`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`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,
`
`v.
`
`RESEARCH CORPORATION TECHNOLOGIES, INC.,
`Patent Owner.
`
`Case No. IPR2016-002041
`Patent No. RE 38,551
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`
`
`1 Case IPR2016-01101, Case IPR2016-01242, and Case IPR2016-01245 have been
`
`joined with this proceeding.
`
`
`
`

`

`Exhibit
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`2006
`
`2007
`2008
`
`2009
`2010
`
`2011
`
`2012
`
`2013
`
`2014
`
`IPR2016-00204
`
`LIST OF EXHIBITS
`
`Description
`Richard H. Mattson, Efficacy and Adverse Effects of Established and
`New Antiepileptic Drugs, 36 (Suppl. 2) Epilepsia S13-S26 (1995).
`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
`http://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. Potent New Agents for the Treatment of Epilepsy, 30 J.
`Med. Chem. 567-574 (1987).
`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.
`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 Löscher & Dieter Schmidt, Strategies in Antiepileptic
`Drug Development: Is Rational Drug Design Superior to Random
`Screening and Structural Variation?, 17 Epilepsy Research 95-134
`(1994).
`
`1
`
`

`

`Exhibit
`2015
`
`2016
`
`2017
`
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`
`2024
`
`IPR2016-00204
`
`Description
`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).
`
`2
`
`

`

`Exhibit
`2025
`
`2026
`
`2027
`
`2028
`2029
`
`2030
`
`2031
`
`2032
`2033
`2034
`2035
`2036
`
`2037
`2038
`
`2039
`2040
`2041
`
`2042
`
`2043
`
`2044
`
`IPR2016-00204
`
`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)
`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, Deposition of Binghe Wang, Ph.D. (July 18, 2016).
`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.
`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) excerpt.
`Lacosamide, SciFinder® Scholar, version 205; Chemical Abstracts
`Service: Columbus, OH.
`J. Hyttel et al., The pharmacological effect of citalopram resides in
`the (S)-(+)-enantiomer, 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
`(last accessed July 25, 2016)
`
`3
`
`

`

`Exhibit
`2045
`
`2046
`
`2047
`
`2048
`
`2049
`
`2050
`
`2051
`
`2052
`
`2053
`
`2054
`
`2055
`
`2056
`
`2057
`
`2058
`
`IPR2016-00204
`
`Description
`Signe Stórustovu et al., R-citalopram functionally antagonises
`escitalopram in vivo and in vitro: evidence for kinetic interaction at
`the serotonin transporter, 142(1) Br. 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 of Drug
`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).
`Our Mission, Epilepsy Foundation, at
`http://www.epilepsy.com/dare-defy-seizures/our-mission (last
`visited July 25, 2016)
`Harold Kohn et al., Anticonvulsant Properties of N-Substituted α,α-
`Diamino Acid Derivatives, 83 J. Pharmaceutical Sci. 689 (May
`1994)
`Patrick Bardel et al., Synthesis and Anticonvulsant Activities of α-
`Acetamido-N-benzylacetamide Derivatives Containing an Electron-
`Deficient α-Heteroaromatic Substituent, 37(26) J. Med. Chem.
`4567–71 (1994)
`M. C. Walker & P. N. Patsalos, Clinical Pharmakokinetics of New
`Antiepileptic Drugs, 67(3) Pharmacol. Ther. 351–84 (1995).
`H. Steve White et al., General Principles: Experimental Selection,
`Quantification, and Evaluation of Antiepileptic Drugs, in
`Antiepileptic Drugs (René H. Levy et al., eds., 4th ed. 1995).
`
`4
`
`

`

`Exhibit
`2059
`
`2060
`
`2061
`2062
`
`2063
`
`2064
`
`2065
`
`2066
`2067
`2068
`
`2069
`2070
`
`2071
`
`2072
`
`2073
`
`IPR2016-00204
`
`Description
`R. Paruszewski et al., Synthesis and anticonvulsant activity of some
`amino acid derivatives Part 1: 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(α-Me), 51(4) Pharmazie 212–15 (1996).
`Polish Patent No. PL 174033 to Paruszewski et al.
`C. N. Hinko et al., Anticonvulsant Activity of Novel Derivatives of 2-
`and 3-Piperidinecarboxylic Acid in Mice and Rats, 35(12)
`Neuropharmacology 1721–35 (1996).
`Christophe Salomé et al., Merging the Structural Motifs of
`Functionalized Amino Acids and α-Aminoamides: Compounds with
`Significant Anticonvulsant Activities, 53(9) J. Med. Chem. 3756–71
`(2010).
`Christophe Salomé et al., Synthesis and Anticonvulsant Activities of
`(R)-N-(4ʹ-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
`of H1-antihistaminic agents in relation to their central sedative side-
`effects, 2(5/6) Eur. J. Pharm. Sci. 373–84 (1994).
`Corwin Hansch et al., The Parabolic Dependence of Drug Action
`upon Lipophilic Character as Revealed by a Study of Hypnotics, 11
`J. Med. Chem. 1–11 (1968).
`Victor Levin, Relationship of Octanol/Water Partition Coefficient
`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).
`
`5
`
`

`

`Exhibit
`2074
`
`2075
`
`2076
`
`2077
`2078
`
`2079
`
`2080
`
`2081
`
`2082
`
`2083
`
`2084
`
`2085
`
`2086
`
`2087
`
`2088
`
`IPR2016-00204
`
`Description
`Han van de Waterbeemd et al., Estimation of Blood-Brain Barrier
`Crossing of Drugs Using Molecular Size and Shape, and H-Bonding
`Descriptors, 6(2) J. Drug Targeting 151–65 (1998).
`R. L. Krall et al., Antiepileptic Drug Development: I. History and a
`Program for Progress, 19(4) Epilepsia 393–408 (1978).
`H. Steve White et al., The National Institutes of Health
`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 Efficacy of Intravenous Lacosamide
`for Adjunctive Treatment of Refractory 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. IJff 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,
`50(Suppl. 5) Am. J. Hos. Pharm. S5–S16 (1993).
`
`6
`
`

`

`Exhibit
`2089
`
`2090
`
`2091
`
`2092
`
`2093
`
`2094
`
`2095
`
`2096
`
`2097
`
`2098
`
`2099
`
`2100
`
`2101
`
`2102
`
`IPR2016-00204
`
`Description
`Willi Cawello et al., Advances in epilepsy treatment: lacosamide
`pharmacokinetic profile, 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 á Rogvi-Hansen & Lennart Gram, Adverse Effects of
`Established and New Antiepileptic Drugs: An Attempted
`Comparison, 68(3) Pharmacol. Ther. 425–34 (1995).
`Prescribing Information for Tegretol, in Physicians’ Desk Reference
`(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
`(1992).
`Martha J. Morrell, The New Antiepileptic Drugs and Women:
`Efficacy, Reproductive Health, Pregnancy, and Fetal Outcome,
`37(Suppl. 6) Epilepsia S34–S44 (1996).
`Kimford J. Meador, Cognitive Side Effects of Antiepileptic Drugs,
`21(Suppl. 3) Can. J. Neurol. Sci. S12–S16 (1994).
`J. Pelekanos et al., Allergic Rash Due to Antiepileptic Drugs:
`Clinical Features and Management 32(4) Epilepsia 554–59 (1991).
`Elson L. So, Update on Epilepsy, 77(1) Contemp. Clin. Neurol.
`203–14 (1993)
`David M. Treiman, Current Treatment Strategies in Selected
`Situations in Epilepsy, 34(Suppl. 5) Epilepsia S17–S23 (1993).
`Epilepsy and the Senior Community, Epilepsy Foundation, at
`http://www.epilepsy.com/learn/age-groups/epilepsy-and-senior-
`community (last visited July 11, 2016).
`J. T. Kamel et al., Clinical experience with using lacosamide for the
`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).
`
`7
`
`

`

`Exhibit
`2103
`
`2104
`
`2105
`
`2106
`
`2107
`
`2108
`
`2109
`
`2110
`
`2111
`
`2112
`
`2113
`
`2114
`
`2115
`
`IPR2016-00204
`
`Description
`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).
`Marcia L. Buck & Howard P. Goodkin, Use of Lacosamide in
`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).
`João 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 (2011).
`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
`al., 52(11) Epilepsia 2139–41 (2011).
`Martin J. Brodie, Meta-analyses of antiepileptic drugs for refractory
`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).
`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).
`
`8
`
`

`

`Exhibit
`2116
`
`2117
`
`2118
`
`2119
`
`2120
`
`2121
`
`2122
`
`2123
`
`2124
`
`2125
`2126
`
`2127
`
`2128
`
`2129
`
`IPR2016-00204
`
`Description
`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 of partial-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
`Epilepsy 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:
`Sodium blockade with a difference?, 22(3) Epilepsy & Behavior
`499–504 (2011).
`Eli Lilly November 7, 1991 letter to RCT
`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. 2013).
`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).
`Neal R. Cutler et al., Evaluation of Multiple Doses of Milacemide in
`the Treatment of Senile Dementia of the Alzheimer’s Type, 6(2) J.
`Geriatr. Psychiatry Neurol. 115–19 (1993).
`
`9
`
`

`

`Exhibit
`2130
`
`2131
`
`2132
`
`2133
`2134
`
`2135
`
`2136
`2137
`
`2138
`
`2139
`
`2140
`2141
`2142
`2143
`2144
`2145
`2146
`
`2147
`
`2148
`2149
`2150
`
`IPR2016-00204
`
`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 h 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.
`Neuropharmacol. 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_Rx (last visited August 5, 2016).
`BRIVIACT Prescribing Information, available at
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205836s
`001,205837s001,205838s001lbl.pdf (last visited August 5, 2016).
`LYRICA Prescribing Information, available at
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021446s
`030,022488s010lbl.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
`Merck Sharp & Dohme Research Laboratories August 6, 1992 letter
`to RCT
`Schering-Plough Corporation May 1, 1992 letter to RCT
`The Upjohn Company May 8, 1992 letter to RCT
`Wyeth-Ayerst Laboratories May 19, 1992 letter to RCT
`
`10
`
`

`

`Exhibit
`2151
`2152
`2153
`2154
`2155
`2156
`2157
`2158
`2159
`2160
`2161
`2162
`2163
`2164
`2165
`2166
`2167
`2168
`2169
`2170
`2171
`2172
`2173
`2174
`2175
`2176
`2177
`2178
`2179
`
`2180
`
`2181
`
`2182
`
`2183
`
`IPR2016-00204
`
`Description
`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
`Bristol-Myers Squibb Company April 8, 1999 letter to Harris
`CoCensys January 16, 1998 letter to Harris
`Eli Lilly April 9, 1999 letter to Harris
`Forest Laboratories June 17, 1998 letter to Harris
`Fujisawa U.S.A., Inc. October 27, 1997 letter to Harris
`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
`Merck January 16, 1998 letter to Harris
`Merck March 9, 1999 letter to Harris
`Pfizer Inc. August 11, 1998 letter to Harris
`Sankyo Co., Ltd. June 19, 1998 letter to McDermott
`Schering-Plough January 27, 1998 letter to Harris
`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
`U.S. AED Prescriptions, 2009 - 2015
`Summary of FAAs in Kohn References
`Chem 3D Conformational Analysis
`VIMPAT U.S. Net Sales, May 2009 - June 2016
`VIMPAT Gross and Net Sales Data, 2009-2016
`VIMPAT Share of Total U.S. AED Dollar Sales, 2009 - 2015
`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 -
`March 2009
`Order, UCB, Inc. et al. v. Accord Healthcare Inc. et al., 1:13-cv-
`01206-LPS (D. Del. August 12, 2016)
`Memorandum Opinion, UCB, Inc. et al. v. Accord Healthcare Inc. et
`al., 1:13-cv-01206-LPS (D. Del. August 12, 2016)
`PTAB Telephonic Conference Transcript, IPR2016–00204, –01101,
`–01242, –01245, –01248 (August 9, 2016).
`11
`
`

`

`
`
`
`IPR2016-00204
`
`
`
`
`
`Exhibit|Description
`2184
`Declaration of Michael Davis in Support of Evidence (served, but
`not filed, Sept. 6, 2016)
`
`Declaration of Shaun Kirkpatrick in Support of Evidence(served,
`2185
`but not filed, Sept. 6, 2016)
`
`Declaration of Harold Kohn, Ph.D., in Support of Evidence (served,
`but not filed, Sept. 6, 2016)
`
`Declaration of Paul M. Petigrow in Support of Evidence (served, but
`2187
`| not filed, Sept. 6, 2016)
`
`Declaration of Christopher A. Vellturo, Ph.D. in Support of
`2188
`Evidence (served, but not filed, Sept. 6, 2016)
`M. Dowd Email to A. Reister (November 14, 2016)
`2189
`2190
`M. DowdLetter to A. Reister (November 15, 2016)
`
`2191
`PTAB Email authorizing submissions regarding Reply (November
`
`29, 2016)
`Office Action from U.S. Reexamination Control No. 90/013,709
`2192
`(December5, 2016)
`
`| Transcript, Deposition of DeForest McDuff, Ph.D. (December 8,
`
`2016).
`(December 10,
`Transcript, Deposition of Binghe Wang, Ph.D.
`2194
`2016).
`
`Transcript, Deposition of Kathryn A. Davis, M.D., MSTR
`2195
`(December 14, 2016).
`Transcript, Testimony of Dr. McDuff, UCB, Inc. et al. v. Accord
`Healthcare Inc. et al., 1:13-cv-01206-LPS (D. Del. Nov. 13, 2015)
`(McDuff Deposition Exhibit 2)
`
`2186
`
`2193
`
`2196
`
`
`
`Dated: December 22, 2016 Respectfully submitted,
`
`COVINGTON & BURLING LLP
`One CityCenter
`850 Tenth Street NW
`Washington, DC 20001
`(202) 662-6000
`
`
`
`Andrea G. Reister
`Registration No.: 36,253
`Jennifer L. Robbins
`Registration No.: 61,163
`Enrique D. Longton
`Registration No.: 47,304
`Attorneys for Patent Owner
`
`12
`
`

`

`CERTIFICATE OF SERVICE
`
`IPR2016-00204
`
`Pursuant to 37 C.F.R. § 42.6,
`
`I hereby certify that on this 22nd day of
`
`December 2016,
`
`the foregoing Patent Owner’s Updated Exhibit List and
`
`Exhibits 2193, 2195, and 2196 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 (sparmelee@wsgr.com)
`Michael T. Rosato (mrosato@wsegr.com)
`Jad A. Mills Gmills@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 (jali@carlsoncaspers.com)
`CARLSON, CASPERS, VANDENBURGH, LINDQUIST & SCHUMAN,P.A.
`
`Dated: December 22, 2016
`
`Bea,
`
`
`
`ennifer L. Robbins, Esq.
`Registration No. 61,163
`
`
`
`