UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________________
`SAWAI USA, INC. AND
`SAWAI PHARMACEUTICAL CO., LTD.
`Petitioners,
`
`v.
`
`BIOGEN MA, INC.
`Patent Owner.
`_______________________________
`Patent No. 8,399,514
`_______________________________
`Inter Partes Review IPR2019-00789
`_______________________________
`
`EXHIBIT LIST
`
`US_138049771v1_385667-00004
`
`
`_______________________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________________
`SAWAI USA, INC. AND
`SAWAI PHARMACEUTICAL CO., LTD.
`Petitioners,
`
`v.
`
`BIOGEN MA, INC.
`Patent Owner.
`_______________________________
`Patent No. 8,399,514
`_______________________________
`Inter Partes Review IPR2019-00789
`_______________________________
`
`EXHIBIT LIST
`
`US_138049771v1_385667-00004
`
`
`
`EXHIBIT
`NO.
`
`DESCRIPTION
`
`1001
`
`1002
`1003
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`U.S. Patent No. 8,399,514, Treatment for Multiple
`Sclerosis (filed Feb. 13, 2012) (issued Mar. 19, 2013)
`Declaration of John R. Corboy, M.D.
`Declaration of Leslie Benet, Ph.D.
`Declaration of Ian McKeague, Ph.D.
`Biogen News Release, Phase II Study of Oral Compound
`BG-12 Meets Primary Endpoint in Multiple Sclerosis (Jan. 9,
`2006)
`S. Schimrigk et al., A Prospective, Open-Label, Phase II
`Study of Oral Fumarate Therapy for the Treatment of
`Relapsing-Remitting Multiple Sclerosis, 10 (Suppl. 2)
`MULTIPLE SCLEROSIS CLIN. & LAB. RES. S258, Abstract
`P642 (2004)
`L. Kappos et al., Efficacy of a Novel Oral Single-Agent
`Fumarate, BG00012, in Patients with Relapsing-Remitting
`Multiple Sclerosis: Results of a Phase 2 Study, 253 (Suppl.
`2) J. NEUROL. II27, O108 (2006)
`International Publication No. WO 2006/0037342 A2
`(published Apr. 13, 2006)
`U.S. Patent No. 7,320,999, Dimethyl Fumarate for the
`Treatment of Multiple Sclerosis (filed July 17, 2002)
`(issued Jan. 22, 2008)
`NCT00168701, CLINICALTRIALS.GOV,
`https://clinicaltrials.gov/ archive/NCT00168701/2005_09_14
`ICH HARMOISED TRIPARITE GUIDELINE – DOSE-RESPONSE
`INFORMATION TO SUPPORT DRUG REGISTRATION E4 (Mar. 10,
`1994)
`
`US_138049771v1_385667-00004
`
`
`
`EXHIBIT
`NO.
`
`DESCRIPTION
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`S. Schimrigk et al., A Prospective, Open-Label, Phase II
`Study of Oral Fumarate Therapy for the Treatment of
`Relapsing-Remitting Multiple Sclerosis (2004), available at
`http://web.archive.org/web/
`20041021033354/http://www.fumapharm.ch:80/pdf/BG-12_
`Schimrigk_Poster_Final.pdf (“Schimrigk 2004 Poster”)
`N. Brune et al., Oral Fumarate Therapy Alters Cytokine
`Production in Patients with Relapsing-Remitting Multiple
`Sclerosis, 10 (suppl. 2) MULTIPLE SCLEROSIS CLIN & LAB.
`RES. S259, ABSTRACT P643 (2004)
`S. Schimrigk et al., An Open-Label, Prospective Study of
`Oral Fumaric Acid Therapy for the Treatment Relapsing-
`Remitting Multiple Sclerosis (RRMS), 64(6)(Suppl. 1)
`NEUROLOGY A392, S46.003 (2005)
`L. Kappos et al., A Randomised, Placebo-controlled Phase II
`Trial of a Novel Oral Single-Agent Fumarate Therapy,
`BG00012, in Patients with Relapsing-Remitting Multiple
`Sclerosis, 252 (Suppl. 2) J. NEUROL. II/148, P574 (2005)
`Biogen News Release, Oral Compound BG-12 Achieves
`Primary Endpoint in Phase II Study of Relapsing-Remitting
`Multiple Sclerosis; Treatment with BG-12 Led to Statistically
`Significant Reductions in MRI Measures (May 30, 2006)
`C. Nieboer et al., Fumaric Acid Therapy in Psoriasis: A
`Double-Blind Comparison between Fumaric Acid Compound
`Therapy and Monotherapy with Dimethylfumaric Acid Ester,
`181 DERMATOLOGICA 33 (1990)
`S. Schimrigk et al., Oral Fumaric Acid Esters for the
`Treatment of Active Multiple Sclerosis: An Open-Label,
`Baseline-Controlled Pilot Study, 13 EUR. J. NEUOL. 604
`(2006)
`
`US_138049771v1_385667-00004
`
`
`
`EXHIBIT
`NO.
`
`DESCRIPTION
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`U. Mrowietz et al., Dimethylfumarate for Psoriasis: More
`than a Dietary Curiosity, 11(1) TRENDS MOL. MED. 43
`(2005)
`Fumaderm® prescribing information
`H.M. Ockenfels et al., The Antipsoriatic Agent
`Dimethylfumarate Immunomodulates T-Cell Cytokine
`Secretion and Inhibits Cytokines of the Psoriatic Cytokine
`Network, 139 BR. J. DERM. 390 (1998)
`INTENTIONALLY LEFT BLANK
`R. de Jong et al., Selective Stimulation of T Helper 2
`Cytokine Responses by the Anti-Psoriasis Agent
`Monomethylfumarate, 26 EUR. J. IMMUNOL. 2067 (1996)
`P. Nibbering et al., Effects of Monomethylfumarate on
`Human Granulocytes, 101 J. INVEST. DERMATOL. 37 (1993)
`U.S. Patent No. 6,509,376, Utilization of Dialkyfumarates
`(filed Oct. 29, 1999) (issued Jan 21, 2003)
`Biogen News Release, BG-12 Psoriasis Study Meets Primary
`Endpoint; Oral Compound Also Being Studied for MS in
`Phase II Trial (Apr. 7, 2005)
`A.D. Ormerod et al., Fumaric Acid Esters, Their Place in the
`Treatment of Psoriasis, 150 Br. J. Dermatol. 630 (2004)
`U. Mrowietz et al., Treatment of Psoriasis with Fumaric Acid
`Esters: Results of a Prospective Multicentre Study,
`138(3) BR. J. DERMATOL. 456 (1998)
`W. Nugteren-Huying et al., Fumaric Acid Therapy for
`Psoriasis: A Randomized, Double-Blind, Placebo-
`Controlled Study,” 22(2) J. AM. ACAD. DERMATOL. 311
`(1990)
`
`US_138049771v1_385667-00004
`
`
`
`EXHIBIT
`NO.
`
`DESCRIPTION
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`
`P. Altmeyer et al., Antipsoriatic Effect of Fumaric Acid
`Derivatives: Results of a Multicenter Double-Blind Study in
`100 Patients, 30 J. AM. ACAD. DERMATOL. 977 (1994)
`C. Nieboer et al., Systemic Therapy with Fumaric Acid
`Derivatives: New Possibilities in the Treatment of Psoriasis,
`20 J. AM. ACAD. DERM. 601 (1989)
`N. Brune et al., Detection of Altered Intracellular TH1- and
`TH2-Type Cytokine Production of Peripheral Blood
`Mononuclear cells (PBMCs) in Patients with Relapsing-
`Remitting Multiple Sclerosis (RRMS) Undergoing an Oral
`Fumaric-Acid Ester Therapy, 4(4) MULTIPLE SCLEROSIS:
`CLINICAL AND LABORATORY RESEARCH P3038 (1998)
`(ECTRIMS 98:14th Congress of the European Committee for
`Treatment and Research in Multiple Sclerosis, Sept. 9-12,
`1998, Stockholm, Sweden)
`S. Schimrigk et al., Oral Fumaric Acid Ester (FAE) in
`Relapsing-Remitting Multiple Sclerosis (RRMS). A Short
`Term, Open, clinical, Immunological and Magnetic
`Resonance Imaging (MRI) Controlled Phase II Trial, 246
`(Suppl. 1) J. NEUROL. I/36, 144 (1999) (Ninth Meeting of the
`European Neurological Society, June 5-9, 1999, Milan, Italy)
`L. Kappos et al., A Randomized, Placebo-Controlled Phase 2
`Trial of a Novel Oral Fumarate, BG00012, in Patients with
`Relapsing-Remitting Multiple Sclerosis (15th Meeting of the
`European Neurological Society, June 18-22, 2005), and
`Declaration of Gilmore O’Neill, M.D.
`A. Wierinckx et al., Detoxication Enzyme Inducers Modify
`Cytokine Production in Rat Mixed Glial Cells, 166 J.
`NEUROIMMUNOL. 132 (2005)
`R. Fox et al., Dimethyl Fumarate to Treat Multiple Sclerosis,
`in MULTIPLE SCLEROSIS THERAPEUTICS 387 (Jeffrey A.
`Cohen et al. eds., 4th ed. 2011)
`
`US_138049771v1_385667-00004
`
`
`
`EXHIBIT
`NO.
`1037
`
`1038
`
`1039
`
`1040
`
`1041
`
`1042
`
`1043
`
`1044
`
`1045
`
`DESCRIPTION
`
`European Medicines Agency, Assessment Report, Tecfidera
`(Nov. 26, 2013)
`R. Gold et al., Placebo-Controlled Phase 3 Study of Oral
`BG-12 for Relapsing Multiple Sclerosis, 367 NEW ENG. J.
`MED. 1098 (2012) (“Define Study”)
`R. Fox et al., Placebo-Controlled Phase 3 Study of Oral BG-
`12 or Glatiramer in Multiple Sclerosis, 367 NEW ENG. J.
`MED. 1087 (2012) (“Confirm Study”)
`E. Frohman et al., Multiple Sclerosis - The Plaque and its
`Pathogenesis, 354 NEW ENG. J. MED. 942 (2006)
`J. Miller, The Importance of Early Diagnosis of Multiple
`Sclerosis, 10(3) J. MANAG. CARE PHARM. S4 (2004)
`MS Prevalence, NATIONALMSSOCIETY.ORG,
`https://www.nationalmssociety.org/About-the-Society/MS-
`Prevalence (last visited July 9, 2018)
`S. Rich et al., Stepped-Care Approach to Treating MS: A
`Managed Care Treatment Algorithm, 10(3) J. MANAG. CARE
`PHARM. S26 (2004)
`D. Meier et al., Monitoring Treatment Efficacy with
`Magnetic Resonance Imaging (MRI) in an Open Phase II
`Study with Fumaric-Acid Esters (Fumaderm®) in Patients
`with relapsing-Remitting MS (RRMS), 4(4) MULTIPLE
`SCLEROSIS: CLINICAL AND LABORATORY RESEARCH P3037
`(1998) (ECTRIMS 98:14th Congress of the European
`Committee for Treatment and Research in Multiple Sclerosis,
`Sept. 9-12, 1998, Stockholm, Sweden)
`N. Brune et al., Oral Fumaric-Acid Ester Therapy (FAE)
`Influence T-Helper Cell Apoptosis in Peripheral Blood
`Lymphocytes (PBLS) and Soluble Intercellular Adhesion
`Molecule-I (SICAM-1) in Serum of Patients with Relapsing-
`Remitting Multiple Sclerosis (RRMS), 246 (Suppl. 1) J.
`
`US_138049771v1_385667-00004
`
`
`
`EXHIBIT
`NO.
`
`1046
`
`1047
`
`1048
`
`1049
`
`1050
`
`1051
`
`1052
`
`1053
`1054
`1055
`
`DESCRIPTION
`NEUROL. I/61, P272 (1999) (Ninth Meeting of the European
`Neurological Society, June 5-9, 1999, Milan, Italy)
`L. Kappos et al., Efficacy of a Novel Oral Single-Agent
`Fumarate, BG00012, in Patients with Relapsing-Remitting
`Multiple Sclerosis: Results of a Phase II Study (16th
`Meeting of the European Neurological Society, May 30,
`2006) attached as Exhibit C to the Declaration of Katherine
`T. Dawson in Biogen U.S. Patent App. No. 12/526,296 and
`marked as Ex. 1018 in Biogen MA Inc. v. Forward Pharma
`A/S, Interference No. 106,023 (“Kappos 2006 Presentation”)
`Leon Shargel et al., APPLIED BIOPHARMACEUTICS &
`PHARMAKINETICS 575-611 (5th ed. 2005)
`L. Kappos et al., Efficacy and Safety of Oral Fumarate in
`Patients with Relapsing-Remitting Multiple Sclerosis: A
`Multicentre, Randomised, Double-Blind, Placebo-Controlled
`Phase IIb Study, 372 LANCET 1463 (2008)
`FDA GUIDANCE FOR INDUSTRY - NON-INFERIORITY CLINICAL
`TRIALS TO ESTABLISH EFFECTIVENESS (Nov. 2016)
`E. de Klerk et al., Patient Compliance in Rheumatoid
`Arthritis, Polymyalgia Rheumatica, and Gout, 30 J.
`RHEUMATOLOGY 44 (2003)
`A. Paes et al., Impact of Dosage Frequency on Patient
`Compliance, 20(10) DIABETES CARE 1512 (1997)
`S. Eisen et al., The Effect of Prescribed Daily Dose
`Frequency on Patient Medication Compliance, 150 ARCH.
`INTERN. MED. 1881 (1990)
`Prosecution History Excerpts, U.S. Patent No. 8,399,514
`Declaration of Robert Mihail
`Declaration of Jennifer Rock
`
`US_138049771v1_385667-00004
`
`
`
`EXHIBIT
`NO.
`1056
`1057
`1058
`1059
`
`DESCRIPTION
`
`Declaration of Robert Walter Baumhener, M.D.
`Declaration of Jacquelyn Bainbridge, Pharm.D.
`Declaration of Ronald G. Marks, Ph.D.
`Declaration of Jennifer Rock
`
`US_138049771v1_385667-00004
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
