UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`ARGENTUM PHARMACEUTICALS LLC
`Petitioner
`
`v.
`
`RESEARCH CORPORATION TECHNOLOGIES, INC.
`Patent Owner
`
`
`
`
`
`Patent No. RE38,551
`Issue Date: July 6, 2004
`Title: ANTICONVULSANT ENANTIOMERIC AMINO ACID DERIVATIVES
`_______________
`
`Inter Partes Review No. IPR2016-00204
`____________________________________________________________
`
`PETITIONER’S OBJECTIONS TO PATENT OWNER’S EVIDENCE
`
`37 C.F.R. § 42.64
`
`
`
`
`
`
`
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`ARGENTUM PHARMACEUTICALS LLC
`Petitioner
`
`v.
`
`RESEARCH CORPORATION TECHNOLOGIES, INC.
`Patent Owner
`
`
`
`
`
`Patent No. RE38,551
`Issue Date: July 6, 2004
`Title: ANTICONVULSANT ENANTIOMERIC AMINO ACID DERIVATIVES
`_______________
`
`Inter Partes Review No. IPR2016-00204
`____________________________________________________________
`
`PETITIONER’S OBJECTIONS TO PATENT OWNER’S EVIDENCE
`
`37 C.F.R. § 42.64
`
`
`
`
`
`
`
`
`Petitioner files these objections under 37 C.F.R. § 42.64 within five business
`
`days of the filing of Patent Owner’s Response on August 15, 2016. Petitioner
`
`objects to the following evidence submitted with the Patent Owner’s Response:
`
`
`
`Exhibit 2036 Declaration of William R. Roush, Ph.D., in Support of Patent
`
`Owner Response Pursuant to 37 C.F.R. § 42.120
`
`Exhibit 2036 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Dr. Roush’s declaration relies on inadmissible
`
`hearsay and relies on upon facts and data not reasonably relied upon in forming an
`
`expert opinion under FRE 703. Dr. Roush’s declaration relies on articles and other
`
`documents that are not shown to be prior art, as detailed herein.
`
`Exhibit 2038 Declaration of Carl W. Bazil, M.D., Ph.D., in Support of
`
`Patent Owner Response Pursuant to 37 C.F.R. § 42.120
`
`Exhibit 2038 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Dr. Bazil’s declaration relies on inadmissible
`
`hearsay and relies on upon facts and data not reasonably relied upon in forming an
`
`expert opinion under FRE 703. Dr. Bazil’s declaration relies on articles and other
`
`documents that are not shown to be prior art, as detailed herein.
`
`Exhibit No. 2042 - Lacosamide, SciFinder® Scholar, version 205; Chemical
`
`Abstracts Service: Columbus, OH.
`
`1
`
`
`
`Exhibit 2042 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2042 is hearsay under FRE 801 and is
`
`inadmissible under FRE 802. Exhibit 2042 is lacks authentication and is therefore
`
`inadmissible under FRE 901. Exhibit 2042 lacks relevance to the extent it is relied
`
`on for an issue that requires prior art because the exhibit is not shown to be prior
`
`art.
`
`Exhibit 2044 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)
`
`Exhibit 2044 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2044 is hearsay under FRE 801 and is
`
`inadmissible under FRE 802. Exhibit 2044 is lacks authentication and is therefore
`
`inadmissible under FRE 901. Exhibit 2044 lacks relevance to the extent it is relied
`
`on for an issue that requires prior art because the exhibit is not shown to be prior
`
`art.
`
`Exhibit 2045 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).
`
`Exhibit 2045 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2045 lacks relevance to the extent it is
`
`
`
`2
`
`
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2046 Overview of the Drug Development Process, available at
`
`http://lillytrials.com/docs/education.html (last accessed August 3, 2016).
`
` Exhibit 2046 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2046 is hearsay under FRE 801 and is
`
`inadmissible under FRE 802. Exhibit 2046 is lacks authentication and is therefore
`
`inadmissible under FRE 901. Exhibit 2046 lacks relevance to the extent it is relied
`
`on for an issue that requires prior art because the exhibit is not shown to be prior
`
`art.
`
`Exhibit 2047 Center for Drug Evaluation and Research, 2011 Novel New
`
`Drugs (Jan. 2012).
`
`Exhibit 2047 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2047 is hearsay under FRE 801 and is
`
`inadmissible under FRE 802. Exhibit 2047 is lacks authentication and is therefore
`
`inadmissible under FRE 901. Exhibit 2047 lacks relevance to the extent it is relied
`
`on for an issue that requires prior art because the exhibit is not shown to be prior
`
`art.
`
`Exhibit 2048 Sunil S. Jambhekar, Biopharmaceutical Properties of Drug
`
`Substances, in Principles of Medicinal Chemistry (William O. Foye et al., eds.,
`
`
`
`3
`
`
`
`4th ed. 1995).
`
`Exhibit 2048 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2048 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2049 Richard B. Silverman, The Organic Chemistry of Drug
`
`Design and Drug Action, Chapter 2 (2nd ed. 2004).
`
`Exhibit 2049 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2049 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2050 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).
`
`Exhibit 2050 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2050 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2051 Hugo Kubinyi, Combinatorial and computational approaches
`
`in structure-based drug design, 1(1) Curr. Opinion Drug Discov. Develop. 16–
`
`
`
`4
`
`
`
`27 (1998).
`
` Exhibit 2051 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2051 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit
`
`2054
`
`Our Mission,
`
`Epilepsy
`
`Foundation,
`
`at
`
`http://www.epilepsy.com/dare-defy-seizures/our-mission (last visited July 25,
`
`2016)
`
`Exhibit 2054 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2054 is hearsay under FRE 801 and is
`
`inadmissible under FRE 802. Exhibit 2054 is lacks authentication and is therefore
`
`inadmissible under FRE 901. Exhibit 2054 lacks relevance to the extent it is relied
`
`on for an issue that requires prior art because the exhibit is not shown to be prior
`
`art.
`
`Exhibit 2057 M. C. Walker & P. N. Patsalos, Clinical Pharmakokinetics of
`
`New Antiepileptic Drugs, 67(3) Pharmacol. Ther. 351–84 (1995).
`
`Exhibit 2057 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2057 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`
`
`5
`
`
`
`Exhibit 2058 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).
`
` Exhibit 2058 is inadmissible for at least the following reasons, including
`
`under the Federal Rules of Evidence: Exhibit 2058 lacks relevance to the extent it
`
`is relied on for an issue that requires prior art because the exhibit is not shown to
`
`be prior art.
`
`Exhibit 2059 R. Paruszewski et al., Synthesis and anticonvulsant activity
`
`of some amino acid derivatives Part 1: Alanine derivatives, 51(3) Pharmazie
`
`145–48 (1996).
`
` Exhibit 2059 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2059 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2060 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).
`
` Exhibit 2060 is inadmissible for at least the following reasons, including
`
`under the Federal Rules of Evidence: Exhibit 2060 lacks relevance to the extent it
`
`is relied on for an issue that requires prior art because the exhibit is not shown to
`
`
`
`6
`
`
`
`be prior art.
`
`Exhibit 2061 Polish Patent No. PL 174033 to Paruszewski et al.
`
`Exhibit 2061 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2061 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2062 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).
`
` Exhibit 2062 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2062 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2063 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).
`
`Exhibit 2063 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2063 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`
`
`7
`
`
`
`Exhibit 2064 Christophe Salomé et al., Synthesis and Anticonvulsant
`
`Activities
`
`of
`
`(R)-N-(4ʹ-Substituted)benzyl
`
`2-Acetamido-3-methoxy-
`
`propionamides, 53(3) J. Med. Chem. 1288–1305 (2010).
`
`Exhibit 2064 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2064 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2066 Univ. of Houston February 16, 1990 letter to Lilly Research
`
`Labs
`
`Exhibit 2066 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2066 is hearsay under FRE 801 and is
`
`inadmissible under FRE 802. Exhibit 2066 is lacks authentication and is therefore
`
`inadmissible under FRE 901. Exhibit 2066 lacks relevance to the extent it is relied
`
`on for an issue that requires prior art because the exhibit is not shown to be prior
`
`art.
`
`Exhibit 2067 Eli Lilly November 5, 1991 letter to RCT
`
`Exhibit 2067 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2067 is hearsay under FRE 801 and is
`
`inadmissible under FRE 802. Exhibit 2067 is lacks authentication and is therefore
`
`inadmissible under FRE 901. Exhibit 2067 lacks relevance to the extent it is relied
`
`
`
`8
`
`
`
`on for an issue that requires prior art because the exhibit is not shown to be prior
`
`art.
`
`Exhibit 2068 Dr. Kohn July 1987 “Short List of Potential New Drug
`
`Candidates for Synthesis and Evaluation” for Lilly
`
`Exhibit 2068 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2068 is hearsay under FRE 801 and is
`
`inadmissible under FRE 802. Exhibit 2068 is lacks authentication and is therefore
`
`inadmissible under FRE 901. Exhibit 2068 lacks relevance to the extent it is relied
`
`on for an issue that requires prior art because the exhibit is not shown to be prior
`
`art.
`
`Exhibit 2069 Eli Lilly December 10, 1991 letter to RCT
`
`Exhibit 2069 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2069 is hearsay under FRE 801 and is
`
`inadmissible under FRE 802. Exhibit 2069 is lacks authentication and is therefore
`
`inadmissible under FRE 901. Exhibit 2069 lacks relevance to the extent it is relied
`
`on for an issue that requires prior art because the exhibit is not shown to be prior
`
`art.
`
`Exhibit 2074 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).
`
`
`
`9
`
`
`
`Exhibit 2074 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2074 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2076 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).
`
`Exhibit 2076 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2076 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2078 Carl W. Bazil et al., Epilepsy, in Merritt’s Neurology (Elan D.
`
`Louis et al., eds., 13th ed. 2016).
`
` Exhibit 2078 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2078 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2079 Carl W. Bazil, Living Well with Epilepsy and Other Seizure
`
`Disorders (2004).
`
` Exhibit 2079 is inadmissible for at least the following reasons, including under
`
`
`
`10
`
`
`
`the Federal Rules of Evidence: Exhibit 2079 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2080 About Epilepsy: The Basics, Epilepsy Foundation, at
`
`http://www.epilepsy.com/learn/about-epilepsy-basics (last visited July 11,
`
`2016)
`
`Exhibit 2080 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2080 is hearsay under FRE 801 and is
`
`inadmissible under FRE 802. Exhibit 2080 is lacks authentication and is therefore
`
`inadmissible under FRE 901. Exhibit 2080 lacks relevance to the extent it is relied
`
`on for an issue that requires prior art because the exhibit is not shown to be prior
`
`art.
`
`Exhibit 2081 Carl W. Bazil, Epilepsy: Management, 6 Encyclopedia of Life
`
`Sciences 487–94 (2002)
`
` Exhibit 2081 is inadmissible for at least the following reasons, including
`
`under the Federal Rules of Evidence: Exhibit 2081 lacks relevance to the extent it
`
`is relied on for an issue that requires prior art because the exhibit is not shown to
`
`be prior art.
`
`Exhibit 2082 Carl W. Bazil & Timothy A. Pedley, Clinical Pharmacology
`
`of Antiepileptic Drugs, 26(1) Clinical Neuropharmacol. 38–52 (2003).
`
`
`
`11
`
`
`
`Exhibit 2082 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2082 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2083 Suller et al., New manage of epileptic status. The power of
`
`the lacosamide (Abstract), 261 (Suppl. 1) J. Neurol. S386 (2014).
`
`Exhibit 2083 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2083 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2084 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).
`
` Exhibit 2084 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2084 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2085 Santamarina et al., Usefulness of intravenous lacosamide in
`
`status epilepticus, 260 J. Neurol. 3122–28 (2013).
`
`Exhibit 2085 is inadmissible for at least the following reasons, including under
`
`
`
`12
`
`
`
`the Federal Rules of Evidence: Exhibit 2085 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2086 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)
`
` Exhibit 2086 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2086 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2087 D.M. IJff et al., Cognitive effects of lacosamide as adjunctive
`
`therapy in refractory epilepsy, 131 Acta Neurol. Scand. 347–54 (2015).
`
` Exhibit 2087 is inadmissible for at least the following reasons, including
`
`under the Federal Rules of Evidence: Exhibit 2087 lacks relevance to the extent it
`
`is relied on for an issue that requires prior art because the exhibit is not shown to
`
`be prior art.
`
` Exhibit 2089 Willi Cawello et al., Advances in epilepsy treatment:
`
`lacosamide pharmacokinetic profile, 1329 Ann. N.Y. Acad. Sci. 18–32 (2014).
`
`
`
`13
`
`
`
`Exhibit 2089 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2089 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2090 Blaise F. D. Bourgeois, Important Pharmacokinetic
`
`Properties of Antiepileptic Drugs, 36 (Suppl. 5) Epilepsia S1–S7 (1995).
`
`Exhibit 2090 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2090 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2091 Bjarke á Rogvi-Hansen & Lennart Gram, Adverse Effects of
`
`Established and New Antiepileptic Drugs: An Attempted Comparison, 68(3)
`
`Pharmacol. Ther. 425–34 (1995).
`
`Exhibit 2091 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2091 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2092 Prescribing Information for Tegretol, in Physicians’ Desk
`
`Reference (49th ed. 1995).
`
`Exhibit 2092 is inadmissible for at least the following reasons, including under
`
`
`
`14
`
`
`
`the Federal Rules of Evidence: Exhibit 2092 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2095 Martha J. Morrell, The New Antiepileptic Drugs and
`
`Women: Efficacy, Reproductive Health, Pregnancy, and Fetal Outcome,
`
`37(Suppl. 6) Epilepsia S34–S44 (1996).
`
`Exhibit 2095 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2095 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2100 Epilepsy and the Senior Community, Epilepsy Foundation, at
`
`http://www.epilepsy.com/learn/age-groups/epilepsy-and-senior-
`
`community
`
`(last visited July 11, 2016).
`
`Exhibit 2100 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2100 is hearsay under FRE 801 and is
`
`inadmissible under FRE 802. Exhibit 2100 is lacks authentication and is therefore
`
`inadmissible under FRE 901. Exhibit 2100 lacks relevance to the extent it is relied
`
`on for an issue that requires prior art because the exhibit is not shown to be prior
`
`art.
`
`Exhibit 2101 J. T. Kamel et al., Clinical experience with using lacosamide
`
`
`
`15
`
`
`
`for the treatment of epilepsy in a tertiary centre, 127(3) Acta Neurol. Scand.
`
`149–53 (2013).
`
`Exhibit 2101 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2101 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2102 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).
`
`Exhibit 2102 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2102 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 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).
`
`Exhibit 2103 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2103 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`
`
`16
`
`
`
`Exhibit 2104 Stefano de Biase et al., Lacosamide for the treatment of
`
`epilepsy, 10(3) Expert Opin. Drug Metab. Toxicol. 459–68 (2014).
`
`Exhibit 2104 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2104 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2105 Jun-Sang Sunwoo et al., A case of lacosamide-induced
`
`hepatoxicity, 53(6) Int. J. Clin. Pharmacol. Ther. 471–73 (2015).
`
` Exhibit 2105 is inadmissible for at least the following reasons, including
`
`under the Federal Rules of Evidence: Exhibit 2105 lacks relevance to the extent it
`
`is relied on for an issue that requires prior art because the exhibit is not shown to
`
`be prior art.
`
`Exhibit 2106 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).
`
`Exhibit 2106 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2106 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2107 Marcia L. Buck & Howard P. Goodkin, Use of Lacosamide in
`
`
`
`17
`
`
`
`Children with Refractory Epilepsy, 17(3) J. Pediatr. Pharmacol. Ther. 211–19
`
`(2012).
`
`Exhibit 2107 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2107 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2108 Jacklyn A. Harris & Julie A. Murphy, Lacosamide and
`
`Epilepsy, 17(6) CNS Neurosci. Ther. 678–82 (2011).
`
`Exhibit 2108 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2108 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2109 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).
`
`Exhibit 2109 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2109 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2110 Pritesh N. Bodalia et al., Comparative efficacy and
`
`
`
`18
`
`
`
`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).
`
`Exhibit 2110 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2110 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2111 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).
`
`Exhibit 2111 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2111 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2112 Martin J. Brodie, Meta-analyses of antiepileptic drugs for
`
`refractory partial (focal) epilepsy: an observation 76(5) Br. J. Clin.
`
`Pharmacol. 630–31 (2013).
`
`Exhibit 2112 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2112 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`
`
`19
`
`
`
`prior art.
`
`Exhibit 2113 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).
`
`Exhibit 2113 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2113 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2114 Prescribing Information for Felbatol, in Physicians’ Desk
`
`Reference 2666 (50th ed. 1996)
`
`Exhibit 2114 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2114 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2115 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).
`
`Exhibit 2115 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2115 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`
`
`20
`
`
`
`prior art.
`
`Exhibit 2116 John M. Pellock, Felbamate, 40(Suppl. 5) Epilepsia S57–S62
`
`(1999).
`
`Exhibit 2116 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2116 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2117 M. Bialer et al., Progress report on new antiepileptic drugs: a
`
`summary of the Third Eilat Conference, 25(3) Epilepsy Res. 299– 319 (1996).
`
`Exhibit 2117 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2117 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2118 Lesley J. Scott, Lacosamide: A Review in Focal Seizures in
`
`Patients with Epilepsy, 75(18) Drugs 2143–54 (2015).
`
`Exhibit 2118 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2118 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2119 Ahmad Beydoun et al., Lacosamide: pharmacology,
`
`
`
`21
`
`
`
`mechanisms of action and pooled efficacy and safety data in partial-onset
`
`seizures, 9(1) Expert Rev. Neurother. 33–42 (2009).
`
`Exhibit 2119 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2119 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2120 Victor Biton, Lacosamide for the treatment of partial-onset
`
`seizures, 12(6) Expert Rev. Neurother. 645–55 (2012).
`
`Exhibit 2120 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2120 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2121 Steve S. Chung, Lacosamide: new adjunctive treatment
`
`option for partial-onset seizures, 11(9) Expert Opin. Pharmacother. 1595–602
`
`(2010).
`
`Exhibit 2121 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2121 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2122 Michael A. Rogawski et al., Current understanding of the
`
`
`
`22
`
`
`
`mechanism of action of the antiepileptic drug lacosamide, 110 Epilepsy Res.
`
`189–205 (2015).
`
`Exhibit 2122 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2122 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2123 G.L. Krauss et al., Lacosamide for the treatment of epilepsy,
`
`44(7/8) Ann. Med. 674–79 (2012).
`
`Exhibit 2123 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2123 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2124 Linda J. Stephen et al., Adjunctive lacosamide in clinical
`
`practice: Sodium blockade with a difference?, 22(3) Epilepsy & Behavior 499–
`
`504 (2011).
`
`Exhibit 2124 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2124 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2125 Eli Lilly November 7, 1991 letter to RCT
`
`
`
`23
`
`
`
`Exhibit 2125 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2125 is hearsay under FRE 801 and is
`
`inadmissible under FRE 802. Exhibit 2125 is lacks authentication and is therefore
`
`inadmissible under FRE 901. Exhibit 2125 lacks relevance to the extent it is relied
`
`on for an issue that requires prior art because the exhibit is not shown to be prior
`
`art.
`
`Exhibit 2126 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).
`
`Exhibit 2126 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2126 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`Exhibit 2127 Marc W. Harrold & Robin M. Zavod, Basic Concepts in
`
`Medicinal Chemistry (2013).
`
`Exhibit 2127 is inadmissible for at least the following reasons, including under
`
`the Federal Rules of Evidence: Exhibit 2127 lacks relevance to the extent it is
`
`relied on for an issue that requires prior art because the exhibit is not shown to be
`
`prior art.
`
`
`
`24
`
`
`
`Exhibit 2128 Preben H. Olesen, The use of bioisosteric groups in lead
`
`optimization, 4(4) Curr. Opin. Drug Discov. Develop. 471–78 (2001).
`
`Exhibit 2128 is inadmissible for at least the following reasons, including under
`
`the Federal
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