UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Filed: March 22, 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’ EXHIBITS
`
`
`
`
`
`Filed: March 22, 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’ EXHIBITS
`
`
`
`
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Petitioner Mylan Pharmaceuticals Inc.
`
`(“Petitioner”) objects to the admissibility of the following exhibits filed by Patent
`
`Owners Pozen Inc. and Horizon Pharma USA, Inc. (“Patent Owners”) in the Patent
`
`Owners’ Preliminary Response 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 ten business days of the institution of trial in this
`
`matter, on March 8, 2018. (Paper No. 18.) Petitioner’s objections provide notice to
`
`Patent Owners that Petitioner may move to exclude these exhibits 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.
`
`Exhibit descriptions provided in this table are taken from Patent Owners’
`
`exhibit list and are used for identification purposes only. The use of the description
`
`does not indicate that Petitioner agrees with the descriptions or characterizations of
`
`the documents.
`
`- 1 -
`
`
`
`Exhibit
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`Description
`Gabriel, S.E., et al., “Risk for Serious
`Gastrointestinal Complications Related to Use of
`Nonsteroidal Anti-inflammatory Drugs,” Annals
`of Internal Medicine, Vol. 115, No. 10, pp. 787-
`796 (1991) (“Gabriel”)
`Cryer, B. and Feldman, M., “Effects of
`Nonsteroidal Anti-inflammatory Drugs on
`Endogenous Gastrointestinal Prostaglandins and
`Therapeutic Strategies for Prevention and
`Treatment of Nonsteroidal Anti-inflammatory
`Drug-Induced Damage,” Archives of Internal
`Medicine, Vol. 152, pp. 1145-1155 (1992)
`(“Cryer”)
`Fries, J.F., et al., “Nonsteroidal Anti-
`Inflammatory Drug-Associated Gastropathy:
`Incidence and Risk Factor Models,” The
`American Journal of Medicine, Vol. 91, pp. 213-
`222 (1991) (“Fries”)
`Second Amended Complaint for Patent
`Infringement, Horizon Pharma, Inc. v. Mylan
`Pharmaceuticals Inc., Civil Action No. 2:15-cv-
`03327 (D.N.J. Feb. 10, 2016)
`Answer to Second Amended Complaint, Separate
`Defenses, And Counterclaims by Defendants
`Mylan Pharmaceuticals Inc., Mylan Laboratories
`Limited and Mylan Inc., Horizon Pharma, Inc. v.
`Mylan Pharmaceuticals Inc., Civil Action No.
`2:15-cv-03327 (D.N.J. Feb. 19, 2016)
`Plaintiffs’ Answer to Defendants’ Counterclaims
`to Second Amended Complaint, Horizon
`Pharma, Inc. v. Mylan Pharmaceuticals Inc.,
`Civil Action No. 2:15-cv-03327 (D.N.J. Mar. 7,
`2016)
`157 Cong. Rec. S5429 (daily ed. Sept. 8, 2011)
`(statement of Sen. Kyl)
`
`Objection
`A, B, N, O
`
`A, B, N, O
`
`A, B, N, O
`
`A, B, N, O
`
`B, N, O
`
`A, B, N, O
`
`A, B, N, O
`
`Petitioner objects to paragraphs in the Patent Owners’ Preliminary Response
`
`that rely on exhibits objected to in this Petitioner’s Objection to Evidence.
`
`- 2 -
`
`
`
`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)
`
`- 3 -
`
`
`
`R:
`S:
`
`T:
`U:
`
`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)
`
`March 22, 2018
`
`
`
`
`
`Respectfully submitted,
`
`/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.
`
`- 4 -
`
`
`
`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’ EXHIBITS 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 22, 2018
`
`/Brandon M. White/
`Brandon M. White
`Reg. No. 52,354
`
`
`
`
`
`Counsel for Petitioner Mylan Pharmaceuticals Inc.
`
`
`
`
`
`
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