Paper No. __
`Filed: January 15, 2016
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`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`RANBAXY INC.
`
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS IRELAND LTD.
`
`Patent Owner
`
`________________
`
`Case IPR2016-00024
`Patent 8,772,306
`________________
`
`JAZZ PHARMACEUTICALS IRELAND LTD.’S EXHIBIT LIST AS OF
`January 15, 2016 PURSUANT TO 37 C.F.R. § 42.63(e)
`
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`
`
`
`
`
`
`
`Filed: January 15, 2016
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`RANBAXY INC.
`
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS IRELAND LTD.
`
`Patent Owner
`
`________________
`
`Case IPR2016-00024
`Patent 8,772,306
`________________
`
`JAZZ PHARMACEUTICALS IRELAND LTD.’S EXHIBIT LIST AS OF
`January 15, 2016 PURSUANT TO 37 C.F.R. § 42.63(e)
`
`
`
`
`
`
`
`
`
`
`
`Case IPR2016-00024
`Patent 8,772,306
`Patent Owner’s Exhibit List
`
`
`DESCRIPTION
`Jazz Pharmaceuticals, Inc., Prescribing Information and
`Medication Guide for XYREM (sodium oxybate) (Nov. 18,
`2005)
`
`(Exhibit 1006 in Par ’306 patent IPR2016-00002)
`Whittle, S. et al., Effects of Anticonvulsants on the Formation of
`γ-Hydroxybutyrate from γ-Aminobutyrate in Rat Brain, J.
`Neurochem., 38(3): 848–51 (1982)
`
`(Exhibit 1040 in Par ’306 patent IPR2016-00002)
`Vijay, N., Role of Monocarboxylate Transporters in Drug
`Delivery to the Brain, Current Pharmaceutical Design, 20: 1487-
`1498 (2014)
`Morse, B., γ-Hydroxybutyrate (GHB)-Induced Respiratory
`Depression: Combined Receptor-Transporter Inhibition
`Therapy for Treatment in GHB Overdose, Molecular
`Pharmacology, 82(2): 226-235 (2012)
`’306 Patent File History, Notice of Allowance
`Cui, D. et al., The Drug of Abuse γ-Hydroxybutyrate Is a
`Substrate for Sodium-Coupled Monocarboxylate Transporter
`(SMCT) 1 (SLC5A8): Characterization of SMCT-Mediated
`Uptake and Inhibition, Drug Metab. Dispos., 37(7): 1404–10
`(2009)
`
`(Exhibit 1027 in Par ’306 patent IPR2016-00002)
`Van der Worp, H.B., Can Animal Models of Disease Reliably
`Inform Human Studies? PLoS Medicine, 7(3): 1-8 (2010)
`Par Pharmaceutical, Inc.’s Petition for Inter Partes Review of
`U.S. Patent No. 8,772,306, IPR2016-00002
`Declaration of John W. Winkelman, M.D., Ph.D.
`
`(Exhibit 1003 in Par ’306 patent IPR2016-00002)
`
`
`
`EXHIBIT NO.
`Exhibit 2001
`
`Exhibit 2002
`
`Exhibit 2003
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`Exhibit 2004
`
`Exhibit 2005
`Exhibit 2006
`
`Exhibit 2007
`
`Exhibit 2008
`
`Exhibit 2009
`
`
`
`
`
`Case IPR2016-00024
`Patent 8,772,306
`Patent Owner’s Exhibit List
`
`
`DESCRIPTION
`Cagnin, A. et al., γ-Hydroxybutyric Acid-Induced Psychosis and
`Seizures, Epilepsy Behav., 21(2): 203–05 (2011) (“Cagnin”)
`
`(Exhibit 1008 in Par ’306 patent IPR2016-00002)
`Shinka, T. et al., Effect of Valproic Acid on the Urinary
`Metabolic Profile of a Patient with Succinic Semialdehyde
`Dehydrogenase Deficiency, J. Chromatogr. B, 792(1): 99–106
`(2003) (“Shinka”)
`
`(Exhibit 1013 in Par ’306 patent IPR2016-00002)
`Kennedy, G. et al., CNS Adverse Events Associated with
`Antiepileptic Drugs, CNS Drugs, 22(9): 739–60 (2008)
`
`(Exhibit 1032 in Par ’306 patent IPR2016-00002)
`Equetro® November 2012 Package Insert
`National Institute of Mental Health, Bipolar Disorder in Adults
`(2012)
`Löscher, W., Basic Pharmacology of Valproate: A Review after
`35 Years of Clinical Use for the Treatment of Epilepsy,
`CNS Drugs, 16(10): 669–42 (2002)
`
`(Exhibit 1033 in Par ’306 patent IPR2016-00002)
`Morantz, C., Recommendations for Prescribing New
`Antiepileptic Drugs, American Family Physician, 70(6):1167-
`1168 (2004)
`Cipraini, A. et al., Valproic Acid, Valproate and Divalproex in
`the Maintenance Treatment of Bipolar Disorder (Review),
`Cochrane Database Syst. Rev., Issue 10, No. CD003196 (2013)
`
`(Exhibit 1025 in Par ’306 patent IPR2016-00002)
`Weisler, R., Carbamazepine extended-release capsules in
`bipolar disorder, Neuropsychiatric Disease and Treatment, 2(1):
`3-11 (2006)
`Peterson, G.M., Valproate: a simple chemical with so much to
`offer, J. of Clinical Pharmacy and Therapeutics, 30: 417-421
`(2005)
`
`
`
`EXHIBIT NO.
`Exhibit 2010
`
`Exhibit 2011
`
`Exhibit 2012
`
`Exhibit 2013
`Exhibit 2014
`
`Exhibit 2015
`
`Exhibit 2016
`
`Exhibit 2017
`
`Exhibit 2018
`
`Exhibit 2019
`
`
`
`
`
`Case IPR2016-00024
`Patent 8,772,306
`Patent Owner’s Exhibit List
`
`
`
`
`Respectfully submitted,
`
`By: /F. Dominic Cerrito (Reg. No. 38,100)/
` F. Dominic Cerrito (Reg. No. 38,100)
` Evangeline Shih (Reg. No. 50,170)
` Frank C. Calvosa (Reg. No. 69,064)
`QUINN EMANUEL URQUHART &
`SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`General Tel: (212) 849-7000
`Fax: (212) 849-7100
`nickcerrito@quinnemanuel.com
`evangelineshih@quinnemanuel.com
`frankcalvosa@quinnemanuel.com
`
`John V. Biernacki
`Reg. No. 40,511
`JONES DAY
`North Point
`901 Lakeside Avenue
`Cleveland, Ohio 44114
`General Tel: (216) 586-3939
`Direct Tel: (216) 586-7747
`Fax: (216) 579-0212
`jvbiernacki@jonesday.com
`
`Attorneys for Jazz Pharmaceuticals
`Ireland Ltd. and Jazz Pharmaceuticals,,
`Inc.
`
`
`
`Date: January 15, 2016
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`RANBAXY INC.
`
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS IRELAND LTD.
`
`Patent Owner
`
`________________
`
`Case IPR2016-00002
`Patent 8,772,306
`________________
`
`CERTIFICATE OF SERVICE
`
`
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), the undersigned hereby certify that JAZZ
`
`PHARMACEUTICALS IRELAND LTD.’S EXHIBIT LIST AS OF January 15,
`
`2016 was served on January 15, 2016 by filing this document through the Patent
`
`Review Processing System, as well as e-mailing a copy to
`
`Joseph.Reisman@knobbe.com, Carol.PitzelCruz@knobbe.com,
`
`Kerry.Taylor@knobbe.com, and BoxRanbaxy332@knobbe.com.
`
`Date: January 15, 2016
`
`
`
` Respectfully submitted,
`
`By: /F. Dominic Cerrito (Reg. No. 38,100)/
` F. Dominic Cerrito (Reg. No. 38,100)
` Evangeline Shih (Reg. No. 50,170)
` Frank C. Calvosa (Reg. No. 69,064)
`QUINN EMANUEL URQUHART &
`SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`General Tel: (212) 849-7000
`Fax: (212) 849-7100
`nickcerrito@quinnemanuel.com
`evangelineshih@quinnemanuel.com
`frankcalvosa@quinnemanuel.com
`
`John V. Biernacki
`Reg. No. 40,511
`JONES DAY
`North Point
`901 Lakeside Avenue
`Cleveland, Ohio 44114
`General Tel: (216) 586-3939
`Direct Tel: (216) 586-7747
`Fax: (216) 579-0212
`jvbiernacki@jonesday.com
`
`
`
`
`
`Attorneys for Jazz Pharmaceuticals
`Ireland Ltd. and Jazz Pharmaceuticals,,
`Inc.
`
`
`
`
`
`
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