Paper No. ___
`Filed: December 22, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________________
`
`
`MYLAN PHARMACEUTICALS INC.
`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 8,624,556 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)
`_____________________________
`
`PETITIONER MYLAN PHARMACEUTICALS INC.’S
`NOTICE OF OBJECTION TO EVIDENCE1
`
`
`1 The word-for-word identical paper is filed in each proceeding identified in the
`
`caption pursuant to the Board’s Scheduling Order (Paper 10).
`
`
`
`
`
`
`Filed: December 22, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________________
`
`
`MYLAN PHARMACEUTICALS INC.
`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 8,624,556 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)
`_____________________________
`
`PETITIONER MYLAN PHARMACEUTICALS INC.’S
`NOTICE OF OBJECTION TO EVIDENCE1
`
`
`1 The word-for-word identical paper is filed in each proceeding identified in the
`
`caption pursuant to the Board’s Scheduling Order (Paper 10).
`
`
`
`
`
`
`
`
`Case IPR2016-01127, -01128, -01129, -01130, -01131, -01132
`
`TABLE OF CONTENTS
`
`I.
`
`INTRODUCTION ........................................................................................ 1
`
`II.
`
`OBJECTIONS .............................................................................................. 1
`
`1.
`
`2.
`
`3.
`
`4.
`
`Objections to Ex. 2001, and any Reference to/Reliance
`Thereon ..................................................................................... 1
`
`Objections to Ex. 2003, and any Reference to/Reliance
`Thereon ..................................................................................... 2
`
`Objections to Ex. 2006, and any Reference to/Reliance
`Thereon ..................................................................................... 3
`
`Objections to Ex. 2008 and any Reference to/Reliance
`Thereon ..................................................................................... 5
`
`III. CONCLUSION ............................................................................................ 6
`
`
`
`
`-i-
`
`
`
`
`Case IPR2016-01127, -01128, -01129, -01130, -01131, -01132
`
`I.
`
`INTRODUCTION
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Mylan Pharmaceuticals Inc.
`
`(“Petitioner”) submits the following objections to Allergan, Inc. (“Patent
`
`Owner”)’s Exhibits 2001, 2003, 2006, and 2008 as listed on each List of Exhibits
`
`filed by Patent Owner in each of Patent Owner’s Preliminary Responses
`
`(“Preliminary Responses”) on September 9, 2016, and any reference to or reliance
`
`on the foregoing Exhibits in the Preliminary Responses or future filings by Patent
`
`Owner. As required by 37 C.F.R. § 42.62, Petitioner’s objections below apply the
`
`Federal Rules of Evidence (“F.R.E.”).
`
`II. OBJECTIONS
`1. Objections to Ex. 2001, and any Reference to/Reliance Thereon
`
`Grounds for Objection: F.R.E. 401, 402 (Irrelevant Evidence Inadmissible);
`
`F.R.E. 403 (Excluding Evidence for Prejudice, Confusion, Waste of Time, or Other
`
`Reasons); F.R.E. 602 (Foundation); F.R.E. 701, 702 (Expert Foundation and
`
`Opinions); F.R.E. 801, 802, 803, 805 (Inadmissible Hearsay); F.R.E. 901
`
`(Authenticating Evidence).
`
`Patent Owner describes EX. 2001 as “NDA 21-023 Cyclosporine
`
`Ophthalmic Emulsion 0.05%, Original NDA Filing, Vol. 1 (Feb. 24, 1999).”
`
`However, EX. 2001 does not purport to have been published in 1999 or on any
`
`particular date before the claimed priority date of the invention of the patent at
`
`
`-1-
`
`
`
`Case IPR2016-01127, -01128, -01129, -01130, -01131, -01132
`
`issue. To the extent that the publication date of EX. 2001 is later than the alleged
`
`date of invention for the patent at issue, the fact that the content of EX. 2001 was
`
`published on the asserted date, even if established by Patent Owner, is irrelevant to
`
`whether the claimed subject matter was obvious at the alleged time of the
`
`invention. F.R.E. 401, 402. Further, EX. 2001 is so attenuated to the question of
`
`whether the claimed invention was obvious at the alleged time of the invention,
`
`that it is unduly prejudicial, misleading, and a waste of time. F.R.E. 403.
`
`To the extent that Patent Owner relies on EX. 2001 or on any statements in
`
`EX. 2001 for the truth of the matter asserted, such statements are inadmissible
`
`hearsay when offered by Patent Owner and also have not been authenticated.
`
`F.R.E. 801, 802, 803, 805, 901. Moreover, Patent Owner provides no foundation
`
`for the statements as either lay testimony or expert testimony of any particular
`
`declarant. F.R.E. 602, 701, 702.
`
`2. Objections to Ex. 2003, and any Reference to/Reliance Thereon
`
`Grounds for Objection: F.R.E. 401, 402 (Irrelevant Evidence Inadmissible);
`
`F.R.E. 403 (Excluding Evidence for Prejudice, Confusion, Waste of Time, or Other
`
`Reasons); F.R.E. 602 (Foundation); F.R.E. 701, 702 (Expert Foundation and
`
`Opinions); F.R.E. 801, 802, 803, 805 (Inadmissible Hearsay); F.R.E. 901
`
`(Authenticating Evidence).
`
`-2-
`
`
`
`Case IPR2016-01127, -01128, -01129, -01130, -01131, -01132
`
`Patent Owner describes EX. 2003 as “Said et al., Investigative
`
`Opthalmology & Visual Science, vol. 48, No. 11 (Nov. 2007): 5000-5006.”
`
`However, EX. 2003 does not purport to have been published before the claimed
`
`priority date of the invention of the patent at issue. To the extent that the
`
`publication date of EX. 2003 is later than the alleged date of invention for the
`
`patent at issue, the fact that the content of EX. 2003 was published on the asserted
`
`date, even if established by Patent Owner, is irrelevant to whether the claimed
`
`subject matter was obvious at the alleged time of the invention. F.R.E. 401, 402.
`
`Further, EX. 2003, which appears to have been created years after the alleged date
`
`of invention, is so attenuated to the question of whether the claimed invention was
`
`obvious at the alleged time of the invention, that it is unduly prejudicial,
`
`misleading, and a waste of time. F.R.E. 403.
`
`To the extent that Patent Owner relies on any statements in EX. 2003 for the
`
`truth of the matter asserted, such statements are inadmissible hearsay and also have
`
`not been authenticated. F.R.E. 801, 802, 803, 805, 901. Moreover, Patent Owner
`
`provides no foundation for the statements as either lay testimony or expert
`
`testimony of any particular declarant. F.R.E. 602, 701, 702.
`
`3. Objections to Ex. 2006, and any Reference to/Reliance Thereon
`
`Grounds for Objection: F.R.E. 401, 402 (Irrelevant Evidence Inadmissible);
`
`F.R.E. 403 (Excluding Evidence for Prejudice, Confusion, Waste of Time, or Other
`
`-3-
`
`
`
`Case IPR2016-01127, -01128, -01129, -01130, -01131, -01132
`
`Reasons); F.R.E. 602 (Foundation); F.R.E. 701, 702 (Expert Foundation and
`
`Opinions); F.R.E. 801, 802, 803, 805 (Inadmissible Hearsay); F.R.E. 901
`
`(Authenticating Evidence).
`
`Patent Owner describes EX. 2006 as “Dorland’s Illustrated Medical
`
`Dictionary, definition of therapeutic.” However, EX. 2006 does not purport to
`
`have been published before the claimed priority date of the invention of the patent
`
`at issue. To the extent that the publication date of EX. 2006 is later than the
`
`alleged date of invention for the patent at issue, the fact that the content of EX.
`
`2006 was published on the asserted date, even if established by Patent Owner, is
`
`irrelevant to whether the claimed subject matter was obvious at the alleged time of
`
`the invention. F.R.E. 401, 402. Further, EX. 2006, which appears to have been
`
`created years after the alleged date of invention, is so attenuated to the question of
`
`whether the claimed invention was obvious at the alleged time of the invention,
`
`that it is unduly prejudicial, misleading, and a waste of time. F.R.E. 403.
`
`To the extent that Patent Owner relies on any statements in EX. 2006 for the
`
`truth of the matter asserted, such statements are inadmissible hearsay and also have
`
`not been authenticated. F.R.E. 801, 802, 803, 805, 901. Moreover, Patent Owner
`
`provides no foundation for the statements as either lay testimony or expert
`
`testimony of any particular declarant. F.R.E. 602, 701, 702.
`
`-4-
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`
`
`Case IPR2016-01127, -01128, -01129, -01130, -01131, -01132
`
`4. Objections to Ex. 2008 and any Reference to/Reliance Thereon
`
`Grounds for Objection: F.R.E. 401, 402 (Irrelevant Evidence Inadmissible);
`
`F.R.E. 403 (Excluding Evidence for Prejudice, Confusion, Waste of Time, or Other
`
`Reasons); F.R.E. 602 (Foundation); F.R.E. 701, 702 (Expert Foundation and
`
`Opinions); F.R.E. 801, 802, 803, 805 (Inadmissible Hearsay); F.R.E. 901
`
`(Authenticating Evidence).
`
`Patent Owner describes EX. 2008 as “RESTASIS® label.” However, EX.
`
`2008 does not purport to have been published before the claimed priority date of
`
`the invention of the patent at issue. To the extent that the publication date of EX.
`
`2008 is later than the alleged date of invention for the patent at issue, the fact that
`
`the content of EX. 2008 was published on the asserted date, even if established by
`
`Patent Owner, is irrelevant to whether the claimed subject matter was obvious at
`
`the alleged time of the invention. F.R.E. 401, 402. Further, EX. 2008, which
`
`appears to have been created years after the alleged date of invention, is so
`
`attenuated to the question of whether the claimed invention 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, EX. 2008 lacks authentication. F.R.E. 901.
`
`To the extent that Patent Owner relies on EX. 2008 or on any statements in
`
`EX. 2008 for the truth of the matter asserted, such statements are inadmissible
`
`hearsay when offered by Patent Owner and also have not been authenticated.
`
`-5-
`
`
`
`Case IPR2016-01127, -01128, -01129, -01130, -01131, -01132
`
`F.R.E. 801, 802, 803, 805, 901. Moreover, Patent Owner provides no foundation
`
`for the statements as either lay testimony or expert testimony of any particular
`
`declarant. F.R.E. 602, 701, 702.
`
`III. CONCLUSION
`
`The aforementioned exhibits were filed together with Patent Owner’s
`
`Preliminary Response, prior to institution. Trial was instituted on December 8,
`
`2016. These objections are made within 10 business days of institution pursuant to
`
`
`
`
`
`Respectfully submitted,
`
`/ Steven W. Parmelee /
` Steven W. Parmelee
` Reg. No. 31,990
`
`
`
`
`37 C.F.R. § 42.64.
`
`
`
`Dated: December 22, 2016
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`-6-
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`
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`Case IPR2016-01127, -01128, -01129, -01130, -01131, -01132
`
`CERTIFICATE OF SERVICE
`
`
`
`This is to certify that I caused to be served a true and correct copy of the
`
`foregoing Petitioner Mylan Pharmaceutical Inc.’s Notice of Objections to
`
`Evidence, on this 22nd day of December, 2016, on the Patent Owner at the
`
`correspondence address of the Patent Owner as follows:
`
`Dorothy P. Whelan
`Michael J. Kane
`Fish & Richardson PC
`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
`
`
`
`Dated: December 22, 2016
`
`
`
`
`
`
`Respectfully submitted,
`
`/ Steven W. Parmelee /
` Steven W. Parmelee, Lead Counsel
` Reg. No. 31,990
`
`
`
`
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`-7-
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