Trials@uspto.gov
`571-272-7822
`
`
`
` Paper: 99
` Entered: August 29, 2016
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`
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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., and MYLAN INC.,
`Petitioner,
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.,
`Patent Owner.
`_______________
`
`Case IPR2015-00902
`Patent 8,669,290 B2
`_______________
`
`
`Before FRANCISCO C. PRATS, ERICA A. FRANKLIN, and
`GRACE KARAFFA OBERMANN, Administrative Patent Judges.
`
`OBERMANN, Administrative Patent Judge.
`
`
`
`ORDER
`Granting Patent Owner’s Renewed Motion to Seal (Paper 96)
`37 C.F.R. §§ 42.14 and 42.54
`
`
`
`
`571-272-7822
`
`
`
` Paper: 99
` Entered: August 29, 2016
`
`
`
`
`
`
`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., and MYLAN INC.,
`Petitioner,
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.,
`Patent Owner.
`_______________
`
`Case IPR2015-00902
`Patent 8,669,290 B2
`_______________
`
`
`Before FRANCISCO C. PRATS, ERICA A. FRANKLIN, and
`GRACE KARAFFA OBERMANN, Administrative Patent Judges.
`
`OBERMANN, Administrative Patent Judge.
`
`
`
`ORDER
`Granting Patent Owner’s Renewed Motion to Seal (Paper 96)
`37 C.F.R. §§ 42.14 and 42.54
`
`
`
`
`
`IPR2015-00902
`Patent 8,669,290 B2
`
`
`
`
`In an Order dated June 21, 2016, the Board denied Patent Owner’s
`
`request to enter a Stipulated Protective Order. Paper 85. That same day, the
`
`Board denied without prejudice all pending motions to seal documents.
`
`Papers 85–89. Thereafter, on July 28, 2016, the Board entered a Final
`
`Written Decision. Paper 90. On July 29, 2016, Patent Owner filed a
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`Renewed Motion to Seal. Paper 96 (“Motion” or “Mot.”). This Order
`
`addresses that Motion. Patent Owner states that “Petitioner Lupin” does not
`
`oppose the Motion, but that entity is not a party to this proceeding. Mot. 1.
`
`Petitioner has not filed an opposition to the Motion.
`
`
`
` Concurrently herewith, we enter an Order granting Petitioner’s
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`unopposed request for entry of the Default Protective Order (Paper 97,
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`App’x A (copy of Default Protective Order)), which governs the disclosure
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`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
`
`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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`
`
`2
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`
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`IPR2015-00902
`Patent 8,669,290 B2
`
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`ORDER MATERIAL—FED R. EVID 615” marking. Id. Patent Owner has
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`completed that action. See Papers 94, 96, Ex. 2015, Ex. 2082, Ex. 2114,
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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 85).
`
`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 85) that denied without prejudice
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`Patent Owner’s prior motion to seal (Paper 36). Mot. 3–4. Patent Owner
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`also indicates that it no longer seeks to seal Exhibits 2255, 2256, or 2257,
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`which in the prior motion to seal (Paper 36) were asserted to reflect
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`confidential information owned by non-party BioScience. Mot. 4. Patent
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`Owner states that a public version of those exhibits will be filed. Id. Patent
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`Owner has completed that action. See Ex. 2220, Ex. 2226, Ex. 2255,
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`Ex. 2256, Ex. 2257.
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`No further action is required regarding the above documents.
`
`
`
`Granting Request to Seal New Drug Application Exhibits
`
`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. 6. Patent
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`Owner identifies those exhibits as excerpts of Patent Owner’s New Drug
`
`Application (“NDA”). We previously denied Patent Owner’s prior motion
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`to seal Exhibit 2096 because Patent Owner sought to seal that document in
`
`its entirety without establishing adequately that all of the material reflected
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`therein is confidential. Paper 85, 7. For example, we observed that page 1
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`
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`3
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`
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`IPR2015-00902
`Patent 8,669,290 B2
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`of Exhibit 2096 “does not appear to contain any confidential or proprietary
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`information” and directed Patent Owner to address that issue in any later-
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`filed motion to seal Exhibit 2096. Id. Patent Owner accompanies its
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`renewed request to seal Exhibit 2096 with a redacted version that addresses
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`adequately the Board’s concerns. Mot. 6; Ex. 2096 (public version).
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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. 7–9. Petitioner has not
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`opposed sealing Ehibits 2096, 2102, 2103, or 2210 as proposed by Patent
`
`Owner. Accordingly, Patent Owner’s request to seal Exhibits 2096, 2102,
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`2103, and 2110 is granted.
`
`Patent Owner seeks to seal other documents alleged to reflect
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`information contained in Exhibits 2096, 2102, 2103, and 2110. Specifically,
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`Patent Owner seeks to seal pages 3, 48, 49, and 51 of Patent Owner’s
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`Response (Paper 34); paragraphs 143, 144, 167, 170, 171, 192, 193, and 194
`
`of the declaration of Dr. Williams (Ex. 2082); paragraphs 16, 41, and 49 of
`
`the declaration of Dr. Trattler (Ex. 2116), paragraphs 17, 56, 82, and 134 of
`
`the declaration of Dr. Jarosz (Ex. 2130); and pages 25, 26, 34, 35, 37–40, 49,
`
`and 53 of the deposition transcript of Mr. Hoffman (Ex. 2273). Mot. 7.
`
`Patent Owner shows sufficiently that those documents “cite or
`
`substantially describe the excerpts from the NDA” and, thereby, reveal
`
`confidential information. Id. Accordingly, Patent Owner’s request to seal
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`those documents is granted.
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`
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`4
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`IPR2015-00902
`Patent 8,669,290 B2
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`
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`Granting Request to Seal Exhibits of Non-Party BioScience
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`In addition, Patent Owner requests to seal exhibits alleged to reflect
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`confidential information owned by non-party BioScience; specifically,
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`Exhibits 2249–2263. Mot. 9. Previously, we denied Patent Owner’s prior
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`request to seal those materials because Patent Owner had “neither
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`demonstrated that the exhibits contain proprietary information nor
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`established its standing to assert” any interest of BioScience in this
`
`proceeding. Paper 88, 3. The instant Motion, by contrast, is supported by a
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`declaration of Deanna J. Field, Vice President of Finance and
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`Administration of BioScience (Ex. 2279). That declaration establishes
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`adequately BioScience’s interest in shielding from public disclosure certain
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`proprietary testing protocol and standard operating procedures, kept
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`confidential by BioScience, as reflected in Exhibits 2249–2263. Mot. 9;
`
`Ex. 2279, 3–11.
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`Patent Owner shows sufficiently that public disclosure of the
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`information sought to be sealed would cause financial damage to
`
`BioScience. Ex. 2279, 10. Patent Owner further shows sufficiently that
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`“BioScience has authorized Patent Owner to request that Exs. 2249–2263 be
`
`sealed.” Mot. 9–10 (citing Ex. 2279, 2). Patent Owner submits an
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`appropriately redacted public version of Ex. 2249. Petitioner also shows
`
`sufficiently that Exhibits 2250–2263 “contain confidential information on all
`
`but one page, thus redaction is not practical.” Mot. 10 (citing Ex. 2279, 3–
`
`11). Accordingly, Patent Owner’s request to seal Exhibits 2249–2263 is
`
`granted.
`
`
`
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`
`5
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`
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`IPR2015-00902
`Patent 8,669,290 B2
`
`
`
`Requiring a Joint Stipulation and Counsel Certification
`
`By September 2, 2016, 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 85, 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. No. 157, Part V at Section I.E.6. (Aug. 14, 2012) (emphasis
`
`added). There is a presumption, therefore, that any confidential information
`
`cited in the Final Written Decision, entered July 28, 2016, shall become
`
`public on September 12, 2016.
`
`
`
`6
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`
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`IPR2015-00902
`Patent 8,669,290 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
`
`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. 4–5,
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`9. 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
`
`the Final Written Decision. Rules of Practice, 77 Fed. Reg. No. 157, Part V
`
`at 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.”).
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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
`
`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
`
`any paper or exhibit identified in the Joint Stipulation by filing, no later than
`
`September 2, 2016, 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
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`revised public version.
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`7
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`IPR2015-00902
`Patent 8,669,290 B2
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`
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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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`
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`It is
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`ORDERED that Patent Owner’s Renewed Motion to Seal is granted
`
`to the extent set forth in this Order;
`
`FURTHER ORDERED that, by September 2, 2016, 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
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`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;
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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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`
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`8
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`IPR2015-00902
`Patent 8,669,290 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
`
`September 2, 2016, 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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`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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`9
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`IPR2015-00902
`Patent 8,669,290 B2
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`
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`PETITIONER:
`
`Jitendra Malik
`jitty.malik@alston.com
`
`Lance Soderstrom
`lance.soderstrom@alston.com
`
`Hidetada James Abe
`james.abe@alston.com
`
`
`
`PATENT OWNER:
`
`Bryan C. Diner
`bryan.diner@finnegan.com
`
`Justin J. Hasford
`justin.hasford@finnegan.com
`
`Joshua L. Goldberg
`joshua.goldberg@finnegan.com
`
`
`
`
`10
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