Paper No. __
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`INNOPHARMA LICENSING, INC., INNOPHARMA LICENSING LLC,
`INNOPHARMA INC., INNOPHARMA LLC,
`MYLAN PHARMACEUTICALS INC., MYLAN INC., LUPIN LTD., and LUPIN
`PHARMACEUTICALS, INC.
`Petitioner,
`v.
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`Patent Owner.
`
`Case IPR2015-00903 (Patent 8,129,431 B2)1
`
`Filed: July 29, 2016
`
`PETITIONER’S MOTION TO SEAL UNDER 37 C.F.R. § 42.54
`
`1 IPR2015-01871 has been joined with IPR2015-00903.
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`INNOPHARMA LICENSING, INC., INNOPHARMA LICENSING LLC,
`INNOPHARMA INC., INNOPHARMA LLC,
`MYLAN PHARMACEUTICALS INC., MYLAN INC., LUPIN LTD., and LUPIN
`PHARMACEUTICALS, INC.
`Petitioner,
`v.
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`Patent Owner.
`
`Case IPR2015-00903 (Patent 8,129,431 B2)1
`
`Filed: July 29, 2016
`
`PETITIONER’S MOTION TO SEAL UNDER 37 C.F.R. § 42.54
`
`1 IPR2015-01871 has been joined with IPR2015-00903.
`
`
`
`TABLE OF CONTENTS
`INTRODUCTION...............................................................................1
`
`INTRODUCTION ............................................................................. ..1
`
`TABLE OF CONTENTS
`
`I.
`
`I.
`
`II.
`
`GOOD CAUSE EXISTS FOR SEALING CONFIDENTIAL
`
`GOOD CAUSE EXISTS FOR SEALING CONFIDENTIAL
`II.
`INFORMATION IN EXHIBITS 2109 AND 2082 AND PATENT OWNER’S
`RESPONSE...............................................................................................................2
`
`INFORMATION IN EXHIBITS 2109 AND 2082 AND PATENT OWNER’S
`
`RESPONSE ............................................................................................................. ..2
`
`III.
`
`III.
`
`CERTIFICATION OF NON-PUBLICATION................................5
`
`CERTIFICATION OF NON-PUBLICATION .............................. ..5
`
`IV.
`
`CERTIFICATION OF CONFERENCE WITH OPPOSING
`IV.
`PARTY PURSUANT TO 37.C.F.R. § 42.54..........................................................6
`PARTY PURSUANT TO 37.C.F.R. § 42.54 ........................................................ ..6
`
`CERTIFICATION OF CONFERENCE WITH OPPOSING
`
`V.
`
`V.
`
`VI.
`
`VI.
`
`PROPOSED PROTECTIVE ORDER..............................................6
`
`PROPOSED PROTECTIVE ORDER ............................................ ..6
`
`CONCLUSION....................................................................................6
`
`CONCLUSION .................................................................................. ..6
`
`i
`
`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`CASES
`Garmin Int’l, Inc. v. Cuozzo Speed Techs. LLC,
`IPR2012-00001, Paper No. 37 (PTAB, Apr. 5, 2013) ......................................... 3
`Sandoz, Inc. v. EKR Therapeutics, LLC,
`IPR2015-00005, Paper No. 21 (PTAB, Apr. 24, 2014) ....................................... 3
`STATUTES
`35 U.S.C. § 316(a)(1)................................................................................................. 2
`35 U.S.C. § 316(a)(7)................................................................................................. 3
`OTHER AUTHORITIES
`37 C.F.R. § 42.14 ...................................................................................................1, 2
`37 C.F.R. § 42.20(c)...................................................................................................3
`37 C.F.R. § 42.54 ...............................................................................................1, 3, 5
`Federal Rules of Civil Procedure 26(c)(1)(G) ...........................................................3
`Office Trial Practice Guide, 77 Fed. Reg. 48756, 48760 (Aug. 14, 2012)................3
`
`ii
`
`
`
`I.
`
`INTRODUCTION
`In its June 21, 2016, Decision relating to both Case IPR2015-00902 and
`
`Case IPR2015-00903, the Patent Trial and Appeal Board (the “Board”) found
`
`deficiencies in both the Patent Owner’s Motion to Seal and Stipulated Protective
`
`Order. Paper 77. Thus, the Board denied both without prejudice. Id. at 8. In its
`
`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. at 8-9. In a related Decision
`
`of the same day, in Case IPR2015-00903, the Board denied without prejudice
`
`Petitioner’s Motion to Seal. Paper 80. In that Decision, the Board ordered that a
`
`party may file a revised or new motion to seal on or before July 31, 2016. Id. at 4.
`
`Accordingly, pursuant to 37 C.F.R. §§ 42.14 and 42.54 InnoPharma
`
`Licensing, Inc., InnoPharma Licensing LLC, InnoPharma Inc., InnoPharma LLC
`
`(collectively, “InnoPharma”), Mylan Pharmaceuticals Inc., and Mylan Inc.
`
`(collectively, “Mylan”) (InnoPharma and Mylan collectively, “Petitioner”)
`
`respectfully move to seal Exhibit 2109 in its entirely, and portions of Exhibit 2082
`
`and Patent Owner’s Response (Paper No. 32), which were submitted by Senju
`
`Pharmaceutical Co., Ltd., Bausch & Lomb, Inc., and Bausch & Lomb Pharma
`
`Holdings Corp. (collectively, “Patent Owner”). Exhibit 2109 contains
`
`InnoPharma’s Abbreviated New Drug Application (“ANDA”). Exhibit 2082,
`
`1
`
`
`
`which contains Patent Owner’s expert Declaration of Robert O. Williams, III,
`
`Ph.D. (the “Williams Declaration”), and Patent Owner’s Response cite to or
`
`substantially describe the confidential information in Ex. 2109 that Petitioner seeks
`
`to seal. Petitioner certifies that the information identified as confidential in this
`
`motion has not been published or otherwise made public.
`
`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
`
`inter partes review are open and available for access by the public, and a party
`
`may file a concurrent motion to seal and the information at issue is sealed pending
`
`the outcome of the motion.
`
`37 C.F.R. § 42.14 provides:
`
`The record of a proceeding, including documents and things,
`
`shall be made available to the public, except as otherwise
`
`ordered. A party intending a document or thing to be sealed shall
`
`file a motion to seal concurrent with the filing of the document
`
`or thing to be sealed.
`
`The document or thing shall be
`
`provisionally sealed on receipt of the motion and remain so
`
`pending the outcome of the decision on the motion.
`
`2
`
`
`
`The rules promulgated by the USPTO “aim to 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.” Office Trial Practice
`
`Guide, 77 Fed. Reg. 48756, 48760 (Aug. 14, 2012). It is, however, only
`
`“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
`
`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
`
`orders for trade secret or other confidential research, development, or commercial
`
`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
`
`disclosure. See Sandoz, Inc. v. EKR Therapeutics, LLC, IPR2015-00005, paper 21
`
`(PTAB, Apr. 24, 2014).
`
`The Exhibits that Petitioner moves 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”),
`
`3
`
`
`
`and is not otherwise available to the public. At issue is InnoPharma’s ANDA,
`
`which was filed confidentially with the FDA in order to obtain FDA approval to
`
`market InnoPharma’s generic pharmaceutical product. The information the parties
`
`seek to seal contains InnoPharma’s highly sensitive, confidential development
`
`information and technical, business information. Petitioner InnoPharma’s product
`
`has not yet been marketed and remains confidential. If InnoPharma’s confidential
`
`information is made public, InnoPharma’s competitors could exploit its
`
`confidential information and gain an unfair competitive advantage over
`
`InnoPharma. Exhibit 2109 is only an excerpt of the much larger InnoPharma
`
`ANDA and redaction of this excerpt would not be practical; therefore, petitioner
`
`requests that Exhibit 2109 be sealed in its entirety.
`
`The Williams Declaration (Ex. 2082) describes the confidential information
`
`contained in the ANDA in connection with secondary considerations of non-
`
`obviousness. Exhibit 2082, ¶181, 187. In particular, the chart at ¶187 shows the
`
`generic bromfenac product components described in Exhibit 2109. Accordingly,
`
`Petitioner requests that these portions of the Williams Declaration be sealed. The
`
`redactions to paragraph 181, 187 as reflected in the redacted version of the
`
`Williams Declaration that was previously filed by Patent Owner and is currently
`
`publicly available adequately redacts the confidential information contained in the
`
`ANDA.
`
`4
`
`
`
`Similarly, page 59 of the Patent Owner’s Response reflects the confidential
`
`information contained in the ANDA. Specifically, the third sentence of the first
`
`full paragraph of page 59 of the Patent Owner’s Response discusses the
`
`InnoPharma’s ANDA product and cites to paragraph 181 of the Williams
`
`Declaration. Accordingly, Petitioner requests that these portions of the Patent
`
`Owner’s Response be sealed. The redactions to page 59 as reflected in the
`
`redacted version of the Patent Owner’s Response that was previously filed by
`
`Patent Owner and is currently publicly available (Paper No. 32) adequately redacts
`
`the confidential information contained in the ANDA.
`
`Because public disclosure of the contents of these documents, or
`
`descriptions of those contents, would disclose confidential business terms in a
`
`highly competitive market, even to co-Petitioner Lupin, Petitioner requests that
`
`Exhibit 2109 and the portions of the Williams Declaration and Patent Owner’s
`
`Response that substantially describe the ANDA exhibits be sealed, as
`
`“PROTECTIVE ORDER MATERIAL - BOARD’S EYES ONLY.”
`
`III. CERTIFICATION OF NON-PUBLICATION
`On behalf of Petitioner, 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.
`
`5
`
`
`
`IV. CERTIFICATION OF CONFERENCE WITH OPPOSING PARTY
`PURSUANT TO 37.C.F.R. § 42.54
`On July 28, 2016, counsel for Petitioner contacted Patent Owner’s counsel
`
`via e-mail regarding Petitioner’s intent to file this Motion to Seal. On July 28,
`
`2016, Patent Owner’s counsel agreed not to oppose this Motion to Seal.
`
`V.
`
`PROPOSED PROTECTIVE ORDER
`Petitioner respectfully requests entry of the Amended Proposed Stipulated
`
`Protective Order, filed on July 25, 2016 (Paper No. 81). Upon entry of the
`
`Amended Stipulated Protective Order, Petitioner designates Exhibit 2109 and
`
`redacted portions of Exhibit 2082 and the Patent Owner’s Response as
`
`“PROTECTIVE ORDER MATERIAL - BOARD’S EYES ONLY.” Confidential
`
`versions of Exhibits 2082 and 2109 and the Patent Owner’s Response were
`
`previously filed. Non-confidential versions of Exhibit 2082 and the Patent
`
`Owner’s Response that redact the information Petitioner seeks to seal were
`
`previously filed.2
`
`VI. CONCLUSION
`For the foregoing reasons, Petitioner respectfully requests that the Board
`
`2To the extent that Patent Owner seeks to refile any version of Exhibit 2109,
`
`Exhibit 2082, or the Patent Owner’s Response, Petitioner has requested that Patent
`
`Owner again redact the confidential information as specified in this motion.
`
`6
`
`
`
`grant the instant Motion to Seal Exhibits 2109 and 2082 and the Patent Owner’s
`
`Response.
`
`Date: July 29, 2016
`
`Respectfully submitted,
`
`Alston & Bird LLP
`
`By: /Jitendra Malik/
`
`Jitendra Malik, Ph.D.
`Reg. No. 55823
`Alston & Bird LLP
`4721 Emperor Blvd., Suite 400
`Durham, NC 27703-8580
`jitty.malik@alston.com
`
`Lead Counsel for Petitioner
`
`7
`
`
`
`CERTIFICATION OF SERVICE
`
`Pursuant to 37 C.F.R. §§ 42.6(e), 42.8(b)(4) and 42.105, the undersigned
`
`certifies that on the 29th day of July, 2016, a complete copy of the foregoing
`
`Petitioner’s Motion to Seal was served on counsel of record for the Patent Owner
`
`and the Lupin Petitioners:
`
`Patent Owner
`Bryan C. Diner
`bryan.diner@finnegan.com
`
`Justin J. Hasford
`justin.hasford@finnegan.com
`
`Joshua L. Goldberg
`Joshua.goldberg@finnegan.com
`
`Lupin Petitioners
`Deborah H. Yellin
`DYellin@Crowell.com
`
`Jonathan Lindsay
`JLindsay@Crowell.com
`
`Shannon Lentz
`SLentz@Crowell.com
`
`Respectfully submitted,
`
`Alston & Bird LLP
`
`By: /Jitendra Malik/
`
`Jitendra Malik, Ph.D.
`Reg. No. 55823
`
`8
`
`
`
`Alston & Bird LLP
`4721 Emperor Blvd., Suite 400
`Durham, NC 27703-8580
`jitty.malik@alston.com
`
`Bryan Skelton, Ph.D.
`Reg. No. 50893
`Alston & Bird LLP
`4721 Emperor Blvd., Suite 400
`Durham, NC 27703-8580
`bryan.skelton@alston.com
`
`Lance Soderstrom
`Reg. No. 65405
`Alston & Bird LLP
`90 Park Avenue
`15th Floor
`New York, NY 10016-1387
`lance.soderstrom@alston.com
`
`Hidetada James Abe
`Reg. No. 61,182
`Alston & Bird LLP
`333 South Hope Street
`16th Floor
`Los Angeles, CA 90071
`james.abe@alston.com
`
`Joseph M. Janusz
`Reg. No. 70396
`ALSTON & BIRD LLP
`101 S. Tryon Street, Suite 4000
`Charlotte, NC 28205
`Telephone: 704-444-1000
`Fax: 704-444-1111
`joe.janusz@alston.com
`
`Attorneys for Petitioners InnoPharma
`Licensing, Inc., InnoPharma Licensing
`LLC, InnoPharma Inc., InnoPharma
`
`9
`
`
`
`LLC, Mylan Pharmaceuticals Inc., and
`Mylan Inc.
`
`10
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