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`Paper No. ___
`Filed: March 30, 2018
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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
`NOVARTIS’S MARCH 23, 2018 SUBMISSIONS
`
`
`
`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.
`and any Reference to/Reliance Thereon .................................... 1
`2.
`Thereon ..................................................................................... 1
`3.
`Thereon ..................................................................................... 2
`4.
`Thereon ..................................................................................... 3
`5.
`Thereon ..................................................................................... 4
`6.
`Thereon ..................................................................................... 4
`7.
`Thereon ..................................................................................... 5
`III. CONCLUSION ............................................................................................ 6
`
`Objections to EX2095-EX2099 and EX2101-EX2106,
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`Objections to EX2095, and any Reference to/Reliance
`
`Objections to EX2096, and any Reference to/Reliance
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`Objections to EX2097 and any Reference to/Reliance
`
`Objections to EX2098 and any Reference to/Reliance
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`Objections to EX2103 and any Reference to/Reliance
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`Objections to EX2104 and any Reference to/Reliance
`
`
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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 2095, 2096, 2097, 2098, 2099, 2101, 2102, 2103, 2104, 2105,
`
`and 2106, as listed on Patent Owner’s Updated Exhibit List filed on March 23,
`
`2018, and any reference to or reliance on the foregoing Exhibits in Patent Owner’s
`
`Sur-Reply, Reply In Support of Contingent Motion to Amend, 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 EX2095-EX2099 and EX2101-EX2106, 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). Petitioners object to Exhibits 2095-2099 and
`
`2101-2106 as improper sur-reply or reply evidence that should have been
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`submitted in November 2017 with Patent Owner’s Response.
`
`2. Objections to EX2095, 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,
`
`
`-1-
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`Case IPR2017-00854
`Patent 9,187,405
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`Duplication, or Other Reasons); F.R.E. 701, 702, 703 (Expert Foundation and
`
`Opinions); F.R.E. 802, 803, 805 (Inadmissible Hearsay); 37 C.F.R. § 42.65.
`
`EX2095 is duplicative of expert testimony offered previously by this witness
`
`and by Patent Owner’s other witnesses, and offers testimony that is irrelevant,
`
`misleading, and a waste of time. F.R.E. 401-403. Petitioners object to Dr. Jusko’s
`
`speculative reliance on documents or information not published before June 2006,
`
`including in paragraphs 31-40. F.R.E. 401-403, 802-805, including in paragraphs
`
`11-12, 14-15, 23, 31, and 32, and including EX2103 and EX2104. F.R.E. 401-403,
`
`802-805. Petitioners object to Dr. Jusko’s testimony based on his analysis in
`
`paragraphs 11-12 under F.R.E. 701-703 and 37 C.F.R. § 42.65. Petitioners object
`
`to EX2095 for relying on hearsay statements for truth of the matters asserted.
`
`F.R.E. 802-805.
`
`3. Objections to EX2096, 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); 37 C.F.R. § 42.65.
`
`EX2096 is duplicative of expert testimony offered previously by this witness
`
`and by Patent Owner’s other witnesses, and offers testimony that is irrelevant,
`
`misleading, and a waste of time. F.R.E. 401-403. Petitioners object to Dr.
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`Case IPR2017-00854
`Patent 9,187,405
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`Steinman’s speculative discussion of documents or information not published
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`before June 2006, including in paragraphs 31-40. F.R.E. 401-403, 802-805.
`
`Petitioners object to Dr. Steinman’s testimony as outside his expertise, including
`
`paragraphs 9-24 and 31-40, and for failure to apply reliable methodology and
`
`disclose the data purportedly underlying his interpretation of the Webb reference.
`
`F.R.E. 701-703 and 37 C.F.R. § 42.65. Petitioners object to EX2096 for relying on
`
`hearsay statements for truth of the matters asserted. F.R.E. 802-805.
`
`4. Objections to EX2097 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,
`
`Duplication, or Other Reasons); F.R.E. 701, 702, 703 (Expert Foundation and
`
`Opinions); F.R.E. 802, 803, 805 (Inadmissible Hearsay); 37 C.F.R. § 42.65.
`
`EX2097 is duplicative of expert testimony offered previously by this witness
`
`and by Patent Owner’s other witnesses, and offers testimony that is irrelevant,
`
`misleading, and a waste of time. F.R.E. 401-403. Petitioners object to Dr. Lublin’s
`
`speculative discussion of documents or information not published before June
`
`2006, including in paragraphs 2, 6, 10, 16, 18, and 20. F.R.E. 401-403, 802-805.
`
`Petitioners object to Dr. Lublin’s testimony as lacking adequate foundation and the
`
`requisite reliability for expert opinion. F.R.E. 701-703 and 37 C.F.R. § 42.65.
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`-3-
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`Case IPR2017-00854
`Patent 9,187,405
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`Petitioners object to EX2097 for relying on hearsay statements for truth of the
`
`matters asserted. F.R.E. 802-805.
`
`5. Objections to EX2098 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); 37 C.F.R. § 42.65.
`
`EX2098 is duplicative of expert testimony offered previously by Patent
`
`Owner’s other witnesses, and offers testimony that is irrelevant, misleading, and a
`
`waste of time. F.R.E. 401-403. Petitioners object to Dr. Chun’s speculative
`
`discussion of documents or information not published before June 2006, including
`
`at paragraphs 6-8 and 26-43, as lacking adequate foundation and the requisite
`
`reliability for expert opinion, and for failing to disclose the granular data
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`purportedly underlying his testimony. F.R.E. 701-703 and 37 C.F.R. § 42.65.
`
`Petitioners object to EX2098 for relying on hearsay statements for truth of the
`
`matters asserted. F.R.E. 802-805.
`
`6. Objections to EX2103 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).
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`-4-
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`Case IPR2017-00854
`Patent 9,187,405
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`Patent Owner describes EX2103 as “Rowland M, Benet LZ. Lead PK
`
`commentary: predicting human pharmacokinetics. J Pharm Sci. 2011 Oct;
`
`100(10):4047-9.”
`
`EX2103 is irrelevant to whether the claimed subject matter was obvious at
`
`the earliest alleged time of the invention because it was published long after the
`
`filing date of the priority document for the ’405 patent. F.R.E. 401, 402. Further,
`
`even if relevant, this exhibit 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, Patent Owner fails to provide foundation or authentication for
`
`EX2103. F.R.E. 602, 901. Despite deposing in this proceeding a purported author
`
`of EX2103, Patent Owner never asked Dr. Benet a single question about EX2103.
`
`7. Objections to EX2104 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 EX2104 as “Anthropometric Reference Data for
`
`Children and Adults, United States, 2003–2006. National Health Statistics Reports,
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`10:1-44, October 22, 2008.”
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`-5-
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`Case IPR2017-00854
`Patent 9,187,405
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`EX2104 is irrelevant to whether the claimed subject matter was obvious at
`
`the earliest alleged time of the invention because it was published long after the
`
`filing date of the priority document for the ’405 patent. F.R.E. 401, 402. Further,
`
`even if relevant, this exhibit 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, Patent Owner fails to provide foundation or authentication for
`
`EX2104. F.R.E. 602, 901.
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`III. CONCLUSION
`
`The aforementioned exhibits were filed together with Patent Owner’s
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`Response on March 23, 2018. These objections are made within 5 business days
`
`pursuant to 37 C.F.R. § 42.64.
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`
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`Dated: March 30, 2018
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`Respectfully submitted,
`
`/ Steven W. Parmelee /
` Steven W. Parmelee
` Reg. No. 31,990
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`-6-
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`Case IPR2017-00854
`Patent 9,187,405
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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 Novartis’s March 23, 2018
`
`Submissions, on this 30th day of March, 2018, 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
`
`
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`Dated: March 30, 2018
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`
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`
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`Respectfully submitted,
`
`/ Steven W. Parmelee /
` Steven W. Parmelee, Lead Counsel
` Reg. No. 31,990
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`-7-
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