Paper No. __
`Filed: February 25, 2015
`
`
`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`LUPIN LTD. and LUPIN PHARMACEUTICALS INC., INNOPHARMA
`LICENSING, INC., INNOPHARMA LICENSING LLC, INNOPHARMA
`INC., INNOPHARMA LLC, MYLAN PHARMACEUTICALS INC., and
`MYLAN INC.,
`
`Petitioner,
`v.
`
` SENJU PHARMACEUTICAL CO., LTD.,
`Patent Owner
`__________________
`Case IPR2015-01097 (Patent 8,754,131 B2) 1,2
`Case IPR2015-01099 (Patent 8,669,290 B2)
`Case IPR2015-01100 (Patent 8,927,606 B1)3
` Case IPR2015-01105 (Patent 8,871,813 B2) 4
`__________________
`
`JOINT MOTION TO SEAL
`
`
`1 A word-for-word identical paper has been filed in each proceeding identified in
`
`the heading.
`
`2 Case IPR 2016-00089 has been joined with this proceeding.
`
`3 Case IPR 2016-00091 has been joined with this proceeding.
`
`4 Case IPR 2016-00090 has been joined with this proceeding.
`
`
`
`1
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`
`Filed: February 25, 2015
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`
`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`LUPIN LTD. and LUPIN PHARMACEUTICALS INC., INNOPHARMA
`LICENSING, INC., INNOPHARMA LICENSING LLC, INNOPHARMA
`INC., INNOPHARMA LLC, MYLAN PHARMACEUTICALS INC., and
`MYLAN INC.,
`
`Petitioner,
`v.
`
` SENJU PHARMACEUTICAL CO., LTD.,
`Patent Owner
`__________________
`Case IPR2015-01097 (Patent 8,754,131 B2) 1,2
`Case IPR2015-01099 (Patent 8,669,290 B2)
`Case IPR2015-01100 (Patent 8,927,606 B1)3
` Case IPR2015-01105 (Patent 8,871,813 B2) 4
`__________________
`
`JOINT MOTION TO SEAL
`
`
`1 A word-for-word identical paper has been filed in each proceeding identified in
`
`the heading.
`
`2 Case IPR 2016-00089 has been joined with this proceeding.
`
`3 Case IPR 2016-00091 has been joined with this proceeding.
`
`4 Case IPR 2016-00090 has been joined with this proceeding.
`
`
`
`1
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`
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`I.
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01099 (Patent 8,669,290 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`Introduction
`Through this Joint Motion to Seal and through the Motion to Enter
`
`Stipulated Protective Order, submitted concurrently by Patent Owner, Patent
`
`Owner and Petitioner Lupin request that Petitioner Lupin Ltd.’s Abbreviated New
`
`Drug Application (“ANDA”) (Ex. 2109) and portions of the confidential versions
`
`of Patent Owner’s Response (Paper 22 in IPR2015-01099 and Paper 23 in
`
`IPR2015-01097, IPR2015-01100, and IPR2015-01105) and portions of the
`
`confidential version of Patent Owner’s expert declaration of Robert O. Williams,
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`Ph.D. (Exs. 2082) citing or substantially describing Ex. 2109 be sealed. The
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`parties certify that the information identified as confidential in this motion has not
`
`been published or otherwise made public.
`
`II. Governing Rules and PTAB Guidance
`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 but a party may
`
`file a concurrent motion to seal and the information at issue is sealed pending the
`
`outcome of the motion.
`
`Similarly, 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
`2
`
`
`
`
`
`
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01099 (Patent 8,669,290 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`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.
`
`It is, however, only “confidential information” that is protected from disclosure. 35
`
`U.S.C. § 316(a)(7)(“The Director shall prescribe regulations -- . . . providing for
`
`protective orders governing the exchange and submission of confidential
`
`information”). In that regard, the Office Trial Practice Guide, 77 Fed. Reg. 48756,
`
`48760 (Aug. 14, 2012) provides:
`
`The rules 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.
`
`* * *
`
`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.
`
`3
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`
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`
`
`
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01099 (Patent 8,669,290 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`The standard for granting a motion to seal is “for good cause,” 37 C.F.R.
`
`§ 42.54, and the moving party has the burden of proof in showing entitlement to
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`the requested relief, 37 C.F.R. § 42.20(c).
`
`A motion to seal is also required to include a proposed protective order and a
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`certification that the moving party has in good faith conferred or attempted to
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`confer with the opposing party in an effort to come to an agreement as to the scope
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`of the proposed protective order for this inter partes review. 37 C.F.R. § 42.54.
`
`III. Background and Identification of Confidential Information
`
`As discussed with the Board on November 17, 2015, the parties, along with
`
`Petitioner InnoPharma Licensing, Inc., are involved in ten related IPR proceedings,
`
`specifically, IPR2015-00902, IPR2015-00903, IPR2016-00089, IPR2016-00090,
`
`and IPR2016-00091 (filed by Petitioner InnoPharma Licensing, Inc. et al.) and
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`IPR2015-01871, IPR2015-01097, IPR2015-01099, IPR2015-01100, and IPR2015-
`
`01105 (filed by Petitioner Lupin Ltd. et al.) (“Related IPR Proceedings”).
`
`Collectively, the Related IPR Proceedings involve five patents (U.S. Patent Nos.
`
`8,669,290; 8,129,431; 8,754,131; 8,927,606; and 8,871,813) (collectively, the
`
`“Patents-at-Issue”), which all share the same specification and are owned by Patent
`
`Owner. On January 25, 2016, the Board granted institution in IPR2015-01871 and
`
`
`
`4
`
`
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01099 (Patent 8,669,290 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`
`joined that proceeding to IPR2015-00903, both involving the ’431 patent.
`
`IPR2015-01871, Paper 13. On February 25, 2016, the Board: (1) granted
`
`institution in IPR2016-00089 and joined that proceeding to IPR2015-01097, both
`
`involving the ’131 patent, see IPR2016-00089, Paper 22; (2) granted institution in
`
`IPR2016-00090 and joined that proceeding to IPR2015-01105, both involving
`
`the ’813 patent, see IPR2016-00090, Paper 13; and (3) granted institution in
`
`IPR2016-00091 and joined that proceeding to IPR2015-01100, both involving
`
`the ’606 patent, see IPR2016-00089, Paper 14.
`
`
`
`In anticipation of the Board’s possible joinder order, Patent Owner and
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`Petitioner Lupin crafted the Proposed Stipulated Protective Order (signed on
`
`February 8, 2016) contemplating that Lupin’s petitions in IPR2015-01097,
`
`IPR2015-01105, and IPR2015-01100, and InnoPharma’s petitions in IPR2016-
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`00089, IPR2016-00090, and IPR2016-00091 could be joined. Now that the
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`proceedings are joined, there are certain exhibits (see, e.g., Ex. 2109) containing
`
`confidential information belonging to Petitioners InnoPharma and Lupin that each
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`would like to keep confidential, including from one another. To accomplish this
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`goal, Patent Owner is filing Ex. 2109 as “PROTECTIVE ORDER MATERIAL -
`
`BOARD’S EYES ONLY” under the Proposed Stipulated Protective Order.
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`
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`5
`
`
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01099 (Patent 8,669,290 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`
`IV. Good Cause Exists for Sealing Petitioner Lupin’s ANDA and Related
`Portions of Patent Owner’s Response and Williams Declaration
`The parties jointly request that Petitioner’s ANDA (Ex. 2109) be sealed in
`
`
`
`its entirety, and that portions of Patent Owner’s Response (Paper 22 in IPR2015-
`
`01099 and Paper 23 in IPR2015-01097, IPR2015-01100, and IPR2015-01105),
`
`specifically on page 50 of each Response, and the Declaration of Patent Owner’s
`
`expert Dr. Robert O. Williams (Ex. 2082), specifically paragraph nos. 206 and 234,
`
`in IPR2015-01097, nos. 201 and 234, in IPR2015-01099, nos. 204 and 238 in
`
`IPR2015-01100, and nos. 204 and 229 in IPR2015-01105, which cite or
`
`substantially describe the excerpts from Lupin’s ANDA be sealed under 37 C.F.R.
`
`§ 42.14.
`
`
`
`The information the parties seek to seal has not been made public by either
`
`party or by the (“FDA”), and is not otherwise available to the public. Lupin’s
`
`ANDA was filed confidentially with the Food and Drug Administration (“FDA”)
`
`in order to obtain FDA approval to market its generic pharmaceutical product.
`
`The information the parties seek to seal contains Lupin’s highly sensitive,
`
`confidential development information and technical, business information.
`
`Petitioner Lupin’s product has not yet been marketed and remains confidential. If
`
`Petitioner Lupin’s confidential information is made public, Petitioner Lupin’s
`
`
`
`6
`
`
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01099 (Patent 8,669,290 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`
`competitors could exploit the Petitioner Lupin’s confidential information and gain
`
`an unfair competitive advantage over Petitioner Lupin. Exhibit 2109 is only an
`
`excerpt of the much larger Lupin ANDA and redaction of this excerpt would not
`
`be practical; therefore, the parties jointly request that Exhibit 2109 be sealed in its
`
`entirety.
`
`
`
`Moreover, Patent Owner’s Response and the Williams declaration (Ex.
`
`2082) describe the confidential information contained in the ANDA in connection
`
`with secondary considerations of non-obviousness. Accordingly, the parties jointly
`
`request that these portions of the Patent Owner’s Response and the Williams
`
`declaration be sealed.
`
`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.
`
`
`
`7
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`
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01099 (Patent 8,669,290 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`
`In sum, here, the public’s interest in the instant proceeding does not outweigh the
`
`parties’ interest in protecting their sensitive business information.
`
`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 potential co-Petitioner InnoPharma in the
`
`Related IPR Proceedings, the parties jointly request that Exhibit 2109 and the
`
`portions of Patent Owner’s Response and the Williams declarations that cite or
`
`substantially describe the ANDA exhibits be sealed, as “PROTECTIVE ORDER
`
`MATERIAL - BOARD’S EYES ONLY.”
`
`V. Conclusion
`For the reasons set forth above, the parties respectfully request that the
`
`Board grant this motion to seal.
`
`Date: February 25, 2016
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`
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`8
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`Respectfully submitted,
`
`
`
`
`
`By: /Deborah Yellin/
`
`Deborah Yellin, Lead Counsel
`Reg. No. 45,904
`Jonathan Lindsay, Back-up Counsel
`Reg. No. 45,810
`CROWELL & MORING LLP
`Intellectual Property Group
`1001 Pennsylvania Avenue, N.W.
`Washington, DC 20004-2595
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01099 (Patent 8,669,290 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`Telephone: (202) 624-2947
`Fax: (202) 628-8844
`
`Counsel for Petitioners
`
`
`
`
`
`
`/Bryan C. Diner/
`By:
`Bryan C. Diner, Lead Counsel
`Reg. No. 32,409
`Justin J. Hasford, Back-up Counsel
`Reg. No. 62,180
`Joshua L. Goldberg, Back-up Counsel
`Reg. No. 59,369
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, L.L.P.
`901 New York Ave. NW
`Washington, DC 20001-4413
`Telephone: (202) 408-4000
`
`Counsel for Patent Owner
`
`
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`9
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`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing Joint Motion
`
`to Seal was served on February 25, 2016, via email directed to counsel of record
`
`for the Petitioner at the following:
`
`Deborah Yellin
`DYellin@crowell.com
`
`Jonathan Lindsay
`JLindsay@crowell.com
`
`Teresa Stanek Rea
`TRea@crowell.com
`
`Chiemi Suzuki
`CSuzuki@crowell.com
`
`Jitendra Malik
`jitty.malik@alston.com
`
`Lance Soderstrom
`lance.soderstrom@alston.com
`
`Hidetada James Abe
`james.abe@alston.com
`
`
`
`
`
`Date: February 25, 2016
`
`
`
`
`
`/Ashley F. Cheung/
`Ashley F. Cheung
`Case Manager
`Finnegan, Henderson, Farabow, Garrett &
`Dunner, LLP
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