Paper No. _
`Date Filed: June 5, 2017
`
`Filed on behalf of: Aventis Pharma S.A.
`
`By:
`
`Dominick A. Conde
`dconde@fchs.com
`(212) 218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`MYLAN LABORATORIES LIMITED
`Petitioner,
`v.
`AVENTIS PHARMA S.A.
`Patent Owner.
`________________
`
`Case IPR2016-00712
`U.S. Patent No. 8,927,592
`________________
`
`PATENT OWNER’S BRIEF IN SUPPORT OF PETITIONER’S MOTIONS
`TO SEAL PATENT OWNER’S CONFIDENTIAL INFORMATION
`(PAPERS 45, 65, 76, 88, 91)
`
`
`Date Filed: June 5, 2017
`
`Filed on behalf of: Aventis Pharma S.A.
`
`By:
`
`Dominick A. Conde
`dconde@fchs.com
`(212) 218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`MYLAN LABORATORIES LIMITED
`Petitioner,
`v.
`AVENTIS PHARMA S.A.
`Patent Owner.
`________________
`
`Case IPR2016-00712
`U.S. Patent No. 8,927,592
`________________
`
`PATENT OWNER’S BRIEF IN SUPPORT OF PETITIONER’S MOTIONS
`TO SEAL PATENT OWNER’S CONFIDENTIAL INFORMATION
`(PAPERS 45, 65, 76, 88, 91)
`
`
`
`I.
`
`RELIEF REQUESTED
`
`Pursuant to 37 C.F.R. §§ 42.14 and 42.54, and for the reasons set forth
`
`below, Patent Owner Aventis Pharma S.A. (“Aventis”) respectfully requests that
`
`the Board grant Petitioner’s motions to seal the following documents as set forth in
`
`Papers 45, 65, 76, 88, and 91:
`
` Petitioner’s Opposition to Patent Owner’s Contingent Motion to Amend
`
`(Paper 43),
`
` Exhibit 1042 (transcript of the deposition of Michael E. Tate),
`
` Exhibit 1043 (Reply Declaration of Dr. Rahul Seth),
`
` Exhibit 1044 (Declaration of Mr. Robert McSorley),
`
` Exhibit 1054 (Jevtana® FDA submission),
`
` Exhibits 1065, 1068-1072, 1074, 1079 (Jevtana® marketing documents),
`
` Petitioner’s Motion to Exclude Evidence (Paper 64),
`
` Petitioner’s Opposition to Patent Owner’s Motion to Exclude Exhibits
`
`1089-1090 (Paper 77),
`
` Petitioner’s Reply in Support of Motion to Exclude Evidence (Paper 89),
`
`and
`
` Petitioner’s Response to Patent Owner’s Motion for Observations on the
`
`Cross-Examination of Mr. Robert McSorley (Paper 92).
`
`1
`
`
`
`II. GOOD CAUSE EXISTS FOR SEALING THE REQUESTED
`INFORMATION
`
`Documents filed in an IPR are generally available to the public. 37 C.F.R.
`
`§ 42.14. However, the Board may, for good cause, protect confidential
`
`information from public disclosure. Id.; see also Garmin Int’l, Inc. v. Cuozzo
`
`Speed Techs. LLC, IPR2012-00001, Paper 36 at 3-4 (P.T.A.B. Apr. 5, 2013).
`
`When determining good cause, the Board must balance the public’s interest
`
`in a complete and understandable file history with the party’s interest in protecting
`
`sensitive information. See Garmin, IPR2012-00001, Paper 36 at 3-4 (citing Office
`
`Patent Trial Practice Guide, 77 Fed. Reg. 48756, 48760 (2012)). However, the
`
`public’s interest in having access to a party’s confidential business or clinical
`
`research information that is only indirectly related to patent validity is “minimal.”
`
`Id. at 8-9 (granting the patent owner’s motion to seal an agreement relating to the
`
`“commercializ[ation]” of the patent-at-issue). Here, the interests in protecting
`
`business, financial, and clinical research information outweigh the public’s interest
`
`in viewing that information.
`
`a. Background
`
`The Board granted Aventis’s unopposed motion for entry of a protective
`
`order and motion to seal Exhibits 2149, 2170, 2171, 2179, 2182, and 2211 on
`
`February 10, 2017 because the exhibits contained “highly sensitive and
`
`confidential business information of Patent Owner.” (Paper 35 at 1, 3). Aventis
`
`2
`
`
`
`filed the Stipulated Protective Order on February 15, 2017. (Paper 36).
`
`On March 14, 2017, Petitioner moved to seal its Opposition to Patent
`
`Owner’s Contingent Motion to Amend (Paper 43) and the Reply Declaration of Dr.
`
`Rahul Seth (Exhibit 1043) because the documents discuss sealed Exhibit 2182.
`
`(Paper 45 at 3-4). Petitioner moved to seal Exhibit 1054 because it was produced
`
`and designated by Aventis as confidential and relates to FDA meeting minutes that
`
`were previously sealed (Exhibit 2211). (Id. at 5). Petitioner also moved to seal the
`
`transcript of the deposition of Mr. Michael E. Tate (Exhibit 1042), whose previous
`
`declaration was sealed Exhibit 2149, because the transcript discusses Aventis’s
`
`confidential business information. (Id. at 4). Petitioner moved to seal Exhibits
`
`1065, 1068-1072, 1074, and 1079 because they were produced and designated
`
`confidential by Aventis and are of “substantially similar character” to previously
`
`sealed Exhibits 2170 and 2179. (See id. at 2, 5). Accordingly, Petitioner also
`
`moved to seal the Declaration of Mr. Robert McSorley (Exhibit 1044) because it
`
`discusses “highly sensitive business information” of Aventis in Exhibits 1065,
`
`1068-1072, 1074, and 1079. (See id. at 2, 4-5).
`
`On May 2, 2017, Aventis filed a motion to seal the transcript of the
`
`deposition of Mr. McSorley (Exhibit 2261) because, inter alia, the transcript
`
`discusses Aventis’s confidential business information from internal marketing
`
`documents. (Paper 62 at 2-3). Also on May 2, 2017, Petitioner filed a motion to
`
`3
`
`
`
`seal its Motion to Exclude Evidence (Paper 64) because the motion discusses the
`
`deposition transcripts of Mr. Tate and Mr. McSorley, both of which have been
`
`designated confidential and are the subject of motions to seal. (Paper 65 at 1). The
`
`parties subsequently exchanged redactions to the deposition transcripts of Mr. Tate
`
`and Mr. McSorley, with public versions of those documents being filed on May 9-
`
`10, 2017. (Papers 69-70).
`
`On May 12, 2017, both parties filed motions to seal their respective
`
`oppositions to the motions to exclude evidence (Papers 72, 77) because they
`
`discuss Mr. Tate’s declaration (Exhibit 2149), Mr. Tate’s deposition testimony
`
`(Exhibit 1042), Mr. McSorley’s declaration (Exhibit 1044), Mr. McSorley’s
`
`deposition testimony (Exhibit 2261), previously sealed Exhibits 2170-71 and 2179,
`
`and/or other documents produced by Aventis under the Stipulated Protective
`
`Order. (Paper 74 at 3-4; Paper 76 at 1). On May 19, 2017, Petitioner moved to
`
`seal its Reply in Support of Motion to Exclude Evidence (Paper 89) because it
`
`discusses Mr. Tate’s deposition testimony (Exhibit 1042), Petitioner’s Motion to
`
`Exclude Evidence (Paper 64), and Aventis’s opposition thereto (Paper 72), all of
`
`which are subject to pending motions to seal. (Paper 88 at 1).
`
`On May 15, 2017, Aventis filed a motion to seal its Motion for Observations
`
`on the Cross-Examination of Mr. Robert McSorley (Paper 81) because it discusses
`
`deposition testimony of Mr. McSorley (Exhibit 2261) and his declaration (Exhibit
`
`4
`
`
`
`1044), which are the subject of pending motions to seal. (Paper 83 at 3-4). On
`
`May 22, 2017, Petitioner filed a motion to seal its Response to Patent Owner’s
`
`Motion for Observations on the Cross-Examination of Mr. McSorley (Paper 92)
`
`because it discusses Mr. McSorley’s declaration (Exhibit 1044), Aventis
`
`documents (Exhibits 1065, 1068, 1071), and Mr. McSorley’s deposition testimony
`
`(Exhibit 2261), all of which are subject to pending motions to seal. (Paper 91 at 1).
`
`Some of Petitioner’s motions to seal mention Aventis filing a paper to justify
`
`sealing its confidential information in Petitioner’s submissions. (Paper 65 at 2;
`
`Paper 76 at 2). Aventis understands that Petitioner does not oppose Aventis’s
`
`submission of this brief to support the motions to seal.
`
`b. Paper 43 and Exhibit 1043
`
`Aventis seeks to seal Petitioner’s Opposition to Patent Owner’s Contingent
`
`Motion to Amend (Paper 43) and Dr. Seth’s Reply Declaration (Exhibit 1043)
`
`because they discuss the contents of previously sealed Exhibit 2182, which is a
`
`document provided by Sanofi to investigators on the TROPIC study that includes
`
`confidential clinical research information regarding Jevtana®. By discussing
`
`Exhibit 2182, Petitioner’s Opposition to Patent Owner’s Contingent Motion to
`
`Amend and Exhibit 1043 discuss highly sensitive clinical research information,
`
`which if made public, could cause competitive harm to Aventis by giving direct
`
`competitors knowledge of Aventis’s clinical research operations. The parties have
`
`5
`
`
`
`separately briefed the confidentiality of Exhibit 2182 in Papers 54, 58, and 71, with
`
`Petitioner having opposed Aventis’s Motion to Seal the Reply Brief and Exhibit
`
`2258.
`
`In addition, the public versions of Petitioner’s Opposition to Patent Owner’s
`
`Contingent Motion to Amend (Paper 44) and Exhibit 1043 have been redacted so
`
`that the thrust of the underlying argument can still be reasonably discerned.
`
`Greene’s Energy Grp., LLC v. Oil States Energy Servs., LLC, IPR2014-00216,
`
`Paper 27 at 5 (P.T.A.B. Sept. 23, 2014). Accordingly, the public’s interest in
`
`knowing Aventis’s clinical research information is relatively low, and is
`
`outweighed by Aventis’s interest in keeping it confidential.
`
`c. Exhibit 1054
`
`Aventis seeks to seal Exhibit 1054 because it is a confidential FDA
`
`submission that includes confidential clinical research information regarding a
`
`clinical trial of Jevtana®. Aventis seeks to maintain the confidentiality of Exhibit
`
`1054 because it contains highly sensitive clinical research information. If this
`
`information is made public, it could cause competitive harm to Aventis by giving
`
`direct competitors knowledge of Aventis’s clinical research operations.
`
`d. Exhibit 1042
`
`Aventis seeks to seal the transcript of Mr. Tate’s deposition because it
`
`discusses his previously sealed declaration (Exhibit 2149) and previously sealed
`
`6
`
`
`
`Aventis documents (Exhibits 2170-2171, 2179). Exhibit 1042 thereby discusses
`
`Aventis’s confidential, internal business documents concerning market share of
`
`treatments for prostate cancer. Aventis seeks to maintain the confidentiality of this
`
`exhibit because it discusses highly sensitive business and financial information. If
`
`this information is made public, it could cause competitive harm to Aventis by
`
`giving direct competitors knowledge of Aventis’s business strategies and financial
`
`operations.
`
`In addition, the public version of Exhibit 1042 has been redacted so that the
`
`thrust of the underlying material can still be reasonably discerned. Greene’s
`
`Energy Grp., LLC, IPR2014-00216, Paper 27 at 5. Accordingly, the public’s
`
`interest in knowing Aventis’s business and financial information is relatively low,
`
`and is outweighed by Aventis’s interest in keeping it confidential.
`
`e. Exhibits 1044, 1065, 1068-1072, 1074, 1079
`
`Aventis seeks to seal Exhibits 1065, 1068-1072, 1074, 1079 because they
`
`are confidential, Aventis internal business documents concerning sales and market
`
`share of treatments for prostate cancer. Aventis seeks to seal the Declaration of
`
`Mr. Robert McSorley (Exhibit 1044) because it discusses previously sealed
`
`Exhibits 2149, 2170-2171, 2179 and Exhibits 1065, 1068-1072, 1074, 1079, and
`
`thereby discusses Aventis internal business documents. Aventis seeks to maintain
`
`the confidentiality of these exhibits because they discuss highly sensitive business
`
`7
`
`
`
`and financial information. If this information is made public, it could cause
`
`competitive harm to Aventis by giving direct competitors knowledge of Aventis’s
`
`business strategies and financial operations.
`
`In addition, the public version of Exhibit 1044 has been redacted so that the
`
`thrust of the underlying argument can still be reasonably discerned. Greene’s
`
`Energy Grp., LLC, IPR2014-00216, Paper 27 at 5. Accordingly, the public’s
`
`interest in knowing Aventis’s business and financial information is relatively low,
`
`and is outweighed by Aventis’s interest in keeping it confidential.
`
`f. Papers 64, 77, 89, 92
`
`Aventis seeks to seal Petitioner’s: Motion to Exclude Evidence (Paper 64),
`
`Opposition to Patent Owner’s Motion to Exclude Exhibits 1089-1090 (Paper 77),
`
`Reply in Support of Motion to Exclude Evidence (Paper 89), and Response to
`
`Patent Owner’s Motion for Observations on the Cross-Examination of Mr. Robert
`
`McSorley (Paper 92) because they discuss either previously sealed Exhibits 2149,
`
`2170-2171, 2179 or other confidential, Aventis internal business documents
`
`concerning sales and market share of treatments for prostate cancer such as
`
`Exhibits 1065, 1068-1072, 1074, and 1079. Aventis seeks to maintain the
`
`confidentiality of these submissions because they discuss highly sensitive business
`
`and financial information. If this information is made public, it could cause
`
`competitive harm to Aventis by giving direct competitors knowledge of Aventis’s
`
`8
`
`
`
`business strategies and financial operations.
`
`In addition, the public versions of these submissions (Papers 68, 78, 94-95)
`
`have been redacted so that the thrust of the underlying argument can still be
`
`reasonably discerned. Greene’s Energy Grp., LLC, IPR2014-00216, Paper 27 at 5.
`
`Accordingly, the public’s interest in knowing Aventis’s business and financial
`
`information is relatively low, and is outweighed by Aventis’s interest in keeping it
`
`confidential.
`
`III. CERTIFICATION OF NON-PUBLICATION
`
`On behalf of Aventis, the undersigned counsel certifies that, to the best of
`
`his knowledge, the information sought to be sealed has not been published or
`
`otherwise made public.
`
`IV. CONCLUSION
`
`For the foregoing reasons, Aventis respectfully requests that the Board grant
`
`Petitioner’s motions to seal.
`
`June 5, 2017
`
`Respectfully submitted,
`
`/Dominick A. Conde/
`Dominick A. Conde (Reg. No. 33,856)
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel: (212) 218-2100
`
`Attorney for Patent Owner,
`Aventis Pharma S.A.
`
`9
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e)(4), I certify that a copy of the foregoing
`
`PATENT OWNER’S BRIEF IN SUPPORT OF PETITIONER’S MOTIONS TO
`
`SEAL PATENT OWNER’S CONFIDENTIAL INFORMATION (PAPERS 45,
`
`65, 76, 88, 91) was served on June 5, 2017 by causing it to be sent by email to
`
`counsel for Petitioner at the following email addresses:
`
`sparmelee@wsgr.com
`
`mrosato@wsgr.com
`
`jmills@wsgr.com
`
`mreed@wsgr.com
`
`namjadi@wsgr.com
`
`wdevine@wsgr.com
`
`June 5, 2017
`
`Respectfully submitted,
`
`/Dominick A. Conde/
`Dominick A. Conde (Reg. No. 33,856)
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel: (212) 218-2100
`
`10
`
`
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