UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`AMNEAL PHARMACEUTICALS LLC
`Petitioner
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`Patent Owner
`
`
`
`
`
`_____________________
`
`Case IPR: Unassigned
`Patent: 8,772,306
`_____________________
`
`
`AMNEAL PHARMACEUTICALS LLC’S EXHIBIT LIST
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 8,772,306
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`AMNEAL PHARMACEUTICALS LLC
`Petitioner
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`Patent Owner
`
`
`
`
`
`_____________________
`
`Case IPR: Unassigned
`Patent: 8,772,306
`_____________________
`
`
`AMNEAL PHARMACEUTICALS LLC’S EXHIBIT LIST
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 8,772,306
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`Inter Partes Review of USPN 8,772,306
`Amneal Exhibit List
`
`
`
`AMN
`Exhibit #
`
`Description
`
`1001
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`1002
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`1003
`1004
`1005
`1006
`
`1007
`
`1008
`
`1009
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`1010
`
`
`
`1011
`
`Mark Eller, U.S. Patent No. 8,772,306 (filed Apr. 29, 2013;
`issued July 8, 2014)
`
`File History for U.S. Patent No. 8,772,306 (filed Apr. 29, 2013;
`issued July 8, 2014)
`Declaration of John R. Horn, Pharm.D. F.C.C.P.
`Curriculum Vitae of John Horn, Pharm.D., F.C.C.P.
`Xyrem Labeling Text, 11/18/2005 (“Xyrem Label”)
`Viviane Hechler et al., γ-Hydroxybutyrate Conversion Into
`GABA Induces Displacement of GABAB Binding that is
`Blocked by Valproate and Ethosuximide, 281:2 J.
`PHARMACOLOGY & EXP. THERAPEUTICS 753-60 (1997)
`(“Hechler”)
`T. Shinka et al., Effect of Valproic Acid on the Urinary
`Metabolic Profile of a Patient with Succinic Semialdehyde
`Dehydrogenase Deficiency, 792 J. Chromatography 99-106
`(2003) (“Shinka”)
`Annachiara Cagnin et al., γ-Hydroxybutyric Acid-Induced
`Psychosis and Seizures, 21 Epilepsy & Behavior 203-05
`(2011) (“Cagnin”)
`Depakote (divalproex sodium) Tablets for Oral Use, FDA
`Labeling Text (October 7, 2011) (“Depakote Label”)
`Guidance for Industry: Drug Interaction Studies – Study
`Design, Data, Analysis, Implications for Dosing, and Labeling
`Recommendations, U.S. Dept. of Health & Human Services,
`Food and Drug Administration (February 2012) (“FDA Draft
`Guidance”)
`
`Anna Waszkielewicz & Jacek Bojarski, γ-Hydroxybutyric Acid
`(GHB) and its Chemical Modifications: A Review Of The
`GHBergic System, 56 Polish J. Pharmacology 43-49 (2004)
`
`1
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`
`AMN
`Exhibit #
`1012
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
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`
`
`Inter Partes Review of USPN 8,772,306
`Amneal Exhibit List
`
`Description
`
`FDA Orange Book Listing
`
`FDA Approval Letter for Xyrem Label (November, 18, 2005)
`
`FDA Supplemental Approval Letter for Depakote (October 7,
`2011)
`
`Elaine E. Kaufman & Thomas Nelson, An Overview of γ-
`Hydroxybutyrate Catabolism: The Role of the Cytosolic NADP+-
`Dependent Oxidoreductase EC 1.1.1.19 and of a Mitochondrial
`Hydroxyacid-Oxoacid Transhydrogenase in the Initial, Rate-
`limiting Step in this Pathway, 16:9 NEUROCHEMICAL RESEARCH
`965-974 (1991) (“Kaufman”)
`
`Tobias Weiss et al., Gamma-Hydroxybutyrate (GHB) and
`Topiramate–Clinically Relevant Drug Interaction Suggested by a
`Case of Coma and Increased Plasma GHB Concentration, 69
`EUR. J. CLIN. PHARMACOL. 1193-94 (2012)
`
`Philippe Vayer et al., Is the Anticonvulsant Mechanism of
`Valproate Linked to its Interaction with the Cerebral γ-
`Hydroxybutyrate System?, 9 TIPS 127-29 (1988)
`
`O.C. Snead et al., Effect of Acute and Chronic Anticonvulsant
`Administration on Endogenous γ-Hydroxybutyrate in Rat Brain,
`19 NEUROPHARMACOLOGY 47-52 (1980)
`
`O. Carter Snead & K. Michael Gibson, γ-Hydroxybutyric Acid,
`352 NEW ENGLAND J. MED. 2721-32 (2005)
`
`Michel Maitre, The γ-Hydroxybutyrate Signalling System in
`Brain: Organization and Functional Implications, 51 PROGRESS
`IN NEUROBIOLOGY 337-61 (1997)
`
`Lawrence Scrima, et al., The Effects of γ-Hydroxybutyrate on the
`Sleep of Narcolepsy Patients: A Double-Blind Study, 13(6)
`SLEEP 479-90 (1990)
`
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`2
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`
`AMN
`Exhibit #
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`
`
`Inter Partes Review of USPN 8,772,306
`Amneal Exhibit List
`
`Description
`
`Wolfgang Löscher, Basic Pharmacology of Valproate: A Review
`After 35 Years of Clinical Use for the Treatment of Epilepsy,
`16(10) CNS DRUGS 669-94 (2002) (“Löscher”)
`
`Pascal Mathivet, et al., Binding Characteristics of γ-
`Hydroxybutyric Acid as a Weak but Selective GABAB Receptor
`Agonist, 321 EUROPEAN J. PHARMACOLOGY 67-75 (1997)
`
`Neil T. Feldman, et al., Sleep Architecture Effects of Sodium
`Oxybate Treatment in Subjects with Sleep-Disordered Breathing,
`20 CHEST 130 (2006)
`
`Neil T. Feldman, Clinical perspective: Monitoring Sodium
`Oxybate-Treated Narcolepsy Patients for the Development of
`Sleep-Disordered Breathing, 14 SLEEP BREATH 77-79 (2010)
`
`Indranil Bhattacharya & Kathleen M.K. Boje, GHB (γ-
`Hydroxybutyrate Carrier-Mediated Transport Across the Blood-
`Brain Barrier, 311 J. PHARMACOLOGY AND EXP. THERAPEUTICS
`92-98 (2004)
`
`A Priori, et al., γ-Hydroxybutyric Acid for Alcohol-Sensitive
`Myoclonus with Dystonia, 54 NEUROLOGY 1706 (2000)
`
`S.J. Frucht, et al., A Pilot Tolerability and Efficacy Trial of
`Sodium-Oxybate in Ethanol-Responsive Movement Disorders, 20
`MOVEMENT DISORDERS 1330-1337 (2011)
`
`Philip D. Hansten & John R. Horn, DRUG INTERACTIONS
`ANALYSIS AND MANAGEMENT, Wolters Kluwer Health, PM1-36
`(2011)
`
`Joseph Johnson, U.S. Patent Publication 2008/0293698 A1,
`(November 27, 2008) (“Johnson”)
`
`Olivier Civelli & Steven Lin, U.S. Patent Publication
`2003/0171270 A1 (September 11, 2003) (“Civelli”)
`
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`3
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`Inter Partes Review of USPN 8,772,306
`Amneal Exhibit List
`
`Description
`
`James T. Daton, et al., U.S. Patent Publication 2011/0237664 A1
`(September 29, 2011) (“Dalton”)
`
`Lowell A. Borgen, et al., The Influence of Gender and Food on
`the Pharmacokinetics of Sodium Oxybate Oral Solution in
`Healthy Subjects, 43 J. CLIN. PHARMACOL. 59-65 (“Borgen”)
`
`P. Divry et al., A New Patient with 4-Hydroxybutyric Aciduria, a
`Possible Defect of 4-Aminobutyrate Metabolism, 129 CLINICA
`CHIMICA ACTA 303-309 (1983)
`
`
`
`AMN
`Exhibit #
`1032
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`1033
`
`1034
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`Respectfully Submitted,
`MADDOX EDWARDS, PLLC
`
`
`
`
`Matthew C. Ruedy
`Registration No. 64,823
`1900 K Street NW – Suite 725
`Washington, D.C. 20006
`(202) 830-0779
`mruedy@meiplaw.com
`Attorney for Petitioner
`
`4
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`
`
`Dated: February 2, 2016
`
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`Inter Partes Review of USPN 8,772,306
`Amneal Exhibit List
`
`CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(e), 42.105(a))
`The undersigned hereby certifies that the above-captioned “Amneal
`
`Pharmaceuticals LLC’s Exhibit List Petition for Inter Partes Review of U.S. Patent
`
`No. 8,772,306” including its supporting evidence (EXHIBITS 1001-1034), was
`
`served in its entirety on February 2, 2016, upon the following parties via Express
`
`
`F. Dominic Cerrito F. Dominic Cerrito
`
`Eric C. Stops Eric C. Stops
`
`Gabriel P. Brier Gabriel P. Brier
`
`QUINN EMANUEL URQUHART & QUINN EMANUEL URQUHART &
`
`SULLIVAN LLP SULLIVAN LLP
`
`51 Madison Avenue 51 Madison Avenue
`
`22nd Floor 22nd Floor
`
`New York, NY 10010 New York, NY 10010
`
`
`
`John V. Biernacki John V. Biernacki
`
`JONES DAY JONES DAY
`
`North Point North Point
`
`901 Lakeside Avenue 901 Lakeside Avenue
`
`Cleveland, OH 44114 Cleveland, OH 44114
`
`
`
`Additional addresses known to Additional addresses known to
`
`Petitioner as likely to effect service Petitioner as likely to effect service
`
`
`
`Mail:
`
`A. Patricia Campbell
`Anthony Insogna
`Jones Day
`222 East 41st St.
`New York, NY 10007
`
`Patent owner’s correspondence
`address of record for U.S. Patent No.
`8,772,306
`
`
`
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`1
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`Dated: February 2, 2016
`
`
`
`Inter Partes Review of USPN 8,772,306
`Amneal Exhibit List
`
`Respectfully Submitted,
`MADDOX EDWARDS, PLLC
`
`
`
`Matthew C. Ruedy
`Registration No. 64,823
`1900 K Street NW – Suite 725
`Washington, D.C. 20006
`(202) 830-0779
`mruedy@meiplaw.com
`Attorney for Petitioner
`
`
`
`
`
`2
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