Trials@uspto.gov
`571-272-7822
`
`Paper: 73
`
` Entered: September 15, 2016
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`LUPIN LTD., LUPIN PHARMACEUTICALS INC.,
`INNOPHARMA LICENSING, INC., INNOPHARMA LICENSING LLC,
`INNOPHARMA INC., INNOPHARMA LLC,
`MYLAN PHARMACEUTICALS INC., and MYLAN INC.,
`Petitioners,
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD.,
`Patent Owner.
`____________
`
`Case IPR2015-01097 (Patent 8,754,131 B2)1
`Case IPR2015-01100 (Patent 8,927,606 B1)2
`Case IPR2015-01105 (Patent 8,871,813 B2)3
`____________
`
`
`Before FRANCISCO C. PRATS, ERICA A. FRANKLIN, and
`GRACE KARAFFA OBERMANN, Administrative Patent Judges.
`
`OBERMANN, Administrative Patent Judge.
`
`
`ORDER4
`Granting Patent Owner’s Renewed Motion to Seal
`37 C.F.R. §§ 42.14
`
`
`
`
`1 Case IPR2016-00089 has been joined with this proceeding.
`2 Case IPR2016-00091 has been joined with this proceeding.
`3 Case IPR2016-00090 has been joined with this proceeding.
`4 This Order addresses issues common to each proceeding; therefore, we
`enter the identical order in each proceeding.
`
`
`571-272-7822
`
`Paper: 73
`
` Entered: September 15, 2016
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`LUPIN LTD., LUPIN PHARMACEUTICALS INC.,
`INNOPHARMA LICENSING, INC., INNOPHARMA LICENSING LLC,
`INNOPHARMA INC., INNOPHARMA LLC,
`MYLAN PHARMACEUTICALS INC., and MYLAN INC.,
`Petitioners,
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD.,
`Patent Owner.
`____________
`
`Case IPR2015-01097 (Patent 8,754,131 B2)1
`Case IPR2015-01100 (Patent 8,927,606 B1)2
`Case IPR2015-01105 (Patent 8,871,813 B2)3
`____________
`
`
`Before FRANCISCO C. PRATS, ERICA A. FRANKLIN, and
`GRACE KARAFFA OBERMANN, Administrative Patent Judges.
`
`OBERMANN, Administrative Patent Judge.
`
`
`ORDER4
`Granting Patent Owner’s Renewed Motion to Seal
`37 C.F.R. §§ 42.14
`
`
`
`
`1 Case IPR2016-00089 has been joined with this proceeding.
`2 Case IPR2016-00091 has been joined with this proceeding.
`3 Case IPR2016-00090 has been joined with this proceeding.
`4 This Order addresses issues common to each proceeding; therefore, we
`enter the identical order in each proceeding.
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`On July 29, 2016, Patent Owner filed a Renewed Motion to Seal.
`
`Paper 68 (“Motion” or “Mot.”).5 Concurrently herewith, we issue an order
`granting the parties’ request for entry of an Amended Proposed Stipulated
`Protective Order. A Final Written Decision was entered by the Board on
`September 12, 2016. Paper 70.
`Patent Owner seeks to seal the following exhibits and papers: (1)
`excerpts of Patent Owner’s New Drug Application (“NDA”) (Exs. 2096,
`2102, 2103, 2110, 2251, 2291–2293); (2) information relating to assertions
`of alleged commercial success of Patent Owner’s product from a related
`district court case (Exs. 2258, 2323); and (3) certain testing reports and
`materials relating to assertedly proprietary testing methods of a third-party
`test company (Ex. 2267–2278, 2294).
`Patent Owner further seeks to seal portions of Patent Owner’s
`Response (Paper 23) and witness declarations (Exs. 2126 (Myers), 2128
`(Paulson), 2082 (Williams), 2116 (Trattler), and 2130 (Jarosz)) alleged to
`cite or describe the above categories of documents. Mot. 1. Patent Owner
`avers that “Petitioner Lupin does not oppose” the Motion. Id. No party has
`filed an opposition.
`
`
`Patent Owner’s NDA Documents and Filings Citing the NDA
`We previously denied a request to seal Exhibits 2096, 2102, 2103,
`
`2110, 2251, 2291–2293 as well as portions of Patent Owner’s Response and
`
`
`5 Patent Owner attests that a “word-for-word identical paper” was filed in
`each proceeding. Mot. 1 n.4. For convenience, we refer to papers filed in
`IPR2015-01097.
`
`
`
`2
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`witness declarations that cite or describe those exhibits. Paper 58, 6–7. We
`denied that request because it was accompanied by a proposed stipulated
`protective order that was “not in an adequate from for entry.” Id. at 3. We
`further noted that the request to seal Exhibit 2096 pertains to the document
`in its entirety without establishing adequately that all of the material
`reflected therein is confidential. Id. at 7.
`
`The parties have addressed adequately our prior concerns about the
`lack of an adequate protective order. Concurrently herewith, we issue an
`order granting the parties’ joint request to enter an Amended Proposed
`Stipulated Protective Order (Paper 64, App’x A), which governs disclosure
`of confidential information in these proceedings.
`Patent Owner also has addressed adequately our prior concerns about
`Exhibit 2096 by providing a revised, redacted version of Exhibit 2096 that is
`available to the public. Patent Owner also 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–
`10. 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.
`
`
`
`
`
`
`
`3
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`
`Information Relating to Allegations of Commercial Success
`Patent Owner seeks to seal Exhibits 2258 and 2323, relating to
`
`allegations of secondary considerations of non-obviousness and, in
`particular, the alleged success of Patent Owner’s commercial product. We
`previously denied a request to seal Exhibit 2258 (deposition 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 58, 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.
`Exhibit 2323 was not the subject of a prior motion to seal. That
`exhibit is a Reply Expert Report of John C. Jarosz. Pages 26 and 39 of
`Exhibit 2323 are alleged to reflect Patent Owner’s market information
`related to the commercial product at issue. Mot. 11.
`Patent Owner presents information sufficient to demonstrate that
`Exhibits 2258 and 2323 reflect Patent Owner’s confidential information and
`that good cause exists for sealing those exhibits. Id. at 10–11. Patent Owner
`also shows sufficiently that portions of Exhibit 2130 (a declaration of Mr.
`Jarosz) reflect confidential information contained in Exhibit 2258. Id. at 11.
`No party opposes the request. Accordingly, we grant Patent Owner’s
`request to seal Exhibits 2258 and 2323, as well as portions of the Jarosz
`declaration (Ex. 2130) that cite or describe those exhibits.
`
`
`
`4
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`
`
`Granting Request 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. 12. 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 58, 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. 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. 12 (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. 12–13 (bridging sentence)
`
`
`
`5
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`(citing Ex. 2347, 3–11). No party has filed an opposition. Accordingly,
`Patent Owner’s request to seal Exhibits 2267–2278 and 2294 is granted.
`
`
`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 58, 5. 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
`
`
`
`6
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`cited in the Final Written Decision shall become public forty five (45) days
`after entry of the Final Written Decision.
`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.
`
`
`
`
`
`
`
`
`7
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`
`It is
`ORDERED that Patent Owner’s Renewed Motion to Seal is granted
`to the extent set forth in this Order;
`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.
`
`
`
`
`
`8
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`
`
`PETITIONER:
`Deborah Yellin
`Jonathan Lindsay
`Teresa Rea
`Shannon Lentz
`CROWELL & MORING LLP
`DYellin@crowell.com
`JLindsay@crowell.com
`trea@crowell.com
`slentz@crowell.com
`
`Jitendra Malik
`Bryan Skelton
`Lance Soderstrom
`Hidetada James Abe
`Joseph Janusz
`ALSTON & BIRD LLP
`jitty.malik@alston.com
`bryan.skelton@alston.com
`lance.soderstrom@alston.com
`james.abe@alston.com
`joe.janusz@alston.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
`
`
`
`
`
`
`
`9
`
`
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