Fresenius Kabi USA, LLC et al. vs Chugai Seiyaku Kabushiki Kaisha et al.

Termination Decision: Pre-DI settlement

Patent Owner's and Petitioners' Joint Motion to Terminate Pursuant to 35 U.S.C. 317

Patent Owner's and Petitioners' Joint Request to Treat Settlement Agreement as Business Confidential Information Pursuant to 35 U.S.C. 317

Exhibit 1101 (BUSINESS CONFIDENTIAL INFORMATION)

Petitioners' Updated Exhibit List

Patent Owners' Waiver of Preliminary Response

Patent Owners' Updated Mandatory Notices

Patent Owners' Mandatory Notices

Chugai Power of Attorney

Hoffmann-La Roche Inc. Power of Attorney

EXPUNGED

NOTICE OF FILING DATE ACCORDED TO PETITION AND TIME FOR FILING PATENT OWNER PRELIMINARY RESPONSE

File History for U.S. Patent No. 10,213,981 - Part 01 of 23 (pp. 1-43)

File History for U.S. Patent No. 10,213,981 - Part 02 of 23 (pp. 44-92)

File History for U.S. Patent No. 10,213,981 - Part 03 of 23 (pp. 93-141)

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File History for U.S. Patent No. 10,213,981 - Part 18 of 23 (pp. 584-642)

File History for U.S. Patent No. 10,213,981 - Part 19 of 23 (pp. 643-701)

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File History for U.S. Patent No. 10,213,981 - Part 22 of 23 (pp. 767-819)

File History for U.S. Patent No. 10,213,981 - Part 23 of 23 (pp. 820-824)

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File History for U.S. Patent No. 10,874,677 - Part 2 of 2 (pp. 216-394)

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Howard L. Levine, Ph.D., Curriculum Vitae

Robert A. Paarlberg, Curriculum Vitae

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N. Kutukculer, S. Caglayan & F. Aydogdu, Study of Pro-Inflammatory

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Ki Hwan Kim & Dong Soo Kim, Juvenile idiopathic arthritis Diagnosis and differential diagnosis

Chugai Pharm. Co., Product Overview of Actemra (May 22, 2008)

Shumpei Yokota et al., Efficacy and safety of tocilizumab in patients with systemic-onset juvenile idiopathic arthritis

C. Aoki et al., Effects of Tocilizumab on Radiological Findings in Polyarticular Juvenile Idiopathic Arthritis

Norihiro Nishimoto, Anti-IL-6 Receptor Antibodies, Usefulness and Issues in Rheumatoid Arthritis

EVALUATION & LICENSING DIVISION, PHARMACEUTICAL & FOOD SAFETY BUREAU; MINISTRY OF HEALTH, LABOUR AND WELFARE

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U.S. FOOD & DRUG ADMIN., Actemra® (tocilizumab), Highlights of Prescribing Information (Apr. 2011)

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Form 8-K, Abbott Laboratories (April 9, 2003)

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FRONTLINE MEDICAL COMMS. INC., TNF Blocker Wins Approvals, 42 INTERNAL MEDICINE NEWS (2009)

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NAT'L INST. OF HEALTH, Extension Study Evaluating the Safety and Efficacy of Subcutaneous Tocilizumab

U.S. NAT'L LIBRARY OF MED., NAT'L INST. OF HEALTH, Clinical Trial Protocol NCT01904279

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U.S. NAT'L LIBRARY OF MED., NAT'L INST. OF HEALTH, Key Record Dates -- NCT02165345

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File History for U.S. Patent No. 9,255,145 - Part 2 of 5 (pp. 391-670)

File History for U.S. Patent No. 9,255,145 - Part 3 of 5 (pp. 671-1000)

File History for U.S. Patent No. 9,255,145 - Part 4 of 5 (pp. 1001-1200)

File History for U.S. Patent No. 9,255,145 - Part 5 of 5 (pp. 1201-1446)

Declaration of Thomas M. Zizic, M.D.

U.S. NAT'L LIBRARY OF MED., NAT'L INST. OF HEALTH, History of Changes NCT02165345 (last visited 5-16-22)

U.S. NAT'L LIBRARY OF MED., NAT'L INST. OF HEALTH, History of Changes for Study NCT02165345, Version 1, (Jun. 16, 2014)

U.S. NAT'L LIBRARY OF MED., NAT'L INST. OF HEALTH, History of Changes for Study NCT02165345, Version 44 (Mar. 3, 2016)

U.S. NAT'L LIBRARY OF MED., NAT'L INST. OF HEALTH, History of Changes for Study NCT02165345, Version 22 (Feb. 5, 2015)

U.S. NAT'L LIBRARY OF MED., NAT'L INST. OF HEALTH, History of Changes for Study NCT02165345, Changes (Merged) for Study

U.S. NAT'L LIBRARY OF MED., NAT'L INST. OF HEALTH, History of Changes for Study NCT02165345, Version 49 (Aug. 1, 2016)

U.S. NAT'L LIBRARY OF MED., NAT'L INST. OF HEALTH, History of Changes for Study NCT02165345, Changes (Merged) for Study

CLINICALTRIALS.GOV, Extension Study Evaluating the Safety and Efficacy of Subcutaneous Tocilizumab

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File History for U.S. Patent No. 8,580,264 - Part 3 of 6 (pp.324-591)

File History for U.S. Patent No. 8,580,264 - Part 4 of 6 (pp. 592-789)

File History for U.S. Patent No. 8,580,264 - Part 5 of 6 (pp. 790-1016)

File History for U.S. Patent No. 8,580,264 - Part 6 of 6 (pp. 1017-1142)

File History for U.S. Patent No. 8,580,264 - Part 1 of 6 (pp. 1-218)

Declaration of Howard Levine, Ph.D.

Declaration of Robert Paarlberg

Petitioner's Power of Attorney - FRESENIUS KABI USA, LLC

Petitioner's Power of Attorney - FRESENIUS KABI SWISSBIOSIM GmbH

Inter Partes Review Petition of U.S. Patent 10,231,981

U.S. Patent No. l0,231,981