Paper No. __
`Filed: January 15, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`PAR PHARMACEUTICAL, INC.
`
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS IRELAND LTD.
`
`Patent Owner
`
`________________
`
`Case IPR2016-00002
`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)
`
`
`
`
`
`
`
`
`
`
`Filed: January 15, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`PAR PHARMACEUTICAL, INC.
`
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS IRELAND LTD.
`
`Patent Owner
`
`________________
`
`Case IPR2016-00002
`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 IPR2016-00002
`Patent 8,772,306
`Patent Owner’s Exhibit List
`
`
`DESCRIPTION
`Maitre M, The γ-Hydroxybutyrate Signalling System in Brain:
`Organization and Functional Implications, Progress in
`Neurobiology, Vol. 51, pp. 337-361 (1997) (“Maitre”)
`
`(Exhibit 1003 in Ranbaxy ’306 patent IPR2016-00024)
`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)
`
`(Exhibit 1018 in Ranbaxy ’306 patent IPR2016-00024)
`Bernasconi et al., Experimental Absence Seizures: Potential
`Role of γ-Hydroxybutyric Acid and GABAB Receptors, J.
`Neural Transm., Vol. 35, pp. 155-177 (1992)
`
`(Exhibit 1014 in Ranbaxy ’306 patent IPR2016-00024)
`Löscher, W., Valproate: A Reappraisal of Its Pharmacodynamic
`Properties and Mechanisms of Action, Progress in Neurobiol.,
`Vol. 58, pp. 31-59 (1999)
`
`(Exhibit 1019 in Ranbaxy ’306 patent IPR2016-00024)
`’306 Patent File History, Supplemental Amendment and
`Response filed November 13, 2013
`
`(Exhibit 1027 in Ranbaxy ’306 patent IPR2016-00024)
`’306 Patent File History, Notice of Allowance
`Okun, M., GHB: An Important Pharmacologic and Clinical
`Update, J. Pharm. Pharmaceut. Sci., Vol. 4(2), pp. 167-175
`(2001) (“Okun”)
`
`(Exhibit 1004 in Ranbaxy ’306 patent IPR2016-00024)
`
`
`
`EXHIBIT NO.
`Exhibit 2001
`
`Exhibit 2002
`
`Exhibit 2003
`
`Exhibit 2004
`
`Exhibit 2005
`
`Exhibit 2006
`Exhibit 2007
`
`
`
`
`
`Case IPR2016-00002
`Patent 8,772,306
`Patent Owner’s Exhibit List
`
`
`EXHIBIT NO.
`Exhibit 2008
`
`Exhibit 2009
`Exhibit 2010
`
`Exhibit 2011
`
`Exhibit 2012
`
`Exhibit 2013
`
`Exhibit 2014
`
`Exhibit 2015
`
`Exhibit 2016
`
`DESCRIPTION
`Van der Worp, H.B., Can Animal Models of Disease Reliably
`Inform Human Studies? PLoS Medicine, Vol. 7(3), pp. 1-8
`(2010)
`Equetro® November 2012 Package Insert
`National Institute of Mental Health, Bipolar Disorder in Adults
`(2012)
`Morantz, C., Recommendations for Prescribing New
`Antiepileptic Drugs, American Family Physician, 70(6), pp.
`1167-1168 (2004)
`Weisler, R., Carbamazepine extended-release capsules in bipolar
`disorder, Neuropsychiatric Disease and Treatment, 2(1), pp. 3-
`11 (2006)
`Study Investigating the Pharmacokinetic Interaction Between
`INX-08189 and Verapamil HCL ER in Healthy Volunteers
`(INX-189-005), clinicaltrials.gov (2012)
`DDI Study of Etravirine and GSK1265744, clinicaltrials.gov
`(2012)
`ERG, Examination of Clinical Trial Costs and Barriers for Drug
`Development (2014)
`Peterson, G.M., Valproate: a simple chemical with so much to
`offer, J. of Clinical Pharmacy and Therapeutics, 30, pp. 417-
`421 (2005)
`
`
`
`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
`
`Date: January 15, 2016
`
`
`
`
`
`Case IPR2016-00002
`Patent 8,772,306
`Patent Owner’s Exhibit List
`
`
`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.
`
`
`
`
`
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`PAR PHARMACEUTICAL, 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
`
`bradford.frese@arentfox.com, janine.carlan@arentfox.com,
`
`richard.berman@arentfox.com, and xyrem@arentfox.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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