UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`_____________________________
`
`ARGENTUM PHARMACEUTICALS LLC, MYLAN PHARMACEUTICALS
`INC., BRECKENRIDGE PHARMACEUTICALS, INC.
`and ALEMBIC PHARMACEUTICALS, LTD.,
`Petitioners,
`
`v.
`
`RESEARCH CORPORATION TECHNOLOGIES, INC.,
`Patent Owner.
`
`_____________________________
`
`Case IPR2016-002041
`Patent RE38,551 E
`_____________________________
`
`PETITIONER’S UPDATED EXHIBIT LIST
`
`
`
`
`
`
`
`
`
`
`
`
`1 Case IPR2016-01101, Case IPR2016-01242, and Case IPR2016-01245 have been
`
`joined with this proceeding.
`
`
`
`
`
`
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`_____________________________
`
`ARGENTUM PHARMACEUTICALS LLC, MYLAN PHARMACEUTICALS
`INC., BRECKENRIDGE PHARMACEUTICALS, INC.
`and ALEMBIC PHARMACEUTICALS, LTD.,
`Petitioners,
`
`v.
`
`RESEARCH CORPORATION TECHNOLOGIES, INC.,
`Patent Owner.
`
`_____________________________
`
`Case IPR2016-002041
`Patent RE38,551 E
`_____________________________
`
`PETITIONER’S UPDATED EXHIBIT LIST
`
`
`
`
`
`
`
`
`
`
`
`
`1 Case IPR2016-01101, Case IPR2016-01242, and Case IPR2016-01245 have been
`
`joined with this proceeding.
`
`
`
`
`
`
`
`Petitioner’s
`
`Ex. No.
`
`Exhibit
`
`Name
`
`PETITIONER'S UPDATED EXHIBIT LIST
`
`IPR2016-00204
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`U.S. Patent No. RE38,551
`
`Declaration of Dr. Binghe Wang
`
`Declaration of Dr. Clayton Heathcock from IPR2014-01126
`
`Joint Statement of Uncontested Facts
`
`U.S. Patent No. 5,773,475
`
`Excerpt from U.S. Patent Application No. 08/818,688
`
`District Court Claim Construction Opinion
`
`Philippe LeGall, 2-Substituted-2-acetamido-N-
`benzylacetamides. Synthesis, Spectroscopic and
`Anticonvulsant Properties (Dec. 1987)
`
`1009
`
`U.S. Patent No. 5,378,729
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`Choi et al., Trimethylsilyl Halides: Effective Reagents for the
`Synthesis of β-Halo Amino Acid Derivatives, Tet. Lett., Vol.
`36(39), pg. 7011 (1995)
`
`Purdie et al., The Alkylation of Sugars, J.A.C.S. Vol. 83, pg.
`1021 (1903)
`
`Kohn et al., Preparation and Anticonvulsant Activity of a
`Series of Functionalized α-Heteroatom-Substituted Amino
`Acids, J. Med.
`Chem. Vol. 34, pg. 2444 (1991)
`
`Silverman, R. B., The Organic Chemistry of Drug Design and
`Drug Action, Academic Press (1992)
`
`Development of New Stereoisomeric Drugs, U.S. F.D.A., May
`1, 1992
`
`1
`
`
`
`
`
`
`
`
`
`1015
`
`PETITIONER'S UPDATED EXHIBIT LIST
`
`IPR2016-00204
`Cortes et al., Effect of Structural Modification of the Hydantoin
`Ring on Anticonvulsant Activity, J. Med. Chem., Vol. 28, pg.
`601 (1985)
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`LeGall et al., Synthesis of Functionalized Non-Natural Amino
`Acid Derivatives via Amidoalkylation Transformations, Int. J.
`Peptide Protein Res. Vol. 32, pg. 279 (1988)
`
`Kohn et al., Synthesis and Anticonvulsant Activities of α-
`Heterocyclic α-Acetamido-N-benzylacetamide Derivatives, J.
`Med. Chem. Vol. 36, pg. 3350 (1993)
`
`Kohn et al., Preparation and Anticonvulsant Activity of a
`Series of Functionalized α-Aromatic and α-Heteroaromatic
`Amino Acids, J. Med. Chem. Vol. 33, pg. 919 (1990)
`
`U.S. Patent No. 5,654,301
`
`Patent Term Extension Request in U.S. Patent No. 5,654,301
`
`FDA Guideline for Industry, November 1994
`
`Schmidt, R., Dose-Finding Studies in Clinical Drug
`Development, Eur. J. Clin. Pharmacol, Vol. 34, pg. 15 (1988)
`
`Isbell, H. S., The Optical Rotation of the Various Asymmetric
`Carbon Atoms in the Hexose and Pentose Sugars, B. S. Jour.
`Research, Vol. 5, pg. 1041 (1929)
`
`Wilson and Gisvold’s Textbook of Organic Medicinal
`Chemistry, Physicochemical Properties in Relation to Biologic
`Action, (Delgado
`J. N. & Remers W. A., eds. 1991)
`
`Thornber, C. W., Isosterism and Molecular Modification in
`Drug Design, Chem. Soc. Rev., Vol. 8(4) (1979)
`
`Reissue Declaration in Reissue of U.S. Patent No. 5,773,475
`
`Subpoena directed to The University of Houston
`
`
`
`2
`
`
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`
`1041
`
`1042
`
`PETITIONER'S UPDATED EXHIBIT LIST
`
`IPR2016-00204
`Texas Public Information Act Requests and Responses
`
`Zhou et al., Decisions under Uncertainty: the Fuzzy
`Compromise Decision Support Problem, Eng. Opt. Vol. 20, pg.
`21 (1992)
`
`Mistree et al., A Decision-Based Perspective for the Design of
`Methods for Systems Design, (1989)
`
`Mistree et al., A Decision-based Approach to Concurrent
`Design, Concurrent Engineering: Contemporary Issues and
`Modern Design Tools, (Parsaei, H. R. & Sullivan W. G. Eds.
`1993)
`
`Ingram W. T., Concerning Periodic Points in Mappings of
`Continua, J. Am. Math. Soc., Vol. 104(2) (1988)
`
`Mattson, Current Challenges in the Treatment of Epilepsy,
`Neurology, Vol. 44(suppl. 5), pg. 84 (1994)
`
`Löscher et al., New Avenues for Anti-Epileptic Drug Discovery
`and Development, Nature Reviews: Drug Discovery, Vol. 12,
`pg. 12 (2013)
`
`Cohen authorized amendment in U.S. Patent Application No.
`08/818,688
`
`Substitute Petition
`
`Marked-up Petition
`
`December 22, 2015 Email from M. Dowd to A. Reister, J.
`Robbins, and R. Longton.
`
`January 4, 2016 Email from M. Dowd to A. Reister, J. Robbins,
`and R. Longton.
`
`February 19, 2016 Email from M. Dowd to A. Reister.
`
`February 25, 2016 Letter from M. Dowd to A. Reister.
`
`February 25, 2016 Letter from M. Dowd to A. Reister.
`
`3
`
`
`
`
`
`
`
`1043
`
`1044
`
`1045
`
`1046
`
`1047
`
`1048
`
`1049
`
`1050
`
`1051
`
`1052
`
`1053
`
`1054
`
`1055
`
`1056
`
`PETITIONER'S UPDATED EXHIBIT LIST
`
`IPR2016-00204
`
`March 18, 2016 Email from M. Dowd to A. Reister.
`
`Docket for UCB Inc. et al v. Accord Healthcare Inc. et al, Case
`No. 1:13-cv-01206-LPS (Dist. Del.).
`
`Petitioner’s Request for Ex Parte Reexam
`
`Ex Parte Reexamination Interview Summary
`
`Grant of Reexamination
`
`Transcript, Deposition of Dr. Carl Bazil (October 10, 2016)
`
`Transcript, Deposition of Dr. Christopher Vellturo (October 14,
`2016)
`
`Transcript, Deposition of Dr. William Roush (October 21,
`2016)
`
`Keppra Vimpat Brivaracetam, 2012 Epilepsy Pipeline Update
`Conference, San Francisco, February 2012
`
`The Merck Veterinary Manual, Principles of Therapy of
`Neurological Disease, Seizure Control (Thomas Schubert)
`
`Charalambous M et al., Antiepileptic Drugs’ Tolerability and
`Safety-A Systematic Review and Meta-Analysis of Adverse
`Effects in Dogs, BMC Veterinary Research, Vol. 12(79) (2016).
`
`Packer RMA, et al., Clinical Risk Factors Associated with Anti-
`Epileptic Drug Responsiveness in Canine Epilepsy, PLoS ONE,
`Vol. 9(8) (2014)
`
`Packer RMA, et al., Assessment into the Usage of
`Levetiracetam in a Canine Epilepsy Clinic, BMC Veterinary
`Research, Vol. 11(25) (2015)
`
`Bhatti S et al., International Veterinary Epilepsy Task Force
`Consensus Proposal: Diagnostic Approach to Epilepsy in
`Dogs, BMC Veterinary Research, Vol. 11(148) (2015)
`
`4
`
`
`
`
`
`
`
`
`
`1057
`
`PETITIONER'S UPDATED EXHIBIT LIST
`
`IPR2016-00204
`Landmark J., Antiepileptic Drugs in Non-Epilepsy Disorders:
`Relations Between Mechanisms of Action and Clinical Efficacy,
`CNS Drugs, Vol. 22(1) (2008)
`
`1058
`
`1059
`
`1060
`
`1061
`
`1062
`
`1063
`
`1064
`
`1065
`
`1066
`
`1067
`
`Aneja S. & Sharma S., Newer Anti-epileptic Drugs, J. Indian
`Pediatrics, Vol. 50, pg. 1033 (2013)
`
`Bazil CW, New Antiepileptic Drugs, Curr. Neurol. Neurosci.
`Rep., Vol. 1(4), pg. 369 (2001)
`
`Bazil CW, Anticonvulsant Drug or Neuromodulator? The
`Growing Case for Anticonvulsant Uses Beyond Epilepsy, Curr.
`Neurol. Neurosci. Rep., Vol. 4, pg. 305 (2004)
`
`Zaccara G., The Adverse Event Profile of Lacosamide: A
`Systematic Review and Meta-Analysis of Randomized
`Controlled Trials, Epilepsia, Vol. 54(1) (2012)
`
`Sawh SC et al., Lacosamide Adjunctive Therapy for Partial-
`Onset Seizures: A Meta-Analysis, Peer J. (2013)
`
`Yasiry Z. & Shorvon S., The Relative Effectiveness of Five
`Antiepileptic Drugs in Treatment of Benzodiazepine-Resistant
`Convulsive Status Epilepticus: A Meta-Analysis of Published
`Studies, Seizure, Vol. 23(3), pg. 167 (2014)
`
`Wheless JW & Vazquez B., Rufinamide: A Novel Broad-
`Spectrum Antiepileptic Drug, Epilepsy Currents, Vol. 10(1)
`(2009)
`
`Trinka E. et al., Pharmacotherapy for Status Epilepticus,
`Drugs, Vol. 75(13), pg. 1499 (2015).
`
`Glauser T. et al., Evidence-Based Guideline: Treatment of
`Convulsive Status Epilepticus in Children and Adults: Report of
`the Guideline Committee of the American Epilepsy Society,
`Epilepsy Currents, Vol. 16, pg. 48 (2016)
`
`Proposed Algorithm for Convulsive Status Epilepticus,
`“Treatment of Convulsive Status Epilepticus in Children and
`Adults,” Epilepsy Currents, Vol. 16 (2016)
`
`
`
`5
`
`
`
`1068
`
`1069
`
`1070
`
`1071
`
`1072
`
`1073
`
`1074
`
`1075
`
`1076
`
`PETITIONER'S UPDATED EXHIBIT LIST
`
`IPR2016-00204
`Manno EM, Status Epilepticus: Current Treatment Strategies,
`Neurohospitalist, Vol. 1, pg. 23 (2011)
`
`French JA et al., Development of New Treatment Approaches
`for Epilepsy: Unmet Needs and Opportunities, Epilepsia, Vol.
`54, sup. 4, pg. 3 (2013).
`
`Shrestha P. et al., Lacosamide-Induced Tactile Hallucinations
`in a Patient with Complex Partial Seizures, J. Neuropsychiatry
`and Clinical Neurosciences, Vol. 26, pg. E8 (2014).
`
`Simko J. et al., The Effect of Lacosamide on Bone Tissue in
`Orchidectomised Male Albino Wistar Rats, Biomed. Pap. Med.
`Fac. Univ. Palacky Olomouc Czech. Repub., Vol. 159(3), pg.
`394 (2015)
`
`Hilgers A & Schaefer M, Systematic Adverse Drug Reaction
`Monitoring of Patients Under Newer Antiepileptic Drugs Using
`Routine Clinical Data of Inpatients, Drugs Real World
`Outcome, Vol. 3(2), pg. 209 (2016)
`
`Mancano, M, Recurrent Small Intestinal Ileus Due to
`Valsartan; Compulsive Behaviors Related to Rasagiline Use;
`Lacosamide- Induced Acute Pancreatitis; Brief Psychotic
`Disorder After Abrupt Withdrawal of Hydroxyzine;
`Hydroxyurea-Associated Acral Erythema; Penicillamine-
`Induced Degenerative Dermatosis, Hosp. Pharm., Vol. 49(1),
`pg. 902 (2014)
`
`Uthman BM et al., Long-Term Add-On Pregabalin Treatment
`in Patients with Partial-Onset Epilepsy: Pooled Analysis of
`Open-Label Clinical Trials, Epilepsia, Vol. 51(6), pg. 968
`(2010).
`
`Damien Garde, UCB Inches Toward the FDA with its Latest
`Epilepsy Contender, FierceBiotech.com, July 23, 2014
`
`BRIVIACT® now available in U.S. pharmacies for epilepsy
`patients living with partial-onset seizures, UCB.com, May 31,
`2016
`
`6
`
`
`
`
`
`
`
`
`
`1077
`
`PETITIONER'S UPDATED EXHIBIT LIST
`
`IPR2016-00204
`French J. & Gazzola D., New Generation Antiepileptic Drugs:
`What Do They Offer in Terms of Improved Tolerability and
`Safety?, Ther. Adv. Drug Saf., Vol. 2(4), pg. 141 (2011)
`
`1078
`
`1079
`
`1080
`
`1081
`
`1082
`
`1083
`
`1084
`
`1085
`
`1086
`
`1087
`
`1088
`
`1089
`
`1090
`
`Döring J. et al., Thirty Years of Orphan Drug Legislation and
`the Development of Drugs to Treat Rare Seizure Conditions: A
`Cross Sectional Analysis, pLoS One, Vol. 11(8) (2016)
`
`Goldenberg M., Overview of Drugs Used for Epilepsy and
`Seizures, PT, Vol. 35(7), pg. 392 (2010).
`
`UCB Heralds Successor to Keppra as EU Approves Vimpat for
`Epilepsy, ihs.com, Sep. 3, 2008
`
`Document marked as Exhibit 1 during Dr. Roush’s Deposition
`dated October 21, 2016
`
`Document marked as Exhibit 2 during Dr. Roush’s Deposition
`dated October 21, 2016
`
`Document marked as Exhibit 3 during Dr. Roush’s Deposition
`dated October 21, 2016
`
`Second Declaration of Dr. Binghe Wang
`
`CAS REGISTRY and CAS Registry Number FAQs, CAS A
`Division of the American Chemical Society,
`http://www.cas.org/content/chemical-substances/faqs
`
`Declaration of Dr. Deforest McDuff
`
`Declaration of Dr. Kathryn Davis
`
`Curriculum Vitae of Dr. Deforest McDuff
`
`Curriculum Vitae of Dr. Kathryn Davis
`
`Hirsch LJ et al., Cross-Sensitivity of Skin Rashes with
`Antiepileptic Drug Use, Neurology, Vol. 71(19), pg. 1527
`(2008)
`
`1091
`
`Davis K, Guideline for Treatment of Status Epilepticus in
`Adults
`
`
`
`7
`
`
`
`
`
`1092
`
`1093
`
`1094
`
`1095
`
`1096
`
`1097
`
`1098
`
`1099
`
`1100
`
`1101
`
`PETITIONER'S UPDATED EXHIBIT LIST
`
`IPR2016-00204
`
`Rowan A.J. et al., New Onset Geriatric Epilepsy: A
`Randomized Study of Gabapentin, Lamotrigine, and
`Carbamazepine, Neurology, Vol. 64(11), pg. 1868 (2005)
`
`Biton V et al., Safety and Tolerability of Lacosamide as
`Adjunctive Therapy for Adults with Partial-Onset Seizures:
`Analysis of Data Pooled from Three Randomized, Double-
`Blind, Placebo-Controlled Clinical Trials, Epilepsy &
`Behavior, Vol. 52, pg. 119 (2015)
`
`U.S. Patent No. 4,837,223
`
`U.S. Patent No. 4,943,639
`
`U.S. Patent No. 5,447,952
`
`Löscher W & Hönack D, Profile of UCB L059, A Novel
`Anticonvulsant Drug, In Models of Partial and Generalized
`Epilepsy in Mice and Rats, Eur. J. Pharmacol., Vol. 232, pg.
`147 (1993)
`
`Gower A et al., UCB L059, A Novel Anti-Convulsant Drug:
`Pharmacological Profile in Animals, Eur. J. Pharmacol., Vol.
`222, pg. 193 (1992)
`
`Vermeij TAC & Edelbroek PM, High-Performance Liquid
`Chromatographic and Megabore Gas—Liquid
`Chromatographic Determination of Levetiracetam (UCB L059)
`In Human Serum After Solid Phase Extraction, J.
`Chromatography B: Biomedical Sciences and Applications,
`Vol. 662(1), pg. 134 (1994)
`
`Wülfert E et al., Facilitation of Calcium-Dependent
`Cholinergic Function by UCB L059, a New “Second
`Generation” Nootropic Agent, Psychopharmacology Bulletin,
`Vol. 25(3), pg. 498 (1989)
`
`Ratnaraj N et al., A Micromethod for the Determination of the
`New Antiepileptic Drug Levetiracetam (UCB L059) In Serum
`or Plasma by High Performance Liquid Chromatography,
`Therapeutic Drug Monitoring, Vol. 18(2), pg. 154 (1996)
`
`
`
`8
`
`
`
`
`
`1102
`
`PETITIONER'S UPDATED EXHIBIT LIST
`
`IPR2016-00204
`Patsalos P & Duncan J, New Antiepileptic Drugs: A Review of
`Their Current Status and Clinical Potential, CNS Drugs, Vol.
`2(1), pg. 40 (1994)
`
`1103
`
`Ratnaraj N et al., Kinetics of Levetiracetam in Rat-Blood and
`Cerebrospinal-Fluid, Epilepsia, Vol. 36(Suppl. 3), pg. S38
`(1995).
`
`1104
`
`Summary of the Protective Indices of all FAA compounds in
`Dr. Kohn’s References
`
`1105
`
`1106
`
`1107
`
`1108
`
`1109
`
`1110
`
`De Deyn PP et al., Assessment of the Safety of Orally
`Administered UCB L059 as Add-On Therapy in Patients
`Treated with Antiepileptic Drugs, Seizures, Vol. 1(Suppl. A)
`(1992)
`
`Singh P et al., A Pilot Study of the Efficacy and Tolerability of
`L059 in Patients with Refractory Epilepsy, Seizure, Vol.
`1(Suppl. A) (1992)
`
`Types of Seizures, Epilepsy Foundation,
`http://www.epilepsy.com/learn/types-seizures
`
`Types of Epilepsy Syndromes, Epilepsy Foundation,
`http://www.epilepsy.com/learn/types-epilepsy-syndromes
`
`Döring JH et al., Thirty Years of Orphan Drug Legislation and
`the Development of Drugs to Treat Rare Seizures Conditions: A
`Cross Sectional Analysis, PLoS One, Vol. 11(8) (2016)
`
`Infantile Spasms/ West’s Syndrome, Epilepsy Foundation,
`http://www.epilepsy.com/learn/types-epilepsy-
`syndromes/infantile-spasms-wests-syndrome
`
`
`
`9
`
`
`
`
`
`1111
`
`PETITIONER'S UPDATED EXHIBIT LIST
`
`IPR2016-00204
`Lennox-Gastaut Syndrome (LGS), Epilepsy Foundation,
`http://www.epilepsy.com/learn/types-epilepsy-
`syndromes/lennox- gastaut-syndrome-lgs
`
`1112
`
`1113
`
`1114
`
`1115
`
`1116
`
`1117
`
`1118
`
`Dravet Syndrome, Epilepsy Foundation,
`http://www.epilepsy.com/learn/types-epilepsy-
`syndromes/dravet- syndrome
`
`Seizures in Newborns, Epilepsy Foundation,
`http://www.epilepsy.com/learn/seizures-youth/about-newborns-
`and- infants/seizures-newborns
`
`Pyridoxine-Dependent Epilepsy, NORD: National Organization
`for Rare Disorders, https://rarediseases.org/rare-
`diseases/pyridoxine- dependent-epilepsy/
`
`Nadkarni S & Devinsky O, Psychotropic Effects of
`Antiepileptic Drugs, Epilepsy Curr., Vol. 5(5), pg. 176 (2005)
`
`Ng F et al., The Role of Lamotrigine in the Management of
`Bipolar Disorder, Neuropsychiatr. Dis. Treat., Vol. 3(4), pg.
`463 (2007)
`
`Anticonvulsant (Antiepileptic Drugs), American Chronic Pain
`Association, https://www.theacpa.org/treatment/anticonvulsant-
`antiepileptic-drugs
`
`Seizure Medications and Pregnancy, Epilepsy Foundation,
`http://www.epilepsy.com/learn/treating-seizures-and-
`epilepsy/seizure- and-epilepsy-medicines/seizure-medications-
`and-0
`
`1119
`
`Hill D et al., Teratogenic Effects of Antiepileptic Drugs, Expert
`Rev. Neurother., Vol. 10(6), pg. 943 (2010)
`
`
`
`10
`
`
`
`
`
`1120
`
`PETITIONER'S UPDATED EXHIBIT LIST
`
`IPR2016-00204
`The North American AED (Antiepileptic Drug) Pregnancy
`Registry History, http://www.aedpregnancyregistry.org/about-
`history/
`
`1121
`
`1122
`
`1123
`
`1124
`
`1125
`
`1126
`
`1127
`
`North American AED Pregnancy Registry, Epilepsy Foundation,
`http://www.epilepsy.com/learn/treating-seizures-and-
`epilepsy/seizure- and-epilepsy-medicines/seizure-medications-
`and
`
`Update on Monotherapy Findings: Comparative Safety of 11
`Antiepileptic Drugs Used During Pregnancy, The North
`American Antiepileptic Drug Pregnancy Registry, Fall 2014
`Newsletter, http://www.aedpregnancyregistry.org/wp-
`content/uploads/newsletter_fall_2014.pdf
`
`Swanborough, N, Lamotrigine Does Not Significantly Increase
`Risk of Birth Defects During Pregnancy, Says New Study,
`epilepsy society, April 8, 2016
`
`Safety and Efficacy of Lacosamide as Additional Therapy in
`Patients Suffering From Epileptic Tonic Clonic Seizures
`(VALUE), UCB Biosciences, Inc.,
`https://clinicaltrials.gov/ct2/show/NCT02408549, Received
`March 31, 2015
`
`Surges R et al., Is Levetiracetam Different From Other
`Antiepileptic Drugs? Levetiracetam and its Cellular Mechanism
`of Action in Epilepsy Revisited, Therapeutic Advances in
`Neurological Disorders, Vol. 1(1), pg. 13 (2008)
`
`Lynch B et al., The Synaptic Vesicle Protein SV2A is the Binding
`Site for the Antiepileptic Drug Levetiracetam, PNAS, Vol.
`101(26), pg. 9861 (2004)
`
`Rogawski MA, Diverse Mechanisms of Antiepileptic Drugs
`in the Development Pipeline, Epilepsy Res., Vol. 69(3), pg.
`273 (2006)
`
`
`
`11
`
`
`
`
`
`1128
`
`PETITIONER'S UPDATED EXHIBIT LIST
`
`IPR2016-00204
`Statistical Review and Evaluation, Antiepileptic Drugs and
`Suicidality, U.S. Department of Health and Human Services,
`Food and Drug Administration, May 23, 2008
`
`1129
`
`1130
`
`1131
`
`1132
`
`1133
`
`1134
`
`Hardy BT et al., Double-Masked, Placebo-Controlled Study of
`Intravenous Levetiracetam for the Treatment of Status
`Epilepticus and Acute Repetitive Seizures in Dogs, J. Vet.
`Intern. Med., Vol. 26, pg. 334 (2012)
`
`de Jong J et al., The Risk of Specific Congenital Anomalies in
`Relation to Newer Antiepileptic Drugs: A Literature Review,
`Drugs Real World Outcomes, Vol. 3(2), pg. 131 (2016)
`
`Silbergleit R et al., Intramuscular Versus Intravenous Therapy
`for Prehospital Status Epilepticus, The New England Journal of
`Medicine, Vol. 366(7), pg. 591 (2012)
`
`Study to Evaluate SAGE-547 Injection as Adjunctive Therapy
`for the Treatment of Super-Refractory Status Epilepticus
`(SRSE), Sage Therapeutics,
`https://clinicaltrials.gov/ct2/show/NCT02052739, Received
`January 28, 2014
`
`Pinkhasov A et al., Lacosamide Induced Psychosis: Case
`Report, Review of Differential Diagnosis and Relevant
`Pharmacokinetics, Clin. Neuropharmacol., Vol. 38(5), pg. 198
`(2015) (Abstract)
`
`Chatzistefanidis D et al., First Case of Lacosamide-Induced
`Psychosis, Clin. Neuropharmacol., Vol. 36(1), pg. 27 (2013)
`(Abstract)
`
`1135
`
`KEPPRA® (levetiracetam), Full Prescribing Information,
`www.keppraxr.com
`
`
`
`12
`
`
`
`
`
`1136
`
`PETITIONER'S UPDATED EXHIBIT LIST
`
`IPR2016-00204
`LYRICA® (pregabalin), Full Prescribing Information,
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021
`446s026,022488s005lbl.pdf
`
`1137
`
`1138
`
`1139
`
`1140
`
`1141
`
`1142
`
`1143
`
`TOPAMAX® (topiramate), Full Prescribing Information,
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020
`505s038s039,020844s032s034lbl.pdf
`
`DILANTIN® (Phenytoin Sodium 100 mg Extended Oral
`Capsule), Full Prescribing Information,
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/010
`151s036lbl.pdf
`
`LAMICTAL® (lamotrigine), Full Prescribing Information,
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022
`251,020764s029,020241s036lbl.pdf
`
`Phenobarbital Sodium-phenobarbital sodium injection, Full
`Prescribing Information, West-ward Pharmaceutical Corp.,
`https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ffca
`a218-ed6a-4557-9645-b9a91128a214
`
`NEURONTIN® (gabapentin), Full Prescribing Information,
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020
`235s043lbl.pdf
`
`DEPAKOTE® (divalproex sodium), Full Prescribing
`Information,
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018
`723s039lbl.pdf
`
`DEPAKENE® (valproic acid), Full Prescribing Information,
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018
`081s046_18082s031lbl.pdf
`
`
`
`13
`
`
`
`
`
`1144
`
`PETITIONER'S UPDATED EXHIBIT LIST
`
`IPR2016-00204
`TEGRETOL® (carbamazepine), Full Prescribing Information,
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016
`608s098lbl.pdf
`
`1145
`
`1146
`
`1147
`
`1148
`
`1149
`
`1150
`
`1151
`
`Backonja M et al., Pharmacologic Management Part 1: Better-
`Studied Neuropathic Pain Diseases, Pain Medicine, Vol. 5(S1),
`pg. S28 (2004)
`
`Sadeghian H & Motiei-Langroudi R, Comparison of
`Levetiracetam and Sodium Valproate in Migraine Prophylaxis:
`A Randomized Placebo-Controlled Study, Ann. Indian Acad.
`Neurol., Vol. 18(1), pg. 45 (2015)
`
`U.S. Subsidiary of Belgian Pharmaceutical Manufacturer
`Pleads Guilty to Off-Label Promotion; Company to Pay More
`Than $34 Million: UCB Inc. Promoted Anti-Epileptic Drug
`Keppra for Off- Label Uses, FBI: Washington Field Office,
`https://archives.fbi.gov/archives/washingtondc/press-
`releases/2011/u.s.-subsidiary-of-belgian-pharmaceutical-
`manufacturer-pleads-guilty-to-off-label-promotion-company-
`to-pay- more-than-34-million (2011)
`
`Novy J et al., Lacosamide Neurotoxicity Associated with
`Concomitant Use of Sodium Channel-Blocking Antiepileptic
`Drugs: A Pharmacodynamic Interaction?, Epilepsy &
`Behavior, Vol. 20, pg. 20 (2011)
`
`Mete M et al., Effects of Lacosamide “A Novel Antiepileptic
`Drug” in the Early Stages of Chicken Embryo Development,
`Childs. Nerv.
`Syst., Vol. 32(9), pg. 1715 (2016)
`
`Sampath D et al., Characterization of Neonatal Seizures in an
`Animal Model of Hypoxic-Ischemic Encephalopathy, Epilepsia,
`Vol. 55(7), pg. 985 (2014)
`
`Chakravarthi S et al., Levetiracetam Versus Phenytoin in
`Management of Status Epilepticus, J. Clin. Neurosci., Vol.
`22(6), pg. 959 (2015)
`
`
`
`14
`
`
`
`
`
`1152
`
`PETITIONER'S UPDATED EXHIBIT LIST
`
`IPR2016-00204
`Landmark J & Patsalos PN, Drug Interactions Involving the
`New Second-and Third-Generation Antiepileptic Drugs, Expert
`Rev. Neurother., Vol. 10(1), pg. 119 (2010)
`
`1153
`
`1154
`
`1155
`
`1156
`
`1157
`
`McCall C & McCall WV, What is the Role of Sedating
`Antidepressants, Antipsychotics, and Anticonvulsants in the
`Management of Insomnia?, Curr. Psychiatry Rep., Vol. 14(5),
`pg. 494 (2012)
`
`Davis K et al., Glutamate Imaging (GluCEST) Lateralizes
`Epileptic Foci in Nonlesional Temporal Lobe Epilepsy, Science
`Translational Medicine, Vol. 7(309) (2015)
`
`Organic Chemistry, Racemic Mixtures, Enantiomeric Excess
`and Optical Purity (8th Edition) (L.G. Wade, Jr.)
`Transcript, Deposition of Dr. John Lehner (December 5, 2014),
`UCB, Inc., et al., v. Accord Healthcare, Inc., et al., No. 13-
`1206-LPS (D. Del., Nov. 9-13, 2015)
`Abou-Khalil B, Levetiracetam in the Treatment of Epilepsy,
`Neuropsychiatric Disease and Treatment, Vol. 4(3), pg. 507
`(2008)
`
`1158
`
`McDuff Declaration Attachment B-1 – D-2s
`
`1159
`
`1160
`
`1161
`
`
`
`
`
`
`
`
`
`Mayo Clinic, Epilepsy: Overview,
`http://www.mayoclinic.org/diseases-
`conditions/epilepsy/home/ovc- 20117206.
`
`Epilepsy Foundation, About Epilepsy: The Basics,
`http://www.epilepsy.com/start-here/about-epilepsy-basics.
`
`Epilepsy Foundation, Seizure and Epilepsy Medicines,
`http://www.epilepsy.com/learn/treating-seizures-and-
`epilepsy/seizure- and-epilepsy-medicines.
`
`15
`
`
`
`
`
`
`
`1162
`
`1163
`
`PETITIONER'S UPDATED EXHIBIT LIST
`
`IPR2016-00204
`American Association for Clinical Chemistry Website,
`“Antiepileptic Drugs: Therapeutic Drug Monitoring of the
`Newer Generation Drugs,” 6/1/2013,
`https://www.aacc.org/publications/cln/articles/2013/june/antiepil
`eptic- drugs.
`UCB, Annual Report, 2008.
`
`1164
`
`UCB, Annual Report, 2009.
`
`1165
`
`UCB, Annual Report, 2014.
`
`1166
`
`Vimpat (lacosamide) Label, 10/28/2008.
`
`1167
`
`Vimpat (lacosamide) Label, 8/29/2014.
`
`1168
`
`1169
`
`1170
`
`1171
`
`1172
`
`022255),
`(NDA
`Vimpat
`Details,
`Drug
`FDA,
`http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
`?fusea ction=Search.DrugDetails.
`
`Letter from FDA to UCB, Re: “Supplement Approval,”
`8/29/2014.
`
`November 13, 2015 Testimony of DeForest McDuff in UCB,
`Inc. et al. v. Accord Healthcare, Inc., et al., Case No. 13-1206-
`LPS (District of Delaware) (Excerpts).
`
`November 13, 2015 Trial Demonstratives from Testimony of
`DeForest McDuff in UCB, Inc. et al. v. Accord Healthcare, Inc.,
`et al., Case No. 13-1206-LPS (District of Delaware).
`
`Radley, David C., Stan N. Finkelstein, Randall S. Stafford
`(2006), "Off-label Prescribing Among Office-Based
`Physicians," Archives of Internal Medicine," 166(9): 1021-1026.
`
`1173
`
`UCB Epilepsy Meetings, UCB: The Epilepsy Company,
`http://www.ucbepilepsymeetings.com/.
`
`1174
`
`UCB, Annual Report, 2008, at 8, 49.
`
`
`
`16
`
`
`
`PETITIONER'S UPDATED EXHIBIT LIST
`
`IPR2016-00204
`
`1175
`
`UCB, Annual Report, 2009.
`
`1176
`
`Pfizer, Financial Report, 2005.
`
`1177
`
`Pfizer, Form 10-K - Financial Report, 2014.
`
`1178
`
`GlaxoSmithKline, Annual Report, 2007, at 37, 78.
`
`1179
`
`Johnson & Johnson, Annual Report, 2008.
`
`1180
`
`Mestre-Ferrandiz, Jorge, Jon Sussex, and Adrian Towse (2012),
`“The R&D Cost of a New Medicine,” Office of Health
`Economics, London UK, 1–86.
`
`1181
`
`1182
`
`DiMasi, Joseph, Henry Grabowski, and Ronald Hansen (2016),
`"Innovation in the pharmaceutical industry: New estimates of
`R&D costs," Journal of Health Economics 47: 20–33.
`
`DiMasi, Joseph, Henry Grabowski, and John Vernon (2004),
`“R&D Costs and Returns by Therapeutic Category,” Drug
`Information Journal 38: 211–223.
`
`1183
`
`Letter from FDA to UCB, Re: “NDA Approval”, 4/20/2010.
`
`1184
`
`1185
`
`David, Jesse and Marion B. Stewart (2005), “Commercial
`Success: Economic Principles Applied to Patent Litigation,” in
`Gregory K. Leonard and Lauren J. Stiroh, ed., Economic
`Approaches to Intellectual Property Policy, Litigation, and
`Management, White Plains, NY: National Economic Research
`Associates, Inc.
`
`Vimpat Clinical Trials,
`https://www.clinicaltrials.gov/ct2/show/NCT00220415?term=V
`impat
`&rcv_s=01%2F01%2F2000&rcv_e=01%2F01%2F2007&rank
`=11
`
`17
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1186
`
`1187
`
`1188
`
`1189
`
`1190
`
`1191
`
`1192
`
`1193
`
`1194
`
`1195
`
`1196
`
`PETITIONER'S UPDATED EXHIBIT LIST
`
`IPR2016-00204
`UCB, Clinical Study Information for Vimpat (lacosamide),
`http://www.ucb.com/rd/clinical-study-information/vimpat-
`lacosamide.
`
`Merck & Co., Inc. v. Teva Pharmaceuticals USA, Inc., 395 F.3d
`1364, 1376–77 (Fed. Cir. 2005).
`FDA Orange Book, 2014.
`
`Fischer, Marc, Peter S. H. Leeflang, and Peter C. Verhoef
`(2010), “Drivers of Peak Sales for Pharmaceutical Brands,”
`Quantitative Marketing and Economics 8(4): 429–460.
`
`Wazana, Ashley (2000), “Physicians and the Pharmaceutical
`Industry,” JAMA 283(3):373-380.
`
`Chren, Mary-Margaret, and Seth Landefeld (1994),
`“Physicians’ Behavior and Their Interactions with Drug
`Companies,” JAMA 271(9): 684-689.
`
`Schwartz, Thomas, and Daniel Kuhles, Michael Wade, and
`Prakash Masand (2001), “Newly Admitted Psychiatric Patient
`Prescriptions and Pharmaceutical Sales Visits,” Annals of
`Clinical Psychiatry 13(3): 159-162.
`
`Gagnon, Marc-Andre and Joel Lexchin (2008), “The Cost of
`Pushing Pills: A New Estimate of Pharmaceutical Promotion
`Expenditures in the United States,” PLoS Med 5(1): 29-33.
`
`Pfizer Website, Dilantin Label,
`http://labeling.pfizer.com/showlabeling.aspx?id=544 (accessed
`5/26/2015).
`FDA Website, Tegretol Label,
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016
`608s09 8lbl.pdf (accessed 5/26/2015).
`
`FDA Website, Depakote Label,
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018
`723s03 9lbl.pdf (accessed 5/26/2015).
`
`
`
`18
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1197
`
`1198
`
`1199
`
`1200
`
`1201
`
`1202
`
`1203
`
`1204
`
`PETITIONER'S UPDATED EXHIBIT LIST
`
`IPR2016-00204
`
`FDA Website, Depakote ER Label,
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/180
`81s44,1
`8082s27,18723s33,19680s22,20593s15,21168s14lbl.pdf
`(accessed 5/26/2015).
`
`FDA Website, Neurontin Label,
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020
`235s04 3lbl.pdf (accessed 5/26/2015).
`
`FDA Website, Lamictal Label,
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022
`251,020 764s029,020241s036lbl.pdf (accessed 5/26/2015).
`
`FDA Website, Lamictal XR Label,
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022
`115s00 6lbl.pdf (accessed 5/26/2015).
`
`FDA Website, Topamax Label,
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020
`505s03 8s039,020844s032s034lbl.pdf (accessed 5/26/2015).
`
`Trokendi XR Website, Trokendi XR Label,
`http://www.trokendixr.com/hcp/pdfs/trokendi-prescribing-
`information.pdf (accessed 5/26/2015).
`
`FDA Website, Qudexy XR Label,
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205
`122s00 0lbl.pdf (accessed 5/26/2015).
`
`FDA Website, Keppra Label,
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021
`035s07 8s080,021505s021s024lbl.pdf (accessed 5/26/2015).
`
`
`
`19
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1205
`
`1206
`
`1207
`
`1208
`
`1209
`
`1210
`
`1211
`
`1212
`
`PETITIONER'S UPDATED EXHIBIT LIST
`
`IPR2016-00204
`
`FDA Website, Keppra XR Label,
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022
`285s00 1lbl.pdf (accessed 5/26/2015).
`
`FDA Website, Trileptal Label,
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021
`014s02 6,021285s021lbl.pdf (accessed 5/26/2015).
`
`FDA Website, Zonegran Label,
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020
`789s02 2s025lbl.pdf (accessed 5/26/2015).
`
`Pfizer Website, Lyrica Label,
`http://labeling.pfizer.com/ShowLabeling.aspx?id=561#section-
`1 (accessed 5/26/2015).
`
`FDA Website, Banzel label,
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021
`911s00 5lbl.pdf (accessed 5/26/2015).
`
`FDA Website, Sabril Label,
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020
`427s00 0lbl.pdf (accessed 5/26/2015).
`
`FDA Website, Potiga Label,
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022
`345s00 0lbl.pdf (accessed 5/26/2015).
`
`FDA Website, Fycompa Label,
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202
`834lbl.p df (accessed 5/26/2015).
`
`
`
`20
`
`
`
`
`
`
`
`1213
`
`
` 1214
`
`PETITIONER'S UPDATED EXHIBIT LIST
`
`IPR2016-00204
`U.S. National Library of Medicine Website, Aptiom Label,
`http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d0
`c9554- eaeb-4694-8089-00133fcadce3 (accessed 5/26/2015).
`
`Email from Matthew Dowd to Jennifer Augsburger and Andrea
`Reister on December 2, 2016 at 1:43PM Eastern Standard
`Time
`
` 1215
`
`Email from Matthew Dowd to Jennifer Augsburger and Andrea
`Reister on November 23, 2016 at 10:21AM Eastern Standard
`Time
`
` 1216
`
`Email from Matthew Dowd to Jennifer Augsburger and Andrea
`Reister on December 2, 2016, with the corrected email address
`for Steve Parmelee
`
` 1217
`
`Evidentiary Declaration from Dr. Binghe Wang in support of
`Petitioner’s Notice of Supplemental Evidence in Response to
`Patent Owner’s Objections to Exhibits
`
` 1218
`
`Amended Version of Exhibit 1104: Summary of the Protective
`Indices of all FAA compounds in Dr. Kohn’s References
`
` 1219
`
` 1220
`
`Evidentiary Declaration from Dr. Kathryn Davis in support of
`Petitioner’s Notice of Supplemental Evidence in Response to
`Patent Owner’s Objections to Exhibits
`
`Evidentiary Declaration from Dr. DeForest McDuff in support
`of Petitioner’s Notice of Supplemental Evidence in Response
`to Patent Owner’s Objections to Exhibits
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`21
`
`
`
`PETITIONER'S UPDATED EXHIBIT LIST
`
`IPR2016-00204
`
`NIH Website, Dilantin Label,
`https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cf
`m?archiveid=174088 (accessed 12/2/2016).
`
`FDA Website, Lyrica Label,
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/02
`1446s029,022488s008lbl.pdf (accessed 12/2/2016).
`
`FDAWebsite, Trokendi XR Label,
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201
`635s000lbl.pdf (accessed 12/5/2016).
`
`FDA Website, Aptiom Label,
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022
`416s000lbl.pdf (accessed 12/2/2016).
`
`1221
`
`1222
`
`1223
`
`1224
`
`Respectfully Submitted,
`
`Dated: December 6, 2016
`
`/Matthew J. Dowd /
`Matthew J. Dowd
`Reg. No. 47,534
`Dowd PLLC
`1717 Pennsylvania
`Avenue, NW Suite 1025
`Washington, D.C. 20006
`mjdowd@dowdpllc.com
`(202) 573-3853
`
`By:
`
`22
`
`
`
`
`
`
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the above-captioned
`
`Petitioner’s Updated Exhibit List will be served on December 6, 2016 via e-mail
`
`to the attorney(s) of record for the patent at the addresses
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
