Paper No. ___
`Filed: August 10, 2016
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________________
`
`
`MYLAN PHARAMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`ASTRAZENECA AB,
`Patent Owner.
`
`_____________________________
`
`Case IPR2015-01340
`Patent RE44,186
`
`_____________________________
`
`PETITIONER MYLAN PHARMACEUTICALS INC.’S
`OBJECTIONS TO EVIDENCE
`
`
`
`
`
`
`
`
`
`
`

`
`
`Case IPR2015-01340
`Patent RE44,186
`
`TABLE OF CONTENTS
`
`I.
`
`INTRODUCTION ........................................................................................ 2
`
`II.
`
`OBJECTIONS .............................................................................................. 2
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`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
`
`9.
`
`Objections to Exs. 2100 and 2181 ........................................... 13
`
`10. Objections to Ex. 2174 and any Reference to/Reliance
`Thereon ................................................................................... 13
`
`III. CONCLUSION .......................................................................................... 22
`
`
`
`-1-
`
`
`
`
`
`

`
`Case IPR2015-01340
`Patent RE44,186
`
`
`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,
`
`2015, and any reference to or reliance on the foregoing Exhibits in Patent Owner’s
`
`Preliminary Response (“Preliminary Response”), Patent Owner’s Response
`
`(“Response”) or future filings by Patent Owner. Pursuant to 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. 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
`
`(Authenticating Evidence).
`
`Patent Owner describes Exs. 2101-2116 and Exs. 2142- 2144 as annual
`
`reports and/or Forms 20-F. By Patent Owner’s own admissions, Exs. 2101- 2116
`
`and Exs. 2142-2144, which contain hundreds of pages of information, were created
`
`years after the alleged date of invention. Each of Exs. 2101-2116 and Exs. 2142-
`
`-2-
`
`

`
`Case IPR2015-01340
`Patent RE44,186
`
`2144 is so attenuated to the question of whether the claimed invention was obvious
`
`at the alleged time of the invention that Exs. 2101- 2116 and Exs. 2142- 2144 are
`
`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
`
`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,
`
`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,
`
`-3-
`
`

`
`Case IPR2015-01340
`Patent RE44,186
`
`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
`
`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
`
`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,
`
`2176, and 2179-80 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
`
`-4-
`
`

`
`Case IPR2015-01340
`Patent RE44,186
`
`either lay testimony or expert testimony of any particular declarant. F.R.E. 602,
`
`701, 702.
`
`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
`
`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).
`
`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 are not substantively discussed or relied
`
`upon in the Patent Owner Response. Accordingly, each of these exhibits is not
`
`relevant to the proceeding, creates confusion, has no probative value, and
`
`consideration of it would therefore be a waste of time and unduly prejudicial.
`
`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);
`
`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).
`
`-5-
`
`

`
`Case IPR2015-01340
`Patent RE44,186
`
`
`Patent Owner describes Exs. 2077, 2079, 2080, 2086, 2120, 2124, 2127-
`
`2135, and 2196-2197 variously as “Prescribing Info,” “Summary of Product
`
`Characteristics,” “Adisinsight,” and printouts from various web sites, with
`
`purported publication, distribution or collection dates as late as 2015 and 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 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,
`
`that it is unduly prejudicial, misleading, and a waste 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
`
`-6-
`
`

`
`Case IPR2015-01340
`Patent RE44,186
`
`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. 2121-2123 and 2081 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. 2081 and 2121-2123 as various press releases
`
`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.
`
`401, 402. Further, even if relevant, Exs. 2081 and 2121-2123, 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
`
`-7-
`
`

`
`Case IPR2015-01340
`Patent RE44,186
`
`alleged time of the invention, that it is unduly prejudicial, misleading, and a waste
`
`of time. F.R.E. 403.
`
`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.
`
`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);
`
`F.R.E. 701, 702 (Expert Foundation and Opinions); F.R.E. 801, 802, 803, 805
`
`(Impermissible Hearsay); F.R.E. 901 (Authenticating Evidence); F.R.E. 1000(d)-
`
`-8-
`
`

`
`Case IPR2015-01340
`Patent RE44,186
`
`(e), 1002-1003 (document produced must accurately reflect or reproduce original
`
`document).
`
`Patent Owner describes Exs. 2117-2119, 2136-2137, and 2148 as various
`
`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
`
`alleged date of invention for the patent at issue, and then are selectively redacted to
`
`obscure significant portions of the documents that would otherwise provide data
`
`for other non-insulin anti-diabetic medications. F.R.E. 401, 402. Further, even if
`
`relevant, each of the selectively redacted Exs. 2117-2119, 2136-2137, and 2148 is
`
`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
`
`waste of time. F.R.E. 403. Patent Owner’s selective modification of, and
`
`submission of an incomplete and partial version of each of Exs. 2117-2119,
`
`violates F.R.E. 106, 1000(d)-(e), 1002-1003.
`
`Further, each of Exs. 2117-2119, 2136-2137, and 2148 appears to be
`
`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.
`
`-9-
`
`

`
`Case IPR2015-01340
`Patent RE44,186
`
`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. 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
`
`(Authenticating Evidence).
`
`Patent Owner describes Exs. 2169, 2172, 2175, 2177, 2178, 2182-2190, and
`
`2199 as various unpublished documents with appellations including “DPP-IV
`
`Targets,” “DP4 Chemistry Significant Events,” “Design and Development of the
`
`Selective DPP-4 Inhibitor Sitagliptin,” “DP4 Future Program,” “Monthly
`
`Summary,” “Excerpts from David Betebenner,” and “Synopsis.” Some of these
`
`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
`
`alleged time of the invention that each of Ex. 2169, 2172, 2175, 2177, 2178, 2182-
`
`-10-
`
`

`
`Case IPR2015-01340
`Patent RE44,186
`
`2190, and 2199 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. 2169, 2172, 2175,
`
`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.
`
`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 Ex. 2172, Ex. 2177, Ex. 2178, and Ex. 2199 lack
`
`foundation and also have not been authenticated. F.R.E. 602, 901.
`
`8. Objections to Exs. 2193-94 and any Reference to/Reliance
`Thereon
`
`Grounds for Objection: 37 C.F.R. §§ 42.6(a)(3) and 42.63; F.R.E. 401, 402
`
`(Irrelevant Evidence Inadmissible); F.R.E. 403 (Excluding Evidence for Prejudice,
`
`Cumulative, 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. 2193 and 2194 as Parts One and Two of
`
`Exhibits for Deposition Transcript of David P. Rotella. Exs. 2193 and 2194 are
`
`each a collection of many different documents, and each collection of documents
`
`exceeds 400 pages. Patent Owner’s submission of these voluminous collections of
`
`-11-
`
`

`
`Case IPR2015-01340
`Patent RE44,186
`
`documents violates the prohibition in 37 CFR § 42.6(a)(3) against combined
`
`documents, the prohibition in 37 C.F.R. § 42.6(d) against submitting a document
`
`already in the record of the proceeding, and the requirements of 37 C.F.R. § 42.63
`
`at least by failing to provide individual documents in the form of an exhibit, failing
`
`to uniquely number individual documents with a sequential exhibit number, and
`
`failing to provide each document with an exhibit label.
`
`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.
`
`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
`
`claimed subject matter was obvious at the alleged time of the invention. F.R.E.
`
`401, 402. Further, even if relevant, the relevance of such documents created after
`
`(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
`
`are cumulative to other exhibits filed as exhibits in this proceeding. F.R.E. 403.
`
`To the extent that Patent Owner relies on any statements in any document
`
`collected in Exs. 2193-94 for the truth of the matter asserted, such statements are
`
`inadmissible hearsay and also have not been authenticated. F.R.E. 801, 802, 803,
`
`-12-
`
`

`
`Case IPR2015-01340
`Patent RE44,186
`
`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.
`
`9. Objections to Exs. 2100 and 2181
`
`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.
`
`10. Objections to Ex. 2174 and any Reference to/Reliance Thereon
`
`Patent Owner describes Ex. 2174 as the Deposition Transcript of David P.
`
`Rotella, Ph.D. Objections to sections of the transcript include those objections set
`
`forth in the deposition transcript itself, as well as those objections set forth in the
`
`chart below, which are set forth together with grounds for each objection.
`
`Page(s)
`
`Line(s)
`
`Objection(s)
`
`22
`
`24-25
`
`25
`
`27
`
`29
`
`30
`
`30-31
`
`15-19
`
`23-03
`
`15-17
`
`05-12
`
`17-20
`
`22-24
`
`25-04
`
`Vague
`
`Compound
`
`Vague
`
`Compound
`
`Scope
`
`Scope
`
`Scope
`
`-13-
`
`

`
`Case IPR2015-01340
`Patent RE44,186
`
`31
`
`05-07
`
`31
`
`31
`
`31-32
`
`32
`
`32
`
`32
`
`42-43
`
`45
`
`46-47
`
`47-48
`
`48
`
`48
`
`51-52
`
`52
`
`52
`
`52-53
`
`54
`
`55
`
`56
`
`56-57
`
`57
`
`57
`
`08-10
`
`11-15
`
`20-01
`
`03-06
`
`07-14
`
`15-22
`
`22-03
`
`15-19
`
`20-04
`
`22-02
`
`03-05
`
`06-11
`
`23-01
`
`06-16
`
`02-05
`
`18-07
`
`10-20
`
`09-15
`
`03-21
`
`22-02
`
`08-19
`
`21-25
`
`Scope
`
`Scope
`
`Scope
`
`Compound/Scope
`
`Scope
`
`Scope
`
`Scope
`
`Vague/Scope
`
`Asked and Answered
`
`Vague
`
`Scope
`
`Scope
`
`Vague/Scope
`
`Scope
`
`Vague/Scope
`
`Scope
`
`Vague
`
`Vague
`
`Vague
`
`Vague/Foundation
`
`Vague/Foundation
`
`Vague
`
`Vague
`
`-14-
`
`

`
`Case IPR2015-01340
`Patent RE44,186
`
`60
`
`10-22
`
`60-61
`
`62-63
`
`63
`
`63-64
`
`63-64
`
`64-65
`
`65
`
`65
`
`66-67
`
`67
`
`67
`
`68-69
`
`69
`
`69
`
`69
`
`70
`
`70
`
`70
`
`70-71
`
`71-72
`
`72-73
`
`73
`
`23-09
`
`20-07
`
`15-17
`
`18-05
`
`18-05
`
`23-04
`
`06-15
`
`18-23
`
`24-02
`
`03-11
`
`17-20
`
`16-15
`
`16-19
`
`20-22
`
`23-25
`
`03-15
`
`01-02
`
`14-15
`
`14-11
`
`16-02
`
`16-03
`
`18-25
`
`Speculation
`
`Scope
`
`Vague/Scope
`
`Scope
`
`Vague/Scope
`
`Scope
`
`Vague/Compound/Scope
`
`Scope
`
`Scope
`
`Scope
`
`Scope
`
`Scope
`
`Scope
`
`Scope
`
`Scope
`
`Scope
`
`Vague/ Lacks Foundation/Speculation/Scope
`
`Scope
`
`Scope
`
`Vague/ Lacks Foundation/Speculation/Scope
`
`Vague/ Lacks Foundation/Speculation/Scope
`
`Vague/ Lacks Foundation/Scope
`
`Vague/ Lacks Foundation/Scope
`
`-15-
`
`

`
`Case IPR2015-01340
`Patent RE44,186
`
`74-75
`
`09-11*
`
`76
`
`79-80
`
`80
`
`80
`
`82
`
`82-83
`
`84-86
`
`86
`
`86-87
`
`87
`
`87
`
`88
`
`88
`
`88-89
`
`89
`
`90
`
`90
`
`91
`
`92-93
`
`93-94
`
`94-95
`
`95
`
`05-11
`
`18-07
`
`15-24
`
`01-07
`
`14-21
`
`23-11
`
`19-02
`
`06-14
`
`22-02
`
`03-12
`
`13-20
`
`10-14
`
`20-22
`
`23-05
`
`7-12
`
`5-11
`
`13-17
`
`11-14
`
`25-08
`
`10-02
`
`04-01
`
`06-20
`
`Vague/ Lacks Foundation/Scope
`
`Vague/ Lacks Foundation/Scope
`
`Vague/ Lacks Foundation/Scope
`
`Vague/ Lacks Foundation/Scope
`
`Scope
`
`Vague
`
`Scope
`
`Vague/ Lacks Foundation/Scope
`
`Vague/ Lacks Foundation/Scope
`
`Vague/ Lacks Foundation/Scope
`
`Vague/ Lacks Foundation/Scope/Speculation
`
`Vague/ Lacks Foundation/Scope/Speculation
`
`Scope
`
`Scope
`
`Vague/ Lacks Foundation/Scope/Speculation
`
`Vague
`
`Vague
`
`Lacks Foundation/Speculation
`
`Scope
`
`Vague/Lacks Foundation/Scope
`
`Vague/Compound/Scope
`
`Vague/Compound/Mischaracterizes Exhibit/Scope
`
`Vague/Compound/Mischaracterizes Exhibit/Scope
`
`-16-
`
`

`
`Case IPR2015-01340
`Patent RE44,186
`
`97
`
`15-19
`
`98
`
`98-99
`
`99
`
`99
`
`101-02
`
`102
`
`102-03
`
`103
`
`103-04
`
`104
`
`104-05
`
`105
`
`107
`
`109
`
`109
`
`111
`
`111-12
`
`112
`
`112
`
`112-13
`
`113
`
`15-19
`
`21-01
`
`02-04
`
`05-08
`
`21-02
`
`19-23
`
`24-02
`
`03-17
`
`18-05
`
`07-16
`
`20-12
`
`14-21
`
`13-21
`
`06-11
`
`13-25
`
`11-21
`
`22-03
`
`07-19
`
`20-21
`
`22-05
`
`07-19
`
`Mischaracterizes Testimony/Scope
`
`Lacks Foundation/Scope
`
`Scope
`
`Scope
`
`Scope
`
`Scope
`
`Scope
`
`Scope
`
`Scope
`
`Lacks Foundation/Scope/Speculation
`
`Scope
`
`Vague/Compound/Foundation/Scope
`
`Vague/Compound/Foundation/Scope/Mischaracterizes
`
`Testimony
`
`Vague/Lacks Foundation/Scope
`
`Vague/Lacks Foundation/Scope
`
`Vague
`
`Scope
`
`Vague/Lacks Foundation/Scope
`
`Scope
`
`Scope
`
`Vague/Compound/scope
`
`Scope
`
`-17-
`
`

`
`Case IPR2015-01340
`Patent RE44,186
`
`113-114
`
`20-05
`
`114
`
`118
`
`119
`
`122
`
`122
`
`122-23
`
`123
`
`124
`
`124
`
`124-25
`
`125
`
`125-26
`
`126
`
`128
`
`131-32
`
`132
`
`132-33
`
`133
`
`134
`
`134
`
`137
`
`07-12
`
`18-24
`
`01-08
`
`13-15
`
`16-21
`
`22-04
`
`05-09
`
`03-10
`
`11-14
`
`15-11
`
`12-21
`
`22-01
`
`22-25
`
`05-16
`
`23-05
`
`11-15
`
`16-04
`
`05-13
`
`01-13
`
`15-21
`
`04-11
`
`Vague/Lacks Foundation/Scope/Mischaracterizes
`
`Testimony
`
`Vague/Lacks Foundation/Scope
`
`Vague/Speculation
`
`Vague/Lacks Foundation
`
`Scope
`
`Scope
`
`Scope
`
`Scope
`
`Scope
`
`Scope
`
`Vague/Lacks Foundation/Scope
`
`Vague/Lacks Foundation/Scope
`
`Scope
`
`Scope
`
`Scope
`
`Scope
`
`Scope
`
`Scope
`
`Scope
`
`Vague/Lacks Foundation/Scope
`
`Scope
`
`Scope
`
`-18-
`
`

`
`Case IPR2015-01340
`Patent RE44,186
`
`137
`
`12-17
`
`137-38
`
`138
`
`138
`
`138-39
`
`139
`
`139-140
`
`140
`
`141
`
`142
`
`144
`
`144
`
`144-45
`
`145
`
`145
`
`146
`
`21-02
`
`03-09
`
`13-20
`
`21-03
`
`06-11
`
`06-03
`
`08-18
`
`13-17
`
`03-09
`
`11-21
`
`05-10
`
`22-03
`
`08-17
`
`04-07
`
`01-10
`
`Scope
`
`Scope
`
`Scope
`
`Scope
`
`Scope
`
`Scope
`
`Vague
`
`Vague
`
`Scope
`
`Vague/Lacks Foundation
`
`Vague/Lacks Foundation/Scope
`
`Scope
`
`Scope
`
`Vague/Lacks Foundation/Scope
`
`Scope
`
`Vague/Lacks Foundation/Legal Conclusion/Scope
`
`147-48
`
`01-24*
`
`Vague/Scope
`
`150
`
`150
`
`151
`
`151
`
`152
`
`154-55
`
`19-24
`
`07-18
`
`01-06
`
`07-13
`
`18-23
`
`25-09
`
`Vague/Compound/Lacks Foundation/Scope
`
`Scope
`
`Scope
`
`Scope
`
`Compound
`
`Asked and Answered
`
`-19-
`
`

`
`Case IPR2015-01340
`Patent RE44,186
`
`157-58
`
`12-11
`
`162-63
`
`163
`
`164
`
`165
`
`166-67
`
`168-69
`
`169
`
`169-70
`
`171
`
`171
`
`171
`
`171
`
`171-72
`
`172
`
`172
`
`172
`
`172-73
`
`173
`
`173
`
`174
`
`174
`
`174
`
`24-07
`
`16-22
`
`19-24
`
`04-09
`
`07-19
`
`22-01
`
`13-18
`
`23-10
`
`02-07
`
`08-12
`
`13-14
`
`15-19
`
`20-01
`
`14-24
`
`03-06
`
`07-13
`
`25-04
`
`05-09
`
`11-17
`
`08-14
`
`14-20
`
`20-25
`
`Vague
`
`Asked and Answered
`
`Vague
`
`Vague
`
`Vague/Lacks Foundation
`
`Scope
`
`Vague
`
`Lacks Foundation/Scope
`
`Lacks Foundation/Scope
`
`Scope
`
`Scope
`
`Scope
`
`Scope
`
`Vague/Scope
`
`Vague/Lacks Foundation/Scope
`
`Scope
`
`Scope
`
`Scope
`
`Vague/Lacks Foundation
`
`Vague/Lacks Foundation/Scope
`
`Scope
`
`Scope
`
`Scope
`
`-20-
`
`

`
`Case IPR2015-01340
`Patent RE44,186
`
`175
`
`01-10
`
`175-76
`
`176
`
`176
`
`177
`
`177
`
`178
`
`178-79
`
`179
`
`179-80
`
`180
`
`181
`
`182
`
`182-83
`
`184
`
`184-85
`
`185
`
`185
`
`185-86
`
`186
`
`186
`
`186-87
`
`21-01
`
`17-24
`
`02-15
`
`08-14
`
`21-25
`
`11-21
`
`22-04
`
`05-17
`
`18-04
`
`12-24
`
`01-19
`
`13-21
`
`23-01
`
`06-10
`
`18-02
`
`04-07
`
`20-24
`
`25-10
`
`11-14
`
`15-20
`
`22-10
`
`Scope
`
`Scope
`
`Vague/Lacks Foundation/Scope
`
`Scope
`
`Lacks Foundation/Scope
`
`Vague
`
`Scope
`
`Scope
`
`Scope
`
`Vague/Lacks Foundation/Scope
`
`Vague/Lacks Foundation/Scope
`
`Vague/Lacks Foundation/Scope
`
`Lacks Foundation/Scope
`
`Scope
`
`Scope
`
`Vague/Lacks Foundation/Scope
`
`Scope
`
`Scope
`
`Vague/Lacks Foundation/Scope
`
`Scope
`
`Vague/Lacks Foundation/Scope
`
`Vague/Lacks Foundation/Scope/Mischaracterizes
`
`Testimony
`
`-21-
`
`

`
`Case IPR2015-01340
`Patent RE44,186
`
`187-88
`
`21-06
`
`188
`
`189
`
`189
`
`190
`
`191
`
`193-94
`
`195
`
`196
`
`
`
`07-13
`
`03-09
`
`18-24
`
`06-08
`
`06-11
`
`08-03
`
`20-25
`
`05-12
`
`Vague/Compound
`
`Vague
`
`Lacks Foundation/Scope
`
`Lacks Foundation/Scope
`
`Scope
`
`Vague
`
`Scope
`
`Lacks Foundation/Scope
`
`Asked and Answered/Lacks Foundation/Scope
`
`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
`
`
`
`
`
`
`
`
`
`
`
`-22-
`
`

`
`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-