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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________________
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`LUPIN LTD., and LUPIN PHARMACEUTICALS INC.
`Petitioners
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`v.
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`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`Patent Owner
`____________________
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`IPR2015-01099 (US Patent No. 8,669,290)
`____________________
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`PETITIONERS’ MOTION TO SEAL UNDER 37 C.F.R. § 42.54
`AND MOTION TO ENTER DEFAULT PROTECTIVE ORDER
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`TABLE OF CONTENTS
`TABLE OF CONTENTS
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`I. INTRODUCTION ............................................................................................. 2
`I.
`INTRODUCTION .............................................................................................2
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`II. GOOD CAUSE EXISTS FOR SEALING CONFIDENTIAL
`II. GOOD CAUSE EXISTS FOR SEALING CONFIDENTIAL
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`INFORMATION IN EXHIBITS 2109 AND 2082, AND THE PATENT
`INFORMATION IN EXHIBITS 2109 AND 2082, AND THE PATENT
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`OWNER’S RESPONSE .......................................................................................... 3
`OWNER’S RESPONSE ..........................................................................................3
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`III. CERTIFICATION OF NON-PUBLICATION ........................................... 6
`III. CERTIFICATION OF NON-PUBLICATION ...........................................6
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`IV. CERTIFICATION OF CONFERENCE WITH OPPOSING PARTY
`IV. CERTIFICATION OF CONFERENCE WITH OPPOSING PARTY
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`PURSUANT TO 37.C.F.R. § 42.54 ......................................................................... 7
`PURSUANT TO 37.C.F.R. § 42.54 .........................................................................7
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`V. PROPOSED PROTECTIVE ORDER ......................................................... 7
`V.
`PROPOSED PROTECTIVE ORDER .........................................................7
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`VI. CONCLUSION ............................................................................................... 7
`VI. CONCLUSION ...............................................................................................7
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`I.
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`INTRODUCTION
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`In its June 21, 2016, Decision relating to IPR2015-01099, the Patent Trial
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`and Appeal Board (the “Board”) found deficiencies in both the Patent Owner’s
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`Motion to Seal and Stipulated Protective Order. Paper 61. Thus, the Board denied
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`both without prejudice. Id. at 9. In its Decision, the Board ordered that the Patent
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`Owner may file the default protective order or an amended protective order and
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`revised motion to seal addressing the identified deficiencies on or before July 31,
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`2016. Id. at 10. In a related Decision of the same day, the Board denied without
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`prejudice Petitioners’ and Patent Owner’s Joint Motion to Seal. Paper 58. In that
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`Decision, the Board ordered that a party may file a revised or new motion to seal
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`on or before July 31, 2016. Id. at 4.
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`Accordingly, pursuant to 37 C.F.R. §§ 42.14 and 42.54 Lupin Ltd., Lupin
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`Pharmaceuticals Inc., (collectively, “Lupin” and “Petitioners”) respectfully move
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`to seal Exhibit 2109 in its entirety, and portions of Exhibit 2082 and Patent
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`Owner’s Response (Paper No. 24), which were submitted by Senju Pharmaceutical
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`Co., Ltd., Bausch & Lomb, Inc., and Bausch & Lomb Pharma Holdings Corp.
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`(collectively, “Patent Owner”). Exhibit 2109 contains Lupin’s Abbreviated New
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`Drug Application (“ANDA”). Exhibit 2082, which contains Patent Owner’s expert
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`Declaration of Robert O. Williams, III, Ph.D. (the “Williams Declaration”), and
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`Patent Owner’s Response cite to or substantially describe the confidential
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`2
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`information in Exhibit 2109 that Petitioners seek to seal. Petitioners certify that
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`the information identified as confidential in this motion has not been published or
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`otherwise made public.
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`Having noted the deficiencies discussed by the Board in its Decision (Paper
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`61), Petitioners also respectfully request entry of the Default Protective Order.
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`Patent Owner does not oppose this motion.
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`II. GOOD CAUSE EXISTS FOR SEALING CONFIDENTIAL
`INFORMATION IN EXHIBITS 2109 AND 2082, AND THE PATENT
`OWNER’S RESPONSE
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`Under 35 U.S.C. § 316(a)(1), the default rule is that all papers filed in an
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`inter partes review are open and available for access by the public, and a party
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`may file a concurrent motion to seal and the information at issue is sealed pending
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`the outcome of the motion.
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`37 C.F.R. § 42.14 provides:
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`The record of a proceeding, including documents and things,
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`shall be made available to the public, except as otherwise
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`ordered. A party intending a document or thing to be sealed
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`shall file a motion to seal concurrent with the filing of the
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`document or thing to be sealed. The document or thing shall be
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`provisionally sealed on receipt of the motion and remain so
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`pending the outcome of the decision on the motion.
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`The rules promulgated by the USPTO “aim to 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.” Office Trial Practice
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`Guide, 77 Fed. Reg. 48756, 48760 (Aug. 14, 2012). It is, however, only
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`“confidential information” that is protected from disclosure. 35 U.S.C. § 316(a)(7).
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`The moving party has the burden of establishing “good cause” for sealing
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`documents containing confidential information. Garmin Int’l, Inc. v. Cuozzo Speed
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`Techs. LLC, IPR2012-00001, Paper 37 at 4 (PTAB, Apr. 5, 2013); see also 37
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`C.F.R. §§ 42.20(c), 42.54.
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`The Board’s rules identify confidential information in a manner consistent
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`with Federal Rule of Civil Procedure 26(c)(1)(G), which provides for protective
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`orders for trade secret or other confidential research, development, or commercial
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`information. Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,760
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`(Aug. 14, 2012). Accordingly, the Board has recognized that an ANDA contains
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`confidential commercial information that should be protected from public
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`disclosure. See Sandoz, Inc. v. EKR Therapeutics, LLC, IPR2015-00005, paper 21
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`(PTAB, Apr. 24, 2014).
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`The Exhibits that Petitioners move to seal contain confidential and highly
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`sensitive proprietary information. The information the parties seek to seal has not
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`been made public by any party or by the Food and Drug Administration (“FDA”),
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`and is not otherwise available to the public. At issue is Lupin’s ANDA, which was
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`filed confidentially with the FDA in order to obtain FDA approval to market
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`Lupin’s generic pharmaceutical product. The information the parties seek to seal
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`contains Lupin’s highly sensitive, confidential development information and
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`technical, business information. Petitioners’ product has not yet been marketed
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`and remains confidential. If Lupin’s confidential information is made public,
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`Lupin’s competitors could exploit its confidential information and gain an unfair
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`competitive advantage over Lupin. Exhibit 2109 is only an excerpt of the much
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`larger Lupin ANDA and redaction of this excerpt would not be practical; therefore,
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`Petitioners request that Exhibit 2109 be sealed in its entirety.
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`The Williams Declaration (Ex. 2082) describes the confidential information
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`contained in the ANDA in connection with secondary considerations of non-
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`obviousness. Exhibit 2082, ¶201, 234. In particular, the chart at ¶234 shows the
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`generic bromfenac product components described in Exhibit 2109. Accordingly,
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`Petitioners request that these portions of the Williams Declarations be sealed. The
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`redactions to paragraphs 201 and 234 as reflected in the redacted version of the
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`Williams Declaration that was previously filed by Patent Owner and is currently
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`publicly available adequately redacts the confidential information contained in the
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`ANDA.
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`Similarly, page 50 of the Patent Owner’s Response reflects the confidential
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`information contained in the ANDA. Specifically, the third sentence of the
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`paragraph beginning on page 50 of the Patent Owner’s Response discusses
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`Lupin’s ANDA product and cites to paragraph 201 of the Williams Declaration.
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`Accordingly, Petitioner requests that these portions of the Patent Owner’s
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`Response be sealed. The redactions to page 50 as reflected in the redacted version
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`of the Patent Owner’s Response that was previously filed by Patent Owner and is
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`currently publicly available (Paper No. 24) adequately redacts the confidential
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`information contained in the ANDA.
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`Because public disclosure of the contents of these documents, or
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`descriptions of those contents, would disclose confidential business terms in a
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`highly competitive market, Petitioners request that Exhibit 2109 and the portions
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`of the Williams Declaration and Patent Owner’s Response that substantially
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`describe the ANDA exhibits be sealed, as “PROTECTIVE ORDER MATERIAL.”
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`III. CERTIFICATION OF NON-PUBLICATION
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`On behalf of Petitioners, undersigned counsel certifies the information
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`identified in Exhibits 2109 and 2082 and the Patent Owner’s Response, to its
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`knowledge, has not been published or otherwise made public.
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`IV. CERTIFICATION OF CONFERENCE WITH OPPOSING PARTY
`PURSUANT TO 37.C.F.R. § 42.54
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`On July 28, 2016, counsel for Petitioners contacted Patent Owner’s counsel
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`via e-mail regarding Petitioners’ intent to file this Motion to Seal and requested
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`that Patent Owner agree to the terms of the default Protective Order. On July 28,
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`2016, Patent Owner’s counsel agreed via email to the default Protective Order.
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`Moreover, Patent Owner agreed not to oppose this Motion to Seal.
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`V.
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`PROPOSED PROTECTIVE ORDER
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`Petitioners respectfully request entry of the default Protective Order. Upon
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`entry of the default Protective Order, Petitioners designate Exhibit 2109 and
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`redacted portions of Exhibit 2082 and the Patent Owner’s Response as
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`“PROTECTIVE ORDER MATERIAL.” Confidential versions of Exhibits 2082
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`and 2109 and the Patent Owner’s Response were previously filed. Non-
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`confidential versions of Exhibit 2082 and the Patent Owner’s Response that redact
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`the information Petitioners seek to seal were previously filed.1
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`VI. CONCLUSION
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`For the foregoing reasons, Petitioners respectfully request that the Board
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`1 To the extent that Patent Owner seeks to refile any version of Exhibit 2109,
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`Exhibit 2082, or the Patent Owner’s Response, Petitioner has requested that Patent
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`Owner again redact the confidential information as specified in this motion.
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`grant the instant Motion to Seal Exhibits 2109 and 2082 and the Patent Owner’s
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`Respectfully submitted,
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`/Deborah Yellin/
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`Deborah Yellin, Lead Counsel
`Reg. No. 45,904
`CROWELL & MORING LLP
`Intellectual Property Group
`1001 Pennsylvania Avenue, N.W.
`Washington, DC 20004-2595
`Telephone: (202) 624-2947
`Fax: (202) 628-8844
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`Counsel for Petitioners
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`Response.
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`Date: July 29, 2016
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`8
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`CERTIFICATION OF SERVICE
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`Pursuant to 37 C.F.R. §§ 42.6(e), 42.8(b)(4) and 42.105, the undersigned
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`certifies that on the 29th day of July, 2016, a complete copy of the foregoing
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`Petitioners’ Motion to Seal and Motion to Enter Default Protective Order was
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`served on Patent Owner’s counsel of record at the following:
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`Patent Owner
`Bryan.Diner@finnegan.com
`Justin.Hasford@finnegan.com
`Joshua.Goldberg@finnegan.com
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`Respectfully submitted,
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`/Shannon M. Lentz/
`Shannon M. Lentz
`Reg. No. 65,382
`CROWELL & MORING LLP
`Intellectual Property Group
`P.O. Box 14300
`Washington, DC 20044-4300
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`July 29, 2016