UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Filed: March 29, 2018
`
`
`____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________
`
`MYLAN PHARMACEUTICALS INC.
`
`Petitioner
`
`v.
`
`POZEN INC. and HORIZON PHARMA USA, INC.
`
`Patent Owners
`____________________________
`
`Case No. IPR2017-01995
`U.S. Patent No. 9,220,698
`____________________________
`
`PETITIONER’S OBJECTIONS TO PATENT OWNERS’ EXHIBIT
`
`
`
`
`
`Filed: March 29, 2018
`
`
`____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________
`
`MYLAN PHARMACEUTICALS INC.
`
`Petitioner
`
`v.
`
`POZEN INC. and HORIZON PHARMA USA, INC.
`
`Patent Owners
`____________________________
`
`Case No. IPR2017-01995
`U.S. Patent No. 9,220,698
`____________________________
`
`PETITIONER’S OBJECTIONS TO PATENT OWNERS’ EXHIBIT
`
`
`
`
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Petitioner Mylan Pharmaceuticals Inc.
`
`(“Petitioner”) objects to the admissibility of the following exhibit filed by Patent
`
`Owners Pozen Inc. and Horizon Pharma USA, Inc. (“Patent Owners”) in support of
`
`Patent Owners’ Request for Rehearing in the above-captioned inter partes review.
`
`Petitioner’s objections are timely under 37 C.F.R. § 42.64(b)(1) because they
`
`are being filed and served within five business days of the service of the evidence,
`
`on March 22, 2018. (Ex. 2010.) Petitioner’s objections provide notice to Patent
`
`Owners that Petitioner may move to exclude the exhibit under 37 C.F.R. § 42.64(c).
`
`In this paper, a reference to “FRE” means the Federal Rules of Evidence, a
`
`reference to “CFR” means the Code of Federal Regulations, and “’698 patent”
`
`means U.S. Patent No. 9,220,698. All objections under FRE 801-803 (hearsay)
`
`apply to the extent Patent Owners rely on the exhibits identified in connection with
`
`that objection for the truth of the matter asserted therein.
`
`The exhibit description below is from Patent Owners’ exhibit list and is used
`
`for identification purposes only. Use of the description does not indicate Petitioner’s
`
`agreement with the description or characterization of the document.
`
`Exhibit
`2010
`
`Description
`Email string from Mylan’s counsel, Robert D.
`Swanson from February 6, 2017 to February 15,
`2017
`
`Objection
`A, B, C, E, N,
`O, R, V
`
`Petitioner objects to paragraphs in the Patent Owners’ Rehearing Request that
`
`rely on the exhibit objected to in this Petitioner’s Objection to Evidence.
`
`- 1 -
`
`
`
`Objection Key:
`
`A:
`B:
`C:
`
`D:
`
`E:
`
`F:
`
`G:
`
`H:
`
`I:
`
`J:
`
`K:
`L:
`M:
`N:
`
`O:
`
`P:
`Q:
`
`FRE 801/802/803 (hearsay)
`FRE 901/902 (lacking authentication)
`FRE 402 (relevance) the document is not relevant to any issue in this IPR
`proceeding because the purported date of the document is after the filing
`date of the ’698 patent or the prior art status is not clear
`FRE 402 (relevance) to the extent the document is relied upon for secondary
`considerations of nonobviousness, there is no nexus to the claimed
`compositions and methods
`FRE 403 (confusing, waste of time) the document is not relevant to any
`issue in this IPR proceeding because the purported date of the document is
`after the filing date of the ’698 patent or the prior art status is not clear
`FRE 403 (confusing, waste of time) to the extent the document is relied
`upon for secondary considerations of nonobviousness, there is no nexus to
`the claimed compositions and methods
`FRE 702 (improper expert testimony) expert testimony that relies on the
`document is not based on sufficient facts or data and/or is not the product of
`reliable principles and methods
`FRE 703 (bases of expert opinion) expert testimony that relies on the
`document is unreliable because the document is not of a type reasonably
`relied upon by experts in the field
`FRE 106 (completeness) the document is incomplete and includes only a
`select portion of a larger document that in fairness should be considered
`along with this document
`FRE 701, 702 (improper expert testimony) improper expert testimony by a
`lay witness
`FRE 1001-1003 (best evidence)
`FRE 403, 901 (improper compilation)
`FRE 403 (cumulative)
`FRE 402 (relevance) the document is not relevant to any issue in the IPR
`proceeding
`FRE 403 (confusing, waste of time) the document is not relevant to any
`issue in the IPR proceeding
`No exhibit filed.
`Expert testimony fails to identify with particularity the underlying facts or
`data on which the opinion is based, violating 37 C.F.R. § 42.65(a)
`
`- 2 -
`
`
`
`R:
`S:
`
`T:
`U:
`
`V:
`
`FRE 602 (lack of personal knowledge)
`FRE 702/703 to the extent that the expert declarant relies on an exhibit
`objected to under grounds G and H, the testimony is (i) not based on
`sufficient facts or data and/or is not the product of reliable principles and
`methods and/or is (ii) is unreliable because the exhibit is not of a type
`reasonably relied upon by experts in the field
`FRE 1006 (improper summary)
`37 C.F.R. § 42.65 (fails to provide underlying facts or data on which opinion
`is based)
`Exhibit is improper new evidence untimely filed with a request for
`rehearing, in violation of 37 C.F.R. § 42.71
`Respectfully submitted,
`
`March 29, 2018
`
`
`
`
`
`/Brandon M. White/
`Brandon M. White, Esq.
`Reg. No. 52,354
`Perkins Coie LLP
`700 Thirteenth Street, N.W.
`Suite 600
`Washington, DC 20005-3960
`bmwhite@perkinscoie.com
`Tel: 202-654-6206
`Fax: 202-654-9681
`
`Counsel for Petitioner
`Mylan Pharmaceuticals Inc.
`
`- 3 -
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), I certify that I caused to be served a true and
`
`correct copy of the foregoing: PETITIONER’S OBJECTIONS TO PATENT
`
`OWNERS’ EXHIBIT by email to the electronic service addresses for Patent Owner:
`
`Thomas A. Blinka
`Jonathan G. Graves
`Susan Krumplitsch
`Cooley LLP
`zIPR2017-01995@cooley.com
`
`Margaret J. Sampson
`Stephen M. Hash
`Jeffrey S. Gritton
`Baker Botts LLP
`pozen-vimovoBB@bakerbotts.com
`
`Dated: March 29, 2018
`
`/Brandon M. White/
`Brandon M. White
`Reg. No. 52,354
`
`
`
`
`
`Counsel for Petitioner Mylan Pharmaceuticals Inc.
`
`
`
`
`
`
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