`Filed: August 10, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_____________________________
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`
`MYLAN PHARAMACEUTICALS INC.,
`Petitioner,
`
`v.
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`ASTRAZENECA AB,
`Patent Owner.
`
`_____________________________
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`Case IPR2015-01340
`Patent RE44,186
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`_____________________________
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`PETITIONER MYLAN PHARMACEUTICALS INC.’S
`OBJECTIONS TO EVIDENCE
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`Case IPR2015-01340
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`TABLE OF CONTENTS
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`I.
`
`INTRODUCTION ........................................................................................ 2
`
`II.
`
`OBJECTIONS .............................................................................................. 2
`
`1.
`
`2.
`
`3.
`
`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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`Objections to Exs. 2101-2116 and Exs. 2142-2144 and
`any Reference to/Reliance Thereon ........................................... 2
`
`Objections to Exs. 2062, 2065, 2067, 2071-2073, 2082,
`2084-2085, 2093, 2097-2098, 2125-2126, 2138, 2141,
`2145-2147, 2159, 2161-2162, 2164-2165, 2171, 2176,
`and 2179-2180, and any Reference to/Reliance Thereon ........... 3
`
`Objections to Exs. 2051-2055, 2058, 2060, 2061-2071,
`2075-2077, 2079-2080, 2082-2097, 2099, 2101-2150,
`2152-2156, 2159, 2162, 2168, 2171-2172, 2176-2180,
`2182, 2192-2194, 2196-2199, and 2210 and any
`Reference to/Reliance Thereon ................................................. 5
`
`Objections to Exs. 2077, 2079, 2080, 2086, 2120, 2124,
`2127-2135, and 2196-2197 and any Reference
`to/Reliance Thereon .................................................................. 5
`
`Objections to Exs. 2121-2123 and 2081 and any
`Reference to/Reliance Thereon ................................................. 7
`
`Objections to Exs. 2117-2119, 2136-2137 and 2148 and
`any Reference to/Reliance Thereon ........................................... 8
`
`Objections to Exs. 2169, 2172, 2175, 2177, 2178, 2182-
`2190, and 2199 and any Reference to/Reliance Thereon ......... 10
`
`Objections to Exs. 2193-94 and any Reference
`to/Reliance Thereon ................................................................ 11
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`9.
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`Objections to Exs. 2100 and 2181 ........................................... 13
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`10. Objections to Ex. 2174 and any Reference to/Reliance
`Thereon ................................................................................... 13
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`III. CONCLUSION .......................................................................................... 22
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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 Astrazeneca AB (“Patent
`
`Owner”)’s Exhibits as listed on Patent Owner’s Exhibit List filed on August 3,
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`2015, and any reference to or reliance on the foregoing Exhibits in Patent Owner’s
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`Preliminary Response (“Preliminary Response”), Patent Owner’s Response
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`(“Response”) or future filings by Patent Owner. Pursuant to 37 C.F.R. § 42.62,
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`Petitioner’s objections below apply the Federal Rules of Evidence (“F.R.E.”).
`
`II. OBJECTIONS
`1. Objections to Exs. 2101-2116 and Exs. 2142-2144 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 (Impermissible Hearsay); F.R.E. 901
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`(Authenticating Evidence).
`
`Patent Owner describes Exs. 2101-2116 and Exs. 2142- 2144 as annual
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`reports and/or Forms 20-F. By Patent Owner’s own admissions, Exs. 2101- 2116
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`and Exs. 2142-2144, which contain hundreds of pages of information, were created
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`years after the alleged date of invention. Each of Exs. 2101-2116 and Exs. 2142-
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`2144 is so attenuated to the question of whether the claimed invention was obvious
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`at the alleged time of the invention that Exs. 2101- 2116 and Exs. 2142- 2144 are
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`each 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 statements in Exs. 2101- 2116
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`and Exs. 2142-2144 for the truth of the matter asserted, such statements are
`
`inadmissible hearsay and also have not been authenticated. F.R.E. 801, 802, 803,
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`805, 901. Moreover, Patent Owner provides no foundation for such statements as
`
`either lay testimony or expert testimony of any particular declarant. F.R.E. 602,
`
`701, 702.
`
`2. Objections to Exs. 2062, 2065, 2067, 2071-2073, 2082, 2084-
`2085, 2093, 2097-2098, 2125-2126, 2138, 2141, 2145-2147,
`2159, 2161-2162, 2164-2165, 2171, 2176, and 2179-2180, 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 (Impermissible Hearsay); F.R.E. 901
`
`(Authenticating Evidence).
`
`Patent Owner describes Exs. 2062, 2065, 2067, 2071-2073, 2077, 2079,
`
`2081-2082, 2084-2085, 2093, 2097-2098, 2125-2126, 2138, 2141, 2145-2147,
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`2159, 2161-2162, 2164-2165, 2171, 2176, and 2179-80 as various documents with
`
`asserted publication dates after the earliest claimed priority date of the invention of
`
`the patent at issue, in some cases more than a decade 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
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`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. 2062, 2065,
`
`2067, 2071-2073, 2077, 2079, 2081-2082, 2084-2085, 2093, 2097-2098, 2125-
`
`2126, 2138, 2141, 2145-2147, 2159, 2161-2162, 2164-2165, 2171, 2176, 2179-80,
`
`which were created after (and in some cases many 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
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`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.
`
`2062, 2065, 2067, 2071-2073, 2077, 2079, 2081-2082, 2084-2085, 2093, 2097-
`
`2098, 2125-2126, 2138, 2141, 2145-2147, 2159, 2161-2162, 2164-2165, 2171,
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`2176, and 2179-80 for the truth of the matter asserted, such statements are
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`inadmissible hearsay and also have not been authenticated. F.R.E. 801, 802, 803,
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`805, 901. Moreover, Patent Owner provides no foundation for the statements as
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`either lay testimony or expert testimony of any particular declarant. F.R.E. 602,
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`701, 702.
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`3. Objections to Exs. 2051-2055, 2058, 2060, 2061-2071, 2075-
`2077, 2079-2080, 2082-2097, 2099, 2101-2150, 2152-2156,
`2159, 2162, 2168, 2171-2172, 2176-2180, 2182, 2192-2194,
`2196-2199, and 2210 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
`
`Reasons).
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`Exs. 2051-2055, 2058, 2060, 2061-2071, 2075-2077, 2079-2080, 2082-
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`2097, 2099, 2101-2150, 2152-2156, 2159, 2162, 2168, 2171-2172, 2176-2180,
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`2182, 2192-2194, 2196-2199, and 2210 are not substantively discussed or relied
`
`upon in the Patent Owner Response. Accordingly, each of these exhibits is not
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`relevant to the proceeding, creates confusion, has no probative value, and
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`consideration of it would therefore be a waste of time and unduly prejudicial.
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`4. Objections to Exs. 2077, 2079, 2080, 2086, 2120, 2124, 2127-
`2135, and 2196-2197 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, 702 (Expert Foundation and
`
`Opinions); F.R.E. 801, 802, 803, 805 (Impermissible Hearsay); F.R.E. 901
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`(Authenticating Evidence).
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`Patent Owner describes Exs. 2077, 2079, 2080, 2086, 2120, 2124, 2127-
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`2135, and 2196-2197 variously as “Prescribing Info,” “Summary of Product
`
`Characteristics,” “Adisinsight,” and printouts from various web sites, with
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`purported publication, distribution or collection dates as late as 2015 and 2016.
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`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
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`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. 2077, 2079, 2080,
`
`2086, 2120, 2124, 2127-2135, and 2196-2197, 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 alleged time of the invention,
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`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 adequate foundation for the document itself or its
`
`authenticity. F.R.E. 602, 901. Further, each of these exhibits appears to be
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`inadmissible hearsay. F.R.E. 801, 802, 803.
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`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
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`relied upon by Patent Owner. F.R.E. 801, 802, 803, 805. Moreover, Patent Owner
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`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,
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`701, 702, 901.
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`5. Objections to Exs. 2121-2123 and 2081 and any Reference
`to/Reliance Thereon
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`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 (Impermissible Hearsay); F.R.E. 901
`
`(Authenticating Evidence).
`
`Patent Owner describes Exs. 2081 and 2121-2123 as various press releases
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`purportedly issued in 2007, 2013, or 2014. 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 in 2007,
`
`2013, or 2015, 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.
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`401, 402. Further, even if relevant, Exs. 2081 and 2121-2123, each of which
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`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.
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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.
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`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
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`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.
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`6. Objections to Exs. 2117-2119, 2136-2137 and 2148 and any
`Reference to/Reliance Thereon
`
`Grounds for Objection: F.R.E. 106 (Remainder of Related Writing); 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);
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`F.R.E. 701, 702 (Expert Foundation and Opinions); F.R.E. 801, 802, 803, 805
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`(Impermissible Hearsay); F.R.E. 901 (Authenticating Evidence); F.R.E. 1000(d)-
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`(e), 1002-1003 (document produced must accurately reflect or reproduce original
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`document).
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`Patent Owner describes Exs. 2117-2119, 2136-2137, and 2148 as various
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`IMS documents purportedly providing an analysis of events occurring as late as
`
`October 2015. These documents are irrelevant to whether the claimed subject
`
`matter was obvious at the alleged time of the invention because they do not purport
`
`to provide information regarding the state of any market until years after the
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`alleged date of invention for the patent at issue, and then are selectively redacted to
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`obscure significant portions of the documents that would otherwise provide data
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`for other non-insulin anti-diabetic medications. F.R.E. 401, 402. Further, even if
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`relevant, each of the selectively redacted Exs. 2117-2119, 2136-2137, and 2148 is
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`so attenuated to the question of whether the claimed invention was obvious at the
`
`alleged time of the invention and, that it is unduly prejudicial, misleading, and a
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`waste of time. F.R.E. 403. Patent Owner’s selective modification of, and
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`submission of an incomplete and partial version of each of Exs. 2117-2119,
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`violates F.R.E. 106, 1000(d)-(e), 1002-1003.
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`Further, each of Exs. 2117-2119, 2136-2137, and 2148 appears to be
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`inadmissible hearsay. F.R.E. 801, 802, 803. To the extent that Patent Owner relies
`
`on any statements in any of these exhibits for the truth of the matter asserted, such
`
`statements are inadmissible hearsay when relied upon by Patent Owner. F.R.E.
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`801, 802, 803, 805. Moreover, Patent Owner provides no foundation for the
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`statements as either lay testimony or expert testimony of any particular declarant,
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`and fails to authenticate them. F.R.E. 602, 701, 702, 901.
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`7. Objections to Exs. 2169, 2172, 2175, 2177, 2178, 2182-2190,
`and 2199 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).
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`Patent Owner describes Exs. 2169, 2172, 2175, 2177, 2178, 2182-2190, and
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`2199 as various unpublished documents with appellations including “DPP-IV
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`Targets,” “DP4 Chemistry Significant Events,” “Design and Development of the
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`Selective DPP-4 Inhibitor Sitagliptin,” “DP4 Future Program,” “Monthly
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`Summary,” “Excerpts from David Betebenner,” and “Synopsis.” Some of these
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`documents include dates ranging from 1998-2002, while others are undated.
`
`Absent evidence that each of Exs. 2169, 2172, 2175, 2177, 2178, 2182-2190, and
`
`2199 was publicly available to a person of skill in the art, their relevance 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 each of Ex. 2169, 2172, 2175, 2177, 2178, 2182-
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`2190, and 2199 is unduly prejudicial, misleading, and a waste of time. F.R.E. 401,
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`402, F.R.E. 403.
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`To the extent that Patent Owner relies on any of Exs. 2169, 2172, 2175,
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`2177, 2178, 2182-2190, and 2199 or statements therein for the truth of the matter
`
`asserted, such statements are inadmissible hearsay. F.R.E. 801, 802, 803, 805.
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`Moreover, Patent Owner provides inadequate foundation for such statements as
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`either lay testimony or expert testimony of any particular declarant. F.R.E. 602,
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`701, 702. Further, at least Ex. 2172, Ex. 2177, Ex. 2178, and Ex. 2199 lack
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`foundation and also have not been authenticated. F.R.E. 602, 901.
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`8. Objections to Exs. 2193-94 and any Reference to/Reliance
`Thereon
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`Grounds for Objection: 37 C.F.R. §§ 42.6(a)(3) and 42.63; F.R.E. 401, 402
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`(Irrelevant Evidence Inadmissible); F.R.E. 403 (Excluding Evidence for Prejudice,
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`Cumulative, Confusion, Waste of Time, or Other Reasons); F.R.E. 602
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`(Foundation); F.R.E. 701, 702 (Expert Foundation and Opinions); F.R.E. 801, 802,
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`803, 805 (Impermissible Hearsay); F.R.E. 901 (Authenticating Evidence).
`
`Patent Owner describes Exs. 2193 and 2194 as Parts One and Two of
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`Exhibits for Deposition Transcript of David P. Rotella. Exs. 2193 and 2194 are
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`each a collection of many different documents, and each collection of documents
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`exceeds 400 pages. Patent Owner’s submission of these voluminous collections of
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`documents violates the prohibition in 37 CFR § 42.6(a)(3) against combined
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`documents, the prohibition in 37 C.F.R. § 42.6(d) against submitting a document
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`already in the record of the proceeding, and the requirements of 37 C.F.R. § 42.63
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`at least by failing to provide individual documents in the form of an exhibit, failing
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`to uniquely number individual documents with a sequential exhibit number, and
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`failing to provide each document with an exhibit label.
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`Further, at least some of the documents included in these collections purport
`
`to have been published after the alleged date of invention for the patent at issue.
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`Thus, 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
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`claimed subject matter was obvious at the alleged time of the invention. F.R.E.
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`401, 402. Further, even if relevant, the relevance of such documents created after
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`(and in some cases 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. Moreover, at least some of the documents in Exs. 2193-94
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`are cumulative to other exhibits filed as exhibits in this proceeding. F.R.E. 403.
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`To the extent that Patent Owner relies on any statements in any document
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`collected in Exs. 2193-94 for the truth of the matter asserted, such statements are
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`inadmissible hearsay and also have not been authenticated. F.R.E. 801, 802, 803,
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`805, 901. Moreover, Patent Owner provides no foundation for the statements as
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`either lay testimony or expert testimony of any particular declarant. F.R.E. 602,
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`701, 702.
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`9. Objections to Exs. 2100 and 2181
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`Grounds for Objection: 37 C.F.R. § 42.13(d).
`
`Patent Owner describes Exs. 2100 and 2181 as published legal authorities.
`
`37 C.F.R. § 42.13 does not authorize filing of legal authorities that are published in
`
`the United States Reports or in the West Reporter System.
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`10. Objections to Ex. 2174 and any Reference to/Reliance Thereon
`
`Patent Owner describes Ex. 2174 as the Deposition Transcript of David P.
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`Rotella, Ph.D. Objections to sections of the transcript include those objections set
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`forth in the deposition transcript itself, as well as those objections set forth in the
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`chart below, which are set forth together with grounds for each objection.
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`Page(s)
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`Line(s)
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`Objection(s)
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`22
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`24-25
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`25
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`27
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`29
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`30
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`30-31
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`15-19
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`23-03
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`15-17
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`05-12
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`17-20
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`22-24
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`25-04
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`Vague
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`Compound
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`Vague
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`Compound
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`Scope
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`Scope
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`Scope
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`31
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`05-07
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`31
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`31
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`31-32
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`32
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`32
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`32
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`42-43
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`45
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`46-47
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`47-48
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`48
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`48
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`51-52
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`52
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`52
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`52-53
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`54
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`55
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`56
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`56-57
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`57
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`57
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`08-10
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`11-15
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`20-01
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`03-06
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`07-14
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`15-22
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`22-03
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`15-19
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`20-04
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`22-02
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`03-05
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`06-11
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`23-01
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`06-16
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`02-05
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`18-07
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`10-20
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`09-15
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`03-21
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`22-02
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`08-19
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`21-25
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`Scope
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`Scope
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`Scope
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`Compound/Scope
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`Scope
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`Scope
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`Scope
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`Vague/Scope
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`Asked and Answered
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`Vague
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`Scope
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`Scope
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`Vague/Scope
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`Scope
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`Vague/Scope
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`Scope
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`Vague
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`Vague
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`Vague
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`-14-
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`Case IPR2015-01340
`Patent RE44,186
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`Patent RE44,186
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`Patent RE44,186
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`Asked and Answered
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`-19-
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`Patent RE44,186
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`08-14
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`Asked and Answered
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`Vague/Lacks Foundation
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`-20-
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`Case IPR2015-01340
`Patent RE44,186
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`175
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`01-10
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`01-19
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`06-10
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`Vague/Lacks Foundation/Scope/Mischaracterizes
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`Testimony
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`-21-
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`Case IPR2015-01340
`Patent RE44,186
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`187-88
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`21-06
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`188
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`05-12
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`Vague/Compound
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`Vague
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`Lacks Foundation/Scope
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`III. CONCLUSION
`
`The aforementioned exhibits were filed together with Patent Owner’s
`
`Response on August 3, 2016. These objections are made within 5 business days of
`
`said filing pursuant to 37 C.F.R. § 42.64.
`
`
`
`
`
`
`
`Respectfully submitted,
`
`/ Steven W. Parmelee /
` Steven W. Parmelee
` Reg. No. 31,990
`
`
`Dated: August 10, 2016
`
`
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`-22-
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`
`
`Case IPR2015-01340
`Patent RE44,186
`
`
`CERTIFICATE OF SERVICE
`
`
`
`This is to certify that I caused to be served a true and correct copy of the
`
`foregoing Petitioner Mylan Pharmaceuticals Inc.’s Objections to Evidence, on this
`
`10th day of August, 2016, on the Patent Owner at the correspondence address of
`
`the Patent Owner as follows:
`
`Charles E. Lipsey (charles.lipsey@finnegan.com)
`
`Eric E. Grondahl (egrondahl@mccarter.com)
`
`John D. Livingstone (john.livingtone@finnegan.com)
`
`Anthony A. Hartmann (anthony.hartmann@finnegan.com)
`
`M. David Weingarten (david.weingarten@finnegan.com)
`
`
`
`
`
`Dated: August 10, 2016
`
`
`
`
`
`
`Respectfully submitted,
`
`/ Steven W. Parmelee /
` Steven W. Parmelee, Lead Counsel
` Reg. No. 31,990
`
`
`
`
`
`-23-