Case number IPR2017-02036
Sandoz, Inc. v. Genentech, Inc. > Documents
| Date Field | Doc. No. | Party | Description |
|---|---|---|---|
| Apr 4, 2018 | 13 | Decision - Denying Institution of Inter Partes Review - 37 CFR 42.108 Download | |
| Feb 2, 2018 | 12 | Petitioner's Authorized Reply to Patent Owner's Preliminary Response Download | |
| Jan 25, 2018 | 11 | Order - re Petitioner's Request for Authorization to File Reply to Patent Owner Preliminary Response Download | |
| Jan 5, 2018 | 10 | Patent Owner's Preliminary Response Download | |
| Jan 5, 2018 | 2007 | Boardside Chat presentation by Judges Lora Green & Brian McNamara, titled "Best Practices For Proving A Document Is A Printed Publication," dated December 7, 2017 Download | |
| Jan 5, 2018 | 2008 | Declaration of Megan Raymond Download | |
| Jan 5, 2018 | 2005 | Stanley B. Cohen et al., Rituximab for Rheumatoid Arthritis Refractory to Anti-Tumor Necrosis Factor Therapy, 54(9) Arthritis & Rheumatism, 2793-2806 (Sept. 2006) Download | |
| Jan 5, 2018 | 2009 | Peter McLaughlin et al., Rituximab Chimeric Anti-CD20 Monoclonal Antibody Therapy for Relapsed Indolent Lymphoma: Half of Patients Respond to a Four-Dose Treatment Program, 16(8) J. of Clinical Oncology, 2825-33 (Aug. 1998) Download | |
| Jan 5, 2018 | 2001 | International Application Publication No. WO 00/74718 A1 to David M. Goldberg et al. Download | |
| Jan 5, 2018 | 2003 | J.K. Jenkins & K.J. Hardy, Biological Modifier Therapy for the Treatment of Rheumatoid Arthritis, 323(4) Am. J. Med. Sci. 197-205 (2002) Download | |
| Jan 5, 2018 | 2004 | Rituxan (Rituximab) Prescribing Information dated February 2010 Download | |
| Jan 5, 2018 | 2002 | Boardside Chat with the Chie presentation by Chief Administrative Patent Judge David P. Ruschke, titled "An Analysis of Multiple Petitions in AIA Trials," dated Oct. 24 2017 Download | |
| Jan 5, 2018 | 2006 | "Arthritis Foundation Statement on Rituximab for Rheumatoid Arthritis" submitted, on May 10, 2012, by Genentech, Inc. to the European Patent Office as an exhibit (D61) to an appeal in the Opposition Proceedings in EP 1613350 Download | |
| Dec 22, 2017 | 9 | Supplemental Mandatory Notice Download | |
| Dec 22, 2017 | 8 | Power of Attorney Download | |
| Oct 5, 2017 | 7 | Notice of Accord Filing Date Download | |
| Sep 21, 2017 | 6 | Mandatory Notice Download | |
| Sep 21, 2017 | 5 | Power of Attorney Download | |
| Sep 21, 2017 | 4 | Mandatory Notice Download | |
| Sep 21, 2017 | 3 | Power of Attorney Download | |
| Aug 31, 2017 | 1016 | International Application Publication No. WO 00/67796 Download | |
| Aug 31, 2017 | 1029 | Maloney DG et al., IDEC-C2B8 (Rituximab) Anti-CD20 Monoclonal Antibody Therapy in Patients With Relapsed Low-Grade Non-Hodgkin's Lymphoma, 90(6) BLOOD 2188-2195 (September 15, 1997) Download | |
| Aug 31, 2017 | 1005 | De Vita S et al., Pathogenic Role of B Lymphocytes in Rheumatoid Synovitis: B Cell Selective Blocking Can Induce a Clinical Response in Patients with Refractory Rheumatoid Arthritis, 53(3) REUMATISMO 323 (2001) Download | |
| Aug 31, 2017 | 1056 | Rituxan™ FDA Drug Label (January 24, 2008) Download | |
| Aug 31, 2017 | 2 | PETITIONER POWER OF ATTORNEY Download | |
| Aug 31, 2017 | 1011 | Felson DT et al., The American College of Rheumatology Preliminary Core Set of Disease Activity Measures for Rheumatoid Arthritis Clinical Trials., 36(6) ARTHRITIS & RHEUMATISM 729-740 (June 1993) Download | |
| Aug 31, 2017 | 1015 | Kalden JR and Manger B, Biologic Agents in the Treatment of Inflammatory Rheumatic Diseases, 9 CURR. OPIN. RHEUMATOLOGY 206-212 (1997) Download | |
| Aug 31, 2017 | 1007 | Declaration of David Fox, M.D. Download | |
| Aug 31, 2017 | 1054 | Capps SB et al., Body Surface Area as a Predictor of Aortic and Pulmonary Valve Diameter, 119 J. THORAC. CARDIOVASC. SURG. 975-82 (2000) Download | |
| Aug 31, 2017 | 1002 | USPTO Assignment Records for U.S. Patent No. 7,976,838 Download | |
| Aug 31, 2017 | 1046 | U.S. Provisional Patent Application No. 60/461,481 (April 9, 2003) Download | |
| Aug 31, 2017 | 1008 | Declaration of William J. Jusko, Ph.D. Download | |
| Aug 31, 2017 | 1018 | Boers M et al., Randomised Comparison of Combined Step-Down Prednisolone, Methotrexate and Sulphasalazine with Sulphasalazine Alone in Early Rheumatoid Arthritis, 350 LANCET 309-318 (1997) Download | |
| Aug 31, 2017 | 1041 | Genentech, Preliminary Positive Data from investigational Randomized Phase II Trial Demonstrates Rituxan as a Potential Treatment for Rheumatoid Arthritis (Oct. 28, 2002) Download | |
| Aug 31, 2017 | 1009 | Elliott MJ et al., Treatment of Rheumatoid Arthritis With Chimeric Monoclonal Antibodies to Tumor Necrosis Factor a, 36(12) ARTHRITIS & RHEUMATISM 1681-1690 (December 1993) Download | |
| Aug 31, 2017 | 1003 | European Patent No. 1,613,350 Download | |
| Aug 31, 2017 | 1060 | De Vita S et al., Efficacy of Selective B Cell Blockade in the Treatment of Rheumatoid Arthritis, 46(8) ARTHRITIS & RHEUMATISM 2029-2033 (August 2002) Download | |
| Aug 31, 2017 | 1057 | Weisman M et al., A Dose Escalation Study Designed to Demonstrate the Safety, Tolerability and Efficacy of the Fully Human Anti-TNF Antibody, D2E7, 43(9) ARTHRITIS & RHEUMATISM S391 (2000) Download | |
| Aug 31, 2017 | 1026 | Rituxan™ FDA Drug Label (November 26, 1997) Download | |
| Aug 31, 2017 | 1022 | Maini RN et al., Therapeutic Efficacy of Multiple Intravenous Infusions of Anti-Tumor Necrosis Factor a Monoclonal Antibody Combined With Low-Dose Weekly Methotrexate in Rheumatoid Arthritis, 41(9) ARTHRITIS & RHEUMATISM 1552-1563 (1998) Download | |
| Aug 31, 2017 | 1020 | Enbrel® FDA Drug Label (January 15, 2002) Download | |
| Aug 31, 2017 | 1050 | Gottlieb AB et al., Anti-CD4 monocloncal antibody treatment of moderate to severe psoriasis vulgaris: Results of a pilot, multicenter, multiple-dose, placebo-controlled study, 43 J. AM. ACAD. DERMATOL. 595-604 (2000) Download | |
| Aug 31, 2017 | 1047 | Tobinai K et al., Feasibility and Pharmacokinetic Study of a Chimeric Anti-CD20 Monoclonal Antibody (IDEC-C2B8, Rituximab) in Relapsed B-Cell Lymphoma, 9 ANN. ONCOL. 527-534 (1998) Download | |
| Aug 31, 2017 | 1001 | U.S. Patent No. 7,976,838 Download | |
| Aug 31, 2017 | 1004 | Decision Revoking the European Patent (Art. 101(3)(b) EPC), Application No. 04,759,142.5, Patent No. 1,613,350 (February 29, 2012) Download | |
| Aug 31, 2017 | 1030 | Iacona I et al., Rituzimab (IDEC-C2B8): Validation of a Sensitive Enxyme-Linked Immunoassay Applied to a Clinical Pharmacokinetic Study, 22(3) THERAPEUTIC DRUG MONITORING 295-301 (2000) Download | |
| Aug 31, 2017 | 1034 | Edwards JCW et al., B-Lymphocyte Depletion Therapy in Rheumatoid Arthritis and Other Autoimmune Disorders, 30(4) BIOCHEMICAL SOC. TRANSACTIONS 824-828 (2002) Download | |
| Aug 31, 2017 | 1038 | Edwards JCW et al., Efficacy and Safety of Rituximab, a B-Cell Targeted Chimeric Monoclonal Antibody: A Randomized, Placebo-Controlled Trial in Patients with Rheumatoid Arthritis, 46(9) ARTHRITIS & RHEUMATISM S197 (2002) Download | |
| Aug 31, 2017 | 1006 | Edwards JCW and Cambridge G, Sustained Improvement in Rheumatoid Arthritis Following a Protocol Designed to Deplete B Lymphocytes, 40 RHEUMATOLOGY 205-211 (2001) Download | |
| Aug 31, 2017 | 1017 | Kirwan JR, The Effect of Glucocorticoids on Joint Destruction in Rheumatoid Arthritis, 333 N. ENGL. J.MED. 142-146 (July 20, 1995) Download | |
| Aug 31, 2017 | 1021 | Remicade® FDA Drug Label (February 27, 2002) Download | |
| Aug 31, 2017 | 1058 | Gordon MS et al., Phase I Safety and Pharmacokinetic Study of Recombinant Human Anti-Vascular Endothelial Growth Factor in Patients with Advanced Cancer, 19(3) J. CLIN. ONCOL. 843-50 (2001) Download | |
| Aug 31, 2017 | 1031 | Edwards JCW and Cambridge G, Rheumatoid Arthritis: The Predictable Effect of Small Immune Complexes in Which Antibody is Also Antigen, 37 BRITISH J. RHEUMATOLOGY 126-130 (1998) Download | |
| Aug 31, 2017 | 1053 | Atkins, Weighting Functions and Data Truncation in the Fitting of Multi-Exponential Functions, 138 BIOCHEM. J. 125-127 (1974) Download | |
| Aug 31, 2017 | 1044 | European Patent Office, Decision of the Technical Board of Appeal, Case No. T 0734/12 -3.3.04 (July 29, 2013) Download | |
| Aug 31, 2017 | 1032 | Edwards JCW, The Case for Killing B Cells With Anti-CD20 in RA, Australian Rheumatology Assoc., 41st Annual Scientific Conference, Sydney, 53 (May 24-27, 1998) Download | |
| Aug 31, 2017 | 1035 | Leandro MJ et al., Clinical Outcome in 22 Patients With Rheumatoid Arthritis With B Lymphocyte Depletion, 61 ANN. RHEUM. DIS. 883-888 (2002) Download | |
| Aug 31, 2017 | 1051 | David J. King, APPLICATIONS AND ENGINEERING OF MONOCLONAL ANTIBODIES (1998) Download | |
| Aug 31, 2017 | 1012 | O'Dell JR, Methotrexate Use in Rheumatoid Arthritis, 23(4) RHEUMATIC DISEASE CLINICS OF NORTH AMERICA 779-796 (November 1997) Download | |
| Aug 31, 2017 | 1061 | Declaration of Siegmund Gutman Download | |
| Aug 31, 2017 | 1039 | Edwards JCW, Is rheumatoid factor relevant, In Bird H, Snaith ML, eds. Rheumatoid arthritis, questions and uncertainties, Oxford: Blackwell Scientific, 3-23 (1999) Download | |
| Aug 31, 2017 | 1014 | Pincus T et al., "No Evidence of Disease" in Rheumatoid Arthritis Using Methotrexate in Combination With Other Drugs: AContemporary Goal For Rheumatology Care?, 15 CLIN. EXP. RHEUMATOLOGY 591-596 (1997) Download | |
| Aug 31, 2017 | 1036 | Tuscano JM, Successful Treatment of Infliximab-Refractory Rheumatoid Arthritis With Rituximab, 46(12) ARTHRITIS & RHEUMATISM 3420 (December 2002) Download | |
| Aug 31, 2017 | 1055 | Bender AE et al., A DICTIONARY OF FOOD AND NUTRITION (1995) Download | |
| Aug 31, 2017 | 1037 | Waldman TA et al., Emerging Therapies: Spectrum of Applications of Monoclonal Antibody Therapy, HEMATOLOGY 394-408 (2000) Download | |
| Aug 31, 2017 | 1033 | Edwards JCW, Can IgG Rheumatoid Factors Explain Everything?, 1(Suppl. 1) ARTHRITIS RES. (1999) Download | |
| Aug 31, 2017 | 1025 | Furst DE et al., Access to Disease Modifying Treatments for Rheumatoid Arthritis Patients, 58 ANN. RHEUM. DIS. I129-I130 (1999) Download | |
| Aug 31, 2017 | 1042 | Certified File History of U.S. Patent No. 7,976,838 Download | |
| Aug 31, 2017 | 1024 | Furst DE et al., Building Towards a Consensus for the Use of Tumour Necrosis Factor Blocking Agents, 58 ANN. RHEUM. DIS. 725-726 (1999) Download | |
| Aug 31, 2017 | 1028 | Maloney DG 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 Lyphoma, 84(8) BLOOD 2457-2466 (October 15, 1994) Download | |
| Aug 31, 2017 | 1019 | Humira® FDA Drug Label (December 20, 2002) Download | |
| Aug 31, 2017 | 1045 | U.S. Patent Application No. 10/818,765 (April 6, 2004) Download | |
| Aug 31, 2017 | 1013 | Kremer JM, Combination Therapy with Biologic Agents in Rheumatoid Arthritis: Perils and Promise, 41(9) ARTHRITIS & RHEUMATISM 1548-1551 (September 1998) Download | |
| Aug 31, 2017 | 1052 | U.S. Dep. of Health and Human Services, FDA, Center for Drug Evaluation and Research (CDER), Guidance for Industry: Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers (2005) Download | |
| Aug 31, 2017 | 1023 | Seymour HE et al., Anti-TNF Agents for Rheumatoid Arthritis, 51 J CLIN. PHARMACOL. 201-208 (2001) Download | |
| Aug 31, 2017 | 1043 | van Vollenhoven R, "Declaration of Ronald F. van Vollenhoven," File in EP1613350 Opposition (Oct. 6, 2010) Download | |
| Aug 31, 2017 | 1010 | American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines, Guidelines for the Management of Rheumatoid Arthritis: 2002 Update, 46(2) ARTHRITIS & RHEUMATISM 328-346 (February 2002) Download | |
| Aug 31, 2017 | 1 | PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 7,976,838 UNDER 35 U.S.C. SEC. 311 AND 37 C.F.R. SEC. 42.100 Download | |
| Aug 31, 2017 | 1027 | Maloney DG et al., IDEC-C2B8: Results of a Phase I Multiple-Dose Trial in Patients With Relapsed Non-Hodgkin's Lymphoma, 15 J. CLIN. ONCOL. 3266-3274 (1997) Download |
