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`Paper No. ___
`Filed: March 27, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_____________________________
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`MYLAN PHARMACEUTICALS INC.
`Petitioner,
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`v.
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`ALLERGAN, INC.
`Patent Owner.
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`_____________________________
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`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
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`1 The word-for-word identical paper is filed in each proceeding identified in the
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`caption pursuant to the Board’s Scheduling Order (Paper 10).
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`Case IPR2016-01127, -01128, -01129, -01130, -01131, -01132
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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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`4.
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`5.
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`6.
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`7.
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`8.
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`9.
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`Objections to Exs. 2011, 2015, 2021, 2032, 2034-2035,
`2042, 2047-2050, 2052-2053, 2060, 2068-2069, 2071,
`and any Reference to/Reliance Thereon .................................... 1
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`Objections to Exs. 2030-2031, 2074, and any Reference
`to/Reliance Thereon .................................................................. 2
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`Objections to Exs. 2046, 2051, 2055, 2056, 2057, 2062-
`2066, 2072-2073, and any Reference to/Reliance
`Thereon ..................................................................................... 4
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`Objections to Ex. 2061 and any Reference to/Reliance
`Thereon ..................................................................................... 5
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`Objections to Exs. 2026 (Exhibit A), 2027, and any
`Reference to/Reliance Thereon ................................................. 6
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`Objections to Ex. 2028, 2038, 2046, and any Reference
`to/Reliance Thereon .................................................................. 7
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`Objections to Ex. 2033, and any Reference to/Reliance
`Thereon ..................................................................................... 9
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`Objections to Ex. 2044, and any Reference to/Reliance
`Thereon ..................................................................................... 9
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`Objections to Ex. 2017 and any Reference to/Reliance
`Thereon ................................................................................... 10
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`III. CONCLUSION .......................................................................................... 11
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`Case IPR2016-01127, -01128, -01129, -01130, -01131, -01132
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`I.
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`INTRODUCTION
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`Pursuant to 37 C.F.R. § 42.64(b)(1), Mylan Pharmaceuticals Inc.
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`(“Petitioner”) submits the following objections to Allergan, Inc. (“Patent
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`Owner”)’s Exhibits 2011, 2015, 2017. 2021, 2026, 2027, 2028, 2030-2035, 2038,
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`2042, 2044, 2046-2053, 2055-2057, 2060-2066, 2068-2069, and 2071-2074 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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`Responses (“PORs”) on March 20, 2017, and any reference to or reliance on the
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`foregoing Exhibits in the PORs or future filings by Patent Owner. As required by
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`37 C.F.R. § 42.62, Petitioner’s objections below apply the Federal Rules of
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`Evidence (“F.R.E.”).
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`II. OBJECTIONS
`1. Objections to Exs. 2011, 2015, 2021, 2032, 2034-2035, 2042,
`2047-2050, 2052-2053, 2060, 2068-2069, 2071, 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).
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`Patent Owner describes Exs. 2011, 2015, 2021, 2032, 2034-2035, 2042,
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`2047-2050, 2052-2053, 2060, 2068-2069, and 2071, as various documents either
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`Case IPR2016-01127, -01128, -01129, -01130, -01131, -01132
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`purporting to have been published after the claimed invention date of the patents or
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`not purporting to have been published at all. To the extent that the publication date
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`of any of these exhibits is later than the alleged date of invention for the patents at
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`issue, the fact that the content of such exhibit was published on the asserted date,
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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 exhibits are so attenuated to the question of whether the claimed invention
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`was obvious at the alleged time of the invention, that they are unduly prejudicial,
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`misleading, and a waste of time. F.R.E. 403.
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`To the extent that Patent Owner relies on these exhibits or on any statements
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`in these exhibits for the truth of the matter asserted, such statements are
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`inadmissible hearsay when offered by Patent Owner and also have not been
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`authenticated. F.R.E. 801, 802, 803, 805, 901. Moreover, Patent Owner provides
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`no foundation for the statements as either lay testimony or expert testimony of any
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`particular declarant. F.R.E. 602, 701, 702.
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`2. Objections to Exs. 2030-2031, 2074, 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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`Case IPR2016-01127, -01128, -01129, -01130, -01131, -01132
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`Opinions); F.R.E. 801, 802, 803, 805 (Inadmissible Hearsay); F.R.E. 901
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`(Authenticating Evidence).
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`Patent Owner describes Exs. 2030-2031, and 2074, as various web page
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`printouts not purporting to have been published before the earliest claimed
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`invention date of the patents. To the extent that the publication date of any of these
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`exhibits is later than the alleged date of invention for the patents at issue, the fact
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`that the content of such exhibit was published on the asserted date, even if
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`established by Patent Owner, is irrelevant to whether the claimed subject matter
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`was obvious at the alleged time of the invention. F.R.E. 401, 402. Further, such
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`exhibits are so attenuated to the question of whether the claimed invention was
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`obvious at the alleged time of the invention, that they are unduly prejudicial,
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`misleading, and a waste of time. F.R.E. 403. Moreover, the documents
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`themselves lack foundation and lack authentication. F.R.E. 602, 902.
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`To the extent that Patent Owner relies on these exhibits or on any statements
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`in these exhibits for the truth of the matter asserted, such statements are
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`inadmissible hearsay when offered by Patent Owner and also have not been
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`authenticated. F.R.E. 801, 802, 803, 805, 901. Moreover, Patent Owner provides
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`no foundation for the statements as either lay testimony or expert testimony of any
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`particular declarant. F.R.E. 602, 701, 702.
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`3. Objections to Exs. 2046, 2051, 2055, 2056, 2057, 2062-2066,
`2072-2073, 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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`F.R.E. 901 (Authenticating Evidence); F.R.E. 1006 (Improper Summary); 37
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`C.F.R. § 42.65 (Disclosure of Underlying Data Required); 37 C.F.R. § 42.53
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`(“Uncompelled direct testimony must be submitted in the form of an affidavit.”)
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`Patent Owner describes Exs. 2046, 2051, 2055, 2056, 2057, 2062-2066, and
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`2072-2073 as various documents related to Restasis and does not purport to assert
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`that any of these documents were publicly available prior to the claimed invention
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`date. Each of these documents lacks sponsoring testimony to provide necessary
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`factual foundation for the documents and to confirm their authenticity. F.R.E. 602,
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`901. Moreover, Patent Owner has not made “the original or duplicates” of the
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`underlying data being summarized in these documents “available for examination
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`or copying, or both” to the Petitioner. F.R.E. 1006; 37 C.F.R. § 42.65.
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`To the extent that Patent Owner relies on these exhibits or on any statements
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`in these exhibits for the truth of the matter asserted, such statements are
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`inadmissible hearsay when offered by Patent Owner and also have not been
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`authenticated. F.R.E. 801, 802, 803, 805, 901. Moreover, Patent Owner provides
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`no foundation for the statements as either lay testimony or expert testimony of any
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`particular declarant. F.R.E. 602, 701, 702; 37 C.F.R. § 42.53.
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`4. Objections to Ex. 2061 and any Reference to/Reliance Thereon
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`Grounds for Objection: F.R.E. 102-103 (Original Document Required);
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`F.R.E. 106 (Complete Document Rule); F.R.E. 602 (Foundation); F.R.E. 701, 702
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`(Expert Foundation and Opinions); F.R.E. 801, 802, 803, 805 (Inadmissible
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`Hearsay); F.R.E. 901 (Authenticating Evidence); F.R.E. 1006 (Improper
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`Summary); 37 C.F.R. § 42.65 (Disclosure of Underlying Data Required); 37
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`C.F.R. § 42.53 (“Uncompelled direct testimony must be submitted in the form of
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`an affidavit.”)
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`Patent Owner describes Ex. 2061 as “Restasis Launch Marketing Plan, dated
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`February 12-13, 2003.” This document lacks sponsoring testimony to provide
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`necessary factual foundation for the document and to confirm its authenticity.
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`F.R.E. 602, 901. Moreover, Patent Owner has not made “the original or
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`duplicates” of the underlying data being summarized in this document “available
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`for examination or copying, or both” to the Petitioner. F.R.E. 1006; 37 C.F.R. §
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`42.65. Moreover, the document is at places illegible, and Patent Owner should
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`produce to Petitioner a legible copy of the document. F.R.E. 102-103, 106.
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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 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
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`declarant. F.R.E. 602, 701, 702; 37 C.F.R. § 42.53.
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`5. Objections to Exs. 2026 (Exhibit A), 2027, 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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`F.R.E. 901 (Authenticating Evidence); F.R.E. 1006 (Improper Summary); 37
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`C.F.R. § 42.65 (Disclosure of Underlying Data Required); 37 C.F.R. § 42.53
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`(“Uncompelled direct testimony must be submitted in the form of an affidavit.”)
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`Patent Owner describes each of Exs. 2026 (Exhibit A), 2027, as PK-98-074
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`and does not assert that either of these documents was publicly available prior to
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`the claimed invention date. Each of these documents lacks sponsoring testimony
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`based on personal knowledge explaining what the documents are, how they came
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`to be, and where the underlying data for the summaries, charts, and calculations
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`therein can be examined. F.R.E. 602, 901, 1006. Moreover, Patent Owner has not
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`made “the original or duplicates” of the underlying data being summarized in these
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`documents “available for examination or copying, or both” to the Petitioner.
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`F.R.E. 1006; 37 C.F.R. § 42.65.
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`To the extent that Patent Owner relies on these exhibits or on any statements
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`in these exhibits for the truth of the matter asserted, such statements are
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`inadmissible hearsay when offered by Patent Owner and also have not been
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`authenticated. F.R.E. 801, 802, 803, 805, 901. Moreover, Patent Owner provides
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`no foundation for the statements as either lay testimony or expert testimony of any
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`particular declarant. F.R.E. 602, 701, 702; 37 C.F.R. § 42.53.
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`6. Objections to Ex. 2028, 2038, 2046, and any Reference
`to/Reliance Thereon
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`Grounds for Objection: F.R.E. 403 (Excluding Evidence for Prejudice,
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`Confusion, Waste of Time, or Other Reasons); F.R.E. 602 (Foundation); F.R.E.
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`701, 702 (Expert Foundation and Opinions); F.R.E. 801, 802, 803, 805
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`(Inadmissible Hearsay); F.R.E. 901 (Authenticating Evidence); 37 C.F.R. § 42.65
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`(Disclosure of Underlying Data Required); 37 C.F.R. § 42.53 (“Uncompelled
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`direct testimony must be submitted in the form of an affidavit.”).
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`Patent Owner describes Exhibit 2038 as the deposition of David LeCause, an
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`individual who has not submitted a declaration in this proceeding. The Maness
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`declaration (Exhibit 2028) cites to Exhibit 2038 and to private conversations Dr.
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`Maness allegedly had with Mr. LeCause in at least paragraphs 50-51, 60, 65, 67-
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`68, 74-75, 88-90, 96. Dr. Maness describes Exhibit 2046 as “LeCause Exhibit 12.”
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`The Maness declaration also lists numerous documents in Appendix B that Dr.
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`Maness purports to have reviewed in preparing his opinions and that appear not to
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`have been served on petitioner. Such documents include unspecified “Marketing
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`Docs for LeCause Deposition,” the set of exhibits to the LeCause deposition,
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`various “IMS Data” sets, various “Restasis” documents, various .xlsx documents,
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`various documents identified with a bates number prefix “AGN_RES,” various
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`“Marketing Plan” and “Strategic Plan” documents, various “Share of Voice”
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`reports and “SOV” documents, certain articles, and certain “Web Sources.” The
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`Maness declaration also relies on private conversations Dr. Maness allegedly had
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`with Christopher Larsen (see Exhibit 2028 at ¶55 & n.59), another individual who
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`has not submitted a declaration in this proceeding.
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`Petitioner objects to Patent Owner’s failure to produce to Petitioner the
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`complete set of documents and witnesses identified by Dr. Maness, as well as Dr.
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`Maness’s selective use of private conversation and deposition transcripts from
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`other proceedings to circumvent the Board requirement that all uncompelled direct
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`testimony be submitted in the form of an affidavit. 37 C.F.R. § 42.65; 37 C.F.R. §
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`42.53. Petitioner also objects to Patent Owner’s selective production of documents
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`apparently produced in its litigation in the Eastern District of Texas, including
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`Patent Owner’s selective production of the deposition exhibits from the LeCause
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`deposition and the various documents identified by Dr. Maness in his Appendix B
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`with a bates number prefix “AGN_RES.”
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`To the extent that Patent Owner relies on Exhibit 2038 or on statements
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`attributed to Mr. LeCause or Mr. Larsen for the truth of the matter asserted, such
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`statements are inadmissible hearsay when offered by Patent Owner. F.R.E. 801,
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`802, 803, 805. Moreover, Exhibit 2038 has not been authenticated. F.R.E. 901.
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`Moreover, Patent Owner provides no foundation for the statements as either lay
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`testimony or expert opinion. F.R.E. 602, 701, 702.
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`7. Objections to Ex. 2033, and any Reference to/Reliance Thereon
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`Grounds for Objection: F.R.E. 102-103 (Original Document Required);
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`F.R.E. 106 (Complete Document Rule); F.R.E. 801, 802, 803, 805 (Inadmissible
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`Hearsay); F.R.E. 901 (Authenticating Evidence).
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`Patent Owner describes Exhibit 2033 as the FDA approval document for
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`Restasis. However, Exhibit 2033 contains redactions to the original document at
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`least on pages 7, 10, 13-14 that in fairness ought to be considered at the same time
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`as the submitted portion of the writing. F.R.E. 102-103, 106.
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`To the extent that Patent Owner relies on any statements in this exhibit for
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`the truth of the matter asserted, such statements are inadmissible hearsay when
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`offered by Patent Owner and also have not been authenticated. F.R.E. 801, 802,
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`803, 805, 901.
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`8. Objections to Ex. 2044, and any Reference to/Reliance Thereon
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`Grounds for Objection: F.R.E. 102-103 (Original Document Required);
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`F.R.E. 106 (Complete Document Rule); F.R.E. 602 (Foundation); F.R.E. 701, 702
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`(Expert Foundation and Opinions); F.R.E. 801, 802, 803, 805 (Inadmissible
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`Hearsay); F.R.E. 901 (Authenticating Evidence).
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`Patent Owner describes Exhibit 2044 as the “FDA label for Xiidra®”.
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`However, page 1 of Exhibit 2044 indicates that it is page 5 of some other
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`document. Patent Owner should produce the entirety of the document to Petitioner
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`so that Petitioner can evaluate whether the entire document ought to be considered
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`in fairness at the same time as the submitted portion of the writing. F.R.E. 102-
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`103, 106, 602, 701, 702.
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`To the extent that Patent Owner relies on any statements in this exhibits for
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`the truth of the matter asserted, such statements are inadmissible hearsay and also
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`have not been authenticated. F.R.E. 801, 802, 803, 805, 901.
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`9. Objections to Ex. 2017 and any Reference to/Reliance Thereon
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`Grounds for Objection: F.R.E. 102-103 (Original Document Required);
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`F.R.E. 106 (Complete Document Rule); F.R.E. 602 (Foundation); F.R.E. 901
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`(Authenticating Evidence).
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`Patent Owner describes Ex. 2017 as “Schaefer et al., ‘Skin permeability,’
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`Spring-Verlag (1982).” However, Ex. 2017 provides only two pages of text from
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`the body of the reference divorced from context, does not provide the entire
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`chapter or identify a section of the reference appearing in the portion of the table of
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`contents provided in Ex. 2017, does not appear to provide the entire table of
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`contents for the reference, and cuts off the page number from the table of contents
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`page that is provided. As such, Patent Owner has failed to provide Petitioner with
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`a complete exhibit sufficient to confirm the authenticity of the exhibit. F.R.E. 602,
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`901. Patent Owner should produce to Petitioner a complete and legible copy of the
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`document. F.R.E. 102-103, 106.
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`III. CONCLUSION
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`The aforementioned exhibits were filed together with Patent Owner’s
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`Response on March 20, 2017. These objections are made within 5 business days
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`of service pursuant to 37 C.F.R. § 42.64.
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`Respectfully submitted,
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`/ Steven W. Parmelee /
` Steven W. Parmelee
` Reg. No. 31,990
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`Dated: March 27, 2017
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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 Petitioner Mylan Pharmaceutical Inc.’s Notice of Objections to
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`Evidence, on this 27th day of March, 2017, on the Patent Owner at the
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`correspondence address of the Patent Owner as follows:
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`Dorothy P. Whelan
`Michael J. Kane
`Susan Morrison Colletti
`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
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`
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`Dated: March 27, 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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