Paper No. __
`Date Filed: June 16, 2017
`
`Filed On Behalf Of:
`
`Alkermes Pharma Ireland Limited and
`Alkermes Controlled Therapeutics, Inc.
`
`By:
`
`Scott K. Reed
`sreed@fchs.com
`212-218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`LUYE PHARMA GROUP LTD., LUYE PHARMA (USA) LTD., SHANDONG
`LUYE PHARMACEUTICAL CO., LTD., and NANJING LUYE
`PHARMACEUTICAL CO., LTD.,
`Petitioners,
`v.
`ALKERMES PHARMA IRELAND LTD and ALKERMES CONTROLLED
`THERAPEUTICS, INC.
`Patent Owners.
`________________
`
`Case IPR2016-01096
`U.S. Patent No. 6,667,061
`________________
`
`PATENT OWNERS’ OBJECTIONS UNDER 37 C.F.R. § 42.64
`
`
`Date Filed: June 16, 2017
`
`Filed On Behalf Of:
`
`Alkermes Pharma Ireland Limited and
`Alkermes Controlled Therapeutics, Inc.
`
`By:
`
`Scott K. Reed
`sreed@fchs.com
`212-218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`LUYE PHARMA GROUP LTD., LUYE PHARMA (USA) LTD., SHANDONG
`LUYE PHARMACEUTICAL CO., LTD., and NANJING LUYE
`PHARMACEUTICAL CO., LTD.,
`Petitioners,
`v.
`ALKERMES PHARMA IRELAND LTD and ALKERMES CONTROLLED
`THERAPEUTICS, INC.
`Patent Owners.
`________________
`
`Case IPR2016-01096
`U.S. Patent No. 6,667,061
`________________
`
`PATENT OWNERS’ OBJECTIONS UNDER 37 C.F.R. § 42.64
`
`
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Alkermes Pharma Ireland Limited and
`
`Alkermes Controlled Therapeutics, Inc. (“Patent Owners”) object to the
`
`admissibility of the following exhibits on the grounds set forth below. All evidence
`
`objected to below was submitted by Petitioners Luye Pharma Group Limited, Luye
`
`Pharma (USA) Limited, Shandong Luye Pharmaceutical Company, Limited, and
`
`Nanjing Luye Pharmaceutical Co., Limited, (“Petitioners” or “Luye”) with their
`
`Petitioners’ Reply (Paper 40) filed on June 9, 2017. Therefore, these objections are
`
`timely.
`
`In this paper, a reference to “F.R.E.” means the Federal Rules of Evidence,
`
`and a reference to “C.F.R.” means the Code of Federal Regulations. All objections
`
`under F.R.E. 802 (hearsay) apply to the extent Petitioners rely on the exhibits
`
`identified in connection with that objection for the truth of the matters asserted
`
`therein.
`
`Patent Owners object as follows:
`
`Exhibit 1024: “Supplemental Declaration of Dr. Patrick P. DeLuca, June 9,
`2017”
`
`Patent Owners object to Exhibit 1024 under F.R.E. 802 (hearsay), 702
`
`(improper expert testimony) and 703 (bases for expert opinion) as the testimony is
`
`not based on sufficient facts or data, is not the product of reliable principles and
`
`1
`
`
`
`methods, and the principles and methods have not been reliably applied to the facts
`
`of the case.
`
`Patent Owners object to Exhibit 1024 under 37 C.F.R. §§ 42.65(a), F.R.E.
`
`702 (improper expert testimony), 402 (relevance), and 403 (confusing, waste of
`
`time) for failing to identify with particularity the underlying facts and data on
`
`which the opinion is based: ¶¶ 5, 11, 15-17, 19, 21-24, 26, 28, 30-31, 37-39, 41-44,
`
`46, 48-52, 54, 57-64, 66-67, 69-71, 73-80, 86-88, 90-91, 93, 101, 104-105, 110-
`
`112, 114, 116-119 fail to cite any support at all, or include at least one statement
`
`that does not cite any support; and ¶¶ 9, 18, 34-36, 42, 68, 95, 102 cite or refer to
`
`entire exhibits without identifying which aspects of those references are relied
`
`upon.
`
`Patent Owners also object to Exhibit 1024 ¶¶ 1-3, 6, 31, 33-42, 45, 53, 72,
`
`77-78, 81, 84-85, 98, 101, 109-112, 121 under F.R.E. 402 (relevance) and 403
`
`(confusing, waste of time) as these paragraphs are not cited in Petitioners’ Reply.
`
`Patent Owners also object to Exhibit 1024 ¶¶ 7-18, 20, 22, 24-30, 32, 35, 43,
`
`47-48, 54-56, 58, 63-65, 68-70, 76, 82-87, 91, 94-95, 100-102, 105-107, 109, 115-
`
`116 under F.R.E. 702 (improper expert testimony), 703 (bases of an expert
`
`opinion), 402 (relevance), and 403 (confusing, waste of time) as these paragraphs
`
`include expert opinion based on documents that are inadmissible under at least
`
`2
`
`
`
`F.R.E. 802 (hearsay), 702 (improper expert testimony), 703 (bases of an expert
`
`opinion), 402 (relevance), or 403 (confusing, waste of time).
`
`Exhibit 1026: “Stedman’s Medical Dictionary (26th ed. 1995)”
`
`Patent Owners object to Exhibit 1026 under F.R.E. 802 (hearsay), 402
`
`(relevance), and 403 (confusing, waste of time).
`
`Exhibit 1027: “Decapetyl components sheet”
`
`Patent Owners object to Exhibit 1027 under F.R.E. 901 (authenticity), 802
`
`(hearsay), 402 (relevance), and 403 (confusing, waste of time).
`
`Exhibit 1028: “International Publication No. WO 97/44039 (“Francois”)”
`
`Patent Owners object to Exhibit 1028 under F.R.E. 802 (hearsay), 402
`
`(relevance), and 403 (confusing, waste of time).
`
`Exhibit 1030: “Nutropin Label (December 1999)”
`
`Patent Owners object to Exhibit 1030 under F.R.E. 901 (authenticity), 802
`
`(hearsay), 402 (relevance), and 403 (confusing, waste of time).
`
`Exhibit 1031: “Deposition Transcript of Cory J. Berkland, Ph.D., May 26,
`2017”
`
`Patent Owners object to Exhibit 1031 under F.R.E. 802 (hearsay), 402
`
`(relevance), and 403 (confusing, waste of time).
`
`3
`
`
`
`Exhibit 1032: “Macket et al., Tolerability of intramuscular injections of
`testosterone ester in oil vehicle, PubMed-NCBI, 10(4) Hum. Reprod. 862-5
`(April 1995)”
`
`Patent Owners object to Exhibit 1032 under F.R.E. 901 (authenticity), 802
`
`(hearsay), 402 (relevance), and 403 (confusing, waste of time).
`
`Exhibit 1034: “USP 23 NF 18, Suspensions, The U.S. Pharmacopeia, The Nat’l
`Formulary, Jan. 1, 1995”
`
`Patent Owners object to Exhibit 1034 under F.R.E. 802 (hearsay), 402
`
`(relevance), and 403 (confusing, waste of time).
`
`Exhibit 1036: “Hawley’s Condensed Chemical Dictionary (12th ed. 1993)”
`
`Patent Owners object to Exhibit 1036 under F.R.E. 802 (hearsay), 402
`
`(relevance), and 403 (confusing, waste of time).
`
`Exhibit 1037: “(Ch.19) Organic Chemistry (2nd ed. 1998)”
`
`Patent Owners object to Exhibit 1037 under F.R.E. 802 (hearsay), 402
`
`(relevance), and 403 (confusing, waste of time).
`
`Exhibit 1038: “U.S. Patent No. 5,417,982”
`
`Patent Owners object to Exhibit 1038 under F.R.E. 802 and 37 C.F.R.
`
`§ 42.61(c) (hearsay), F.R.E. 901 (authenticity), 402 (relevance), and 403
`
`(confusing, waste of time).
`
`4
`
`
`
`Exhibit 1039: “Biochemicals and Reagents for Life Science Research, Sigma-
`Aldrich 1998”
`
`Patent Owners object to Exhibit 1039 under F.R.E. 901 (authenticity), 802
`
`(hearsay), 402 (relevance), and 403 (confusing, waste of time).
`
`Exhibit 1040: “Biochemicals and Reagents for Life Science Research, Sigma-
`Aldrich 1999”
`
`Patent Owners object to Exhibit 1040 under F.R.E. 901 (authenticity), 802
`
`(hearsay), 402 (relevance), and 403 (confusing, waste of time).
`
`Exhibit 1041: “Biochemicals and Reagents for Life Science Research, Sigma-
`Aldrich 2000/2001”
`
`Patent Owners object to Exhibit 1041 under F.R.E. 901 (authenticity), 802
`
`(hearsay), 402 (relevance), and 403 (confusing, waste of time).
`
`Exhibit 1042: “Lupron Label, Center for Drug Evaluation and Research,
`Application”
`
`Patent Owners object to Exhibit 1042 under F.R.E. 901 (authenticity), 802
`
`(hearsay), 402 (relevance), and 403 (confusing, waste of time).
`
`Exhibit 1043: “International Publication No. WO 99/013780”
`
`Patent Owners object to Exhibit 1043 under F.R.E. 802 (hearsay), 402
`
`(relevance), and 403 (confusing, waste of time).
`
`5
`
`
`
`Exhibit 1044: “Deposition Transcript of Robson Storey, Ph.D., May 3, 2016”
`
`Patent Owners object to Exhibit 1044 under F.R.E. 802 (hearsay), 402
`
`(relevance), and 403 (confusing, waste of time).
`
`June 16, 2017
`
`Respectfully submitted,
`
`/Scott Reed/
`Scott K. Reed (Reg. No. 32,433)
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel: (212) 218-2100
`
`Counsel for Patent Owners
`
`6
`
`
`
`CERTIFICATE OF SERVICE
`
`I certify that a copy of the foregoing PATENT OWNERS’ OBJECTIONS
`
`UNDER 37 C.F.R. § 42.64 was served on June 16, 2017 by causing it to be sent by
`
`email to counsel for Petitioners, who have consented to electronic service, at the
`
`following email addresses:
`
`wmentlik.ipr@lernerdavid.com
`
`pkochanski@lernerdavid.com
`
`tvanbuskirk@lernerdavid.com
`
`nvaleyko@lernerdavid.com
`
`June 16, 2017
`
`Respectfully submitted,
`
`/Scott Reed/
`Scott K. Reed (Reg. No. 32,433)
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel: (212) 218-2100
`
`Counsel for Patent Owners
`
`7
`
`
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