`
`__________
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________
`
`
`
`PAR PHARMACEUTICAL, INC.,
`Petitioner
`
`v.
`
`HYPERION THERAPEUTICS, INC.,
`Patent Owner
`
`__________
`
`
`
`Case IPR2015-01117*
`Patent 8,642,012
`
`__________
`
`
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`
`
`* Case IPR2015-00283, instituted on a petition filed by Lupin Ltd. and Lupin
`Pharmaceuticals, Inc., has been joined with this proceeding.
`
`
`
`
`
`Pursuant to 37 C.F.R. § 42.63(e), the Patent Owner hereby provides an
`
`updated exhibit list:
`
`Exhibit No. Description
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
`
`2011
`
`2012
`
`Complaint for Patent Infringement, filed April 23, 2014, in Eastern
`District of Texas District Court, Case 2:14-cv-00384
`
`Par Pharm., Inc. v. Jazz Pharm., Inc., IPR2015-00551, Paper 19
`(PTAB July 28, 2015) (“Jazz Decision”)
`Defendants Par Pharmaceutical Companies, Inc. and Par
`Pharmaceutical, Inc.’s Answer, Separate Defenses, and Par
`Pharmaceutical, Inc.’s Counterclaims, filed August 7, 2014 in
`Salix Pharm., Ltd. et al. v. Par Pharm. Co., Inc. and Par Pharm.,
`Inc., Case 1:14-Cv-00946 (D. Del.)
`Par Pharmaceutical Companies, Inc. Form 10-Q for the quarterly
`period ending March 31, 2015
`
`Par Website Excerpts Re Marketing of Drugs
`
`Trademarks/Service Marks of Par Pharmaceutical Companies, Inc.
`
`Plea Agreement between U.S. Department of Justice and Par
`Pharmaceutical Companies, Inc., dated January 3, 2013
`
`Par Pharmaceutical Companies, Inc. Form 10-K for the fiscal year
`ending December 31, 2014
`
`Haughey Employment Agreement dated as of September 28, 2012
`
`Summons in a Civil Action, dated April 23, 2014, in Eastern
`District of Texas District court, Case 2:14-cv-00384
`
`Maestri et al. (1992), “Plasma glutamine concentration: a guide to
`the management of urea cycle disorders,” J. Pediatr. 121:259-261
`
`Transcript of Deposition of Dr. Neal Sondheimer, March 10-11,
`2016
`
`IPR2015-01117
`
`
`
`Page 1 of 3
`
`
`
`2013
`
`2014
`
`2015
`
`2016
`
`2017
`
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`
`2024
`
`2025
`
`2026
`
`Gerard Berry & Robert Steiner, "Long-term management of
`patients with urea cycle disorders," J. Ped., 138(1):S56-61 (2001)
`
`Summar et al., “Unmasked Adult-Onset Urea Cycle Disorders in
`the Critical Care Setting,” Crit. Care Clin., S1-S8 (2005)
`
`Geraghty, M.T. and Brusilow, S.W., “Disorders of the Urea
`Cycle,” in Liver Disease in Children, 827-842 (2001)
`
`Endo, F. et al., “Clinical Manifestations of Inborn Errors of the
`Urea Cycle and Related Metabolic Disorders During Childhood,”
`J. Nutrition, 134, 1605S-1069S (2004)
`
`Maestri et al., “Long-term survival of patients with
`argininosuccinate synthetase deficiency,” J. Ped., 929-35 (1995)
`
`Lichter-Konecki et al., “Ammonia control in children with urea
`cycle disorders (UCDs): Phase 2 comparison of sodium
`phenylbutyrate and glycerol phenylbutyrate,” Mol. Gen. & Metab.,
`103:323-29 (2011)
`
`Not Used
`
`Singh et al., “Nutritional Management of Urea Cycle Disorders,”
`in Presentation and Management of Urea Cycle Disorders Outside
`the Newborn Period, Critical Care Clinics, 21:S27-35 (2005)
`
`Not Used
`
`Not Used
`
`The Urea Cycle Disorders Conference Group, Consensus
`Statement from a Conference for the Management of Patients with
`Urea Cycle Disorders, J. Ped. (Supplement) S1-S5 (2001)
`
`Not Used
`
`BUPHENYL® Prescribing Information (2003)
`
`James et al., “The Conjugation of phenylacetic acid in man, sub-
`human primates and some non-primate species,” Proc. R. Soc.
`Lond., 182, 25-35 (1972)
`
`IPR2015-01117
`
`
`
`Page 2 of 3
`
`
`
`2027
`
`2028
`
`2029
`
`Ambrose, Power & Sherwin, “Further Studies on the Detoxication
`of Phenylacetic Acid,” J. Biol. Chem., 101, 669-675 (1933)
`
`Horizon Therapeutics, Inc. v. Par Pharma., Inc., 14-cv-384 (E.D.
`Tex.), Joint Claim Construction Charts, D.I. 80
`
`P. B. Hawk and O. Bergeim, Practical Physiological Chemistry,
`pp. 304-07 (9th Ed. 1926)
`
`
`Respectfully submitted,
`
`By: / M.C. Phillips /
`Matthew C. Phillips
`Registration No. 43,403
`Backup Counsel for Patent Owner
`
`
`
`
`
`Date: 2016 June 30
`
`IPR2015-01117
`
`
`
`Page 3 of 3
`
`
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that on June 30, 2016, copies of the foregoing PATENT
`
`OWNER’S UPDATED EXHIBIT LIST and all documents filed with it were
`
`served via electronic mail, as agreed to by counsel, upon the following counsel for
`
`the Petitioners:
`
`David H. Silverstein: dsilverstein@axinn.com
`
`Aziz Burgy: aburgy@axinn.com
`
`Elizabeth J. Holland: eholland@goodwinproctor.com
`
`Cynthia Lambert Hardman: chardman@goodwinprocter.com
`
`/ M.C. Phillips /
`Matthew C. Phillips
`Registration No. 43,403
`
`
`
`
`
`IPR2015-01117
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