UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`PAR PHARMACEUTICAL, 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 IPR2017-01767
`Patent 9,254,278
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`PATENT OWNER’S UPDATED EXHIBIT LIST
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`PAR PHARMACEUTICAL, 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 IPR2017-01767
`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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`Exhibit
`No.
`2001
`2002
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`2003
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`2004
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`2005
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`2006
`2007
`2008
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`Description
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`RESERVED.
`
`Notice of Allowance dated December 23, 2015, Prosecution History
`of U.S. Patent No. Patent 9,254,278.
`
`Dixon et al., “Intercurrent Illness in Inborn Errors of Intermediary
`Metabolism,” Archives of Disease in Childhood, 67:1387-1391
`(1992) (“Dixon”).
`
`Rani H. Singh, et al., “Nutritional Management of Urea Cycle
`Disorders,” Crit. Care. Clin. 21:S27-S35 (2005). (“Singh”).
`
`Portion of Par Pharmaceutical, Inc.’s Initial Invalidity Contentions
`and Non-Infringement Contentions for U.S. Pat. Nos. 8,404,215 and
`8,642,012 (pgs. 16-22), Hyperion Therapeutics, Inc. v. Par
`Pharmaceutical, Inc., C.A. No. 2:14-cv-00384 (JRG)(RSP) (E.D.
`Tex.)
`
`Declaration of Dr. Gregory M. Enns.
`
`Curriculum vitae of Dr. Gregory M. Enns.
`
`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, 138:S46-S55,
`no. 1 (2001). (“Batshaw”).
`
`2010
`
`Nancy E. Maestri, et al., “Prospective Treatment of Urea Cycle
`Disorders,” J. of Pediatrics, 119:923-28, no. 6 (1991). (“Maestri”).
`
`IPR2017-01767
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`
`
`Page 1
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`
`
`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”).
`
`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”).
`
`2014
`
`
`2015
`
`2016
`
`2017
`
`2018
`
`2019
`
`2020
`
`Guoyao Wu, “Amino Acids: Metabolism, Functions, and Nutrition,”
`Amino Acids 37:1–17 (2009). (“Wu”).
`
`Alexander Broomfield & Stephanie Grunewald, “How to use Serum
`Ammonia,” Archives of Disease in Childhood—Education and
`Practice 97:72–77 (2012). (“Broomfield”).
`
`Fumio 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”).
`
`Gregory M. Enns, “Nitrogen Sparing Therapy Revisited 2009,”
`Molecular Genetics and Metabolism 100:S65–S71 (2010). (“Enns
`2010”).
`
`Takhar Kasumov, et al., “New Secondary Metabolites of
`Phenylbutyrate in Humans and Rats,” Drug Metabolism and
`Disposition, 32:10–19, no. 1 (2004). (“Kasumov”).
`
`Johannes Häberle, et al., “Suggested Guidelines for the Diagnosis and
`Management of Urea Cycle Disorders,” Orphanet J. Rare Diseases,
`7:32, 1–30 (2012). (“Häberle”).
`
`Johannes Häberle, “Clinical Practice: The Management of
`Hyperammonemia,” Eur. J. of Pediatrics 170:21–34 (2011).
`(“Häberle Clinical”).
`
`2021
`
`J.V. Leonard & A. A. M. Morris, “Urea Cycle Disorders,” Seminars
`in Neonatology 7:27–35 (2002). (“Leonard 2002”).
`
`IPR2017-01767
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`Page 2
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`
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`2022
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`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”).
`
`2023 Marshall Summar & Mendel Tuchman, “Proceedings of a Consensus
`Conference for the Management of Patients with Urea Cycle
`Disorders,” J. Pediatrics, 138:S6–S10, no. 1 (2001). (“Summar”).
`
`2024
`
`2025
`
`2026
`
`2027
`
`2028
`
`2029
`
`Saul W. Brusilow & Nancy E. Maestri, “Urea Cycle Disorders:
`Diagnosis, Pathophysiology, and Therapy,” Advances in Pediatrics
`43:127–70 (1996). (“Brusilow 1996”).
`
`Colloquium, “Consensus Statement from a Conference for the
`Management of Patients with Urea Cycle Disorders,” J. Pediatrics,
`Supplement 1, 138:S1–S5, no. 1 (2001). (“Consensus”).
`
`“Specialties of Genetics,” Am. Board of Medical Genetics and
`Genomics (last accessed Jan. 17, 2017),
`http://abmgg.org/pages/training_specialties.shtml. (“ABMGG”).
`
`“About Us,” Urea Cycle Disorders Consortium (last accessed Oct.
`25, 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,” The New
`England J. of Medicine 356:2282–92 (2007). (“Enns”).
`
`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 J. of Medicine
`310:1500–1505 (1984). (“Msall”).
`
`2031
`
`B.D. Cheson, et al., “Novel Therapeutic Agents for the Treatment of
`Myelodysplastic Syndromes,” in Seminars in Oncology, 27:560–77,
`no. 5 (John W. Yarbro, et al. eds., 2000). (“Cheson”).
`
`IPR2017-01767
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`Page 3
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`
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`2032
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`2033
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`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”).
`
`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 Marshall Summar, “Current Strategies for the Management of
`Neonatal Urea Cycle Disorders,” J. Pediatrics 138:S30–S39, no. 1
`(2001). (“Summar 2001”).
`
`2035 Marshall L. Summar, et al., “The Incidence of Urea Cycle Disorders,”
`Molecular Genetics and Metabolism 110:179–180 (2013). (“Summar
`2013”).
`
`2036 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”).
`
`2037
`
`2038
`
`2039
`
`2040
`
`Bridget Wilcken, “Problems in the Management of Urea Cycle
`Disorders,” Molecular Genetics and Metabolism 81: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”, last
`accessed Feb. 9, 2017)
`
`Gregory M. Enns, “Neurologic Damage and Neurocognitive
`Dysfunction in Urea Cycle Disorders,” Seminars in Pediatric
`Neurology, 15:132-139 (2008). (“Enns 2008”).
`
`Ravicti® product insert,
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203284s
`005lbl.pdf. (“Ravicti Label”).
`
`2041
`
`RESERVED for Declaration of Robert F. Green In Response to
`Petitioner’s Objections to Evidence.
`
`IPR2017-01767
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`Page 4
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`2042
`2043
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`2044
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`2045
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`2046
`2047
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`2048
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`2049
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`2050
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`2051
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`RESERVED for International Publication No. WO 2010/025303 A1.
`
`RESERVED for Certificate of Service dated November 13, 2014, for
`Par Pharmaceutical, Inc.’s Initial Invalidity Contentions and Non-
`Infringement Contentions for U.S. Pat. Nos. 8,404,215 and 8,642,012
`(pgs. 16-22), Hyperion Therapeutics, Inc. v. Par Pharmaceutical,
`Inc., C.A. No. 2:14-cv-00384 (JRG)(RSP) (E.D. Tex.)
`
`RESERVED for The Online Metabolic and Molecular Bases of
`Inherited Disease, (last accessed Feb. 27, 2017),
`http://ommbid.mhmedical.com/book.aspx?bookID=971.
`
`RESERVED for Drugs@FDA:FDA Approved Drug Products, Search
`results for “Buphenyl”, (last accessed Feb. 27, 2017),
`https://www.accessdata.fda.gov/scripts/CDER/daf/index.cfm?event=
`BasicSearch.process.
`
`Transcript of April 19, 2018 Deposition of Dr. Neal Sondheimer.
`
`RESERVED for Alexander Broomfield & Stephanie Grunewald,
`“How to use Serum Ammonia,” Archives of Disease in Childhood—
`Education and Practice 97:72–77 (2012), with reference list included.
`(“Broomfield with references”).
`
`RESERVED for Guoyao Wu, “Amino Acids: Metabolism, Functions,
`and Nutrition,” Amino Acids 37:1–17 (2009), print version. (“Wu
`Print”).
`
`RESERVED for Alexander Broomfield & Stephanie Grunewald,
`“How to use Serum Ammonia,” Archives of Disease in Childhood—
`Education and Practice 97:72–77 (2012), print version. (“Broomfield
`Print”).
`
`RESERVED for Gregory M. Enns, “Nitrogen Sparing Therapy
`Revisited 2009,” Molecular Genetics and Metabolism 100:S65–S71
`(2010), print version. (“Enns 2010 Print”).
`
`RESERVED for Johannes Häberle, “Clinical Practice: The
`Management of Hyperammonemia,” Eur. J. of Pediatrics 170:21–34
`(2011), print version. (“Häberle Clinical Print”).
`
`IPR2017-01767
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`
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`Page 5
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`
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`2052
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`2053
`
`2054
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`2055
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`2056
`
`2057
`
`RESERVED for 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), print version.
`(“Summar 2008 Print”).
`
`RESERVED for Gregory M. Enns, “Neurologic Damage and
`Neurocognitive Dysfunction in Urea Cycle Disorders,” Seminars in
`Pediatric Neurology, 15:132-139 (2008), print version. (“Enns 2008
`Print”).
`
`RESERVED for Declaration of Ann K. Kotze In Response to
`Petitioner’s Objections to Evidence.
`
`RESERVED for Declaration of Dr. Gregory Enns In Response to
`Petitioner’s Objections to Evidence.
`
`RESERVED for Marshall L. Summar, et al., “The Incidence of Urea
`Cycle Disorders,” Molecular Genetics and Metabolism, 110:179–180
`(2013), print version. (“Summar 2013 Print”).
`
`RESERVED for Saul W. Brusilow & Arthur L. Horwich, “Urea Cycle
`Enzymes,” in The Metabolic and Molecular Bases of Inherited
`Disease, ch. 85, 1909-1963 (Charles R. Scriver et al., eds., 8th ed.
`2001). (“Brusilow Print”).
`
`2058
`
`September 17, 2018 Settlement Agreement (Confidential).
`
`
`
`
`
`Date: September 28, 2018
`
`
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`
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`Respectfully submitted,
`
` By: / M.C. Phillips /
`Matthew C. Phillips
`Registration No. 43,403
`Backup Counsel for Patent Owner
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`IPR2017-01767
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`Page 6
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`CERTIFICATE OF SERVICE
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`I hereby certify that on September 28, 2018, copies of the foregoing
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`PATENT OWNER’S UPDATED EXHIBIT LIST and all documents filed with it
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`were served via electronic mail, as agreed to by counsel, upon the following
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`counsel for the Petitioners:
`
`David H. Silverstein: dsilverstein@axinn.com
`Aziz Burgy: aburgy@axinn.com
`Dan Feng Mei: dmei@axinn.com; Ravicti@axinn.com
`Christopher M. Gallo: cgallo@axinn.com
`
`
`Dated: September 28, 2018
`
`
`
`
`
`By:/ M.C. Phillips /
`Matthew C. Phillips
`Registration No. 43,403
`Backup Counsel for Patent Owner
`
`
`
`IPR2017-01767
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`
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`Page 7
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