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`Paper No. ___
`Filed: August 1, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________________
`
`
`APOTEX INC. AND
`APOTEX CORP.
`Petitioners,
`
`v.
`
`NOVARTIS A.G.,
`Patent Owner.
`
`_____________________________
`
`Case IPR2017-00854
`Patent No. 9,187,405
`
`_____________________________
`
`
`PETITIONERS APOTEX INC. AND APOTEX CORP.’S
`NOTICE OF OBJECTIONS TO EVIDENCE
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`
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`Case IPR2017-00854
`Patent 9,187,405
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`TABLE OF CONTENTS
`
`I.
`
`INTRODUCTION ........................................................................................ 1
`
`II.
`
`OBJECTIONS .............................................................................................. 1
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`Objections to EX2003, and any Reference to/Reliance
`Thereon ..................................................................................... 1
`
`Objections to EX2005, and any Reference to/Reliance
`Thereon ..................................................................................... 2
`
`Objections to EX2013, and any Reference to/Reliance
`Thereon ..................................................................................... 3
`
`Objections to EX2015, and any Reference to/Reliance
`Thereon ..................................................................................... 4
`
`Objections to EX2016, and any Reference to/Reliance
`Thereon ..................................................................................... 5
`
`Objections to EX2017, and any Reference to/Reliance
`Thereon ..................................................................................... 6
`
`Objections to EX2018, and any Reference to/Reliance
`Thereon ..................................................................................... 7
`
`Objections to EX2019, and any Reference to/Reliance
`Thereon ..................................................................................... 8
`
`III. CONCLUSION ............................................................................................ 9
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`
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`-i-
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`Case IPR2017-00854
`Patent 9,187,405
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`I.
`
`INTRODUCTION
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Apotex Inc. and Apotex Corp.
`
`(“Petitioner”) submits the following objections to Novartis A.G. (“Patent
`
`Owner”)’s Exhibits 2003, 2005, 2013, 2015, 2016, 2017, 2018, and 2019, as listed
`
`on Patent Owner’s Exhibit List filed on May 3, 2017, 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.”).
`
`II. OBJECTIONS
`1. Objections to EX2003, 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, 703 (Expert Foundation and
`
`Opinions); F.R.E. 802 (Inadmissible Hearsay); 37 C.F.R. § 42.6(a)(3).
`
`Petitioner objects to the paragraphs 5-7 and 56-57 of EX2003 as irrelevant,
`
`confusing, or a waste of time as these paragraphs are not cited in Patent Owner’s
`
`Preliminary Response. F.R.E. 401, 402, 403. Petitioner similarly objects to
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`paragraphs 8-18, 19-26, 27-33, 36-43, 45, and 54-55 of EX2003 as irrelevant,
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`confusing, or a waste of time as these paragraphs are cited in Patent Owner’s
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`-1-
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`Patent 9,187,405
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`Preliminary Response only as part of long block citations that violate Board rules.
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`F.R.E. 401, 402, 403. 37 C.F.R. § 42.6(a)(3) (“Arguments must not be
`
`incorporated by reference from one document into another document.”).
`
`Petitioner further objects to Exhibit 2003 to the extent it relies upon any of
`
`Exhibits 2004, 2008-2012, or 2014 for the truth of the matter asserted. F.R.E. 802.
`
`2. Objections to EX2005, 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, 703 (Expert Foundation and
`
`Opinions); F.R.E. 802 (Inadmissible Hearsay); 37 C.F.R. § 42.6(a)(3).
`
`Petitioner objects to paragraphs 41-42 of EX2005 as irrelevant, confusing, or
`
`a waste of time as these paragraphs are not cited in Patent Owner’s Preliminary
`
`Response. F.R.E. 401, 402, 403. Petitioner similarly objects to paragraphs 1-21
`
`and 24-32 of EX2005 as irrelevant, confusing, or a waste of time as these
`
`paragraphs are cited in Patent Owner’s Preliminary Response only as part of long
`
`block citations. F.R.E. 401, 402, 403. 37 C.F.R. § 42.6(a)(3) (“Arguments must
`
`not be incorporated by reference from one document into another document.”).
`
`Petitioner further objects to Exhibit 2005 to the extent it relies upon any of
`
`Exhibits 2013, 2015, 2016, 2017, or 2018 (which exhibits are individually
`
`discussed below). F.R.E. 602, 702, 402, 403.
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`-2-
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`Patent 9,187,405
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`Petitioner further objects to Exhibit 2005 to the extent it relies upon any of
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`Exhibits 2006, 2011, 2013-2018 for the truth of the matter asserted. F.R.E. 802.
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`3. Objections to EX2013, and any Reference to/Reliance Thereon
`
`Grounds for Objection: F.R.E. 401, 402 (Irrelevant Evidence Inadmissible);
`
`F.R.E. 403 (Excluding Evidence for Prejudice, Confusion, Waste of Time, or Other
`
`Reasons); F.R.E. 602 (Foundation); F.R.E. 701, 702 (Expert Foundation and
`
`Opinions); F.R.E. 801, 802, 803, 805 (Inadmissible Hearsay); F.R.E. 901
`
`(Authenticating Evidence).
`
`Patent Owner describes EX2013 as a LinkedIn profile for a non-party who is
`
`not participating in this proceeding. EX2013 does not assert to have a publication
`
`date before the earliest claimed priority date of the invention of the patent at issue
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`and is irrelevant to whether the claimed subject matter was obvious. EX2013 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
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`of time. F.R.E. 403.
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`To the extent that Patent Owner relies on any statements in EX2013 for the
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`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
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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-
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`Case IPR2017-00854
`Patent 9,187,405
`4. Objections to EX2015, 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 (Inadmissible Hearsay); F.R.E. 901
`
`(Authenticating Evidence).
`
`Patent Owner describes EX2015 as an FDA “Guidance” document obtained
`
`in March 2009. However, EX2015 indicates that it is a “DRAFT” document
`
`seeking “comments and suggestions.”
`
`The fact that the content of this exhibit was publicly available after 2009,
`
`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, EX2015,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, neither the Patent Owner nor the exhibit provides adequate
`
`foundation for the document itself or its authenticity. F.R.E. 602, 901. Further,
`
`EX2015 appears to be inadmissible hearsay. F.R.E. 801, 802, 803.
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`-4-
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`Case IPR2017-00854
`Patent 9,187,405
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`To the extent that Patent Owner relies on any statements in EX2015 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.
`
`5. Objections to EX2016, and any Reference to/Reliance Thereon
`
`Grounds for Objection: F.R.E. 401, 402 (Irrelevant Evidence Inadmissible);
`
`F.R.E. 403 (Excluding Evidence for Prejudice, Confusion, Waste of Time, or Other
`
`Reasons); F.R.E. 602 (Foundation); F.R.E. 701, 702 (Expert Foundation and
`
`Opinions); F.R.E. 801, 802, 803, 805 (Inadmissible Hearsay); F.R.E. 901
`
`(Authenticating Evidence).
`
`Patent Owner describes EX2016 as a FDA “Guidance” document obtained
`
`in December 2016. However, EX2016 indicates that it contains only “Nonbinding
`
`Recommendations.”
`
`The fact that the content of this exhibit was publicly available after 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, EX2016,which appears to have been created years after the
`
`alleged date of invention, is so attenuated to the question of whether the claimed
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`-5-
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`Case IPR2017-00854
`Patent 9,187,405
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`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, neither the Patent Owner nor the exhibit provides adequate
`
`foundation for the document itself or its authenticity. F.R.E. 602, 901. Further,
`
`EX2016 appears to be inadmissible hearsay. F.R.E. 801, 802, 803.
`
`To the extent that Patent Owner relies on any statements in EX2016 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 EX2017, and any Reference to/Reliance Thereon
`
`Grounds for Objection: F.R.E. 401, 402 (Irrelevant Evidence Inadmissible);
`
`F.R.E. 403 (Excluding Evidence for Prejudice, Confusion, Waste of Time, or Other
`
`Reasons); F.R.E. 602 (Foundation); F.R.E. 701, 702 (Expert Foundation and
`
`Opinions); F.R.E. 801, 802, 803, 805 (Inadmissible Hearsay); F.R.E. 901
`
`(Authenticating Evidence).
`
`Patent Owner describes EX2017 as a Bloomberg profile for a non-party who
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`is not participating in this proceeding. EX2017 does not purport to have a
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`publication date before the earliest claimed priority date of the invention of the
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`Case IPR2017-00854
`Patent 9,187,405
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`patent at issue and is irrelevant to whether the claimed subject matter was obvious.
`
`EX2017 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.
`
`To the extent that Patent Owner relies on any statements in EX2017 for the
`
`truth of the matter asserted, such statements are inadmissible hearsay and also have
`
`not been authenticated. F.R.E. 801, 802, 803, 805, 901. Moreover, Patent Owner
`
`provides no foundation for the statements as either lay testimony or expert
`
`testimony of any particular declarant. F.R.E. 602, 701, 702.
`
`7. Objections to EX2018, and any Reference to/Reliance Thereon
`
`Grounds for Objection: F.R.E. 401, 402 (Irrelevant Evidence Inadmissible);
`
`F.R.E. 403 (Excluding Evidence for Prejudice, Confusion, Waste of Time, or Other
`
`Reasons); F.R.E. 602 (Foundation); F.R.E. 701, 702 (Expert Foundation and
`
`Opinions); F.R.E. 801, 802, 803, 805 (Inadmissible Hearsay); F.R.E. 901
`
`(Authenticating Evidence).
`
`Patent Owner describes EX2018 as a LinkedIn profile for a non-party who is
`
`not participating in this proceeding. EX2018 does not purport to have a
`
`publication date before the earliest claimed priority date of the invention of the
`
`patent at issue and is irrelevant to whether the claimed subject matter was obvious.
`
`EX2018 is so attenuated to the question of whether the claimed invention was
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`-7-
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`Case IPR2017-00854
`Patent 9,187,405
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`obvious at the alleged time of the invention that it is unduly prejudicial,
`
`misleading, and a waste of time. F.R.E. 403.
`
`To the extent that Patent Owner relies on any statements in EX2018 for the
`
`truth of the matter asserted, such statements are inadmissible hearsay and also have
`
`not been authenticated. F.R.E. 801, 802, 803, 805, 901. Moreover, Patent Owner
`
`provides no foundation for the statements as either lay testimony or expert
`
`testimony of any particular declarant. F.R.E. 602, 701, 702.
`
`8. Objections to EX2019, and any Reference to/Reliance Thereon
`
`Grounds for Objection: F.R.E. 401, 402 (Irrelevant Evidence Inadmissible);
`
`F.R.E. 403 (Excluding Evidence for Prejudice, Confusion, Waste of Time, or Other
`
`Reasons); F.R.E. 602 (Foundation); F.R.E. 701, 702 (Expert Foundation and
`
`Opinions); F.R.E. 801, 802, 803, 805 (Inadmissible Hearsay)
`
`Patent Owner describes EX2019 as “Bibliographic Data of Application No.
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`06/633,481, accessed on May 1, 2017.” EX2019 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, EX2019 is so attenuated to the question of
`
`whether the claimed invention was obvious at the alleged time of the invention that
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`it is unduly prejudicial, misleading, and a waste of time. F.R.E. 403.
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`-8-
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`Case IPR2017-00854
`Patent 9,187,405
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`Neither the Patent Owner nor the exhibit provides adequate foundation for
`
`the document itself or its authenticity. F.R.E. 602, 901. Further, EX2019 appears
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`to be inadmissible hearsay. F.R.E. 801, 802, 803.
`
`To the extent that Patent Owner relies on any statements in EX2019 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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`III. CONCLUSION
`
`The aforementioned exhibits were filed together with Patent Owner’s
`
`Preliminary Response, prior to institution. Trial was instituted on July 18, 2017.
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`These objections are made within 10 business days of institution pursuant to 37
`
`C.F.R. § 42.64.
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`Dated: August 1, 2017
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`Respectfully submitted,
`
`/ Steven W. Parmelee /
` Steven W. Parmelee, Lead Counsel
` Reg. No. 31,990
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`Case IPR2017-00854
`Patent 9,187,405
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`CERTIFICATE OF SERVICE
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`
`
`This is to certify that I caused to be served a true and correct copy of the
`
`foregoing Petitioners Apotex Inc. and Apotex Corp.’s Notice of Objections to
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`Evidence, on this 1st day of August, 2017, on the Patent Owner at the
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`correspondence address of the Patent Owner as follows:
`
`Jane M. Love, Ph.D.
`Robert W. Trenchard
`GIBSON, DUNN & CRUTCHER LLP
`200 Park Avenue, 47th Floor
`New York, NY 10166
`Email: jlove@gibsondunn.com
`Email: rtrenchard@gibsondunn.com
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`
`
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`
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`Dated: August 1, 2017
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`Respectfully submitted,
`
`/ Steven W. Parmelee /
` Steven W. Parmelee, Lead Counsel
` Reg. No. 31,990
`
`
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`
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`-10-
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