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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`Paper No. ___
`Filed: January 5, 2018
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`ACRUX DDS PTY LTD., ACRUX LIMITED, and
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioners,
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`v.
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`KAKEN PHARMACEUTICAL CO., LTD. and
`VALEANT PHARMACEUTICALS INTERNATIONAL, INC.,
`Patent Owner.
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`Case: IPR2017-001901
`U.S. Patent No. 7,214,506
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`PATENT OWNER’S MOTION TO SEAL
`PATENT OWNER’S OPPOSITION TO
`PETITIONERS’ MOTION TO EXCLUDE EVIDENCE
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`1 Case IPR2017-01429 has been joined with the instant proceeding.
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
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`TABLE OF CONTENTS
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`Introduction and Statement of Relief Requested ............................................. 1
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`Standard for Granting a Motion to Seal .......................................................... 2
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`I.
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`II.
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`III. Good Cause Exists to Seal Kaken’s and Valeant’s Confidential
`Information ...................................................................................................... 3
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`IV. Certifications .................................................................................................... 6
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`V.
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`Conclusion ....................................................................................................... 6
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
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`TABLE OF AUTHORITIES
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` Page(s)
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`Cases
`Garmin Int’l, Inc. v. Cuozzo Speed Techs. LLC,
`IPR2012-00001, Paper 34 (PTAB Mar. 14, 2013) ............................................... 2
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`Illumina, Inc. v. The Trustees of Columbia Univ. in the City of New York,
`IPR2012-00006, paper 64 (PTAB 2013) .............................................................. 5
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`Regulations and Statutes
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`35 U.S.C. § 316(a)(1) ................................................................................................. 3
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`35 U.S.C. § 316(a)(7) ................................................................................................. 2
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`37 C.F.R. § 42.14 ...................................................................................................1, 3
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`37 C.F.R. § 42.54 ...................................................................................................1, 2
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`37 C.F.R. § 42.64(c) ...............................................................................................1, 6
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`Office Patent Trial Practice Guide,
`77 Fed. Reg. 48,756 (Aug. 14, 2012 ..................................................................... 2
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`ii
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`I.
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
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`Introduction and Statement of Relief Requested
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`Pursuant to 37 C.F.R. §§ 42.14 and 42.54, Kaken Pharmaceutical Co., Ltd.
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`and Valeant Pharmaceuticals International, Inc. (collectively “Patent Owner”)
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`respectfully move to seal portions of “Patent Owner’s Opposition to Petitioners’
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`Motion to Exclude Evidence Submitted by Patent Owner Under 37 C.F.R. §
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`42.64(c)” (the “Opposition”), which is filed concurrently herewith.
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`Good cause to seal portions of the Opposition exists because those portions
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`include discussions of confidential and proprietary sales and commercial market
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`information of Kaken and Valeant, which Patent Owner and Petitioners have
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`previously moved to seal. (Paper No. 25 (addressing Exhibits 2093-2095, 2099,
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`and 2099); Paper No. 36 (addressing Mr. Thomas’s deposition transcript (Exhibit
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`1507), Mr. Staines’s Declaration (Exhibit 1511), and Exhibit 1663); Paper No. 50
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`(addressing Petitioner’s Motion to Exclude); and Paper No. 59 (addressing Mr.
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`Staines’s deposition transcript (Exhibit 2116A).) Patent Owner maintains that this
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`information is commercially sensitive, non-public information that only retains its
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`value when treated in accordance with laws that protect such confidential
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`information (e.g., trade secret law). Both Kaken and Valeant restrict the use of
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`their respective confidential information to avoid public disclosure. Accordingly,
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`Patent Owner files this motion to protect certain confidential information from
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`1
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`public disclosure, while allowing the parties access to that information in this
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
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`proceeding.
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`II.
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`Standard for Granting a Motion to Seal
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`A motion to seal may be granted for good cause. 37 C.F.R. § 42.54. To
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`determine whether good cause exists, the Board must “strike a balance between the
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`public’s interest in maintaining a complete and understandable file history and the
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`parties’ interest in protecting truly sensitive information.” Garmin Int’l, Inc. v.
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`Cuozzo Speed Techs. LLC, IPR2012-00001, Paper 34, at 2 (PTAB Mar. 14, 2013)
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`(quoting Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,760 (Aug.
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`14, 2012)). To that end, only “confidential information” may be sealed. 35 U.S.C.
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`§ 316(a)(7) (“The Director shall prescribe regulations . . . providing for protective
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`orders governing the exchange and submission of confidential information”);
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`Garmin Int’l, IPR2012-00001, Paper 34, at 2. The Office Trial Practice Guide
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`defines confidential information as follows:
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`Confidential Information: The rules identify confidential
`information in a manner consistent with Federal Rule of
`Civil Procedure 26(c)(1)(G), which provides for
`protective orders for trade secret or other confidential
`research, development, or commercial information.
`§ 42.54.
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`77 Fed. Reg. 48756, 48760 (Aug. 14, 2012).
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`2
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`Under 35 U.S.C. § 316(a)(1), a party may file a document with a concurrent
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
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`motion to seal, and the document will be sealed pending the outcome of the
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`motion. See also 37 C.F.R. § 42.14.
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`III. Good Cause Exists to Seal Kaken’s and Valeant’s Confidential
`Information
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`Petitioner’s Motion to Exclude and, consequently, Patent Owner’s
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`opposition contain information that Kaken and Valeant contend is confidential and
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`proprietary and only retains its value so long as it remains protected from public
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`disclosure. Otherwise, disclosure may lead to competitive business harm.
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`Accordingly, both Kaken and Valeant require certain protections when using their
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`respective confidential information and, thus in this instance, seek to designate the
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`information as “PROTECTIVE ORDER MATERIAL” to be filed under seal.
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`As previously discussed in an earlier motion to seal (Paper No. 25), Exhibits
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`2093-2095, 2098, and 2099 contain confidential Kaken or Valeant’s proprietary
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`commercial and financial information that, to Patent Owners’ knowledge, has not
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`been published or otherwise made public. Exhibit 1663 is a similar type of
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`document. Specifically, Exhibits 1663, 2093-2095, 2098, and 2099 contain select
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`sales and prescription data that constitute Kaken’s and Valeant’s confidential
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`commercial and financial information, derived from confidential material provided
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`by third party health analytics companies IMS Health and Symphony Health. IMS
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`3
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`and Symphony maintain proprietary databases of information regarding various
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
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`pharmaceuticals, including their U.S. and international prescriptions, units, and
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`dollar sales, among other performance metrics. Exhibits 1663, 2093-2095, 2098,
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`and 2099 are selected portions of these databases that constitute Valeant’s and
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`Kaken’s confidential commercial and financial information.
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`In the depositions of Mr. Staines and Mr. Thomas, and in the declaration of
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`Mr. Staines (Exhibits 2116A, 1507, and 1511), there are discussions related to
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`Exhibits 1663, 2093-2095, 2098, and 2099 and the confidential information
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`therein. Where used in the Opposition, Patent Owner seeks to have these
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`discussions sealed.
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`Finally, Petitioners’ Motion to Exclude seeks to exclude testimony of Mr.
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`Thomas (Exhibit 2028) and documents that he relied on, namely Exhibits 2093,
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`2095, 2098, and 2099. In doing so, Petitioners address the confidential
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`information therein and have sought to seal those portions of their Motion. See
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`Paper No. 50. In order to respond to Petitioner’s arguments, Patent Owner must
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`also reference the confidential information.
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`Because public disclosure of the contents of these documents, or
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`descriptions of their contents, would disclose Kaken’s and Valeant’s confidential
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`commercial and financial information, Patent Owners request that portions of the
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`Opposition filed concurrently herewith which cite or substantially describe
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`4
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`Kaken’s or Valeant’s confidential information should be designated
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
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`“PROTECTIVE ORDER MATERIAL” and sealed for the duration of this
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`proceeding.
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`As Petitioners have signed the Standard Acknowledgements for Access to
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`Protective Order Material provided in the Default Protective Order, all parties to
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`the proceedings―Patent Owner and Petitioners―are able to rely on the
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`confidential information, while the motion to seal will protect the confidentiality of
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`that information.
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`The Board has granted a motion to seal under similar circumstances. In
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`Illumina, Inc. v. The Trustees of Columbia Univ. in the City of New York, IPR2012-
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`00006, paper 64 at 6 (PTAB 2013), the Board granted a Patent Owner’s motion to
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`seal certain exhibits containing confidential information, such as of Columbia’s
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`licensee. The Patent Owner and licensee did not want the exhibits entering the
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`public domain, because they contained the licensee’s confidential information. The
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`Board stated that “when we consider the apparent content of the exhibits, along
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`with the parties’ representations and the reasonably limited scope of the protection
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`sought, we determine that there is good cause to grant the Motion.” Id.
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`Accordingly, the Board permitted the exhibits to be sealed, shielding the
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`information from the public, while still making it available to the parties under the
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`terms of a Protective Order. The same should be done here.
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`5
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`IV. Certifications
`Patent Owner certifies that, to the best of Kaken’s and Valeant’s knowledge,
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
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`none of the confidential information has previously been made publicly available.
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`Patent Owner also certifies that it conferred in good faith with counsel for
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`Petitioners, and Petitioners do not oppose this motion. As Petitioners cannot fully
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`assess the propriety of Patent Owner’s confidentiality designations until after
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`filing, Petitioners reserve the right to challenge the sealing of any portions that do
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`not, in fact, contain confidential information.
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`V. Conclusion
`For these reasons, Patent Owner respectfully requests that the Board grant its
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`motion to seal portions of “Patent Owner’s Opposition to Petitioners’ Motion to
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`Exclude Evidence Submitted by Patent Owner Under 37 C.F.R. § 42.64(c)”, which
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`is filed concurrently herewith.
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`Dated: January 5, 2018
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`Respectfully submitted,
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`By: /John D. Livingstone/
`John D. Livingstone, Reg. No. 59,613
`FINNEGAN, HENDERSON, FARABOW,
` GARRETT & DUNNER, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`(202) 408-4000
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`Counsel for Patent Owner in
`IPR2017-00190
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
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`CERTIFICATE OF SERVICE
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`The undersigned certifies that a copy of the foregoing Patent Owner’s
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`Motion to Seal Patent Owner’s Opposition to Petitioners’ Motion to Exclude
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`Evidence was served electronically via email on January 5, 2018, in its entirety on
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`the following:
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`E. Anthony Figg
`Aydin H. Harston
`Lisa N. Phillips
`Rothwell, Figg, Ernst & Manbeck, P.C.
`607 14th Street, N.W., Suite 800
`Washington, DC 20005
`efigg@rothwellfigg.com
`aharston@rothwellfigg.com
`lphillips@rothwellfigg.com
`litigationparalegals@rothwellfigg.com
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`Teresa Stanek Rea
`Shannon M. Lentz
`Crowell & Moring LLP
`Intellectual Property Group
`1001 Pennsylvania Ave., NW
`Washington, DC 20004-2595
`trea@crowell.com
`slentz@crowell.com
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`Tyler C. Liu
`Argentum Pharmaceuticals, LLC
`tliu@agpharm.com
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`By: /John D. Livingstone/
`John D. Livingstone
`Reg. No. 59,613
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