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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`SLAYBACK PHARMA LLC,
`Petitioner
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`v.
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`SUMITOMO DAINIPPON PHARMA CO., LTD.,
`Patent Owner
`
`
`
`
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`Case IPR2020-01053
`Patent No. 9,815,827
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`PATENT OWNER’S MOTION TO SEAL UNDER 37 CFR § 42.54
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`
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`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
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`I. Introduction
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`Pursuant to 37 CFR § 42.54, Patent Owner, Sumitomo Dainippon Pharma
`
`Co., Ltd, respectfully submits this Motion to Seal Exhibits 2058-2060, 2069, 2074-
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`2076, 2078, 2080, 2082-2083, 2089-2090, 2092-2095, 2131, 2132, and 2138, as
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`well as its Patent Owner Response. In the case of Ex. 2131 and its Patent Owner
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`Response, Patent Owner submits herewith non-confidential (redacted versions).
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`Below, Patent Owner explains that Good Cause exists for placing these exhibits
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`and the Patent Owner Response under seal.
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`II. Applicable Legal Principles for Sealing Confidential Information
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`There is a strong public policy for making all information filed in a quasi-
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`judicial administrative proceeding open to the public, especially in an inter partes
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`review which determines the patentability of claims in a patent and therefore
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`affects the rights of the public. St. Jude Medical, Cardiology Division, Inc. v.
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`Volcano Corp., IPR2013-00258, Decision to Revised Motion to Seal 37 C.F.R. §§
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`42.14 and 42.54, Paper 28 at 2. Under 35 U.S.C. § 316(a)(1), the default rule is
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`that all papers filed in an inter partes review are open and available for access by
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`the public; and a party may file a concurrent motion to seal and the information at
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`issue is sealed pending the outcome of the motion. Id.
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`It is, however, only “confidential information” that is protected from
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`disclosure. 35 U.S.C. § 316(a)(7) (“The Director shall prescribe regulations -- …
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`1
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`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`providing for protective orders governing the exchange and submission of
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`confidential information”). Id. In that regard, the Office Patent Trial Practice
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`Guide, 77 Fed. Reg. 48756, 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.
`* * *
`identify confidential
`rules
`Information: The
`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. Patent Owner, as the moving party, has the burden of proof in showing
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`entitlement to the requested relief. Id.
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`III. Good Cause Exists for Sealing Exhibits 2058-2060, 2069, 2074-2076,
`2078, 2080, 2082-2083, 2089-2090, 2092-2095, 2131, 2132, and 2138, and the
`Patent Owner Response.
`Exhibit 2132: Exhibit 2132 is the declaration of Dr. Brian Reisetter. Dr.
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`
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`Reisetter opines that the invention claimed in the challenged patent (U.S.
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`9,815,827) has been commercially successful. In reaching his opinion, Dr.
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`Reisetter relies upon and discusses sensitive financial and competitive commercial
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`2
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`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`information from Patent Owner—in particular Exhibits 2069, 2074-2076, 2078,
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`2080, 2082-2083, and 2089-2090.
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`
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`Exhibit 2069: Exhibit 2069 (Lurasidone, Strategic Business Plan, October
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`1, 2009) contains sensitive financial and competitive commercial information
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`relating to the anticipated commercial launch of LATUDA®.
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`
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`Exhibit 2074: Exhibit 2074 (Latuda Financial Information FY11-FY20
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`YTD) contains sensitive financial information, including sales and pricing
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`information, related to LATUDA®.
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`
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`Exhibit 2075: Exhibit 2075 (LATUDA Monthly Commercial Analytics
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`Meeting, June 2016) contains sensitive financial and competitive commercial
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`information related to LATUDA®.
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`
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`
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`Exhibit 2076: Exhibit 2076 (LATUDA Situational Assessment – FY 2020,
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`Aug 2, 2020) contains sensitive financial and competitive commercial information,
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`as well as confidential business analyses related to LATUDA®.
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`
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`Exhibit 2078: Exhibit 2078 (Latuda® (lurasidone HCl) 2013 Brand Plan)
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`contains sensitive financial and competitive commercial information relating to the
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`2013 marketing plan for LATUDA®.
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`
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`Exhibit 2080: Exhibit 2080 (Latuda Physician ATU Tracker Findings,
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`Q3’11 Insights Report) contains proprietary data and analysis related to the use of
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`LATUDA® by physicians.
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`3
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`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`Exhibit 2082: Exhibit 2083 (LATUDA – Bipolar Depression HCP ATU,
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`FY16-Q4, March 20, 2017) contains proprietary data and analysis related to the
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`use of LATUDA® for treating bipolar depression by physicians.
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`
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`Exhibit 2083: Exhibit 2083 (The Bipolar Disorder Patient Journey,
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`Sunovion Commercial Insights & Analytics, INSYNC, June 22, 2020) includes
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`proprietary competitive commercial analysis relating to LATUDA® and its use to
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`treat bipolar disorder.
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`
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`Exhibit 2089: Exhibit 2089 (Sunovion Senior Leadership Budget
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`Presentation, Latuda Brand Strategy and Budget, December 10, 2010) contains
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`sensitive financial and competitive commercial information relating to the budget
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`and marketing strategy for LATUDA®.
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`
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`Exhibit 2090: Exhibit 2090 (Latuda® 2012 Budget Presentation Meeting,
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`November 7, 2011) contains sensitive financial and competitive commercial
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`information relating to the proposed LATUDA® budget for 2012.
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`
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`Exhibit 2131: Exhibit 2131 is the declaration of Dr. Stephen Stahl. In the
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`declaration, Dr. Stahl expresses his opinion that claims 1-75 of the challenged
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`patent (U.S. 9,815,827) would not have been obvious. In forming his opinion, Dr.
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`Stahl relied upon and discusses confidential documents containing proprietary data
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`and confidential communications with FDA and third parties.
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`4
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`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`Exhibits 2058, 2059, 2060: Exhibits 2058-2060 are confidential Clinical
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`Study Reports submitted to FDA relating to LATUDA®. Each contains
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`proprietary data related to various clinical studies.
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`
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`Exhibit 2092: Exhibit 2092 (Covance Cardiac Safety Services, Phase III
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`Repolarization Assessment Plan, Lurasidone, Feb. 13, 2007) is a document
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`describing a plan prepared by a third party at Patent Owner’s request to assess
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`lurasidone. It contains proprietary scientific protocols and data.
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`
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`Exhibit 2093: Exhibit 2093 (Medifacts International, Review of the
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`Preliminary Results from MK-3756 Protocol 023, February 7, 2007) describes the
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`results of a study performed by a third party at Patent Owner’s request relating to
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`lurasidone. It contains proprietary scientific protocols and data.
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`
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`Exhibit 2094: Exhibit 2094 (Clinical Pharmacology and Biopharmaceutics
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`Review Aid, Dainippon Sumitomo Pharma America, Inc., Lurasidone) describes
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`the results of a clinical study performed by Patent Owner. It contains proprietary
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`scientific protocols and data.
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`Exhibit 2095: Exhibit 2095 (Sunovion FDA Contact Report, Lurasidone
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`HCl, October 25, 2010) describes proprietary communications between Patent
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`Owner and FDA regarding lurasidone.
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`5
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`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`Exhibit 2138: Exhibit 2138 (Memorandum With Respect to Lurasidone
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`
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`Development Handover Status (2007) describes a confidential agreement between
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`Patent Owner and a third party relating to the development of lurasidone.
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`Patent Owner Response: The Patent Owner Response includes portions
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`that refer to and discuss the above-described exhibits.
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`IV. Certification of Non-Publication
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`On behalf of Patent Owner, undersigned counsel certifies the information
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`sought to be sealed has not been published or otherwise made public. Further, the
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`confidentiality of this information has been consistently maintained by the Patent
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`Owner during this proceeding, and any related proceedings.
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`V. Certification of Conference with Opposing Party Pursuant to 37 C.F.R.
`§42.54
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`Patent Owner has conferred in good faith with Petitioner and has reached
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`agreement as to the terms and the scope of the Proposed Protective Order.
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`Specifically, Patent Owner and Petitioner have agreed to use the default protective
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`order set forth in the Office Patent Trial Practice Guide to govern the handling of
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`confidential information in this proceeding.
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`VI. Proposed Protective Order
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`The Protective Order attached hereto as Appendix A corresponds to the
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`default protective order set forth in the Office Patent Trial Practice Guide. Patent
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`Owner and Petitioner have agreed to use the attached protective order to govern the
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`6
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`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`handling of confidential information in this proceeding. Per agreement of the
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`parties, confidential information will be designated “IPR Protective Order
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`Material.” Accordingly, Patent Owner respectfully requests entry of the Proposed
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`Protective Order.
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`VII. Confidential and Non-Confidential Versions
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` Submitted herewith are non-confidential versions of the Patent Owner
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`Response and Ex. 2131. Confidential versions are being filed concurrently.
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`VIII. Conclusion
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`For the above reasons, Patent Owner, Sumitomo Dainippon Pharma Co.,
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`Ltd, respectfully requests Exhibits 2058-2060, 2069, 2074-2076, 2078, 2080,
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`2082-2083, 2089-2090, 2092-2095, 2132, and 2138, and the unredacted versions
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`of Ex. 2131 and the Patent Owner Response, to be treated as confidential
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`information and be placed under seal.
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`
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`Date: March 11, 2021
`
`
`Fish & Richardson P.C.
`Telephone: (612) 335-5070
`Facsimile: (877) 769-7945
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`
` Respectfully submitted,
`
` /Dorothy P. Whelan/
` Dorothy P. Whelan
` Reg. No. 33,814
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`7
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`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`CERTIFICATE OF SERVICE
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`Pursuant to 37 CFR §§ 42.6(e)(4), the undersigned certifies that on March
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`11, 2021, a complete and entire copy of this Patent Owner’s Motion to Seal was
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`provided by email to the Petitioner by serving the correspondence email addresses
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`of record as follows:
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`
`
`Louis H. Weinstein
`Patrick G. Pollard
`Windels Marx Lane & Mittendorf, LLP
`1 Giralda Farms
`Madison, NJ 07940
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`Email: lweinstein@windelsmarx.com
`ppollard@windelsmarx.com
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`/Diana Bradley/
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`Diana Bradley
`Fish & Richardson P.C.
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`(858) 678-5667
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`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
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`APPENDIX A
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`
`9
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`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
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`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`
`
`
`
`
`
`SLAYBACK PHARMA LLC,
`Petitioners
`
`v.
`
`SUMITOMO DAINIPPON PHARMA CO., LTD.,
`Patent Owner
`
`
`
`
`
`
`
`
`
`
`
`
`Case IPR2020-01053
`Patent No. 9,815,827
`
`
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`
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`PROTECTIVE ORDER
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`This standing protective order governs the treatment and filing of
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`confidential information, including documents and testimony.
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`1. Confidential information shall be clearly marked ‘‘IPR PROTECTIVE
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`ORDER MATERIAL.’’
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`10
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`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`2. Access to confidential information is limited to the following individuals
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`who have executed the acknowledgment appended to this order:
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`(A) Parties. Persons who are owners of a patent involved in the proceeding
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`and other persons who are named parties to the proceeding.
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`(B) Party Representatives. Representatives of record for a party in the
`
`proceeding.
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`(C) Experts. Retained experts of a party in the proceeding who further
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`certify in the Acknowledgement that they are not a competitor to any party, or a
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`consultant for, or employed by, such a competitor with respect to the subject matter
`
`of the proceeding.
`
`(D) In-house counsel. In-house counsel of a party.
`
`(E) Other Employees of a Party. Employees, consultants or other persons
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`performing work for a party, other than in-house counsel and in-house counsel’s
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`support staff, who sign the Acknowledgement shall be extended access to
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`confidential information only upon agreement of the parties or by order of the
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`Board upon a motion brought by the party seeking to disclose confidential
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`information to that person. The party opposing disclosure to that person shall have
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`the burden of proving that such person should be restricted from access to
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`confidential information.
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`11
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`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`(F) The Office. Employees and representatives of the Office who have a need
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`for access to the confidential information shall have such access without the
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`requirement to sign an Acknowledgement. Such employees and representatives
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`shall include the Director, members of the Board and their clerical staff, other
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`support personnel, court reporters, and other persons acting on behalf of the Office.
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`(G) Support Personnel. Administrative assistants, clerical staff, court
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`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
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`Acknowledgement, but shall be informed of the terms and requirements of the
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`Protective Order by the person they are supporting who receives confidential
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`information.
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`3. Persons receiving confidential information shall use reasonable efforts to
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`maintain the confidentiality of the information, including:
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`(A) Maintaining such information in a secure location to which persons not
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`authorized to receive the information shall not have access;
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`(B) Otherwise using reasonable efforts to maintain the confidentiality of the
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`information, which efforts shall be no less rigorous than those the recipient uses to
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`maintain the confidentiality of information not received from the disclosing party;
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`12
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`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`(C) Ensuring that support personnel of the recipient who have access to the
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`confidential information understand and abide by the obligation to maintain the
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`confidentiality of information received that is designated as confidential; and
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`(D) Limiting the copying of confidential information to a reasonable number
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`of copies needed for conduct of the proceeding and maintaining a record of the
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`locations of such copies.
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`4. Persons receiving confidential information shall use the following
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`procedures to maintain the confidentiality of the information:
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`(A) Documents and Information Filed With the Board.
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`(i) A party may file documents or information with the Board under seal,
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`together with a non-confidential description of the nature of the confidential
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`information that is under seal and the reasons why the information is confidential
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`and should not be made available to the public. The submission shall be treated as
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`confidential and remain under seal, unless, upon motion of a party and after a
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`hearing on the issue, or sua sponte, the Board determines that the documents or
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`information do not to qualify for confidential treatment.
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`(ii) Where confidentiality is alleged as to some but not all of the information
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`submitted to the Board, the submitting party shall file confidential and non-
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`confidential versions of its submission, together with a Motion to Seal the
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`confidential version setting forth the reasons why the information redacted from
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`13
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`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`the non-confidential version is confidential and should not be made available to the
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`public. The nonconfidential version of the submission shall clearly indicate the
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`locations of information that has been redacted. The confidential version of the
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`submission shall be filed under seal. The redacted information shall remain under
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`seal unless, upon motion of a party and after a hearing on the issue, or sua sponte,
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`the Board determines that some or all of the redacted information does not qualify
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`for confidential treatment.
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`(B) Documents and Information Exchanged Among the Parties. Information
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`designated as confidential that is disclosed to another party during discovery or
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`other proceedings before the Board shall be clearly marked as “IPR PROTECTIVE
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`ORDER MATERIAL” and shall be produced in a manner that maintains its
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`confidentiality.
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`(j) Standard Acknowledgement of Protective Order. The following form may
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`be used to acknowledge a protective order and gain access to information covered
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`by the protective order:
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`14
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`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
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`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`
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`
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`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`
`
`
`
`
`
`SLAYBACK PHARMA LLC,
`Petitioners
`
`v.
`
`SUMITOMO DAINIPPON PHARMA CO., LTD.,
`Patent Owner
`
`
`
`Standard Acknowledgment for Access to
`Protective Order Material
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`
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`Case IPR2020-01053
`Patent No. 9,815,827
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`
` I
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` _____________________________, affirm that I have read the Protective
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`Order; that I will abide by its terms; that I will use the confidential information
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`only in connection with this proceeding and for no other purpose; that I will only
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`allow access to support staff who are reasonably necessary to assist me in this
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`15
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`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`proceeding; that prior to any disclosure to such support staff I informed or will
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`inform them of the requirements of the Protective Order; that I am personally
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`responsible for the requirements of the terms of the Protective Order and I agree to
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`submit to the jurisdiction of the Office and the United States District Court for the
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`Eastern District of Virginia for purposes of enforcing the terms of the Protective
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`Order and providing remedies for its breach.
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`
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`Signed ____________________________________________
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`16
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