`Patent 9,095,559 B2
`UNITED STATES PATENT AND TRADEMARK OFFICE
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`___________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
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`LUPIN LTD. and LUPIN PHARMACEUTICALS, INC.
`Petitioners,
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`v.
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`HORIZON THERAPEUTICS, LLC
`Patent Owner.
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`
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`Case IPR2016-00829
`Patent 9,095,559 B2
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`PETITIONERS’ UPDATED EXHIBIT LIST
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`
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`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`Ex. No.
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`List of Exhibits
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`Description
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`Case IPR2016-00829
`Patent 9,095,559 B2
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`Ex. 1001
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`U.S. Patent No. 9,095,559 to Scharschmidt et al. (“ʼ559 patent”)
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`Ex. 1002
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`Declaration of Keith Vaux, M.D.
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`Ex. 1003
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`Curriculum vitae of Keith Vaux, M.D.
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`Ex. 1004
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`Brusilow, et al., Treatment of Episodic Hyperammonemia in
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`Children with Inborn Errors of Urea Synthesis, 310 The New
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`England Journal of Medicine, 1630-1634 (1984). (“Brusilow
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`ʼ84”).
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`Ex. 1005
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`Simell, et al., Waste Nitrogen Excretion Via Amino Acid
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`Acylation: Benzoate and Phenylacetate in Lysinuric Protein
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`Intolerance, 20 Pediatric Research, 1117-1121 (1986). (“Simell”).
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`Ex. 1006
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`Blau, Duran, Blaskovics, Gibson (editors), Physician’s Guide to
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`the Laboratory Diagnosis of Metabolic Diseases, 261-276 (2d ed.
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`1996). (“Blau”).
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`Ex. 1007
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`U.S. Patent Publication No. 2010/0008859, filed January 7, 2009,
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`published January 14, 2010. (the “ʼ859 Publication”).
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`Ex. 1008
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`Scientific Discussion for Ammonaps, EMEA 2005, available at
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`http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-
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`Case IPR2016-00829
`Patent 9,095,559 B2
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`_Scientific_Discussion/human/000219/WC500024748.pdf.
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`(“Scientific Discussion”).
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`Ex. 1009
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`Dixon, et al., Intercurrent Illness in Inborn Errors of Intermediary
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`Metabolism, 67 Archives of Disease in Childhood, 1387-1391
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`(1992). (“Dixon”).
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`Ex. 1010
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`UMass Memorial Laboratories, Lab Updates, February 2007,
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`Measurement of Ammonia in Blood
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`Ex. 1011
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`Brusilow, Phenylacetylglutamine May Replace Urea as a Vehicle
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`for Waste Nitrogen Excretion, 29 Pediatric Research, 147-150
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`(1991). (“Brusilow ʼ91”).
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`Ex. 1012
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`Yajima, et al., Diurnal Fluctuation of Blood Ammonia Levels in
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`Adult-Type Citrullinemia, 137 Tohoku J. Exp. Med., 213-220
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`(1982). (“Yajima”).
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`Ex. 1013
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`Batshaw, et al., Treatment of Carbamyl Phosphate Synthetase
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`Deficiency with Keto Analogues of Essential Amino Acids, 292
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`The New England J. Medicine, 1085-1090 (1975). (“Batshaw”).
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`Ex. 1014
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`Kasumov, et al., New Secondary Metabolites of Phenylbutyrate in
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`Humans and Rats, 32 Drug Metabolism and Disposition, 10-19
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`(2004). (“Kasumov”).
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`Ex. 1015
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`Case IPR2016-00829
`Patent 9,095,559 B2
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`Barsotti, Measurement of Ammonia in Blood, 138 J Pediatrics,
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`S11- S20 (2001). (“Barsotti”).
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`Ex. 1016
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`Berry, et al., Long-term management of patients with urea cycle
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`disorders, Journal of Pediatrics, Vol. 138, No. 1, S56–S61 (2001).
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`(“Berry”).
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`Ex. 1017
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`Levin, et al., Hyperammonaemia A Variant Type of Deficiency of
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`Liver Ornithine Transcarbamylase, Arch. Dis. Childh., 1964, 44.
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`162 (1968).
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`Ex. 1018
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`Prosecution History of U.S. Patent No. 8,404,215.
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`Ex. 1019
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`Excerpt from Stedman’s Medical Dictionary (Lippincott
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`Williams & Wilkins 2006).
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`Ex. 1020
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`Buphenyl® label, Physician’s Desk Reference, 60th ed. (2006) at
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`3327-28.
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`Ex. 1021
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`Ammonul® label, Physician’s Desk Reference, 60th ed. (2006) at
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`3323-26.
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`Ex. 1022
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`Prosecution History of U.S. Patent No. 9,095,559 (part 1 of 2).
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`Ex. 1023
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`Prosecution History of U.S. Patent No. 9,095,559 (part 2 of 2).
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`Ex. 1024
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`Affidavit of Robert V. Cerwinski In Support of Motion for Pro
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`Hac Vice Admission.
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`Ex. 1025
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`Case IPR2016-00829
`Patent 9,095,559 B2
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`The American Board of Pediatrics Content Outline, General
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`Pediatrics
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`Ex. 1026
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`Deposition Transcript of Gregory Enns, M.D. in IPR2016-00829
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`Respectfully submitted,
`/Cynthia Lambert Hardman/
`Elizabeth J. Holland (Reg. No. 47,657)
`Cynthia Lambert Hardman (Reg. No.
`53,179)
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018
`(212) 813-8800 (telephone)
`(212) 355-3333 (facsimile)
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`
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`Counsel for Petitioners
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`(May 5, 2017)
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`
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`Dated: May 12, 2017
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`CERTIFICATE OF SERVICE
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`Case IPR2016-00829
`Patent 9,095,559 B2
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`The undersigned hereby certifies that PETITIONERS’ UPDATED EXHIBIT
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`LIST was served electronically via email on May 12, 2017 on the following:
`
`James B. Monroe (lead counsel, Reg. No. 33,971)
`Maureen D. Queler (backup counsel, Reg. No. 61,879)
`FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP
`James.monroe@finnegan.com
`Maureen.queler@finnegan.com
`
`Matthew Phillips (backup counsel, Reg. No. 43,403)
`LAURENCE & PHILLIPS IP LAW LLP
`mphillips@lpiplaw.com
`
`Robert Green (backup counsel, Reg. No. 27,555)
`Emer Simic (backup counsel, Reg. No. 61,235)
`Jessica Tyrus (backup counsel, Reg. No. 64,742)
`GREEN, GRIFFITH & BORG-BREEN, LLP
`rgreen@greengriffith.com
`esimic@greengriffith.com
`jtyrus@greengriffith.com
`
`Dennis Bennett (backup counsel, Reg. No. 34,547)
`GLOBAL PATENT GROUP, LLC
`dennisbennett@globalpatentgroup.com
`
`/Albert M. Lessard/
`Albert M. Lessard
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`6
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`
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`Dated: May 12, 2017
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