Paper No. ___
`Filed: May 16, 2016
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`
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`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
`NOTICE OF OBJECTION TO EVIDENCE
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`Case IPR2015-01340
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`TABLE OF CONTENTS
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`II.
`
`INTRODUCTION ........................................................................................ 4
`
`III. OBJECTIONS .............................................................................................. 4
`
`1.
`
`2.
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`3.
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`4.
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`5.
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`6.
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`7.
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`8.
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`9.
`
`Objections to Ex. 2002 and any Reference to/Reliance
`Thereon ..................................................................................... 4
`
`Objections to Ex. 2003 and any Reference to/Reliance
`Thereon ..................................................................................... 5
`
`Objections to Ex. 2004 and any Reference to/Reliance
`Thereon ..................................................................................... 8
`
`Objections to Ex. 2014 and any Reference to/Reliance
`Thereon ..................................................................................... 9
`
`Objections to Ex. 2015 and any Reference to/Reliance
`Thereon ................................................................................... 10
`
`Objections to Ex. 2018 and any Reference to/Reliance
`Thereon ................................................................................... 11
`
`Objections to Ex. 2019 and any Reference to/Reliance
`Thereon ................................................................................... 12
`
`Objections to Ex. 2020, and any Reference to/Reliance
`Thereon ................................................................................... 13
`
`Objections to Ex. 2021, and any Reference to/Reliance
`Thereon ................................................................................... 13
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`10. Objections to Ex. 2022 and any Reference to/Reliance
`Thereon ................................................................................... 14
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`11. Objections to Ex. 2023 and any Reference to/Reliance
`Thereon ................................................................................... 14
`
`12. Objections to Ex. 2024 and any Reference to/Reliance
`Thereon ................................................................................... 15
`
`13. Objections to Ex. 2025 and any Reference to/Reliance
`Thereon ................................................................................... 15
`
`14. Objections to Ex. 2026 and any Reference to/Reliance
`Thereon ................................................................................... 16
`
`15. Objections to Ex. 2027 and any Reference to/Reliance
`Thereon ................................................................................... 16
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`16. Objections to Ex. 2028 and any Reference to/Reliance
`Thereon ................................................................................... 17
`
`17. Objections to Ex. 2029 and any Reference to/Reliance
`Thereon ................................................................................... 17
`
`18. Objections to Ex. 2030 and any Reference to/Reliance
`Thereon ................................................................................... 18
`
`19. Objections to Ex. 2031 and any Reference to/Reliance
`Thereon ................................................................................... 18
`
`20. Objections to Ex. 2032 and any Reference to/Reliance
`Thereon ................................................................................... 19
`
`21. Objections to Ex. 2033 and any Reference to/Reliance
`Thereon ................................................................................... 19
`
`22. Objections to Ex. 2034 and any Reference to/Reliance
`Thereon ................................................................................... 20
`
`23. Objections to Ex. 2035 and any Reference to/Reliance
`Thereon ................................................................................... 20
`
`24. Objections to Ex. 2036 and any Reference to/Reliance
`Thereon ................................................................................... 21
`
`25. Objections to Ex. 2037 and any Reference to/Reliance
`Thereon ................................................................................... 21
`
`26. Objections to Ex. 2038 and any Reference to/Reliance
`Thereon ................................................................................... 22
`
`27. Objections to Ex. 2039 and any Reference to/Reliance
`Thereon ................................................................................... 23
`
`28. Objections to Ex. 2040 and any Reference to/Reliance
`Thereon ................................................................................... 23
`
`29. Objections to Ex. 2041 and any Reference to/Reliance
`Thereon ................................................................................... 24
`
`30. Objections to Ex. 2042 and any Reference to/Reliance
`Thereon ................................................................................... 24
`
`31. Objections to Ex. 2043 and any Reference to/Reliance
`Thereon ................................................................................... 25
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`32. Objections to Ex. 2045 and any Reference to/Reliance
`Thereon ................................................................................... 25
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`33. Objections to Ex. 2046 and any Reference to/Reliance
`Thereon ................................................................................... 27
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`34. Objections to Ex. 2047 and any Reference to/Reliance
`Thereon ................................................................................... 28
`
`35. Objections to Ex. 2048 and any Reference to/Reliance
`Thereon ................................................................................... 29
`
`36. Objections to Ex. 2049 and any Reference to/Reliance
`Thereon ................................................................................... 30
`
`37. Objections to Ex. 2050 and any Reference to/Reliance
`Thereon ................................................................................... 31
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`IV. CONCLUSION .......................................................................................... 33
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`II.
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`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 2002-2004, 2006, 2014-2015, 2018-2019, 2020-2043, and
`
`2045-2050, as listed on Patent Owner’s Exhibit List filed on September 25, 2015,
`
`and any reference to or reliance on the foregoing Exhibits in Patent Owner’s
`
`Preliminary Response (“Preliminary Response”) 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.”).
`
`III. OBJECTIONS
`1.
`Objections to Ex. 2002 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 Ex. 2002 as “David R. Magnin et al., Synthesis of
`
`Novel Potent Dipeptidyl Peptidase IV Inhibitors with Enhanced Chemical
`
`Stability: Interplay Between the N-Terminal Amino Acid Alkyl Side Chain and the
`
`Cyclopropyl Group of α-Aminoacyl-L-cis-4,5-methanoprolinenitrile-Based
`
`Inhibitors, 47 J. MED. CHEM. 2587 (2004).” Because the asserted publication
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`date of 2004 is years later than the alleged date of invention for the patent at issue,
`
`the fact that the content of Ex. 2002 was published in 2004, 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, Ex. 2002,
`
`which was 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 Ex. 2002 is unduly prejudicial, misleading, and a waste of time.
`
`F.R.E. 403.
`
`To the extent that Patent Owner relies on any statements in Ex. 2002 for the
`
`truth of the matter asserted, such statements are inadmissible hearsay and also have
`
`not been authenticated. F.R.E. 801, 802, 805, 901. Moreover, Patent Owner
`
`provides no foundation for the statements as either lay testimony or expert
`
`testimony of any particular declarant. F.R.E. 602, 701, 702.
`
`2.
`
`Objections to Ex. 2003 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).
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`Patent Owner describes Ex. 2003 as “Jeffrey A. Robl & Lawrence G.
`
`Hamann, The Discovery of the Dipeptidyl Peptidase-4 (DPP4) Inhibitor
`
`Onglyza™: From Concept to Market, in ACCOUNTS IN DRUG DISCOVERY:
`
`CASE STUDIES IN MEDICINAL CHEMISTRY 1 (Joel C. Barrish et al. eds.,
`
`2011).” Because the asserted publication date of 2011 is years later than the
`
`alleged date of invention for the patent at issue, the fact that the content of Ex.
`
`2003 was published in 2011, 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, Ex. 2003, which was created
`
`approximately 10 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 Ex. 2003 is unduly prejudicial, misleading, and a waste of time.
`
`F.R.E. 403.
`
`To the extent that Patent Owner relies on any statements in Ex. 2003 for the
`
`truth of the matter asserted, such statements are inadmissible hearsay and also have
`
`not been authenticated. F.R.E. 801, 802, 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.Objections to Ex. 2006
`
`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, 805 (Impermissible Hearsay); F.R.E. 901
`
`(Authenticating Evidence).
`
`Patent Owner describes Ex. 2006 as “Kathleen Aertgeerts et al., Crystal
`
`Structure of Human Dipeptidyl Peptidase IV in Complex with a Decapeptide
`
`Reveals Details on Substrate Specificity and Tetrahedral intermediate Formation,
`
`13 PROTEIN SCI. 412 (2004)” Because the asserted publication date of 2004 is
`
`years later than the alleged date of invention for the patent at issue, the fact that the
`
`content of Ex. 2006 was published in 2004, 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, Ex. 2006, which was
`
`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 Ex. 2006 is unduly prejudicial, misleading, and a waste of time. F.R.E. 403.
`
`To the extent that Patent Owner relies on any statements in Ex. 2006 for the
`
`truth of the matter asserted, such statements are inadmissible hearsay and also have
`
`not been authenticated. F.R.E. 801, 802, 805, 901. Moreover, Patent Owner
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`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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`3.
`
`Objections to Ex. 2004 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 Ex. 2004 as “ASTRAZENECA ANNUAL REPORT
`
`AND FORM 20-F INFORMATION 2014, available at
`
`www.astrazeneca.com/annualreport2014.” By Patent Owner’s own admission, Ex.
`
`2004, which contains hundreds of pages of information, was created more than a
`
`decade after the alleged date of invention. Ex. 2004 is so attenuated to the question
`
`of whether the claimed invention was obvious at the alleged time of the invention
`
`that Ex. 2004 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 statements in Ex. 2004 for the
`
`truth of the matter asserted, such statements are inadmissible hearsay and also have
`
`not been authenticated. F.R.E. 801, 802, 805, 901. Moreover, Patent Owner
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`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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`4.
`
`Objections to Ex. 2014 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 Ex. 2014 as “Ligaya M. Simpkins et al., Potent Non-
`
`Nitrile Dipeptidic Dipeptidyl Peptidase IV Inhibitors, 17 BIOORG.&MED.
`
`CHEM. LETT. 6476 (2007).” Because the asserted publication date of 2007 is
`
`years later than the alleged date of invention for the patent at issue, the fact that the
`
`content of Ex. 2014 was published in 2007, 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, Ex. 2014, which was
`
`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 Ex. 2014 is unduly prejudicial, misleading, and a waste of time. F.R.E. 403.
`
`To the extent that Patent Owner relies on any statements in Ex. 2014 for the
`
`truth of the matter asserted, such statements are inadmissible hearsay and also have
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`not been authenticated. F.R.E. 801, 802, 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.
`
`5.
`
`Objections to Ex. 2015 and any Reference to/Reliance Thereon
`
`Grounds for Objection: F.R.E. 106 (Remainder of or Related Writings or
`
`Recorded Statements); 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 Ex. 2015 as “Pioneer and Analogue Drugs, in
`
`ANALOGUE-BASED DRUG DISCOVERY III 3 (János Fischer et al. eds.,
`
`2013).” Because the asserted publication date of 2013 is years later than the
`
`alleged date of invention for the patent at issue, the fact that the content of Ex.
`
`2015 was published in 2013, 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, Ex. 2015, which was 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 Ex.
`
`2015 is unduly prejudicial, misleading, and a waste of time. F.R.E. 403.
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`To the extent that Patent Owner relies on any statements in Ex. 2015 for the
`
`truth of the matter asserted, such statements are inadmissible hearsay and also have
`
`not been authenticated. F.R.E. 801, 802, 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.
`
`Ex. 2015 purports to be a single chapter from multi-chapter, multi-volume
`
`book. Ex. 2015 references other chapters and volumes that were not included in
`
`Ex. 2015. Thus, it appears that Ex. 2015 omits parts of the record “that in fairness
`
`ought to be considered at the same time.” F.R.E. 106.
`
`6.
`
`Objections to Ex. 2018 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 Ex. 2018 as “Aiying Wang et al., Potency,
`
`Selectivity and Prolonged Binding of Saxagliptin to DPP4: Maintenance of DPP4
`
`Inhibition by Saxagliptin In Vitro and Ex Vivo When Compared to a Rapidly-
`
`Dissociating DPP4 Inhibitor, 12 BMC PHARM. 1 (2012).” Because the asserted
`
`publication date of 2012 is years later than the alleged date of invention for the
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`patent at issue, the fact that the content of Ex. 2018 was published in 2012, 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, Ex. 2018, which was created more than a decade 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 Ex. 2018 is unduly prejudicial,
`
`misleading, and a waste of time. F.R.E. 403.
`
`To the extent that Patent Owner relies on any statements in Ex. 2018 for the
`
`truth of the matter asserted, such statements are inadmissible hearsay and also have
`
`not been authenticated. F.R.E. 801, 802, 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.
`
`7.
`
`Objections to Ex. 2019 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).
`
`Patent Owner describes Ex. 2019 as “Defendants Joint Initial Invalidity
`
`Contentions Regarding U.S. Patent No. RE44,186.” Ex. 2019 is not substantively
`
`discussed or relied upon in the Preliminary Patent Owner Response or in the
`
`Petition. Accordingly, Ex. 2019 is not relevant to the proceeding, creates
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`confusion, has no probative value, and consideration of it would therefore be a
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`waste of time and unduly prejudicial.
`
`8.
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`Objections to Ex. 2020, 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).
`
`Patent Owner describes Ex. 2020 as “M.A. Nauck et al., Effects of
`
`Subcutaneous Glucagon-Like Peptide 1(GLP-1 [7–36 Amide]) in Patients with
`
`NIDDM, 39 DIABETOLOGIA 1546 (1996)” Ex. 2020 is not substantively
`
`discussed or relied upon in the Preliminary Patent Owner Response or in the
`
`Petition. Accordingly, Ex. 2020 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.
`
`9.
`
`Objections to Ex. 2021, 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).
`
`Patent Owner describes Ex. 2021 as “Nancy L. Thompson et al., A Fischer
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`Rat Substrain Deficient in Dipeptidyl Peptidase IV Activity Makes Normal Steady-
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`State RNA Levels and an Altered Protein: Use as a Liver-Cell Transplantation
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`Model, 273 J. BIOCHEM. 497 (1991).” Ex. 2021 is not substantively discussed or
`
`relied upon in the Preliminary Patent Owner Response or in the Petition.
`
`Accordingly, Ex. 2021 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.
`
`10. Objections to Ex. 2022 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).
`
`Patent Owner describes Ex. 2022 as “Int’l Pub. No. WO 95/15309.” Ex.
`
`2022 is not substantively discussed or relied upon in the Preliminary Patent Owner
`
`Response or in the Petition. Accordingly, Ex. 2022 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.
`
`11. Objections to Ex. 2023 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).
`
`Patent Owner describes Ex. 2023 as “U.S. Patent No. 6,011,155.” Ex. 2023
`
`is not substantively discussed or relied upon in the Preliminary Patent Owner
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`Response or in the Petition. Accordingly, Ex. 2023 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.
`
`12. Objections to Ex. 2024 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).
`
`Patent Owner describes Ex. 2024 as “Von R. Hiltmann et al., 2-
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`Acylaminopyridin-Derivate mit morphinagonistischer und -antagonistischer
`
`Wirksamkeit, 24 ARZNEIM. FORSCH. 584 (1974).” Ex. 2024 is not substantively
`
`discussed or relied upon in the Preliminary Patent Owner Response or in the
`
`Petition. Accordingly, Ex. 2024 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.
`
`13. Objections to Ex. 2025 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).
`
`Patent Owner describes Ex. 2025 as “U.S. Patent No. 4,591,598.” Ex. 2025
`
`is not substantively discussed or relied upon in the Preliminary Patent Owner
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`Response or in the Petition. Accordingly, Ex. 2025 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.
`
`14. Objections to Ex. 2026 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).
`
`Patent Owner describes Ex. 2026 as “German Patent Pub. No. 25 21 895
`
`A1.” Ex. 2026 is not substantively discussed or relied upon in the Preliminary
`
`Patent Owner Response or in the Petition. Accordingly, Ex. 2026 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.
`
`15. Objections to Ex. 2027 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).
`
`Patent Owner describes Ex. 2027 as “U.S. Patent No. 3,325,478.” Ex. 2027
`
`is not substantively discussed or relied upon in the Preliminary Patent Owner
`
`Response or in the Petition. Accordingly, Ex. 2027 is not relevant to the
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`proceeding, creates confusion, has no probative value, and consideration of it
`
`would therefore be a waste of time and unduly prejudicial.
`
`16. Objections to Ex. 2028 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).
`
`Patent Owner describes Ex. 2028 as “Stephen Hanessian et al., Probing the
`
`Importance of Spacial and Conformational Domains in Captopril Analogs for
`
`Angiotensin Converting Enzyme Activity, 8 BIOORG.&MED. CHEM. LETT. 2123
`
`(1998).” Ex. 2028 is not substantively discussed or relied upon in the Preliminary
`
`Patent Owner Response or in the Petition. Accordingly, Ex. 2028 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.
`
`17. Objections to Ex. 2029 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. 1001-1003 (Best Evidence, Readable Document).
`
`Patent Owner describes Ex. 2029 as “Koert Gerzon et al., The Adamantyl
`
`Group in Medicinal Agents I. Hypoglycemic N-Arylsulfonyl-N’adamantylureas, 6
`
`J.MED. CHEM. 760 (1963).” Ex. 2029 is not substantively discussed or relied
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`upon in the Preliminary Patent Owner Response or in the Petition. Additionally,
`
`Ex. 2029 is partially illegible. F.R.E. 1001-1003. Accordingly, Ex. 2029 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.
`
`18. Objections to Ex. 2030 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).
`
`Patent Owner describes Ex. 2030 as “F. R. Rubio et al., Urinary Metabolites
`
`of Rimantadine in Humans, 16 DRUG METABOLISM & DISPOSITION 773
`
`(1988).” Ex. 2030 is not substantively discussed or relied upon in the Preliminary
`
`Patent Owner Response or in the Petition. Accordingly, Ex. 2030 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.
`
`19. Objections to Ex. 2031 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).
`
`Patent Owner describes Ex. 2031 as “Gunter Fischer et al., The
`
`Conformation Around the Peptide Bond Between the P1- And P2-Positions Is
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`Important for Catalytic Activity of Some Proline-Specific Proteases, 742 BBA 452
`
`(1983).” Ex. 2031 is not substantively discussed or relied upon in the Preliminary
`
`Patent Owner Response or in the Petition. Accordingly, Ex. 2031 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.
`
`20. Objections to Ex. 2032 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).
`
`Patent Owner describes Ex. 2032 as “U.S. Patent No. 4,954,158.” Ex. 2032
`
`is not substantively discussed or relied upon in the Preliminary Patent Owner
`
`Response or in the Petition. Accordingly, Ex. 2032 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.
`
`21. Objections to Ex. 2033 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).
`
`Patent Owner describes Ex. 2033 as “Masahiro Yoshioka et al., Role of Rat
`
`Intestinal Brush-Border Membrane Angiotensin-Converting Enzyme in Dietary
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`Protein Digestion, 253 AM. J. PHYSIOL. G781 (1987).” Ex. 2033 is not
`
`substantively discussed or relied upon in the Preliminary Patent Owner Response
`
`or in the Petition. Accordingly, Ex. 2033 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.
`
`22. Objections to Ex. 2034 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).
`
`Patent Owner describes Ex. 2034 as “German Patent Pub. No. 3324263 A1.”
`
`Ex. 2034 is not substantively discussed or relied upon in the Preliminary Patent
`
`Owner Response or in the Petition. Accordingly, Ex. 2034 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.
`
`23. Objections to Ex. 2035 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).
`
`Patent Owner describes Ex. 2035 as “Stephen Hanessian et al., The
`
`Stereocontrolled Synthesis of Enantiopure α-Methano Heterocycles and
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`Constrained Amino Acid Analogs, 37 TETRAHEDRON LETT. 8967 (1996).” Ex.
`
`2035 is not substantively discussed or relied upon in the Preliminary Patent Owner
`
`Response or in the Petition. Accordingly, Ex. 2035 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.
`
`24. Objections to Ex. 2036 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. 901 (Authenticating Evidence).
`
`Patent Owner describes Ex. 2036 as “Caplus Records for German Patent
`
`Pub. No. 3324263 A1.” Ex. 2036 is not substantively discussed or relied upon in
`
`the Preliminary Patent Owner Response or in the Petition. Additionally, Patent
`
`Owner provides no foundation for Ex. 2036 and does not provide evidence
`
`authenticating Ex. 2036. Accordingly, Ex. 2036 is not relevant to th