`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`PAR PHARMACEUTICAL, INC.,
`Petitioner,
`
`v.
`
`HORIZON THERAPEUTICS, INC.,
`Patent Owner.
`
`_____________________
`
`Case IPR: Unassigned
`Patent 9,254,278
`_____________________
`
`PETITIONER PAR PHARMACEUTICAL, INC.’S 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
`
`
`
`
`
`
`
`Inter Partes Review of USPN 9,254,278
`Par Exhibit List
`
`List of Exhibits and Abbreviations for Exhibits
`
`ABBREVIATION
`(if applicable)
`
`the ’278 Patent
`
`
`
`
`
`the ’859 Publication
`
`Moser
`
`Blau
`
`Simell
`
`Feillet
`
`DESCRIPTION
`
`U.S. Patent No. 9,254,278 to Scharschmidt
`et al., filed August 3, 2015, issued February
`9, 2016
`
`Declaration of Dr. Neal Sondheimer
`
`Curriculum vitae of Dr. Neal Sondheimer
`
`U.S. Patent Publication No. 2010/0008859,
`filed January 7, 2009, published January 14,
`2010
`
`Moser et al., Argininoscuccinic Aciduria
`Report of Two New Cases and
`Demonstration of Intermittent Elevation of
`Blood Ammonia, 42 Am. J. Medicine, 9-26
`(1967)
`
`Blau, Duran, Blaskovics, Gibson (editors),
`Physician’s Guide to the Laboratory
`Diagnosis of Metabolic Diseases, 261–276
`(2d ed. 1996)
`
`Simell et al., Waste Nitrogen Excretion Via
`Amino Acid Acylation: Benzoate and
`Phenylacetate in Lysinuric Protein
`Intolerance, 20 Pediatric Research, 1117–
`1121 (1986)
`
`Feillet et al., Alternative Pathway Therapy
`for Urea Cycle Disorders, 21 Journal of
`Inherited Metabolic Disease Suppl 1, 101-
`111 (1998)
`
`1
`
`EXHIBIT
`NO.
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`
`
`
`
`
`
`
`
`EXHIBIT
`NO.
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`Inter Partes Review of USPN 9,254,278
`Par Exhibit List
`
`DESCRIPTION
`
`Scientific Discussion for Ammonaps,
`EMEA, 1-12 (2005)
`
`Lee 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, 100 Molecular Genetics
`and Metabolism, 221-228 (2010)
`
`Buphenyl Label
`
`ABBREVIATION
`(if applicable)
`
`Ammonaps
`
`Lee
`
`
`
`Prosecution History of U.S. Patent
`No. 8,404,215
`
`the ’215 Parent
`Patent
`
`Assignment History of U.S. Patent 8,642,012
`
`’278 Patent Infringement Complaint with
`Return of Service
`
`Fernandes et al., Inborn Metabolic Diseases
`Diagnosis and Treatment, 214-22 (J.
`Fernandes et al., eds., 3d ed. 2002)
`
`Leonard et al., Hypothesis: Proposals for
`the Management of a Neonate at Risk of
`Hyperammonaemia Due to a Urea Cycle
`Disorder, 167 Eur. J. Pediatr. 305-309
`(2008)
`
`Lichter-Konecki et al., Ammonia Control in
`Children with Urea Cycle Disorders
`(UCDs): Phase 2 Comparison of Sodium
`Phenylbutyrate and Glycerol
`Phenylbutyrate, 103 Molecular Genetics and
`Metabolism, 323-329 (2011)
`
`
`
`
`
`Fernandes
`
`Leonard 2008
`
`Lichter-Konecki
`
`
`
`2
`
`
`
`
`
`EXHIBIT
`NO.
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`Inter Partes Review of USPN 9,254,278
`Par Exhibit List
`
`DESCRIPTION
`
`Pandya et al., N-Acetylglutamate Synthetase
`Deficiency: Clinical and Laboratory
`Observations, 14 J. Inher. Metab. Dis. 685-
`690 (1991)
`
`U.S. Patent No. 5,968,979
`
`McGuire et al., Pharmacology and Safety of
`Glycerol Phenylbutyrate in Healthy Adults
`and Adults with Cirrhosis, 51(6) Hepatology
`2077-2085 (2010)
`
`Diaz et al., Phase 3 Blinded, Randomized,
`Crossover Comparison of Sodium
`Phenylbutyrate (NaPBA) and glycerol
`phenylbutyrate (GPB): Ammonia (NH3)
`Control in Adults with Urea Cycle Disorders
`(UCDs), 102 Molecular Genetics and
`Metabolism 276-77 (2011)
`
`Barsotti, Measurement of Ammonia in Blood,
`138 J. Pediatrics, S11-S20 (2001)
`
`Yajima, et al., Diurnal Fluctuations of Blood
`Ammonia Levels in Adult-Type
`Citrullinemia, 137 Tokohu J. Ex/ Med, 213-
`220 (1982)
`
`Batshaw, et al., Treatment of Carbamyl
`Phosphate Synthetase Deficiency with Keto
`Analogues of Essential Amino Acids, 292
`New Eng. J. Med. 1085−90 (1975)
`
`ABBREVIATION
`(if applicable)
`
`Pandya
`
`the ’979 patent
`
`McGuire
`
`Diaz
`
`Barsotti
`
`Yajima
`
`Batshaw
`
`
`
`3
`
`
`
`
`
`EXHIBIT
`NO.
`
`1025
`
`Inter Partes Review of USPN 9,254,278
`Par Exhibit List
`
`DESCRIPTION
`
`Brusilow, Phenylacetylglutamine May
`Replace Urea as a Vehicle for Waste
`Nitrogen Excretion, 29 Pediatric Research,
`147-150 (1991)
`
`ABBREVIATION
`(if applicable)
`
`Brusilow ’91
`
`
`
`Date: July 13, 2017
`AXINN, VELTROP &
`HARKRIDER LLP
`114 WEST 47TH STREET,
`24TH FLOOR
`NEW YORK, NY 10036
`TEL: 212-261-5651
`
`
`
`
`Respectfully Submitted,
`
`
`David H. Silverstein
`Registration No. 61,948
`Attorney for Petitioner
`Par Pharmaceutical, Inc.
`
`
`
`4
`
`
`
`Inter Partes Review of USPN 9,254,278
`Par Exhibit List
`Certificate of Service
`
`
`CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(e), 42.105(a))
`
`The undersigned hereby certifies that the above-captioned “Petitioner Par
`
`Pharmaceutical, Inc.’s Exhibit List,” along with Exhibits 1001 –1025 were served
`
`in their entirety on July 13, 2017 upon the following parties via FEDEX, a means
`
`at least as fast and reliable as Priority Mail Express®:
`
`
`
`Horizon Therapeutics, LLC
`520 Lake Cook Rd.
`Suite 520
`Deerfield, IL 60015
`
`Horizon Therapeutics, LLC
`150 S. Saunders Rd.
`Lake Forest, IL 60045
`
`Duane Morris LLP
`5100 Town Center Circle
`Suite 650
`Boca Raton, FL 33486
`
`Global Patent Group, LLC
`17014 New College Avenue
`Suite 201
`Grover, MO 63040
`
`Patent owner’s correspondence
`address of record for U.S. Patent
`No. 9,254,278
`
`
`
`
`
`
`Dennis Bennett:
`dennisbennett@globalpatentgroup.com
`
`Robert Green: rgreen@greengriffith.com
`Emer Simic: esimic@greengriffith.com
`Ann Kotze: akotze@greengriffith.com
`
`Additional addresses known to
`Petitioner as likely to effect service
`
`1
`
`
`
`Inter Partes Review of USPN 9,254,278
`Par Exhibit List
`Certificate of Service
`
`
`Respectfully Submitted,
`
`
`David H. Silverstein
`Registration No. 61,948
`Attorney for Petitioner
`Par Pharmaceutical, Inc.
`
`
`
`Date: July 13, 2017
`AXINN, VELTROP &
`HARKRIDER LLP
`114 WEST 47TH STREET,
`24TH FLOOR
`NEW YORK, NY 10036
`TEL: 212-261-5651
`
`
`
`
`
`2
`
`
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