Paper No. __
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________________
`
`LUPIN LTD., LUPIN PHARMACEUTICALS INC., INNOPHARMA
`LICENSING, INC., INNOPHARMA LICENSING LLC, INNOPHARMA
`INC., INNOPHARMA LLC, MYLAN PHARMACEUTICALS INC., and
`MYLAN INC.
`Petitioners
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`Patent Owner
`____________________
`
`IPR2015-01100 (US Patent No. 8,927,606)1
`____________________
`
`PETITIONERS’ MOTION TO SEAL UNDER 37 C.F.R. § 42.54
`
`
`1 IPR2016-00091 has been joined with IPR2015-01100.
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________________
`
`LUPIN LTD., LUPIN PHARMACEUTICALS INC., INNOPHARMA
`LICENSING, INC., INNOPHARMA LICENSING LLC, INNOPHARMA
`INC., INNOPHARMA LLC, MYLAN PHARMACEUTICALS INC., and
`MYLAN INC.
`Petitioners
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`Patent Owner
`____________________
`
`IPR2015-01100 (US Patent No. 8,927,606)1
`____________________
`
`PETITIONERS’ MOTION TO SEAL UNDER 37 C.F.R. § 42.54
`
`
`1 IPR2016-00091 has been joined with IPR2015-01100.
`
`
`
`
`
`TABLE OF CONTENTS
`TABLE OF CONTENTS
`
`I. INTRODUCTION ............................................................................................. 2
`I.
`INTRODUCTION .............................................................................................2
`
`II. GOOD CAUSE EXISTS FOR SEALING CONFIDENTIAL
`II. GOOD CAUSE EXISTS FOR SEALING CONFIDENTIAL
`
`INFORMATION IN EXHIBITS 2109 AND 2082, AND PATENT OWNER’S
`INFORMATION IN EXHIBITS 2109 AND 2082, AND PATENT OWNER’S
`
`RESPONSE ............................................................................................................... 3
`RESPONSE ...............................................................................................................3
`
`III. CERTIFICATION OF NON-PUBLICATION ........................................... 6
`III. CERTIFICATION OF NON-PUBLICATION ...........................................6
`
`IV. CERTIFICATION OF CONFERENCE WITH OPPOSING PARTY
`IV. CERTIFICATION OF CONFERENCE WITH OPPOSING PARTY
`
`PURSUANT TO 37.C.F.R. § 42.54 ......................................................................... 6
`PURSUANT TO 37.C.F.R. § 42.54 .........................................................................6
`
`V. PROPOSED PROTECTIVE ORDER ......................................................... 6
`V.
`PROPOSED PROTECTIVE ORDER .........................................................6
`
`VI. CONCLUSION ............................................................................................... 7
`VI. CONCLUSION ...............................................................................................7
`
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`i
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`I.
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`INTRODUCTION
`
`In its June 21, 2016, Decision relating to IPR2015-01097, IPR2015-01100,
`
`and IPR2015-01105, the Patent Trial and Appeal Board (the “Board”) found
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`deficiencies in both the Patent Owner’s Motion to Seal and Stipulated Protective
`
`Order. Paper 58. Thus, the Board denied both without prejudice. Id. at 10. In its
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`Decision, the Board ordered that the Patent Owner may file the default protective
`
`order or an amended protective order and revised motion to seal addressing the
`
`identified deficiencies on or before July 31, 2016. Id. In a related Decision of the
`
`same day, the Board denied without prejudice Petitioners’ Motion to Seal. Paper
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`60. In that Decision, the Board ordered that a party may file a revised or new
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`motion to seal 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
`
`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. 25), 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
`
`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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`
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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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`II. GOOD CAUSE EXISTS FOR SEALING CONFIDENTIAL
`INFORMATION IN EXHIBITS 2109 AND 2082, AND PATENT
`OWNER’S RESPONSE
`
`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,
`
`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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`3
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`
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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).
`
`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
`
`Techs. LLC, IPR2012-00001, Paper 37 at 4 (PTAB, Apr. 5, 2013); see also 37
`
`C.F.R. §§ 42.20(c), 42.54.
`
`The Board’s rules identify confidential information in a manner consistent
`
`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
`
`(Aug. 14, 2012). Accordingly, the Board has recognized that an ANDA contains
`
`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
`
`(PTAB, Apr. 24, 2014).
`
`The Exhibits that Petitioners move to seal contain confidential and highly
`
`sensitive proprietary information. The information the parties seek to seal has not
`
`been made public by any party or by the Food and Drug Administration (“FDA”),
`
`and is not otherwise available to the public. At issue is Lupin’s ANDA, which was
`
`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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`4
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`
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`contains Lupin’s highly sensitive, confidential development information and
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`technical, business information. Lupin’s product has not yet been marketed and
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`remains confidential. If Lupin’s confidential information is made public, Lupin’s
`
`competitors could exploit its confidential information and gain an unfair
`
`competitive advantage over Lupin. Exhibit 2109 is an excerpt of the much larger
`
`Lupin ANDA and redaction of this excerpt would not be practical; therefore,
`
`Petitioners request that Exhibit 2109 be sealed in its entirety.
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`The Williams Declaration (Ex. 2082) describes the confidential information
`
`contained in the ANDA in connection with secondary considerations of non-
`
`obviousness. Exhibit 2082, ¶204, 238. In particular, the chart at ¶238 shows the
`
`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 204 and 238 as reflected in the redacted version of the
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`Williams Declaration that was previously filed by Patent Owner and is currently
`
`publicly available adequately redacts the confidential information contained in the
`
`ANDA.
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`
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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 first sentence on page 50 of
`
`the Patent Owner’s Response discusses the Lupin’s ANDA product and cites to
`
`paragraph 204 of the Williams Declaration. Accordingly, Petitioners request that
`
`5
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`
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`these portions of the Patent Owner’s Response be sealed. The redactions to page
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`50 as reflected in the redacted version of the Patent Owner’s Response that was
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`previously filed by Patent Owner and is currently publicly available (Paper No. 25)
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`adequately redacts the confidential information contained in the ANDA.
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`Because public disclosure of the contents of these documents, or
`
`descriptions of those contents, would disclose confidential business terms in a
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`highly competitive market, even to co-Petitioner InnoPharma, Petitioners request
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`that Exhibit 2109 and the portions of the Williams Declaration and Patent Owner’s
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`Response that substantially describe the ANDA exhibits be sealed, as
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`“PROTECTIVE ORDER MATERIAL - BOARD’S EYES ONLY.”
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`III. CERTIFICATION OF NON-PUBLICATION
`
`
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`On behalf of Petitioners, undersigned counsel certifies the information
`
`identified in Exhibits 2109 and 2082 and the Patent Owner’s Response, to its
`
`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
`
`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. On July 28,
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`2016, Patent Owner’s counsel agreed not to oppose this Motion to Seal.
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`V.
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`
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`PROPOSED PROTECTIVE ORDER
`
`Petitioners respectfully request entry of the Amended Proposed Stipulated
`
`6
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`
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`
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`Protective Order, filed on July 18, 2016 (Paper No. 64). Upon entry of the
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`Amended Stipulated Protective Order, Petitioners designate Exhibit 2109 and
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`redacted portions of 2082 and the Patent Owner Response as “PROTECTIVE
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`ORDER MATERIAL - BOARD’S EYES ONLY.” Confidential versions of
`
`Exhibit 2082 and 2109 and the Patent Owner’s Response were previously filed.
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`Non-confidential versions of Exhibit 2082 and the Patent Owner’s Response that
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`redact the information Petitioners seek to seal were previously filed.2
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`VI. CONCLUSION
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`
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`For the foregoing reasons, Petitioners respectfully request that the Board
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`grant the instant Motion to Seal Exhibits 2109 and 2082 and the Patent Owner’s
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`Response.
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`
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`2 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
`
`Owner again redact the confidential information as specified in this motion.
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`7
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`Date: July 29, 2016
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`Respectfully submitted,
`
`/Deborah Yellin/
`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
`Counsel for Petitioners
`
`
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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 was served on Patent Owner’s counsel of record and
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`counsel of record for Petitioners InnoPharma at the following:
`
`Patent Owner
`Bryan.Diner@finnegan.com
`Justin.Hasford@finnegan.com
`Joshua.Goldberg@finnegan.com
`
`Petitioners InnoPharma
`jitty.malik@alston.com;
`bryan.skelton@alston.com;
`lance.soderstrom@alston.com;
`james.abe@alston.com; and
`Joe.janusz@alston.com
`
`Respectfully submitted,
`
`
`
`/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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`9
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`July 29, 2016
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