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`Case IPR2017-01159
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`Patent 9,254,278
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`___________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`
`LUPIN LTD. and LUPIN PHARMACEUTICALS, INC.
`Petitioner,
`v.
`HORIZON THERAPEUTICS, INC.
`Patent Owner
`
`
`Case IPR2017-01159
`Patent 9,254,278
`
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`PETITIONERS’ UPDATED EXHIBIT LIST
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`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`PO Box 1450
`Alexandria, Virginia 22313-1450
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`Ex. No.
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`Ex. 1001
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`Ex. 1002
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`Ex. 1003
`Ex. 1004
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`Ex. 1005
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`Ex. 1006
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`Ex. 1007
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`Ex. 1008
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`Ex. 1009
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`Ex. 1010
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`Ex. 1011
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`Case IPR2017-01159
`Patent 9,254,278
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`Updated List of Exhibits
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`Description
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`U.S. Patent No. 9,254,278 to Scharschmidt et al. (“ʼ278 Patent”)
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`Declaration of Keith Vaux, M.D.
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`U.S. Patent No. 9,326,966 to Scharschmidt et al. (“ʼ966 Patent”)
`Brusilow, et al., Treatment of Episodic Hyperammonemia in
`Children with Inborn Errors of Urea Synthesis, 310 The New
`England Journal of Medicine, 1630-1634 (1984). (“Brusilow
`ʼ84”).
`Simell, et al., Waste Nitrogen Excretion Via Amino Acid
`Acylation: Benzoate and Phenylacetate in Lysinuric Protein
`Intolerance, 20 Pediatric Research, 1117-1121 (1986). (“Simell”).
`Blau, Duran, Blaskovics, Gibson (editors), Physician’s Guide to
`the Laboratory Diagnosis of Metabolic Diseases, 261-276 (2d ed.
`1996). (“Blau”).
`U.S. Patent Publication No. 2010/0008859, filed January 7, 2009,
`published January 14, 2010. (the “ʼ859 Publication”).
`Scientific Discussion for Ammonaps, EMEA 2005, available at
`http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-
`_Scientific_Discussion/human/000219/WC500024748.pdf.
`(“Scientific Discussion”).
`Dixon, et al., Intercurrent Illness in Inborn Errors of Intermediary
`Metabolism, 67 Archives of Disease in Childhood, 1387-1391
`(1992). (“Dixon”).
`UMass Memorial Laboratories, Lab Updates, February 2007,
`Measurement of Ammonia in Blood
`Brusilow, Phenylacetylglutamine May Replace Urea as a Vehicle
`for Waste Nitrogen Excretion, 29 Pediatric Research, 147-150
`(1991). (“Brusilow ʼ91”).
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`- 2 -
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`Ex. 1012
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`Ex. 1013
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`Ex. 1014
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`Ex. 1015
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`Ex. 1016
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`Ex. 1017
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`Ex. 1018
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`Ex. 1019
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`Ex. 1020
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`Ex. 1021
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`Ex. 1022
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`Ex. 1023
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`Ex. 1024
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`Ex. 1025
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`Case IPR2017-01159
`Patent 9,254,278
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`Yajima, et al., Diurnal Fluctuation of Blood Ammonia Levels in
`Adult-Type Citrullinemia, 137 Tohoku J. Exp. Med., 213-220
`(1982). (“Yajima”).
`
`Batshaw, et al., Treatment of Carbamyl Phosphate Synthetase
`Deficiency with Keto Analogues of Essential Amino Acids, 292
`The New England J. Medicine, 1085-1090 (1975). (“Batshaw”).
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`Kasumov, et al., New Secondary Metabolites of Phenylbutyrate in
`Humans and Rats, 32 Drug Metabolism and Disposition, 10-19
`(2004). (“Kasumov”).
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`Barsotti, Measurement of Ammonia in Blood, 138 J Pediatrics,
`S11- S20 (2001). (“Barsotti”).
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`Berry, et al., Long-term management of patients with urea cycle
`disorders, Journal of Pediatrics, Vol. 138, No. 1, S56–S61 (2001).
`(“Berry”).
`
`Levin, et al., Hyperammonaemia A Variant Type of Deficiency of
`Liver Ornithine Transcarbamylase, Arch. Dis. Childh., 1964, 44.
`162 (1968).
`
`Prosecution History of U.S. Patent No. 8,404,215.
`
`Excerpt from Stedman’s Medical Dictionary (Lippincott
`Williams & Wilkins 2006).
`Buphenyl® label, Physician’s Desk Reference, 60th ed. (2006) at
`3327-28.
`Ammonul® label, Physician’s Desk Reference, 60th ed. (2006) at
`3323-26.
`Prosecution History of U.S. Patent No. 9,254,278.
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`Curriculum vitae of Keith Vaux, M.D.
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`U.S. Patent No. 5,968,979 (“Brusilow ’979 Patent”).
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`Prosecution History of U.S. Patent No. 9,326,966.
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`Ex. 1026
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`Ex. 1027
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`Ex. 1028
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`Ex. 1029
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`Case IPR2017-01159
`Patent 9,254,278
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`Petition for Inter Partes Review of U.S. Patent No. 9,254,278 -
`IPR2017-01159 – Dr. Gregory Enns Deposition Exhibit
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`Petition for Inter Partes Review of U.S. Patent No. 9,326,966 -
`IPR2017-01160 – Dr. Gregory Enns Deposition Exhibit
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`Final Written Decision in Inter Partes Review of U.S. Patent No.
`9,095,559 - IPR2016-00829 – Dr. Gregory Enns Deposition Exhibit
`April 23, 2018 Deposition Transcript of Dr. Gregory Enns taken in
`IPR2017-01159 and IPR2017-01160
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`Ex. 1030
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`U.S. Patent No. 9,095,559
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`
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`Dated: May 11, 2018
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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)
`
`Counsel for Petitioners
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`Case IPR2017-01159
`Patent 9,254,278
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that PETITIONERS’ UPDATED EXHIBIT
`
`LIST PURSUANT TO 37 C.F.R. 42.64 was served electronically via email on
`
`May 11, 2018 on the following:
`
`Robert Green
`Emer Simic
`Ann Kotze
`Green, Griffith & Borg-Breen, LLP
`rgreen@greengriffith.com
`esimic@greengriffith.com
`akotze@greengriffith.com
`
`Matthew Phillips
`Laurence & Phillips IP Law LLP
`mphillips@lpiplaw.com
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`Dennis Bennett
`GLOBAL PATENT GROUP, LLC
`dennisbennett@globalpatentgroup.com
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`Dated: May 11, 2018
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`
`/Cynthia Lambert Hardman/
`Cynthia Lambert Hardman
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`- 5 -
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