UNITED STATES PATENT AND TRADEMARK OFFICE
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`
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
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`MYLAN PHARMACEUTICALS INC., MYLAN LABORATORIES LIMITED,
`ALEMBIC PHARMACEUTICALS LIMITED, TORRENT
`PHARMACEUTICALS LIMITED, AND AMERIGEN PHARMACEUTICALS
`LIMITED
`Petitioners,
`
`v.
`
`UCB PHARMA GMBH
`Patent Owner.
`
`Patent No. 6,858,650
`Case IPR2016-00510
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`
`
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`PETITIONER MYLAN PHARMACEUTICALS INC. AND MYLAN
`LABORATORIES LIMITED’S RESPONSE TO PATENT
`OWNER’S NOTICE OF OBJECTIONS UNDER 37 C.F.R. § 42.64
`TO EVIDENCE SUBMITTED IN SUPPORT OF PETITIONER’S
`CORRECTED REPLY
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
`
`MYLAN PHARMACEUTICALS INC., MYLAN LABORATORIES LIMITED,
`ALEMBIC PHARMACEUTICALS LIMITED, TORRENT
`PHARMACEUTICALS LIMITED, AND AMERIGEN PHARMACEUTICALS
`LIMITED
`Petitioners,
`
`v.
`
`UCB PHARMA GMBH
`Patent Owner.
`
`Patent No. 6,858,650
`Case IPR2016-00510
`
`
`
`
`PETITIONER MYLAN PHARMACEUTICALS INC. AND MYLAN
`LABORATORIES LIMITED’S RESPONSE TO PATENT
`OWNER’S NOTICE OF OBJECTIONS UNDER 37 C.F.R. § 42.64
`TO EVIDENCE SUBMITTED IN SUPPORT OF PETITIONER’S
`CORRECTED REPLY
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`Petitioners Mylan Pharmaceuticals Inc. and Mylan Laboratories Limited
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`(jointly “Mylan”)1 submits the following in Response to Patent Owner UCB
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`Pharma GmbH (“UCB”) Objections to Evidence submitted with Mylan’s
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`Corrected Reply, dated and served on January 24, 2017. Mylan reserves all rights
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`to respond to UCB’s objections to Exhibits that are not specifically referenced
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`below and to respond further to UCB’s objections to Exhibits that are referenced
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`below.
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`Section 42.64(b)(1) requires that evidentiary objections “must identify the
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`grounds for the objection with sufficient particularity to allow correction in the
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`form of supplemental evidence.” 37 C.F.R. § 42.61(b)(1), 77 Fed. Reg. 48676
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`(Aug. 14, 2012). Many of UCB’s objections contain only conclusory reference to
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`objections or the Federal Rules of Evidence, and thus do not provide the required
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`particularity. For example, UCB objects to Exhibits 1073-1076 under Federal
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`Rules of Evidence 401-403 and “for reasons made on the record during the
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`deposition” lack the required particularity.
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`UCB’s objections to Exhibit 1073-1076 under the Federal Rules of Evidence
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`401-403 are without merit, particularly because the parties agreed that each of
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`
`1 Petitioners Alembic Pharmaceuticals Limited from IPR2016-01596, Torrent
`Pharmaceuticals Limited from IPR2016-01636, and Amerigen Pharmaceuticals
`Limited from IPR2016-01665 have been joined as Petitioners to this proceedings.
`
`
`
`
`1
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`
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`deposition transcripts reflected in these exhibits would serve as the cross
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`examination testimony of individuals who submitted affidavits in support of Patent
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`Owner’s Response. See 37 C.F.R. § 42.51(b)(1)(ii), which permits as routine
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`discovery the cross examination of affidavit testimony in IPR proceedings.
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`Nevertheless, Mylan serves herewith Exhibit 1077 as supplemental evidence to
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`provide additional information on the relevance of the exhibits to this proceeding.
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`Exhibit 1073
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`FRE 106; FRE 401; FRE 402; FRE 403; “for reasons
`made on the record during the depositions”; lacking
`foundation and misleading; mischaracterizes the testimony
`Exhibit 1073 is a portion of the deposition transcript of Dr.
`William Roush. Patent Owner submitted an affidavit of
`Dr. Roush in support of Patent Owner’s Response, which
`was given under the penalty of perjury. As further detailed
`in Exhibit 1077, the parties agreed that the deposition
`transcript of Dr. Roush in a district court litigation
`regarding validity of this patent would serve as the cross
`examination testimony of Dr. Roush in this proceeding.
`Exhibit 1073 is relevant at least to further explain the
`opinion of Dr. Roush expressed in this proceeding.
`Exhibit 1074
`
`FRE 106; FRE 401; FRE 402; FRE 403; “for reasons
`made on the record during the depositions”; lacking
`foundation and misleading; mischaracterizes the testimony
`Exhibit 1074 is a portion of the deposition transcript of Dr.
`Hans Maag. Patent Owner submitted an affidavit of Dr.
`Maag in support of Patent Owner’s Response, which was
`given under the penalty of perjury. As further detailed in
`Exhibit 1077, the parties agreed that the deposition
`transcript of Dr. Maag in a district court litigation
`regarding validity of this patent would serve as the cross
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`2
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`Objection(s)
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`Response
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`Objection(s)
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`Response
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`examination testimony of Dr. Maag in this proceeding.
`Exhibit 1073 is relevant at least to further explain the
`opinion of Dr. Maag expressed in this proceeding.
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`Petitioner admits that its reply included a quote of Dr.
`Maag, “tolterodine is not actually a very good product
`because it doesn’t get converted completely to 5-HMT,”
`that inadvertently failed to change the word “product” to
`“prodrug” as identified in Dr. Maag’s errata sheet.
`Petitioner disagrees that this error mischaracterizes the
`testimony because it is clear persons of skill viewed dosing
`of tolterodine akin to dosing a prodrug.
`Exhibit 1075
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`FRE 106; FRE 401; FRE 402; FRE 403; “for reasons
`made on the record during the depositions”; lacking
`foundation and misleading; mischaracterizes the testimony
`Exhibit 1075 is a portion of the deposition transcript of Dr.
`Leonard Chyall. Patent Owner submitted an affidavit of
`Dr. Chyall in support of Patent Owner’s Response, which
`was given under the penalty of perjury. As further detailed
`in Exhibit 1077, the parties agreed that the deposition
`transcript of Dr. Chyall in a district court litigation
`regarding validity of this patent would serve as the cross
`examination testimony of Dr. Chyall in this proceeding.
`Exhibit 1073 is relevant at least to further explain the
`opinion of Dr. Chyall expressed in this proceeding.
`Exhibit 1076
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`FRE 106; FRE 401; FRE 402; FRE 403; “for reasons
`made on the record during the depositions”; lacking
`foundation and misleading; mischaracterizes the testimony
`Exhibit 1076 is a portion of the deposition transcript of Dr.
`Clause Meese. Patent Owner submitted an affidavit of Dr.
`Meese in support of Patent Owner’s Response, which was
`given under the penalty of perjury. As further detailed in
`Exhibit 1077, the parties agreed that the deposition
`transcript of Dr. Meese in a district court litigation
`regarding validity of this patent would serve as the cross
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`3
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`Objection(s)
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`Response
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`Objection(s)
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`Response
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`examination testimony of Dr. Meese in this proceeding.
`Exhibit 1073 is relevant at least to further explain the
`opinion of Dr. Meese expressed in this proceeding.
`Further, Mylan hereby submits the following additional supplemental
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`information as additional support in responding to UCB’s objections, and this
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`additional information should resolve UCB’s objections to Exhibits 1073-1076.
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`Exhibit 1073A
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`Deposition transcript of Dr. William Roush2
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`Exhibit 1074A
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`Deposition transcript of Dr. Hans Maag3
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`Exhibit 1075A
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`Deposition transcript of Dr. Leonard Chyall4
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`Exhibit 1076A
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`Deposition transcript of Dr. Clause Meese5
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`Exhibit 1077
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`Declaration of Alyson L. Wooten Regarding Exhibits 1073-
`10766
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`2 Served but not filed, as supplemental information, pursuant to 37 C.F.R. §
`42.64(b)(2). A request for permission to file a motion to file supplemental
`information pursuant to 37 C.F.R. § 42.123(a) has been sent to the Board
`concurrently with this filing.
`3 Served but not filed, as supplemental information, pursuant to 37 C.F.R. §
`42.64(b)(2). A request for permission to file a motion to file supplemental
`information pursuant to 37 C.F.R. § 42.123(a) has been sent to the Board
`concurrently with this filing.
`4 Served but not filed, as supplemental information, pursuant to 37 C.F.R. §
`42.64(b)(2). A request for permission to file a motion to file supplemental
`information pursuant to 37 C.F.R. § 42.123(a) has been sent to the Board
`concurrently with this filing.
`5 Served but not filed, as supplemental information, pursuant to 37 C.F.R. §
`42.64(b)(2). A request for permission to file a motion to file supplemental
`information pursuant to 37 C.F.R. § 42.123(a) has been sent to the Board
`concurrently with this filing.
`6 Served but not filed, as supplemental information, pursuant to 37 C.F.R. §
`42.64(b)(2).
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`4
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`Date: February 13, 2017
`
`By: /s/ Mitchell G. Stockwell
`Mitchell G. Stockwell
`Registration No. 39,389
`Lead Counsel for Petitioner
`Lead Counsel
`Mitchell G. Stockwell
`Reg. No. 39,389
`mstockwell@kilpatricktownsend.com
`Kilpatrick Townsend & Stockton
`LLP
`1100 Peachtree Street, NE
`Suite 2800
`Atlanta, Georgia 30309
`(404) 815 6500
`
`
`
`
`
`
`Back-Up Counsel
`D. Clay Holloway
`Reg. No. 58,011
`cholloway@kilpatricktownsend.com
`Kilpatrick Townsend & Stockton LLP
`1100 Peachtree Street, NE
`Suite 2800
`Atlanta, Georgia 30309
`(404) 815 6500
`
`Alyson L. Wooten
`Reg. No. 58,045
`awooten@kilpatricktownsend.com
`Kilpatrick Townsend & Stockton LLP
`1100 Peachtree Street, NE
`Suite 2800
`Atlanta, Georgia 30309
`(404) 815 6500
`
`5
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`
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of PETITIONER MYLAN
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`PHARMACEUTICALS INC. AND MYLAN LABORATORIES LIMITED’S
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`RESPONSE TO PATENT OWNER’S NOTICE OF OBJECTIONS UNDER
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`37 C.F.R. § 42.64 TO EVIDENCE SUBMITTED IN SUPPORT OF
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`PETITIONER’S CORRECTED REPLY was served on February 13, 2017, by
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`filing this document through the Patent Trial and Appeal Board End to End system,
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`as well as delivering a copy via electronic mail upon the following attorneys of
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`record:
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`Jeffrey Ginsberg
`Kenyon & Kenyon LLP
`One Broadway
`New York, New York 10004-1007
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`with a courtesy copy to counsel for Pfizer Inc. and UCB Pharma GMBH, Plaintiffs
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`in the underlying litigation as follows:
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`Jack Blumenfeld
`Morris, Nichols, Arsht & Tunnell LLP
`1201 North Market Street
`Wilmington DE 19899
`Dimitrios T. Drivas
`Jeffrey J. Oelke
`James S. Trainor, Jr.
`Ryan P. Johnson
`Robert Counihan
`WHITE &CASE LLP
`1155 Avenue of the Americas
`New York, NY 10036
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`Dated: February 13, 2017
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`
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`By: /s/ Mitchell G. Stockwell
`Registration No. 39,389
`Counsel for Petitioner
`
`
`
`
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