`571-272-7822
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` Paper: 91
` Entered: August 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.,
`LUPIN LTD., and LUPIN PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.,
`Patent Owner.
`_______________
`
`Case IPR2015-009031
`Patent 8,129,431 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 and 42.54
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`
`
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`1 Case IPR2015-1871 has been joined with this proceeding.
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`IPR2015-00903
`Patent 8,129,431 B2
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`
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`In an Order dated June 21, 2016, the Board denied Patent Owner’s
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`request to enter a Stipulated Protective Order. Paper 77. That same day, the
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`Board denied without prejudice all pending motions to seal documents.
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`Papers 77–80. On July 29, 2016, Petitioner filed a Renewed Motion to Seal.
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`Paper 86 (“Motion” or “Mot.”). This Order addresses that Motion. Patent
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`Owner avers that “Petitioner Lupin” does not oppose the Motion. See
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`Mot. 1. No party has filed an opposition to the Motion.
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`Concurrently herewith, we enter an Order granting the parties’ joint
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`request for entry of an Amended Stipulated Protective Order (Paper 81,
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`App’x A (copy of Amended Stipulated Protective Order)), which governs
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`disclosure of confidential information in this proceeding.
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`
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`New Public Versions of Certain Documents Marked Confidential
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`Patent Owner does not seek to seal certain portions of documents that
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`were marked confidential and filed provisionally under seal in this
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`proceeding. Mot. 2–3 (identifying documents previously marked as
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`confidential and filed provisionally under seal; namely, portions of Patent
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`Owner’s Response (Paper 33), Petitioner’s Reply to Patent Owner’s
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`Response to Petition (Ex. 2271), Patent Owner’s Motion for Observations
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`(Paper 58), and declarations or testimony of Dr. Paul Laskar (Ex. 2114 and
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`Ex. 2272), Ivan Hoffman (Ex. 2273), Robert O. Williams (Ex. 2082), and
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`Stephen G. Davies (Ex. 2105)). Patent Owner states that it will file new
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`public versions of those papers and exhibits without the “PROTECTIVE
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`ORDER MATERIAL—FED R. EVID 615” marking. Id. Patent Owner has
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`completed that action. See Papers 33, 58, Ex. 2015, Ex. 2082, Ex. 2114,
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`2
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`IPR2015-00903
`Patent 8,129,431 B2
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`Ex. 2271, Ex. 2272, Ex. 2273. Most of those documents were the subject of
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`Patent Owner’s prior motion to seal (Paper 36) that was denied without
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`prejudice (Paper 77).
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`Patent Owner further states that is does not seek to seal certain
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`research and development presentations (Ex. 2220 and Ex. 2226) that were
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`the subject of our prior decision (Paper 77) that denied without prejudice
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`Patent Owner’s prior motion to seal (Paper 36). Mot. 2–3. Patent Owner
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`states that a public version of those exhibits will be filed. Id. at 3. Patent
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`Owner has completed that action. See Ex. 2220, Ex. 2226.
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`No further action is required regarding the above documents.
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`
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`Granting Request to Seal New Drug Application Exhibits
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`Patent Owner requests to seal portions of Exhibits 2096, and further,
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`to seal in their entirety Exhibits 2102, 2103, and 2110. Mot. 1. Patent
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`Owner identifies those exhibits as excerpts of Patent Owner’s New Drug
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`Application (“NDA”). Id. at 5. We previously denied Patent Owner’s prior
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`motion to seal Exhibit 2096 because Patent Owner sought to seal that
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`document in its entirety without establishing adequately that all of the
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`material reflected therein is confidential. Paper 77, 7. For example, we
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`observed that page 1 of Exhibit 2096 “does not appear to contain any
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`confidential or proprietary information” and directed Patent Owner to
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`address that issue in any later-filed motion to seal Exhibit 2096. Id. Patent
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`Owner accompanies its renewed request to seal Exhibit 2096 with a redacted
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`version that addresses adequately the Board’s concerns. Mot. 5, 6; Ex. 2096
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`(public version).
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`3
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`IPR2015-00903
`Patent 8,129,431 B2
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`Based on our review of Exhibits 2102, 2103, and 2110, and Patent
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`Owner’s arguments pertaining to them, we are persuaded that good cause
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`exists to seal those exhibits in their entirety. Mot. 6 (explaining that
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`redaction “would not be practical”). “Petitioner Lupin” does not oppose
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`sealing Exhibits 2096, 2102, 2103, or 2210 as proposed by Patent Owner,
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`and no party has filed an opposition to that request. See id. at 5. Under the
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`circumstances, Patent Owner’s request to seal Exhibits 2096, 2102, 2103,
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`and 2110 is granted.
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`Patent Owner requests to seal other documents alleged to reflect
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`information contained in the exhibits relating to the NDA. Specifically,
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`Patent Owner seeks to seal pages 3, 55–57, and 59 of Patent Owner’s
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`Response (Paper 34); paragraphs 152, 153, 177, 178, 180, 181, 185, 186,
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`and 187 of the declaration of Dr. Williams (Ex. 2082); paragraphs 16, 41,
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`and 49 of the declaration of Dr. Trattler (Ex. 2116), paragraphs 17, 56, 82,
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`and 134 of the declaration of Dr. Jarosz (Ex. 2130); and pages 25, 26, 34, 35,
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`37–40, 49, and 53 of the deposition transcript of Mr. Hoffman (Ex. 2273).
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`Mot. 5.
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`Patent Owner shows sufficiently that those documents “describe the
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`confidential information contained in the NDA.” Id. at 6. “Petitioner
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`Lupin” does not oppose the sealing of those documents and, further, no party
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`has filed an opposition to the Motion. See id. at 5. Accordingly, Patent
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`Owner’s request to seal those documents is granted.
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`4
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`IPR2015-00903
`Patent 8,129,431 B2
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`
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`Requiring a Joint Stipulation and Counsel Certification
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`By September 2, 2016, Patent Owner and Petitioner shall file a Joint
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`Stipulation that identifies with particularity the exact portions (by page or
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`paragraph number) of all sealed papers and exhibits that are cited in the
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`Final Written Decision. The Joint Stipulation shall include a Counsel
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`Certification attesting to the accuracy and completeness of the Joint
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`Stipulation, including a statement verifying that the exact portion of each
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`paper and exhibit cited in the Final Written Decision is identified (by page or
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`paragraph number) in the Joint Stipulation.
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`We specifically provided the parties advance notice “that information
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`subject to a protective order will become public if identified in a final
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`written decision in this proceeding.” Paper 77, 4. Further, the Rules of
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`Practice for Trial Before the Patent Trial and Appeal Board (“Rules of
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`Practice”) provide that:
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`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.
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`77 Fed. Reg. No. 157, Part V at Section I.E.6. (Aug. 14, 2012) (emphasis
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`added). There is a presumption, therefore, that any confidential information
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`cited in the Final Written Decision, entered July 28, 2016, shall become
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`public on September 12, 2016.
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`5
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`IPR2015-00903
`Patent 8,129,431 B2
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`A strong public interest favors maintaining a complete and
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`understandable record of the patent history, including the factual basis for
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`the Board’s findings and the intelligibility of the Final Written Decision.
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`Patent Owner recognizes that public interest but fails to show sufficiently
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`that it is outweighed by any private business interest. In this case Mot. 2–5.
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`By placing confidential information before the Board, Patent Owner
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`accepted the risk that the information would become public if relied upon in
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`the Final Written Decision. Rules of Practice, 77 Fed. Reg. No. 157, Part V
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`at Section I.E.6. (Aug. 14, 2012) (“There is an expectation that information
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`will be made public where the existence of the information . . . is identified
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`in a final written decision following a trial.”).
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`Accordingly, all papers and exhibits identified in the Joint Stipulation
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`shall be unsealed and made publicly available on September 12, 2016, unless
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`a revised public version of the paper or exhibit, conforming to the following
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`requirements, is filed by September 2, 2016 (that is, ten days prior to the
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`date set for unsealing). Specifically, a party may prevent the unsealing of
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`any paper or exhibit identified in the Joint Stipulation by filing, no later than
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`September 2, 2016, a revised public version of the paper or exhibit in which
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`each page or paragraph cited in the Final Written Decision is left unredacted.
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`Material not cited in the Final Written Decision may be redacted in the
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`revised public version.
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`6
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`IPR2015-00903
`Patent 8,129,431 B2
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`Other Matters
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`Any request for reconsideration of this Order shall be filed no later
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`than September 2, 2016.
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`No further briefing is authorized at this time.
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`Should the parties require assistance in complying with this Order, the
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`Board is available for a teleconference during the week of August 29, 2016.
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`Counsel may initiate a request for a teleconference by sending an email to
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`Trials@USPTO.gov.
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`It is
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`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, by September 2, 2016, Patent Owner and
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`Petitioner shall file a Joint Stipulation as described in this Order, which
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`identifies with particularity the exact portions (by page or paragraph
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`number) of all sealed papers and exhibits that are cited in the Final Written
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`Decision;
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`FURTHER ORDERED that the Joint Stipulation shall include a
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`Counsel Certification attesting to the accuracy and completeness of the Joint
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`Stipulation, including a statement verifying that the exact portion of each
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`paper and exhibit cited in the Final Written Decision is identified (by page or
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`paragraph number) in the Joint Stipulation;
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`FURTHER ORDERED that all papers and exhibits identified in the
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`Joint Stipulation shall be unsealed and made publicly available on
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`7
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`IPR2015-00903
`Patent 8,129,431 B2
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`September 12, 2016, unless a revised public version of the paper or exhibit,
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`conforming to the requirements of this Order, is filed by September 2, 2016;
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`FURTHER ORDERED that a party may prevent the unsealing of any
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`paper or exhibit identified in the Joint Stipulation by filing, no later than
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`September 2, 2016, a revised public version of the paper or exhibit in which
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`each page or paragraph cited in the Final Written Decision is left unredacted;
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`and
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`FURTHER ORDERED that any request for reconsideration of this
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`Order shall be filed no later than September 2, 2016.
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`8
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`IPR2015-00903
`Patent 8,129,431 B2
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`PETITIONER:
`Jitendra Malik
`jitty.malik@alston.com
`Lance Soderstrom
`lance.soderstrom@alston.com
`Hidetada James Abe
`james.abe@alston.com
`Joseph Janusz
`joe.janusz@alston.com
`
`Deborah Yellin
`dyellin@crowell.com
`Jonathan Lindsay
`jLindsay@Crowell.com
`Shannon Lentz
`SLentz@Crowell.com
`
`PATENT OWNER:
`Bryan C. Diner
`bryan.diner@finnegan.com
`Justin J. Hasford
`justin.hasford@finnegan.com
`Joshua L. Goldberg
`joshua.goldberg@finnegan.com
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`9
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