The detailed information for PTAB case with proceeding number IPR2017-01093 filed by Celltrion Inc. et al. against Biogen, Inc. on Mar 15, 2017. This includes filing dates, application numbers, tech centers, patent numbers, and current case status.

Case Details

Proceeding Number
IPR2017-01093
Filing Date
Mar 15, 2017
Petitioner
Celltrion Inc. et al.
Respondent
Biogen, Inc.
Status
Institution Denied
Respondent Application Number
11840956
Respondent Tech Center
1600
Respondent Patent Number
8329172
Institution Decision Date
Oct 6, 2017

Proceeding Documents

The table below shows documents filed in the case, listing each document name, filing date, document type, and filing party. Tracking these filings indicates the activity of the parties involved in the case, and the types of documents filed can provide insights into the legal strategies being employed.


Document NameFiling DateCategoryFiling Party

Alert me when new update on this case

Notice of Refund

Nov 14, 2017PAPERBOARD

Petitioner's Request for Refund of Post-Institution Fee

Nov 9, 2017PAPERPETITIONER

Decision Denying Institution of Inter Partes Review

Oct 6, 2017PAPERBOARD

Ex. 2001 Prior IPR Board Decision

Jul 10, 2017EXHIBITPATENT OWNER

Ex. 2002 Al-Ismail 1987

Jul 10, 2017EXHIBITPATENT OWNER

Ex. 2003 Hiddemann 1995

Jul 10, 2017EXHIBITPATENT OWNER

Ex. 2004 Wiernik 1996

Jul 10, 2017EXHIBITPATENT OWNER

Patent Owner Preliminary Response

Jul 10, 2017PAPERPATENT OWNER

Ex. 2008 WayBack Machine

Jul 10, 2017EXHIBITPATENT OWNER

Ex. 2009 Schein et al. 1975 Cancer

Jul 10, 2017EXHIBITPATENT OWNER

Ex. 2016 Dana 1998

Jul 10, 2017EXHIBITPATENT OWNER

Ex. 2026 Grossbard 2002-Excerpts

Jul 10, 2017EXHIBITPATENT OWNER

Ex. 2028 2010-05-10 IDS

Jul 10, 2017EXHIBITPATENT OWNER

Ex. 2029 Lu Declaration

Jul 10, 2017EXHIBITPATENT OWNER

Ex. 2005 2009-10-15 Restriction Requirement

Jul 10, 2017EXHIBITPATENT OWNER

Ex. 2006 2010-01-29 Response to Restriction Requirement

Jul 10, 2017EXHIBITPATENT OWNER

Ex. 2007 Rosenberg 1991

Jul 10, 2017EXHIBITPATENT OWNER

Ex. 2010 Cabanillas 1992

Jul 10, 2017EXHIBITPATENT OWNER

Ex. 2011 IPR2015-00418 Archived ECOG Website (12-12-1998)

Jul 10, 2017EXHIBITPATENT OWNER

Ex. 2012 Ezdinli 1987

Jul 10, 2017EXHIBITPATENT OWNER

Ex. 2013 van Oers 2006

Jul 10, 2017EXHIBITPATENT OWNER

Ex. 2014 McGrath 1997 - Excerpts

Jul 10, 2017EXHIBITPATENT OWNER

Ex. 2015 Arranz 1998

Jul 10, 2017EXHIBITPATENT OWNER

Ex. 2017 Peterson 1997

Jul 10, 2017EXHIBITPATENT OWNER

Ex. 2018 Chisesi 1991

Jul 10, 2017EXHIBITPATENT OWNER

Ex. 2019 Rohatiner 2005

Jul 10, 2017EXHIBITPATENT OWNER

Ex. 2020 Davis AACR 1998

Jul 10, 2017EXHIBITPATENT OWNER

Ex. 2021 Multani-Grossbard 1998

Jul 10, 2017EXHIBITPATENT OWNER

Ex. 2022 Habermann

Jul 10, 2017EXHIBITPATENT OWNER

Ex. 2023 Carlson 1997

Jul 10, 2017EXHIBITPATENT OWNER

Ex. 2024 Leget 1998

Jul 10, 2017EXHIBITPATENT OWNER

Ex. 2025 Czuczman 1996

Jul 10, 2017EXHIBITPATENT OWNER

Ex. 2027 Aviles 1997

Jul 10, 2017EXHIBITPATENT OWNER

Patent Owner's Exhibit List

Jul 10, 2017PAPERPATENT OWNER

NOTICE OF ACCEPTING CORRECTED PETITION

Apr 14, 2017PAPERBOARD

(Corrected) Rituxan (Rituximab) label (Nov. 1997)

Apr 12, 2017EXHIBITPETITIONER

(Corrected) Hochster H., et. al., Maintenance Rituximab After Cyclophosphamide, Vincristine, and Prednisone Prolongs Progression-Free Survival in Advanced Indolent Lymphoma: Results of the Randomized Phase III ECOG1496 Study, J. Clin. Oncol., 27(10)

Apr 12, 2017EXHIBITPETITIONER

Notice of Corrected Exhibits

Apr 12, 2017PAPERPETITIONER

Notice of Accord Filing Date

Apr 10, 2017PAPERBOARD

Power of Attorney

Apr 5, 2017PAPERPATENT OWNER

Mandatory Notice

Apr 5, 2017PAPERPATENT OWNER

Longo Declaration (Corrected)

Mar 17, 2017EXHIBITPETITIONER

ECOG 1496 Patient Consent Form (Corrected)

Mar 17, 2017EXHIBITPETITIONER

Lossos Declaration (Corrected)

Mar 17, 2017EXHIBITPETITIONER

Certificate of Service re Corrected Exhibits

Mar 17, 2017PAPERPETITIONER

Petitioner's Updated Mandatory Notice re Lead Backup Counsel

Mar 17, 2017PAPERPETITIONER

Petition for Inter Partes Review of U.S. Patent No. 8,329,172

Mar 15, 2017PAPERPETITIONER

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

Mar 15, 2017EXHIBITPETITIONER

Expert Declaration of Dr. Izidore Lossos

Mar 15, 2017EXHIBITPETITIONER

EXPUNGED

Mar 15, 2017EXHIBITPETITIONER

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)

Mar 15, 2017EXHIBITPETITIONER

Peitioner's Power of Attorney

Mar 15, 2017PAPERPETITIONER

Expert Declaration of Dr. Walter Longo

Mar 15, 2017EXHIBITPETITIONER

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

Mar 15, 2017EXHIBITPETITIONER

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 (Apri. 1993)

Mar 15, 2017EXHIBITPETITIONER

Eastern Cooperative Oncology Group 9"ECOG") E1496 Patient Consent Form

Mar 15, 2017EXHIBITPETITIONER

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

Mar 15, 2017EXHIBITPETITIONER

Hainsworth, J.D. et al., Rituximab Induction and Maintenance Therapy in Patients (pts) with Previously Untreated Low-Grade Non-Hodgkin's Lymphoma (NHL); Prelimiary Results of a Minnie Pearl Cancer Research Network Phase II Trial

Mar 15, 2017EXHIBITPETITIONER

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")

Mar 15, 2017EXHIBITPETITIONER

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)

Mar 15, 2017EXHIBITPETITIONER

U.S. Application No. 11/840,956 ("the '956 application")

Mar 15, 2017EXHIBITPETITIONER

ECOG E 1496 Protocol (1998)

Mar 15, 2017EXHIBITPETITIONER

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

Mar 15, 2017EXHIBITPETITIONER

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")

Mar 15, 2017EXHIBITPETITIONER

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

Mar 15, 2017EXHIBITPETITIONER

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")

Mar 15, 2017EXHIBITPETITIONER

Foon, K.A. & Fisher, R.I., Chapter 111: Lymphomas, in Williams Hematology, Fifth Edition, 1076-1096 (Beutler, E. et al., eds., 1995)

Mar 15, 2017EXHIBITPETITIONER

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")

Mar 15, 2017EXHIBITPETITIONER

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

Mar 15, 2017EXHIBITPETITIONER

Grillo-Lopez, A.J. et al., Overview of the Clinical Development of Rituximab: First Monoclonal Antibody Approved for the Treatment of Lymphoma, Semin. Oncol. 26(5, Supp. 14):66-73 (Oct. 1999)

Mar 15, 2017EXHIBITPETITIONER

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

Mar 15, 2017EXHIBITPETITIONER

Palmieri, G. et al., Maintenance therapy with recombinant interferon alpha-2B (aIFN) in prognostically unfavourable aggressive non-Hodgkin's lymphomas (NHL), Oncol. Rep., 3(4):733-735 (July/Aug. 1996)

Mar 15, 2017EXHIBITPETITIONER

EXPUNGED

Mar 15, 2017EXHIBITPETITIONER

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)

Mar 15, 2017EXHIBITPETITIONER

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)

Mar 15, 2017EXHIBITPETITIONER

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)

Mar 15, 2017EXHIBITPETITIONER

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)

Mar 15, 2017EXHIBITPETITIONER

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)

Mar 15, 2017EXHIBITPETITIONER

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)

Mar 15, 2017EXHIBITPETITIONER

Hainsworth, J.D. et al., Rituximab as First-Line and Maintenance Therapy for Patients With Indolent Non-Hodgkin's Lymphoma, J. Clin. Oncol., 20(20):4261-4267 (Oct. 15, 2002)

Mar 15, 2017EXHIBITPETITIONER

U.S. Application No. 09/372,202 ("the '202 application")

Mar 15, 2017EXHIBITPETITIONER

U.S. Provisional Application No. 60/096,180 ("the '180 provisional application")

Mar 15, 2017EXHIBITPETITIONER

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

Mar 15, 2017EXHIBITPETITIONER

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

Mar 15, 2017EXHIBITPETITIONER

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) (Mar. 1995)

Mar 15, 2017EXHIBITPETITIONER

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)

Mar 15, 2017EXHIBITPETITIONER

White, C., Rituximab Immunotherapy for Non-Hodgkin's Lymphoma, Cancer Biother. Radio., 14(4):241-50 (Aug. 1999) ("White 1999")

Mar 15, 2017EXHIBITPETITIONER

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)

Mar 15, 2017EXHIBITPETITIONER

McLaughlin, P. et al., Rituximab Chimeric Anti-CD20 Monoclonal Antibody Therapy for Relapsed Indolent Lymphoma: Half of Patients Respond to a Four-Dose Treatment Program, J. Clin. Oncol., 16(8):2825-2833 (Aug. 1998) ("McLauglin 1998")

Mar 15, 2017EXHIBITPETITIONER

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

Mar 15, 2017EXHIBITPETITIONER

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

Mar 15, 2017EXHIBITPETITIONER

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)

Mar 15, 2017EXHIBITPETITIONER

ECOG Protocols Active as of 05/19/98

Mar 15, 2017EXHIBITPETITIONER

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")

Mar 15, 2017EXHIBITPETITIONER

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)

Mar 15, 2017EXHIBITPETITIONER

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)

Mar 15, 2017EXHIBITPETITIONER

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")

Mar 15, 2017EXHIBITPETITIONER

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)

Mar 15, 2017EXHIBITPETITIONER

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

Mar 15, 2017EXHIBITPETITIONER

U.S. Application No. 13/524,896, Feb. 5, 2014 Amendment and Response to Office Action

Mar 15, 2017EXHIBITPETITIONER

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

Mar 15, 2017EXHIBITPETITIONER

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)

Mar 15, 2017EXHIBITPETITIONER

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)

Mar 15, 2017EXHIBITPETITIONER

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")

Mar 15, 2017EXHIBITPETITIONER

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)

Mar 15, 2017EXHIBITPETITIONER

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)

Mar 15, 2017EXHIBITPETITIONER

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)

Mar 15, 2017EXHIBITPETITIONER

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™

Mar 15, 2017EXHIBITPETITIONER

E1496 Forms Packet

Mar 15, 2017EXHIBITPETITIONER

E1496 On Study Dates

Mar 15, 2017EXHIBITPETITIONER