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`Paper No. ___
`Filed: July 20, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_____________________________
`
`MYLAN PHARMACEUTICALS INC., TEVA PHARMACEUTICALS USA,
`INC. and AKORN INC.,1
`
`Petitioner,
`
`v.
`
`ALLERGAN, INC.
`Patent Owner.
`
`_____________________________
`
`Case IPR2016-01127 (US 8,685,930 B2)
`Case IPR2016-01128 (US 8,629,111 B2)
`Case IPR2016-01129 (US 8,642,556 B2)
`Case IPR2016-01130 (US 8,633,162 B2)
`Case IPR2016-01131 (US 8,648,048 B2)
`Case IPR2016-01132 (US 9,248,191 B2)
`_____________________________
`
`PETITIONERS’ NOTICE OF OBJECTION TO EVIDENCE
`
`
`1 Cases IPR2017-00576 and IPR2017-00594, IPR2017-00578 and IPR2017-
`00596, IPR2017-00579 and IPR2017-00598, IPR2017-00583 and IPR2017-00599,
`IPR2017-00585 and IPR2017-00600, and IPR2017-00586 and IPR2017-00601,
`have respectively been joined with the captioned proceedings. The word-for-word
`identical paper is filed in each proceeding identified in the caption pursuant to the
`Board’s Scheduling Order (Paper 10).
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`TABLE OF CONTENTS
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`I.
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`INTRODUCTION ........................................................................................ 1
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`II.
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`OBJECTIONS .............................................................................................. 1
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`1.
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`2.
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`3.
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`Objections to EX2077 and any Reference to/Reliance
`Thereon ..................................................................................... 1
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`Objections to EX2078, and any Reference to/Reliance
`Thereon ..................................................................................... 2
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`Objections to EX2079, and any Reference to/Reliance
`Thereon ..................................................................................... 3
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`III. CONCLUSION ............................................................................................ 5
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`-i-
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`I.
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`INTRODUCTION
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`Pursuant to 37 C.F.R. § 42.64(b)(1), Petitioners submit the following
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`objections to Allergan, Inc. (“Patent Owner”)’s Exhibits 2077, 2078 and 2079 as
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`listed on each List of Exhibits filed by Patent Owner in each of Patent Owner’s
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`Sur-Replies (“Sur-Reply”) filed on July 14, 2017, and any reference to or reliance
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`on the foregoing Exhibits in filings by Patent Owner. As required by 37 C.F.R. §
`
`42.62, Petitioner’s objections below apply the Federal Rules of Evidence
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`(“F.R.E.”).
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`II. OBJECTIONS
`1. Objections to EX2077 and any Reference to/Reliance Thereon
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`Grounds for Objection: F.R.E. 602 (Foundation); F.R.E. 701, 702 (Expert
`
`Foundation and Opinions).
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`Patent Owner describes EX2077 as an article cited in EX1011 (Kaswan).
`
`Kaswan’s discussion regarding what constitutes a therapeutic level of cyclosporin
`
`was discussed in the Petitions and Amiji declarations filed therewith. Patent
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`Owner’s Responses to the Petitioner were due in March 2017, making Patent
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`Owner’s filing of EX2077 almost four months late and contrary to the case
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`scheduling order in this case. Paper 10.
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`Patent Owner provides no foundation for EX2077 or the statements
`
`contained therein. F.R.E. 602, 701, 702. Indeed, none of Allergan’s declarants
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`-1-
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`
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`discusses EX2077 in their declarations, provides any foundation for this document,
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`identifies the source of the document, or purports to have any knowledge regarding
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`the document or the information contained therein. Thus, Allergan offers Exhibit
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`2077 without foundation or expert analysis, in violation of F.R.E. 602, 701, 702.
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`2. Objections to EX2078, and any Reference to/Reliance Thereon
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`Grounds for Objection: F.R.E. 401, 402 (Irrelevant Evidence Inadmissible);
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`F.R.E. 403 (Excluding Evidence for Prejudice, Confusion, Waste of Time, or Other
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`Reasons); F.R.E. 602 (Foundation); F.R.E. 701, 702 (Expert Foundation and
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`Opinions); F.R.E. 801, 802, 803, 805 (Inadmissible Hearsay); F.R.E. 901
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`(Authenticating Evidence); F.R.E. 1002, 1006 (Summary requires production of
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`original or duplicate of underlying data); 37 C.F.R. § 42.53 (uncompelled
`
`testimony); 37 C.F.R. § 42.65 (Disclosure of Underlying Data Required).
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`Patent Owner describes EX2078 as a Medical Officer’s Review of NDA 21-
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`023. Patent Owner’s Responses to the Petitioner were due in March 2017, making
`
`Patent Owner’s filing of EX2078 to provide a bases for establishing criticality or
`
`unexpected results of the claimed formulation almost four months late and violates
`
`the case scheduling order in this case. Paper 10.
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`Moreover, EX2078 does not purport to be a published document, let alone
`
`published on a date before the claimed priority date of the patent at issue. Rather,
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`EX2078 appears to combine multiple reports in non-chronological order. To the
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`-2-
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`
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`extent that EX2078 lacks a publication date before the alleged date of invention for
`
`the patent at issue, the fact that the context of EX2078 was publically available,
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`even if established by Patent Owner, is irrelevant to whether the claimed subject
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`matter was obvious at the alleged time of the invention. F.R.E. 401, 402. Further,
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`such an exhibit is so attenuated to the question of whether the claimed invention
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`was obvious at the alleged time of the invention, that it is unduly prejudicial,
`
`misleading, and a waste of time. F.R.E. 403. Moreover, the document itself lacks
`
`foundation and lacks authentication. F.R.E. 602, 902.
`
`To the extent that Patent Owner relies on this exhibit or on any statements in
`
`this exhibit for the truth of the matter asserted, such statements are inadmissible
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`hearsay when offered by Patent Owner and also have not been authenticated.
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`F.R.E. 801, 802, 803, 805, 901. Moreover, Patent Owner provides no foundation
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`for the statements as either lay testimony or expert testimony of any particular
`
`declarant. F.R.E. 602, 701, 702; 37 C.F.R. § 42.53.
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`Moreover, Patent Owner has not made “the original or duplicates” of the
`
`underlying data being summarized in this document “available for examination or
`
`copying, or both” to the Petitioner. F.R.E. 1002, 1006; 37 C.F.R. § 42.65.
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`3. Objections to EX2079, and any Reference to/Reliance Thereon
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`Grounds for Objection: F.R.E. 602 (Foundation); F.R.E. 701, 702 (Expert
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`Foundation and Opinions); F.R.E. 801, 802, 803, 805 (Inadmissible Hearsay);
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`-3-
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`
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`F.R.E. 1002, 1006 (Summary requires production of original or duplicate of
`
`underlying data); 37 C.F.R. § 42.65 (Disclosure of Underlying Data Required).
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`Patent Owner describes EX2079 as a “Correction to Sall article (Ex. 1007).”
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`Patent Owner’s Responses to the Petitioner were due in March 2017, making
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`Patent Owner’s filing of EX2077 to provide a bases for establishing criticality or
`
`unexpected results of the claimed formulation almost four months late and violates
`
`the case scheduling order in this case. Paper 10.
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`EX2079 lacks sponsoring testimony to provide necessary factual foundation
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`for the document and Patent Owner provides no foundation for the document or
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`statements contained therein. F.R.E. 602, 701, 702. Indeed, none of Allergan’s
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`declarants discuss EX2079 in their declaration, provide any foundation for this
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`document, identify the source of the document, or purport to have any knowledge
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`regarding the document or the information contained therein. Moreover, Patent
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`Owner has not made “the original or duplicates” of the underlying data being
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`summarized in this document “available for examination or copying, or both” to
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`the Petitioner. F.R.E. 1002, 1006; 37 C.F.R. § 42.65.
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`To the extent that Patent Owner relies on this exhibit or on any statements in
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`this exhibit for the truth of the matter asserted, such statements are inadmissible
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`hearsay when offered by Patent Owner. F.R.E. 801, 802, 803, 805.
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`-4-
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`III. CONCLUSION
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`The aforementioned exhibits were filed together with Patent Owner’s Sur-
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`Replies on July 14, 2017. These objections are made within 5 business days of
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`service pursuant to 37 C.F.R. § 42.64.
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`
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`Dated: July 20, 2017
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`Respectfully submitted,
`
`/ Steven W. Parmelee /
` Steven W. Parmelee
` Reg. No. 31,990
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`-5-
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`
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`CERTIFICATE OF SERVICE
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`
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`This is to certify that I caused to be served a true and correct copy of the
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`foregoing Petitioners’ Notice of Objection to Evidence, on this 20th day of July,
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`2017, on the Patent Owner at the correspondence address of the Patent Owner as
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`follows:
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`Dorothy P. Whelan
`Michael Kane
`Susan Morrison Colletti
`Robert M. Oakes
`Jonathan Singer
`Fish & Richardson P.C.
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`Email: IPR13351-0008IP1@fr.com
`Email: IPR13351-0008IP2@fr.com
`Email: IPR13351-0008IP3@fr.com
`Email: IPR13351-0008IP4@fr.com
`Email: IPR13351-0008IP5@fr.com
`Email: IPR13351-0008IP6@fr.com
`Email: PTABInbound@fr.com
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`And on the remaining petitioners as follows:
`
`
`Gary Speier
`Mark Schuman
`CARLSON, CASPERS, VANDENBURGH,
`LINDQUIST & SCHUMAN, P.A.
`225 South Sixth Street, Suite 4200
`Minneapolis, MN 55402
`Email: gspeier@carlsoncaspers.com
`Email: mschuman@carlsoncaspers.com
`Attorneys for Teva Pharmaceuticals USA, Inc.
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`-6-
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`
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`Michael Dzwonczyk
`Azadeh Kokabi
`Travis Ribar
`SUGHRUE MION, PLLC
`2100 Pennsylvania Ave., NW
`Washington, DC 20037
`Email: mdzwonczyk@sughrue.com
`Email: akokabi@sughrue.com
`Email: tribar@sughrue.com
`Attorneys for Akorn Inc.
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`Dated: July 20, 2017
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`Respectfully submitted,
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`/ Steven W. Parmelee /
` Steven W. Parmelee, Lead Counsel
` Reg. No. 31,990
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`-7-
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