The detailed information for PTAB case with proceeding number IPR2017-02036 filed by Sandoz, Inc. against Genentech, Inc. on Aug 31, 2017. This includes filing dates, application numbers, tech centers, patent numbers, and current case status.

Case Details

Proceeding Number
IPR2017-02036
Filing Date
Aug 31, 2017
Petitioner
Sandoz, Inc.
Respondent
Genentech, Inc.
Status
Institution Denied
Respondent Application Number
12052606
Respondent Tech Center
1600
Respondent Patent Number
7976838
Institution Decision Date
Apr 4, 2018

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

Decision - Denying Institution of Inter Partes Review - 37 CFR 42.108

Apr 4, 2018PAPERBOARD

Petitioner's Authorized Reply to Patent Owner's Preliminary Response

Feb 2, 2018PAPERPETITIONER

Order - re Petitioner's Request for Authorization to File Reply to Patent Owner Preliminary Response

Jan 25, 2018PAPERBOARD

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

Jan 5, 2018EXHIBITPATENT OWNER

International Application Publication No. WO 00/74718 A1 to David M. Goldberg et al.

Jan 5, 2018EXHIBITPATENT OWNER

J.K. Jenkins & K.J. Hardy, Biological Modifier Therapy for the Treatment of Rheumatoid Arthritis, 323(4) Am. J. Med. Sci. 197-205 (2002)

Jan 5, 2018EXHIBITPATENT OWNER

Rituxan (Rituximab) Prescribing Information dated February 2010

Jan 5, 2018EXHIBITPATENT OWNER

Stanley B. Cohen et al., Rituximab for Rheumatoid Arthritis Refractory to Anti-Tumor Necrosis Factor Therapy, 54(9) Arthritis & Rheumatism, 2793-2806 (Sept. 2006)

Jan 5, 2018EXHIBITPATENT OWNER

"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

Jan 5, 2018EXHIBITPATENT OWNER

Boardside Chat presentation by Judges Lora Green & Brian McNamara, titled "Best Practices For Proving A Document Is A Printed Publication," dated December 7, 2017

Jan 5, 2018EXHIBITPATENT OWNER

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)

Jan 5, 2018EXHIBITPATENT OWNER

Declaration of Megan Raymond

Jan 5, 2018EXHIBITPATENT OWNER

Patent Owner's Preliminary Response

Jan 5, 2018PAPERPATENT OWNER

Supplemental Mandatory Notice

Dec 22, 2017PAPERPATENT OWNER

Power of Attorney

Dec 22, 2017PAPERPATENT OWNER

Notice of Accord Filing Date

Oct 5, 2017PAPERBOARD

Power of Attorney

Sep 21, 2017PAPERPATENT OWNER

Mandatory Notice

Sep 21, 2017PAPERPATENT OWNER

Genentech, Preliminary Positive Data from investigational Randomized Phase II Trial Demonstrates Rituxan as a Potential Treatment for Rheumatoid Arthritis (Oct. 28, 2002)

Aug 31, 2017EXHIBITPETITIONER

European Patent Office, Decision of the Technical Board of Appeal, Case No. T 0734/12 -3.3.04 (July 29, 2013)

Aug 31, 2017EXHIBITPETITIONER

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

Aug 31, 2017PAPERPETITIONER

PETITIONER POWER OF ATTORNEY

Aug 31, 2017PAPERPETITIONER

U.S. Patent No. 7,976,838

Aug 31, 2017EXHIBITPETITIONER

USPTO Assignment Records for U.S. Patent No. 7,976,838

Aug 31, 2017EXHIBITPETITIONER

European Patent No. 1,613,350

Aug 31, 2017EXHIBITPETITIONER

Decision Revoking the European Patent (Art. 101(3)(b) EPC), Application No. 04,759,142.5, Patent No. 1,613,350 (February 29, 2012)

Aug 31, 2017EXHIBITPETITIONER

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)

Aug 31, 2017EXHIBITPETITIONER

Edwards JCW and Cambridge G, Sustained Improvement in Rheumatoid Arthritis Following a Protocol Designed to Deplete B Lymphocytes, 40 RHEUMATOLOGY 205-211 (2001)

Aug 31, 2017EXHIBITPETITIONER

Declaration of David Fox, M.D.

Aug 31, 2017EXHIBITPETITIONER

Declaration of William J. Jusko, Ph.D.

Aug 31, 2017EXHIBITPETITIONER

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)

Aug 31, 2017EXHIBITPETITIONER

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)

Aug 31, 2017EXHIBITPETITIONER

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)

Aug 31, 2017EXHIBITPETITIONER

O'Dell JR, Methotrexate Use in Rheumatoid Arthritis, 23(4) RHEUMATIC DISEASE CLINICS OF NORTH AMERICA 779-796 (November 1997)

Aug 31, 2017EXHIBITPETITIONER

Kremer JM, Combination Therapy with Biologic Agents in Rheumatoid Arthritis: Perils and Promise, 41(9) ARTHRITIS & RHEUMATISM 1548-1551 (September 1998)

Aug 31, 2017EXHIBITPETITIONER

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)

Aug 31, 2017EXHIBITPETITIONER

Kalden JR and Manger B, Biologic Agents in the Treatment of Inflammatory Rheumatic Diseases, 9 CURR. OPIN. RHEUMATOLOGY 206-212 (1997)

Aug 31, 2017EXHIBITPETITIONER

International Application Publication No. WO 00/67796

Aug 31, 2017EXHIBITPETITIONER

Kirwan JR, The Effect of Glucocorticoids on Joint Destruction in Rheumatoid Arthritis, 333 N. ENGL. J.MED. 142-146 (July 20, 1995)

Aug 31, 2017EXHIBITPETITIONER

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)

Aug 31, 2017EXHIBITPETITIONER

Humira® FDA Drug Label (December 20, 2002)

Aug 31, 2017EXHIBITPETITIONER

Enbrel® FDA Drug Label (January 15, 2002)

Aug 31, 2017EXHIBITPETITIONER

Remicade® FDA Drug Label (February 27, 2002)

Aug 31, 2017EXHIBITPETITIONER

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)

Aug 31, 2017EXHIBITPETITIONER

Seymour HE et al., Anti-TNF Agents for Rheumatoid Arthritis, 51 J CLIN. PHARMACOL. 201-208 (2001)

Aug 31, 2017EXHIBITPETITIONER

Furst DE et al., Building Towards a Consensus for the Use of Tumour Necrosis Factor Blocking Agents, 58 ANN. RHEUM. DIS. 725-726 (1999)

Aug 31, 2017EXHIBITPETITIONER

Furst DE et al., Access to Disease Modifying Treatments for Rheumatoid Arthritis Patients, 58 ANN. RHEUM. DIS. I129-I130 (1999)

Aug 31, 2017EXHIBITPETITIONER

Rituxan™ FDA Drug Label (November 26, 1997)

Aug 31, 2017EXHIBITPETITIONER

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)

Aug 31, 2017EXHIBITPETITIONER

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)

Aug 31, 2017EXHIBITPETITIONER

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)

Aug 31, 2017EXHIBITPETITIONER

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)

Aug 31, 2017EXHIBITPETITIONER

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)

Aug 31, 2017EXHIBITPETITIONER

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)

Aug 31, 2017EXHIBITPETITIONER

Edwards JCW, Can IgG Rheumatoid Factors Explain Everything?, 1(Suppl. 1) ARTHRITIS RES. (1999)

Aug 31, 2017EXHIBITPETITIONER

Edwards JCW et al., B-Lymphocyte Depletion Therapy in Rheumatoid Arthritis and Other Autoimmune Disorders, 30(4) BIOCHEMICAL SOC. TRANSACTIONS 824-828 (2002)

Aug 31, 2017EXHIBITPETITIONER

Leandro MJ et al., Clinical Outcome in 22 Patients With Rheumatoid Arthritis With B Lymphocyte Depletion, 61 ANN. RHEUM. DIS. 883-888 (2002)

Aug 31, 2017EXHIBITPETITIONER

Tuscano JM, Successful Treatment of Infliximab-Refractory Rheumatoid Arthritis With Rituximab, 46(12) ARTHRITIS & RHEUMATISM 3420 (December 2002)

Aug 31, 2017EXHIBITPETITIONER

Waldman TA et al., Emerging Therapies: Spectrum of Applications of Monoclonal Antibody Therapy, HEMATOLOGY 394-408 (2000)

Aug 31, 2017EXHIBITPETITIONER

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)

Aug 31, 2017EXHIBITPETITIONER

Edwards JCW, Is rheumatoid factor relevant, In Bird H, Snaith ML, eds. Rheumatoid arthritis, questions and uncertainties, Oxford: Blackwell Scientific, 3-23 (1999)

Aug 31, 2017EXHIBITPETITIONER

Certified File History of U.S. Patent No. 7,976,838

Aug 31, 2017EXHIBITPETITIONER

van Vollenhoven R, "Declaration of Ronald F. van Vollenhoven," File in EP1613350 Opposition (Oct. 6, 2010)

Aug 31, 2017EXHIBITPETITIONER

U.S. Patent Application No. 10/818,765 (April 6, 2004)

Aug 31, 2017EXHIBITPETITIONER

U.S. Provisional Patent Application No. 60/461,481 (April 9, 2003)

Aug 31, 2017EXHIBITPETITIONER

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)

Aug 31, 2017EXHIBITPETITIONER

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)

Aug 31, 2017EXHIBITPETITIONER

David J. King, APPLICATIONS AND ENGINEERING OF MONOCLONAL ANTIBODIES (1998)

Aug 31, 2017EXHIBITPETITIONER

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)

Aug 31, 2017EXHIBITPETITIONER

Atkins, Weighting Functions and Data Truncation in the Fitting of Multi-Exponential Functions, 138 BIOCHEM. J. 125-127 (1974)

Aug 31, 2017EXHIBITPETITIONER

Capps SB et al., Body Surface Area as a Predictor of Aortic and Pulmonary Valve Diameter, 119 J. THORAC. CARDIOVASC. SURG. 975-82 (2000)

Aug 31, 2017EXHIBITPETITIONER

Bender AE et al., A DICTIONARY OF FOOD AND NUTRITION (1995)

Aug 31, 2017EXHIBITPETITIONER

Rituxan™ FDA Drug Label (January 24, 2008)

Aug 31, 2017EXHIBITPETITIONER

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)

Aug 31, 2017EXHIBITPETITIONER

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)

Aug 31, 2017EXHIBITPETITIONER

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)

Aug 31, 2017EXHIBITPETITIONER

Declaration of Siegmund Gutman

Aug 31, 2017EXHIBITPETITIONER