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Case IPR2016-01096
`Patent No. 6,667,061
`Objections Under 37 C.F.R. § 42.64
`Attorney Docket No. 9LUYE 7.1R-004
`
`
`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.
`
`
`Patent No. 6,667,061 to Ramstack et al.
`Issue Date: December 23, 2003
`Title: PREPARATION OF INJECTABLE
`SUSPENSIONS HAVING IMPROVED INJECTABILITY
`____________________________
`Inter Partes Review No. IPR2016-01096
`__________________________________________________________________
`
`PETITIONERS’ OBJECTIONS
`UNDER 37 C.F.R. § 42.64 TO EVIDENCE
`SUBMITTED BY PATENT OWNERS POST-INSTITUTION
`
`
`Mail Stop: Patent Board
`Patent Trial and Appeal Board
`U.S. Patent And Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`4912007_1.docx
`
`

`

`Case IPR2016-01096
`Objections Under 37 C.F.R. § 42.64
`Patent No. 6,667,061
`Attorney Docket No. 9LUYE 7.1R-004
`
`
`Petitioners Luye Pharma Group Ltd., Luye Pharma (USA) Ltd., Shandong
`
`Luye Pharmaceutical Co., Ltd., and Nanjing Luye Pharmaceutical Co., Ltd.
`
`(collectively “Petitioners”) object under the Federal Rules of Evidence (“FRE”)
`
`and 37 C.F.R. § 42.64 to the admissibility of the following exhibits on the grounds
`
`set forth below. All evidence objected to below was served by Patent Owners
`
`Alkermes Pharma Ireland Ltd. and Alkermes Controlled Therapeutics, Inc.
`
`(collectively “Patent Owners”) with Patent Owners’ Response on March 8, 2017
`
`(Paper No. 33). Therefore, Petitioners’ objections are timely.
`
`All objections under FRE 802 (hearsay) apply to the extent Patent Owners
`
`rely on the exhibits identified in connection with that objection for the truth of the
`
`matters asserted therein.
`
`Petitioners object as follows:
`
`Exhibit 2014
`Petitioners object to Exhibit 2014 under FRE 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 methods,
`
`and the principles and methods have not been reliably applied to the facts of the
`
`
`
`
`
`

`

`Case IPR2016-01096
`Objections Under 37 C.F.R. § 42.64
`Attorney Docket No. 9LUYE 7.1R-004
`
`case. Petitioners further object to Exhibit 2014 under 37 C.F.R. § 42.65(a),
`
`FRE 402 (relevance), and FRE 403 (confusing, waste of time).
`
`Exhibit 2016
`Petitioners reassert and reserve all their objections under 37 C.F.R.
`
`§ 42.64(a) made during the deposition of Dr. Patrick DeLuca.
`
`Exhibit 2017
`Petitioners object to Exhibit 2017 under FRE 802 (hearsay), FRE 402
`
`(relevance), and FRE 403 (confusing, waste of time).
`
`Exhibit 2018
`Petitioners object to Exhibit 2018 under FRE 802 (hearsay), FRE 402
`
`(relevance), and FRE 403 (confusing, waste of time).
`
`Exhibit 2019
`Petitioners object to Exhibit 2019 under FRE 802 (hearsay), FRE 402
`
`(relevance), and FRE 403 (confusing, waste of time).
`
`Exhibit 2020
`Petitioners object to Exhibit 2020 under FRE 802 (hearsay), FRE 402
`
`(relevance), and FRE 403 (confusing, waste of time).
`
`Exhibit 2021
`Petitioners object to Exhibit 2021 under FRE 802 (hearsay), FRE 402
`
`(relevance), and FRE 403 (confusing, waste of time).
`
`2
`
`

`

`Case IPR2016-01096
`Objections Under 37 C.F.R. § 42.64
`Attorney Docket No. 9LUYE 7.1R-004
`
`Exhibit 2022
`Petitioners object to Exhibit 2022 under FRE 802 (hearsay), FRE 402
`
`(relevance), and FRE 403 (confusing, waste of time).
`
`Exhibit 2023
`Petitioners object to Exhibit 2023 under FRE 802 (hearsay), FRE 402
`
`(relevance), and FRE 403 (confusing, waste of time).
`
`Exhibit 2024
`Petitioners object to Exhibit 2024 under FRE 802 (hearsay), FRE 402
`
`(relevance), and FRE 403 (confusing, waste of time).
`
`Exhibit 2025
`Petitioners object to Exhibit 2025 under FRE 802 (hearsay), FRE 402
`
`(relevance), and FRE 403 (confusing, waste of time).
`
`Exhibit 2026
`Petitioners object to Exhibit 2026 under FRE 802 (hearsay), FRE 402
`
`(relevance), and FRE 403 (confusing, waste of time).
`
`Exhibit 2027
`Petitioners object to Exhibit 2027 under FRE 802 (hearsay), FRE 402
`
`(relevance), and FRE 403 (confusing, waste of time).
`
`Exhibit 2028
`Petitioners object to Exhibit 2028 under FRE 802 (hearsay), FRE 402
`
`(relevance), and FRE 403 (confusing, waste of time).
`
`3
`
`

`

`Case IPR2016-01096
`Objections Under 37 C.F.R. § 42.64
`Attorney Docket No. 9LUYE 7.1R-004
`
`Exhibit 2029
`Petitioners object to Exhibit 2029 under FRE 802 (hearsay), FRE 402
`
`(relevance), and FRE 403 (confusing, waste of time).
`
`Exhibit 2030
`Petitioners object to Exhibit 2030 under FRE 802 (hearsay), FRE 402
`
`(relevance), and FRE 403 (confusing, waste of time).
`
`Exhibit 2031
`Petitioners object to Exhibit 2031 under FRE 802 (hearsay), FRE 402
`
`(relevance), and FRE 403 (confusing, waste of time).
`
`Exhibit 2032
`Petitioners object to Exhibit 2032 under FRE 802 (hearsay), FRE 402
`
`(relevance), and FRE 403 (confusing, waste of time).
`
`Exhibit 2033
`Petitioners object to Exhibit 2033 under FRE 802 (hearsay), FRE 402
`
`(relevance), and FRE 403 (confusing, waste of time).
`
`Exhibit 2034
`Petitioners object to Exhibit 2034 under FRE 802 (hearsay), FRE 402
`
`(relevance), FRE 403 (confusing, waste of time), and FRE 901 (lack of
`
`authentication).
`
`4
`
`

`

`Case IPR2016-01096
`Objections Under 37 C.F.R. § 42.64
`Attorney Docket No. 9LUYE 7.1R-004
`
`Exhibit 2035
`Petitioners object to Exhibit 2035 under FRE 802 (hearsay), FRE 402
`
`(relevance), and FRE 403 (confusing, waste of time).
`
`Exhibit 2036
`Petitioners object to Exhibit 2036 under FRE 802 (hearsay), FRE 402
`
`(relevance), FRE 403 (confusing, waste of time), and FRE 901 (lack of
`
`authentication).
`
`Exhibit 2037
`Petitioners object to Exhibit 2037 under FRE 802 (hearsay), FRE 402
`
`(relevance), and FRE 403 (confusing, waste of time).
`
`Exhibit 2038
`Petitioners object to Exhibit 2038 under FRE 802 (hearsay), FRE 402
`
`(relevance), FRE 403 (confusing, waste of time), and FRE 901 (lack of
`
`authentication).
`
`Exhibit 2039
`Petitioners object to Exhibit 2039 under FRE 802 (hearsay), FRE 402
`
`(relevance), FRE 403 (confusing, waste of time), and FRE 901 (lack of
`
`authentication).
`
`5
`
`

`

`Case IPR2016-01096
`Objections Under 37 C.F.R. § 42.64
`Attorney Docket No. 9LUYE 7.1R-004
`
`Exhibit 2040
`Petitioners object to Exhibit 2040 under FRE 802 (hearsay), FRE 402
`
`(relevance), FRE 403 (confusing, waste of time), and FRE 901 (lack of
`
`authentication).
`
`Exhibit 2041
`Petitioners object to Exhibit 2041 under FRE 802 (hearsay), FRE 402
`
`(relevance), and FRE 403 (confusing, waste of time).
`
`Exhibit 2042
`Petitioners object to Exhibit 2042 under FRE 802 (hearsay), FRE 402
`
`(relevance), and FRE 403 (confusing, waste of time).
`
`Exhibit 2043
`Petitioners object to Exhibit 2043 under FRE 802 (hearsay), FRE 402
`
`(relevance), and FRE 403 (confusing, waste of time).
`
`Exhibit 2044
`Petitioners object to Exhibit 2044 under FRE 802 (hearsay), FRE 402
`
`(relevance), and FRE 403 (confusing, waste of time).
`
`Exhibit 2045
`Petitioners object to Exhibit 2045 under FRE 802 (hearsay), FRE 402
`
`(relevance), and FRE 403 (confusing, waste of time).
`
`6
`
`

`

`Case IPR2016-01096
`Objections Under 37 C.F.R. § 42.64
`Attorney Docket No. 9LUYE 7.1R-004
`
`Exhibit 2046
`Petitioners object to Exhibit 2046 under FRE 802 (hearsay), FRE 402
`
`(relevance), and FRE 403 (confusing, waste of time).
`
`Exhibit 2047
`Petitioners object to Exhibit 2047 under FRE 802 (hearsay), FRE 402
`
`(relevance), and FRE 403 (confusing, waste of time).
`
`Exhibit 2048
`Petitioners object to Exhibit 2048 under FRE 802 (hearsay), FRE 402
`
`(relevance), and FRE 403 (confusing, waste of time).
`
`Exhibit 2049
`Petitioners object to Exhibit 2049 under FRE 802 (hearsay), FRE 402
`
`(relevance), FRE 403 (confusing, waste of time), and FRE 901 (lack of
`
`authentication).
`
`Exhibit 2050
`Petitioners object to Exhibit 2050 under FRE 802 (hearsay), FRE 402
`
`(relevance), and FRE 403 (confusing, waste of time).
`
`Exhibit 2051
`Petitioners object to Exhibit 2051 under FRE 802 (hearsay), FRE 402
`
`(relevance), and FRE 403 (confusing, waste of time).
`
`7
`
`

`

`Case IPR2016-01096
`Objections Under 37 C.F.R. § 42.64
`Attorney Docket No. 9LUYE 7.1R-004
`
`Exhibit 2052
`Petitioners object to Exhibit 2052 under FRE 802 (hearsay), FRE 402
`
`(relevance), FRE 403 (confusing, waste of time), and FRE 901 (lack of
`
`authentication).
`
`Exhibit 2053
`Petitioners object to Exhibit 2053 under FRE 802 and 37 C.F.R. § 42.61(c)
`
`(hearsay), FRE 402 (relevance), and FRE 403 (confusing, waste of time).
`
`Exhibit 2054
`Petitioners object to Exhibit 2054 under FRE 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 methods,
`
`and the principles and methods have not been reliably applied to the facts of the
`
`case. Petitioners further object to Exhibit 2054 under 37 C.F.R. § 42.65(a),
`
`FRE 402 (relevance), and FRE 403 (confusing, waste of time).
`
`Exhibit 2055
`Petitioners object to Exhibit 2055 under FRE 802 and 37 C.F.R. § 42.61(c)
`
`(hearsay), FRE 402 (relevance), and FRE 403 (confusing, waste of time).
`
`8
`
`

`

`Case IPR2016-01096
`Objections Under 37 C.F.R. § 42.64
`Attorney Docket No. 9LUYE 7.1R-004
`
`Exhibit 2056
`Petitioners object to Exhibit 2056 under FRE 802 (hearsay), FRE 402
`
`(relevance), FRE 403 (confusing, waste of time), and FRE 901 (lack of
`
`authentication).
`
`Exhibit 2057
`Petitioners object to Exhibit 2057 under FRE 802 (hearsay), FRE 402
`
`(relevance), FRE 403 (confusing, waste of time), and FRE 901 (lack of
`
`authentication).
`
`Exhibit 2058
`Petitioners object to Exhibit 2058 under FRE 802 (hearsay), FRE 402
`
`(relevance), FRE 403 (confusing, waste of time), and FRE 901 (lack of
`
`authentication).
`
`Exhibit 2059
`Petitioners object to Exhibit 2059 under FRE 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 methods,
`
`and the principles and methods have not been reliably applied to the facts of the
`
`case. Petitioners further object to Exhibit 2054 under 37 C.F.R. § 42.65(a),
`
`FRE 402 (relevance), and FRE 403 (confusing, waste of time).
`
`9
`
`

`

`Case IPR2016-01096
`Objections Under 37 C.F.R. § 42.64
`Attorney Docket No. 9LUYE 7.1R-004
`
`Exhibit 2061
`Petitioners object to Exhibit 2061 under FRE 802 (hearsay), FRE 402
`
`(relevance), FRE 403 (confusing, waste of time), and FRE 901 (lack of
`
`authentication).
`
`Exhibit 2062
`Petitioners object to Exhibit 2062 under FRE 802 (hearsay), FRE 402
`
`(relevance), FRE 403 (confusing, waste of time), and FRE 901 (lack of
`
`authentication).
`
`Exhibit 2063
`Petitioners object to Exhibit 2063 under FRE 802 (hearsay), FRE 402
`
`(relevance), FRE 403 (confusing, waste of time), and FRE 901 (lack of
`
`authentication).
`
`Exhibit 2064
`Petitioners object to Exhibit 2064 under FRE 802 (hearsay), FRE 402
`
`(relevance), FRE 403 (confusing, waste of time), and FRE 901 (lack of
`
`authentication).
`
`Exhibit 2065
`Petitioners object to Exhibit 2065 under FRE 802 (hearsay), FRE 402
`
`(relevance), FRE 403 (confusing, waste of time), and FRE 901 (lack of
`
`authentication).
`
`10
`
`

`

`Case IPR2016-01096
`Objections Under 37 C.F.R. § 42.64
`Attorney Docket No. 9LUYE 7.1R-004
`
`Exhibit 2066
`Petitioners object to Exhibit 2066 under FRE 802 (hearsay), FRE 402
`
`(relevance), FRE 403 (confusing, waste of time), and FRE 901 (lack of
`
`authentication).
`
`Exhibit 2067
`Petitioners object to Exhibit 2067 under FRE 802 (hearsay), FRE 402
`
`(relevance), FRE 403 (confusing, waste of time), and FRE 901 (lack of
`
`authentication).
`
`Exhibit 2068
`Petitioners object to Exhibit 2068 under FRE 802 (hearsay), FRE 402
`
`(relevance), FRE 403 (confusing, waste of time), and FRE 901 (lack of
`
`authentication).
`
`Exhibit 2069
`Petitioners object to Exhibit 2069 under FRE 802 (hearsay), FRE 402
`
`(relevance), FRE 403 (confusing, waste of time), and FRE 901 (lack of
`
`authentication).
`
`Exhibit 2071
`Petitioners object to Exhibit 2071 under FRE 802 (hearsay), FRE 402
`
`(relevance), and FRE 403 (confusing, waste of time).
`
`11
`
`

`

`Case IPR2016-01096
`Objections Under 37 C.F.R. § 42.64
`Attorney Docket No. 9LUYE 7.1R-004
`
`Exhibit 2072
`Petitioners object to Exhibit 2072 under FRE 802 (hearsay), FRE 402
`
`(relevance), FRE 403 (confusing, waste of time), and FRE 901 (lack of
`
`authentication).
`
`Respectfully submitted,
`
`LERNER, DAVID, LITTENBERG,
` KRUMHOLZ & MENTLIK, LLP
`600 South Avenue West
`Westfield, NJ 07090-1496
`Tel: 908.654.5000
`Fax: 908.654.7866
`
`
`
`By: s/ Tedd Van Buskirk /
`Tedd W. Van Buskirk
`Registration No. 46,282
`tvanbuskirk@lernerdavid.com
`
`
`
`Dated:
`
`March 15, 2017
`
`
`
`
`
`
`
`
`12
`
`

`

`Case IPR2016-01096
`Objections Under 37 C.F.R. § 42.64
`Attorney Docket No. 9LUYE 7.1R-004
`
`
`CERTIFICATE OF SERVICE
`The undersigned hereby certifies
`that a copy of
`
`the
`
`foregoing
`
`PETITIONERS’ OBJECTIONS UNDER 37 C.F.R. § 42.64 TO EVIDENCE
`
`SUBMITTED BY PATENT OWNERS POST-INSTITUTION was served on
`
`March 15, 2017, as follows.
`
`VIA E-MAIL
`
`FITZPATRICK, CELLA, HARPER & SCINTO
`Scott Reed
`sreed@fchs.com
`Justin J. Oliver
`joliver@fchs.com
`Ha Kung Wong
`hwong@fchs.com
`Christina Schwarz
`cschwarz@fchs.com
`Melinda Roberts
`mroberts@fchs.com
`Una Fan
`ufan@fchs.com
`
`alkermesipr@fchs.com
`
`Counsel for Patent Owners Alkermes Pharma Ireland
`Ltd., and Alkermes Controlled Therapeutics, Inc.
`
`March 15, 2017
`
`
`
`Respectfully submitted,
`
`By: s/ Tedd Van Buskirk /
`Tedd W. Van Buskirk
`Registration No. 46,282
`tvanbuskirk@lernerdavid.com
`
`
`
`13
`
`
`
`
`Dated:
`
`4912007_1.docx
`
`

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