Case No. IPR2018-00272
`Patent No. 9,393,208
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________
`
`MYLAN PHARMACEUTICALS INC. and
`DR. REDDY'S LABORATORIES, INC.
`
`Petitioners
`
`v.
`
`HORIZON PHARMA USA, INC. and NUVO PHARMACEUTICALS
`(IRELAND) DESIGNATED ACTIVITY COMPANY.
`Patent Owners
`____________________________
`
`Case No. IPR2018-002721
`U.S. Patent No. 9,393,208
`____________________________
`
`
`
`PATENT OWNERS’ OBJECTIONS TO PETITIONER’S EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64(b)(1)
`
`
`
`
`
`
`
`
`1 Petitioner Dr. Reddy’s Laboratories, Inc., from IPR2018-01341, has been
`joined as a Petitioner to this proceeding.
`
`
`Patent No. 9,393,208
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________
`
`MYLAN PHARMACEUTICALS INC. and
`DR. REDDY'S LABORATORIES, INC.
`
`Petitioners
`
`v.
`
`HORIZON PHARMA USA, INC. and NUVO PHARMACEUTICALS
`(IRELAND) DESIGNATED ACTIVITY COMPANY.
`Patent Owners
`____________________________
`
`Case No. IPR2018-002721
`U.S. Patent No. 9,393,208
`____________________________
`
`
`
`PATENT OWNERS’ OBJECTIONS TO PETITIONER’S EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64(b)(1)
`
`
`
`
`
`
`
`
`1 Petitioner Dr. Reddy’s Laboratories, Inc., from IPR2018-01341, has been
`joined as a Petitioner to this proceeding.
`
`
`
`Case No. IPR2018-00272
`Patent No. 9,393,208
`
`I.
`
`INTRODUCTION
`
`Pursuant to 37 C.F.R. § 42.64(b)(1) and the Federal Rules of Evidence
`
`(“FRE”), Patent Owners submit the following objections to evidence filed by Mylan
`
`Pharmaceuticals, Inc. (“Mylan” or “Petitioner”) with Petitioner’s Reply to Patent
`
`Owner’s Response (“Reply”). These objections are timely filed within five business
`
`days of service of the Reply, May 8, 2019. (Paper 49).
`
`II.
`
`IDENTIFICATION OF CHALLENGED EXHIBITS AND GROUNDS
`FOR OBJECTIONS
`
`A. Exhibit 1060
`
`Exhibit 1060 is purportedly an article authored by Hawkey and published in
`
`the journal New England Journal of Medicine in 1998. Patent Owner objects to
`
`Exhibit 1060 as not properly authenticated under FRE 901. Petitioner has produced
`
`insufficient evidence to support a finding that this exhibit is what Petitioner claims
`
`it is. Patent Owner further objects to this exhibit as inadmissible hearsay under FRE
`
`802 and as not supporting Petitioner’s characterization of the truth of the matter
`
`asserted. (See, e.g., Ex. 1059 at 9, 11, 12 (citing Ex. 1060).)
`
`B.
`
`Exhibit 1061
`
`Exhibit 1061 is purportedly an article authored by Yeomans and published in
`
`the journal New England Journal of Medicine in 1998. Patent Owner objects to
`
`Exhibit 1061 as not properly authenticated under FRE 901. Petitioner has produced
`
`insufficient evidence to support a finding that this exhibit is what Petitioner claims
`
`1
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`Case No. IPR2018-00272
`Patent No. 9,393,208
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`it is. Patent Owner further objects to this exhibit as inadmissible hearsay under FRE
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`802 and as not supporting Petitioner’s characterization of the truth of the matter
`
`asserted. (See, e.g., Ex. 1059 at 9, 10, 11, 12 (citing Ex. 1061).)
`
`C. Exhibit 1062
`
`Exhibit 1062 is purportedly an article authored by Agrawal and published in
`
`the journal Annals of Internal Medicine in 1991. Patent Owner objects to Exhibit
`
`1062 as not properly authenticated under FRE 901. Petitioner has produced
`
`insufficient evidence to support a finding that this exhibit is what Petitioner claims
`
`it is. Patent Owner further objects to this exhibit as inadmissible hearsay under FRE
`
`802 and as not supporting Petitioner’s characterization of the truth of the matter
`
`asserted. (See, e.g., Ex. 1059 at 10 (citing Ex. 1062).)
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`D. Exhibit 1063
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`Exhibit 1063 is purportedly an article authored by Brown and published in the
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`journal Drug Safety in 1999. Patent Owner objects to Exhibit 1063 as not properly
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`authenticated under FRE 901. Petitioner has produced insufficient evidence to
`
`support a finding that this exhibit is what Petitioner claims it is. Patent Owner further
`
`objects to this exhibit as inadmissible hearsay under FRE 802 and as not supporting
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`Petitioner’s characterization of the truth of the matter asserted. (See, e.g., Ex. 1059
`
`at 5, 6, 10, 12 (citing Ex. 1063).)
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`Case No. IPR2018-00272
`Patent No. 9,393,208
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`E.
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`Exhibits 1064, 1076, and 1088
`
`Exhibits 1064, 1076, and 1088 are purportedly an excerpt from the
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`Physicians’ Desk Reference (54 ed. 2000). Exhibits 1064, 1076, and 1088 are
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`purportedly submitted as an earlier version of Exhibit 1009, submitted in Petitioner’s
`
`Petition. Patent Owner objects to these exhibits as untimely and new prior art
`
`evidence, in violation of 37 C.F.R. § 42.23(b). 37 C.F.R. § 42.23(b) does not
`
`authorize or otherwise provide a means for supplementing the evidence of record.
`
`Petitioner does not contend that Exhibits 1064, 1076, and 1088 were not available
`
`to Petitioner at the time of filing of Petitioner’s Petition. Patent Owner further
`
`objects to Exhibits 1064, 1076, and 1088 as not properly authenticated under FRE
`
`901. Petitioner has produced insufficient evidence to support a finding that these
`
`exhibits are what Petitioner claims they are. Patent Owner further objects to these
`
`exhibits under the best evidence rule under FRE 1001-1003. Patent Owner further
`
`objects to these exhibits as irrelevant under FRE 402/403. Patent Owner further
`
`objects to these exhibits as inadmissible hearsay under FRE 802 and as not
`
`supporting Petitioner’s characterization of the truth of the matter asserted. (See, e.g.,
`
`Reply at 20; Ex. 1059 at 18, 19, 25 (citing Ex. 1064).)
`
`F.
`
`Exhibit 1065
`
`Exhibit 1065 is purportedly the Nexium prescribing information. Exhibit
`
`1065 is purportedly submitted as another version of Exhibit 1043, submitted in
`
`3
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`Case No. IPR2018-00272
`Patent No. 9,393,208
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`Petitioner’s Petition. Patent Owner objects to this exhibit as untimely and new prior
`
`art evidence, in violation of 37 C.F.R. § 42.23(b). 37 C.F.R. § 42.23(b) does not
`
`authorize or otherwise provide a means for supplementing the evidence of record.
`
`Petitioner does not contend that Exhibit 1065 was not available to Petitioner at the
`
`time of filing of Petitioner’s Petition. Patent Owner further objects to Exhibit 1065
`
`as not properly authenticated under FRE 901. Petitioner has produced insufficient
`
`evidence to support a finding that this exhibit is what Petitioner claims it is. Patent
`
`Owner further objects to this exhibit as irrelevant under FRE 402/403. Patent Owner
`
`further objects to this exhibit as inadmissible hearsay under FRE 802 and as not
`
`supporting Petitioner’s characterization of the truth of the matter asserted. (See, e.g.,
`
`Ex. 1059 at 19 (citing Ex. 1065).)
`
`G. Exhibit 1066
`
`Exhibit 1066 is purportedly the EC-Naprosyn prescribing information.
`
`Exhibit 1066 is purportedly submitted as another version of Exhibit 1009, submitted
`
`in Petitioner’s Petition. Patent Owner objects to this exhibit as untimely and new
`
`prior art evidence, in violation of 37 C.F.R. § 42.23(b). 37 C.F.R. § 42.23(b) does
`
`not authorize or otherwise provide a means for supplementing the evidence of
`
`record. Petitioner does not contend that Exhibit 1066 was not available to Petitioner
`
`at the time of filing of Petitioner’s Petition. Patent Owner further objects to Exhibit
`
`1066 as not properly authenticated under FRE 901. Petitioner has produced
`
`4
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`Case No. IPR2018-00272
`Patent No. 9,393,208
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`insufficient evidence to support a finding that this exhibit is what Petitioner claims
`
`it is. Patent Owner further objects to this exhibit as irrelevant under FRE 402/403.
`
`Patent Owner further objects to this exhibit as inadmissible hearsay under FRE 802
`
`and as not supporting Petitioner’s characterization of the truth of the matter asserted.
`
`(See, e.g., Ex. 1059 at 19 (citing Ex. 1066).)
`
`H. Exhibit 1067
`
`Exhibit 1067 is purportedly an article authored by Katz and published in the
`
`journal Alimentary Pharmacology & Therapeutics in 2004. Patent Owner objects to
`
`Exhibit 1067 as not properly authenticated under FRE 901. Petitioner has produced
`
`insufficient evidence to support a finding that this exhibit is what Petitioner claims
`
`it is. Patent Owner further objects to this exhibit as inadmissible hearsay under FRE
`
`802 and as not supporting Petitioner’s characterization of the truth of the matter
`
`asserted. (See, e.g., Ex. 1059 at 20-21 (citing Ex. 1067).)
`
`I.
`
`Exhibit 1068
`
`Exhibit 1068 is purportedly an article authored by Junghard and published in
`
`the journal European Journal of Clinical Pharmacology in 2002. Patent Owner
`
`objects to Exhibit 1068 as not properly authenticated under FRE 901. Petitioner has
`
`produced insufficient evidence to support a finding that this exhibit is what Petitioner
`
`claims it is. Patent Owner further objects to this exhibit as inadmissible hearsay
`
`under FRE 802 and as not supporting Petitioner’s characterization of the truth of the
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`5
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`Case No. IPR2018-00272
`Patent No. 9,393,208
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`matter asserted. (See, e.g., Ex. 1059 at 21 (citing Ex. 1068).)
`
`J.
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`Exhibit 1069
`
`Exhibit 1069 is purportedly an article authored by Hammer and published in
`
`the Alimentary Pharmacology & Therapeutics in 2004. Patent Owner objects to
`
`Exhibit 1069 as not properly authenticated under FRE 901. Petitioner has produced
`
`insufficient evidence to support a finding that this exhibit is what Petitioner claims
`
`it is. Patent Owner further objects to this exhibit as inadmissible hearsay under FRE
`
`802 and as not supporting Petitioner’s characterization of the truth of the matter
`
`asserted. (See, e.g., Ex. 1059 at 21 (citing Ex. 1069).)
`
`K. Exhibit 1073
`
`Exhibit 1073 is purportedly an article authored by Ekström and published in
`
`the Scandinavian Journal of Gastroenterology in 1996. Patent Owner objects to
`
`Exhibit 1073 as not properly authenticated under FRE 901. Petitioner has produced
`
`insufficient evidence to support a finding that this exhibit is what Petitioner claims
`
`it is. Patent Owner further objects to this exhibit as inadmissible hearsay under FRE
`
`802 and as not supporting Petitioner’s characterization of the truth of the matter
`
`asserted. (See, e.g., Ex. 1059 at 6 (citing Ex. 1073).)
`
`L.
`
`Exhibit 1077
`
`Exhibit 1077 is purportedly an article authored by Miner and published in the
`
`American Journal of Gastroenterology in 2003. Patent Owner objects to Exhibit
`
`1077 as not properly authenticated under FRE 901. Petitioner has produced
`
`6
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`Case No. IPR2018-00272
`Patent No. 9,393,208
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`insufficient evidence to support a finding that this exhibit is what Petitioner claims
`
`it is. Patent Owner further objects to this exhibit as inadmissible hearsay under FRE
`
`802 and as not supporting Petitioner’s characterization of the truth of the matter
`
`asserted. (See, e.g., Ex. 1074 at 26 (citing Ex. 1077).)
`
`M. Exhibit 1080
`
`Exhibit 1080 is purportedly an excerpt from U.S. Patent Application No.
`
`61/095,584 prosecution history. Patent Owner objects to Exhibit 1080 as irrelevant
`
`under FRE 402/403.
`
`N. Exhibit 1081
`
`Exhibit 1081 is purportedly the Office Action Summary, U.S. Patent
`
`Application No. 12/553,107 (June 16, 2014). Patent Owner objects to Exhibit 1081
`
`as irrelevant under FRE 402/403.
`
`O. Exhibit 1082
`
`Exhibit 1082 is purportedly the Office Action Summary, U.S. Patent
`
`Application No. 12/553,107 (Mar. 26, 2015). Patent Owner objects to Exhibit 1082
`
`as irrelevant under FRE 402/403.
`
`P.
`
`Exhibit 1083
`
`Exhibit
`
`is
`
`a
`
`webpage
`
`printout
`
`purportedly
`
`from
`
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=002
`
`& Appl_No=022511&Appl_type=N. Patent Owner objects to Exhibit 1083 as
`
`irrelevant under FRE 402/403.
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`7
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`
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`Q. Exhibit 1084
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`Exhibit 1084 is purportedly U.S. Patent No. 6,365,184. Patent Owner objects
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`Case No. IPR2018-00272
`Patent No. 9,393,208
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`to Exhibit 1084 as irrelevant under FRE 402/403.
`
`III. CONCLUSION
`
`To the extent Petitioner fails to correct the defects associated with the
`
`Challenged Exhibits in view of Patent Owner’s objections herein, Patent Owner may
`
`file a motion to exclude the Challenged Exhibits under 37 C.F.R. § 42.64(c).
`
`
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`Dated: May 15, 2019
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`Respectfully submitted,
`
`
`/s/ Thomas A. Blinka
`Thomas A. Blinka, Ph.D.
`Reg. No. 44,541
`Counsel for Patent Owner
`
`8
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`Case No. IPR2018-00272
`Patent No. 9,393,208
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`
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`
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`CERTIFICATION OF SERVICE UNDER 37 C.F.R. § 42.6(e)
`
`I, Thomas A. Blinka, hereby certify that on this 15th day of May, 2019, the
`
`foregoing PATENT OWNERS’ OBJECTIONS TO PETITIONER’S EVIDENCE
`
`PURSUANT TO 37 C.F.R. § 42.64(b)(1) was served electronically via email on
`
`the following:
`
`
`
`Counsel for MYLAN
`
`
`
`Counsel for DR. REDDY'S
`
`
`
`
`
`Brandon M. White
`Emily J. Greb
`Autumn N. Nero
`Bryan D. Beel
`Maria A. Stubbings
`PERKINS COIE LLP
`bmwhite@perkinscoie.com
`egreb@perkinscoie.com
`anero@perkinscoie.com
`bbeel@perkinscoie.com
`mstubbings@perkinscoie.com
`EsoNaproxen@perkinscoie.com
`
`Alan H. Pollack
`Stuart D. Sender
`Louis H. Weinstein
`WINDELS MARX LANE &
`MITTENDORF, LLP
`apollack@windelsmarx.com
`ssender@windelsmarx.com
`lweinstein@windelsmarx.com.com
`
`
`Date: May 15, 2019
`
`BY:
`
`/Thomas A. Blinka/
`
`
`
`
`
`
`
`
`Thomas A. Blinka, Ph.D.
`Reg. No. 44,541
`Counsel for Patent Owner
`
`9
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