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

Other: Fed Circuit mandate

Notice of Appeal_IPR2022-00579

Final Written Decision

Dose Definition and Meaning

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 Sur-reply

Patent Owner's Updated Exhibit List

Ex. 2080 - Boers Reply Depo Transcript

Ex. 2081 - Dalby Reply Depo Transcript

Ex. 2082 - Lassman Reply Depo Transcript

Ex. 2083 - Shah Reply Depo Transcript

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 Hoffman 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

Request for Oral Argument

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”)

“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

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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”)

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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)

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(“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

EXPUNGED

Exhibit 3001

Conduct of the Proceedings 37 C.F.R. § 42.5

EXPUNGED

Joint Notice of Stipulation to Change Due Dates

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

Declaration of Brigid Morris ISO Motion for PHV Admission

Patent Owners' Second Updated Mandatory Notices

Panel Change Order

Petitioner's Objections to Patent Owner's Response Evidence

Celltrion 677 POR - 2022.12.15

Little Declaration

Samara Declaration

Silverman Declaration

Patent Owners' Updated Exhibit List IPR2022-00579

Frey 2007

Kelley's 2001

Boers Transcript

Dalby Transcript

Lassman Transcript

Wang 2007

Krishnan 2010

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Lindqvist 2005

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Shah Transcript

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Krishnamurthy 2002

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FDA Population Pharmacokinetics

FDA Points to Consider

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Samara CV

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Joint Notice of Stipulation to Change Due Dates

Notice of Deposition of Dr. Paul A. Dalby

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. Maarten Boers

Notice of Deposition of Dr. Dhaval K. Shah

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

Motion for Pro Hac Vice Admission of Kristin L. Froehle

Declaration of Kristin L. Froehle

Patent Owners' Exhibit List

Notice of Deposition of Mr. Lassman

Institution Decision: Granting Institution of Inter Partes Review 35 U.S.C. sec. 314

Order: SCHEDULING ORDER

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 HLR's Power of Attorney

Notice: Notice filing date accorded

Petitioner's Power of Attorney

U.S. Patent No. 10,874,677 (���the ���677 Patent���)

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

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

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Sequence Listing for WO2009/041621 A1

Package Insert for HUMIRA (Adalimumab), Revised (December 2002) (���2002 Humira FDA Label���)

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

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 (���Actemra 2011 Label���)

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. 10,874,677

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