Paper No. __
`Filed: July 29, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
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`INNOPHARMA LICENSING, INC., INNOPHARMA LICENSING LLC,
`INNOPHARMA INC., INNOPHARMA LLC, MYLAN PHARMACEUTICALS
`INC., MYLAN INC.,
`Petitioner
`v.
`
` SENJU PHARMACEUTICAL CO., LTD.,
`Patent Owner
`__________________
`
`Case IPR2015-00902 (Patent 8,669,290 B2)
`__________________
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`RENEWED MOTION TO SEAL
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`Filed: July 29, 2016
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`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.,
`Petitioner
`v.
`
` SENJU PHARMACEUTICAL CO., LTD.,
`Patent Owner
`__________________
`
`Case IPR2015-00902 (Patent 8,669,290 B2)
`__________________
`
`RENEWED MOTION TO SEAL
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`1
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`I.
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`II.
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`TABLE OF CONTENTS
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`Introduction ...................................................................................................... 1
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`Procedural History ........................................................................................... 1
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`III. Governing Rules and PTAB Guidance ............................................................ 4
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`IV.
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`Identification of Confidential Information ...................................................... 6
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`V. Good Cause Exists for Sealing Certain Confidential Information .................. 6
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`A.
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`Patent Owner’s NDA and Related Portions of Patent Owner’s
`Response, the Williams, Trattler, and Jarosz Declarations and
`the Hoffman Transcript Should Be Sealed ............................................ 7
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`1.
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`2.
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`The NDA Contains Patent Owner’s Highly Sensitive,
`Confidential Information ............................................................ 7
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`Good Cause Exists to Seal the NDA Exhibits as
`“CONFIDENTIAL” Under the Proposed Stipulated
`Protective Order .......................................................................... 8
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`B.
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`Third Party BioScience’s Confidential Testing Reports and
`Materials Documenting Proprietary Testing Methods and the
`Related Paulson Declaration Should Be Sealed .................................... 9
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`VI. Conclusion ..................................................................................................... 10
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`TABLE OF AUTHORITIES
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`Page(s)
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`BOARD DECISIONS
`Sandoz, Inc. v. EKR Therapeutics, LLC,
`IPR2015-00005, Paper 21 .................................................................................... 8
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`
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`FEDERAL STATUTES
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`35 U.S.C. § 316 ...................................................................................................... 4, 5
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`FEDERAL REGULATIONS
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`37 C.F.R. § 42.14 .............................................................................................. 5, 7, 9
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`37 C.F.R. § 42.20 ...................................................................................................... 5
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`37 C.F.R. § 42.54 ...................................................................................................... 5
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`Office Patent Trial Practice Guide,
`77 Fed. Reg. 48756 (Aug. 14, 2012) .......................................................... 5, 8, 10
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`ii
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`I.
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`Introduction
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`Through this Renewed Motion to Seal, Patent Owner requests that the
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`IPR2015-00902 (Patent 8,669,290 B2)
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`following exhibits be sealed: (1) excerpts of Patent Owner’s New Drug
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`Application (“NDA”) (Exs. 2096, 2102, 2103, 2110); and (2) confidential testing
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`reports and materials documenting the proprietary testing methods of a third-party
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`test company (Exs. 2249-2263). Patent Owner also requests that portions of its
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`Patent Owner’s Response (Paper 34), expert declarations Exs. 2082 (Williams),
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`2116 (Trattler), and 2130 (Jarosz), and the transcript of testimony Ex. 2273
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`(Hoffman) citing or substantially describing the above categories of documents be
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`sealed. To the best of Patent Owner’s knowledge, the Patent Owner certifies 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. Petitioner Lupin does not oppose this motion.
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`II.
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`Procedural History
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`Patent Owner has filed multiple Motions to Seal. On December 28, 2015,
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`Patent Owner filed Motion to Seal and Motion to Enter Stipulated Protective Order
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`(Paper 36), requesting that certain exhibits and pleadings be sealed, specifically:
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`Exs. 2096, 2102, 2103, 2110 (related to Patent Owner’s NDA), Ex. 2082
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`(Petitioner’s ANDA); Exs. 2220 and 2226 (Patent Owner’s presentations); Ex.
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`2114 (transcript of expert testimony); portions of Patent Owner’s Response (Paper
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`34); and Exs. 2082, 2105, 2116, 2130 (declarations of various experts citing or
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`1
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`IPR2015-00902 (Patent 8,669,290 B2)
`substantially describing the categories of documents sought to be sealed). On
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`March 31, 2016 , Patent Owner filed a Motion to Seal (Paper 67) requesting that
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`transcripts of expert testimony (Ex. 2272 and 2273), Patent Owner’s Motion for
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`Observation Regarding Cross-Examination (Paper 64), be filed under seal. On
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`April 6, 2016, Patent Owner filed a Motion to Seal (Paper 71) requesting that Exs.
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`2249-2263 (testing reports and materials from third-party test companies, and
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`related supplemental expert reports citing same) be filed under seal.
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`On June 21, 2016, the Board denied the parties request to enter the
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`Stipulated Protective Order (Paper 85) and denied all pending requests to seal
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`exhibits and pleadings without prejudice (Papers 85, 89). The parties met and
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`conferred and agreed that in light of the Board’s orders and the completion of
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`discovery, the “PROTECTIVE ORDER MATERIAL-BOARD’S EYES ONLY”
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`and “PROTECTIVE ORDER MATERIAL-FED R. EVID 615” designations are
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`no longer applicable to this proceeding. As a result, the parties agreed that the
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`Default Protective Order should govern in this case. Accordingly, in this Motion,
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`Patent Owner will not be seeking to seal portions of: Patent Owner’s Response
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`(Paper 33), Patent Owner’s Motion for Observations (Paper 58); Petitioner’s
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`Reply to Patent Owner’s Response to Petition (Ex. 2271); and of the declarations
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`or testimony of Dr. Paul Laskar (Ex. 2114 and Ex. 2272), Robert O. Williams (Ex.
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`2082), Stephen G. Davies (Ex. 2105) or Ivan Hoffman (Ex. 2273) that were
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`2
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`IPR2015-00902 (Patent 8,669,290 B2)
`previously marked as Confidential under FRE 615. Patent Owner will be refiling
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`these exhibits without the “PROTECTIVE ORDER MATERIAL-FED R. EVID
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`615” marking.
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`In this Motion, Patent Owner will not be seeking to seal portions of Patent
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`Owner’s Response (Paper 33), Petitioner’s Reply to Patent’s Owner’s Response to
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`Petition (Ex. 2271), Patent Owner’s Motion for Observations (Paper 64) and of the
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`declarations or testimony of Dr. Paul Laskar (Exs. 2114 and 2272), Ivan Hoffman
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`(Ex. 2273), Robert O. Williams (Ex. 2082), and Stephen G. Davies (Ex. 2105) that
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`were previously marked as Confidential under FRE 615. Patent Owner will be
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`refiling these exhibits without the “PROTECTIVE ORDER MATERIAL-FED R.
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`EVID 615” marking.
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`As to the research and development presentations (Exs. 2220 and 2226), the
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`Board noted that, in its view, the Patent Owner had “not identified what portions of
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`the Patent Owner’s Response contain the asserted confidential material.” (Paper
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`85 at 7.) Patent Owner did not request that any portions of the Patent Owner’s
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`Response be sealed, because the information from Exs. 2220 and 2226 was not
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`directly quoted in the Patent Owner’s Response. Nonetheless, Patent Owner’s
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`Response relied on the testimony of Dr. Jarosz (Ex. 2130) regarding the benefits of
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`the invention (Paper 33 at 59 (citing Ex. 2130 at ¶¶ 85, 135)) and Dr. Jarosz
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`supported his testimony with citations to Patent Owner’s research and development
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`3
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`IPR2015-00902 (Patent 8,669,290 B2)
`presentations (see e.g., Ex. 2130 at ¶ 95 (citing Ex. 2220), Ex. 2130 at ¶¶ 82, 96
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`(citing Ex. 2226)). Thus Patent Owner’s original request was not deficient in this
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`regard. Upon further consideration, Patent Owner will not request that Exs. 2220
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`or 2226 be sealed. Public versions of Exs. 2220 and 2226 will be filed.
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`As to the third-party confidential materials, in its Decision, the Board stated:
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`“Patent Owner has neither demonstrated that [Exhibits 2249-2263] contain
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`proprietary information nor established its standing to assert the ‘interest’ of a non-
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`party third party in this proceeding.” Paper 88 at 3.1 Accordingly, as explained
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`below, BioScience prepared a declaration authorizing Patent Owner to request that
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`these exhibits be filed under seal and providing additional information supporting
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`Patent Owner’s request. Upon further consideration, Patent Owner will not request
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`that Exs. 2255, 2256, or 2257 be sealed. A public version of these exhibits will be
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`filed.
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`III. 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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`1 On July 8, the Board authorized BioScience to submit a declaration authorizing
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`Senju to seek protection of BioScience’s proprietary information on BioScience’s
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`behalf and explaining what information contained in Exhibits 2249-2263 is
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`proprietary and why. (Ex. 2278).
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`IPR2015-00902 (Patent 8,669,290 B2)
`file a concurrent motion to seal and the information at issue is sealed pending the
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`outcome of the motion. See also 37 C.F.R. § 42.14. It is, however, only
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`“confidential information” that is protected from disclosure. 35 U.S.C. §
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`316(a)(7)(“The Director shall prescribe regulations -- . . . providing for protective
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`orders governing the exchange and submission of confidential information”). In
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`that regard, the Office Trial Practice Guide, 77 Fed. Reg. 48756, 48760 (Aug. 14,
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`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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`5
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`IV.
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`IPR2015-00902 (Patent 8,669,290 B2)
`Identification of Confidential Information
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`In this Second Motion to Seal, Patent Owner requests that two categories of
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`exhibits be sealed as “PROTECTIVE ORDER MATERIAL” under the Default
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`Protective Order. First, Patent Owner requests that excerpts of Patent Owner’s
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`NDA (Exs. 2096, 2102, 2103, and 2110) be sealed.2 As noted by the Board in its
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`Decision, Patent Owner will provide a redacted version of Ex. 2096. Second,
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`Patent Owner requests that confidential testing reports and materials documenting
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`the proprietary testing methods of third-party test company BioScience (Exs. 2249-
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`2263) be sealed. BioScience has authorized Patent Owner to file a redacted
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`version of Ex. 2249. In addition, Patent Owner also requests that portions of the
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`confidential versions of its Patent Owner’s Response (Paper 34) and portions of
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`confidential versions of Patent Owner’s expert declarations Exs. 2082 (Williams),
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`2116 (Trattler), and 2130 (Jarosz)) and the transcript of testimony Ex. 2273
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`(Hoffman) citing or substantially describing the above categories of documents be
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`sealed.
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`V. Good Cause Exists for Sealing Certain Confidential Information
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`As noted above, Patent Owner requests that excerpts of Patent Owner’s
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`NDA and portions of its Response and supporting declarations citing or
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`2 Patent Owner understands that Petitioner will be requesting that Ex. 2086
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`(Petitioner’s ANDA excerpt) be filed under seal in a separate pleading.
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`IPR2015-00902 (Patent 8,669,290 B2)
`substantially describing those exhibits be sealed. As explained herein, good cause
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`exists for sealing each category of information.
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`A.
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`Patent Owner’s NDA and Related Portions of Patent Owner’s
`Response, the Williams, Trattler, and Jarosz Declarations and the
`Hoffman Transcript Should Be Sealed
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`
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`Patent Owner requests that certain excerpts from Patent Owner’s NDA (Exs.
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`2102, 2103, and 2110) be sealed in their entirety, portions of Ex. 2096 be sealed,
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`and portions of Patent Owner’s Response (Paper 34), specifically pages 3, 48, 49,
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`and 51, the Declarations of Patent Owner’s experts, including: Dr. Robert O.
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`Williams (Ex. 2082), specifically: paragraph nos. 143, 144, 167, 170, 171, 192,
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`193, and 194; Dr. William Trattler (Ex. 2116), specifically paragraph nos. 16, 41,
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`and 49; Dr. Jarosz (Ex. 2130), specifically paragraph nos. 17, 56, 82, and 134; and
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`the transcript of Mr. Hoffman (Ex. 2273), specifically on pages 25, 26, 34, 35, 37-
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`40, 49, and 53 which cite or substantially describe the excerpts from the NDA be
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`sealed under 37 C.F.R. § 42.14. Petitioner Lupin does not oppose sealing these
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`Exhibits and related materials.
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`1.
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`The NDA Contains Patent Owner’s Highly Sensitive,
`Confidential Information
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`The information Patent Owner seeks to seal has not been made public by
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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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`7
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`IPR2015-00902 (Patent 8,669,290 B2)
`product. The information Patent Owner seeks to seal contains Patent Owner’s
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`highly 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 (or further redaction in the case of Ex. 2096) would not be practical;
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`therefore, Patent Owner requests that these Exs. 2102, 2103, and 2110 be sealed in
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`their entirety and portions Ex. 2096 be filed under seal. Moreover, the Patent
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`Owner’s Response and the supporting declarations (Ex. 2082, 2116, 2130) and
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`transcript (Ex. 2273) describe the confidential information contained in the NDA.
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`Accordingly, Patent Owner requests that these portions of the Patent Owner’s
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`Response and the supporting declarations be sealed.
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`2. Good Cause Exists to Seal the NDA Exhibits as
`“CONFIDENTIAL” Under the Proposed Stipulated
`Protective Order
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`The Board’s rules identify confidential information in a manner consistent
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`with Federal Rule of Civil Procedure 26(c)(1)(G), which provides for protective
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`orders for trade secret or other confidential research, development, or commercial
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`information. Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,760 (Aug.
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`14, 2012). The Board has recognized that NDAs contain confidential commercial
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`information that should be protected from public disclosure. See Sandoz, Inc. v.
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`EKR Therapeutics, LLC, IPR2015-00005, paper 21. In sum, here, the public’s
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`8
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`IPR2015-00902 (Patent 8,669,290 B2)
`interest in the instant proceeding does not outweigh the parties’ interest in
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`protecting their 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 terms in a
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`highly competitive market, Patent Owner requests that Exhibits 2096, 2102, 2103,
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`2110, and the portions of Patent Owner’s Response and the Williams, Trattler, and
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`Jarosz declarations and the Hoffman transcript that cite or substantially describe
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`the NDA exhibits be sealed, as “PROTECTIVE ORDER MATERIAL”, for the
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`duration of this proceeding. These exhibits will be refiled with this marking.
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`B.
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`Third Party BioScience’s Confidential Testing Reports and
`Materials Documenting Proprietary Testing Methods and the
`Related Paulson Declaration Should Be Sealed
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`
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`For similar reasons, Patent Owner requests that the confidential materials of
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`third party BioScience (Exs. 2249-2263) be sealed under 37 C.F.R. § 42.14. As
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`outlined in the declaration of Deanna J. Field, Vice President of Finance and
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`Administration of BioScience Laboratories, Inc., (Ex. 2279), Exs. 2249-2263
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`contain confidential BioScience information related to its proprietary testing
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`protocol and standard operating procedures, which has been kept confidential by
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`BioScience. Id. at 3-11. Disclosure of this confidential information to the public,
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`including BioScience’s competitors, would cause irreparable financial damage to
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`BioScience. Id. at 11. BioScience has authorized Patent Owner to request that Exs.
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`9
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`IPR2015-00902 (Patent 8,669,290 B2)
`2249-2263 be sealed. Id. at 2. A redacted version of Ex. 2249 will be filed. But,
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`the remaining documents contain confidential information on all but one page, thus
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`redaction is not practical. Id. at 3-11. 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 a third party’s interest
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`in protecting this limited sensitive business information. Because public disclosure
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`of the contents of these documents, or descriptions of those contents, would
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`disclose confidential business methods of a third party, Patent Owner requests that
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`Exhibits 2249-2263 be sealed, as “PROTECTIVE ORDER MATERIAL”, for the
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`duration of this proceeding.
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`VI. Conclusion
`For the reasons set forth above, Patent Owner respectfully requests that the
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`Board grant this motion to seal.
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`Respectfully,
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`
`
` /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
`Counsel for Patent Owner
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`10
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`IPR2015-00902 (Patent 8,669,290 B2)
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing Renewed
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`Motion to Seal was served on July 29, 2016, via email directed to counsel of
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`record for the Petitioner at the following:
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`Jitendra Malik
`jitty.malik@alston.com
`
`Bryan Skelton
`bryan.skelton@alston.com
`
`Lance Soderstrom
`lance.soderstrom@alston.com
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`Hidetada James Abe
`James.abe@alston.com
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`Joseph Janusz
`joe.janusz@alston.com
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`
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`Date: July 29, 2016
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`
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`
`
`/Bradley J. Moore/
`Bradley J. Moore
`Litigation Legal Assistant
`Finnegan, Henderson, Farabow, Garrett &
`Dunner, LLP
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`
`
`
`11
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