Sandoz Inc. vs Genentech, Inc. - IPR2017-02042

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

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

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

Boardside "Chat with the Chief" presentation by Chief Administrative Patent Judge David P. Ruschke, titled "An Analysis of Multiple Petitions in AIA Trials," dated Oct. 24 2017

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

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

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

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)

Rituxan (Rituximab) Prescribing Information dated February 2010

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

Declaration of Megan Raymond

Patent Owner's Preliminary Response

Patent Owner's Supplemental Mandatory Notice

Power of Attorney

Notice of Accord Filing Date

Power of Attorney

Mandatory Notice

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)

PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 7,976,838 UNDER 35 U.S.C. § 311 AND 37 C.F.R. § 42.100

PETITIONER POWER OF ATTORNEY

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

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

European Patent No. 1,613,350

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

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)

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

Declaration of David Fox, M.D.

Declaration of William J. Jusko, Ph.D.

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)

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)

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)

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

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

Pincus T et al., "No Evidence of Disease" in Rheumatoid Arthritis Using Methotrexate in Combination With Other Drugs: A Contemporary Goal For Rheumatology Care?, 15 CLIN. EXP. RHEUMATOLOGY 591-596 (1997)

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

International Application Publication No. WO 00/67796

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

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)

Humira® FDA Drug Label (December 20, 2002)

Enbrel® FDA Drug Label (January 15, 2002)

Remicade® FDA Drug Label (February 27, 2002)

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)

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

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

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

Rituxan™ FDA Drug Label (November 26, 1997)

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)

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)

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)

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)

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)

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

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

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)

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

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

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

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

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

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

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

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)

U.S. Department 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)

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

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

Patel DD, B Cell-Ablative Therapy for the Treatment of Autoimmune Diseases, 46(8) ARTHRITIS & RHEUMATISM 1984-1985 (August 2002)

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

Roche, MabThera (rituximab) Research Report No. 1005599 (Nov. 2003)

Edwards JCW et al., Efficacy of B-Cell-Targeted Therapy with Rituximab in Patients with Rheumatoid Arthritis, 350 N. ENGL. J.MED. 2572-81 (2004)

Lopez-Olivio MA et al., Rituximab for Rheumatoid Arthritis (Review), 1(CD007356) COCHRANE DATABASE OF SYSTEMATIC REVIEWS 1-367 (2015)

Declaration of Siegmund Gutman