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`Paper No. ____
`Filed: June 26, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________________
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`ICOS CORPORATION,
`Patent Owner.
`
`_____________________________
`
`Case No. IPR2017-00323
`Patent No. 6,943,166
`
`_____________________________
`
`
`PETITIONER MYLAN PHARMACEUTICALS INC.’S
` OBJECTIONS TO EVIDENCE
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`I.
`
`INTRODUCTION ........................................................................................ 1
`
`II.
`
`OBJECTIONS .............................................................................................. 1
`
`i.
`
`ii.
`
`Objections to Ex. 2001, and any Reference to/Reliance
`Thereon ..................................................................................... 1
`
`Objections to Ex. 2002, and any Reference to/Reliance
`Thereon ..................................................................................... 2
`
`iii. Objections to Ex. 2003, and any Reference to/Reliance
`Thereon ..................................................................................... 2
`
`iv. Objections to Ex. 2005, and any Reference to/Reliance
`Thereon ..................................................................................... 3
`
`v.
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`Objections to Ex. 2006, and any Reference to/Reliance
`Thereon ..................................................................................... 3
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`vi. Objections to Ex. 2007, and any Reference to/Reliance
`Thereon ..................................................................................... 4
`
`III. CONCLUSION ............................................................................................ 4
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`
`
`-i-
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`
`
`I.
`
`INTRODUCTION
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Mylan Pharmaceuticals Inc.
`
`(“Petitioner”) submits the following objections to ICOS Corporation’s (“Patent
`
`Owner”) Exhibits 2001-2003 and 2005-2007, as listed on the List of Exhibits filed
`
`by Patent Owner with the Patent Owner’s Preliminary Response (“Preliminary
`
`Response”) on March 13, 2017, and any reference to or reliance on the foregoing
`
`Exhibits in the 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
`
`i. Objections to Ex. 2001, and any Reference to/Reliance Thereon
`
`Grounds for Objection: F.R.E. 602 (Foundation); F.R.E. 801, 802, 803, 805
`
`(Inadmissible Hearsay); F.R.E. 901 (Authenticating Evidence).
`
`Patent Owner describes Ex. 2001 as “Eli Lilly & Co., Heritage” printed from
`
`the website www.lilly.com. Ex. 2001 contains no print date. Neither the Patent
`
`Owner nor the exhibit provides adequate foundation for the document itself or its
`
`authenticity. F.R.E. 602, 901. Further, the document itself appears to be
`
`inadmissible hearsay. F.R.E. 801, 802, 803. To the extent that Patent Owner relies
`
`on any statements in this exhibit for the truth of the matter asserted, such
`
`-1-
`
`
`
`
`
`statements are inadmissible hearsay when relied upon by Patent Owner. F.R.E.
`
`801, 802, 803, 805.
`
`ii. Objections to Ex. 2002, and any Reference to/Reliance Thereon
`
`Grounds for Objection: F.R.E. 602 (Foundation); F.R.E. 801, 802, 803, 805
`
`(Inadmissible Hearsay); F.R.E. 901 (Authenticating Evidence).
`
`Patent Owner describes Ex. 2002 as “Bloomberg: Company Overview of
`
`Mylan Pharmaceuticals, Inc.,” printed from the website Bloomberg.com. Neither
`
`the Patent Owner nor the exhibit provides adequate foundation for the document
`
`itself or its authenticity. F.R.E. 602, 901. Further, the document itself appears to
`
`be inadmissible hearsay. F.R.E. 801, 802, 803. To the extent that Patent Owner
`
`relies on any statements in this exhibit for the truth of the matter asserted, such
`
`statements are inadmissible hearsay. F.R.E. 801, 802, 803, 805.
`
`iii. Objections to Ex. 2003, and any Reference to/Reliance Thereon
`
`Ground Grounds for Objection: F.R.E. 602 (Foundation); F.R.E. 801, 802,
`
`803, 805 (Inadmissible Hearsay); F.R.E. 901 (Authenticating Evidence).
`
`Patent Owner describes Ex. 2003 as a Mylan N.V. Annual Report (Form
`
`10K) dated February 15, 2016, downloaded from “shareholder.com.” Patent
`
`Owner has failed to establish any foundation for “shareholder.com” as an authentic
`
`source of Mylan N.V. SEC filings, and the document is hundreds of pages long,
`
`making a comparison with the authentic document to confirm its authenticity
`
`-2-
`
`
`
`
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`unwieldly and burdensome. F.R.E. 602, 901. To the extent that Patent Owner
`
`relies on any unauthenticated statements in Ex. 2003 for the truth of the matter
`
`asserted, such statements are inadmissible hearsay. F.R.E. 801, 802, 803, 805.
`
`iv. Objections to Ex. 2005, and any Reference to/Reliance Thereon
`
`Grounds for Objection: F.R.E. 602 (Foundation); F.R.E. 801, 802, 803, 805
`
`(Inadmissible Hearsay); F.R.E. 901 (Authenticating Evidence).
`
`Patent Owner describes Ex. 2005 as “FDA’s Review Process for New Drug
`
`Applications: A Management Review, Office of Inspector General, OEI-01-01-
`
`00590 (March 2003).” Neither the Patent Owner nor the exhibit provides adequate
`
`foundation for the document itself, its authenticity, or how it was obtained. F.R.E.
`
`602, 901. Further, Exhibit 2005 appears to contain inadmissible hearsay. F.R.E.
`
`801, 802, 803, 805.
`
`v. Objections to Ex. 2006, and any Reference to/Reliance Thereon
`
`Grounds for Objection: F.R.E. 602 (Foundation); F.R.E. 801, 802, 803, 805
`
`(Inadmissible Hearsay); F.R.E. 901 (Authenticating Evidence).
`
`Patent Owner describes Ex. 2006 as “Manual of Policies and Procedure,
`
`Center for Drug Evaluation and Research, Office of Communications,
`
`Communicating Drug Approval Information, MAPP 4520.1, Rev. 1 (Effective
`
`8/20/14).” Neither the Patent Owner nor the exhibit provides adequate foundation
`
`for the document itself, its authenticity, or how it was obtained. F.R.E. 602, 901.
`
`-3-
`
`
`
`
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`Further, Exhibit 2006 appears to contain inadmissible hearsay. F.R.E. 801, 802,
`
`803, 805.
`
`vi. Objections to Ex. 2007, and any Reference to/Reliance Thereon
`
`Grounds for Objection: F.R.E. 602 (Foundation); F.R.E. 801, 802, 803, 805
`
`(Inadmissible Hearsay); F.R.E. 901 (Authenticating Evidence).
`
`Patent Owner describes Ex. 2007 as “Manual of Policies and Procedure,
`
`Center for Drug Evaluation and Research, Office of Training and
`
`Communications, Communicating Drug Approval Information, MAPP 4520.1,
`
`(3/25/98).” Neither the Patent Owner nor the exhibit provides adequate foundation
`
`for the document itself, its authenticity, or how it was obtained. F.R.E. 602, 901.
`
`Further, Exhibit 2007 appears to contain inadmissible hearsay. F.R.E. 801, 802,
`
`803, 805.
`
`III. CONCLUSION
`
`The aforementioned exhibits were filed together with Patent Owner’s
`
`Preliminary Response, prior to institution. Trial was instituted on June 12, 2017.
`
`These objections are made within 10 business days of institution pursuant to 37
`
`C.F.R. § 42.64.
`
`Dated: June 26, 2017
`
`
`
`
`
`Respectfully submitted,
`
`/ Steven W. Parmelee /
` Steven W. Parmelee
` Reg. No. 31,990
`
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`-4-
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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 Petitioner Mylan Pharmaceuticals Inc.’s Objections to Evidence, on this
`
`26th day of June, 2017, on the Patent Owner at the correspondence address of the
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`Patent Owner as follows:
`
`Mark J. Feldstein
`Joshua L. Goldberg
`Yieyie Yang
`Maureen D. Queler
`FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`Email: mark.feldstein@finnegan.com
`Email: joshua.goldberg@finnegan.com
`Email: yieyie.yang@finnegan.com
`Email: maureen.queler@finnegan.com
`Email : ICOS-IPRs@finnegan.com
`
`Mark J. Stewart
`Dan L. Wood
`Gerald P. Keleher
`Eli Lilly and Company
`Lilly Corporate Center
`Indianapolis, IN 46285
`Email: stewart_mark@lilly.com
`Email: wood_dan_l@lilly.com
`Email: keleher_gerald@lilly.com
`
`
`
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`
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`Dated: June 26, 2017
`
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`
`
`/ Steven W. Parmelee /
`Steven W. Parmelee,
`Reg. No. 31,990
`
`
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`-5-
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