Filed: March 18, 2016
`
`
`By:
`
`Filed on behalf of:
`Ranbaxy Inc.
`Joseph M. Reisman
`Carol Pitzel Cruz
`Kerry S. Taylor
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2040 Main Street, 14th Floor
`Irvine, CA 92614
`Tel.: (949) 760-0404
`Fax: (949) 760-9502
`E-mail: BoxRanbaxy332@knobbe.com
`
`
`
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`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________________________
`
`RANBAXY INC.,
`Petitioner
`
`v.
`
`JAZZ PHARMACEUTICALS, INC., and
`JAZZ PHARMACEUTICALS IRELAND LTD.,
`Patent Owners
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Case No. TBD
`Patent 9,050,302
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`PETITIONER’S CORRECTED EXHIBIT LIST
`
`
`
`
`By:
`
`Filed on behalf of:
`Ranbaxy Inc.
`Joseph M. Reisman
`Carol Pitzel Cruz
`Kerry S. Taylor
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2040 Main Street, 14th Floor
`Irvine, CA 92614
`Tel.: (949) 760-0404
`Fax: (949) 760-9502
`E-mail: BoxRanbaxy332@knobbe.com
`
`
`
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________________________
`
`RANBAXY INC.,
`Petitioner
`
`v.
`
`JAZZ PHARMACEUTICALS, INC., and
`JAZZ PHARMACEUTICALS IRELAND LTD.,
`Patent Owners
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Case No. TBD
`Patent 9,050,302
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`PETITIONER’S CORRECTED EXHIBIT LIST
`
`
`
`Ranbaxy v. Jazz
`IPR re U.S. Pat. 9,050,302
`
`
`
`
`
`Pursuant to 37 C.F.R. § 42.63(e), Petitioner hereby provides a corrected list
`
`of its exhibits to include Exhibit 1002.
`
`Exhibit No.
`
`Description
`
`Ex. 1001
`
`U.S. Patent No. 9,050,302, issued June 9, 2015
`
`Ex. 1002
`
`Declaration of David P. Rotella, Ph.D. (“Rotella Declaration”)
`
`Ex. 1003 Maitre, M., The γ-Hydroxybutyrate Signalling System in
`Brain Organization and Functional Implications, Progress
`in Neurobiology, Vol. 51, pp. 337-361 (1997) (“Maitre”)
`
`Ex. 1004
`
`Okun, M., GHB: An Important Pharmacologic and Clinical
`Update, J. Pharm. Pharmaceut. Sci., Vol. 4(2), pp. 167-175
`(2001) (“Okun”)
`
`Ex. 1005
`
`The Xyrem® Package Insert entry in the Physician’s Desk
`Reference Edition, pp. 1688-1692, (2007) (“the Xyrem® PI”)
`
`Ex. 1006
`
`Xyrem® Titration Schedule published in 2008 (“the
`Xyrem®-TS”)
`Ex. 1007 Waszkielewicz, et al., γ-Hydroxybutyric acid (GHB) and its
`Chemical Modifications: A Review of the GHBergic System,
`Pol. J. Pharmacol., Vol. 56, pp. 43-49 (2004)
`(“Waszkielewicz”)
`Broughton, R., The Treatment of Narcolepsy-Cataplexy with
`Nocturnal Gamma-Hydroxybutyrate, Can. J. Neurol. Sci.,
`Vol. 6(1), pp. 1-6 (1979)
`
`Ex. 1008
`
`Ex. 1009
`
`Broughton, R., Effects of Nocturnal Gamma-
`Hydroxybutyrate on Sleep/Waking Patterns in Narcolepsy-
`Cataplexy; Can. J. Neurol. Sci., Vol. 7(1), pp. 23-31 (1980)
`
`- 1 -
`
`
`
`Ranbaxy v. Jazz
`IPR re U.S. Pat. 9,050,302
`
`
`
`Exhibit No.
`
`Ex. 1010
`
`Description
`
`Cash, C. D., Gammahydroxybutyrate: An Overview of the
`Pros and Cons for it Being a Neurotransmitter And/Or a
`Useful Therapeutic Agent, Neurosci. Biobehavioral Rev.,
`Vol. 18(2), pp. 291-304 (1994)
`
`Ex. 1011 Mamelak, et al., Treatment of Narcolepsy with
`Hydroxybutyrate. A Review of Clinical and Sleep Laboratory
`Findings, Sleep, Vol. 9(1), pp. 285-289 (1986)
`
`Ex. 1012
`
`Ex. 1013
`
`Ex. 1014
`
`Ex. 1015
`
`Ex. 1016
`
`Ex. 1017
`
`Scharf, et al., The Effects and Effectiveness of
`γ-Hydroxybutyrate in Patients with Narcolepsy; J. Clin.
`Psychiatry, Vol. 46, pp. 222-225 (1985)
`
`Scharf, et al., Pharmacokinetics of Gammahydroxybutyrate
`(GHB) in Narcoleptic Patients, Sleep, Vol. 21(5), pp. 507-514
`(1998)
`
`Bernasconi, et al., Experimental Absence Seizures: Potential
`Role of γ-Hydroxybutyric Acid and GABAB Receptors, J.
`Neural Transm., Vol. 35, pp. 155-177 (1992)
`
`Hechler, et al., γ-Hydroxybutyrate Conversion into GABA
`Induces Displacement of GABAB Binding that is Blocked by
`Valproate and Ethosuximide, JPET, Vol. 281(2), pp. 753-760
`(1997)
`
`Kaufman, et al., Evidence for the Participation of a Cytosolic
`NADP+-Dependent Oxidoreductase in the Catabolism of
`Gamma-Hydroxybutyrate In Vivo, J. Neurochem., Vol. 48(6),
`pp. 1935-1941 (1987)
`Kaufman, et al., An Overview of γ-Hydroxybutyrate
`Catabolism: The Role of the Cytosolic NADP+-Dependent
`Oxidoreductase EC 1.1.1.19 and a Mitochondrial
`Hydroxyacid-Oxoacid Transhydrogenase in the Initial, Rate-
`Limiting Step in This Pathway, Neurochem. Res., Vol. 16(9),
`pp. 965-974 (1991)
`
`- 2 -
`
`
`
`Ranbaxy v. Jazz
`IPR re U.S. Pat. 9,050,302
`
`
`
`Exhibit No.
`
`Ex. 1018
`
`Description
`
`Knerr, et al., Therapeutic Concepts in Succinate
`Semialdehyde Dehydrogenase (SSADH; ALDH5a1)
`Deficiency (γ-Hydroxybutyric Aciduria). Hypotheses
`Evolved From 25 Years of Patient Evaluation, Studies in
`Aldh5a1-/- Mice and Characterization of γ-Hydroxybutyric
`Acid Pharmacology, J. Inherit. Metab. Dis., Vol. 30, pp. 279-
`294 (2007)
`
`Ex. 1019
`
`Löscher, W., Valproate: A Reappraisal of Its
`Pharmacodynamic Properties and Mechanisms of Action,
`Progress in Neurobiol., Vol. 58, pp. 31-59 (1999)
`
`Ex. 1020
`
`Ex. 1021
`
`Löscher, W., Basic Pharmacology of Valproate: A Review
`After 35 Years of Clinical Use for the Treatment of Epilepsy,
`CNS Drugs, Vol. 16(1), pp. 669-694 (2002)
`Vayer, et al., 3’-5’ Cyclic-Guanosine Monophosphate
`Increase in Rat Brain Hippocampus after Gamma-
`Hydroxybutyrate Administration. Prevention by Valoprate
`and Naloxone, Life Sciences, Vol. 41, pp. 605-610 (1987)
`Vayer, et al., Is the Anticonvulsant Mechanism of Valproate
`Linked to its Interaction with the Cerebral γ-Hydroxybutyrate
`System? TIPS, Vol. 9, pp. 127-129 (1988)
`Ex. 1023 Weiss, et al., Gamma-hydroxybutyrate (GHB) and
`Topiramate – Clinically Relevant Drug Interaction Suggested
`by a Case of Coma and Increased Plasma GHB
`Concentration, Eur. J. Clin. Pharmacol., Vol. 69, pp. 1193-94
`(2013)
`Cagnin, et al., γ-Hydroxybutyric Acid–Induced Psychosis
`Seizures, Epilepsy and Behav., Vol. 21, pp. 203-205 (2011)
`
`Ex. 1022
`
`Ex. 1024
`
`- 3 -
`
`
`
`Ranbaxy v. Jazz
`IPR re U.S. Pat. 9,050,302
`
`
`
`Exhibit No.
`
`Description
`
`Ex. 1025 Morris, et al., Overview of the Proton-coupled MCT (SLC16A)
`Family of Transporters: Characterization, Function and Role in
`the Transport of the Drug of Abuse γ-Hydroxybutyric Acid,
`AAPS J., 10(2), pp.311-321 (2008) (“Morris I”)
`
`Ex. 1026 Morris, et al., Monocarboxylate Transporter with Osmotic
`Diuresis Increases γ-Hydroxybutyrate Renal Elimination in
`Humans: A Proof-of-Concept Study, J. Clin. Tox., 1(2),
`1000105, pp. 1-4 (2011) (“Morris II”)
`
`Ex. 1027
`
`Ex. 1028
`
`Ex. 1029
`
`Ex. 1030
`
`Ex. 1031
`
`Ex. 1032
`
`Ex. 1033
`
`Ex. 1034
`
`Ex. 1035
`
`Bhattacharya, et al., GHB (γ-Hydroxybutyrate) Carrier-
`Mediated Transport across the Blood-Brain Barrier, J. Pharm. &
`Experimental Therapeutics, 311(1), pp. 92-98 (2004)
`Curriculum Vitae for David Rotella, Ph.D.
`
`Depakene® Package Insert dated October 2011 (“Depakene®
`Package Insert”)
`
`Draft FDA Guidance dated February 2012 (“FDA Guidance”)
`Lamictal® Package Insert dated November 29, 2011
`(“Lamictal® Package Insert”)
`
`U.S. Patent No. 8,772,306 Patent File History, Supplemental
`Amendment and Response filed November 13, 2013
`U.S. Patent No. 8,772,306, issued July 8, 2014
`
`Petition for Inter Partes Review of U.S. Patent No. 8,772,306,
`Par Pharmaceutical, Inc. v. Jazz Pharmaceuticals, Inc.,
`IPR2016-00002
`Declaration of John W. Winkelman, Par Pharmaceutical, Inc.
`v. Jazz Pharmaceuticals, Inc., IPR2016-00002
`
`- 4 -
`
`
`
`Ranbaxy v. Jazz
`IPR re U.S. Pat. 9,050,302
`
`
`
`Exhibit No.
`
`Ex. 1036
`
`Ex. 1037
`
`Ex. 1038
`
`Ex. 1039
`
`Ex. 1040
`
`Description
`
`Petition for Inter Partes Review of U.S. Patent
`No. 8,772,306, Ranbaxy, Inc. v. Jazz Pharmaceuticals, Inc.,
`IPR2016-00024
`Declaration of David Rotella, Ph.D., Ranbaxy, Inc. v. Jazz
`Pharmaceuticals, Inc., IPR2016-00024
`
`Vayer, et al., Gamma Hydroxybutyrate Distribution and
`Turnover Rates in Discrete Brain Regions of the Rat,
`Neurochem Int., 12(1), pp. 53-59 (1988)
`
`Havelaar, et al., Purification of the Lysosomal Sialic Acid
`Transporter, J. Biological Chem., 273(51), pp. 34568-34574
`(1998)
`
`Chateauvieux, et al., Molecular and Therapeutic Potential and
`Toxicity of Valproic Acid, J. Biomed. Biotechnol., 2010,
`pp. 1-18 (2010)
`
`Respectfully submitted,
`
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`
`
`
`By: /Joseph M. Reisman/
`Joseph M. Reisman (Reg. No. 43,878)
`Carol Pitzel Cruz (Reg. No. 61,224)
`Kerry S. Taylor (Reg. No. 43,974)
`Customer No. 20,995
`
`Attorneys for Petitioner
`RANBAXY INC.
`(949) 760-0404
`
`- 5 -
`
`
`
`
`
`Dated: March 18, 2016
`
`
`
`
`
`Ranbaxy v. Jazz
`IPR re U.S. Pat. 9,050,302
`
`
`
`CERTIFICATE OF SERVICE
`
`
`
`I hereby certify
`
`that
`
`true and correct copies of
`
`the
`
`foregoing
`
`PETITIONER’S CORRECTED EXHIBIT LIST is being served on Jazz
`
`Pharmaceuticals, Inc., via FedEx Priority Overnight, on counsel of record at the
`
`U.S. Patent and Trademark Office for U.S. Pat. 9,050,302, at:
`
`A. Patricia Campbell (Reg. No. 67,116)
`Anthony Insogna (Reg. No. 35,203)
`JONES DAY
`222 East 41st Street
`New York, New York 10017-6702
`(212) 326-3939
`
`The Petition and exhibits are also being served on counsel of record for Jazz
`
`
`
`Pharmaceuticals, Inc. in Jazz Pharmaceuticals, Inc., et al. v. Sun Pharmaceutical
`
`Industries Ltd., et al. , 2:15-cv-08229 (D.N.J.), via FedEx Priority Overnight, at:
`
`F. Dominic Cerrito
`QUINN EMANUEL URQUHART & SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, New York 10010
`(212) 849-7000
`
`
`
` /Joseph M. Reisman/
`Joseph M. Reisman (Reg. No. 43,878)
`
`Attorney for Petitioner
`RANBAXY INC.
`
`
`
`- 6 -
`
`
`
`Dated: March 18, 2016
`
`
`22939228
`031816
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