`
`
`
`Paper No. ___
`Filed: March 27, 2017
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`
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`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).
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`Case IPR2016-01127, -01128, -01129, -01130, -01131, -01132
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`TABLE OF CONTENTS
`
`I.
`
`INTRODUCTION ........................................................................................ 1
`
`II.
`
`OBJECTIONS .............................................................................................. 1
`
`1.
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`2.
`
`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.
`
`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
`
`Objections to Exs. 2030-2031, 2074, and any Reference
`to/Reliance Thereon .................................................................. 2
`
`Objections to Exs. 2046, 2051, 2055, 2056, 2057, 2062-
`2066, 2072-2073, and any Reference to/Reliance
`Thereon ..................................................................................... 4
`
`Objections to Ex. 2061 and any Reference to/Reliance
`Thereon ..................................................................................... 5
`
`Objections to Exs. 2026 (Exhibit A), 2027, and any
`Reference to/Reliance Thereon ................................................. 6
`
`Objections to Ex. 2028, 2038, 2046, and any Reference
`to/Reliance Thereon .................................................................. 7
`
`Objections to Ex. 2033, and any Reference to/Reliance
`Thereon ..................................................................................... 9
`
`Objections to Ex. 2044, and any Reference to/Reliance
`Thereon ..................................................................................... 9
`
`Objections to Ex. 2017 and any Reference to/Reliance
`Thereon ................................................................................... 10
`
`III. CONCLUSION .......................................................................................... 11
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`
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`-i-
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`Case IPR2016-01127, -01128, -01129, -01130, -01131, -01132
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`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 2011, 2015, 2017. 2021, 2026, 2027, 2028, 2030-2035, 2038,
`
`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
`
`Responses (“PORs”) on March 20, 2017, and any reference to or reliance on the
`
`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
`
`Evidence (“F.R.E.”).
`
`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
`
`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 Exs. 2011, 2015, 2021, 2032, 2034-2035, 2042,
`
`2047-2050, 2052-2053, 2060, 2068-2069, and 2071, as various documents either
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`-1-
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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
`
`issue, the fact that the content of such exhibit 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,
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`such exhibits are so attenuated to the question of whether the claimed invention
`
`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.
`
`To the extent that Patent Owner relies on these exhibits or on any statements
`
`in these exhibits 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 Exs. 2030-2031, 2074, 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
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`-2-
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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).
`
`Patent Owner describes Exs. 2030-2031, and 2074, as various web page
`
`printouts not purporting to have been published before the earliest claimed
`
`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
`
`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
`
`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
`
`in these exhibits 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.
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`Case IPR2016-01127, -01128, -01129, -01130, -01131, -01132
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`3. Objections to Exs. 2046, 2051, 2055, 2056, 2057, 2062-2066,
`2072-2073, and any Reference to/Reliance Thereon
`
`Grounds for Objection: 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); F.R.E. 1006 (Improper Summary); 37
`
`C.F.R. § 42.65 (Disclosure of Underlying Data Required); 37 C.F.R. § 42.53
`
`(“Uncompelled direct testimony must be submitted in the form of an affidavit.”)
`
`Patent Owner describes Exs. 2046, 2051, 2055, 2056, 2057, 2062-2066, and
`
`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
`
`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
`
`underlying data being summarized in these documents “available for examination
`
`or copying, or both” to the Petitioner. F.R.E. 1006; 37 C.F.R. § 42.65.
`
`To the extent that Patent Owner relies on these exhibits or on any statements
`
`in these exhibits 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; 37 C.F.R. § 42.53.
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`-4-
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`Case IPR2016-01127, -01128, -01129, -01130, -01131, -01132
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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
`
`Hearsay); F.R.E. 901 (Authenticating Evidence); F.R.E. 1006 (Improper
`
`Summary); 37 C.F.R. § 42.65 (Disclosure of Underlying Data Required); 37
`
`C.F.R. § 42.53 (“Uncompelled direct testimony must be submitted in the form of
`
`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
`
`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
`
`duplicates” of the underlying data being summarized in this document “available
`
`for examination or copying, or both” to the Petitioner. F.R.E. 1006; 37 C.F.R. §
`
`42.65. Moreover, the document is at places illegible, and Patent Owner should
`
`produce to Petitioner a legible copy of the document. F.R.E. 102-103, 106.
`
`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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`-5-
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`Case IPR2016-01127, -01128, -01129, -01130, -01131, -01132
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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
`
`Grounds for Objection: F.R.E. 602 (Foundation); F.R.E. 701, 702 (Expert
`
`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
`
`(“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
`
`and does not assert that either of these documents was publicly available prior to
`
`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
`
`to be, and where the underlying data for the summaries, charts, and calculations
`
`therein can be examined. F.R.E. 602, 901, 1006. Moreover, Patent Owner has not
`
`made “the original or duplicates” of the underlying data being summarized in these
`
`documents “available for examination or copying, or both” to the Petitioner.
`
`F.R.E. 1006; 37 C.F.R. § 42.65.
`
`To the extent that Patent Owner relies on these exhibits or on any statements
`
`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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`Case IPR2016-01127, -01128, -01129, -01130, -01131, -01132
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`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; 37 C.F.R. § 42.53.
`
`6. Objections to Ex. 2028, 2038, 2046, and any Reference
`to/Reliance Thereon
`
`Grounds for Objection: 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); 37 C.F.R. § 42.65
`
`(Disclosure of Underlying Data Required); 37 C.F.R. § 42.53 (“Uncompelled
`
`direct testimony must be submitted in the form of an affidavit.”).
`
`Patent Owner describes Exhibit 2038 as the deposition of David LeCause, an
`
`individual who has not submitted a declaration in this proceeding. The Maness
`
`declaration (Exhibit 2028) cites to Exhibit 2038 and to private conversations Dr.
`
`Maness allegedly had with Mr. LeCause in at least paragraphs 50-51, 60, 65, 67-
`
`68, 74-75, 88-90, 96. Dr. Maness describes Exhibit 2046 as “LeCause Exhibit 12.”
`
`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
`
`have been served on petitioner. Such documents include unspecified “Marketing
`
`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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`-7-
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`Case IPR2016-01127, -01128, -01129, -01130, -01131, -01132
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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”
`
`reports and “SOV” documents, certain articles, and certain “Web Sources.” The
`
`Maness declaration also relies on private conversations Dr. Maness allegedly had
`
`with Christopher Larsen (see Exhibit 2028 at ¶55 & n.59), another individual who
`
`has not submitted a declaration in this proceeding.
`
`Petitioner objects to Patent Owner’s failure to produce to Petitioner the
`
`complete set of documents and witnesses identified by Dr. Maness, as well as Dr.
`
`Maness’s selective use of private conversation and deposition transcripts from
`
`other proceedings to circumvent the Board requirement that all uncompelled direct
`
`testimony be submitted in the form of an affidavit. 37 C.F.R. § 42.65; 37 C.F.R. §
`
`42.53. Petitioner also objects to Patent Owner’s selective production of documents
`
`apparently produced in its litigation in the Eastern District of Texas, including
`
`Patent Owner’s selective production of the deposition exhibits from the LeCause
`
`deposition and the various documents identified by Dr. Maness in his Appendix B
`
`with a bates number prefix “AGN_RES.”
`
`To the extent that Patent Owner relies on Exhibit 2038 or on statements
`
`attributed to Mr. LeCause or Mr. Larsen for the truth of the matter asserted, such
`
`statements are inadmissible hearsay when offered by Patent Owner. F.R.E. 801,
`
`802, 803, 805. Moreover, Exhibit 2038 has not been authenticated. F.R.E. 901.
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`-8-
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`Case IPR2016-01127, -01128, -01129, -01130, -01131, -01132
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`Moreover, Patent Owner provides no foundation for the statements as either lay
`
`testimony or expert opinion. F.R.E. 602, 701, 702.
`
`7. Objections to Ex. 2033, and any Reference to/Reliance Thereon
`
`Grounds for Objection: F.R.E. 102-103 (Original Document Required);
`
`F.R.E. 106 (Complete Document Rule); F.R.E. 801, 802, 803, 805 (Inadmissible
`
`Hearsay); F.R.E. 901 (Authenticating Evidence).
`
`Patent Owner describes Exhibit 2033 as the FDA approval document for
`
`Restasis. However, Exhibit 2033 contains redactions to the original document at
`
`least on pages 7, 10, 13-14 that in fairness ought to be considered at the same time
`
`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
`
`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.
`
`8. Objections to Ex. 2044, and any Reference to/Reliance Thereon
`
`Grounds for Objection: F.R.E. 102-103 (Original Document Required);
`
`F.R.E. 106 (Complete Document Rule); 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).
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`-9-
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`Case IPR2016-01127, -01128, -01129, -01130, -01131, -01132
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`Patent Owner describes Exhibit 2044 as the “FDA label for Xiidra®”.
`
`However, page 1 of Exhibit 2044 indicates that it is page 5 of some other
`
`document. Patent Owner should produce the entirety of the document to Petitioner
`
`so that Petitioner can evaluate whether the entire document ought to be considered
`
`in fairness at the same time as the submitted portion of the writing. F.R.E. 102-
`
`103, 106, 602, 701, 702.
`
`To the extent that Patent Owner relies on any statements in this exhibits 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.
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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);
`
`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,’
`
`Spring-Verlag (1982).” However, Ex. 2017 provides only two pages of text from
`
`the body of the reference divorced from context, does not provide the entire
`
`chapter or identify a section of the reference appearing in the portion of the table of
`
`contents provided in Ex. 2017, does not appear to provide the entire table of
`
`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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`Case IPR2016-01127, -01128, -01129, -01130, -01131, -01132
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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
`
`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
`
`of service pursuant to 37 C.F.R. § 42.64.
`
`
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`Respectfully submitted,
`
`/ Steven W. Parmelee /
` Steven W. Parmelee
` Reg. No. 31,990
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`Dated: March 27, 2017
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`Case IPR2016-01127, -01128, -01129, -01130, -01131, -01132
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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
`
`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:
`
`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
`
`
`
`Dated: March 27, 2017
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`
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`
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`Respectfully submitted,
`
`/ Steven W. Parmelee /
` Steven W. Parmelee, Lead Counsel
` Reg. No. 31,990
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`-12-
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