Celltrion Inc. et al. vs Biogen, Inc.

Patent Owner Biogen, Inc.'s Notice of Appeal

Termination Decision Document

Hearing Transcript

Patent Owner's Motion to Accept Objections to Petitioner's Demonstratives on August 17, 2018

Patent Owner's Objections to Petitioner's Demonstratives

Petitioner's Objections to Patent Owner's Demonstrative Exhibit

Petitioner's Motion to Accept Objections to Patent Owner's Demonstratives on August 17, 2018

Petitioner's Authorized Response to Patent Owner's Statement Regarding Petitioner's Reply

Order - 37 C.F.R. 42.70

Patent Owner's Statement Regarding Petitioner's Reply Arguments and Evidence Beyond the Proper Scope

Patent Owner's Request for Oral Argument

Petitioner's Request for Oral Hearing

Patent Owner's Objections to Evidence Under 37 C.F.R. 42.64

McLaughlin et al., Stage 1-11 low-grade lymphomas: A prospective trial of combination chemotherapy and radiotherapy, Ann. Oncol., 2(Suppl. 2):137-140 (1991)

Online Computer Library Center's ("OCLC") Connexion database record of Ex. 1304, Foon, K.A. & Fisher, R.I., Chapter 111: Lymphomas, in Williams Hematology, Fifth Edition, etc.

MARC record of Ex. 1310, Czuczman, et al., IDEC-C2B8 and CHOP Chemoimmunotherapy of Low-Grade Lymphoma, etc.

Edgar Database page from Internet Archive

General Information on the EDGAR Database page from Internet Archive

10-K/A .txt file from EDGAR system

Petitioner's Combined Reply ISO Its Petition for Inter Partes Review

Declaration of Daniel J. Knauss ISO Petitioner's Combined Reply

McLaughlin et al., Pivotal Phase III Clinical Trial (PII CT) of the Chimeric Anti-CD20 Antibody (MAB) IDEC-C2B8 etc.

Declaration of Sylvia Hall-Ellis Ph.D. ISO Petitioner's Reply

Foon, K.A. & Fisher, R. I., Chapter 111: Lymphomas, in Williams Hematology, Fifth Edition, etc.

Machine-Readable Cataloging ("MARC") record of Ex. 1304, Foon K.A. & Fisher, R.I., Chapter 111: in Williams Hematology, Fifth Edition, etc.

Dana et al., Long-Term Follow-Up of Patients with Low-Grade Malignant Lymphomas Treated With Doxorubicin-Based Chemotherapy or Chemoimmunotherapy, etc.

MARC record of Exhibit 1307, Dana et al., Long-Term Follow-Up of Patents with Low-Grade Malignant Lymphomas, etc.

OCLC record of Ex. 1307, Dana et al., Long-Term Follow-Up of Patients with Low-Grade Malignant Lymphomas Treated with, etc.

Czuczman et al., IDEC-C2B8 and CHOP Chemoimmunotherapy of Low-Grade Lymphoma, Blood, 86(10, Suppl. 1):55a (Abstract 206) (Nov. 15, 1995)

OCLC record of Ex. 1310, Czuczman et al., IDEC-C2B8 and CHOP Chemoimmunotherapy of Low-Grade Lymphoma, etc.

Marcus, et al., CVP chemotherapy plus rituximab compared with CVP as first-line treatment for advanced follicular lymphoma, Blood, 105(4):1417-1423 (Feb. 15, 2005)

MARC record of Ex. 1313, Marcus et al., CVP chemotherapy plus rituximab compared with CVP as first-line treatment for advanced follicular lymphoma, etc.

OCLC record of Ex. 1313, Marcus et al., CVP chemotherapy plus rituximab compared with CVP as first-line treatment for advanced follicular lymphoma, etc.

Important Information About EDGAR page from Internet Archive

Search the EDGAR database page from Internet Archive

EDGAR Form Pick, Customized Forms Selection page from Internet Archive

EDGAR Filing Details

Affidavit of Christopher Butler

Patent Owner's Preliminary Response, Celltrion Inc. v. Biogen Inc., IPR2017-01094, Paper No. 10 (PTAB July 5, 2017)

Foon, K.A. & Fisher R. I., Chapter 111: Lymphomas, in Williams Hematology, Fifth Edition, etc. (Date Stamped Second Copy)

McLaughlin et al., Stage 1-11 low-grade lymphomas: A prospective trial of combination chemotherapy and radiotherapy, Ann. Oncol., 2(Suppl. 2):137-140 (1991)

Petitioner's Update Exhibit List

Joint Stipulation to Modify Due Date 4B

Notice of Deposition of Izidore Lossos, M.D.

EX2030 - Deposition Transcript of Patent Owner¿¿¿s Expert Peter McLaughlin, M.D. dated April 18, 2018

EX2031 - Declaration of Ann Simpson

EX2032 - USPTO, Guidance on the Impact of SAS on AIA Trial Proceedings, dated April 26, 2018

Patent Owner's Supplemental Response

Joint Stipulation to Modify Due Dates 4 and 5

Modifying Scheduling Order

Order Conduct of Proceeding

Modified Scheduling Order

Conduct of the Proceeding - 37 C.F.R. 42.5

ORDER Conduct of Proceeding 37 C.F.R. §§ 42.5, 42.53(a)

Patent Owners Mandatory Notice Updating Related Matters

Petitioner's Updated Mandatory Notice Updating Related Matters

Notice of Deposition of Dr. Peter McLaughlin

Scheduling Stipulation Resetting Due Dates 4 and 5

Petitioner's Updated Mandatory Notice Replacing First Backup Counsel

Petitioner's Updated Certificate of Service of Petitioner's Objections to Patent Owner's Evidence

Petitioner's Objections to Patent Owner's Evidence

EX 2013 - Lopez-Guillermo

EX 2014 - Rigacci

EX 2015 - Rituxan Label

EX 2016 - Megan Raymond's Declaration

EX 2018 - McLaughlin (1992)

EX 2019 - Smalley

EX 2020 - Han

EX 2022 - Raphael

EX 2023 - Ezdinli

EX 2017 - Fisher

EX 2021 - Gribben

EX 2026 - McLaughlin (1987)

EX 2029 - Expert Declaration McLaughlin

Patent Owner Response

EX 2024 - Hagenbeek

EX 2025 - Peterson

EX 2027 - Lossos Depo

EX 2028 - Korsmeyer

Modifying Scheduling Order

Decision Granting Unopposed Motion for Pro Hac Vice Admission of Mr. David Gindler

Notice of Deposition of Walter L. Longo, M.D.

Notice of Deposition of Izidore Lossos, M.D.

Decision - Denying Petitioner's Request for Rehearing

Power of Attorney

Supplemental Mandatory Notice

Scheduling Stipulation Resetting Due Dates 1 and 2

Petitioner's Updated Exhibit List

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Ex 2012 Gindler PHV Declaration

Motion to Appear Pro Hac Vice (Gindler)

Petitioner's Updated Power of Attorney Appointing Additional Backup Counsel

Petitioner's Updated Mandatory Notice re Additional Backup Counsel

Petitioner's Request for Rehearing Pursuant to 37 C.F.R. ¿¿ 42.71(c) and (d)

Patent Owner's Objections to Exhibits

Trial Instituted Document

Scheduling Order

Biogen's Patent Owner Preliminary Response

Ex. 2002 McLaughlin 1998

Ex. 2006 Amendment and Reply (August 25, 2010)

Ex. 2008 Reply and Amendment (Sept 14, 2001)

Ex. 2009 Carlson 1997

Ex. 2010 Prior 172 IPR Board Decision

Ex. 2001 Al-Ismail 1987

Ex. 2003 Application No. 11_840,956

Ex. 2004 U.S. Patent No. 8,329,172

Ex. 2005 Application No. 10_196,732

Ex. 2007 Amendment and Reply (June 6, 2011)

Ex. 2011 Song Declaration

Patent Owner's Exhibit List

NOTICE OF ACCEPTING CORRECTED PETITION

(Corrected ) IDEC Pharmaceuticals Corporation, Form 10-K/A for the Fiscal Year ended December 31, 1997, filed with the U.S. Securities and Exchange Commission

(Corrected) Dana, B. et al., Long-Term Follow-Up of Patients With Low-Grade Malignant Lymphomas Treated With Doxorubicin-Based Chemotherapy or Chemoimmunotherapy, J. Clin. Oncol., 11(4):644-651 (Apr. 1993)

(Corrected) Czuczman, M.S. et al., IDEC-C2B8 and CHOP Chemoimmunotherapy of Low-Grade Lymphoma, Blood 86(10, Supp. 1):55a (Abstract 206) (Nov. 15, 1995) ("Czuczman No. 1996")

(Corrected) Sriskandan, S. et al., Aggressive management of doxorubicin-induced cardiomyopathy associated with 'low' doses of doxorubicin, Postgrad. Med. J., 70(828):759-761 (Oct. 1994)

(Corrected) File History of U.S. Patent Application No. 09/372,202 ("the '202 application")

(Corrected) U.S. Patent No. 5,736,137 ("the '137 Patent")

(Corrected) Foon, K.A. & Fisher, R.I., Chapter 111: Lymphomas, in Williams Hematology, Fifth Edition, 1076-96 (Beutler, E. et al., eds., 1995)

(Corrected) Link, B.K. et al., Phase II Pilot Study of the Safety and Efficacy of Rituximab in Combination with CHOP Chemotherapy in Patients with Previously Untreated Intermediate- or High-Grade NHL, Program/Proceedings Am. Soc. Clin. Oncol., 17:3a

(Corrected) U.S. Patent No. 6,399,061 ("the '061 Patent")

(Corrected) Czuczman, M. et al., Phase II Clinical Trial of IDEC-C2B8/CHOP Combination Chemotherapy in Low Grade Lymphoma: Preliminary Results, Program/Proceedings Am. Soc. Clin. Oncol., 14:401 (Abstract 1261) (Apr. 1995)

(Corrected) Grossbard, M.L. and Multani, P.S., The McLaughlin, et al. Article [Clinical Status and Optimal Use of Rituximab for B-Cell Lymphomas] Reviewed, Oncology, 12(12):1769-1781 (Dec. 1, 1998)

(Corrected) File History of U.S. Patent Application No. 13/524,896 ("the '896 application")

(Corrected) Cabanillas, F. et al., Anti-CD20 Antibody (MAB), IDEC-C2B8: Clearance of Bcl-2 t(14:18) Positive Cells from Peripheral Blood (PB) and Bone Marrow (BM) in Patients (PTS) with Relapsed Low-Grade or Follicular Lymphoma (LG/F NHL), Blood, 1996; 88

Notice of Corrected Exhibits

Notice of Accord Filing Date

Power of Attorney

Mandatory Notice

Lossos Declaration (Corrected)

Longo Declaration (Corrected)

Certificate of Service re corrected exhibits

Petitioner's Updated Mandatory Notice re Lead Backup Counsel

Petitioner's Power of Attorney

Petition for Inter Partes Review of U.S. Patent No. 9,296,821

U.S. Patent No. 9,296,821 ("the '821 patent")

Expert Declaration of Dr. Izidore Lossos

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Reff, M.E. et al., Depletion of B Cells In Vivo by a Chimeric Mouse Human Monoclonal Antibody to CD20, Blood, 83(2):435-445 (Jan. 15, 1994) ("Reff 1994")

Devita, V. T., Jr. et al., Chapter 44: Hodgkin's Disease and the Non-Hodgkin's Lymphomas, in Cancer: Principles & Practice of Oncology, Second Edition (DeVita, Jr. et al., eds., 1985)

Rituxan (Rituximab) label (Nov. 1997)

Declaration of Walter Longo, MD

Piro, L. et al., RITUXAN™ (rituximab, IDEC-C2B8): Interim analysis of a phase II study of once weekly times 8 dosing in patients with relapsed low-grade or follicular non-Hodgkin's lymphoma, Blood 90(10, Supp. 1):510a (Abstract 2272) (Nov. 15, 1997)

Marcus, R. et al., CVP Chemotherapy plus rituximab compared with CVP as first-line treatment for advanced follicular lymphoma, Blood, 105(4):1417-1423 (Feb. 15, 2005) ("Marcus 2005")

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Nadler, L.M. et al., Serotherapy of a patient with a monoclonal antibody directed against a human lymphoma associated antigen, Cancer Res., 40(9):3147-3154 (Sept. 1980) ("Nadler 1980")

Stashenko, P. et al., Characterization of a Human B Lymphocyte-Specific Antigen, J. Immunol., 125(4):1678-1685 (Oct. 1980) ("Stashenko 1980")

Anderson, K.C. et al., Expression of Human B Cell-Associated Antigens on Leukemias and Lymphomas: A model of Human B Cell Differentiation, Blood, 63(6):1424-1433 (June 1984) (Anderson 1984)

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Czuczman, M.S. et al, Treatment of patients with Low-grade B-Cell Lymphoma with the Combination of Chimeric Anti-20 Monoclonal Antibody and CHOP Chemotherapy, J. Clin. Oncol. 17(1):268-276 (Jan. 1999) ("Czuczman 1999")

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Maloney, D.G. et al., IDEC-C2B8: Results of a Phase I Multiple-Dose Trial in Patients With Relapsed Non-Hodgkin's Lymphoma, J. Clin. Oncol., 15(10):3266-3274 (Oct. 1997)

Hoppe, T.E. et al., The Treatment of Advanced Stage Favorable Histology Non-Hodgkin's Lymphoma: A Preliminary Report of a Randomized Trial Comparing Single Agent Chemotherapy, Combination Chemotherapy, and Whole Body Irradiation,

Rosenberg, S.A., The Low-Grade Non-Hodgkin's Lymphomas: Challenges and Opportunities, J. Clin. Oncol., 3(3):299-310 (Mar. 1985)

Czuczman, M. et al., RituxanTM/CHOP Chemo Immunotherapy in Patients with Low-Grade or Follicular (LG/F) Non-Hodgkin's Lymphoma (NHL), J. Immunother., 20(5):401 (1997)

Smith, M.R., Rituximab (monoclonal anti-CD20 antibody): mechanisms of action and resistance, Oncogene, 22(47):7359-7368 (Oct. 20, 2003)

Maloney, D.G. et al., Phase I Clinical Trial Using Escalating Single-Dose Infusion of Chimeric Anti-CD20 Monoclonal Antibody (IDEC-C2B8) in Patients With Recurrent B-Cell Lymphoma, Blood, 84(8):2457-2466 (Oct. 15, 1994) ("Maloney 1994")

EDGAR® FILER MANUAL: Guide for Electronic Filing with the U.S. Securities and Exchange Commission, EDGAR® Release 5.10 (Sept. 1996) [excerpts]

Attachment 2: IDEC Pharmaceuticals Filing Details on the EDGAR system, available at https://www.sec.gov/Archives/edgar/data/875045/ 0000936392-98-000361-index.html

ECOG E1496 Patient Consent Form

O'Brien, S. et al., Lack of Effect of 2-Chlorodeoxyadenosine Therapy in Patients with Chronic Lymphocytic Leukemia Refractory to Fludarabine Therapy, New Engl. J. Med. 330(5):319-322 (Feb. 3, 1994)

Ruuls, S.R. et al., Novel human antibody therapeutics: the age of the Umabs, Biotechnol. J., 3:1157-1171 (2008)

Demiden, A. et al., Chimeric Anti-CD20 Antibody (IDEC-C2B8) Is Apoptotic and Sensitizes Drug Resistant Human B Cell Lymphomas and Aids Related Lymphomas to the Cytotoxic Effect of CDDP, VP-16 and Toxins, Experimental Biology 95™

Leget, G.A. et al., Use of rituximab, the new FDA-approved antibody, Curr. Opin. Oncol. 10(6):548-551 (Nov. 1998)

Maloney, D.G. and Press, O.W., Newer Treatments for Non-Hodgkin's Lymphoma: Monoclonal Antibodies, Oncology 12(10, Supp. 8):63-76 (Oct. 1998)

Coiffier B., et al., Rituximab (Anti-CD20 Monoclonal Antibody) for the Treatment of Patients With Relapsing or Refractory Aggressive Lymphoma: A Multicenter Phase II Study, Blood, 92(6):1927-1932 (Sept. 15, 1998)

Horning S., Treatment Approaches to the Low-Grade Lymphomas, Blood 83(4):881-884 (Feb. 15, 1994)

Maloney, D.G. et al., IDEC-C2B8 (Rituximab) Anti-CD20 Monoclonal Antibody Therapy in Patients With Relapsed Low-Grade Non-Hodgkin's Lymphoma, Blood, 90(6): 2188-2195 (Sept. 15, 1997)

Czuczman, M.S., et al., Prolonged Clinical and Molecular Remission in Patients With Low-Grade or Follicular Non-Hodgkin's Lymphoma Treated With Rituximab Plus CHOP Chemotherapy: 9-Year Follow-Up, J. Clin. Oncol., 22(23):4711-4716 (Dec. 1, 2004)

Steward, W.P. et al., Maintenance Chlorambucil After CVP in the Management of Advanced Stage, Low-Grade Histologic Type Non-Hodgkin's Lymphoma: A Randomized Prospective Study With an Assessment of Prognostic Factors, Cancer 61(3):441-447 (Feb. 1, 1988)

Berinstein, N.L., et al., Association of serum Rituximab (IDEC-C2B8) concentration and anti-tumor response in the treatment of recurrent low-grade or follicular non-Hodgkin's lymphoma, Ann. Oncol., 9:995-1001 (July 1998)

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Bishop, J.F. et al., A Randomized Trial of High Dose Cyclophosphamide, Vincristine, and Prednisone Plus or Minus Doxorubicin (CVP versus CAVP) with Long-Term Follow-Up in Advanced Non-Hodgkin's Lymphoma, Leukemia, 1(6):508-513 (June 1987)

Rogers, J. et al., Analysis of bcl-2 t(14;18) translocation in relapsed B-cell lymphoma patients treated with the chimeric anti-CD20 antibody IDEC-C2B8, P. Am. Assoc. Canc. Res., 37:213 (Abstract 1456) (Mar. 1996)

Czuczman, M.S. et al., IDEC-C2B8/CHOP chemoimmunotherapy in patients with low-grade lymphoma: interim clinical and bcl-2 (PCR) results, Ann. Oncol., 7(Supp. 1):56 (Abstract 191) (1996)

Czuczman, M.S. et al., Chemoimmunotherapy of Low-Grade Lymphoma with Anti-CD20 Antibody IDEC-C2B8 in Combination with CHOP Chemotherapy, Cancer Invest., 14(Supp. 1):59-61 (Abstract 53) (1996)

Czuczman, M. et al., IDEC-C2B8/CHOP Chemoimmunotherapy in Patients with Low-Grade Lymphoma: Clinical and bcl-2 (PCR) Final Results, Blood, 88(10, Supp. 1):453a (Abstract 1799) (Nov. 15, 1996)

Canellos, G.P. et al., Chemotherapy of the Non-Hodgkin's Lymphomas, Cancer, 42(2):932-940 (Aug. 1978)

Kimby, E. et al., Chlorambucil/prednisone vs. CHOP in symptomatic low-grade non-Hodgkin's lymphomas: A randomized trial from the Lymphoma Group of Central Sweden, Ann. Oncol., 5(Supp. 2):67-71 (1994)

Czuczman, M. et al., IDEC-C2B8 clears bcl2 (t14;18) in patients (pts) with relapsed low grade or follicular lymphoma (LG/F NHL), P. Am. Assoc. Canc. Res., 38:84 (Abstract 565) (Mar. 1997)

Czuczman, M.S. et al., IDEC-C2B8 (Rituximab) Alone and in Combination with CHOP in the Treatment of Low-Grade B-Cell Lymphoma, Cancer Invest., 16 (Suppl. 1):21-22 (Abstract 17) (1998)

IDEC Pharmaceuticals Corporation Press Release, IDEC Pharmaceuticals and Genentech Announce Positive Final Results for Pivotal Phase III Trial of IDEC-C2B8 as Single Agent (Dec. 9, 1996)

Public Hearing Transcript, Biological Response Modifiers Advisory Committee, Center for Biological Evaluation and Research, Food and Drug Administration, nineteenth meeting (July 25, 1997) ("FDA Transcript")

FDA FOIA response letter dated August 26, 2016

McNeil, C., Non-Hodgkin's Lymphoma Trials In Elderly Look Beyond CHOP, J. Nat'l Cancer Inst., 90(4):266-67 (Feb. 18, 1998) ("McNeil")

Rituxan (Rituximab) label (Feb. 28, 2006)

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Eastern Cooperative Oncology Group ("ECOG") E1496 Protocol (1998)

File History of U.S. Patent Application No. 13/524,896 ("the '896 application")

ECOG Protocols Active as of 05/19/98

E1496 Forms Packet

E1496 On Study Dates

Demidem A. et al., Chimeric Anti-CD20 (IDEC-C2B8) Monoclonal Antibody Sensitizes a B Cell Lymphoma Cell Line to Cell Killing by Cytotoxic Drugs, Cancer Biother. Radio., 12(3):177-186 (1997)

Haq, M.M. et al., Doxorubicin-Induced Congestive Heart Failure in Adults, Cancer, 56(6):1361-1365 (Sept. 15, 1985)

Harris, N.L. et al., A Revised European-American Classification of Lymphoid Neoplasms: A Proposal From the International Lymphoma Study Group, Blood, 84(5):1361-1392 (Sept. 1, 1994)