UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL
`BOARD
`
`SANDOZ INC.,
`Petitioner
`
`v.
`
`ABBVIE BIOTECHNOLOGY LTD.,
`Patent Owner
`
`U.S. Patent No.: 8,911,737
`Issue Date: Dec. 16, 2014
`Title: Methods of Administering Anti-TNFa Antibodies
`
`DECLARATION OF VICTORIA L. REINES
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL
`BOARD
`
`SANDOZ INC.,
`Petitioner
`
`v.
`
`ABBVIE BIOTECHNOLOGY LTD.,
`Patent Owner
`
`U.S. Patent No.: 8,911,737
`Issue Date: Dec. 16, 2014
`Title: Methods of Administering Anti-TNFa Antibodies
`
`DECLARATION OF VICTORIA L. REINES
`
`
`
`DECLARATION OF VICTORIA L. REINES
`
`I, Victoria L. Reines declare that:
`
`1.
`
`I am an associate at the law firm Arnold & Porter Kaye Scholer LLP,
`
`250 West 55th St., New York, NY 10019, which represents Petitioner Sandoz Inc.
`
`in the above matter. I make the following statements based on personal
`
`knowledge.
`
`2.
`
`The table below identifies the true and correct copies of exhibits
`
`submitted along with this declaration.
`
`Description
`
`Exhibit
`No.
`1018 Remicadew (infliximab) 1998 label (Aug. 1998)
`United States Patent No. 9,017,680, filed Nov. 14, 2014, issued
`Apr. 28, 2015
`Luke Timmerman, Abbott's Humira, the 3rd-in-Class Drug That
`Toppled Lipitor as No. 1, XCONOMY (Apr. 16, 2012), available at
`http://wvvvv.xconomy.com/nationa1/2012/04/16/abbotts-humira-
`the-3rd-in-class-drug-that-toppled-lipitor-as-no-1/#
`Amgen Inc. v. AbbVie Biotech. Ltd., No. IPR2015-01517 (Patent
`Owner's Preliminary Response, Oct. 19, 2015)
`United States Patent No. 9,090,689, filed Apr. 8, 2015, issued
`July 28, 2015
`Coherus BioSciences Inc. v. AbbVie Biotechnology Ltd., No.
`IPR2016-00172, Patent Owner's Updated Exhibit List (as of
`January 19, 2017) (January 19, 2017)
`United States Patent No. 9,073,987, filed May 30, 2014, issued
`July 7, 2015
`Coherus BioSciences Inc. v. AbbVie Biotechnology Ltd., No.
`IPR2016-00172, Patent Owner's Response (Sept. 13, 2016)
`
`1021
`
`1031
`
`1035
`
`1049
`
`1069
`
`1098
`
`1105
`
`64199436
`
`
`
`3.
`
`I ordered a copy of N. Swartz, The Treatment of 124 Cases of
`
`Ulcerative Colitis With Salazopyrin and Attempts of Destabilisation in Cases of
`
`Hypersensitives to Sulfa, 130 AcTA MED. ScAND. 465 (1948) from the Arnold &
`
`Porter Kaye Scholer LLP Library, and they obtained a copy of the article with a
`
`cover sheet (Exhibit 1033) from WTS. Exhibit 1033 states that the article was
`
`published in 1948.
`
`4.
`
`According to Amazon's database, the 2001 Physician's Desk
`
`Reference (55th ed.) was published in November 2000, excerpts of which are
`
`attached to the Declarations as exhibits 1007 and 1051. Exhibit 1048 is a true and
`
`correct printout from Amazon at the following URL which demonstrates this
`
`publication date: https://www.amazon.com/Physicians-Desk-Reference-2001-
`
`Pdr/dp/1563633752.
`
`5. As shown in Exhibit 1071, the website for the journal
`
`Gastroenterology indicates that Feagan II (ex. 1099) was published in
`
`Gastroenterology, volume 118 in April 2000, available at
`
`http://vvww.gastrojournal.org/article/S0016-5085(00)84761-7/abstract.
`
`6. At my direction, library personnel at the New York Academy of
`
`Medicine obtained copies of the following references:
`
`2
`
`64199436
`
`
`
`1004
`
`Description
`Ex. No.
`1003 B. A. van de Putte et al., Efficacy of the Fully Human Anti-TNF
`Antibody D2E7 in Rheumatoid Arthritis, 42 ARTHRITIS & RHEUMATISM
`(1999) (ACR Abstract Concurrent Session, RA: TNF Blockade, Wed.,
`Nov. 17, 1999 5400)
`Joachim Kempeni, Preliminary Results of Early Clinical Trials with the
`Fully Human Anti-TNFa Monoclonal Antibody D2E7, 58 ANNALS
`RHEUMATIC DISEASES 170 (1999)
`1022 Hendrik M. van Dullemen et al., Treatment of Therapy-Resistant
`Perineal Metastatic Crohn's Disease After Proctectomy Using Anti-
`Tumor Necrosis Factor Chimeric Monoclonal Antibody, cA2, 41
`DISEASES COLON & RECTUM 98 (1998)
`1023 William J. Sandborn et al., An Engineered Human Antibody to TNF
`(CDP571) for Active Crohn's Disease: A Randomized Double-Blind
`Placebo-Controlled Trial, 120 GASTROENTEROLOGY 1330 (May 2001)
`TEXTBOOK OF RHEUMATOLOGY vol. 1 (William N. Kelley et al. eds.,
`4th ed. 1993)
`1099 Brian G. Feagan et al., A Randomized, Double-Blind, Placebo-
`Controlled, Multi-Center Trial of the Engineered Human Antibody to
`TNF (CDP571) for Steroid Sparing and Maintenance of Remission in
`Patients with Steroid-Dependent Crohn's Disease, 118
`GASTROENTEROLOGY A655 (April 2000)
`1103 Hendrik M. Van Dullemen et al., Treatment of Crohn's Disease with
`Anti-Tumor Necrosis Factor Chimeric Monoclonal Antibody (cA2), 109
`GASTROENTEROLOGY 129 (1995)
`
`1029
`
`7. (cid:9)
`
`At my direction, Independence Legal Support and the Arnold &
`
`Porter Kaye Scholer Library obtained copies of the following exhibits from the
`
`following libraries:
`
`Description
`
`Exhibit
`No.
`1005 William J. Sandborn & Stephen B. Hanauer,
`Antitumor Necrosis Factor Therapy for
`Inflammatory Bowel Disease: A Review of Agents,
`Pharmacology, Clinical Results, and Safety, 5
`
`Library
`
`National Library
`of Medicine
`
`3
`
`64199436
`
`
`
`Exhibit
`No.
`
`Description
`
`1007
`
`1025
`
`1026
`
`INFLAMMATORY BOWEL DISEASES 119 (1999)
`2001 PHYSICIAN'S DESK REFERENCE (55th ed.,
`published Nov. 2000) (excerpts)
`1016 Douglas J. Perkins et al., Reduction of NOS2
`Overexpression in Rheumatoid Arthritis Patients
`Treated with Anti-Tumor Necrosis Factor a
`Monoclonal Antibody (cA2), 41 ARTHRITIS &
`RHEUMATISM 2205 (1998)
`E. C. C. Rankin et al., The Therapeutic Effects of
`an Engineered Human Anti-Tumour Necrosis
`Factor Alpha Antibody (CDP571) in Rheumatoid
`Arthritis, 34 BRIT. J. RHEUMATOLOGY 334 (1995)
`Ernest H.S. Choy et al., The Engineered Human
`Anti-Tumor Necrosis Factor-a Antibody CDP571
`Inhibits Inflammatory Pathways But Not T Cell
`Activation in Patients with Rheumatoid Arthritis,
`26 J. RHEUMATOLOGY 2310 (1999)
`SLEISENGER & FORDTRAN'S GASTROINTESTINAL
`AND LIVER DISEASE: PATHOPHYSIOLOGY,
`DIAGNOSIS, MANAGEMENT vol. 2 (Mark Feldman et
`al. eds., 6th ed. 1998)
`1032 Ute Kettritz et al., Crohn's Disease: Pilot Study
`Comparing MRI of the Abdomen with Clinical
`Evaluation, 21 J. CLINICAL GASTROENTEROLOGY
`249 (1995)
`1034 K. Eberhardt & E. Fex, Clinical Course and
`Remission Rate in Patients with Early Rheumatoid
`Arthritis: Relationship to Outcome After 5 Years,
`37 BRIT. J. RHEUMATOLOGY 1324 (1998)
`1036 A. M. Denman, Rheumatoid Arthritis: Aetiology, 4
`BRIT. MED. J. 601 (1970)
`Rodrick J. Chiodini et al., Possible Role of
`Mycobacteria in Inflammatory Bowel Disease: I.
`An Unclassified Mycobacterium Species Isolated
`from Patients with Crohn's Disease, 29 DIGESTIVE
`DISEASES & SCI. 1073 (1984)
`1038 W. E. W. Roediger, A New Hypothesis for the
`
`1027
`
`1037
`
`4
`
`Library
`
`Arnold & Porter
`Library
`National Library
`of Medicine
`
`National Library
`of Medicine
`
`National Library
`of Medicine
`
`National Library
`of Medicine
`
`Library of
`Congress
`
`National Library
`of Medicine
`
`National Library
`of Medicine
`Library of
`Congress
`
`National Library
`
`64199436
`
`
`
`Exhibit
`No.
`
`Description
`
`1039
`
`1040
`
`1045
`
`1047
`
`Aetiology of Crohn's Disease—Evidence from Lipid
`Metabolism and Intestinal Tuberculosis, 67
`POSTGRADUATE MED. J. 666 (1991)
`Robert W. Chandler et al., Serological
`Investigations for Evidence of an Infectious
`Aetiology of Rheumatoid Arthritis, 30 ANNALS
`RHEUMATIC DISEASES 274 (1971)
`Joel B. Baseman & Joseph G. Tully, Mycoplasmas:
`Sophisticated, Reemerging, and Burdened by Their
`Notoriety, 3 EMERGING INFECTIOUS DISEASES 21
`(1997)
`1043 Michael T. Collins et al., Results of Multiple
`Diagnostic Tests for Mycobacterium avium subsp.
`paratuberculosis in Patients with Inflammatory
`Bowel Disease and in Controls, 38 J. CLINICAL
`MICROBIOLOGY 4373 (Dec. 2000)
`R. G. White & J. Gordon, Adjuvant-Activity of
`Diphtheroid' Organisms Isolated from the Joints
`of Cases of Rheumatoid Arthritis, 7 CLINICAL &
`EXPERIMENTAL IMMUNOLOGY 139 (1970)
`Pieter C. M. Res et al., Synovial Fluid T Cell
`Reactivity Against 65 kD Heat Shock Protein of
`Mycobacteria in Early Chronic Arthritis, 2 LANCET
`478 (1988)
`(Infliximab) Package Insert, 2001
`Remicade (cid:9)
`Physician's Desk Reference (Centocor, Inc. 1999)
`Stephan R. Targan et al., A Short-Term Study of
`Chimeric Monoclonal Antibody cA2 to Tumor
`Necrosis Factor a For Crohn's Disease, 337 NEW
`ENG. J. MED. 1029 (1997)
`T. T. MacDonald et al., Tumour Necrosis Factor-
`Alpha and Interferon-Gamma Production
`Measured at the Single Cell Level in Normal and
`Inflamed Human Intestine, 81 CLINICAL &
`EXPERIMENTAL IMMUNOLOGY 301 (1990)
`1054 Nick Di Girolamo et al., Expression of TNF-a by
`Human Plasma Cells in Chronic Inflammation, 61
`
`1051
`
`1052
`
`1053
`
`Library
`
`of Medicine
`
`National Library
`of Medicine
`
`National Library
`of Medicine
`
`Library of
`Congress
`
`Library of
`Congress
`
`Library of
`Congress
`
`Arnold & Porter
`Library
`Library of
`Congress
`
`Library of
`Congress
`
`Library of
`Congress
`
`5
`
`64199436
`
`
`
`Exhibit
`No.
`
`Description
`
`J. LEUKOCYTE BIOLOGY 667 (1997)
`1055 George Kollias et al., The Function of Tumour
`Necrosis Factor and Receptors in Models of Multi-
`Organ Inflammation, Rheumatoid Arthritis,
`Multiple Sclerosis and Inflammatory Bowel
`Disease, 58 ANNALS RHEUMATIC DISEASES 132
`(1999)
`1056 A. Glennas et al., Auranofin Is Safe and Superior to
`Placebo in Elderly-Onset Rheumatoid Arthritis, 36
`BRIT. J. RHEUMATOLOGY 870 (1997)
`1059 N. Svartz, The Treatment of 124 Cases of
`Ulcerative Colitis with Salazopyrine and Attempts
`of Desensibilization in Cases of Hypersensitiveness
`to Sulfa, 130 ACTA MEDICA SCANDINAVICA 465
`(1948)
`1060 A. P. Dick et al., Controlled Trial of
`Sulphasalazine in the Treatment of Ulcerative
`Colitis, 5 GUT 437 (1964)
`J. Hayllar & I. Bjarnason, Sulphasalazine in
`Ulcerative Colitis: In Memoriam?, 32 GUT 462
`(1991)
`1062 Maarten Boers et al., Randomised Comparison of
`Combined Step-Down Prednisolone, Methotrexate
`and Sulphasalazine with Sulphasalazine Alone in
`Early Rheumatoid Arthritis, 350 LANCET 309
`(1997)
`1064 D. S. Rampton & G. E. Sladen, Prostaglandin
`Synthesis Inhibitors in Ulcerative Colitis:
`Flurbiprofen Compared with Conventional
`Treatment, 21 PROSTAGLANDINS 417 (1981)
`1065 D. S. Rampton & G. E. Sladen, Relationship
`Between Rectal Mucosal Prostaglandin Production
`and Water and Electrolyte Transport in Ulcerative
`Colitis, 30 DIGESTION 13 (1984)
`Christian Moens & J. Brocteur, Treatment of
`Rheumatoid Arthritis with Immunosuppresive
`Drugs ,1 1 ACTA RHEUMATOLOGICA SCANDINAVICA
`
`1068
`
`1061
`
`Library
`
`University of
`Washington
`
`National Library
`of Medicine
`
`National Library
`of Medicine
`
`National Library
`of Medicine
`
`National Library
`of Medicine
`
`National Library
`of Medicine
`
`Library of
`Congress
`
`National Library
`of Medicine
`
`National Library
`of Medicine
`
`6
`
`64199436
`
`
`
`Exhibit
`No.
`
`Description
`
`1070
`
`1072
`
`212 (1961)
`S. Candy et al., A Controlled Double Blind Study of
`Azathioprine in the Management of Crohn's
`Disease, 37 GUT 674 (1995)
`J. Woodland et al., Azathioprine in Rheumatoid
`Arthritis: Double-Blind Study of Full Versus Half
`Doses Versus Placebo, 40 ANNALS RHEUMATIC
`DISEASES 355 (1981)
`1073 Knut Joachim Berg et al., Side Effects of
`Cyclosporin A Treatment in Patients with
`Rheumatoid Arthritis, 29 KIDNEY INT'L 1180
`(1986)
`1074 A.W.A.M. van Rijthoven et al., Cyclosporin
`Treatment for Rheumatoid Arthritis: A Placebo
`Controlled, Double Blind, Multicentre Study, 45
`ANNALS RHEUMATIC DISEASES 726 (1986)
`E. C. Huskisson et al., Trial Comparing D-
`Penicillamine and Gold in Rheumatoid Arthritis,
`33 ANNALS RHEUMATIC DISEASES 532 (1974)
`1083 M. Lemann et al., Methotrexate for the Treatment
`of Refractory Crohn's Disease, 10 ALIMENT
`PHARMACOLOGY & THERAPIES 309 (1996)
`E. C. Huskisson et al., Immunostimulant Therapy
`with Levamisole for Rheumatoid Arthritis, 1
`LANCET 393 (1976)
`Bruce Miller et al., Double-Blind Placebo
`Controlled Crossover Evaluation of Levamisole in
`Rheumatoid Arthritis, 23 ARTHRITIS &
`RHEUMATISM 172 (1980)
`P. Franchimont et al., Double-Blind Placebo-
`Controlled Evaluation of Levamisole in Chronic
`Rheumatoid Arthritis, 8 SCANDINAVIAN J.
`RHEUMATOLOGY 43 (1979)
`1089 A. W. Segal et al., Levamisole in the Treatment of
`Crohn's Disease, 2 LANCET 382 (1977)
`Susan V. Onrust & Harriet M. Lamb, Infliximab: A
`Review of its Use in Crohn's Disease and
`
`1080
`
`1086
`
`1087
`
`1088
`
`1090
`
`Library
`
`National Library
`of Medicine
`
`National Library
`of Medicine
`
`Library of
`Congress
`
`National Library
`of Medicine
`
`National Library
`of Medicine
`
`National Library
`of Medicine
`
`Library of
`Congress
`
`National Library
`of Medicine
`
`National Library
`of Medicine
`
`Library of
`Congress
`National Library
`of Medicine
`
`7
`
`64199436
`
`
`
`Exhibit
`No .
`
`Description
`
`1094
`
`1106
`
`Rheumatoid Arthritis, 10 BioDRuGs 397 (1998)
`1091 Kevin J. Tracey et al., Shock and Tissue Injury
`Induced by Recombinant Human Cachectin, 234
`Sci. 470 (1986)
`1092 Xiao-ming Sun & Wei Hsueh, Bowel Necrosis
`Induced by Tumor Necrosis Factor in Rats Is
`Mediated by Platelet-Activating Factor, 81 J.
`CLINICAL INVESTIGATION 1328 (1988)
`GOODMAN & GILMAN'S THE PHARMACOLOGICAL
`BASIS OF THERAPEUTICS (Joel G. Hardman et al.,
`eds., 9th ed. 1996)
`1095 Ann Gardulf et al., Subcutaneous Immunoglobulin
`Replacement in Patients with Primary Antibody
`Deficiencies: Safety and Costs, 345 LANCET 365
`(1995)
`1100 A. M. van Gestel et al., Development and
`Validation of the European League Against
`Rheumatism Response Criteria for Rheumatoid
`Arthritis, 39 ARTHRITIS & RHEUMATISM 34 (1996)
`R. Munro & H. Capell, Prevalence of Low Body
`Mass in Rheumatoid Arthritis: Association with the
`Acute Phase Response, 56 ANNALS RHEUMATIC
`DISEASES 326 (1997)
`1108 Michael Weisman et al., A Dose Escalation Study
`Designed to Demonstrate the Safety, Tolerability
`and Efficacy of the Fully Human Anti-TNF
`Antibody, D2E7, Given in Combination with
`Methotrexate (MTX) in Patients with Active RA, 43
`ARTHRITIS & RHEUMATISM 5391 (Sept. 2000)
`(supplement)
`R. Rau et al., Long-Term Treatment with the Fully
`Human Anti-TNF-Antibody D2E7 Slows
`Radiographic Disease Progression in Rheumatoid
`Arthritis, 42 ARTHRITIS & RHEUMATISM 5400
`(1999)
`
`1109
`
`Library
`
`Library of
`Congress
`
`Library of
`Congress
`
`Arnold & Porter
`Library
`
`Library of
`Congress
`
`National Library
`of Medicine
`
`National Library
`of Medicine
`
`University of
`Washington
`
`National Library
`of Medicine
`
`8
`
`64199436
`
`
`
`I further declare that all statements made herein of my own knowledge are
`
`true, that all statements made on information and belief are believed to be true, and
`
`that these statements were made with the knowledge that willful false statements
`
`and the like so made are punishable by fine or imprisonment, or both, under
`
`section 1001 of Title 18 of the United States Code.
`
`Dated: August 18, 2017
`
`New York, New York (cid:9)
`
`Victoria L. Reine
`
`9
`
`64199436
`
`
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