`Patent No. 6,667,061
`Objections Under 37 C.F.R. §§ 42.63 and 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. §§ 42.63
`AND 42.64 TO EVIDENCE SUBMITTED BY PATENT OWNERS’
`POST-INSTITUTION (EXHIBITS 2073-2079, 2081)
`
`
`Mail Stop: Patent Board
`Patent Trial and Appeal Board
`U.S. Patent And Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`5086748_1.docx
`
`
`
`Case IPR2016-01096
`Objections Under 37 C.F.R. §§ 42.63 and 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. §§ 42.63 and 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’ Exhibit
`
`List 5 on July 24, 2017 (Paper No. 52). 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 2073
`Petitioners object to Exhibit 2073 under FRE 802 (hearsay), FRE 402
`
`(relevance), FRE 403 (confusing, waste of
`
`time), and FRE 901 (lack of
`
`authentication).
`
`
`
`
`
`
`
`Case IPR2016-01096
`Objections Under 37 C.F.R. §§ 42.63 and 42.64
`Attorney Docket No. 9LUYE 7.1R-004
`
`Exhibit 2074
`Petitioners object to Exhibit 2074 under FRE 402 (relevance) and FRE 403
`
`(confusing, waste of time).
`
`Exhibit 2075
`Petitioners object to Exhibit 2075 under FRE 402 (relevance), FRE 403
`
`(confusing, waste of time), and 37 C.F.R. § 42.63(b) (failing to provide an English
`
`translation and an affidavit attesting to the accuracy of the translation).
`
`Exhibit 2076
`Petitioners object to Exhibit 2076 under FRE 402 (relevance) and FRE 403
`
`(confusing, waste of time).
`
`Exhibit 2077
`Petitioners object to Exhibit 2077 under FRE 402 (relevance), FRE 403
`
`(confusing, waste of time), and 37 C.F.R. § 42.63(b) (failing to provide an English
`
`translation and an affidavit attesting to the accuracy of the translation).
`
`Exhibit 2078
`Petitioners object to Exhibit 2078 under FRE 402 (relevance) and FRE 403
`
`(confusing, waste of time).
`
`Exhibit 2079
`Petitioners object to Exhibit 2079 under FRE 402 (relevance) and FRE 403
`
`(confusing, waste of time).
`
`2
`
`
`
`Case IPR2016-01096
`Objections Under 37 C.F.R. §§ 42.63 and 42.64
`Attorney Docket No. 9LUYE 7.1R-004
`
`Exhibit 2081
`Petitioners
`
`reserve
`
`all
`
`their
`
`objections
`
`under
`
`reassert
`
`and
`
`37 C.F.R. § 42.64(a) made during the deposition of Dr. Patrick DeLuca on July 13,
`
`2017.
`
`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/ Paul H. Kochanski /
`Paul H. Kochanski
`Registration No. 29,660
`pkochanski@lernerdavid.com
`
`
`
`Dated:
`
`July 31, 2017
`
`
`
`
`
`
`
`
`3
`
`
`
`Case IPR2016-01096
`Objections Under 37 C.F.R. §§ 42.63 and 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. §§ 42.63 AND 42.64 TO
`
`EVIDENCE SUBMITTED BY PATENT OWNERS’ POST-INSTITUTION
`
`(EXHIBITS 2073-2079, 2081) was served on July 31, 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.
`
`July 31, 2017
`
`
`
`Respectfully submitted,
`
`By: s/ Paul H. Kochanski /
`Paul H. Kochanski
`Registration No. 29,660
`pkochanski@lernerdavid.com
`
`
`
`4
`
`
`
`
`Dated:
`
` 5086748_1.docx
`
`
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