`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`PAR PHARMACEUTICAL, INC.,
`Petitioner,
`
`v.
`
`HORIZON THERAPEUTICS, LLC,
`Patent Owner.
`
`_____________________
`
`Case IPR2017-01767
`Patent 9,254,278
`_____________________
`
`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
`
`
`
`
`
`IPR2017-01767
`Patent No. 9,254,278
`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 supplemental evidence
`
`submitted by Patent Owner Horizon Therapeutics, LLC (“Patent Owner”) on
`
`May 31, 2018. Petitioner maintains each of its objections to Exhibits 2002-2046 as
`
`stated in Petitioner’s Objections Under 37 C.F.R. § 42.64 to Evidence Submitted
`
`by Patent Owner, dated May 16, 2018 (Paper No. 24).
`
`In this paper, a reference to “FRE” means the Federal Rules of Evidence, a
`
`reference to “CFR” means the Code of Federal Regulations, and “’278 patent”
`
`means U.S. Patent No. 9,254,278. 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, dated May 31, 2018 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
`2047
`
`2048
`
`Description
`RESERVED for Alexander Broomfield & Stephanie
`Grunewald, “How to use Serum Ammonia,” Archives
`of Disease in Childhood—Education and Practice
`97:72–77 (2012), with reference list included.
`(“Broomfield with references”).
`RESERVED for Guoyao Wu, “Amino Acids:
`Metabolism, Functions, and Nutrition,” Amino Acids
`
`Objection
`A, B, C, E,
`K, L, N, O
`
`A, B, C, E,
`K, L, M, N,
`
`1
`
`
`
`IPR2017-01767
`Patent No. 9,254,278
`Par’s Objections to Evidence
`
`37:1–17 (2009), print version. (“Wu Print”).
`RESERVED for Alexander Broomfield & Stephanie
`Grunewald, “How to use Serum Ammonia,” Archives
`of Disease in Childhood—Education and Practice
`97:72–77 (2012), print version. (“Broomfield Print”).
`RESERVED for Gregory M. Enns, “Nitrogen Sparing
`Therapy Revisited 2009,” Molecular Genetics and
`Metabolism 100:S65–S71 (2010), print version.
`(“Enns 2010 Print”).
`RESERVED for Johannes Häberle, “Clinical Practice:
`The Management of Hyperammonemia,” Eur. J. of
`Pediatrics 170:21–34 (2011), print version. (“Häberle
`Clinical Print”).
`RESERVED for 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), print
`version. (“Summar 2008 Print”).
`RESERVED for Gregory M. Enns, “Neurologic
`Damage and Neurocognitive Dysfunction in Urea
`Cycle Disorders,” Seminars in Pediatric Neurology,
`15:132-139 (2008), print version. (“Enns 2008 Print”).
`RESERVED for Declaration of Ann K. Kotze In
`Response to Petitioner’s Objections to Evidence.
`RESERVED for Declaration of Dr. Gregory Enns In
`Response to Petitioner’s Objections to Evidence.
`RESERVED for Marshall L. Summar, et al., “The
`Incidence of Urea Cycle Disorders,” Molecular
`Genetics and Metabolism, 110:179–180 (2013), print
`version. (“Summar 2013 Print”).
`RESERVED for Saul W. Brusilow & Arthur L.
`Horwich, “Urea Cycle Enzymes,” in The Metabolic
`and Molecular Bases of Inherited Disease, ch. 85,
`1909-1963 (Charles R. Scriver et al., eds., 8th ed.
`2001). (“Brusilow Print”).
`
`O
`A, B, C, E,
`K, L, N, O
`
`A, B, C, E,
`K, L, N, O
`
`A, B, C, E,
`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
`A, B, K, L,
`N
`A, B, C, E,
`K, L, N, O
`
`A, B, C, E,
`K, L, M, N,
`O
`
`
`
`2049
`
`2050
`
`2051
`
`2052
`
`2053
`
`2054
`
`2055
`
`2056
`
`2057
`
`
`
`2
`
`
`
`
`Objection Key:
`
`IPR2017-01767
`Patent No. 9,254,278
`Par’s Objections to Evidence
`
`A:
`B:
`C:
`
`D:
`
`E:
`
`F:
`
`G:
`
`H:
`I:
`J:
`K:
`
`L:
`
`M:
`N:
`
`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 ’278 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 ’278 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.
`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).
`
`3
`
`
`
`IPR2017-01767
`Patent No. 9,254,278
`Par’s Objections to Evidence
`
`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).
`
`
`
`O:
`
`P:
`
`
`
`
`Dated: June 7, 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.
`
`4
`
`
`
`
`
`IPR2017-01747
`Patent No. 9,254,278
`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 June 7, 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
`Ann Kotze: akotze@greengriffith.com
`
`
`Dated: June 7, 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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