UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`LUPIN LTD. AND LUPIN PHARMACEUTICALS INC.,
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`Petitioner
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`v.
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`HORIZON THERAPEUTICS, INC.,
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`Patent Owner
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`Case IPR 2016-00829
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`Patent 9,095,559
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`PATENT OWNER’S EXHIBIT LIST
`(as of February 10, 2017)
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`LUPIN LTD. AND LUPIN PHARMACEUTICALS INC.,
`
`Petitioner
`
`v.
`
`HORIZON THERAPEUTICS, INC.,
`
`Patent Owner
`
`Case IPR 2016-00829
`
`Patent 9,095,559
`
`PATENT OWNER’S EXHIBIT LIST
`(as of February 10, 2017)
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`Case No. IPR20 1 6—00829
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`U.S. Patent No. 9,095,559
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`Exhibit No.
`
`Complaint for Patent Infringement, Horizon Therapeutics, Inc. v.
`Lupin Ltd. et al., Civil Action No. 15—cv—07624—RBK—JS (D.N.J.
`filed Oct. 19, 2015).
`
`Amended Complaint for Patent Infringement, Horizon
`Therapeutics, Inc. v. Lupin Ltd. et al., Civil Action No. 15—cv-
`07624—RBK—JS (D.N.J. filed Apr. 6, 2016).
`
`Olli Simell, Lysinuric Protein Intolerance and Other Cationic
`Aminoacidurias, in THE METABOLIC & MOLECULAR BASES OF
`INHERITED DISEASE at 4949 (Charles R. Scriver et al. eds., 8"’
`ed. 2001 ).
`
`Rani H. Singh et al., Nutritional Management of Urea Cycle
`Disorders, 21 CRITICAL CARE CLINICS, no. 4S, S27-S35 (2005).
`(“Singh”).
`
`Portion of Invalidity Contentions (pages 16-22), served Nov. 13,
`2014 in Hyperion Therapeutics, Inc. v. Par Pharma., Inc., 2:14-cv-
`00384-JRG-RSP (E.D. Tex.)
`
`Declaration of Gregory M. Enns, M.D.
`
`2007
`
`Curriculum vitae of Gregory M. Enns, M.D.
`
`2008
`
`Ari Auron, Patrick D. Brophy, Hyperammonemia in Review:
`Pathophysiology, Diagnosis, and Treatment, 27 PEDIATRIC
`NEPHROLOGY, Issue 2, 207-22 (2012). (“Auron”).
`
`Mark L. Batshaw, et al., Alternative Pathway Therapyfor Urea
`Cycle Disorders: Twenty Years Later, 38 THE JOURNAL OF
`PEDIATRICS, no. 1, S46—S55 (2001). (“Batshaw”).
`
`Nancy E. Maestri, et al., Prospective Treatment of Urea Cycle
`Disorders, 119 THE JOURNAL OF PEDIATRICS, no. 6, 923-28 (1991).
`(“Maestri”).
`
`
`
`
`Case No. IPR2016-00829
`U.S. Patent No. 9,095,559
`
`Nancy E. Maestri, et al., Plasma Glutamine Concentration: A Guide
`in the Management of Urea Cycle Disorders, 121 THE JOURNAL OF
`PEDIATRICS, no. 2, 259–61 (1992). (“Maestri 1992”).
`
`U.S. Patent Publication 2012/0022157 A1, filed August 27, 2009,
`published January 26, 2012. (“’157 App”).
`
`Mendel Tuchman & Mark L. Batshaw, Management of Inherited
`Disorders of Ureagenesis, 12 THE ENDOCRINOLOGIST 99–109
`(2002). (“Tuchman”).
`
`Guoyao Wu, Amino Acids: Metabolism, Functions, and Nutrition,
`37 AMINO ACIDS 1–17 (2009). (“Wu”).
`
`Alexander Broomfield & Stephen Grunewald, How to use Serum
`Ammonia, 97 ARCHIVES OF DISEASE IN CHILDHOOD—EDUCATION
`AND PRACTICE 72–77 (2012). (“Broomfield”).
`
`Fumino Endo, et al., Clinical Manifestations of Inborn Errors of the
`Urea Cycle and Related Metabolic Disorders During Childhood,
`134 THE JOURNAL OF NUTRITION 1605S–09S (2004). (“Endo”)
`
`Gregory M. Enns, Nitrogen Sparing Therapy Revisited 2009, 100
`MOLECULAR GENETICS AND METABOLISM S65–S71 (2010). (“Enns
`2010”).
`
`Francois Feillet & J. V. Leonard, Alternative Pathway Therapy for
`Urea Cycle Disorders, 21 Journal of Inherited Metabolic Disease,
`Supplement 1, 101–111 (1998). (“Feillet”).
`Johannes Haberle, et al., Suggested Guidelines for the Diagnosis
`and Management of Urea Cycle Disorders, 7 ORPHANET JOURNAL
`OF RARE DISEASES, no. 32, 1–30 (2012). (“Haberle”).
`
`Johannes Haberle, Clinical Practice: The Management of
`Hyperammonemia, 170 EUROPEAN JOURNAL OF PEDIATRICS 21–34
`(2011). (“Haberle Clinical”).
`
`2
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`2011
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`2012
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`2013
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`2014
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`2015
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`2016
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`2017
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`2018
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`2019
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`2020
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`Case No. IPR2016-00829
`U.S. Patent No. 9,095,559
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`2021
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`2022
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`2023
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`2024
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`2025
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`2026
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`2027
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`2028
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`2029
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`J.V. Leonard & A. A. M. Morris, Urea Cycle Disorders, 7
`SEMINARS IN NEONATOLOGY 27–35 (2002). (“Leonard”).
`
`Ann-Kaisa Niemi & Gregory M. Enns, Sodium Phenylacetate and
`Sodium Benzoate in the Treatment of Neonatal Hyperammonemia, 7
`NEOREVIEWS, no. 9, e486–e95 (2006). (“Niemi”).
`Marshall Summar & Mendel Tuchman, Proceedings of a Consensus
`Conference for the Management of Patients with Urea Cycle
`Disorders, 138 THE JOURNAL OF PEDIATRICS, no. 1, S6–S10 (2001).
`(“Summar”).
`Saul W. Brusilow & Nancy E. Maestri, Urea Cycle Disorders:
`Diagnosis, Pathophysiology, and Therapy, 43 ADVANCES IN
`PEDIATRICS 127–70 (1996). (“Brusilow 1996”).
`Colloquium, Consensus Statement from a Conference for the
`Management of Patients with Urea Cycle Disorders, 138 THE
`JOURNAL OF PEDIATRICS, Supplement 1, S1–S5 (2001).
`(“Consensus”).
`
`Specialties of Genetics, AMERICAN BOARD OF MEDICAL GENETICS
`AND GENOMICS (last accessed Jan. 17, 2017),
`http://abmgg.org/pages/training_specialties.shtml.
`
`About Us, UREA CYCLE DISORDERS CONSORTIUM (last accessed Jan.
`17, 2017), https://www.rarediseasesnetwork.org/cms/ucdc/About-
`Us.
`
`Gregory M. Enns, et al., Survival After Treatment with
`Phenylacetate and Benzoate for Urea-Cycle Disorders, 356 THE
`NEW ENGLAND JOURNAL OF MEDICINE 2282–92 (2007). (“Enns”).
`
`Gregory M. Enns & Tina M. Cowan, Hyperammonemia, in SIGNS
`AND SYMPTOMS OF GENETIC CONDITIONS: A HAND BOOK 18 261–
`279 (Louanne Hudgins et al., eds., 2014). (“Enns 2014”).
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`Case No. IPR2016-00829
`U.S. Patent No. 9,095,559
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`2030
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`2031
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`2032
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`2033
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`2034
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`Michael Msall, et al., Neurologic Outcome in Children with Inborn
`Errors of Urea Synthesis, 310 THE NEW ENGLAND JOURNAL OF
`MEDICINE 1500–1505 (1984). (“Msall”).
`
`B.D. Cheson, et al., Novel Therapeutic Agents for the Treatment of
`Myelodysplastic Syndromes, 27 SEMINARS IN ONCOLOGY, no. 5,
`560–77 (2000). (“Cheson”).
`Fernando Scaglia, et al., Effect of Alternative Pathway Therapy on
`Branched Chain Amino Acid Metabolism in Urea Cycle Disorder
`Patients, 81 MOLECULAR GENETICS AND METABOLISM, Supplement
`1, S79–S85 (2004). (“Scaglia”).
`Saul W. Brusilow & Arthur L. Horwich, Urea Cycle Enzymes, in
`THE ONLINE METABOLIC AND MOLECULAR BASES OF INHERITED
`DISEASE ch. 85 1–89 (David Valle et al. eds., 2015). (“Brusilow
`Online”).
`
`Deposition of Dr. Keith Vaux
`
`2035
`
`Dr. Vaux’s University of California San Diego online biography.
`(“Vaux UCSD”).
`
`2036
`
`Ephrem Chin, et al., Novel Human Pathological Mutations, 126
`HUMAN GENETICS 329–352 (2009). (“Chin”).
`
`2037
`
`Keith K. Vaux, Book Reviews: A Clinical Guide to Inherited
`Metabolic Diseases, 2nd ed., 94 Journal of Heredity, no. 2, 196
`(2003). (“Vaux Book Review”).
`
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`Case No. IPR2016-00829
`U.S. Patent No. 9,095,559
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`2038
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`Inherited Metabolic Disorders, WEBMD (last accessed Feb. 2,
`2017), http://www.webmd.com/a-to-z-guides/inherited-metabolic-
`disorder-types-and-treatments#1.
`(“WebMD”).
`
`2039
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`RESERVED
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`2040
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`2041
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`2042
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`2043
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`2044
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`2045
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`Marshall Summar, Current Strategies for the Management of
`Neonatal Urea Cycle Disorders, 138 THE JOURNAL OF PEDIATRICS,
`no. 1, S30–S39 (2001). (“Summar 2001”).
`
`Ravicti® product insert,
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203284s
`004lbl.pdf. (“Ravicti”).
`
`Marshall L. Summar, et al., The Incidence of Urea Cycle Disorders,
`110 MOLECULAR GENETICS AND METABOLISM 179–180 (2013).
`(“Summar 2013”).
`
`Marshall L. Summar, et al., Diagnosis, Symptoms, Frequency and
`Mortality of 260 Patients with Urea Cycle Disorders from a 21-
`Year, Multicentre Study of Acute Hyperammonaemic Episodes, 97
`ACTA PAEDIATRICA 1420–25 (2008). (“Summar 2008”).
`
`Bridget Wilcken, Problems in the Management of Urea Cycle
`Disorders, 81 MOLECULAR GENETICS AN METABOLISM S86–S91
`(2004). (“Wilcken”).
`
`Information About FDA-Approved Drug, Buphenyl,
`http://www.accessdata.fda.gov/scripts/cder/daf/ (search Drug Name,
`Active Ingredient, or Application Number field for “020572”)
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`Dated: February 10, 2017
`
`
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`By:
`
`
`Case No. IPR2016-00829
`U.S. Patent No. 9,095,559
`
`Respectfully submitted,
`
`
`
`/Maureen D. Queler/
`Maureen D. Queler, Reg. No. 61,879
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`(202) 408-4000
`Counsel for Patent Owner in
`IPR2016-00829
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`Case No. IPR2016-00829
`U.S. Patent No. 9,095,559
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`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that copies of the foregoing PATENT
`
`OWNER’S EXHIBIT LIST and Exhibits 2006-2038 and 2040-2045 were
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`served on February 10, 2017, via electronic mail directed to counsel of record for
`
`the Petitioner at the following:
`
`
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`Elizabeth J. Holland: eholland@goodwinproctor.com
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`
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`Cynthia Lambert Hardman: chardman@goodwinprocter.com
`
`
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`Robert V. Cerwinski: RCerwinski@goodwinprocter.com
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`Petitioners have agreed to electronic service.
`
`
`
`
` /Maureen D. Queler/
` Maureen D. Queler
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`
`
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`
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`Dated: February 10, 2017
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