`571-272-7822
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`Paper: 71
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` Entered: September 15, 2016
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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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`LUPIN LTD. and LUPIN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD.,
`Patent Owner.
`____________
`
`Case IPR2015-01099
`Patent 8,699,290 B2
`____________
`
`
`
`Before FRANCISCO C. PRATS, ERICA A. FRANKLIN, and
`GRACE KARAFFA OBERMANN, Administrative Patent Judges.
`
`OBERMANN, Administrative Patent Judge.
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`
`
`ORDER
`Granting Patent Owner’s Renewed Motion to Seal
`37 C.F.R. §§ 42.14
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`IPR2015-01099
`Patent 8,699,290 B2
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`On July 29, 2016, Patent Owner filed a Renewed Motion to Seal.
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`Paper 67 (“Motion” or “Mot.”). Concurrently herewith, we grant
`Petitioner’s unopposed motion to enter the Board’s Default Protective Order,
`which governs the disclosure of confidential information in this proceeding.
`Patent Owner states that “Petitioner Lupin does not oppose this motion.”
`Mot. 1. No party has filed an opposition. This Order addresses the Motion.
`Patent Owner requests sealing of the following documents: (1)
`excerpts of Patent Owner’s New Drug Application (“NDA”) (Exs. 2096,
`2102, 2103, 2110, 2251, 2291-2293); (2) information related to alleged
`commercial success of Patent Owner’s product from a related district court
`case (Ex. 2258, 2323); and (3) testing reports and materials that allegedly
`document proprietary testing methods of a non-party test company
`(Exs. 2267-2278, 2294). Mot. 1. Patent Owner also requests sealing of
`portions of its Patent Owner’s Response (Paper 22) and witness declarations
`(Exs. 2126 (Myers), 2128 (Paulson), 2082 (Williams), 2116 (Trattler), and
`2130 (Jarosz)) on the basis that they cite or substantially describe the above
`categories of documents. Id.
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`The Board previously denied requests to seal the same documents that
`are the subject of the instant Motion. Paper 57 (for Exhibit 2323); Paper 61
`(for all other documents that are the subject of the Motion). On
`September 12, 2016, we entered a Final Written Decision. Paper 69.
`
`
`Motion to Seal Exhibit 2323
`Among other documents, Patent Owner seeks to seal Exhibit 2323.
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`Mot. 1. We previously denied Patent Owner’s request to seal portions of
`Exhibit 2323. Paper 57. We determined that “Patent Owner has sufficiently
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`IPR2015-01099
`Patent 8,699,290 B2
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`established that the cited portions of Exhibit 2323 contain confidential
`information.” Id. at 3. However, we denied the prior motion because we
`further determined that “a protective order has not been entered” in the
`proceeding, “and an acceptable proposed protective order has not been
`filed.” Id. Given that a suitable protective order is entered concurrently
`herewith, and in light of our prior determination that Patent Owner has
`shown good cause for sealing Exhibit 2323, we grant Patent Owner’s
`renewed request to seal that document.
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`
`Motion to Seal NDA Documents and Filings Citing the NDA
`We previously denied a request to seal Exhibits 2096, 2102, 2103,
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`2110, 2251, 2291–2293 as well as portions of Patent Owner’s Response and
`witness declarations that cite or describe those exhibits. Paper 61, 6–7. We
`denied that request because it was accompanied by a proposed stipulated
`protective order that was “not in an adequate form for entry.” Id. at 3. We
`further noted that Exhibit 2096 was sought to be sealed in its entirety
`without an adequate showing that all of the material reflected therein is
`confidential. Id. at 7. We also noted “that the entirety of Exhibit 2293 lacks
`any content. Every page of that exhibit is essentially blank, containing only
`a portion of an empty grid.” Id. Our prior concerns have been addressed.
`Concurrently herewith, we issue an order granting the parties’ joint request
`to enter the Board’s Default Protective Order, which governs disclosure of
`confidential information in these proceedings. Patent Owner, moreover, has
`provided revised redacted versions of Exhibits 2096 and 2293 that address
`the issues noted in our prior decision—a public version of Exhibit 2096
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`Patent 8,699,290 B2
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`containing appropriate redactions has been filed, and Exhibit 2293 has been
`refiled with content instead of a blank grid.
`Patent Owner presents information sufficient to demonstrate that
`Exhibits 2096, 2102, 2103, 2110, 2251, 2291–2293 reflect Patent Owner’s
`confidential information and that good cause exists for sealing those
`exhibits, as well as specific portions of the Patent Owner’s Response and the
`Myers, Trattler, Jarosz, and Willaims declarations that cite or describe the
`confidential information contained in those exhibits. Mot. 8–11. No party
`opposes the request. Accordingly, we grant Patent Owner’s request to seal
`the NDA and related portions of Patent Owner’s Response and witness
`declarations that cite or describe the NDA.
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`Motion to Seal Exhibit 2258
`We previously denied a request to seal Exhibit 2258 (deposition
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`testimony of Ms. Tracy Valorie, an officer of Patent Owner’s parent
`company) because the exhibit contained “seven inconsecutive pages from a
`transcript of the deposition” and the first and second pages were not shown
`to reflect any confidential information. Paper 61, 8. Under those
`circumstances, we were not persuaded that Patent Owner had shown good
`cause for sealing Exhibit 2258 in its entirety. Id. Patent Owner has filed a
`revised public version of Exhibit 2258 that addresses our prior concerns,
`redacting no material on the first or second pages of the exhibit. No party
`opposes the Motion. According, we grant Patent Owner’s request to seal
`Exhibit 2258.
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`Motion to Seal Exhibits of Non-Party BioScience
`In addition, Patent Owner requests to seal exhibits alleged to reflect
`confidential information owned by non-party BioScience, specifically,
`Exhibits 2267–2278, 2294 and portions of the Declaration of Dr. Paulson
`(Ex. 2128) that cite or describe those exhibits. Mot. 11. Previously, we
`denied Patent Owner’s prior request to seal those materials because Patent
`Owner had “neither demonstrated that the exhibits contain proprietary
`information nor established its standing to assert” any interest of BioScience
`in this proceeding. Paper 61, 8–9. The instant Motion, by contrast, is
`supported by a declaration of Deanna J. Field, Vice President of Finance and
`Administration of BioScience (Ex. 2347). That declaration establishes
`adequately BioScience’s interest in shielding from public disclosure certain
`proprietary testing protocol and standard operating procedures, kept
`confidential by BioScience, as reflected in Exhibits 2249–2263. Mot. 11–
`12; Ex. 2347, 3–11.
`Patent Owner shows sufficiently that public disclosure of the
`information sought to be sealed would cause financial damage to
`BioScience. Ex. 2347, 11. Patent Owner further shows sufficiently that
`“BioScience has authorized Patent Owner to request that Exs. 2267-2278
`and 2294 be sealed.” Mot. 11–12 (bridging sentence) (citing Ex. 2347, 2).
`Patent Owner submits an appropriately redacted public version of Exhibit
`2267. Petitioner further shows sufficiently that the remaining exhibits in this
`category (Exhibits 2268–2278 and 2294) “contain confidential information
`on all but one page, thus redaction is not practical.” Mot. 12 (citing Ex.
`2347, 3–11). No party has filed an opposition. Accordingly, Patent
`Owner’s request to seal Exhibits 2267–2278, 2294 is granted.
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`Requiring a Joint Stipulation and Counsel Certification
`Within thirty five (35) days after entry of the Final Written Decision,
`Patent Owner and Petitioner shall file a Joint Stipulation that identifies with
`particularity the exact portions (by page or paragraph number) of all sealed
`papers and exhibits that are cited in the Final Written Decision. The Joint
`Stipulation shall include a Counsel Certification attesting to the accuracy
`and completeness of the Joint Stipulation, including a statement verifying
`that the exact portion of each paper and exhibit cited in the Final Written
`Decision is identified (by page or paragraph number) in the Joint Stipulation.
`We specifically provided the parties advance notice “that information
`subject to a protective order will become public if identified in a final
`written decision in this proceeding.” Paper 61, 4. Further, the Rules of
`Practice for Trial Before the Patent Trial and Appeal Board (“Rules of
`Practice”) provide that:
`Confidential information that is subject to a protective order
`ordinarily will become public 45 days after denial of a petition to
`institute a trial or 45 days after final judgment in a trial. There is
`an expectation that information will be made public where the
`existence of the information is referred to in a decision to grant
`or deny a request to institute a review or is identified in a final
`written decision following a trial. A party seeking to maintain
`the confidentiality of information, however, may file a motion to
`expunge the information from the record prior to the information
`becoming public.
`77 Fed. Reg. 48756, 48761, Section I.E.6. (Aug. 14, 2012) (emphasis
`added). There is a presumption, therefore, that any confidential information
`cited in the Final Written Decision shall become public forty five (45) days
`after entry of the Final Written Decision.
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`A strong public interest favors maintaining a complete and
`understandable record of the patent history, including the factual basis for
`the Board’s findings and the intelligibility of the Final Written Decision. By
`placing confidential information before the Board, Petitioner accepted the
`risk that the information will become public if relied upon in the Final
`Written Decision. Rules of Practice, 77 Fed. Reg. 48756, 48761, Section
`I.E.6. (Aug. 14, 2012) (“There is an expectation that information will be
`made public where the existence of the information . . . is identified in a
`final written decision following a trial.”).
`Accordingly, all papers and exhibits identified in the Joint Stipulation
`shall be unsealed and made publicly available forty five (45) days after entry
`of the Final Written Decision, unless a revised public version of the paper or
`exhibit, conforming to the following requirements, is filed no later than
`thirty five (35) days (that is, ten days prior to the date set for unsealing) after
`entry of the Final Written Decision. Specifically, a party may prevent the
`unsealing of any paper or exhibit identified in the Joint Stipulation by filing,
`no later than thirty five (35) days after entry of the Final Written Decision, a
`revised public version of the paper or exhibit in which each page or
`paragraph cited in the Final Written Decision is left unredacted. Material
`not cited in the Final Written Decision may be redacted in the revised public
`version.
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`It is
`ORDERED that Patent Owner’s Renewed Motion to Seal is granted
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`to the extent set forth in this Order;
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`FURTHER ORDERED that, within thirty five (35) days after entry of
`the Final Written Decision, Patent Owner and Petitioner shall file a Joint
`Stipulation as described in this Order, which identifies with particularity the
`exact portions (by page or paragraph number) of all sealed papers and
`exhibits that are cited in the Final Written Decision;
`FURTHER ORDERED that the Joint Stipulation shall include a
`Counsel Certification attesting to the accuracy and completeness of the Joint
`Stipulation, including a statement verifying that the exact portion of each
`paper and exhibit cited in the Final Written Decision is identified (by page or
`paragraph number) in the Joint Stipulation;
`FURTHER ORDERED that all papers and exhibits identified in the
`Joint Stipulation shall be unsealed and made publicly available forty five
`(45) days after entry of the Final Written Decision, unless a revised public
`version of the paper or exhibit, conforming to the requirements of this Order,
`is filed no later than thirty five (35) days (that is, ten days prior to the date
`set for unsealing) after entry of the Final Written Decision;
`FURTHER ORDERED that a party may prevent the unsealing of any
`paper or exhibit identified in the Joint Stipulation by filing, no later than
`thirty five (35) days after entry of the Final Written Decision, a revised
`public version of the paper or exhibit in which each page or paragraph cited
`in the Final Written Decision is left unredacted.
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`Patent 8,699,290 B2
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`PETITIONER:
`Deborah Yellin
`Jonathan Lindsay
`Teresa Rea
`Shannon Lentz
`CROWELL & MORING LLP
`DYellin@crowell.com
`JLindsay@crowell.com
`trea@crowell.com
`slentz@crowell.com
`
`
`PATENT OWNER:
`Bryan Diner
`Justin Hasford
`Joshua Goldberg
`FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP
`bryan.diner@finnegan.com
`justin.hasford@finnegan.com
`joshua.goldberg@finnegan.com
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