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 OBJECTIONS UNDER 37 C.F.R. § 42.62
`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
`
`
`
`
`
`Par Pharmaceutical, Inc. Ex. 1034
`Par v. Hyperion, IPR2015-01117
`Page 1 of 7
`
`
`_____________________
`
`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 OBJECTIONS UNDER 37 C.F.R. § 42.62
`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
`
`
`
`
`
`Par Pharmaceutical, Inc. Ex. 1034
`Par v. Hyperion, IPR2015-01117
`Page 1 of 7
`
`
`
`Pursuant to 37 C.F.R. §42.64(b)(1), Petitioner Par Pharmaceutical, Inc.
`
` IPR2015-01117
`Patent No. 8,642,012
`Par’s Objections to Evidence
`
`
`objects as follows to the admissibility of evidence submitted by the Patent Owner
`
`on March 28, 2016.
`
`In this paper, a reference to “FRE” means the Federal Rules of Evidence, a
`
`reference to “CFR” means the Code of Federal Regulations, and “’012 patent”
`
`means U.S. Patent No. 8,642,012. 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 Patent Owner’s exhibit list 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
`
`Description
`
`2012 Transcript of Deposition of Dr. Neal Sondheimer,
`March 10-11, 2016
`
`2013 Gerard Berry & Robert Steiner, "Long-term
`management of patients with urea cycle disorders," J.
`Ped., 138(1):S56-61 (2001)
`
`Objection
`A, G, H, K, L1
`
`A, B, K, L, N,
`O
`
`
`1 Par also maintains each of its objections as stated in the March 10-11, 2016
`Deposition of Dr. Neal Sondheimer.
`
`
`
`Par Pharmaceutical, Inc. Ex. 1034
`Par v. Hyperion, IPR2015-01117
`Page 2 of 7
`
`
`
` IPR2015-01117
`Patent No. 8,642,012
`Par’s Objections to Evidence
`
`
`2014
`
`Summar et al., “Unmasked Adult-Onset Urea Cycle
`Disorders in the Critical Care Setting,” Crit. Care Clin.,
`S1-S8 (2005)
`
`A, B, K, L, N,
`O
`
`2015 Geraghty, M.T. and Brusilow, S.W., “Disorders of the
`Urea Cycle,” in Liver Disease in Children, 827-842
`(2001)
`
`2016 Endo, F. et al., “Clinical Manifestations of Inborn
`Errors of the Urea Cycle and Related Metabolic
`Disorders During Childhood,” J. Nutrition, 134, 1605S-
`1069S (2004)
`
`2017 Maestri et al., “Long-term survival of patients with
`argininosuccinate synthetase deficiency,” J. Ped., 929-
`35 (1995)
`
`2018 Lichter-Konecki et al., “Ammonia control in children
`with urea cycle disorders (UCDs): Phase 2 comparison
`of sodium phenylbutyrate and glycerol phenylbutyrate,”
`Mol. Gen. & Metab., 103:323-29 (2011)
`
`2020
`
`Singh et al., “Nutritional Management of Urea Cycle
`Disorders,” in Presentation and Management of Urea
`Cycle Disorders Outside the Newborn Period, Critical
`Care Clinics, 21:S27-35 (2005)
`
`2023 The Urea Cycle Disorders Conference Group,
`Consensus Statement from a Conference for the
`Management of Patients with Urea Cycle Disorders, J.
`Ped. (Supplement) S1-S5 (2001)
`
`2025 BUPHENYL® Prescribing Information (2003)
`
`2026
`
`James et al., “The Conjugation of phenylacetic acid in
`man, subhuman primates and some non-primate
`species,” Proc. R. Soc. Lond., 182, 25-35 (1972)
`
`A, B, G, K, L,
`N, O
`
`A, B, K, L, N,
`O
`
`A, B, K, L, N,
`O
`
`A, B, C, D, E,
`F, K, L, N, O
`
`A, B, K, L, N,
`O
`
`A, B, G, K, L,
`N, O
`
`A, B, K, L, N,
`O
`
`A, B, K, L, N,
`O
`
`
`
`Par Pharmaceutical, Inc. Ex. 1034
`Par v. Hyperion, IPR2015-01117
`Page 3 of 7
`
`
`
` IPR2015-01117
`Patent No. 8,642,012
`Par’s Objections to Evidence
`
`
`2027 Ambrose, Power & Sherwin, “Further Studies on the
`Detoxication of Phenylacetic Acid,” J. Biol. Chem.,
`101, 669-675 (1933)
`
`2028 Horizon Therapeutics, Inc. v. Par Pharma., Inc., 14-cv-
`384 (E.D. Tex.), Joint Claim Construction Charts, D.I.
`80
`
`A, B, K, L, N,
`O
`
`A, K, L, O
`
`
`
`Objection Key:
`
`A: FRE 802 (hearsay).
`
`B:
`
`C:
`
`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 ’012 patent or the prior art status is not clear.
`
`D: 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.
`
`E:
`
`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 ’012 patent or the prior art status is not clear.
`
`
`
`Par Pharmaceutical, Inc. Ex. 1034
`Par v. Hyperion, IPR2015-01117
`Page 4 of 7
`
`
`
` IPR2015-01117
`Patent No. 8,642,012
`Par’s Objections to Evidence
`
`FRE 403 (confusing, waste of time) to the extent the document is relied
`
`F:
`
`upon for secondary considerations of nonobviousness, there is no nexus to
`
`the claimed compositions and methods.
`
`G: 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.
`
`H: FRE 1001-1003 (best evidence).
`
`I:
`
`J:
`
`FRE 403, 901 (improper compilation).
`
`FRE 403 (cumulative).
`
`K: FRE 402 (relevance) the document is not relevant to any issue in the IPR
`
`proceeding.
`
`L:
`
`FRE 403 (confusing, waste of time) the document is not relevant to any
`
`issue in the IPR proceeding.
`
`M: No exhibit filed.
`
`N: FRE 602 (lack of personal knowledge).
`
`O: 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
`
`
`
`Par Pharmaceutical, Inc. Ex. 1034
`Par v. Hyperion, IPR2015-01117
`Page 5 of 7
`
`
`
` IPR2015-01117
`Patent No. 8,642,012
`Par’s Objections to Evidence
`
`because the exhibit is not of a type reasonably relied upon by experts in the
`
`field.
`
`P:
`
`FRE 1006 (improper summary).
`
`Date: April 4, 2016
`Axinn, Veltrop & Harkrider LLP
`950 F Street, N.W.
`Washington, DC 20004
`Tel: (202) 912-4700
`
`Respectfully Submitted,
`
`
`
`Aziz Burgy
`Registration No. 51,514
`Attorney for Petitioner
`Par Pharmaceutical, Inc.
`
`
`
`
`
`
`
`Par Pharmaceutical, Inc. Ex. 1034
`Par v. Hyperion, IPR2015-01117
`Page 6 of 7
`
`
`
`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
`
`Objections Under 37 C.F.R. § 42.62 to Evidence Submitted by Patent Owner” was
`
`served in its entirety on April 4, 2016 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
`
`Respectfully Submitted,
`
`
`
`Aziz Burgy
`Registration No. 51,514
`Attorney for Petitioner
`Par Pharmaceutical, Inc.
`
`
`Date: April 4, 2016
`Axinn, Veltrop & Harkrider LLP
`950 F Street, N.W.
`Washington, DC 20004
`Tel: (202) 912-4700
`
`
`
`
`
`
`
`
`
`Par Pharmaceutical, Inc. Ex. 1034
`Par v. Hyperion, IPR2015-01117
`Page 7 of 7
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