`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`PAR PHARMACEUTICAL, INC.,
`Petitioner,
`
`v.
`
`HORIZON THERAPEUTICS, LLC,
`Patent Owner.
`
`_____________________
`
`Case IPR2017-01769
`Patent 9,326,966
`_____________________
`
`PETITIONER’S OBJECTIONS UNDER 37 C.F.R. § 42.64
`TO EVIDENCE SUBMITTED BY PATENT OWNER
`
`
`
`
`
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`IPR2017-01769
`Patent No. 9,326,966
`Par’s Objections to Evidence
`
`Pursuant to 37 C.F.R. §42.64(b)(1), Petitioner Par Pharmaceutical, Inc.
`
`
`
`(“Petitioner”) objects as follows to the admissibility of evidence submitted by
`
`Patent Owner Horizon Therapeutics, LLC (“Patent Owner”) on May 9, 2018 in
`
`connection with Horizon Therapeutics, LLC’s Response to Petition for Inter Partes
`
`Review (Paper No. 22, “Patent Owner’s Response”).
`
`In this paper, a reference to “FRE” means the Federal Rules of Evidence, a
`
`reference to “CFR” means the Code of Federal Regulations, and “’966 patent”
`
`means U.S. Patent No. 9,326,966. All objections under FRE 802 (hearsay) apply
`
`to the extent Patent Owner relies on the exhibits identified in connection with that
`
`objection for the truth of the matter asserted therein.
`
`Exhibit descriptions provided in this table are as listed in Patent Owner’s
`
`Updated Exhibit List (Paper No. 23) and are used for identification purposes only.
`
`The use of the description does not indicate that Petitioner agrees with the
`
`descriptions or characterizations of the documents.
`
`Exhibit
`2001
`
`2002
`
`2003
`
`Description
`Statutory Disclaimer under 37 C.F.R. § 1.321(a) of
`claims 12, 14 and 15 of U.S. Patent 9,326,966, filed
`June 28, 2017.
`Notice of Allowance dated March 8, 2016,
`Prosecution History of U.S. Patent No. 9,326,966.
`Dixon et al., “Intercurrent Illness in Inborn Errors of
`Intermediary Metabolism,” 67 Archives of Disease in
`Childhood, 1387-1391 (1992) (“Dixon”).
`
`Objection
`A, B, G, K,
`L, N, O
`
`A, B, G, K,
`L, M, N, O
`A, B, K, L,
`N, O
`
`1
`
`
`
`
`
`2004
`
`2005
`
`2006
`
`2007
`2008
`
`2009
`
`2010
`
`2011
`
`2012
`
`2013
`
`IPR2017-01769
`Patent No. 9,326,966
`Par’s Objections to Evidence
`
`Rani H. Singh et al., “Nutritional Management of Urea
`Cycle Disorders,” Crit. Care. Clin. 21:S27-35 (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, M.D.
`
`Curriculum vitae of Dr. Gregory M. Enns, M.D.
`Ari Auron, Patrick D. Brophy, “Hyperammonemia in
`Review: Pathophysiology, Diagnosis, and Treatment,”
`Pediatric Nephrology, 27:207-22 (2012). (“Auron”).
`Mark L. Batshaw, et al., “Alternative Pathway
`Therapy for Urea Cycle Disorders: Twenty Years
`Later,” J. Pediatrics, 38:S46-S55 (2001). (“Batshaw”).
`Nancy E. Maestri, et al., “Prospective Treatment of
`Urea Cycle Disorders,” J. of Pediatrics, 119:923-28,
`no. 6 (1991). (“Maestri”).
`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”).
`U.S. Patent Publication 2012/0022157 A1, filed
`August 27, 2009, published January 26, 2012. (“’157
`App”).
`Mendel Tuchman & Mark L. Batshaw, “Management
`of Inherited Disorders of Ureagenesis,” The
`Endocrinologist 12:99–109, no. 2 (2002).
`(“Tuchman”).
`
`A, B, K, L,
`M, N, O
`
`A, B, G, K,
`L, M, N, O
`
`A, B, K, L,
`N
`A, K, L, N
`A, B, C, E,
`K, L, N, O
`
`A, B, K, L,
`N, O
`
`A, B, K, L,
`M, N, O
`
`A, B, K, L,
`M, N, O
`
`A, B, C, E,
`K, L, N, O
`
`A, B, K, L,
`N, O
`
`2
`
`
`
`
`
`2014
`
`2015
`
`2016
`
`2017
`
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`IPR2017-01769
`Patent No. 9,326,966
`Par’s Objections to Evidence
`
`Guoyao Wu, “Amino Acids: Metabolism, Functions,
`and Nutrition,” Amino Acids 37:1–17 (2009). (“Wu”).
`
`Alexander Broomfield & Stephen 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 (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”).
`J.V. Leonard & A. A. M. Morris, “Urea Cycle
`Disorders,” Seminars in Neonatology 7:27–35 (2002).
`(“Leonard 2002”).
`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”).
`
`A, B, C, E,
`K, L, M, N,
`O
`A, B, C, E,
`K, L, N, O
`
`A, B, K, L,
`N, O
`
`A, B, C, E,
`K, L, N, O
`
`A, B, K, L,
`N, O
`
`A, B, C, E,
`K, L, N, O
`
`A, B, C, E,
`K, L, N, O
`
`A, B, N
`
`A, B, K, L,
`M, N, O
`
`3
`
`
`
`
`
`2023
`
`2024
`
`2025
`
`2026
`
`2027
`
`2028
`
`2029
`
`2030
`
`IPR2017-01769
`Patent No. 9,326,966
`Par’s Objections to Evidence
`
`Marshall Summar & Mendel Tuchman, “Proceedings
`of a Consensus Conference for the Management of
`Patients with Urea Cycle Disorders,” J. Pediatrics,
`138:S6–S10 (2001). (“Summar”).
`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
`(2001). (“Consensus”).
`“Specialties of Genetics,” Am. Board of Medical
`Genetics and Genomics (last accessed Jan. 17, 2017),
`http://abmgg.org/pages/training_options.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 Journal 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”).
`Michael Msall, et al., “Neurologic Outcome in
`Children with Inborn Errors of Urea Synthesis,” The
`New England Journal of Medicine 310:1500–1505
`(1984). (“Msall”).
`
`A, B, K, L,
`M, N, O
`
`A, B, K, L,
`M, N, O
`
`A, B, K, L,
`N, O
`
`A, B, C, E,
`K, L, N, O
`
`A, B, C, E,
`K, L, M, N,
`O
`
`A, B, K, L,
`M, N, O
`
`A, B, C, E,
`K, L, M, N,
`O
`
`A, B, K, L,
`M, N, O
`
`4
`
`
`
`
`
`2031
`
`2032
`
`2033
`
`2034
`
`2035
`
`2036
`
`2037
`
`2038
`
`IPR2017-01769
`Patent No. 9,326,966
`Par’s Objections to Evidence
`
`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”).
`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”).
`Marshall Summar, “Current Strategies for the
`Management of Neonatal Urea Cycle Disorders,” J.
`Pediatrics 138:S30–S39 (2001). (“Summar 2001”).
`Marshall L. Summar, et al., “The Incidence of Urea
`Cycle Disorders,” Molecular Genetics and
`Metabolism 110:179–180 (2013). (“Summar 2013”).
`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”).
`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)
`
`A, B, K, L,
`N, O
`
`A, B, K, L,
`N, O
`
`A, B, C, E,
`K, L, M, N,
`O
`
`A, B, K, L,
`N, O
`
`A, B, C, E,
`K, L, N, O
`
`A, B, C, E,
`K, L, N, O
`
`A, B, K, L,
`N, O
`
`A, B, C, E,
`K, L, N, O
`
`5
`
`
`
`IPR2017-01769
`Patent No. 9,326,966
`Par’s Objections to Evidence
`
`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
`/2017/203284s005lbl.pdf. (“Ravicti Label”).
`
`A, B, C, E,
`K, L, N, O
`
`A, B, C, E,
`K, L, M, N,
`O
`
`Transcript of April 19, 2018 Deposition of Dr. Neal
`Sondheimer
`
`A, G, H, K,
`L1
`
`
`
`2039
`
`2040
`
`2046
`
`
`
`Objection Key:
`
`A:
`B:
`C:
`
`D:
`
`E:
`
`F:
`
`G:
`
`FRE 802 (hearsay).
`FRE 901 (lacking authentication).
`FRE 402 (relevance) the document is not relevant to any issue in this
`IPR proceeding because the purported date of the document is after the
`filing date of the ’966 patent or the prior art status is not clear.
`FRE 402 (relevance) to the extent the document is relied upon for
`secondary considerations of nonobviousness, there is no nexus to the
`claimed compositions and methods.
`FRE 403 (confusing, waste of time) the document is not relevant to any
`issue in this IPR proceeding because the purported date of the document
`is after the filing date of the ’966 patent or the prior art status is not clear.
`FRE 403 (confusing, waste of time) to the extent the document is relied
`upon for secondary considerations of nonobviousness, there is no nexus
`to the claimed compositions and methods.
`FRE 106 (completeness) the document is incomplete and includes only a
`select portion of a larger document that in fairness should be considered
`along with this document.
`
`
`1 Par also maintains each of its objections as stated in the April 19, 2018
`Deposition of Dr. Neal Sondheimer.
`
`6
`
`
`
`IPR2017-01769
`Patent No. 9,326,966
`Par’s Objections to Evidence
`
`FRE 1001-1003 (best evidence).
`FRE 403, 901 (improper compilation).
`FRE 403 (cumulative).
`FRE 402 (relevance) the document is not relevant to any issue in this
`IPR proceeding.
`FRE 403 (confusing, waste of time) the document is not relevant to any
`issue in this IPR proceeding.
`Exhibit not cited in Patent Owner’s Response.
`FRE 602 (lack of personal knowledge).
`FRE 702/703 to the extent that the patent owner seeks to rely on
`statements made in an exhibit as improper expert opinion, the exhibit is
`objected to on the grounds that it: (i) is not based on sufficient facts or
`data; and/or (ii) is not the product of reliable principles and methods;
`and/or (iii) is unreliable because the exhibit is not of a type reasonably
`relied upon by experts in the field.
`FRE 1006 (improper summary).
`
`
`
`H:
`I:
`J:
`K:
`
`L:
`
`M:
`N:
`O:
`
`P:
`
`
`
`
`Dated: May 16, 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
`
`Attorney for Petitioner
`Par Pharmaceutical, Inc.
`
`7
`
`
`
`
`
`IPR2017-01769
`Patent No. 9,326,966
`Certificate of Service
`
`CERTIFICATION OF SERVICE
`The undersigned hereby certifies that the above-captioned “PETITIONER’S
`
`OBJECTIONS UNDER 37 C.F.R. § 42.64 TO EVIDENCE SUBMITTED BY
`
`PATENT OWNER” was served in its entirety on May 16, 2018 through the Patent
`
`Trial and Appeal Board End to End (PTAB E2E) system, and additionally upon the
`
`following parties via Electronic Mail, as agreed to by counsel:
`
`Robert Green: rgreen@greengriffith.com
`Matthew Phillips: mphillips@lpiplaw.com
`Emer Simic: esimic@greengriffith.com
`Dennis Bennett: dennisbennett@globalpatentgroup.com
`
`
`Dated: May 16, 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
`
`Attorney for Petitioner
`Par Pharmaceutical, Inc.
`
`
`
`
`
`
`
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