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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Paper No. ___
`Filed: January 5, 2018
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`ACRUX DDS PTY LTD., ACRUX LIMITED, and
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioners,
`
`v.
`
`KAKEN PHARMACEUTICAL CO., LTD. and
`VALEANT PHARMACEUTICALS INTERNATIONAL, INC.,
`Patent Owner.
`
`
`
`Case: IPR2017-001901
`U.S. Patent No. 7,214,506
`
`
`
`PATENT OWNER’S MOTION TO SEAL
`PATENT OWNER’S OPPOSITION TO
`PETITIONERS’ MOTION TO EXCLUDE EVIDENCE
`
`
`
`
`
`
`
`
`
`
`1 Case IPR2017-01429 has been joined with the instant proceeding.
`
`
`
`

`

`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
`
`TABLE OF CONTENTS
`
`Introduction and Statement of Relief Requested ............................................. 1
`
`Standard for Granting a Motion to Seal .......................................................... 2
`
`
`
`I.
`
`II.
`
`III. Good Cause Exists to Seal Kaken’s and Valeant’s Confidential
`Information ...................................................................................................... 3
`
`IV. Certifications .................................................................................................... 6
`
`V.
`
`Conclusion ....................................................................................................... 6
`
`
`
`
`
`
`i
`
`

`

`
`
`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Garmin Int’l, Inc. v. Cuozzo Speed Techs. LLC,
`IPR2012-00001, Paper 34 (PTAB Mar. 14, 2013) ............................................... 2
`
`Illumina, Inc. v. The Trustees of Columbia Univ. in the City of New York,
`IPR2012-00006, paper 64 (PTAB 2013) .............................................................. 5
`
`Regulations and Statutes
`
`35 U.S.C. § 316(a)(1) ................................................................................................. 3
`
`35 U.S.C. § 316(a)(7) ................................................................................................. 2
`
`37 C.F.R. § 42.14 ...................................................................................................1, 3
`
`37 C.F.R. § 42.54 ...................................................................................................1, 2
`
`37 C.F.R. § 42.64(c) ...............................................................................................1, 6
`
`Office Patent Trial Practice Guide,
`77 Fed. Reg. 48,756 (Aug. 14, 2012 ..................................................................... 2
`
`
`
`ii
`
`

`

`
`I.
`
`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
`
`Introduction and Statement of Relief Requested
`
`Pursuant to 37 C.F.R. §§ 42.14 and 42.54, Kaken Pharmaceutical Co., Ltd.
`
`and Valeant Pharmaceuticals International, Inc. (collectively “Patent Owner”)
`
`respectfully move to seal portions of “Patent Owner’s Opposition to Petitioners’
`
`Motion to Exclude Evidence Submitted by Patent Owner Under 37 C.F.R. §
`
`42.64(c)” (the “Opposition”), which is filed concurrently herewith.
`
`Good cause to seal portions of the Opposition exists because those portions
`
`include discussions of confidential and proprietary sales and commercial market
`
`information of Kaken and Valeant, which Patent Owner and Petitioners have
`
`previously moved to seal. (Paper No. 25 (addressing Exhibits 2093-2095, 2099,
`
`and 2099); Paper No. 36 (addressing Mr. Thomas’s deposition transcript (Exhibit
`
`1507), Mr. Staines’s Declaration (Exhibit 1511), and Exhibit 1663); Paper No. 50
`
`(addressing Petitioner’s Motion to Exclude); and Paper No. 59 (addressing Mr.
`
`Staines’s deposition transcript (Exhibit 2116A).) Patent Owner maintains that this
`
`information is commercially sensitive, non-public information that only retains its
`
`value when treated in accordance with laws that protect such confidential
`
`information (e.g., trade secret law). Both Kaken and Valeant restrict the use of
`
`their respective confidential information to avoid public disclosure. Accordingly,
`
`Patent Owner files this motion to protect certain confidential information from
`
`1
`
`

`

`
`public disclosure, while allowing the parties access to that information in this
`
`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
`
`proceeding.
`
`II.
`
`Standard for Granting a Motion to Seal
`
`A motion to seal may be granted for good cause. 37 C.F.R. § 42.54. To
`
`determine whether good cause exists, the Board must “strike a balance between the
`
`public’s interest in maintaining a complete and understandable file history and the
`
`parties’ interest in protecting truly sensitive information.” Garmin Int’l, Inc. v.
`
`Cuozzo Speed Techs. LLC, IPR2012-00001, Paper 34, at 2 (PTAB Mar. 14, 2013)
`
`(quoting Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,760 (Aug.
`
`14, 2012)). To that end, only “confidential information” may be sealed. 35 U.S.C.
`
`§ 316(a)(7) (“The Director shall prescribe regulations . . . providing for protective
`
`orders governing the exchange and submission of confidential information”);
`
`Garmin Int’l, IPR2012-00001, Paper 34, at 2. The Office Trial Practice Guide
`
`defines confidential information as follows:
`
`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.
`
`77 Fed. Reg. 48756, 48760 (Aug. 14, 2012).
`
`2
`
`

`

`Under 35 U.S.C. § 316(a)(1), a party may file a document with a concurrent
`
`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
`
`
`
`motion to seal, and the document will be sealed pending the outcome of the
`
`motion. See also 37 C.F.R. § 42.14.
`
`III. Good Cause Exists to Seal Kaken’s and Valeant’s Confidential
`Information
`
`Petitioner’s Motion to Exclude and, consequently, Patent Owner’s
`
`opposition contain information that Kaken and Valeant contend is confidential and
`
`proprietary and only retains its value so long as it remains protected from public
`
`disclosure. Otherwise, disclosure may lead to competitive business harm.
`
`Accordingly, both Kaken and Valeant require certain protections when using their
`
`respective confidential information and, thus in this instance, seek to designate the
`
`information as “PROTECTIVE ORDER MATERIAL” to be filed under seal.
`
`As previously discussed in an earlier motion to seal (Paper No. 25), Exhibits
`
`2093-2095, 2098, and 2099 contain confidential Kaken or Valeant’s proprietary
`
`commercial and financial information that, to Patent Owners’ knowledge, has not
`
`been published or otherwise made public. Exhibit 1663 is a similar type of
`
`document. Specifically, Exhibits 1663, 2093-2095, 2098, and 2099 contain select
`
`sales and prescription data that constitute Kaken’s and Valeant’s confidential
`
`commercial and financial information, derived from confidential material provided
`
`by third party health analytics companies IMS Health and Symphony Health. IMS
`
`3
`
`

`

`
`and Symphony maintain proprietary databases of information regarding various
`
`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
`
`pharmaceuticals, including their U.S. and international prescriptions, units, and
`
`dollar sales, among other performance metrics. Exhibits 1663, 2093-2095, 2098,
`
`and 2099 are selected portions of these databases that constitute Valeant’s and
`
`Kaken’s confidential commercial and financial information.
`
`In the depositions of Mr. Staines and Mr. Thomas, and in the declaration of
`
`Mr. Staines (Exhibits 2116A, 1507, and 1511), there are discussions related to
`
`Exhibits 1663, 2093-2095, 2098, and 2099 and the confidential information
`
`therein. Where used in the Opposition, Patent Owner seeks to have these
`
`discussions sealed.
`
`Finally, Petitioners’ Motion to Exclude seeks to exclude testimony of Mr.
`
`Thomas (Exhibit 2028) and documents that he relied on, namely Exhibits 2093,
`
`2095, 2098, and 2099. In doing so, Petitioners address the confidential
`
`information therein and have sought to seal those portions of their Motion. See
`
`Paper No. 50. In order to respond to Petitioner’s arguments, Patent Owner must
`
`also reference the confidential information.
`
`Because public disclosure of the contents of these documents, or
`
`descriptions of their contents, would disclose Kaken’s and Valeant’s confidential
`
`commercial and financial information, Patent Owners request that portions of the
`
`Opposition filed concurrently herewith which cite or substantially describe
`
`4
`
`

`

`
`Kaken’s or Valeant’s confidential information should be designated
`
`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
`
`“PROTECTIVE ORDER MATERIAL” and sealed for the duration of this
`
`proceeding.
`
`As Petitioners have signed the Standard Acknowledgements for Access to
`
`Protective Order Material provided in the Default Protective Order, all parties to
`
`the proceedings―Patent Owner and Petitioners―are able to rely on the
`
`confidential information, while the motion to seal will protect the confidentiality of
`
`that information.
`
`The Board has granted a motion to seal under similar circumstances. In
`
`Illumina, Inc. v. The Trustees of Columbia Univ. in the City of New York, IPR2012-
`
`00006, paper 64 at 6 (PTAB 2013), the Board granted a Patent Owner’s motion to
`
`seal certain exhibits containing confidential information, such as of Columbia’s
`
`licensee. The Patent Owner and licensee did not want the exhibits entering the
`
`public domain, because they contained the licensee’s confidential information. The
`
`Board stated that “when we consider the apparent content of the exhibits, along
`
`with the parties’ representations and the reasonably limited scope of the protection
`
`sought, we determine that there is good cause to grant the Motion.” Id.
`
`Accordingly, the Board permitted the exhibits to be sealed, shielding the
`
`information from the public, while still making it available to the parties under the
`
`terms of a Protective Order. The same should be done here.
`
`5
`
`

`

`
`IV. Certifications
`Patent Owner certifies that, to the best of Kaken’s and Valeant’s knowledge,
`
`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
`
`none of the confidential information has previously been made publicly available.
`
`Patent Owner also certifies that it conferred in good faith with counsel for
`
`Petitioners, and Petitioners do not oppose this motion. As Petitioners cannot fully
`
`assess the propriety of Patent Owner’s confidentiality designations until after
`
`filing, Petitioners reserve the right to challenge the sealing of any portions that do
`
`not, in fact, contain confidential information.
`
`V. Conclusion
`For these reasons, Patent Owner respectfully requests that the Board grant its
`
`motion to seal portions of “Patent Owner’s Opposition to Petitioners’ Motion to
`
`Exclude Evidence Submitted by Patent Owner Under 37 C.F.R. § 42.64(c)”, which
`
`is filed concurrently herewith.
`
`Dated: January 5, 2018
`
`Respectfully submitted,
`
`
`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
`
`Counsel for Patent Owner in
`IPR2017-00190
`
`
`
`6
`
`

`

`
`
`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the foregoing Patent Owner’s
`
`Motion to Seal Patent Owner’s Opposition to Petitioners’ Motion to Exclude
`
`Evidence was served electronically via email on January 5, 2018, in its entirety on
`
`the following:
`
`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
`
`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
`
`Tyler C. Liu
`Argentum Pharmaceuticals, LLC
`tliu@agpharm.com
`
`
`
`
`
`
`By: /John D. Livingstone/
`John D. Livingstone
`Reg. No. 59,613
`
`
`
`

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