`Filed: May 6, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`AMNEAL PHARMACEUTICALS LLC
`
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS IRELAND LTD.
`
`Patent Owner
`
`________________
`
`Case IPR2016-00546
`Patent 8,772,306
`________________
`
`PATENT OWNER EXHIBIT LIST AS OF
`May 6, 2016 PURSUANT TO 37 C.F.R. § 42.63(e)
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`Case IPR2016-00546
`Patent 8,772,306
`Patent Owner’s Exhibit List
`
`
`DESCRIPTION
`
`Peterson, G.M., Valproate: a simple chemical with so much to
`offer, J. Clinical Pharmacy and Therapeutics, 30, pp. 417-
`421 (2005)
`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., 30, pp. 279-294 (2007)
`Morris, M. 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. 311–21 (2008)
`Bernasconi et al., Experimental Absence Seizures: Potential
`Role of γ-Hydroxybutyric Acid and GABAB Receptors, J.
`Neural Transm., 35, pp. 155-177 (1992)
`Löscher, W., Valproate: A Reappraisal of Its Pharmacodynamic
`Properties and Mechanisms of Action, Progress in Neurobiol.,
`58, pp. 31-59 (1999)
`Whittle, S. et al., Effects of Anticonvulsants on the Formation of
`γ-Hydroxybutyrate from γ-Aminobutyrate in Rat Brain, J.
`Neurochem. 38(3), pp. 848–51 (1982)
`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), pp. 1404–10
`(2009)
`Okun, M., et al. GHB: An Important Pharmacologic and Clinical
`Update, J. Pharm. Pharmaceut. Sci., 4(2), pp. 167-175
`(2001)
`Vayer, P. et al., 3’-5’ Cyclic-Guanosine Monophosphate
`Increase in Rat Brain Hippocampus after Gamma-
`Hydroxybutyrate Administration: Prevention by Valproate and
`Naloxone, Life Sci. 41(5), pp. 605–10 (1987)
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`EXHIBIT
`NO.
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`Exhibit 2001
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`Exhibit 2002
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`Exhibit 2003
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`Exhibit 2004
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`Exhibit 2005
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`Exhibit 2006
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`Exhibit 2007
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`Exhibit 2008
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`Exhibit 2009
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`
`
`Case IPR2016-00546
`Patent 8,772,306
`Patent Owner’s Exhibit List
`
`
`EXHIBIT
`NO.
`
`Exhibit 2010
`
`DESCRIPTION
`
`Kennedy, G. et al., CNS Adverse Events Associated with
`Antiepileptic Drugs, CNS Drugs 22(9), pp. 739–60 (2008)
`
`Exhibit 2011
`
`Equetro® November 2012 Package Insert
`
`Exhibit 2012
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`Exhibit 2013
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`Exhibit 2014
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`Exhibit 2015
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`Exhibit 2016
`
`National Institute of Mental Health, Biopolar Disorder in Adults
`(2012)
`Morantz, C., Recommendations for Prescribing New
`Antiepileptic Drugs, American Family Physician, 70(6), pp.
`1167-1168 (2004)
`Cipraini, A. et al., Valproic Acid, Valproate and Divalproex in
`the Maintenance Treatment of Bipolar Disorder (Review), 10
`Cochrane Database Syst. Rev. Art. No. CD003196 (2013)
`Weisler, R., Carbamazepine extended-release capsules in bipolar
`disorder, Neuropsychiatric Disease and Treatment, 2(1), pp. 3-
`11 (2006)
`Carson, Good Clinical, Laboratory and Maufacturing Practices –
`Techniques for the QA Professional, p. 307 (2007)
`
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`Case IPR2016-00546
`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)
`QUINN EMANUEL URQUHART &
`SULLIVAN LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`Tel: (212) 849-7000
`Fax: (212) 849-7100
`nickcerrito@quinnemanuel.com
`
`Lead counsel for Jazz Pharmaceuticals
`Ireland Ltd. and Jazz Pharmaceuticals,
`Inc..
`
`
`
`Date: May 6, 2016
`
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`AMNEAL PHARMACEUTICALS LLC
`
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS IRELAND LTD.
`
`Patent Owner
`
`________________
`
`Case IPR2016-00546
`Patent 8,772,306
`________________
`
`CERTIFICATE OF SERVICE
`
`
`
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`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), the undersigned hereby certify that JAZZ
`
`PHARMACEUTICALS IRELAND’S EXHIBIT LIST AS OF May 6, 2016
`
`was served on May 6,2016 by filing this document through the Patent Review
`
`Processing System, as well as e-mailing a copy to mruedy@meiplaw.com, and
`
`smaddox@meiplaw.com.
`
`Date: May 6, 2016
`
`Respectfully submitted,
`
`By: /F. Dominic Cerrito (Reg. No. 38,100)/
` F. Dominic Cerrito (Reg. No. 38,100)
`QUINN EMANUEL URQUHART &
`SULLIVAN LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`Tel: (212) 849-7000
`Fax: (212) 849-7100
`nickcerrito@quinnemanuel.com
`
`Lead counsel for Jazz Pharmaceuticals
`Ireland Ltd. and Jazz Pharmaceuticals,
`Inc..