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`Paper No. ___
`Filed: November 20, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________________
`
`
`APOTEX INC., APOTEX CORP., ARGENTUM PHARMACEUTICALS LLC,
`ACTAVIS ELIZABETH LLC, TEVA PHARMACEUTICALS USA, INC., SUN
`PHARMACEUTICAL INDUSTIRES, LTD., SUN PHARMACEUTICAL
`INDUSTRIES, INC., AND SUN PHARMA GLOBAL FZE,
`Petitioners,
`
`v.
`
`NOVARTIS A.G.,
`Patent Owner.
`
`_____________________________
`
`IPR2017-008541
`Patent No. 9,187,405
`
`_____________________________
`
`
`PETITIONERS’ NOTICE OF OBJECTIONS TO EVIDENCE
`
`
`
`1 Cases IPR2017-01550, IPR2017-01946, and IPR2017-01929 have been joined
`with this proceeding.
`
`
`
`
`
`
`
`
`Case IPR2017-00854
`Patent 9,187,405
`
`I.
`II.
`
`TABLE OF CONTENTS
`
`INTRODUCTION ........................................................................................ 1
`OBJECTIONS .............................................................................................. 1
`1.
`Thereon ..................................................................................... 1
`2.
`Thereon ..................................................................................... 2
`3.
`Thereon ..................................................................................... 2
`4.
`and 2062 and any Reference to/Reliance Thereon ..................... 3
`5.
`2067-2069 and any Reference to/Reliance Thereon .................. 5
`6.
`Thereon ..................................................................................... 7
`7.
`Thereon ..................................................................................... 8
`8.
`Thereon ..................................................................................... 8
`9.
`to/Reliance Thereon .................................................................. 8
`10. Objections to Exs. 2063-2066 and any Reference
`to/Reliance Thereon .................................................................. 9
`11. Objections to Ex. 2072 and any Reference to/Reliance
`Thereon ................................................................................... 10
`III. CONCLUSION .......................................................................................... 11
`
`Objections to EX2022, and any Reference to/Reliance
`
`Objections to EX2024, and any Reference to/Reliance
`
`Objections to EX2025 and any Reference to/Reliance
`
`Objections to Exs. 2027, 2032, 2033, 2048, 2054, 2056,
`
`Objections to Exs. 2035, 2038, 2040, 2042, 2058, and
`
`Objections to EX2037 and any Reference to/Reliance
`
`Objections to EX2039 and any Reference to/Reliance
`
`Objections to EX2047 and any Reference to/Reliance
`
`Objections to Exs. 2057 and 2070 and any Reference
`
`
`
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`-i-
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`Case IPR2017-00854
`Patent 9,187,405
`
`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 2022, 2024, 2025, 2026, 2027, 2032, 2033, 2035, 2037, 2038,
`
`2039, 2040, 2042, 2047, 2048, , 2054, 2056, 2057, 2058, 2062-2068, 2069, 2070,
`
`and 2072, as listed on Patent Owner’s Updated Exhibit List filed on November 13,
`
`2017, and any reference to or reliance on the foregoing Exhibits in Patent Owner’s
`
`Response (“POR”), its expert declarations, 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 EX2022, 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,
`
`Duplication, or Other Reasons); F.R.E. 701, 702, 703 (Expert Foundation and
`
`Opinions); F.R.E. 802, 803, 805 (Inadmissible Hearsay).
`
`EX2022 is duplicative of expert testimony offered by Patent Owner’s other
`
`witnesses. Petitioner further objects to Exhibit 2022 to the extent it relies upon any
`
`of Exhibits 2027, 2032, 2033, 2048, 2054, 2056, and 2062 for the truth of the
`
`matter asserted. F.R.E. 802.
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`Patent 8,927,592
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`2. Objections to EX2024, 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. 701, 702, 703 (Expert Foundation and Opinions); F.R.E. 802,
`
`803, 805 (Inadmissible Hearsay).
`
`EX2024 is duplicative of expert testimony offered by Patent Owner’s other
`
`witnesses. Petitioner further objects to Exhibit 2024 to the extent it relies upon any
`
`of Exhibits 2027, 2032, 2033, 2048, 2054, 2056, and 2062 for the truth of the
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`matter asserted. F.R.E. 802.
`
`3. Objections to EX2025 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).
`
`EX2025 is duplicative of expert testimony offered by Patent Owner’s other
`
`witnesses. Petitioner further objects to Exhibit 2025 to the extent it relies upon any
`
`of Exhibits 2027, 2032, 2033, 2048, 2054, 2056, and 2062 for the truth of the
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`matter asserted. F.R.E. 802.
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`Patent 8,927,592
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`4. Objections to Exs. 2027, 2032, 2033, 2048, 2054, 2056, and
`2062 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. 801, 802, 803, 805 (Inadmissible
`
`Hearsay); F.R.E. 901 (Authenticating Evidence).
`
`Patent Owner describes EX2017 as the “American Autoimmune Related
`
`Diseases Association, Inc. Autoimmune Disease List,” which was accessed from
`
`www.aarda.org/diseaselist on October 5, 2017.
`
`Patent Owner describes EX2032 as “Fingolimod, Chemical Abstract
`
`Registry No. 162359-55-9.” Patent Owner provides no source information or
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`publication date.
`
`Patent Owner describes EX2033 as “2-amino-2-[2-(4-
`
`octylphenyl)ethyl]propane-1,3-diol;hydrochloride, Chemical Abstract Registry No.
`
`162359-56-0.” Patent Owner provides no source information or publication date.
`
`Patent Owner describes EX2048 as “Park et al. ‘Peripheral Blood FTY720
`
`Pharmacokinetic/Pharmacodynamic (PK/PD) Modeling in Renal Transplanted
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`Recipients,’ Abstract #707, Kidney: Pharmacogenetics, Kinetics and New Drug, p.
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`333-334.” Patent Owner provides no source information or publication date.
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`Patent 8,927,592
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`Patent Owner describes EX2054 as “Lymphocytopenia - Hematology and
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`Oncology - Merck Manuals Professional Edition,” which was accessed from
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`www.merckmanuals.com/professional/hematology-
`
`andoncology/leukopenias/lymphocytopenia on November 7, 2017. Patent Owner
`
`provides no publication date.
`
`Patent Owner describes EX2056 as “Derfuss et al. The ACROSS study:
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`long-term efficacy of fingolimod in patients with RRMS (Follow-up at 10 years)
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`ECTRIMS Online Library. Sep 16, 2016; 145896.” Patent Owner provides no
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`publication date.
`
`Patent Owner describes EX2062 as “Functional Systems Scores (FSS) and
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`Expanded Disability Status Scale (EDSS), National MS Society,” which was
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`accessed from www.nationalmssociety.org on November 10, 2017. Patent Owner
`
`provides no publication date.
`
`Exhibits 2027, 2032, 2033, 2048, 2054, 2056, and 2062 appear to all be
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`computer printouts from recently accessed websites. The fact that the content of
`
`these exhibits is publicly available after the effective filing date of the patent, even
`
`if established by Patent Owner, is irrelevant to whether the claimed subject matter
`
`was obvious at the alleged time of the invention. F.R.E. 401, 402. Further, even if
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`relevant, these exhibits appear to have been created years after the alleged date of
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`invention and are so attenuated to the question of whether the claimed invention
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`Patent 8,927,592
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`was obvious at the alleged time of the invention, that it is unduly prejudicial,
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`misleading, and a waste of time. F.R.E. 403.
`
`Moreover, neither the Patent Owner nor any of the exhibits provides
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`adequate foundation or establishes authenticity for any of these documents. F.R.E.
`
`602, 901. Further, each exhibit 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.
`
`5. Objections to Exs. 2035, 2038, 2040, 2042, 2058, and 2067-
`2069 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 EX2035 as “Oral fingolimod or intramuscular
`
`interferon for relapsing multiple sclerosis,” published in the N Eng J. Med in
`
`February 2010.
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`Patent 8,927,592
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`Patent Owner describes EX2038 as “Brain penetration of the oral
`
`immunomodulatory drug FTY720 and its phosphorylation in the central nervous
`
`system during experimental autoimmune encephalomyelitis: consequences for
`
`mode of action in multiple sclerosis,” published in the J. Pharmacol Exp Ther on
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`August 6, 2007.
`
`Patent Owner describes EX2040 as “Gilenya label,” publication date
`
`unknown but apparently after Feb. 2016, the date upon which the label was
`
`revised.
`
`Patent Owner describes EX2042 as “Safety and efficacy of fingolimod in
`
`patients with relapsing-remitting multiple sclerosis (FREEDOMS II): a double-
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`blind, randomised, placebo-controlled, phase 3 trial,” published in Lancet Neurol
`
`in June 2014.
`
`Patent Owner describes EX2058 as “Development of transitional
`
`pharmacokinetic-pharmacodynamic models,” published in Clin Pharmacol Ther in
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`June 2008.
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`Patent Owner describes EX2067 as “Reduced fingolimod dosage treatment
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`for patients with multiple sclerosis and lymphopenia or neutropenia,” published in
`
`Mult Scler August 2013.
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`Patent Owner describes EX2068 as “Safety and efficacy of reduced
`
`fingolimod dosage treatment,” published in J Neuroimmunol on August 15, 2015.
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`Patent Owner describes EX2069 as “Half-dose fingolimod for treating
`
`relapsing remitting multiple sclerosis: Observational study” published in Mult
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`Scler on Febuary 1, 2017.
`
`Exs. 2035, 2038, 2042, 2058, and 2067-2069 exhibits are irrelevant to
`
`whether the claimed subject matter was obvious at the earliest alleged time of the
`
`invention because each of these exhibits was published after the filing date of the
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`priority document for the ’405 patent. F.R.E. 401, 402. Further, even if relevant,
`
`these exhibits are 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, Patent Owner fails to provide foundation or authentication for
`
`EX2040. F.R.E. 602, 901. EX2040 is purportedly a label for the approved Gilenya
`
`product. No foundation or authentication is provided by Patent Owner or the
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`document itself.
`
`6. Objections to EX2037 and any Reference to/Reliance Thereon
`
`Grounds for Objection: F.R.E. 801, 802, 803, 805 (Inadmissible Hearsay).
`
`EX2037 purports to be an approval letter from the FDA. 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.
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`Patent 8,927,592
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`7. Objections to EX2039 and any Reference to/Reliance Thereon
`
`Grounds for Objection: F.R.E. 106 (incomplete writing)
`
`EX2039 purports to be the final deposition transcript from Dr. Giesser’s
`
`October 2, 2017 deposition. However, the transcript contains an error in the
`
`appearances of petitioner’s counsel on page 3, which the reporter corrected in the
`
`final transcript.
`
`8. Objections to EX2047 and any Reference to/Reliance Thereon
`
`Grounds for Objection: F.R.E. 106 (Incomplete Writing).EX2047 purports
`
`to be chapters from “McAlpine’s Multiple Sclerosis, 4th Edition.” EX2047
`
`contains portions of Chapter 7 (pp.347-347), p. 667, and pp.805-806. The exhibit is
`
`incomplete as it is missing a portion of Chapter 7 and most of the chapters that
`
`comprise p. 667 and pp. 805-806. F.R.E. 106.
`
`9. Objections to Exs. 2057 and 2070 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. 801, 802, 803, 805 (Inadmissible
`
`Hearsay); F.R.E. 901 (Authenticating Evidence).
`
`Patent Owner describes EX2057 as “Effects of FTY720 on experimental
`
`autoimmune encephalomyelitis-induced angiogenesis (acute and relapsing)” which
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`Patent 8,927,592
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`is allegedly an internal Novartis report produced on May 12, 2009. The signature
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`sheet associated with EX2057 is blank. The foundation for the report has not been
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`adequately laid. F.R.E. 602. EX2070 purports to be the signature sheet associated
`
`with the report but it is not connected with the original document calling into
`
`question the authenticity of both EX2057 and 2070. F.R.E. 901. Moreover, the
`
`contents of the report are inadmissible hearsay. F.R.E. 801, 802, 803, 805. The
`
`contents of the report lack relevance and risk confusion and waste of time. F.R.E.
`
`401-403.
`
`10. Objections to Exs. 2063-2066 and any Reference to/Reliance
`Thereon
`
`Grounds for Objection: F.R.E. 106 (Incomplete); 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. 801, 802, 803,
`
`805 (Inadmissible Hearsay); F.R.E. 901 (Authenticating Evidence).
`
`Patent Owner describes EX2063 as “Redacted Email from Sylvia Burns with
`
`cc to Fred Lublin.” Patent Owner describes EX2064 as “ Novartis Letter to Dr.
`
`Katz dated March 3, 2008 re DSMB's benefit/risk analysis of 0.5 mg dose.” Patent
`
`Owner describes EX2065 as “Email from Tom Watson to Colleen Farrell dated
`
`June 5, 2007 regarding ‘letter for you IRB.’” Patent Owner describes EX2066 as
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`“Novartis Letter to Dr. Miller dated June 5, 2007 regarding Protocol
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`CFTY720D2302.”
`
`EX2063 is incomplete as it is missing at least a portion of the email
`
`exchanges regarding the IRB decision. F.R.E. 106. Each of EX2063-EX2066 is
`
`incomplete because it comprises only a portion of the communications at issue and
`
`includes only a portion of the documents quoted therein. In particular, EX2066
`
`purports to quote one sentence of “the FDA minutes of the February 2, 2005 face-
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`to-face meeting” without providing a complete record of the minutes. In each case,
`
`without the complete record, each of these exhibits is irrelevant or 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.
`
`401, 402, 403. Moreover, the contents of the exhibits are inadmissible hearsay.
`
`F.R.E. 801, 802, 803, 805.
`
`11. Objections to Ex. 2072 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. 801, 802, 803, 805 (Inadmissible
`
`Hearsay); F.R.E. 901 (Authenticity).
`
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`Case IPR2016-00712
`Patent 8,927,592
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`III. CONCLUSION
`
`The aforementioned exhibits were filed together with Patent Owner’s
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`Response on November 13, 2017. These objections are made within 5 business
`
`days pursuant to 37 C.F.R. § 42.64.
`
`
`
`Dated: November 20, 2017
`
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`Respectfully submitted,
`
`/ Steven W. Parmelee /
` Steven W. Parmelee
` Reg. No. 31,990
`
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`Case IPR2016-00712
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`CERTIFICATE OF SERVICE
`
`
`
`This is to certify that I caused to be served a true and correct copy of the
`
`foregoing Petitioners’ Notice of Objections to Evidence, on this 20th day of
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`November, 2017, on the Patent Owner at the 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
`
`
`
`Dated: November 20, 2017
`
`
`
`
`
`
`Respectfully submitted,
`
`/ Steven W. Parmelee /
` Steven W. Parmelee, Lead Counsel
` Reg. No. 31,990
`
`
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`-12-
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