`UNITED STATES PATENT AND TRADEMARK OFFICE
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`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, LLC,
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`Patent Owner
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`Case IPR2017-01159
`Patent 9,254,278
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`PATENT OWNER’S UPDATED EXHIBIT LIST
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`Pursuant to 37 C.F.R. § 42.63 (e), the Patent Owner hereby provides an
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`updated exhibit list:
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`Description
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`Ex.
`No.
`2001 Declaration of Dr. Gregory M. Enns, M.D., Lupin Ltd. et al. v. Horizon
`Therapeutics, Inc., IPR2016-00829, Exhibit 2006, filed February 10, 2017.
`2002 RESERVED.
`2003 Simell, “Lysinuric Protein Intolerance and Other Cationic
`Aminoacidurias,” in The Metabolic & Molecular Bases of Inherited
`Disease, Ch. 192, pp. 4933-4956 (Scriver et al., eds., 8th ed. 2001).
`(“Simell 2001”).
`2004 Singh et al., “Nutritional Management of Urea Cycle Disorders,” Crit.
`Care. Clin. 21:S27-35 (2005). (“Singh”).
`2005 U.S. Patent No. 9,095,559. (“’559 Patent”).
`2006 Declaration of Dr. Gregory M. Enns, M.D.
`2007 Curriculum vitae of Dr. Gregory M. Enns, M.D.
`2008 Ari Auron, Patrick D. Brophy, “Hyperammonemia in Review:
`Pathophysiology, Diagnosis, and Treatment,” Pediatric Nephrology,
`27:207-22 (2012). (“Auron”).
`2009 Mark L. Batshaw, et al., “Alternative Pathway Therapy for Urea Cycle
`Disorders: Twenty Years Later,” J. Pediatrics, 38:S46-S55 (2001).
`(“Batshaw”).
`2010 Nancy E. Maestri, et al., “Prospective Treatment of Urea Cycle
`Disorders,” J. of Pediatrics, 119:923-28, no. 6 (1991). (“Maestri”).
`2011 Nancy E. Maestri, et al., “Plasma Glutamine Concentration: A Guide in
`the Management of Urea Cycle Disorders,” J. Pediatrics, 121:259–61, no.
`2 (1992). (“Maestri 1992”).
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`IPR2017-01159
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`Page 1
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`2012 U.S. Patent Publication 2012/0022157 A1, filed August 27, 2009,
`published January 26, 2012. (“’157 App”).
`2013 Mendel Tuchman & Mark L. Batshaw, “Management of Inherited
`Disorders of Ureagenesis,” The Endocrinologist 12:99–109, no. 2 (2002).
`(“Tuchman”).
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`Guoyao Wu, “Amino Acids: Metabolism, Functions, and Nutrition,”
`Amino Acids 37:1–17 (2009). (“Wu”).
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`2014
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`2015 Alexander Broomfield & Stephen Grunewald, “How to use Serum
`Ammonia,” Archives of Disease in Childhood—Education and Practice
`97:72–77 (2012). (“Broomfield”).
`2016 Fumino Endo, et al., “Clinical Manifestations of Inborn Errors of the Urea
`Cycle and Related Metabolic Disorders During Childhood,” J. Nutrition
`134:1605S–09S (2004). (“Endo”).
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`2017 Gregory M. Enns, “Nitrogen Sparing Therapy Revisited 2009,” Molecular
`Genetics and Metabolism 100:S65–S71 (2010). (“Enns 2010”).
`2018 Francois Feillet & J. V. Leonard, “Alternative Pathway Therapy for Urea
`Cycle Disorders,” J. Inherited Metabolic Disease, Supplement 1, 21:101–
`111 (1998). (“Feillet”).
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`2019
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`2020
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`Johannes Haberle, et al., “Suggested Guidelines for the Diagnosis and
`Management of Urea Cycle Disorders,” Orphanet J. Rare Diseases, 7:32,
`1–30 (2012). (“Haberle”).
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`Johannes Haberle, “Clinical Practice: The Management of
`Hyperammonemia,” Eur. J. of Pediatrics 170:21–34 (2011). (“Haberle
`Clinical”).
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`2021
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`J.V. Leonard & A. A. M. Morris, “Urea Cycle Disorders,” Seminars in
`Neonatology 7:27–35 (2002). (“Leonard”).
`2022 Ann-Kaisa Niemi & Gregory M. Enns, “Sodium Phenylacetate and
`Sodium Benzoate in the Treatment of Neonatal Hyperammonemia,”
`NeoReviews, 7:e486–e95, no. 9 (2006). (“Niemi”).
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`IPR2017-01159
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`Page 2
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`2023 Marshall Summar & Mendel Tuchman, “Proceedings of a Consensus
`Conference for the Management of Patients with Urea Cycle Disorders,” J.
`Pediatrics, 138:S6–S10 (2001). (“Summar”).
`2024 Saul W. Brusilow & Nancy E. Maestri, “Urea Cycle Disorders: Diagnosis,
`Pathophysiology, and Therapy,” Advances in Pediatrics 43:127–70 (1996).
`(“Brusilow 1996”).
`2025 Colloquium, “Consensus Statement from a Conference for the
`Management of Patients with Urea Cycle Disorders,” J. Pediatrics,
`Supplement 1, 138:S1–S5 (2001). (“Consensus”).
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`2026
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`“Specialties of Genetics,” Am. Board of Medical Genetics and Genomics
`(last accessed Jan. 17, 2017),
`http://abmgg.org/pages/training_specialties.shtml. (“ABMGG”).
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`2027
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`“About Us,” Urea Cycle Disorders Consortium (last accessed Jan. 17,
`2017), https://www.rarediseasesnetwork.org/cms/ucdc/About-Us.
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`2028 Gregory M. Enns, et al., “Survival After Treatment with Phenylacetate and
`Benzoate for Urea-Cycle Disorders,” The New England Journal of
`Medicine 356:2282–92 (2007). (“Enns”).
`2029 Gregory M. Enns & Tina M. Cowan, “Hyperammonemia,” in Signs and
`Symptoms of Genetic Conditions: A Handbook, ch. 18, 261–279 (Louanne
`Hudgins et al., eds., 2014). (“Enns 2014”).
`2030 Michael Msall, et al., “Neurologic Outcome in Children with Inborn Errors
`of Urea Synthesis,” The New England Journal of Medicine 310:1500–1505
`(1984). (“Msall”).
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`2031 B.D. Cheson, et al., “Novel Therapeutic Agents for the Treatment of
`Myelodysplastic Syndromes,” Seminars in Oncology, 27:560–77, no. 5
`(2000). (“Cheson”).
`2032 Fernando Scaglia, et al., “Effect of Alternative Pathway Therapy on
`Branched Chain Amino Acid Metabolism in Urea Cycle Disorder
`Patients,” Molecular Genetics and Metabolism, Supplement 1, 81:S79-S85
`(2004). (“Scaglia”).
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`IPR2017-01159
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`Page 3
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`2033 Saul W. Brusilow & Arthur L. Horwich, “Urea Cycle Enzymes,” in The
`Online Metabolic and Molecular Bases of Inherited Disease, Ch. 85, pp.
`1–89 (David Valle et al. eds., 2015). (“Brusilow Online”).
`2034 Transcript of January 31, 2017 Deposition of Dr. Keith Vaux, Lupin Ltd. et
`al. v. Horizon Therapeutics, Inc., IPR2016-00829.
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`2035
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`Jennifer Seminara, et al., “Establishing a consortium for the study of rare
`diseases: The Urea Cycle Disorders Consortium,” Molecular Genetics and
`Metabolism 100:S97-S105 (2010). (“Seminara”).
`2036 RESERVED.
`2037 Keith K. Vaux, “Book Reviews: A Clinical Guide to Inherited Metabolic
`Diseases, 2nd ed.,” J. Heredity 94:195 (2) (2003). (“Vaux Book Review”).
`2038 RESERVED.
`2039 RESERVED.
`2040 Marshall Summar, “Current Strategies for the Management of Neonatal
`Urea Cycle Disorders,” J. Pediatrics 138:S30–S39 (2001). (“Summar
`2001”).
`2041 RAVICTI® product insert,
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203284s
`004lbl.pdf. (“Ravicti”).
`2042 Marshall L. Summar, et al., “The Incidence of Urea Cycle Disorders,”
`Molecular Genetics and Metabolism 110:179–180 (2013). (“Summar
`2013”).
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`2043 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,” Acta
`Paediatrica 97:1420–25 (2008). (“Summar 2008”).
`2044 Bridget Wilcken, “Problems in the Management of Urea Cycle Disorders,”
`Molecular Genetics and Metabolism 81:S86–S91 (2004). (“Wilcken”).
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`IPR2017-01159
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`2045
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`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”).
`2046 RESERVED for Declaration of Emer L. Simic In Response to Petitioner’s
`Objections to Evidence.
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`2047 RESERVED for International Publication No. WO 2010/025303 A1.
`2048 RESERVED for The Online Metabolic and Molecular Bases of Inherited
`Disease, (last accessed Feb. 27, 2017),
`http://ommbid.mhmedical.com/book.aspx?bookID=971.
`2049 RESERVED for A Clinical Guide to Inherited Metabolic Diseases, 2nd ed.,
`(last accessed Feb. 27, 2017),
`https://www.researchgate.net/publication/279484103_A_Clinical_Guide_t
`o_Inherited_Metabolic_Disease_2nd_ed.
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`2050 RESERVED for Drugs@FDA: FDA Approved Drug Products, Search
`results for “Buphenyl”, (last accessed Feb. 27, 2017),
`http://www.accessdata.fda.gov/scripts/CDER/daf/index.cfm?event=BasicS
`earch.process.
`2051 Transcript of February 7, 2018 Deposition of Dr. Keith Vaux, M.D.
`2052 Declaration of Dr. Keith Vaux, M.D., Lupin Ltd. et al. v. Horizon
`Therapeutics, LLC, IPR2018-00459, Exhibit 1002, filed January 12, 2018.
`(“Vaux ’197 Declaration”).
`2053 Errata and Signature Page for Dr. Gregory Enns’ April 23, 2018
`Deposition.
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`Date: May 22, 2018
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`Respectfully submitted,
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` By: / M.C. Phillips /
`Matthew C. Phillips
`Registration No. 43,403
`Backup Counsel for Patent Owner
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`IPR2017-01159
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`Page 5
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`CERTIFICATE OF SERVICE
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`I hereby certify that on May 22, 2018, copies of the foregoing PATENT
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`OWNER’S UPDATED EXHIBIT LIST and all documents filed with it were
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`served via electronic mail, as agreed to by counsel, upon the following counsel for
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`the Petitioners:
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`Elizabeth J. Holland: eholland@goodwinlaw.com
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`Cynthia Lambert Hardman: chardman@goodwinlaw.com
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`Dated: May 22, 2018
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`By: / M.C. Phillips /
`Matthew C. Phillips
`Registration No. 43,403
`Backup Counsel for Patent Owner
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`IPR2017-01159
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`Page 6
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