IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ARGENTUM PHARMACEUTICALS LLC, MYLAN PHARMACEUTICALS
`INC., BRECKENRIDGE PHARMACEUTICAL, INC., and ALEMBIC
`
`PHARMACEUTICALS, LTD.,
`
`Petitioners,
`
`RESEARCH CORPORATION TECHNOLOGIES, INC.,
`Patent Owner.
`
`Case No. IPR2016~002O41
`
`Patent No. RE 38,55 1
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`1 Case IPR2016-01101, Case IPR2016-01242, and Case IPR2016—O1245 have been
`
`joined with this proceeding.
`
`

`
`IPR2016-00204
`
`029819.0100-US03
`
`LIST OF EXHIBITS
`
`
`
`Exhibit tion Descri
`
`
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`2006
`
`2007
`2008
`
`2009
`2010
`
`2011
`
`2012
`
`2013
`
`2014
`
`
`
`Richard H. Mattson, Efficacy and Adverse Effects ofEstablished and
`New Antiepileptic Drugs, 36 (Suppl. 2Epilepsia S13-S26
`Richard H. Mattson, Drug Treatment of Uncontrolled Seizures, in
`Surgical Treatment of Epilepsy 29-35 (William H. Theodore ed.,
`1992).
`FDA Approved Labeling Text dated August 27, 2012 for
`FELBATOL® (felbamate) , available at
`http2//www.accessdata.fda.gov/drugsatfda_docs/label/2012/020189s
`027lbl.pdf (last visited Feb. 2, 2016).
`Judith D. Conley & Harold Kohn, Functionalized DL—Amino Acid
`Derivatives. PotentNew Agents for the Treatment ofEpilepsy, 30 J.
`Med. Chem. 567-574 (1987).
`T}
`U.S. Provisional Patent Application No. 60/013,522.
`Bialer et al., Progress report on new antiepileptic drugs: a summary
`of the Sixth Eilat Conference (EILAT VI), 51 Epilepsy Res. 31-71
`(2002).
`Jerry March, Advanced Organic Chemistry 94-96 (4th ed. 1992).
`Decision Denying Institution of Inter Partes Review, IPR2014—
`01126, Paper 22.
`l Curriculum Vitae of Dr. Farrokh Mistree, September 2014.
`Marcy Barge & W.T. Ingram, Inverse Limits on [0,1] Using Logistic
`Bonding Maps, 72 Topology and its Applications 159-72 (1996).
`Jack McBryde Jr., Inverse Limits on Arcs Using Certain Logistic
`Maps as Bonding Maps, Master’s Thesis, University of Houston,
`(1987).
`Trial Testimony of Dr. Clayton Heathcock, UCB, Inc., et al., v.
`Accord Healthcare, Inc., et. al., No. 13—1206—LPS (D. Del., Nov. 9,
`2015)
`FDA Approved Labeling Text dated July 9, 2015 for VIMPAT®
`(lacosamide), available at
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022253s
`030,022254s022,022255s016lbl.pdf (last visited Feb. 2, 2016).
`Wolfgang Loscher & Dieter Schmidt, Strategies in Antiepileptic
`Drug Development: Is Rational Drug Design Superior to Random
`Screening and Structural Variation ?, 17 Epilepsy Research 95-134
`(1994).
`
`

`
`IPR2016-00204
`
`029819.0100—US03
`
`
`Exhibit
`2015
`
` 2016
`
`2017
`
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`
`2024
`
`
`
`
`Descrip_tion
`Michael A. Rogawski & Roger J. Porter, Antiepileptic Drugs:
`Pharmacological Mechanisms and Clinical Efficacy with
`Consideration of Promising Developmental Stage Compounds,
`42(3) Pharmacological Reviews 223-86 (1990).
`John M. Pellock, Standard Approach to Antiepileptic Drug
`Treatment in the United States 35 (Suppl. 4) Epilepsia S11—S18
`(1994).
`Approval Listing dated December 27, 1994 for lamotrigine,
`Approved Drug Products with Therapeutic Equivalence Evaluations
`(Electronic Orange Book),
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Ap
`pl__No=020241&TABLE1=OB__Rx (last visited Feb. 2, 2016).
`The Merck Index 77, 290, 404, 407, 408, 508, 640, 670, 733, 915,
`998, 999, 1020, 1028, 1207, 1246, 1247, 1251, 1259, 1260, 1330,
`1654 (Susan Budavari et al. eds., 12th ed. 1996).
`Approval Listing dated August 5, 1996 for fosphenytoin sodium,
`Approved Drug Products with Therapeutic Equivalence Evaluations
`(Electronic Orange Book),
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Ap
`pl_No=020450&TABLE1=OB_Rx (last visited Feb. 2, 2016).
`FDA Approved Labeling Text dated January 2014 for CEREBYX®
`(fosphenytoin sodium injection) , available at
`http://www.accessdata.fda.gov/drugsatfda__docs/label/2014/020450s
`023lbl.pdf (last visited Feb. 2, 2016).
`ChemIDPlus, Toxnet, U.S. Nat’l Library of Medicine, Beclamide,
`http://chem.sis.nlm.nih.gov/chemidplus/rn/501—68—8 (last visited
`Feb. 2, 2016).
`ChemIDPlus, Toxnet, U.S. Nat’l Library of Medicine, Phenacemide,
`http://chem.sis.nlm.nih.gov/chemidplus/rn/63-98-9 (last Visited Feb.
`2, 2016).
`ChemIDPlus, Toxnet, U.S. Nat’l Library of Medicine, Valproic
`acid, http://chem.sis.nlm.nih.gov/chemidplus/rn/99-66-1 (last visited
`Feb. 2,2016).
`Portfolio — Mont Alto Capital,
`http://www.montaltocapital.com/portfolio/ (last visited Feb. 23,
`2016).
`
`

`
`IPR2016-00204
`
`029819.0100—US03
`
`[ Exhibit
`2025
`
`2026
`
`2027
`
`2028
`2029
`
`2030
`
`2031
`
`L2032
`2033
`2034
`2035
`2036
`
`2037
`
`2038
`
`2039
`2040
`2041
`
`2042
`
`2043
`
`2044
`
`Description
`Trial Transcript, UCB, Inc., et al., v. Accord Healthcare, Inc., et. al.,
`No. 13-1206-LPS (D. Del., Nov. 9-13, 2015). (served, but not filed,
`March 17, 2016)
`PTAB Telephonic Conference Transcript, IPR2016-00204 (March
`8, 2016).
`PTAB Telephonic Conference Transcript, IPR2016—00204 (April 4,
`2016).
`PTAB Email to Counsel of Record (January 12, 2016).
`U.S. Provisional Patent Application No. 60/013,522 file history.
`(served, but not filed, June 21, 2016) (filed and served, August 15,
`2016)
`l IPR2014—01126 Petition for Inter Partes Review of U.S. Patent No.
`
`RE 38,551 (July 10, 2014)
`PTAB Telephonic Conference Transcript, IPR2016—00204 (June 22,
`2016).
`M. Dowd Email to A. Reister (March 31, 2016)
`M. Dowd Email to A. Reister (April 13, 2016)
`M. Dowd Email to A. Reister (May 26, 2016)
`Transcript, I))_eposition of Binghe Wang, Ph.D. (July 18, 201_6).
`Declaration of William R. Roush, Ph.D., in Support of Patent Owner
`Response Pursuant to 37 C.F.R. §42.120.
`William R. Roush, Ph.D. curriculum vitae.
`
`J
`
`4
`
`Declaration of Carl W. Bazil, M.D., Ph.D., in Support of Patent
`Owner Response Pursuant to 37 C.F.R. §42.120.
`Carl W. Bazil, M.D., Ph.D. curriculum vitae.
`(Jerry March, Advanced Organic Chemistry (3rd ed. 1985) excerpts.
`Jean Jacques et al., Enantiomers, Racemates, and Resolutions
`(Reprint Ed. 1991) exce_rpt.
`Lacosamide, SciFinder® Scholar, version 205; Chemical Abstracts
`Service: Columbus, OH.
`
`J. Hyttel et al., The pharmacological effect of citalopram resides in
`ythe (S)-(+)—enanti0mer, 88(_2) J. Neural Transm. 157-60 (1992).
`Seizure Medication List, Epilepsy Foundation, at
`http://www.epilepsy.com/learn/treating—seizures—and—
`epilepsy/seizure—and—epilepsy-medicines/seizure-medication—list
`Qast accessed Ju_ly_25, 2016)
`
`

`
`IPR2016-00204
`
`029819.0100—US03
`
`Exhibit
`
`2045
`
`2046
`
`2047
`
`2048
`
`2049
`
`2050
`
`205 1
`
`2052
`
`2053
`
`2054
`
`2055
`
`2056
`
`2057
`
`2058
`
`Description
`Signe Stérustovu et al., R—citalopram functionally antagonises
`escitalopram in vivo and in vitro: evidence for kinetic interaction at
`the serotonin transporter, 142(1LBr. J. Pharmacol. 172-80(2004).
`Overview of the Drug Development Process, available at
`http://lillytrials.com/docs/education.html (last accessed August 3,
`2016).
`Center for Drug Evaluation and Research, 2011 Novel New Drugs
`(Jan. 2012).
`Sunil S. Jambhekar, Biopharmaceutical Properties ofDrug
`Substances, in Principles of Medicinal Chemistry (William O. Foye
`et al., eds., 4th ed. 1995).
`Richard B. Silverman, The Organic Chemistry of Drug Design and
`Drug Action, Chapter 2 (2nd ed. 2004).
`F. Raymond Salemme et al., Serendipity meets precision.‘ the
`integration of structure-based drug design and combinatorial
`chemistry for efficient drug discovery, 5(3) Structure 319-24 (1997).
`Hugo Kubinyi, Combinatorial and computational approaches in
`structure-based drug design, 1(1) Curr. Opinion Drug Discov.
`Develop. 16-27 (1998).
`Harold Kohn & Judith D. Conley, New antiepileptic agents, 24(3)
`Chemistry in Britain 231-34 (1988).
`Harold Kohn et al., Marked stereospecificity in a new class of
`anticonvulsants, 457 Brain Res. 371-75 (1988).
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`http://wwW.epilepsy.com/dare—defy—seizures/our-mission (last
`visited July 25, 2016)
`Harold Kohn et al., Anticonvulsant Properties of N—Substituted a,a—
`Diamino Acid Derivatives, 83 J. Pharmaceutical Sci. 689 (May
`1994)
`Patrick Bardel et al., Synthesis and Anticonvulsant Activities of0(-
`Acetamido—N-benzylacetamide Derivatives Containing an Electron—
`Deficient a~Heteroaromatic Substituent, 37(26) J. Med. Chem.
`4567-71 (1994)
`M. C. Walker & P. N. Patsalos, Clinical Pharmakokinetics ofNew
`Antiepileptic Drugs, 67(3) Pharmacol. Ther. 351-84 (1995).
`H. Steve White et al., General Principles: Experimental Selection,
`Quantification, and Evaluation ofAntiepileptic Drugs, in
`Antiepileptic Drugs (Rene H. Levy et al., eds., 4th ed. 1995)_._
`
`4
`
`

`
`IPR2016—00204
`
`029819.0100—US03
`
`Description
`R. Paruszewski et al. , Synthesis and anticonvulsant activity of some
`amino acid derivatives Part I .' Alanine derivatives, 51(3) Pharmazie
`145-48 (1996).
`R. Paruszewski et al., Synthesis and anticonvulsant activity of some
`amino acid derivatives Part 2: Derivatives of Gly, Ala, Leu, Pro,
`Trp, Phe(4 cl), Ala(a-Me), 51L4) Pharmazie 212-15 (1996).
`Polish Patent No. PL 174033 to Paruszewski et al.
`
`4
`
`C. N. Hinko et al., Anticonvulsant Activity ofNovel Derivatives of 2-
`and 3-Piperidinecarboxylic Acid in Mice and Rats, 35(12)
`Neuropharmacology 1721-35 (1996).
`Christophe Salome et al., Merging the Structural Motifs of
`Functionalized Amino Acids and on-Aminoamides: Compounds with
`SignificantAnticonvulsantActivities, 53(9) J. Med. Chem. 3756-71
`(2010).
`Christophe Salome et al., Synthesis and Anticonvulsant Activities of
`(R)-N-(4 ’-Substituted)benzyl 2-Acetamido—3—methoxypropionamides,
`53(3) J. Med. Chem. 1288-1305 (2010).
`Kihachiro Takahara et al., Studies on the Reductive Cleavage of
`Canavanine and Canavaninosuccinic Acid, 145 Arch. Biochem.
`Biophys. 85-95 (1971).
`Univ. of Houston February 16, 1990 letter to Lilly Research Labs
`Eli Lilly November 5, 1991 letter to RCT
`Dr. Kohn July 1987 “Short List of Potential New Drug Candidates
`for Synthesis and Evaluation” for Lilly
`Eli Lilly December 10, 1991 letter to RCT
`A. M. ter Laak et al., Lipophilicity and hydrogen bonding capacity
`ofH1-antihistaminic agents in relation to their central sedative side-
`effects, 2(5/6) Eur. J. Pharm. Sci. 373-84
`Corwin Hansch et al. , The Parabolic Dependence ofDrug Action
`upon Lipophilic Character as Revealed by a Study ofHypnotics, 11
`J. Med. Chem. 1-11 (1968).
`Victor Levin, Relationship of 0ctanol/Water Partition Coeflicient
`and Molecular Weight to Rat Brain Capillary Permeability, 23(6) J.
`Med. Chem. 682-84 (1980).
`Han van de Waterbeemd & Manfred Kansy, Hydrogen-Bonding
`
`
`
`
`
`
`Capacity and Brain Penetration, 46(7/8)_Chimia 299-303 1992 .
`
`I
`
`Exhnmt
`2059
`
`2060
`
`2061
`
`2062
`
`2063
`
`2064
`
`2065
`
`2066
`
`2067
`
`2068
`
`F2069
`
`2070
`
`2071
`
`2072
`
`[2073
`
`

`
`IPR2016—00204
`
`0298190100-US03
`
`
`
`2074
`
`Exhibit
`
`
`
`
`
`
`
`2076
`
` 2077
`
`2078
`
`2079
`
`2080
`
`2081
`
`2082
`
`2083
`
`2084
`
`2085
`
`2086
`
`2087
`
`2088
`
`I
`
`tion
`rD—escri
`Han van de Waterbeemd et al., Estimation ofBlood—Brain Barrier
`Crossing ofDrugs Using Molecular Size and Shape, and H-Bonding
`Descriptors, 6(2)]. Drug Targeting 151-65 (1998).
`R. L. Krall et al., Antiepileptic Drug Development.‘ 1. History and a
`Pro ram or Progfess, 19(4) Epilepsia 393-408 (1978).
`H. Steve White et al., The National Institutes ofHealth
`Anticonvulsant Drug Development Program.‘ Screening for Efficacy,
`76 Antiepileptic Drug Development: Advances in Neurology 29-39
`(1998).
`Carl W. Bazil et al., What Do I Do Now? Epilepsy (2011).
`Carl W. Bazil et al., Epilepsy, in Merritt’s Neurology (Elan D. Louis
`et al., eds., 13th ed. 2016).
`Carl W. Bazil, Living Well with Epilepsy and Other Seizure
`Disorders (2004).
`About Epilepsy: The Basics, Epilepsy Foundation, at
`http://www.epilepsy.com/learn/about-epilepsy—basics (last visited
`July 11, 2016)
`Carl W. Bazil, Epilepsy.‘ Management, 6 Encyclopedia of Life
`Sciences 487-94 (2002)
`Carl W. Bazil & Timothy A. Pedley, Clinical Pharmacology of
`Antiepileptic Drugs, 26(1) Clinical Neuropharmacol. 38-52 (2003).
`Suller et al., New manage of epileptic status. The power of the
`lacosamide (Abstract), 261 (Suppl. 1) J. Neurol. S386 (2014).
`Raoul Sutter et al., Safety and Efiicacy ofIntravenous Lacosamide
`for Adjunctive Treatment ofRefractory Status Epilepticus.‘ A
`Comparative Cohort Study, 27(4) CNS Drugs, 321-29 (2013).
`Santamarina et al., Usefulness of intravenous lacosamide in status
`epilepticus, 260 J. Neurol. 3122-28 (2013).
`Stephen Yates et al., Lacosamide for Uncontrolled Primary
`Generalized Tonic~Clonic Seizures: An Open-label Extension Study,
`82(Suppl. P3.276) Neurology, Abstract (2014), available at
`http://www.neurology.org/content/82/10_Supplement/P3.276 (last
`visited July 11, 2016)
`D.M. lJff et al., Cognitive effects of lacosamide as adjunctive
`therapy in refractory epilepsy, 131 Acta Neurol. Scand. 347-54
`(2015).
`Gregory L. Holmes, Critical issues in the treatment of epilepsy,
`5Q(Suppl. 5) Am. J. Hos. Pharm. S5-S16g(1993).
`
`6
`
`

`
`IPR2016~00204
`
`029819.0100—US03
`
`Exhibit
`
`2089
`
`2090
`
`2091
`
`2092
`
`2093
`
`2094
`
`2095
`
`2096
`
`2097
`
`2098
`
`12099
`
`2100
`
`2101
`
`2102
`
`1 Description
`Willi Cawello et al.,Advances in epilepsy treatment: lacosamide
`harmacokineticprofile, 1329 Ann. N.Y. Acad. Sci. 18-32 (2014).
`Blaise F. D. Bourgeois, Important Pharmacokinetic Properties of
`Antiepileptic Drugs, 36 (Suppl. 5) Epilepsia S1-S7 (1995).
`Bjarke a RogVi—Hansen & Lennart Gram, Adverse Effects of
`Established and New Antiepileptic Drugs: An Attempted
`Comparison, 68(3_) Pharmacol. Ther. 425-34 (1995).
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`(49th ed. 1995).
`Collaborative Group for Epidemiology of Epilepsy, Adverse
`Reactions to Antiepileptic Drugs: A Follow-Up Study of 355
`Patients with Chronic Antiepileptic Drug Treatment, 29(6) Epilepsia
`787-93 (1988).
`Neil Buchanan, The occurrence, management and outcome of
`antiepileptic drug side effects in 767 patients, 1(1) Seizure 89-98
`1 (1992).
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`Eflicacy, Reproductive Health, Pregnancy, and Fetal Outcome,
`37(Suppl. 6) Epilepsia S34—S44 (1996);
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`21(Suppl. 3) Can. J. Neurol. Sci. S12—S16 (1994).
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`Clinical Features and Management 32(4) Epilepsia 554-59 (1991).
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`203-1411993)
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`Situations in Epilepsy, 34(Suppl. 5) Epilepsia S17-S23 (1993)_.
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`treatment of epilepsy in a tertiary centre, 127(3) Acta Neurol.
`Scand. 149-53 (2013).
`Juan Luis Becerra et al., Review of Therapeutic Options for
`Adjuvant Treatment of Focal Seizures in Epilepsy: Focus on
`Lacosamide, 25_(Suppl. 1) CNS Drugs 3-16 (2011).
`
`.+_j....
`
`

`
`IPR2016—00204
`
`029819.0100—US03
`
`2104
`
`2105
`
`2106
`
`2107
`
`gt:
`
`L Exhibit _JDescription
`2103
`Elinor Ben—Menachem et al., Efficacy and Safety of Oral
`Lacosamide as Adjunctive Therapy in Adults with Partial-Onset
`Seizures, 48(7) Epilepsia 1308 (2007).
`Stefano de Biase et al., Lacosamide for the treatment of epilepsy,
`10(3) Expert Opin. Drug Metab. Toxicol. 459-68 (2014).
`Jun-Sang Sunwoo et al.,A case of lacosamide—induced hepatoxicity,
`53(6) Int. J. Clin. Pharmacol. Ther. 471-73 (2015).
`) Ylse Gutiérrez—Grobe et al., Acute Liver Failure Associated with
`Levetiracetam and Lacosamide Combination Treatment for
`Unspecified Epileptic Disorder, 2013 Case Rep. Emerg. Med.,
`Article ID 634174 (2013).
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`Children with Refractory Epilepsy, 17(3) J. Pediatr. Pharmacol.
`Ther. 211-19 (2012).
`[Jacklyn A. Harris & Julie A. Murphy, Lacosamide and Epilepsy,
`17(6) CNS Neurosci. Ther. 678-82 (2011);
`Joao Costa et al., Clinical comparability of the new antiepileptic
`drugs in refractory partial epilepsy: A systematic review and meta-
`analysis, 52(7) Epilepsia 1280-91 @011).
`Pritesh N. Bodalia et al., Comparative efficacy and tolerability of
`anti—epileptic drugs for refractory focal epilepsy: systematic review
`and network meta-analysis reveals the need for long term
`comparator trials, 76(5) Br. J. Clin. Pharmacol. 649-67 (2013).
`Sylvain Rheims et al., Clinical comparability of the new
`antiepileptic drugs in refractory partial epilepsy: Reply to Costa et
`PL, 52(11) Epilepsia 2139-41 (2011).
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`partial (focal) epilepsy: an observation 76(5) Br. J. Clin. Pharmacol.
`630-31 (2013).
`Gaetano Zaccara et al., Network meta-analysis and the comparison
`of efficacy and tolerability of anti-epileptic drugs for treatment of
`refractory focal epilepsy, 76(5) Br. J. Clin. Pharmacol. 827-28
`(2013);
`
`2108
`
`2109
`
`2110
`
`2111
`
`2112
`
`2113
`
`2114
`
`2115
`
`J Prescribing Information for Felbatol, in Physicians’ Desk Reference
`
`2666 (50th ed. 1996)
`J. P. Stables et al., Progress report on new antiepileptic drugs: A
`summary of the Second Eilat Conference 22(3) Epilepsy Res. 235-
`46 (1995).
`
`

`
`IPR2016-00204
`
`0298l9.0100—US03
`
`Exhibit
`2116
`
`2117
`
`2118
`
`2119
`
`2120
`
`2121
`
`2122
`
`2123
`
`2124
`
`2125
`2126
`
`2127
`
`2128
`
`2129
`
`)
`
`...a
`
`ljgescription
`John M. Pellock, Felbamate, 40(Suppl. 5) Epilepsia S57-S62
`(1999).
`M. Bialer et al., Progress report on new antiepileptic drugs.‘ a
`summary of the Third Eilat Conference, 25(3) Epilepsy Res. 299-
`319 (1996).
`Lesley J. Scott, Lacosamide: A Review in Focal Seizures in Patients
`with Epilepsy, 75(18) Drugs 2143-54 (2015).
`Ahmad Beydoun et al., Lacosamide: pharmacology, mechanisms of
`action and pooled efficacy and safety data in partial—onset seizures,
`9(1) Expert Rev. Neurother. 33-42 (2009).
`Victor Biton, Lacosamide for the treatment ofpartial—onset seizures,
`12(6) Expert Rev. Neurother. 645-55 (2012);
`Steve S. Chung, Lacosamide: new adjunctive treatment option for
`partial—onset seizures, 11(9) Expert Opin. Pharmacother. 1595-602
`(2010).
`Michael A. Rogawski et al., Current understanding of the
`mechanism of action of the antiepileptic drug lacosamide, 110
`Epilep_s_y Res. 189-205 (2015).
`G.L. Krauss et al., Lacosamide for the treatment of epilepsy, 44(7/8)
`Ann. Med. 674-79 (2012).
`Linda J. Stephen et al., Adjunctive lacosamide in clinical practice:
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`499-504 (201 1).
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`Robin M. Zavod & James J. Knittel, Drug Design and Relationship
`of Functional Groups to Pharmacologic Activity, in Foye’s
`Principles of Medicinal Chemistry (Thomas L. Lemke et al., eds.,
`7th ed. 201;).
`_J
`l Marc W. Harrold & Robin M. Zavod, Basic Concepts in Medicinal
`Chemistry (2013).
`Preben H. Olesen, The use of bioisosteric groups in lead
`optimization, 4(4) Curr. Opin. Drug Discov. Develop. 471-78
`2001).
`
`l-lqeal R. Cutler et al., Evaluation ofMultiple Doses ofMilacemide in
`
`the Treatment ofSenile Dementia of the Alzheimer ’s Type, 6(2) J.
`Geriatr. P§y_chiatry Neurol. 115-19 (1993L
`
`

`
`IPR2016—00204
`
`__|.._.__._
`
`029819.0100—US03
`
`Exhibit
`2130
`
`2131
`
`2132
`
`2133
`2134
`
`2135
`
`2136
`2137
`
`2138
`
`2139
`
`2140
`2141
`2142
`2143
`2144
`2145
`2146
`
`2147
`
`2148
`2149
`
`2150
`
`
`
`Description
`Epilepsy Therapy Screening Program (“ETSP”), available at
`http://www.ninds.nih.gov/research/asp/index.htm (last visited
`August 8, 2016_).
`Jean—Louis Rakotoamboa et al., Fasting for 24 It reveals liver
`microsteatosis after continuous i. v. infusion of milacemide in the rat,
`68 Arch. Toxicol. 266-71 (1994).
`Declaration of Christopher A. Vellturo, Ph.D. in Support of Patent
`Owner Response
`Christopher A. Vellturo, Ph.D. curriculum Vitae.
`Treatment of Epilepsy, available at
`http://www.medicinenet.com/epilepsy_treatment/article.htm (last
`visited August 5, 2016).
`Erik K. St. Louis et al., "Antiepileptic Drug Monotherapy: The
`Initial Approach in Epilepsy Management," 7 Curr.
`JVNeuropharrnacol. 77-82 (2009).
`AED Market Basket, April 2007 ~ February 2015
`BRIVIACT Orange Book Listing, available at
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Ap
`pl_No=205836&TABLE1=OB____R3( Qast visited August 5, 2016).
`BRIVIACT Prescribing Information, available at
`http://www.accessdata.fda.gov/drugsatfda___docs/label/2016/2058365
`001,205837s001,205838s001lbhpdf glast visited August 5, 2016).
`LYRICA Prescribing Information, available at
`http://www.accessdata.fda.gov/drugsatfda__docs/label/2016/0214465
`030,022488s0101bl.pdf (last visited August 5, 2016).
`):Pharmaceutical Sales Data, 1992 — 2014
`Abbott Laboratories June 25, 1992, letter to RCT
`Burroughs Wellcome Co. November 3, 1992 letter to RCT
`Hoffmann—La Roche Inc. December 21, 1992 letter to RCT
`Marion Merrel Dow, Inc. November 13, 1992 letter from RCT
`McNeil Pharmaceutical June 2, 1992 letter to RCT
`Merck Sharp & Dohme Research Laboratories May 7, 1992 letter to
`RCT
`
`l
`
`Merck Sharp & Dohme Research Laboratories August 6, 1992 letter
`to RCT
`I Schering-Plough Corporation May 1, 1992 letter to RCT
`]lThe Upjohn Company May 8, 1992 letter to RCT
`
`Wyeth—Ayerst Laboratories May 19, 1992 letter to RCT
`
`10
`
`

`
`J
`
`J
`
`7
`
`J
`
`IPR2016—00204
`
`T
`
`029819.0100—US03
`
`Exhibit
`2151
`2152
`2153
`2154
`J 2155
`2156
`2157
`2158
`2159
`2160
`2161
`r2162
`2163
`2164
`J 2165
`2166
`2167
`2168
`2169
`2170
`
`Description
`J Akzo Nobel October 10, 1997 letter to Harris
`Astra Pharmaceuticals October 1, 1998 letter to Harris
`Bayer AG March 9, 1998 letter to Harris
`Boehringer Ingelheim GmbH March 3, 1999 letter to Harris
`J Bristol-Mjyers Squibb Company April 8, 1999 letter to Harris
`CoCensys January 16, 1998 letter to Harris
`JEli Lilly April 9, 1999 letter to Harris
`Forest Laboratories June 17, 1998 letter to Harris
`Fuiisawa U.S.A., Inc. October 27, 1997 letter to Harris
`l Gador S.A. October 28, 1997 letter to Harris
`Glaxo Wellcome March 16, 1998 letter to Harris
`ICAgen Inc. February 16, 1998 letter to Harris
`l Merck January 16, 1998 letter to Harris
`Merck March 9, 1999 letter to Harris
`Pfizer Inc. August 11, 1998 letter to Harris
`I Sankyo Co., Ltd. June 19, 1998 letter to McDermott
`Schering—Plough January 27, 1998 letter to Harris
`J Uriach Corp. October 23, 1997 letter to Harris
`Wyeth~Ayerst Laboratories October 22, 1997 letter to Harris
`Zeneca Pharmaceuticals March 17, 1998 letter to Harris
`
`2171
`2172
`2173
`J 2174
`2175
`2176
`J 2177
`2178
`2179
`
`r2180
`
`2181
`
`2182
`
`2183
`
`I
`
`J
`
`J
`
`U.S. AED Prescriptions, 2009 - 2015
`J Summary of FAAs in Kohn References
`Chem 3D Conformational Analysis
`J VIMPAT U.S. Net Sales, May 2009 — June 2016
`VIMPAT Gross and Net Sales Data, 2009-2016
`J VIMPAT Share of Total U.S. AED Dollar Sales, 2009 — 2015
`J AED Marketing Spend, 2009-2014
`AED U.S. Sales Dollars Associated with Epilepsy Indications
`IMS Health, Integrated Promotional Services Data, April 2009 -
`December 2014
`IMS Health, Integrated Promotional Services Data, January 2009 — wl
`JMarch 2009
`Order, UCB, Inc. et al. 12. Accord Healthcare Inc. et al., 1:13—cV—
`01206-LPS
`Del. August 12, 2016)
`l Memorandum Opinion, UCB, Inc. et al. v. Accord Healthcare Inc. er
`al., 1:13—cV—01206—LPS
`Del. August 12, 2016)__
`PTAB Telephonic Conference Transcript, IPR2016—00204, —01101,
`—01242, —01245, —01248 gAugust 9, 2016).
`
`11
`
`

`
`IPR2016-00204
`
`0298190100-US03
`
`
`
`I 2189
`I 2190
`
`1
`Description
`Declaration of Michael Davis in Support of Evidence (served, but
`not filed, Sept. 6, 2016)
`Declaration of Shaun Kirkpatrick in Support of Evidence (served,
`but not filed, Sept. 6, 2016)
`Declaration of Harold Kohn, Ph.D., in Support of Evidence (served,
`but not filed, Sept. 6, 2016)
`3
`Declaration of Paul M. Petigrow in Support of Evidence (served, but
`not filed, Sept. 6, 2016)
`Declaration of Christopher A. Vellturo, Ph.D. in Support of
`Evidence (served, but not filed, Sept. 6, 2016)
`M. Dowd Email to A. Reister (November 14, 2016)
`M. Dowd Letter to A. Reister (November 15, 2016)
`
`Respectfully submitted,
`
`;
`
`
`Dated: November 21 2016
`
`COVINGTON & BURLING LLP
`
`Andrea G. R ister
`
`One CityCenter
`850 Tenth Street NW
`
`Washington, DC 20001
`(202) 662-6000
`
`Registration No.: 36,253
`Jennifer L. Robbins
`
`Registration No.: 61,163
`Enrique D. Longton
`Registration No.: 47,304
`Attorneys for Patent Owner
`
`12
`
`

`
`IPR2016—00204
`
`029819.0100—USO3
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6,
`
`I hereby certify that on this 21st day of
`
`November 2016,
`
`the foregoing Patent Owner’s Updated Exhibit List and
`
`Exhibits 2189-2190 were served by electronic mail, by agreement of the parties,
`
`on the following counsel of record for Petitioners:
`
`PETITIONER (IPR2016~00204)
`Matthew J. Dowd (mjdowd@dowdpllc.com)
`DOWD PLLC
`
`William G. Jenks (wjenks@jenksiplaw.com)
`JENKS IP LAW
`
`PETITIONER (IPR2016—01101)
`Steven W. Parmelee (sparmalee@wsgr.com)
`Michael T. Rosato (mrosato@wsgr.com)
`Jad A. Mills (jmills@wsgr.com)
`WILSON SONSINI GOODRICH & ROSATI
`
`PETITIONER (IPR2016—01242)
`Matthew L. Fedowitz (mfedowitz@merchantgould.com)
`Daniel R. Evans (devans@merchantgould.com)
`MERCHANT & GOULD P.C.
`
`PETITIONER (IPR2016-01245)
`Gary J . Speier (gspeier@carlsoncaspers.com)
`Jeffer Ali (]°ali@carlsoncaspers.com)
`CARLSON, CASPERS, VANDENBURGH, LINDQUIST & SCHUMAN, P.A.
`
`Dated: November 21 2016
`
`
`
` L,/:1/7f”;»«Z7”(:e5?”“”
`
`
`r, Esq.
`Andrea G. Reis
`Registration No. 36,253