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Patent Owner

Biogen, Inc.

Petitioner

Celltrion Inc.

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Celltrion Inc. v. Biogen, Inc.

IPR2017-01095 | Patent Trial and Appeal Board

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Filed March 15, 2017

Terminated Oct. 4, 2018

Judges Erica Franklin, Jacqueline Harlow, and Sheridan Snedden

Case Type Inter Partes Review

Status Final Written Decision

Challenged Patent 13/524,896

Patent No. 9,296,821 assignments

Tech Center 1600

Art Unit 1644

Inventors Antonio J. Grillo-López

Last Updated: 4 months, 2 weeks ago

Filing Date	#	Filing and Exhibits
Entries matching. Show All.
12/4/2018	12-04-2018-Patent_Owner	Event: Notice of Appeal Patent Owner Notice of Appeal 61: Patent Owner Biogen, Inc.'s Notice of Appeal
10/4/2018	10-04-2018-Board	Event: Final Written Decision (All Claims Cancelled) Board Termination Decision Document 60: Termination Decision Document
9/25/2018	09-25-2018-Board	Board Hearing Transcript 59: Hearing Transcript
8/24/2018	08-24-2018-Petitioner	Petitioner Objection 57: Petitioner's Objections to Patent Owner's Demonstrative Exhibit Petitioner Motion 58: Petitioner's Motion to Accept Objections to Patent Owner's Demonstratives on August 17, 2018
8/24/2018	08-24-2018-Patent_Owner	Patent Owner Motion 55: Patent Owner's Motion to Accept Objections to Petitioner's Demonstratives on August 17, 2018 Patent Owner Objection 56: Patent Owner's Objections to Petitioner's Demonstratives
8/2/2018	08-02-2018-Petitioner	Petitioner Response 54: Petitioner's Authorized Response to Patent Owner's Statement Regarding Petitioner's Reply
8/1/2018	08-01-2018-Board	Board Order 53: Order - 37 C.F.R. 42.70
7/26/2018	07-26-2018-Patent_Owner	Patent Owner Other (Not for motions) 52: Patent Owner's Statement Regarding Petitioner's Reply Arguments and Evidence Beyond the Proper Scope
7/19/2018	07-19-2018-Petitioner	Petitioner Oral Hearing Request 51: Petitioner's Request for Oral Hearing
7/19/2018	07-19-2018-Patent_Owner	Patent Owner Oral Hearing Request 50: Patent Owner's Request for Oral Argument
7/12/2018	07-12-2018-Patent_Owner	Patent Owner Objection 49: Patent Owner's Objections to Evidence Under 37 C.F.R. 42.64
7/5/2018	07-05-2018-Petitioner	Petitioner Reply 47: Petitioner's Combined Reply ISO Its Petition for Inter Partes Review Petitioner Exhibit List 48: Petitioner's Update Exhibit List Petitioner Exhibit 1203: 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 Exhibit 1300: Declaration of Daniel J. Knauss ISO Petitioner's Combined Reply Petitioner Exhibit 1301: 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 Exhibit 1302: McLaughlin et al., Pivotal Phase III Clinical Trial (PII CT) of the Chimeric Anti-CD20 Antibody (MAB) IDEC-C2B8 etc. Petitioner Exhibit 1303: Declaration of Sylvia Hall-Ellis Ph.D. ISO Petitioner's Reply Petitioner Exhibit 1304: Foon, K.A. & Fisher, R. I., Chapter 111: Lymphomas, in Williams Hematology, Fifth Edition, etc. Petitioner Exhibit 1305: Machine-Readable Cataloging ("MARC") record of Ex. 1304, Foon K.A. & Fisher, R.I., Chapter 111: in Williams Hematology, Fifth Edition, etc. Petitioner Exhibit 1306: 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. Petitioner Exhibit 1307: Dana et al., Long-Term Follow-Up of Patients with Low-Grade Malignant Lymphomas Treated With Doxorubicin-Based Chemotherapy or Chemoimmunotherapy, etc. Petitioner Exhibit 1308: MARC record of Exhibit 1307, Dana et al., Long-Term Follow-Up of Patents with Low-Grade Malignant Lymphomas, etc. Petitioner Exhibit 1309: OCLC record of Ex. 1307, Dana et al., Long-Term Follow-Up of Patients with Low-Grade Malignant Lymphomas Treated with, etc. Petitioner Exhibit 1310: Czuczman et al., IDEC-C2B8 and CHOP Chemoimmunotherapy of Low-Grade Lymphoma, Blood, 86(10, Suppl. 1):55a (Abstract 206) (Nov. 15, 1995) Petitioner Exhibit 1311: MARC record of Ex. 1310, Czuczman, et al., IDEC-C2B8 and CHOP Chemoimmunotherapy of Low-Grade Lymphoma, etc. Petitioner Exhibit 1312: OCLC record of Ex. 1310, Czuczman et al., IDEC-C2B8 and CHOP Chemoimmunotherapy of Low-Grade Lymphoma, etc. Petitioner Exhibit 1313: 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) Petitioner Exhibit 1314: MARC record of Ex. 1313, Marcus et al., CVP chemotherapy plus rituximab compared with CVP as first-line treatment for advanced follicular lymphoma, etc. Petitioner Exhibit 1315: OCLC record of Ex. 1313, Marcus et al., CVP chemotherapy plus rituximab compared with CVP as first-line treatment for advanced follicular lymphoma, etc. Petitioner Exhibit 1316: Edgar Database page from Internet Archive Petitioner Exhibit 1317: Important Information About EDGAR page from Internet Archive Petitioner Exhibit 1318: General Information on the EDGAR Database page from Internet Archive Petitioner Exhibit 1319: Search the EDGAR database page from Internet Archive Petitioner Exhibit 1320: EDGAR Form Pick, Customized Forms Selection page from Internet Archive Petitioner Exhibit 1321: EDGAR Filing Details Petitioner Exhibit 1322: 10-K/A .txt file from EDGAR system Petitioner Exhibit 1323: Affidavit of Christopher Butler Petitioner Exhibit 1324: Patent Owner's Preliminary Response, Celltrion Inc. v. Biogen Inc., IPR2017-01094, Paper No. 10 (PTAB July 5, 2017) Petitioner Exhibit 1325: Foon, K.A. & Fisher R. I., Chapter 111: Lymphomas, in Williams Hematology, Fifth Edition, etc. (Date Stamped Second Copy)
6/6/2018	06-06-2018-Patent_Owner	Patent Owner Other (Not for motions) 44: Joint Stipulation to Modify Due Date 4B Patent Owner Notice of Deposition 45: Notice of Deposition of Izidore Lossos, M.D. Patent Owner Response 46: Patent Owner's Supplemental Response Patent Owner Exhibit 2030: EX2030 - Deposition Transcript of Patent Owner¿¿¿s Expert Peter McLaughlin, M.D. dated April 18, 2018 Patent Owner Exhibit 2031: EX2031 - Declaration of Ann Simpson Patent Owner Exhibit 2032: EX2032 - USPTO, Guidance on the Impact of SAS on AIA Trial Proceedings, dated April 26, 2018
5/16/2018	05-16-2018-Patent_Owner	Patent Owner Other (Not for motions) 43: Joint Stipulation to Modify Due Dates 4 and 5
5/11/2018	05-11-2018-Board	Board Order 42: Modifying Scheduling Order
5/7/2018	05-07-2018-Board	Board Order Conduct of Proceeding 40: Order Conduct of Proceeding Board Order 41: Modified Scheduling Order
4/30/2018	04-30-2018-Board	Board Order Conduct of Proceeding 39: Conduct of the Proceeding - 37 C.F.R. 42.5
4/18/2018	04-18-2018-Patent_Owner	Patent Owner Notice 38: Patent Owners Mandatory Notice Updating Related Matters
4/18/2018	04-18-2018-Board	Board Order 37: ORDER Conduct of Proceeding 37 C.F.R. §§ 42.5, 42.53(a)
4/17/2018	04-17-2018-Petitioner	Petitioner Notice 36: Petitioner's Updated Mandatory Notice Updating Related Matters
3/28/2018	03-28-2018-Petitioner	Petitioner Notice of Deposition 33: Notice of Deposition of Dr. Peter McLaughlin Petitioner Notice 34: Scheduling Stipulation Resetting Due Dates 4 and 5 Petitioner Notice 35: Petitioner's Updated Mandatory Notice Replacing First Backup Counsel
2/16/2018	02-16-2018-Petitioner	Petitioner Other (Not for motions) 32: Petitioner's Updated Certificate of Service of Petitioner's Objections to Patent Owner's Evidence
2/14/2018	02-14-2018-Petitioner	Petitioner Objection 31: Petitioner's Objections to Patent Owner's Evidence
2/7/2018	02-07-2018-Patent_Owner	Patent Owner Response 30: Patent Owner Response Patent Owner Exhibit 2013: EX 2013 - Lopez-Guillermo Patent Owner Exhibit 2014: EX 2014 - Rigacci Patent Owner Exhibit 2015: EX 2015 - Rituxan Label Patent Owner Exhibit 2016: EX 2016 - Megan Raymond's Declaration Patent Owner Exhibit 2017: EX 2017 - Fisher Patent Owner Exhibit 2018: EX 2018 - McLaughlin (1992) Patent Owner Exhibit 2019: EX 2019 - Smalley Patent Owner Exhibit 2020: EX 2020 - Han Patent Owner Exhibit 2021: EX 2021 - Gribben Patent Owner Exhibit 2022: EX 2022 - Raphael Patent Owner Exhibit 2023: EX 2023 - Ezdinli Patent Owner Exhibit 2024: EX 2024 - Hagenbeek Patent Owner Exhibit 2025: EX 2025 - Peterson Patent Owner Exhibit 2026: EX 2026 - McLaughlin (1987) Patent Owner Exhibit 2027: EX 2027 - Lossos Depo Patent Owner Exhibit 2028: EX 2028 - Korsmeyer Patent Owner Exhibit 2029: EX 2029 - Expert Declaration McLaughlin
1/24/2018	01-24-2018-Board	Board Order 29: Modifying Scheduling Order
1/11/2018	01-11-2018-Board	Board Order 27: Decision Granting Unopposed Motion for Pro Hac Vice Admission of Mr. David Gindler
1/11/2018	01-11-2018-Patent_Owner	Patent Owner Notice of Deposition 28: Notice of Deposition of Walter L. Longo, M.D.
1/10/2018	01-10-2018-Patent_Owner	Patent Owner Notice of Deposition 26: Notice of Deposition of Izidore Lossos, M.D.
1/2/2018	01-02-2018-Board	Board Decision Denying Request for Rehearing-Petitioner 25: Decision - Denying Petitioner's Request for Rehearing
12/22/2017	12-22-2017-Patent_Owner	Patent Owner Power of Attorney 23: Power of Attorney Patent Owner Notice 24: Supplemental Mandatory Notice
12/8/2017	12-08-2017-Petitioner	Petitioner Other (Not for motions) 22: Scheduling Stipulation Resetting Due Dates 1 and 2
11/7/2017	11-07-2017-Petitioner	Petitioner Exhibit List 21: Petitioner's Updated Exhibit List
11/3/2017	11-03-2017-Petitioner	Petitioner Other (Not for motions) 19: EXPUNGED Petitioner Exhibit List 20: EXPUNGED
10/26/2017	10-26-2017-Patent_Owner	Patent Owner Motion 18: Motion to Appear Pro Hac Vice (Gindler) Patent Owner Exhibit 2012: Ex 2012 Gindler PHV Declaration
10/25/2017	10-25-2017-Petitioner	Petitioner Power of Attorney 16: Petitioner's Updated Power of Attorney Appointing Additional Backup Counsel Petitioner Notice 17: Petitioner's Updated Mandatory Notice re Additional Backup Counsel
10/20/2017	10-20-2017-Patent_Owner	Patent Owner Objection 15: Patent Owner's Objections to Exhibits
10/20/2017	10-20-2017-Petitioner	Petitioner Rehearing Request - in re Partial Institution Decision Granted 14: Petitioner's Request for Rehearing Pursuant to 37 C.F.R. ¿¿ 42.71(c) and (d)
10/6/2017	10-06-2017-Board	Event: Petition Institution (Granted and Denied) Board Institution Decision 12: Trial Instituted Document Board Order 13: Scheduling Order
7/10/2017	07-10-2017-Patent_Owner	Event: Preliminary Response Patent Owner Preliminary Response 10: Biogen's Patent Owner Preliminary Response Patent Owner Exhibit List 11: Patent Owner's Exhibit List Patent Owner Exhibit 2001: Ex. 2001 Al-Ismail 1987 Patent Owner Exhibit 2002: Ex. 2002 McLaughlin 1998 Patent Owner Exhibit 2003: Ex. 2003 Application No. 11_840,956 Patent Owner Exhibit 2004: Ex. 2004 U.S. Patent No. 8,329,172 Patent Owner Exhibit 2005: Ex. 2005 Application No. 10_196,732 Patent Owner Exhibit 2006: Ex. 2006 Amendment and Reply (August 25, 2010) Patent Owner Exhibit 2007: Ex. 2007 Amendment and Reply (June 6, 2011) Patent Owner Exhibit 2008: Ex. 2008 Reply and Amendment (Sept 14, 2001) Patent Owner Exhibit 2009: Ex. 2009 Carlson 1997 Patent Owner Exhibit 2010: Ex. 2010 Prior 172 IPR Board Decision Patent Owner Exhibit 2011: Ex. 2011 Song Declaration
4/14/2017	04-14-2017-Board	Board Corrected Petition 9: NOTICE OF ACCEPTING CORRECTED PETITION
4/12/2017	04-12-2017-Petitioner	Petitioner Notice 8: Notice of Corrected Exhibits Petitioner Exhibit 1006: (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 Petitioner Exhibit 1007: (Corrected) U.S. Patent No. 5,736,137 ("the '137 Patent") Petitioner Exhibit 1008: (Corrected) Foon, K.A. & Fisher, R.I., Chapter 111: Lymphomas, in Williams Hematology, Fifth Edition, 1076-96 (Beutler, E. et al., eds., 1995) Petitioner Exhibit 1009: (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) Petitioner Exhibit 1010: (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 Petitioner Exhibit 1011: (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") Petitioner Exhibit 1012: (Corrected) U.S. Patent No. 6,399,061 ("the '061 Patent") Petitioner Exhibit 1017: (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) Petitioner Exhibit 1030: (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) Petitioner Exhibit 1034: (Corrected) File History of U.S. Patent Application No. 09/372,202 ("the '202 application") Petitioner Exhibit 1061: (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 Petitioner Exhibit 1064: (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) Petitioner Exhibit 1069: (Corrected) File History of U.S. Patent Application No. 13/524,896 ("the '896 application")
4/10/2017	04-10-2017-Board	Board Notice of Filing Date Accorded to Petition 7: Notice of Accord Filing Date
4/5/2017	04-05-2017-Patent_Owner	Patent Owner Power of Attorney 5: Power of Attorney Patent Owner Mandatory Notice 6: Mandatory Notice
3/17/2017	03-17-2017-Petitioner	Petitioner Other (Not for motions) 3: Certificate of Service re corrected exhibits Petitioner Notice 4: Petitioner's Updated Mandatory Notice re Lead Backup Counsel Petitioner Exhibit 1002: Lossos Declaration (Corrected) Petitioner Exhibit 1003: Longo Declaration (Corrected)
3/15/2017	03-15-2017-Petitioner	Petitioner Power of Attorney 1: Petitioner's Power of Attorney Event: Petition Petitioner Petition 2: Petition for Inter Partes Review of U.S. Patent No. 9,296,821 Petitioner Exhibit 1001: U.S. Patent No. 9,296,821 ("the '821 patent") Petitioner Exhibit 1002: Expert Declaration of Dr. Izidore Lossos Petitioner Exhibit 1003: Declaration of Walter Longo, MD Petitioner Exhibit 1004: 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) Petitioner Exhibit 1005: 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") Petitioner Exhibit 1006: EXPUNGED Petitioner Exhibit 1007: EXPUNGED Petitioner Exhibit 1008: EXPUNGED Petitioner Exhibit 1009: EXPUNGED Petitioner Exhibit 1010: EXPUNGED Petitioner Exhibit 1011: EXPUNGED Petitioner Exhibit 1012: EXPUNGED Petitioner Exhibit 1013: 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") Petitioner Exhibit 1014: Stashenko, P. et al., Characterization of a Human B Lymphocyte-Specific Antigen, J. Immunol., 125(4):1678-1685 (Oct. 1980) ("Stashenko 1980") Petitioner Exhibit 1015: 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) Petitioner Exhibit 1016: 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") Petitioner Exhibit 1017: EXPUNGED Petitioner Exhibit 1018: 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) Petitioner Exhibit 1019: Rituxan (Rituximab) label (Nov. 1997) Petitioner Exhibit 1020: 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") Petitioner Exhibit 1021: Leget, G.A. et al., Use of rituximab, the new FDA-approved antibody, Curr. Opin. Oncol. 10(6):548-551 (Nov. 1998) Petitioner Exhibit 1022: 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) Petitioner Exhibit 1024: 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) Petitioner Exhibit 1025: Horning S., Treatment Approaches to the Low-Grade Lymphomas, Blood 83(4):881-884 (Feb. 15, 1994) Petitioner Exhibit 1027: 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) Petitioner Exhibit 1028: 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) Petitioner Exhibit 1030: EXPUNGED Petitioner Exhibit 1031: 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) Petitioner Exhibit 1032: 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) Petitioner Exhibit 1033: 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) Petitioner Exhibit 1034: EXPUNGED Petitioner Exhibit 1036: 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) Petitioner Exhibit 1038: 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) Petitioner Exhibit 1039: 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) Petitioner Exhibit 1041: 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) Petitioner Exhibit 1043: 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) Petitioner Exhibit 1044: 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, Petitioner Exhibit 1045: Canellos, G.P. et al., Chemotherapy of the Non-Hodgkin's Lymphomas, Cancer, 42(2):932-940 (Aug. 1978) Petitioner Exhibit 1046: Rosenberg, S.A., The Low-Grade Non-Hodgkin's Lymphomas: Challenges and Opportunities, J. Clin. Oncol., 3(3):299-310 (Mar. 1985) Petitioner Exhibit 1047: 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) Petitioner Exhibit 1048: 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) Petitioner Exhibit 1049: 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) Petitioner Exhibit 1050: 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) Petitioner Exhibit 1051: 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) Petitioner Exhibit 1053: Smith, M.R., Rituximab (monoclonal anti-CD20 antibody): mechanisms of action and resistance, Oncogene, 22(47):7359-7368 (Oct. 20, 2003) Petitioner Exhibit 1054: 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") Petitioner Exhibit 1055: EDGAR® FILER MANUAL: Guide for Electronic Filing with the U.S. Securities and Exchange Commission, EDGAR® Release 5.10 (Sept. 1996) [excerpts] Petitioner Exhibit 1056: 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 Petitioner Exhibit 1057: 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") Petitioner Exhibit 1058: FDA FOIA response letter dated August 26, 2016 Petitioner Exhibit 1059: 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") Petitioner Exhibit 1060: Rituxan (Rituximab) label (Feb. 28, 2006) Petitioner Exhibit 1061: EXPUNGED Petitioner Exhibit 1064: EXPUNGED Petitioner Exhibit 1065: Eastern Cooperative Oncology Group ("ECOG") E1496 Protocol (1998) Petitioner Exhibit 1066: ECOG E1496 Patient Consent Form Petitioner Exhibit 1068: 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) Petitioner Exhibit 1069: File History of U.S. Patent Application No. 13/524,896 ("the '896 application") Petitioner Exhibit 1070: Ruuls, S.R. et al., Novel human antibody therapeutics: the age of the Umabs, Biotechnol. J., 3:1157-1171 (2008) Petitioner Exhibit 1071: ECOG Protocols Active as of 05/19/98 Petitioner Exhibit 1074: E1496 Forms Packet Petitioner Exhibit 1075: E1496 On Study Dates Petitioner Exhibit 1078: 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™ Petitioner Exhibit 1079: 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) Petitioner Exhibit 1080: Haq, M.M. et al., Doxorubicin-Induced Congestive Heart Failure in Adults, Cancer, 56(6):1361-1365 (Sept. 15, 1985) Petitioner Exhibit 1081: 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)

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Celltrion Inc. v. Biogen, Inc.

IPR2017-01095 | Patent Trial and Appeal Board

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