Celltrion, Inc. et al. vs Chugai Seiyaku Kabushiki Kaisha (Chugai Pharmaceutical Co., Ltd.) et al.

Other: Fed Circuit mandate

Notice of Appeal_IPR2022-00578

Judgment Final Written Decision

Other: Hearing transcript

Transcript of Board Telephone Conference on May 24, 2023

Petitioner's Updated List of Exhibits

Petitioner's Objections to Patent Owner's Demonstratives

Patent Owner's Identification of Arguments

Patent Owner's Demonstratives

Petitioner's Reply In Support of Motion to Exclude

ORDER Granting Patent Owners Motion for Admission Pro Hac Vice of Ian M. Swenson 37 C.F.R. sec 42.10

Petitioner's Identification of New Arguments in Patent Owner's Sur-Reply

EX1162 - Petitioner's Demonstratives (Not Evidence)

Petitioner's Updated List of Exhibits

Order Conduct of the Proceeding

Exhibit 3002

Patent Owner's Opposition to Petitioner's Motion to Exclude

LEAP Practitioner Request and Verification Form (Patent Owner)

Petitioner's Motion to Exclude

Patent Owner's Updated Exhibit List

Ex. 2080 - Boers Reply Transcript

Ex. 2081 - Dalby Reply Transcript

Ex. 2082 - Lassman Reply Transcript

Ex. 2083 - Shah Reply Transcript

Patent Owner's Sur-reply

Order: Panel Change Order

Joint Stipulation to Modify the Scheduling Order

Motion for Pro Hac Vice Admission of Ian Swenson

Pro Hac Vice Declaration of Ian Swenson

Patent Owner Genentech, Inc's Power of Attorney

Patent Owner Hoffmann-La Roche Inc's Power of Attorney

Patent Owner Chugai Seiyaku Kabushiki Kaisha's Power of Attorney

Updated Mandatory Notice

Revised Notice of Deposition of Dr. Shah

Order: Hearing Order

EXPUNGED

Request for Oral Argument (corrected)

Patent Owner's Request for Oral Argument

Notice of Deposition of Dr. Paul A. Dalby

Notice of Deposition of Mr. Prescott Lassman

Notice of Deposition of Dr. Shah

Patent Owner's Objections to Petitioner's Reply Evidence

Notice of Deposition of Dr. Boers

Rong Deng et al., “Subcutaneous bioavailability of therapeutic antibodies as a function of FcRn binding affinity in mice,” mAbs 4:1, 101-09 (February 2012) (“Deng 2012”)

“Application Number: 125472Orig1s000 Medical Review(s),” Center for Drug Evaluation and Research (March 6, 2009) - Part 1

“Application Number: 125472Orig1s000 Medical Review(s),” Center for Drug Evaluation and Research (March 6, 2009) - Part 2

“Application Number: 125472Orig1s000 Medical Review(s),” Center for Drug Evaluation and Research (March 6, 2009) - Part 3

“Application Number: 125472Orig1s000 Medical Review(s),” Center for Drug Evaluation and Research (March 6, 2009) - Part 4

“Application Number: 125472Orig1s000 Medical Review(s),” Center for Drug Evaluation and Research (March 6, 2009) - Part 5

“Application Number: 125472Orig1s000 Medical Review(s),” Center for Drug Evaluation and Research (March 6, 2009) - Part 6

ACTEMRA® (tocilizumab) Label

“Application Number: 125276 Medical Review(s),” Center for Drug Evaluation and Research (November 12, 2009) - Part 1

“Application Number: 125276 Medical Review(s),” Center for Drug Evaluation and Research (November 12, 2009) - Part 2

“Application Number: 125276 Medical Review(s),” Center for Drug Evaluation and Research (November 12, 2009) - Part 3

“Application Number: 125276 Medical Review(s),” Center for Drug Evaluation and Research (November 12, 2009) - Part 4

“Application Number: 125276 Medical Review(s),” Center for Drug Evaluation and Research (November 12, 2009) - Part 5

Letter to Alan Mart, Genentech, Inc., re Supplement BLA Approval (January 4, 2011)

Roy M. Fleischmann et al., “Tocilizumab Inhibits Structural Joint Damage and Improves Physical Function in Patients with Rheumatoid Arthritis and Inadequate Responses to Methotrexate: LITHE Study 2-year Results,” J. Rheumatology 40(2):113-26 (2013) (“Fleischmann”)

Mark C. Genovese et al., “Efficacy and Safety of Tabalumab, an Anti-B-Cell Activating Factor Monoclonal Antibody in a Heterogeneous Rheumatoid Arthritis Population,” J. Clinical Rheumatology, 21(5):231-38 (2015) (“Genovese”)

ClinicalTrials.gov Search Results 3/13/2023 (March 13, 2023)

ClinicalTrials.gov Search Result 22 of 66 for “Subcutaneous Tocilizumab”, ClinicalTrials.gov

ClinicalTrials.gov Search Result 36 of 66 for “Subcutaneous Tocilizumab”, ClinicalTrials.gov

ClinicalTrials.gov Search Result 42 of 66 for “Subcutaneous Tocilizumab”, ClinicalTrials.gov

Deposition Transcript of Dr. Emil Samara, February 24, 2023

Deposition Transcript of Dr. Steven Little, March 9, 2023

Deposition Transcript of Dr. Gregg Silverman, March 14, 2023

Letter to Director Vidal of the United States Patent and Trademark Office (February 22, 2023)

Nádia Emi Aikawa et al., “Immunogenicity of Anti-TNF-α Agents in Autoimmune Diseases,” Clinic Rev. Allerg. Immunol 38:82-89 (2010) (“Aikawa”)

Charlotte Louise Maria Krieckaert et al., “The effect of immunomodulators on the immunogenicity of TNF-blocking therapeutic monoclonal antibodies: a review,” Arthritis Research & Therapy 12:217 (2010) (“Krieckaert”)

Sean M. Falconer et al., “Synchronized Tag Clouds for Exploring Semi-Structured Clinical Trial Data,” Conference of the Centre for Advanced Studies on Collaborative Research (2008) (“Falconer”)

Rebecca J. Williams, “New Look for ClinicalTrials.gov” NLM Technical Bulletin available at https://www.nlm.nih.gov/pubs/techbull/so07/ so07_clinical_trials.html (November 9, 2007, last accessed March 21, 2023) (“Williams”)

CHMP Assessment Report - Herceptin, European Medicines Agency: Science Medicines Health (June 27, 2013) (“Herceptin EMA Report”)

Assessment Report for Stelara, European Medicines Agency (2009)

ClinicalTrials.gov search results for: subcutaneous tocilizumab, ClinicalTrials.gov (accessed March 21, 2023) (“Subcutaneous Tocilizumab” Search Results)

ClinicalTrials.gov search results for: subcutaneous tocilizumab, first posted on or before 11/08/2010, ClinicalTrials.gov (accessed March 21, 2023) (“Subcutaneous Tocilizumab” Search Results Prior to Nov. 8, 2010)

ClinicalTrials.gov search results for: tocilizumab, ClinicalTrials.gov (accessed March 21, 2023) (“Tocilizumab” Search Results)

ClinicalTrials.gov search results for: tocilizumab, first posted on or before 11/08/2010 ClinicalTrials.gov (accessed March 21, 2023) (“Tocilizumab” Search Results Prior to Nov. 8, 2010)

Google search results for: subcutaneous tocilizumab, Google.com (accessed March 20, 2023) (Google Search Results)

Joel M. Kremer et al., “Tocilizumab Inhibits Structural Joint Damage in Rheumatoid Arthritis Patients with Inadequate Responses to Methotrexate,” Arthritis & Rheumatism 63(3):609-621 (2011) (“Kremer 2011”)

Catherine De Angelis et al., “Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors,” N. Engl. J. Med., 351:1250-1251 (Sept. 16, 2004) (“ICMJE Statement”)

Hisham Abdallah et al., “Pharmacokinetic and Pharmacodynamic Analysis of Subcutaneous Tocilizumab in Patients with Rheumatoid Arthritis From 2 Randomized, Controlled Trials: SUMMACTA and BREVACTA,” J. Clin. Pharmacol. 57(4):459-468 (Nov. 2017) (“Abdallah”)

(“Application Number: 125276 Labeling,” Center for Drug Evaluation and Research)

Declaration of Aviv Zalcenstein, Esq. (“Zalcenstein Decl.”)

“Application Number: 125276 REMS,” Center for Drug Evaluation and Research (2010)

“Application Number: BLA 125276/S049,” Center for Drug Evaluation and Research (2011)

Declaration of Prescott M. Lassman, Esq. in support of Petitioner’s Reply

Declaration of Dhaval K. Shah, B. Pharm., M.S., Ph.D in support of Petitioner’s Reply

Declaration of Paul A. Dalby, Ph.D. in support of Petitioner’s Reply

Declaration of Maarten Boers, M.D., M.Sc., Ph.D. in support of Petitioner’s Reply

Petitioner's Updated List of Exhibits

Petitioner's Reply

ORDER Granting Petitioner’s Motions for Admission Pro Hac Vice of Robert Cerwinski, Aviv Zalcenstein, and Brigid Morris 37 C.F.R. sec 42.10

Updated Power of Attorney

Updated Mandatory Notice

Petitioner's Notice of Deposition of Dr. Gregg Silverman

Petitioner's Notice of Deposition of Dr. Steven Little

Petitioner's Updated Mandatory Notices

Petitioner's Notice of Deposition of Dr. Emil Samara

Corrected Declaration of Brigid Morris ISO of Motion for Pro Hac Vice Admission

Exhibit 3001

Joint Notice of Stipulation to Change Due Dates

EXPUNGED

Celltrion, Inc. Unopposed Motion for Pro Hac Vice Admission of Robert Cerwinski

Declaration of Robert Cerwinski ISO Motion for PHV Admission

Celltrion, Inc. Unopposed Motion for Pro Hac Vice Admission of Aviv Zalcenstein

Declaration of Aviv Zalcenstein ISO Motion for PHV Admission

Celltrion, Inc. Unopposed Motion for Pro Hac Vice Admission of Brigid Morris

Second Updated Mandatory Notice

Panel Change Order

Petitioner's Objections to Patent Owner's Response Evidence

Celltrion 264 POR - 2022.12.15

Little Declaration

Samara Declaration

Silverman Declaration

Patent Owners' Updated Exhibit List IPR2022-00578

Frey 2007

Kelley's 2001

Boers Transcript

Dalby Transcript

Lassman Transcript

Wang 2007

Krishnan 2010

Shire 2004

Weiner 2006

Turner 2018

Dirks 2010

Wang 2009

Lobo 2004

Ponce 2005

Lindqvist 2005

Mould 2010

McDonald 2010

FDA Guidance for Industry

Braun 1997

Stas 2010

Haller 2007

Rau 2002

ClinicalTrials.gov Search Results

Manheimer 2002

New Oxford American Dictionary

Webster's New World Dictionary

Kivitz 2013

Shah Transcript

Hermeling 2004

Wang 1999

Krishnamurthy 2002

Rowland and Tozer

Sanchez-Felix 2020

FDA Population Pharmacokinetics

FDA Points to Consider

1999 FDA Guidance

Rixtuxan Label

NCT00930514

Bittner 2014

Ryman 2017

2002 Guidelines

Aletaha 2002

Bulpitt 1999

2001 PDR - Remicade

Calabrese 2003

Elliott 1995

2002 Humira BLA

NCT00800436

Bittner 2012

Herceptin Label

FDA Immunogenicity

Frost 2007

Little CV

Siboni Golimumbab

Samara CV

Silverman CV

Kay 2008

Badkar 2021

Orr 2018

Narasimhan 2012

Joint Notice of Stipulation to Change Due Dates

Notice of Deposition of Dr. Paul A. Dalby

Notice of Deposition of Dr. Maarten Boers

ORDER Granting Patent Owners Motions for Admission Pro Hac Vice of Paul B. Gaffney, Charles L. McCloud, Angela X. Gao, and Kristin L. Froehle 37 C.F.R. Sec 42.10

Notice of Deposition of Dr. Dhaval K. Shah

EXPUNGED

ORDER Granting Petitioner's Motion to Submit Supplemental Information

Motion for Pro Hac Vice Admission of Paul B. Gaffney

Declaration of Paul B. Gaffney

Motion for Pro Hac Vice Admission of Charles L. McCloud

Declaration of Charles L. McCloud

Motion for Pro Hac Vice Admission of Angela X. Gao

Declaration of Angela X. Gao

Patent Owners' Exhibit List

Motion for Pro Hac Vice Admission of Kristin L. Froehle

Declaration of Kristin L. Froehle

Notice of Deposition of Mr. Lassman

Patent Owners' Opposition to Petitioner's Motion to Submit Supplemental Information

Petitioner's Motion to Submit Supplemental Information

EX1118 - Transcript of Board Telephone Conference on Sept. 21, 202

EX1119 - Second Declaration of Dr. Maarten Boers..pdf

Order: Conduct of Proceeding

Institution Decision: Grant

SCHEDULING OREDER

Patent Owners' Waiver of Preliminary Response

Patent Owners' First Updated Mandatory Notices

Patent Owners' Mandatory Notices

Patent Owner Chugai's Power of Attorney

Patent Owner Genentech's Power of Attorney

Patent Owner HLR's Power of Attorney

Notice: Notice filing date accorded

Petitioner's Power of Attorney

U.S. Patent No. 8,580,264 (���the ���264 Patent���)

Curriculum Vitae of Dhaval K. Shah B. Pharm., M.S., Ph.D.

Excerpts from Milo Gibaldi and Donald Perrier, Pharmacokinetics. 2d Ed. (2007)

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Gino Vena et al., ���Drug focus: adalimumab in the treatment of moderate to severe psoriasis���, Biologics: Targets & Therapy 2007:1(2) 93-103 (���Vena 2007���)

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Package Insert for SIMPONI (golimumab), Revised April 2009, available at https://www.accessdata.fda.gov/drugsatfda _docs/label/2009/125289s000lbl.pdf (���Simponi 2009 Label���)

Excerpt of Physicians��� Desk Reference, 61st Edition (2000) for Xolair�� (omalizumab) (���PDR 2007 Excerpt ��� Xolair���)

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Naoto Hayashi et al., ���A mechanism-based binding model for the population pharmacokinetics and pharmacodynamics of omalizumab���, Br. J. Clin. Pharmacol. 63(5):548-561 (2006) (���Hayashi 2006���)

WM Awni et al., ���Steady-state Adalimumab (HUMIRA) Pharmacokinetics (PK) Following Every Other Week (eow) Dosing of 40mg Subcutaneous (s.c.) Injection, in Rheumatoid...��� (2004) (���Awni 2004���)

David Z. D���Argenio et al., ADAPT V User���s Guide (July 2009) (���ADAPT V User���s Guide���)

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Part 2 - Prosecution File History of U.S. Patent No. 8,580,264

Part 3 - Prosecution File History of U.S. Patent No. 8,580,264

Part 4 - Prosecution File History of U.S. Patent No. 8,580,264

Part 5 - Prosecution File History of U.S. Patent No. 8,580,264

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Part 2 - Prosecution File History of U.S. Patent No. 10,874,677

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Curriculum Vitae of Paul A. Dalby, Ph.D.

Certificate of Translation (pg. 1-2), Translation (pgs. 3-32), & Original (pg. 33���64): PCT International Publication No. WO 2009084659A1

U.S. Patent No. 8,568,720

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

September 17, 2013 PTO Notice of Final Determination and Requirement for Election for U.S. Pat. No. 5,795,965

Part 1 - Prosecution File History of U.S. Patent No. 8,568,720

Part 2 - Prosecution File History of U.S. Patent No. 8,568,720

Package Insert for ACTEMRA (tocilizumab), Revised March 2021, available at https://www.accessdata.fda.gov/drugsatfda_ docs/label/2021/125276s131lbl.pdf

Declaration of Prescott M. Lassman, Esq.

Declaration of Paul A. Dalby, Ph.D.

Excerpt from Y. Chernajovsky and A. Nissim, Handbook of Experimental Pharmacology 181, ���Humanized Antihuman IL-6 Receptor Antibody, Tocilizumab��� 151-60 (2008)

Sequence Listing for WO2009/041621 A1

Package Insert for HUMIRA (Adalimumab), Revised (December 2002)

U.S. Nat.Library of Medicine, NIH, Press Release: National Institutes of Health Launches ���ClinicalTrials.gov��� (February 29, 2000), https://www.nlm.nih.gov/archive/20040831/news/ press_releases/clntrlpr00.html

Package Insert for CIMZIA (certolizumab pegol), Revised May 2009 (���CIMZIA 2009 Label���)

Norihiro Nishimoto et al., ���Toxicity, Pharmacokinetics, and Dose-Finding Study of Repetitive Treatment with the Humanized Anti-Interleukin 6 Receptor Antibody MRA...,��� The Journal of Rheumatology 30:1426���35 (2003)

ACTEMRA�� (tocilizumab) Prescribing Information (Revised January 2011), available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125276s007s010s011lbl.pdf

Declaration of Yahn Lin Chu, Esq.

Declaration of Maarten Boers, M.D., M.Sc., Ph.D.

Petition for Inter Partes Review of U.S. Patent No. 8,580,264

Declaration of Dhaval K. Shah, B. Pharm., M.S., Ph.D