IPR2015-01097 (Patent 8,754,131 B2)
` Paper No. __
`Filed: February 25, 2016
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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
`__________________
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`PATENT OWNER’S MOTION TO SEAL AND MOTION TO ENTER
`STIPULATED PROTECTIVE ORDER
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`1 Case IPR 2016-00089 has been joined with this proceeding.
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` Paper No. __
`Filed: February 25, 2016
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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
`__________________
`
`PATENT OWNER’S MOTION TO SEAL AND MOTION TO ENTER
`STIPULATED PROTECTIVE ORDER
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`
`
`
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`
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`1 Case IPR 2016-00089 has been joined with this proceeding.
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`Case IPR2015-01097 (Patent 8,754,131 B2)
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`TABLE OF CONTENTS
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`
`Introduction ...................................................................................................... 1
`I.
`Governing Rules and PTAB Guidance ............................................................ 2
`II.
`III. Background and Identification of Confidential Information ........................... 4
`IV. Good Cause Exists for Sealing Certain Confidential Information .................. 7
`A.
`Patent Owner’s New Drug Application (“NDA”) and Related
`Portions of Patent Owner’s Response, and the Myers, Williams,
`Trattler, and Jarosz Declarations Should Be Sealed ............................. 7
`1.
`The NDA and ANDA Contain Highly Sensitive,
`Confidential Information to Their Respective Owners .............. 8
`Good Cause Exists to Seal the NDA Exhibits as
`“BOARD’S EYES ONLY” Under the Proposed
`Stipulated Protective Order ......................................................... 9
`Patent Owner’s Confidential Presentations Related to its
`Research and Development, Testimony of Patent Owner’s
`Officer, and Related Jarosz Declaration Should Be Sealed ................ 10
`Third Party’s Confidential Testing Reports and Materials
`Documenting Proprietary Testing Methods and Related Paulson
`Declarations Should Be Sealed ........................................................... 11
`D. Under the Rule on Witnesses, the Transcript of Petitioner
`Lupin’s Expert Should Be Sealed Until Petitioner InnoPharma’s
`Expert Has Concluded His Testimony in the Related IPR
`Proceedings ......................................................................................... 12
`Proposed Stipulated Protective Order ........................................................... 14
`V.
`VI. Conclusion ..................................................................................................... 15
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`2.
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`B.
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`C.
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`Case IPR2015-01097 (Patent 8,754,131 B2)
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`TABLE OF AUTHORITIES
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`FEDERAL CASES
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`Page(s)
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`Geders v. United States,
`425 U.S. 80 (1976) .............................................................................................. 13
`
`BOARD DECISIONS
`Sandoz, Inc. v. EKR Therapeutics, LLC,
`IPR2015-00005, Paper 21 .................................................................................... 9
`
`FEDERAL STATUTES
`35 U.S.C. § 316 .......................................................................................................... 2
`
`FEDERAL REGULATIONS
`37 C.F.R. § 42.14 ...................................................................................... 2, 8, 10, 11
`37 C.F.R. § 42.20 ...................................................................................................... 3
`37 C.F.R. § 42.54 .................................................................................................. 2, 3
`37 C.F.R. § 42.62 .................................................................................................... 12
`Office Patent Trial Practice Guide,
`77 Fed. Reg. 48756 (Aug. 14, 2012) .................................................... 3, 9, 10, 11
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`I.
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`
`Introduction
`Through this Motion to Seal and Motion to Enter Stipulated Protective Order,
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`Patent Owner requests that four categories of exhibits be sealed: (1) excerpts of
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`Patent Owner’s New Drug Application (“NDA”) (Exs. 2096, 2102, 2103, 2110,
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`2251, 2291-2293); (2) three confidential presentations related to Patent Owner’s
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`research and development of the patented formulation (Exs. 2220, 2226, and 2296)
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`and testimony related to the market share of Patent Owner’s product in a related
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`district court case (Ex. 2258); (3) confidential testing reports and materials
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`documenting the proprietary testing methods of third-party test companies (Exs.
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`2267-2278, 2286, 2294); and (4) the transcript of testimony of InnoPharma
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`Licensing’s expert, Dr. Paul Laskar in the related IPR2015-00902 and -00903 (Ex.
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`2114) and the transcript of testimony of Lupin’s expert, Dr. Jayne Lawrence (Ex.
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`2316). In addition, Patent Owner also requests that portions of the confidential
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`versions of its Patent Owner’s Response (Paper 23 (BOARD’S EYES ONLY
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`version, containing no redactions) and Paper 24 (FED. R. EVID. 615 version,
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`redacting BOARD’S EYES ONLY material, to be made public once FED. R.
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`EVID. 615 has been lifted, as explained herein)), and portions of confidential
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`versions of Patent Owner’s expert declarations (Exs. 2126 (Myers), 2128 (Paulson),
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`2082 (Williams), 2105 (Davies), 2116 (Trattler), and 2130 (Jarosz)) citing or
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`substantially describing the above categories of documents be sealed. Finally,
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`under 37 C.F.R. § 42.54, Patent Owner further requests entry of the Proposed
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`Stipulated Protective Order, submitted concurrently herewith. To the best of
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`Patent Owner’s knowledge, the Patent Owner certifies that the information
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`identified as confidential in this motion has not been published or otherwise made
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`public. Petitioner Lupin does not oppose this motion.
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`II. Governing Rules and PTAB Guidance
`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 but a party may
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`file a concurrent motion to seal and the information at issue is sealed pending the
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`outcome of the motion.
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`Similarly, 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 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.
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`It is, however, only “confidential information” that is protected from disclosure. 35
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`U.S.C. § 316(a)(7)(“The Director shall prescribe regulations -- . . . providing for
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`protective orders governing the exchange and submission of confidential
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`information”). In that regard, the Office Trial Practice Guide, 77 Fed. Reg. 48756,
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`48760 (Aug. 14, 2012) provides:
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`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.
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`* * *
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`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.
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`The standard for granting a motion to seal is “for good cause,” 37 C.F.R.
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`§ 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).
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`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.
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`III. Background and Identification of Confidential Information
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`As discussed with the Board on November 17, 2015, this IPR is related to
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`nine other IPR proceedings, specifically, IPR2015-00902, IPR2015-00903,
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`IPR2016-00089, IPR2016-00090, and IPR2016-00091 (filed by Petitioner
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`InnoPharma Licensing, Inc. et al.), and IPR2015-01871, IPR2015-01099,
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`IPR2015-01100, and IPR2015-01105 (filed by Petitioner Lupin Ltd. et al.)
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`(“Related IPR Proceedings”). Collectively, these ten proceedings involve five
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`patents (U.S. Patent Nos. 8,669,290; 8,129,431; 8,754,131; 8,927,606; and
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`8,871,813) (collectively, the “Patents-at-Issue”), which all share the same
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`specification and are owned by Patent Owner. On January 25, 2016, the Board
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`granted institution in IPR2015-01871 and joined that proceeding to IPR2015-
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`00903, both involving the ’431 patent. IPR2015-01871, Paper 13. On February 25,
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`2016, the Board: (1) granted institution in IPR2016-00089 and joined that
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`proceeding to IPR2015-01097, both involving the ’131 patent, see IPR2016-0089,
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`Paper 22; (2) granted institution in IPR2016-00090 and joined that proceeding to
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`IPR2015-01105, both involving the ’813 patent, see IPR2016-0090, Paper 13; and
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`(3) granted institution in IPR2016-00091 and joined that proceeding to IPR2015-
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`01100, both involving the ’606 patent, see IPR2016-0089, Paper 14.
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`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
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`February 8, 2016) contemplating that Lupin’s petitions in IPR2015-01097,
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`IPR2015-01105, and IPR2015-01100 and InnoPharma’s petitions in IPR2016-
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`00089, IPR2016-00090, and IPR2016-00091 could be joined.
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`
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`In support of their respective petitions in the Related IPR Proceedings,
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`Petitioner Lupin has relied on the opinions of Dr. Lawrence and Petitioner
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`InnoPharma has relied on the opinions of Dr. Laskar. Although their declarations
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`are not identical, Drs. Laskar and Lawrence rely on the same references to support
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`their opinions regarding the validity of the Patents-at-Issue. Because the
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`proceedings are proceeding on various timelines, Senju has already cross examined
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`Dr. Laskar in some of these proceedings (see, e.g., IPR2015-00902, IPR2015-
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`00903) and Dr. Lawrence in others (see, e.g., IPR2015-01099, IPR2015-01097),
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`but has not yet cross examined either expert in support of either Petitioner’s Reply
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`briefs in any proceeding. As explained herein, under Federal Rule of Evidence 615,
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`Patent Owner requests that the transcript of testimony of Dr. Lawrence be sealed
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`from Dr. Laskar until the cross examination on all of the Petitioners’ Reply briefs
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`have concluded. To that end, the parties have crafted the Proposed Stipulated
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`Protective Order contemplating that the transcript of testimony of an expert may be
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`sealed for a limited period of time under FRE 615. To do so, Patent Owner is filing
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`the Laskar Transcript, Ex. 2114 and the Lawrence Transcript, Ex. 2316, as
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`“PROTECTIVE ORDER MATERIAL - FED R. EVID 615” under the Proposed
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`Stipulated Protective Order.
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`
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`Moreover, in support of its Response, Patent Owner’s expert Dr. Daryl S.
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`Paulson, President and CEO of BioScience Laboratories, Inc., relies on
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`confidential, proprietary test results and related materials (Exs. 2267-2278, 2294)
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`disclosing proprietary BioScience Laboratories testing methods. Likewise, Patent
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`Owner’s expert Dr. Adam C. Myers, Senior Research Investigator at SSCI relies
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`on similar information (Ex. 2286). Finally, Patent Owner’s expert Dr. John Jarosz
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`of Analysis Group, Inc. relies on three confidential, proprietary presentations from
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`Patent Owner (Exs. 2220, 2226, and 2296) related to Patent Owner’s research and
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`development of the patented formulation and the testimony of Tracy Valorie of
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`Bausch & Lomb (Ex. 2258) regarding the competitive marketplace for Patent
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`Owner’s commercial product. To protect the information contained in these
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`presentations and testimony, Patent Owner is filing these exhibits as
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`“PROTECTIVE ORDER MATERIAL” under the Proposed Stipulated Protective
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`Order.
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`
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`Finally, Patent Owner and Petitioner InnoPharma are also currently litigating
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`the patent-at-issue in this IPR before the United States District Court for the
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`District of New Jersey in Senju Pharmaceutical Co., Ltd., Bausch & Lomb, Inc.,
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`and Bausch & Lomb Pharma Holdings Corp. v. InnoPharma Licensing, Inc.,
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`InnoPharma Licensing, LLC, InnoPharma, Inc., and InnoPharma, LLC, C.A. No.
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`1:14-cv-06893-JBS-KMW (D.N.J. filed Nov. 3, 2014) (hereinafter “the
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`Litigation”). The Court has entered a Stipulated Discovery Confidentiality Order in
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`the Litigation, and Patent Owner and InnoPharma have exchanged certain
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`confidential discovery under that Order.
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`IV. Good Cause Exists for Sealing Certain Confidential Information
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`As noted above, Patent Owner requests that four categories of exhibits and
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`portions of its Response and supporting declarations citing or substantially
`
`describing those exhibits be sealed. As explained herein, good cause exists for
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`sealing each category of information.
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`A.
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`Patent Owner’s New Drug Application (“NDA”) and Related
`Portions of Patent Owner’s Response, and the Myers, Williams,
`Trattler, and Jarosz Declarations Should Be Sealed
`Patent Owner requests that certain excerpts from Patent Owner’s NDA (Exs.
`
`
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`2096, 2102, 2103, 2110, 2251, 2291-2293) be sealed in their entirety, and portions
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`of Patent Owner’s Response (Paper 23), specifically pages 2, 3, 46-48, and 50, the
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`Declarations of Patent Owner’s experts, including: Dr. Myers (Ex. 2126),
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`specifically paragraph nos. 12, 15-16, 18, and 22; Dr. Robert O. Williams (Ex.
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`2082), specifically paragraph nos. 65, 178-179, 202-203, 205-206, and 238-240;
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`Dr. William Trattler (Ex. 2116), specifically paragraph nos. 16, 40, and 49-50; and
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`Dr. Jarosz (Ex. 2130), specifically paragraph nos. 18, 50, 81, 84, and 148, which
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`cite or substantially describe the excerpts from the NDA be sealed under 37 C.F.R.
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`§ 42.14. Based on Patent Owner’s representations about these documents,
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`Petitioner Lupin does not oppose sealing these Exhibits and related materials.
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`1.
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`The NDA and ANDA Contain Highly Sensitive,
`Confidential Information to Their Respective Owners
`The information Patent Owner seeks to seal has not been made public by
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`
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`either party or by the Food and Drug Administration (“FDA”), and is not otherwise
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`available to the public. Patent Owner’s NDA was filed confidentially with the
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`FDA in order to obtain FDA approval to market its innovative pharmaceutical
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`product. The information Patent Owner seeks to seal contains each parties’ highly
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`sensitive, confidential development information and technical, business
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`information. The Exhibits listed above are only excerpts of the much larger NDA
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`and redaction would not be practical; therefore, Patent Owner requests that these
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`Exs. 2096, 2102, 2103, 2110, 2251, 2291-2293 be sealed in their entirety.
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`
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`Moreover, Patent Owner’s Response and the supporting declarations (Ex.
`
`2082, 2116, 2126, 2130) describe the confidential information contained in the
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`NDA. For instance, Patent Owner relies on limited excerpts of its own NDA in
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`part to establish Patent Owner’s commercial success. Accordingly, Patent Owner
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`requests that these portions of the Patent Owner’s Response and the supporting
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`declarations be sealed.
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`2. Good Cause Exists to Seal the NDA Exhibits as “BOARD’S
`EYES ONLY” Under the Proposed Stipulated Protective
`Order
`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
`
`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.
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`14, 2012). Accordingly, the Board has recognized that New Drug Applications
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`(“NDA”) contain confidential commercial information that should be protected
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`from public disclosure. See Sandoz, Inc. v. EKR Therapeutics, LLC, IPR2015-
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`00005, paper 21. In sum, here, the public’s interest in the instant proceeding does
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`not outweigh the parties’ interest in protecting their sensitive business information.
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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, Patent Owner requests that Exhibits 2096, 2102, 2103,
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`2110, 2251, 2291-2293 and the portions of Patent Owner’s Response and the
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`Myers, Williams, Trattler, and Jarosz declarations that cite or substantially describe
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`the NDA exhibits be sealed, as “PROTECTIVE ORDER MATERIAL - BOARD’S
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`EYES ONLY”, for the duration of this proceeding.
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`B.
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`Patent Owner’s Confidential Presentations Related to its
`Research and Development, Testimony of Patent Owner’s Officer,
`and Related Jarosz Declaration Should Be Sealed
`For similar reasons, Patent Owner requests that its confidential presentations
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`
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`(Exs. 2220, 2226, 2296) and testimony of Ms. Valorie, an officer of Patent
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`Owner’s parent company (Ex. 2258) related to Patent Owner’s commercial
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`embodiment of the patent at issue and the portions of the Declaration of Patent
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`Owner’s expert Dr. Jarosz (Ex. 2130), specifically paragraph nos. 13, 40, 42, 50,
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`68, 81, and 98-101, citing these presentations and testimony be sealed under 37
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`C.F.R. § 42.14. These presentations contain Patent Owner’s proprietary
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`information related to Patent Owner’s methods of conducting confidential
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`discussion groups and market information related to its commercial embodiment of
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`the Patents-at-Issue. Patent Owner and Dr. Jarosz rely on these materials to show
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`Patent Owner’s commercial success. Petitioner Lupin does not oppose sealing
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`these Exhibits and related materials.
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`The Board’s rules provide for the protection of trade secret or other
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`confidential commercial information. See 77 Fed. Reg. at 48,760. Here, the
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`public’s interest in the instant proceeding does not outweigh the parties’ interest in
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`protecting this limited sensitive business information.
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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 methods,
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`Patent Owner requests that Exhibits 2220, 2226, 2296, and 2258 and the portions
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`of Patent Owner’s Response and the Jarosz declaration (Ex. 2130) that cite or
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`substantially describe these confidential presentation exhibits be sealed, as
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`“PROTECTIVE ORDER MATERIAL”, for the duration of this proceeding.
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`C. Third Party’s Confidential Testing Reports and Materials
`Documenting Proprietary Testing Methods and Related Paulson
`Declarations Should Be Sealed
`For similar reasons, Patent Owner requests that its confidential materials of
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`
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`third parties BioScience and SSCI (Exs. 2267-2278, 2286, 2294) and the portions
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`of the Declaration of Dr. Paulson (Ex. 2128), specifically paragraph nos. 10, 14,
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`17-18, and 20-25, citing these confidential documents be sealed under 37 C.F.R.
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`§ 42.14. These documents contain third party BioScience’s and SSCI’s proprietary
`
`information related to each company’s proprietary testing methods. Dr. Paulson
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`relied on these materials to document preservative effectiveness testing that
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`BioScience performed on samples of Patent Owner’s commercial product, in
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`support of Dr. Williams’ opinions on objective evidence of non-obviousness.
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`Petitioner Lupin does not oppose sealing these Exhibits and related materials.
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`The Board’s rules provide for the protection of trade secret or other
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`confidential commercial information. See 77 Fed. Reg. at 48,760. Here, the
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`public’s interest in the instant proceeding does not outweigh a third party’s interest
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`in protecting this limited sensitive business information.
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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 methods of a
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`third party, Patent Owner requests that Exhibits 2267-2278, 2286, and 2294 and
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`the portions of Patent Owner’s Response and the Paulson declaration (Ex. 2128)
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`that cite or substantially describe these confidential documents exhibits be sealed,
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`as “PROTECTIVE ORDER MATERIAL”, for the duration of this proceeding.
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`D. Under the Rule on Witnesses, the Transcript of Petitioner Lupin’s
`Expert Should Be Sealed Until Petitioner InnoPharma’s Expert
`Has Concluded His Testimony in the Related IPR Proceedings
`Patent Owner further requests that the transcript of Dr. Jayne Lawrence’s
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`
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`testimony (Ex. 2316) be sealed in its entirety under Federal Rule of Evidence 615
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`(“FRE”) (Excluding Witnesses) until such time as the cross examination of
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`Petitioner InnoPharma’s expert Dr. Paul Laskar in connection with InnoPharma’s
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`petitions in the Related IPR Proceedings have been concluded. Dr. Laskar may
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`still be cross-examined in connection with Petitioner InnoPharma’s Reply in some
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`of those related proceedings, but has relied on the same references as Dr. Lawrence
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`in rendering his opinions regarding validity of the patents at issue. Petitioner
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`Lupin does not oppose sealing this Exhibit and materials that cite to or
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`substantially describe this Exhibit.
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`The Federal Rules of Evidence (“FRE”) generally apply to inter partes
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`reviews. See 37 C.F.R. § 42.62(a). Under FRE 615, “[a]t a party’s request, the
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`court must order witnesses excluded so that they cannot hear other witnesses’
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`testimony.” The U.S. Supreme Court has long-recognized the goal of sequestering
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`witnesses, known as the “rule on witnesses,” is two-fold. Geders v. United States,
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`425 U.S. 80, 87 (1976). First, the rule “exercises a restraint on witnesses
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`‘tailoring’ their testimony to that of earlier witnesses.” Id. Second, the rules “aids
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`in detecting testimony that is less than candid.” Id. (internal citation omitted). For
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`the same reasons, given the similarity of their positions on validity of the patent at
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`issue, good cause exists to seal the testimony of Dr. Lawrence for a limited time,
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`until Dr. Laskar has been cross-examined in connection with InnoPharma’s
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`petition on the patent at issue. For similar reasons, the testimony of Dr. Laskar in
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`the earlier InnoPharma’s proceedings, IPR2015-00902 and IPR2015-00903 should
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`remain sealed until Dr. Lawrence has completed her testimony in the other Related
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`Proceedings. Once expert testimony has been completed in all of the Related
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`Proceedings, then the transcripts of both experts can be unsealed and made public.
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`Similarly, Patent Owner requests that portions of Patent Owner’s Response
`
`(Paper 23, specifically pages 5, 9-12, 14-15, 17-18, 20, 22-26, 34, 39- 41, 43, 47-
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`48, 53, 55-56, and 59), the declarations of Patent Owner’s experts Dr. Williams
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`(Ex. 2082, specifically paragraph nos. 58, 61-63, 65-70, 72, 74, 76-77, 79, 83-89,
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`93-95, 98, 100-101, 104, 107, 110, 112, 114-116, 122, 124-126, 131-138, 140, 142,
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`145, 149, 151, 155, 158, 160, 163, 165-167, 170, 173-175, 179, 182, 186, 188189,
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`Case IPR2015-01097 (Patent 8,754,131 B2)
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`191192, 194, 199, 201-203, 207, 213, 215, 230, 235, and 237), and Dr. Stephen
`
`Davies (Exs. 2105, specifically paragraphs nos. 41, 43, 50, 58, 60-61, 70, 76- 77,
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`79, 82, 84, 86, 90-91, 93-94, and 99), citing or substantially describing Dr.
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`Lawrence’s or Dr. Laskar’s testimony be likewise sealed for the same duration.
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`Patent Owner has provided redacted versions of the Patent Owner’s Response and
`
`the related declarations to be publicly available in the meantime.
`
`Because public disclosure of the contents of the Lawrence testimony, the
`
`Laskar testimony, or descriptions of those contents, would risk the harms described
`
`by the Supreme Court in Gedars, Patent Owner requests that the testimony of Dr.
`
`Lawrence (Ex. 2316) and Dr. Laskar (Ex. 2114) be sealed in their entirety and the
`
`portions of Patent Owner’s Response (Paper 23) and the Williams and Davies
`
`declarations (Exs. 2082, 2105, portions noted specifically above) that cite or
`
`substantially describe Dr. Lawrence’s or Dr. Laskar’s testimony be sealed, under
`
`Federal Rule of Evidence 615, as “PROTECTIVE ORDER MATERIAL - FED R.
`
`EVID 615” until such time as the expert testimony in the Related Proceedings has
`
`concluded.
`
`V.
`
`Proposed Stipulated Protective Order
`On February 8, 2016, Patent Owner and Petitioner Lupin have agreed to the
`
`terms of the Proposed Stipulated Protective Order as described above and as
`
`
`
`14
`
`
`
`Case IPR2015-01097 (Patent 8,754,131 B2)
`
`located in attached Appendix A.2 In accordance with the terms of the Proposed
`
`Stipulated Protective Order, confidential versions (marked “PROTECTIVE
`
`ORDER MATERIAL - BOARD’S EYES ONLY”, “PROTECTIVE ORDER
`
`MATERIAL - FED R. EVID 615”, or “PROTECTIVE ORDER MATERIAL” as
`
`appropriate), and non-confidential versions of the documents have been filed.
`
`VI. Conclusion
`For the reasons set forth above, Patent Owner respectfully requests that the
`
`Board grant this motion to seal.
`
`Date: February 25, 2016
`
`
`
`
`
`Respectfully submitted,
`
`
`
`
`By: /Bryan C. Diner/
`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.
`
`
`2 The Board joined Petitioner InnoPharma’s IPR2016-00089 with this proceeding
`
`on February 25, 2016. In light of the deadline to file the Patent Owner Response
`
`on the same day, counsel for Patent Owner consulted with the Board’s paralegal
`
`who authorized filing of an Amended Stipulated Proposed Protective Order at a
`
`later date to include Petitioner InnoPharma.
`
`
`
`15
`
`
`
`Case IPR2015-01097 (Patent 8,754,131 B2)
`
`
`901 New York Ave. NW
`Washington, DC 20001-4413
`(202) 408-4000
`
`Counsel for Patent Owner
`
`
`
`16
`
`
`
`Case IPR2015-01097 (Patent 8,754,131 B2)
`
`
`
`
`
`
`APPENDIX A
`
`
`
`
`
`
`
`
`
`
`
`Paper No. __
`Filed: February 25, 2015
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`LUPIN LTD. and LUPIN PHARMACEUTICALS INC.,
`Petitioner
`v.
`
` SENJU PHARMACEUTICAL CO., LTD.,
`Patent Owner
`__________________
`
`Case IPR2015-01097 (Patent 8,754,131 B2)
`Case IPR2015-01099 (Patent 8,669,290 B2)
`Case IPR2015-01100 (Patent 8,927,606 B1)
` Case IPR2015-01105 (Patent 8,871,813 B2) 1
`__________________
`
`
`
`PROPOSED STIPULATED PROTECTIVE ORDER
`
`
`
`
`
`
`
`
`
`
`
`
`
`1 A word-for-word identical paper has been filed in each proceeding identified in
`
`the heading.
`
`
`
`1
`
`
`
`
`
`
`
`
`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)
`
`This joint protective order governs the treatment and filing of confidential
`
`information, including documents and testimony.2
`
`1. Marking of Confidential Information. Confidential information shall be
`
`clearly marked as either “PROTECTIVE ORDER MATERIAL - BOARD’S EYES
`
`ONLY” or “PROTECTIVE ORDER MATERIAL - FED R. EVID 615” or
`
`“PROTECTIVE ORDER MATERIAL”.
`
`2.
`
`Persons Having Access to Confidential Information Marked
`
`“PROTECTIVE ORDER MATERIAL - BOARD’S EYES ONLY”. For the
`
`confidential information marked “PROTECTIVE ORDER MATERIAL -
`
`BOARD’S EYES ONLY”, access to confidential information is limited to the
`
`Employees and representatives of the Office who have a need for access to the
`
`confidential information. Such employees and representatives shall have such
`
`access without the requirement to sign an Acknowledgement. Such employees and
`
`representatives shall include the Director, members of the Board and their clerical
`
`staff, other support personnel, court reporters, and other persons acting on behalf of
`
`the Office.
`
`
`2 Nothing in this Order prevents any Party from challenging a confidentiality
`
`designation to any Exhibit by raising the matter with the Board.
`
`
`
`2
`
`
`
`
`
`
`3.
`
`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)
`
`Persons Having Access to Confidential Information Marked
`
`“PROTECTIVE ORDER MATERIAL - FED R. EVID 615”. For the
`
`confidential information marked, “PROTECTIVE ORDER MATERIAL - FED R.
`
`EVID 615”, access to confidential information about one expert’s deposition
`
`testimony is limited to the following individuals who have executed the
`
`acknowledgment appended to this order and shall not be disclosed to any other
`
`expert in any Related Proceeding3 (unless the information is already known to that
`
`expert) until after such time as the Board has lifted the Rule on Witnesses under
`
`Fed. R. Evid. 615, and then only upon the formal request of any Party to the Board,
`
`
`3 Related Proceeding is defined as “any other IPR proceeding or district court
`
`proceeding involving the patent at issue, the patent owners, and any one of
`
`Petitioners InnoPharma Licensing, Inc., InnoPharma Licensing LLC, InnoPharma
`
`Inc., InnoPharma LLC, Mylan Pharmaceuticals Inc., Mylan Inc., Lupin, Ltd., or
`
`Lupin Pharmaceuticals, Inc.”).
`
`
`
`3
`
`
`
`
`
`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)
`
`
`or upon a joint request by the Parties to the Board’s administrative staff to do so
`
`without raising the matter with the Board:4
`
`(A) Parties. Persons who are owners of a patent involved in the
`
`proceeding and other persons who are identified as a real party-in-interest in
`
`any Related Proceeding.
`
`(B) Outside Counsel. Outside counsel of record for a party in any Related
`
`Proceeding.
`
`(C)
`
`In-house counsel. In-house counsel of a party or in-house counsel of a
`
`real party-in-interest.
`
`(D) Other Employees of a Party. Employees, other than in-house counsel
`
`and in-house counsel’s support staff, who sign the Acknowledgement shall
`
`be extended access to confidential information only upon agreement of the
`
`parties or by order of the Board upon a motion brought by the party seeking
`
`to disclose confidential information to that person. The party opposing
`
`
`4 Upon termination of the “PROTECTIVE ORDER MATERIAL - FED R. EVID
`
`615” designation, any party may, in good faith, request that the Information be re-
`
`designated to “PROTECTIVE ORDER MATERIAL.”
`
`
`
`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)
`
`disclosure to that person shall have the burden of proving that such person
`
`should be restricted from access to confidential information.
`
`(E) The Office. Employees and representatives of the Office who have a
`
`need for access to the confidential information shall have such access
`
`without the requirement to sign an Acknowledgement. Such employees and
`
`representatives shall include the Director, members of the Board and their
`
`clerical staff, other support personnel, court reporters, and other persons
`
`acting on behalf of the Office.
`
`(F) Support Personnel. Administrative assistants, clerical staff, court
`
`reporters and other support personnel of the foregoing persons who are
`
`reasonably necessary to assist those persons in the proceeding shall not be
`
`required to sign an Acknowledgement, but shall be
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