITIONER¿¿¿S MOTION FOR THE PRO HAC VICE ADMISSION OF SARAH K. TSOU

DECLARATION OF SARAH K. TSOU IN SUPPORT OF PETITIONERS MOTION FOR THE PRO HAC VICE ADMISSION

Patent Owner's Updated Mandatory Notice

Decisoin - Granting Patent Owner's Motions for Pro Hac Vice Recognition of Mr. Robert J. Gunter, Jr. and Ms. Daralyn J. Durie - 37 CFR 42.10(c)

Patent Owner's Objections to Evidence

Petitioner Pfizer¿¿¿s Objections to Admissibility of Evidence

Scheduling Order

Trial Instituted Document

Patent Owner Third Updated Mandatory Notices

Petitioners Updated Mandatory Notices

Petitioners Updated Mandatory Notices

Gunther PHV

Gunther Declaration

Durie PHV

Durie Declaration

Patent Owner's Preliminary Response

Kalsi, Structure-Function Analysis

Jenkins, Modifications of Therapeutic Proteins

Storto Declaration

Wang Declaration

Pikal The Effects of Formulation Variables

Holzman, Gene Therapy

Hoyle, Genentech Is Poised

Kishishita, Effect of Temperature Shift

Basey Declaration

Blank Declaration

Simpson Declaration

Yang Declaration

Brunner Investigation of the Interactions of Critical Scale-Up Parameters

Rao Separation of Monoclonal Antibodies

Petitioner's Updated Mandatory Notices

Patent Owner's Updated Mandatory Notices

Patent Owner's Updated Mandatory Notice

Genentech, Inc.'s Power of Attorney

Patent Owner's Mandatory Notice

Genentech, Inc.'s Power of Attorney

Notice of Accord Filing Date

Petitioner's Power of Attorney

Petition For Inter Partes Review of U.S. Patent No. 6,339,142 Under 35 U.S.C. 311 And 37 C.F.R. 42.100

U.S. Patent No. 6,339,142

Application No. 09/679,397 File History

Declaration of Dr. Carl Scandella

International PCT Application No. WO 97/04801 to Andya et al.

Reed J. Harris, Processing of C-terminal Lysine and Arginine Residues of Proteins Isolated from Mammalian Cell Culture, 705 J. Chromatography A 129 (1995)

Reed J. Harris, Chromatographic Techniques for the Characterization of Human MAbs (Slides presented at the Waterside Monoclonal Conference held at the Omni Waterside Hotel in Harborside-Norfolk, Virginia on Apr. 22-25, 1996)

U.S. Patent No. 6,489,447

Application No. 12/418,905 File History

Application No. 10/949,683 File History

Application No. 10/253,366 File History

U.S. Patent No. 6,267,958

Application No. 08/615,369 File History

Baselga et al., Phase II Study of Weekly Intravenous Recombinant Humanized Anti-p185 HER2 Monoclonal Antibody in Patients with HER2/neu-Overexpressing Metastatic Breast Cancer, 14(3) J. Clin. Oncol. 737-44 (1996)

1998 FDA Approved Label for Herceptin

Press Release, Genentech, Inc. Biotechnology Breakthrough In Breast Cancer Wins FDA Approval (Sept. 25, 1998) (on file at Genentech company website)

Hudziak et al p185 HER2 Monoclonal Antibody Has Antiproliferative Effects In Vitro and Sensitizes Human Breast Tumor Cells to Tumor Necrosis Factor, 9(3) Molecular Cellular Biology 1165-72 (1989)

Manning et al., Stability of Protein Pharmaceuticals, 6 Pharm. Research 11 (1989)

Genentech, Inc. Annual Report (Form 10-K) (Jan. 22, 1999)

U.S. Patent No. 5,821,337

USPTO Assignment Record for Application No. 09/304,465

European Patent Number EP 1 308 455

European Patent Office Opposition Division Decision for European Patent No. 1 308 455 (October 5, 2010)

Boards of Appeal of the European Patent Office Decision for European Patent No. 1 308 455 (April 16, 2015)

Approved Judgment from Hospira UK Ltd. v. Genentech Inc., Case No. HC12 C03487, High Court of Justice, Chancery Division, Patents Court (April 10, 2014)

Declaration of Simon Charles Cohen

Hospiras Re-Amended Grounds of Invalidity from Hospira UK Ltd. v. Genentech Inc., Case No. HC12 C03487, High Court of Justice, Chancery Division, Patents Court (December 13, 2013)

Genentechs Re-Amended Defence from Hospira UK Ltd. v. Genentech Inc., Case No. HC12 C03487, High Court of Justice, Chancery Division, Patents Court (January 10, 2014)

2017 FDA Approved Label for Herceptin

Carter, Targeting The Product Of The HER2/neu Protooncogene For Therapy, Breast Cancer Advances in Biology and Therapeutics, 21st Meeting of the International Association for Breast Cancer Research, July 3-5, 1996

Paul Carter et al., Humanization of an Anti-p185 HER2 Antibody for Human Cancer Therapy, 89 Proc. Natl Acad. Sci. USA 4285-89 (1992)

Pete Gagnon, Purification Tools for Monoclonal Antibodies (Validated Biosystems, Inc., 1996)

U.S. Patent No. 5,821,337 File History

Lubert Stryer, Biochemistry (4th ed., W.H. Freeman and Co., 1995) [VOL. 1]

Lubert Stryer, Biochemistry (4th ed., W.H. Freeman and Co., 1995) [VOL. 2]

Lubert Stryer, Biochemistry (4th ed., W.H. Freeman and Co., 1995) [VOL. 3]

Lubert Stryer, Biochemistry (4th ed., W.H. Freeman and Co., 1995) [VOL. 4]

Lubert Stryer, Biochemistry (4th ed., W.H. Freeman and Co., 1995) [VOL. 5]

Lubert Stryer, Biochemistry (4th ed., W.H. Freeman and Co., 1995) [VOL. 6]

Reed J. Harris et al., Identification of Multiple Sources of Charge Heterogeneity in a Recombinant Antibody, 752 J. Chromatography B 233 (March, 2001)

L.A. Sorbera et al., Herceptin, 23(10) Drugs of the Future 1078-82 (1998)

Application No. 13/313,931 File History

Declaration of Karen Younkins

Declaration of Christopher Lowden

Library of Congress Record for Exhibit 1013

Library of Congress Record for Exhibit 1030

Library of Congress Record for Exhibit 1033

Declaration of Keith Carson

Declaration of Richard Buick

International PCT Application No. WO 92/22653 to Carter et al.

Martin Jordan et. al., Transfecting mammalian cells: optimization of critical parameters affecting calcium-phosphate precipitate formation, 24(4) Nucleic Acids Research 596-601 (1996)

Instructions (71-7090-00) for Protein A Sepharose CL-4B, GE Healthcare Life Sciences (May, 2011)

Instructions (71-7090-00) for Protein A Sepharose CL-4B, Pharmacia BioTech (Feb. 1994)

Frederick M. Ausubel, et al., Current Protocols in Molecular Biology (1994)