UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`
`
`
`PAR PHARMACEUTICAL, INC.,
`Petitioner,
`
`v.
`
`HYPERION THERAPEUTICS, INC.,
`Patent Owner.
`
`_____________________
`
`Case IPR2015-01117
`Patent 8,642,012
`_____________________
`
`PETITIONER’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
`
`
`
`
`
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`
`
`
`PAR PHARMACEUTICAL, INC.,
`Petitioner,
`
`v.
`
`HYPERION THERAPEUTICS, INC.,
`Patent Owner.
`
`_____________________
`
`Case IPR2015-01117
`Patent 8,642,012
`_____________________
`
`PETITIONER’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
`
`
`
`
`
`
`
` IPR2015-01117
`Patent No. 8,642,012
`Petitioner’s Updated Exhibit List
`
`Pursuant to 37 C.F.R. § 42.63(e), the Petitioner hereby provides an updated
`
`exhibit list:
`
`Exhibit #
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`Description
`
`U.S. Patent No. 8,642,012 to Scharschmidt (“the ’012 patent),
`filed January 7, 2009, issued February 4, 2014.
`
`Declaration of Dr. Neal Sondheimer.
`
`Curriculum vitae of Dr. Neal Sondheimer.
`
`Reserved.
`
`Simell, et al., Waste Nitrogen Excretion Via Amino Acid
`Acylation: Benzoate and Phenylacetate in Lysinuric Protein
`Intolerance, 20 Pediatric Research, 1117–1121 (1986).
`(“Simell”).
`
`Reserved.
`
`Reserved.
`
`Reserved.
`
`Reserved.
`
`Reserved.
`
`Fernandes, Saudubray Berghe (editors), Inborn Metabolic
`Diseases Diagnosis and Treatment, 219–220 (3d ed. 2000).
`(“Fernandes”).
`
`Brusilow, Phenylacetylglutamine May Replace Urea as a
`Vehicle for Waste Nitrogen Excretion, 29 Pediatric Research,
`147–150 (1991). (“Brusilow ’91”).
`
`1013
`
`Reserved.
`
`
`
`
`
` IPR2015-01117
`Patent No. 8,642,012
`Petitioner’s Updated Exhibit List
`
`
`Exhibit #
`
`Description
`
`1014
`
`Reserved.
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`Kasumov, et al., New Secondary Metabolites of Phenylbutyrate
`in Humans and Rats, 32 Drug Metabolism and Disposition, 10–
`19 (2004). (“Kasumov”).
`
`Sherwin, et al., The Maximum Production of Glutamine by the
`Human Body as Measured by the Output of
`Phenylacetylglutamine, 37 J. Biol. Chem., 113–119 (1919).
`(“Sherwin”).
`
`Shiple, et al.., Synthesis of Amino Acids in Animal Organisms. I.
`Synthesis of Glycocoll and Glutamine in the Human Organism,
`44 J. American Chem. Society, 618–624 (1922). (“Shiple”).
`
`U.S. Patent No. 4,284,647 to Brusilow et al., filed March 31,
`1980, issued August 18, 1981 (“the ’647 patent”).
`
`Reserved.
`
`Reserved.
`
`Prosecution History of the ’012 patent.
`
`Joint Claim Construction filed March 13, 2015 in Eastern
`District of Texas District Court, Case 2:14-cv-00384.
`
`Piscitelli, et al., Disposition of Phenylbutyrate and its
`Metabolites, Phenylacetate and Phenylacetylglutamine, 35 J.
`Clin. Pharmacol., 368–373 (1995). (“Piscitelli”).
`
`1024
`
`Reserved.
`
`1025
`
`Comte, et al., Identification of phenylbutyrylglutamine, a new
`metabolite of phenylbutyrate metabolism in humans, 37 J. Mass.
`Spectrom. 581–90 (2002). (“Comte”).
`
`
`
`
`
` IPR2015-01117
`Patent No. 8,642,012
`Petitioner’s Updated Exhibit List
`
`
`Exhibit #
`
`Description
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`
`1037
`
`U.S. Patent No. 5,968,979 to Brusilow, filed Feb. 7, 1995,
`issued Oct. 19, 1999 (“the ’979 patent”).
`
`Collins et al., Oral Sodium Phenylbutyrate Therapy in
`Homozygous β Thalassemia: A Clinical Trial, 85 Blood 43
`(1995). (“Collins”).
`
`Declaration of Barry Gilman.
`
`Declaration of Dr. Neal Sondheimer, Ex. 1002 previously filed
`in IPR2015-01117. (Deposition Exhibit, Not Filed)
`
`Declaration of Dr. Neal Sondheimer, Ex. 1002 previously filed
`in IPR2015-01127. (Deposition Exhibit, Not Filed)
`
`Current curriculum vitae of Dr. Neal Sondheimer, prepared
`January 23, 2016. (Deposition Exhibit, Not Filed)
`
`API website printout re sodium phenylbutyrate. (Deposition
`Exhibit, Not Filed)
`
`Deardorff, M. et al., Complex Management of a Patient with a
`Contiguous Xp11.4 Gene Deletion Involving Ornithine
`Transcarbamylase: A Role for Detailed Molecular Analysis in
`Complex Presentations of Classical Diseases, 94(4) Mol. Genet.
`Metab. 498-502 (2008). (Deposition Exhibit, Not Filed)
`
`Reserved.
`
`Reserved.
`
`Reserved.
`
`Dawson-Saunders, B. et al., Basic & Clinical Biostatistics, 46
`(Appelton & Lange, 2d ed. 1994).
`
`1038
`
`Reserved.
`
`
`
`
`
` IPR2015-01117
`Patent No. 8,642,012
`Petitioner’s Updated Exhibit List
`
`
`Exhibit #
`
`Description
`
`1039
`
`Mokhtarani, M. 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, 110(4) Mol. Genet.
`Metab. 446-453 (2013).
`
`1040
`
`Kingsbury, F. et al., A Rapid Method for the Determination of
`Hippuric Acid in Urine, 48 J. Biol. Chem. 13-20 (1921)
`
`Respectfully Submitted,
`/David H. Silverstein/
`David H. Silverstein
`Registration No. 61,948
`Attorney for Petitioner
`Par Pharmaceutical, Inc.
`
`
`
`
`Date: May 27, 2016
`Axinn, Veltrop & Harkrider LLP
`950 F Street, N.W.
`Washington, DC 20004
`Tel: (202) 912-4700
`
`
`
`
`
`CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(e), 42.105(a))
`
` IPR2015-01117
`Patent No. 8,642,012
`Certificate of Service
`
`
`The undersigned hereby certifies that the above-captioned “PETITIONER’S
`
`UPDATED EXHIBIT LIST” and Exhibits 1037-1040 were served in their entirety
`
`on May 27, 2016 through the Patent Review Processing System, and additionally
`
`upon the following parties via Electronic Mail:
`
`
`
`Lauren Stevens: lstevens@horizonpharma.com
`Matthew C. Phillips: matthew.phillips@renaissanceiplaw.com
`Dennis Bennett: dennisbennett@globalpatentgroup.com
`
`Robert Green: rgreen@greengriffith.com
`Emer Simic: esimic@greengriffith.com
`Jessica Tyrus: jtyrus@greengriffith.com
`
`
`Date: May 27, 2016
`Axinn, Veltrop & Harkrider LLP
`950 F Street, N.W.
`Washington, DC 20004
`Tel: (202) 912-4700
`
`Respectfully Submitted,
`/David H. Silverstein/
`David H. Silverstein
`Registration No. 61,948
`Attorney for Petitioner
`Par Pharmaceutical, Inc.
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