Paper No. ___
`Filed: January 3, 2017
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________________
`
`
`MYLAN LABORATORIES LIMITED
`Petitioner,
`
`v.
`
`
`
`
`
`AVENTIS PHARMA S.A.
`Patent Owner.
`
`_____________________________
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`Case IPR2016-00712
`Patent No. 8,927,592
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`_____________________________
`
`PETITIONER MYLAN LABORATORIES LIMITED’S
`NOTICE OF OBJECTION TO EVIDENCE SERVED ON DECEMBER 23, 2016
`
`
`
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`Case IPR2016-00712
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`TABLE OF CONTENTS
`
`I.
`
`INTRODUCTION ........................................................................................ 1
`
`II.
`
`OBJECTIONS .............................................................................................. 1
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
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`6.
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`7.
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`8.
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`9.
`
`Objections to Exs. 2123-2126, 2168, 2183, 2192, 2205,
`2209, 2212, 2219, 2221, 2232, and any Reference
`to/Reliance Thereon .................................................................. 1
`
`Objections to Exs. 2114-2115, 2138, 2151-2155, 2157,
`2159-2160, 2163-2164, 2167- 2169, 2221, and any
`Reference to/Reliance Thereon ................................................. 3
`
`Objections to Exs. 2127-2134 and any Reference
`to/Reliance Thereon .................................................................. 4
`
`Objections to Exs. 2146, 2150, 2173-2175, 2196-2200,
`2202, 2204, 2206, 2208, 2225, and any Reference
`to/Reliance Thereon .................................................................. 5
`
`Objections to Exs. 2156, 2158, 2161, 2162, 2165, 2166,
`2189, and any Reference to/Reliance Thereon .......................... 6
`
`Objections to Exs. 2218, 2222, and any Reference
`to/Reliance Thereon .................................................................. 8
`
`Objections to Exs. 2170-2171, 2178-2179, 2182, 2211,
`2220, 2227, and any Reference to/Reliance Thereon ................. 9
`
`Objections to Ex. 2172, and any Reference to/Reliance
`Thereon ................................................................................... 10
`
`Objections to Exs. 2181 and 2229, and any Reference
`to/Reliance Thereon ................................................................ 12
`
`10. Objections to Exs. 2220 and 2227, and any Reference
`to/Reliance Thereon ................................................................ 13
`
`11. Objections to Ex. 2176 and any Reference to/Reliance
`Thereon ................................................................................... 14
`
`12. Objections to Ex. 2149 and any Reference to/Reliance
`Thereon ................................................................................... 16
`
`13. Objections to Ex. 2231 and any Reference to/Reliance
`Thereon ................................................................................... 18
`
`III. CONCLUSION .......................................................................................... 19
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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 Laboratories Limited
`
`(“Petitioner”) submits the following objections to Aventis Pharma S.A. (“Patent
`
`Owner”)’s Exhibits 2114-2115, 2123-2126, 2127-2134, 2138, 2146, 2149, 2150-
`
`2161, 2163-2166, 2168-2175, 2176, 2178-2179, 2181-2183, 2189, 2192, 2196-
`
`2200, 2202, 2204-2206, 2208-2209, 2211-2212, 2218-2222, 2225, 2227, 2229,
`
`2231, 2232 as listed on Patent Owner’s Exhibit List filed on December 23, 2016,
`
`and any reference to or reliance on the foregoing Exhibits in Patent Owner’s
`
`Response (“Response”), Contingent Motion to Amend, 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 Exs. 2123-2126, 2168, 2183, 2192, 2205, 2209,
`2212, 2219, 2221, 2232, 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).
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`Patent Owner describes Exs. 2123-2126, 2168, 2183, 2192, 2205, 2209,
`
`2212, 2219, 2221, and 2232 as various documents with asserted publication dates
`
`after the earliest claimed priority date of the invention of the patent at issue, in
`
`some cases several years after the earliest claimed priority date. Because the
`
`asserted publication dates are later than the alleged date of invention for the patent
`
`at issue, the fact that the content of any of these exhibits 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, even if relevant, each of Exs. 2123-2126, 2168, 2183, 2192,
`
`2205, 2209, 2212, 2219, 2221, and 2232, which were created after (and in some
`
`cases several 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 each of these exhibits is unduly prejudicial, misleading, and a waste
`
`of time. F.R.E. 403.
`
`To the extent that Patent Owner relies on any statements in any of Exs.
`
`2123-2126, 2168, 2183, 2192, 2205, 2209, 2212, 2219, 2221, and 2232 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.
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`2. Objections to Exs. 2114-2115, 2138, 2151-2155, 2157, 2159-
`2160, 2163-2164, 2167- 2169, 2221, 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. 2114-2115, 2138, 2151-2155, 2157, 2159-
`
`2160, 2163-2164, 2167-2169, and 2221 as printouts from various web sites. Exs.
`
`2114-2115, 2138, 2151-2155, 2157, 2159-2160, 2163-2164, 2167-2169, and 2221
`
`purport to have been printed from the internet in 2016, and none of the documents
`
`printed in Exs. 2115, 2138, 2151-2153, 2157, 2159-2160, 2163-2164, 2167, 2169,
`
`or 2221 purport to have existed prior to 2015 or 2016 . The fact that the content of
`
`these exhibits was publicly available in 2015 or 2016, 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, even if relevant, Exs.
`
`2115, 2138, 2151-2155, 2157, 2159-2160, 2163-2164, 2167-2169, and 2221, each
`
`of 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
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`alleged time of the invention, that it is unduly prejudicial, misleading, and a waste
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`of time. F.R.E. 403.
`
`Moreover, with regard to each of these exhibits, neither the Patent Owner
`
`nor the exhibit provides adequate foundation for the document itself or its
`
`authenticity. F.R.E. 602, 901. Further, each of these exhibits appears to be
`
`inadmissible hearsay. F.R.E. 801, 802, 803.
`
`To the extent that Patent Owner relies on any statements in these exhibits for
`
`the truth of the matter asserted, such statements are inadmissible hearsay when
`
`relied upon by Patent Owner. F.R.E. 801, 802, 803, 805. Moreover, Patent Owner
`
`provides no foundation for the statements as either lay testimony or expert
`
`testimony of any particular declarant, and fails to authenticate them. F.R.E. 602,
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`701, 702, 901.
`
`3. Objections to Exs. 2127-2134 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).
`
`Patent Owner describes Exs. 2127-2134 as various SEC filings. To the
`
`extent that Patent Owner relies on any statements in Exs. 2127-2134 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, Patent Owner provides no
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`foundation for such 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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`4.
`
`Objections to Exs. 2146, 2150, 2173-2175, 2196-2200, 2202, 2204,
`2206, 2208, 2225, 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, 805 (Impermissible Hearsay); F.R.E. 901
`
`(Authenticating Evidence).
`
`Patent Owner describes Exs. 2146, 2150, 2173-2175, 2196-2200, 2202,
`
`2204, 2206, 2208, and 2225 as various drug labels. Because Patent Owner has not
`
`established that any of these documents were publicly available before the alleged
`
`date of invention for the patent at issue, the fact that the content of these
`
`documents was publicly available at some point after the alleged invention date of
`
`the patent, 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, even if relevant, Exs. 2146, 2150, 2173-2175, 2196-2200, 2202, 2204,
`
`2206, 2208, and 2225, are so attenuated to the question of whether the claimed
`
`invention was obvious at the alleged time of the invention, that Exs. 2146, 2150,
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`2173-2175, 2196-2200, 2202, 2204, 2206, 2208, and 2225 are unduly prejudicial,
`
`misleading, and a waste of time. F.R.E. 403.
`
`Moreover, Patent Owner provides no sponsoring witness for Exs. 2146,
`
`2150, 2173-2175, 2196-2200, 2202, 2204, 2206, 2208, and 2225, and these
`
`exhibits do not provide foundation for the documents themselves or their
`
`authenticity. F.R.E. 602, 901. Further, each of Exs. 2146, 2150, 2173-2175, 2196-
`
`2200, 2202, 2204, 2206, 2208, and 2225 itself appears to be inadmissible hearsay.
`
`F.R.E. 801, 802.
`
`To the extent that Patent Owner relies on any statements in Exs. 2146, 2150,
`
`2173-2175, 2196-2200, 2202, 2204, 2206, 2208, and 2225 for the truth of the
`
`matter asserted, such statements are inadmissible hearsay when relied upon by
`
`Patent Owner. F.R.E. 801, 802, 805. Moreover, Patent Owner provides no
`
`foundation for the statements as either lay testimony or expert testimony of any
`
`particular declarant, and fails to authenticate them. F.R.E. 602, 701, 702, 901.
`
`5. Objections to Exs. 2156, 2158, 2161, 2162, 2165, 2166, 2189,
`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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`Opinions); F.R.E. 801, 802, 803, 805 (Inadmissible Hearsay); F.R.E. 901
`
`(Authenticating Evidence).
`
`Patent Owner describes Exs. 2156, 2158, 2161, 2162, 2165, 2166, and 2189,
`
`as various documents from the FDA. However, none of Exs. 2156, 2158, 2161,
`
`2162, 2165, 2166, or 2189 purport to have been published at any particular time or
`
`place. Absent evidence that each of Exs. 2156, 2158, 2161, 2162, 2165, 2166, and
`
`2189, was publicly available to a person of skill in the art, its relevance is so
`
`attenuated to the question of whether the claimed invention was obvious at the
`
`alleged time of the invention that each of Exs. 2156, 2158, 2161, 2162, 2165, 2166,
`
`and 2189 is unduly prejudicial, misleading, and a waste of time. F.R.E. 401, 402,
`
`F.R.E. 403.
`
`With regard to each of Exs. 2156, 2158, 2161, 2162, 2165, 2166, and 2189,
`
`neither the Patent Owner nor the exhibit provides adequate foundation for the
`
`document itself or its authenticity. F.R.E. 602, 901. Further, each of these exhibits
`
`appears to be inadmissible hearsay. F.R.E. 801, 802, 803.
`
`To the extent that Patent Owner relies on any statements in these exhibits for
`
`the truth of the matter asserted, such statements are inadmissible hearsay when
`
`relied upon by Patent Owner. F.R.E. 801, 802, 803, 805. Moreover, Patent Owner
`
`provides no foundation for the statements as either lay testimony or expert
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`testimony of any particular declarant, and fails to authenticate them. F.R.E. 602,
`
`701, 702, 901.
`
`6. Objections to Exs. 2218, 2222, 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. 2218 and 2222 as various press releases
`
`purportedly issued in 2010 and 2012, but printed as late as 2016. Because these
`
`documents do not purport to have been published before the alleged date of
`
`invention for the patent at issue, the fact that the content of these exhibits was
`
`publicly available on the asserted dates, 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, even if relevant, Exs. 2218 and 2222, each
`
`of which appears to have been created 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.
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`Moreover, with regard to each of these exhibits, neither the Patent Owner
`
`nor the exhibit provides foundation for the document itself or its authenticity.
`
`F.R.E. 602, 901. Further, each of these exhibits appears to be inadmissible
`
`hearsay. F.R.E. 801, 802, 803.
`
`To the extent that Patent Owner relies on any statements in these exhibits for
`
`the truth of the matter asserted, such statements are inadmissible hearsay when
`
`relied upon by Patent Owner. F.R.E. 801, 802, 803, 805. Moreover, Patent Owner
`
`provides no foundation for the statements as either lay testimony or expert
`
`testimony of any particular declarant, and fails to authenticate them. F.R.E. 602,
`
`701, 702, 901.
`
`7. Objections to Exs. 2170-2171, 2178-2179, 2182, 2211, 2220,
`2227, 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, 805 (Impermissible Hearsay); F.R.E. 901
`
`(Authenticating Evidence).
`
`Patent Owner describes Exs. 2170-2171, 2178-2179, 2182, 2211, 2220, and
`
`2227 as various unpublished documents with appellations including “Market Share
`
`with Docetaxel in Prior Treatment,” “Monthly Jevtana Prostate Cancer Treatment
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`Report,” “Sanofi Q3 2016 Results,” “Underlying data,” “Minimum Information
`
`Requires for Written Subject Information, ,” and “2006-06-29 Email.” Some of
`
`these documents include dates ranging from 2006-2016, while others are undated.
`
`Absent evidence that each of Exs. 2170-2171, 2178-2179, 2182, 2211, 2220, and
`
`2227 was publicly available to a person of skill in the art, its relevance is so
`
`attenuated to the question of whether the claimed invention was obvious at the
`
`alleged time of the invention that each of Ex. 2170-2171, 2178-2179, 2182, 2211,
`
`2220, and 2227 is unduly prejudicial, misleading, and a waste of time. F.R.E. 401,
`
`402, F.R.E. 403.
`
`To the extent that Patent Owner relies on any of Exs. 2170-2171, 2178-2179,
`
`2182, 2211, 2220, and 2227 or statements therein 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, Patent Owner provides inadequate
`
`foundation for such statements as either lay testimony or expert testimony of any
`
`particular declarant. F.R.E. 602, 701, 702. Further, at least Exs. 2170-2171, 2178-
`
`2179, 2182, 2211, 2220, and 2227 lack foundation and also have not been
`
`adequately authenticated. F.R.E. 602, 901.
`
`8. Objections to Ex. 2172, 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
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`Reasons); F.R.E. 602 (Foundation); F.R.E. 701, 702 (Expert Foundation and
`
`Opinions); F.R.E. 801, 802, 805 (Impermissible Hearsay); F.R.E. 901
`
`(Authenticating Evidence); F.R.E. 1002 (Actual Document Required to Prove
`
`Contents); F.R.E. 1006 (Summaries to Prove Content).
`
`Patent Owner describes Ex. 2172 as “Red Book Data of Xtandi®, Zytiga®,
`
`Xogifo®, and Jevtana®.” However, Ex. 2172 provides no indication that it was
`
`publicly available to a person of skill in the art. Thus, the relevance of Ex. 2172 is
`
`so attenuated to the question of whether the claimed invention was obvious at the
`
`alleged time of the invention that Ex. 2172 is unduly prejudicial, misleading, and a
`
`waste of time. F.R.E. 401, 402, F.R.E. 403.
`
`To the extent that Patent Owner relies on any of Ex. 2172 or statements
`
`therein 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,
`
`Patent Owner provides inadequate foundation for such statements as either lay
`
`testimony or expert testimony of any particular declarant. F.R.E. 602, 701, 702.
`
`Further, Ex. 2172 lacks foundation and has not been sufficiently authenticated.
`
`F.R.E. 602, 901. Ex. 2172 itself does not purport to be a copy or excerpt of the
`
`“Red Book,” and Patent Owner is required to provide the actual Red Book to prove
`
`its contents under F.R.E. 1002. Further, Ex. 2172 is not a valid summary under
`
`F.R.E 1006, as Patent Owner has not made the original Red Book available for
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`examination or copying as the web page provided by Patent Owner requires a
`
`license to access to the Red Book.
`
`9. Objections to Exs. 2181 and 2229, 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, 805 (Impermissible Hearsay); F.R.E. 901
`
`(Authenticating Evidence).
`
`Patent Owner describes Exs. 2181 and 2229 as “Common Toxicity Criteria
`
`for Adverse Events v.2.0” and “Common Toxicity Criteria Manual Version 2.0.”
`
`However, neither exhibit provides any indication that it was publicly available to a
`
`person of skill in the art before the invention date of the patent at issue. Thus, the
`
`relevance of each of Exs. 2181 and 2229 is so attenuated to the question of whether
`
`the claimed invention was obvious at the alleged time of the invention that Exs.
`
`2181 and 2229 are unduly prejudicial, misleading, and a waste of time. F.R.E.
`
`401, 402, 403.
`
`To the extent that Patent Owner relies on any of Ex. 2181, Ex. 2229, or
`
`statements therein for the truth of the matter asserted, such statements are
`
`inadmissible hearsay. F.R.E. 801, 802, 803, 805. Moreover, Patent Owner
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`provides inadequate foundation for such statements as either lay testimony or
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`expert testimony of any particular declarant. F.R.E. 602, 701, 702. Further, Exs.
`
`2181 and 2229 lack foundation and have not been authenticated. F.R.E. 602, 901.
`
`10. Objections to Exs. 2220 and 2227, 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, 805 (Impermissible Hearsay); F.R.E. 901
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`(Authenticating Evidence); F.R.E. 1002 (Actual Document Required to Prove
`
`Contents).
`
`Patent Owner describes Exs. 2220 and 2227 as “Omlin et al.” and “H2
`
`Blockers Increase Risk of Docetaxel-Induced Skin Toxicity), and asserts that they
`
`were published in 2015 and 2009, respectively. However, Ex. 2220 states that the
`
`Omlin article is only an “Article in Press,” does not provide a volume or page
`
`number or indicate whether the document was ever made publicly available.
`
`Neither exhibit provides any indication that it was publicly available to a person of
`
`skill in the art before the invention date of the patent at issue. Ex. 2227 contains
`
`text on only a small portion of a single page. Ex. 2227 does not appear to be a
`
`complete document and does not provide a volume number or the publication
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`information for the document. Moreover, the text that appears in Ex. 2227 does
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`not match the text that appears on the asco.org web site identified at the bottom of
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`Ex. 2227, which web site does not establish that either the text on its web site or
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`the text in Ex. 2227 was publicly available before the alleged invention date of the
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`patent at issue. Thus, the relevance of each of Exs. 2220 and 2227 is so attenuated
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`to the question of whether the claimed invention was obvious at the alleged time of
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`the invention that Exs. 2220 and 2227 are unduly prejudicial, misleading, and a
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`waste of time. F.R.E. 401, 402, F.R.E. 403.
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`To the extent that Patent Owner relies on any of Ex. 2220, Ex. 2227, or
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`statements therein for the truth of the matter asserted, such statements are
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`inadmissible hearsay. F.R.E. 801, 802, 803, 805. Moreover, Patent Owner
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`provides inadequate foundation for such statements as either lay testimony or
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`expert testimony of any particular declarant. F.R.E. 602, 701, 702. Further, Exs.
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`2220 and 2227 lack foundation and have not been authenticated. F.R.E. 602, 901.
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`11. Objections to Ex. 2176 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. 701, 702, 703 (Expert Foundation and Opinions); F.R.E. 802
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`(Inadmissible Hearsay).
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`Petitioner objects to paragraphs 15-26, 40-44, 48-49, 111, 113, 148, 156,
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`166, 175, 177, 191, 203, 208, 215. 220, 222-228, and 251 of Ex. 2176 as irrelevant,
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`confusing, or a waste of time as these paragraphs are not cited in Patent Owner’s
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`Response or Contingent Motion to Amend. F.R.E. 401, 402, 403.
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`Petitioner further objects to paragraphs 45, 49, 60-61, 70, 72, 79, 87, 88, 91,
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`112, 154, 162, 164, and 252 as improper expert testimony, irrelevant, confusing, or
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`a waste of time for failing to identify with particularity the underlying facts and
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`data on which the opinion in based. 37 C.F.R. § 42.65(a); F.R.E. 702, 402, 403.
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`Petitioner also objects to Exhibit 2176 as improper expert testimony, lacking
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`basis for expert opinion, irrelevant, confusing, or a waste of time (F.R.E. 702, 703,
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`402, 403) to the extent it is based on documents that are inadmissible as discussed
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`in Objections 1-10 above.
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`Petitioner objects to paragraphs 44, 55, 62-64, 69, 81-110, 113-133, 140-
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`143, 148-152, 154-155, 158-162, 164-170, 179, and 230-233 of Ex. 2176 as
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`irrelevant, unduly prejudicial, misleading, and a waste of time, because they apply
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`claim constructions that are contrary to the claim constructions adopted by the
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`Board and/or are contrary to applicable law regarding patentable subject matter and
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`reasonable expectation of success. F.R.E. 401, 402, 403.
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`12. Objections to Ex. 2149 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. 701, 702, 703 (Expert Foundation and Opinions); 37 C.F.R. §§
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`42.65(a) (Disclosure of Underlying Facts or Data Required); F.R.E. 602
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`(Foundation); F.R.E. 1002 (Actual Document Required to Prove Contents); F.R.E.
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`1006 (Summaries to Prove Content).
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`Petitioner objects to paragraphs 1-23, 26, and 31-35 of Ex. 2149 as
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`irrelevant, confusing, or a waste of time as these paragraphs are not cited in Patent
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`Owner’s Response or Contingent Motion to Amend. F.R.E. 401, 402, 403.
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`Petitioner further objects to paragraphs 11-25 and 33-34 of Exhibit 2149 as
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`improper expert testimony under F.R.E. 702 because Patent Owner has not
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`established that Mr. Tate is qualified as an expert who has scientific, technical, or
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`other specialized knowledge regarding “Prostate Cancer,” “Treatment Options” for
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`prostate cancer, the “Benefits of Jevtana,” or “New Chemical Entity Exclusivity.”
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`Petitioner further objects to Mr. Tate’s legal conclusions in paragraphs 25, 31-32,
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`34 as outside the expertise of Mr. Tate and unhelpful to the Board under F.R.E.
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`702.
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`Petitioner further objects to paragraphs 26-35 of Exhibit 2149 as improper
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`expert testimony under F.R.E. 702 and 703 and as irrelevant, confusing, or a waste
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`of time under F.R.E. 401, 402, 403. Mr. Tate has failed to base his opinion of
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`commercial success on facts or data and has instead assumed that “the clinical
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`benefits offered by Jevtana® are directly attributable to the patented features.” Mr.
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`Tate has failed entirely “to opine on the nexus between the commercial success of
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`Jevtana® and the ’592 patent,” and thereby fails to apportion any amount of the
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`alleged commercial success to any novel element of any of the claims. Mr. Tate
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`has also failed to analyze or disclose any analysis regarding the impact of
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`advertising efforts on the sales and market share of Jevtana. Mr. Tate has thus
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`assumed without disclosing supporting facts or data that there is a nexus and that
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`advertising has not impacted sales or market share. F.R.E. 401, 402, 403, 702,
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`703.
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`Petitioner also objects to paragraphs 28-30 of Exhibit 2149 as lacking
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`foundation, being improper expert testimony, failing to provide original documents
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`or the underlying documents used to prepare a summary to prove content, and
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`being irrelevant, confusing, or a waste of time for failing to identify with
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`particularity the underlying facts and data on which the opinion in based. 37 C.F.R.
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`§ 42.65(a); F.R.E. 602, 702, 402, 403, 1002, 1006. Mr. Tate relies exclusively on
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`Exhibits 2170, 2171, and 2179 to provide the market share figures that he cites, but
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`Mr. Tate does not explain the provenance of these documents, provide any
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`foundation for them, or purport to have any personal knowledge regarding the
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`documents, the studies they describe (including how or when the studies were
`
`conducted and how the data was gathered, recorded, tabulated, calculated or
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`interpreted). Moreover, Mr. Tate does not cite (or even acknowledge the existence
`
`of) the raw data files that must have been used to generate the data underlying
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`Exhibits 2170, 2171, and 2179, or provide any foundation for any of these exhibits
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`as summaries to prove content. F.R.E. 1002, 1006.
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`Petitioner also objects to Exhibit 2149 as improper expert testimony, lacking
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`basis for expert opinion, irrelevant, confusing, or a waste of time (F.R.E. 702, 703,
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`402, 403) to the extent it is based on documents that are inadmissible as discussed
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`in Objections 1-10 above.
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`13. Objections to Ex. 2231 and any Reference to/Reliance Thereon
`
`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
`
`Reasons); F.R.E. 602 (Foundation); F.R.E. 701 (Lay Opinions); F.R.E. 702; F.R.E.
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`802 (Inadmissible Hearsay).
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`Petitioner objects to paragraphs 2-7 of Ex. 2231 as lacking foundation and
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`not being based on the witness’s perception or any purported expertise. Mr.
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`Lathers does not explain what personal knowledge he has based on his own
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`perceptions to establish who prepared Exhibits 2170, 2171, and 2179, how these
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`documents were prepared, where or how the data underlying these documents was
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`collected (by whom and from whom), or even whether he was involved in any way
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`in the preparation or use of these particular documents. Mr. Lathers does not even
`
`identify his job title or job responsibilities at the time these documents were
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`purportedly created. Mr. Lathers also fails to provide any foundation for offering
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`any expert opinion of any kind.
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`III. CONCLUSION
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`The aforementioned exhibits were filed and served together with Patent
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`Owner’s Response on December 23, 2016. These objections are made within 5
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`business days of service pursuant to 37 C.F.R. § 42.64.
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`
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`Respectfully submitted,
`
`/ Steven W. Parmelee /
` Steven W. Parmelee
` Reg. No. 31,990
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`Dated: January 3, 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 Laboratories Limited’s Notice of Objections to
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`Evidence Served on December 23, 2016, on this 3rd day of January, 2017, on the
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`Patent Owner at the correspondence address of the Patent Owner as follows:
`
`Dominick A. Conde
`William E. Solander
`Jason A. Leonard
`Whitney L. Meier
`Daniel J. Minion
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 1014-3800
`Email: dconde@fchs.com
`Email: wsolander@fchs.com
`Email: jleonard@fchs.com
`Email: wmeier@fchs.com
`Email: dminion@fchs.com
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`
`
`Dated: January 3, 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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`-20-