`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`__________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________
`
`
`LUPIN LTD. AND LUPIN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`HORIZON THERAPEUTICS, LLC,
`Patent Owner
`
`__________
`
`
`Case IPR2018-00459
`Patent 9,561,197
`
`__________
`
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`
`
`
`
`
`
`Pursuant to 37 C.F.R. § 42.63 (e), the Patent Owner hereby provides an
`
`updated exhibit list:
`
`2004
`
`2005
`
`2006
`
`2007
`
`Exhibit
`Description
`No.
`2001 Declaration of Vernon Reid Sutton, M.D.
`2002
`Curriculum vitae of Vernon Reid Sutton, M.D. (“Sutton CV”)
`2003 Marshall Summar et al., “The Incidence of Urea Cycle Disorders,”
`Mol. Gen. Metab. 110, 179-180, 180 (2013) (“Summar 2013”)
`Johannes Haberle et al., “Suggested Guidelines for the Diagnosis and
`Management of Urea Cycle Disorders,” Orphanet J. Rare Dis.,7:32,1-
`30 at 1-2 (2012) (“Haberle 2012”)
`Marshall Summar et al., “Current Strategies for the Management of
`Neonatal Urea Cycle Disorders,” J. Pediatrics, 138(1), S30-S39, S30
`(2001) (“Summar 2001”)
`Ari Auron et al., “Hyperammonemia in Review: Pathophysiology,
`Diagnosis, and Treatment,” Pediatr. Neophrol., Feb. 27(2), 207-222,
`207 (2012) (“Auron”)
` The Management of
`Johannes Haberle, “Clinical Practice:
`Hyperammonemia,” Eur. J. Pediatr. 170:21-34, 21 (2011) (“Haberle
`2011”)
`Marshall Summar et al., “Diagnosis, Symptoms, Frequency and
`Mortality of 260 Patients with Urea Cycle Disorders from a 21-year,
`Multicenter Study of Acute Hyperammonaemic Episodes,” Acta
`Paediatr., 97:1420-1425, 1423, Fig. 3 (2008) (“Summar 2008”)
`2009 Gregory Enns, “Nitrogen Sparing Therapy Revisited 2009,” Mol. Gen.
`Metab. 100:S65-S71, S65 (2010) (“Enns 2009”)
`Fumio Endo et al., “Clinical Manifestations of Inborn Errors of the
`Urea Cycle and Related Metabolic Disorders During Childhood,” J.
`Nutrition, 134(6):1605S-1609S, 1605S-1606S, 1608S (2004) (“Endo”)
`Michael Msall et al., “Neurologic Outcome in Children with Inborn
`Errors of Urea Synthesis: Outcome of Urea Cycle Enzymopathies,”
`New Engl. J. Med., 310(23):1500-1505, 1502 (1984) (“Msall”)
`
`2008
`
`2010
`
`2011
`
`IPR2018-00459
`
`
`
`Page 2
`
`
`
`2012
`
`2013
`
`2016
`
`2017
`
`J.V. Leonard et al., “Urea Cycle Disorders,” Semin. Neonatol. 7:27-35,
`33-34 (2002) (“Leonard”)
`F. Feillet et al., “Alternative Pathway Therapy for Urea Cycle
`Disorders,” J. Inher. Metab. Dis. 21:101-111, 101, 109 (1998)
`(“Feillet”)
`2014 Gerard Berry et al., “Long-Term Management of Patients with Urea
`Cycle Disorders,” J. Pediatr. 138(1):S56-S61, S56 (2001) (“Berry”)
`2015 Nicholas Mew et al., “Urea Cycle Disorders Overview,” GeneReviews,
`1-23 at 3/23-4/23 (2015) (“Mew”)
`Marwan Ghabril et al., “Glycerol Phenylbutyrate in Patients With
`Cirrhosis and Episodic Hepatic Encephalopathy: A Pilot Study of
`Safety and Effect on Venous Ammonia Concentration,” Clin. Pharm.
`Drug Dev. 2(3):278-284 (2013) (“Ghabril”)
`Alain Thibault et al., “Phase I Study of Phenylacetate Administered
`Twice Daily to Patients with Cancer,” Cancer Vol. 75, No. 12, 2932,
`2937 (1995) (“Thibault 1995”)
`M. Mokhtarani et al., “Elevated Phenylacetic Acid Levels Do Not
`Correlate with Adverse Events in Patients with Urea Cycle Disorders
`or Hepatic Encephalopathy and Can Be Predicted Based on the Plasma
`PAA to PAGN Ratio,” Mol. Gen. Metab. 110:446-453, 447 (2013)
`(“Mokhtarani 2013”)
`
`“Specialties in Medical Genetics and Genomics,” Am. Board of
`Medical Genetics and Genomics (last accessed May 22, 2018),
`http://www.abmgg.org/pages/training_options.shtml (“ABMGG”)
`Declaration of Inventor Bruce F. Scharschmidt, M.D., in Support of
`Plaintiff Horizon’s Opposition To Par’s Motion For Summary
`Judgment Of Invalidity Under 35 U.S.C. § 101, Horizon Therapeutics
`LLC v. Par Pharmaceutical, Inc., Case No. 2:17-cv-5901-KM-MAH
`(D.N.J.) (Docket Item 62-3) (“Scharschmidt”)
`June 27, 2018 Settlement Agreement (Confidential).
`
`2018
`
`2019
`
`2020
`
`2021
`
`
`
`/ M.C. Phillips /
`Matthew C. Phillips, Reg. No. 43,403
`Backup Counsel for Patent Owner
`
`IPR2018-00459
`
`
`
`Page 3
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`
`
`I hereby certify that on July 9, 2018, copies of the foregoing PATENT
`
`OWNER’S UPDATED EXHIBIT LIST and all documents filed with it were served
`
`via electronic mail, as agreed to by counsel, upon the following counsel for the
`
`Petitioner:
`
`Elizabeth J. Holland: EHolland@goodwinlaw.com
`
`Cynthia Lambert Hardman: CHardman@goodwinlaw.com
`
`Andrew E. Riley: ARiley@goodwinlaw.com
`
`
`
`/ M.C. Phillips /
`Matthew C. Phillips
`Registration No. 43,403
`
`
`
`
`
`
`
`
`
`IPR2018-00459
`
`
`
`Page 4
`
`
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