`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`PAR PHARMACEUTICAL, INC.,
`Petitioner,
`
`v.
`
`HORIZON THERAPEUTICS, LLC,
`Patent Owner.
`
`_____________________
`
`Case No.: IPR2018-01550
`U.S. Patent No. 9,561,197
`_____________________
`
`PETITIONER PAR PHARMACEUTICAL, INC.’S
`UPDATED EXHIBIT LIST
`
`
`
`
`
`
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`
`1004
`
`1005
`
`1006
`
`Exhibit
`Description
`No.
`1001 Scharschmidt, B. and Mokhtarani, M., U.S. Patent No. 9,561,197 (filed
`Sept. 11, 2012; issued Feb. 7, 2017) (“the ’197 patent”)
`1002 Declaration of Neal Sondheimer, M.D., Ph.D.
`1003 Curriculum Vitae of Neal Sondheimer, M.D., Ph.D.
`Lee, B., et al., Phase 2 Comparison of a Novel Ammonia Scavenging
`Agent with Sodium Phenylbutyrate in Patients with Urea Cycle
`Disorders: Safety, Pharmacokinetics and Ammonia Control,
`MOLECULAR GENETICS METABOLISM, 100: 221-28 (2010) (“Lee”)
`Praphanphoj, V., et al., Three Cases of Intravenous Sodium Benzoate
`and Sodium Phenylacetate Toxicity Occurring in the Treatment in the
`Treatment of Acute Hyperammonaemia, J. INHERIT. METAB. DIS., 23:
`129-36 (2000) (“Praphanphoj”)
`Thibault, A., et al., A Phase I and Pharmacokinetic Study of
`Intravenous Phenylacetate in Patients with Cancer, CANCER
`RESEARCH, 54: 1690-94 (1994) (“Thibault”)
`Carducci, M.A., et al., A Phase I Clinical and Pharmacological
`Evaluation of Sodium Phenylbutyrate on an 120-h Infusion Schedule,
`CLINICAL CANCER RESEARCH, 7: 3047-55 (2001) (“Carducci”)
`Msall, M., et al., Neurologic Outcome in Children with Inborn Errors
`of Urea Synthesis — Outcome of Urea-Cycle Enzymopathies, NEW
`ENGLAND JOURNAL OF MEDICINE, 310: 1500-05 (1984)
`1009 File History for U.S. Patent No. 9,561,197
`MacArthur, R.B., et al., Pharmacokinetics of Sodium Phenylacetate
`and Sodium Benzoate Following Intravenous Administration As Both a
`Bolus and Continuous Infusion to Healthy Adult Volunteers,
`MOLECULAR GENETICS AND METABOLISM, 81: S67-S73 (2004)
`McGuire, B.M., et al., Pharmacology and Safety of Glycerol
`Phenylbutyrate in Healthy Adults and Adults with Cirrhosis,
`HEPATOLOGY, 51: 2077-85 (2010)
`1012 Buxton, I.L.O., Goodman & Gilman’s: The Pharmacological Basis of
`Therapeutics, 1-39 (L. Brunton et al., eds., 11th ed. 2006)
`1013 Ravicti Product Label, Revised: Apr. 2017
`
`1010
`
`1007
`
`1008
`
`1011
`
`1
`
`
`
`
`
`Description
`
`Exhibit
`No.
`1014 Buphenyl Label, Revised: Apr. 2008
`1015 Ammonul Label, Revised: Feb. 2005
`1016 Center for Drug Evaluation and Research, NDA No. 203284, Summary
`Review
`1017 Feillet, F. and Leonard, J.V., Alternative Pathway Therapy for Urea
`Cycle Disorders, J. INHER. METAB. DIS., 21: 101-11 (1998).
`1018 Fernandes, J., et al., Inborn Metabolic Diseases Diagnosis and
`Treatment, 214-222 (J. Fernandes et al., eds., 3d ed. 2000)
`1019 Scientific Discussion for Ammonaps, EMEA, 1-12 (2005)
`1020 Scharschmidt, B., U.S. Patent Appl. Pub. No. 2010/0008859 (filed Jan.
`7, 2009; published Jan. 14, 2010)
`1021 Scharschmidt, B., U.S. Patent Appl. Pub. No. 2012/0022157 (filed
`Aug. 27, 2009; published Jan. 26, 2012)
`1022 Brusilow, Phenylacetylglutamine May Replace Urea as a Vehicle for
`Waste Nitrogen Excretion, PEDIATRIC RESEARCH, 29: 147-50 (1991)
`1023 Brusilow, S.W., U.S. Patent No. 5,968,979 (filed Jan. 13, 1998; issued
`Oct. 19, 1999)
`Yang, D., et al., Assay of the Human Liver Citric Acid Cycle Probe
`Phenylacetylglutamine and of Phenylacetate in Plasma by Gas
`Chromatography-Mass Spectrometry, ANALYTICAL BIOCHEMISTRY,
`212: 277-82 (1993)
`Yamaguchi, M. and Nakamura, M., Determination of Free and Total
`Phenylacetic Acid in Human and Rat Plasma by High-Performance
`Liquid Chromatography with Fluorescence Detection, CHEM. PHARM.
`BULL., 35: 3740-45 (1987)
`Laryea, M.D., et al., Simultaneous LC-MS/MS Determination of
`Phenylbutyrate, Phenylacetate Benzoate and their Corresponding
`Metabolites Phenylacetylglutamine and Hippurate in Blood and
`Urine, J. INHERITED METABOLIC DISEASES, 33: S321-S328 (2010)
`
`1024
`
`1025
`
`1026
`
`2
`
`
`
`
`
`Exhibit
`No.
`
`Description
`
`1027
`
`1028
`
`1029
`
`Ravicti Orange Book Entry, available at
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?
`Product_No=001&Appl_No=203284&Appl_type=N (last accessed
`June 19, 2018)
`PubChem Open Chemistry Database, Compound Summary for CID
`999, Phenylacetic Acid, available at
`https://pubchem.ncbi.nlm.nih.gov/compound/phenylacetic_acid (last
`accessed August 16, 2018)
`PubChem Open Chemistry Database, Compound Summary for CID
`92258, Phenylacetylglutamine, available at
`https://pubchem.ncbi.nlm.nih.gov/compound/Phenylacetylglutamine
`(last accessed August 16, 2018)
`Buphenyl Approval Information, available at
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=
`overview.process&ApplNo=020573 (last accessed August 16, 2018)
`Ammonul Approval Information, available at
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=
`overview.process&ApplNo=020645 (last accessed August 16, 2018)
`1032 Biochemistry, 426-59 (Reginald H. Garrett & Charles M. Grisham,
`eds., 2nd ed. 1999)
`Affidavit of Christopher M. Gallo in Support of Petitioner’s Motion to
`Accept Filing of Petition for Inter Partes Review of U.S. Patent
`No. 9,561,197 on August 16, 2018 Under 37 C.F.R. § 42.6(b)
`1034 August 16, 2018 Email from D. Silverstein to R. Green et al., re: Inter
`Partes Review of U.S. Patent No. 9,561,197
`1035 August 16, 2018 Email from D. Silverstein to Trials@uspto.gov,
`re: Inter Partes Review of U.S. Patent No. 9,561,197
`1036 FedEx proofs of delivery for service documents shipped
`August 16, 2018
`1037 August 21, 2018 Email from A. Kellogg to D. Silverstein, re: Inter
`Partes Review of U.S. Patent No. 9,561,197
`
`1030
`
`1031
`
`1033
`
`3
`
`
`
`
`
`Exhibit
`Description
`No.
`1038 August 20, 2018 Email from D. Silverstein to R. Green et al., re: Inter
`Partes Review of U.S. Patent No. 9,561,197
`
`
`Dated: August 21, 2018
`
`
`
`David H. Silverstein (Reg. No. 61,948)
`AXINN, VELTROP & HARKRIDER LLP
`114 West 47th Street, 22nd Floor
`New York, NY 10036
`(212) 261-5651
`
`Counsel for Petitioner
`Par Pharmaceutical, Inc.
`
`4
`
`
`
`
`
`CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(e))
`The undersigned hereby certifies that the above-captioned “PETITIONER
`
`PAR PHARMACEUTICAL, INC.’S UPDATED EXHIBIT LIST,” including its
`
`supporting evidence (Exhibits 1033 – 1038), was served in its entirety on
`
`August 21, 2018 upon the following parties via FedEx®, a means at least as fast
`
`and reliable as Priority Mail Express®:
`
`Global Patent Group – HOR
`17014 New College Avenue
`Suite 201
`St. Louis, MO 63040
`
`Patent owner’s correspondence
`address of record for U.S. Patent
`No. 9,561,197
`
`
`
`Dated: August 21, 2018
`
`
`
`
`Robert Green
`Caryn Borg-Breen
`Emer Simic
`Ann Kotze
`Rachel Bell
`GREEN GRIFFITH & BORG-BREEN LLP
`676 North Michigan Avenue
`Suite 3900
`Chicago, Illinois 60611
`(312) 883-8000
`rgreen@greengriffith.com
`cborg-breen@greengriffith.com
`esimic@greengriffith.com
`akotze@greengriffith.com
`rbell@greengriffith.com
`
`Additional addresses known to
`Petitioner as likely to effect service
`
`
`David H. Silverstein (Reg. No. 61,948)
`AXINN, VELTROP & HARKRIDER LLP
`114 West 47th Street, 22nd Floor
`New York, NY 10036
`(212) 261-5651
`Counsel for Petitioner
`Par Pharmaceutical, Inc.
`
`
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