Trials @uspto.gov Paper 100
`571-272-7822 Entered: September 26, 2017
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`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
`Patent 8,927,592 B2
`
`
`Before BRIAN P. MURPHY, TINA E. HULSE, and
`CHRISTOPHER M. KAISER, Administrative Patent Judges.
`
`MURPHY, Administrative Patent Judge.
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`
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`
`
`DECISION
`On Motions to Seal
`37 C.F.R. §§ 42.14
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`571-272-7822 Entered: September 26, 2017
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`
`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
`Patent 8,927,592 B2
`
`
`Before BRIAN P. MURPHY, TINA E. HULSE, and
`CHRISTOPHER M. KAISER, Administrative Patent Judges.
`
`MURPHY, Administrative Patent Judge.
`
`
`
`
`
`DECISION
`On Motions to Seal
`37 C.F.R. §§ 42.14
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`IPR2016-00712
`Patent 8,927,592 B2
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`On February 10, 2017, we granted Patent Owner’s Motion to Seal
`Exhibits 2149 (portions of ¶ 29), 2170, 2171, 2176 (portions of ¶¶ 47, 164),
`2179, 2182, and 2211. Paper 35. We stated that Patent Owner has
`demonstrated good cause for keeping the identified information under seal,
`because it relates to highly sensitive and confidential business information of
`Patent Owner that could cause competitive harm to Patent Owner. Id. at 3.
`Patent Owner has filed public versions of Exhibits 2149 (Tate Declaration) and
`2176 (Sartor Declaration) with appropriately limited redactions (Ex. 2149 ¶ 29;
`Ex. 2176 ¶¶ 47, 164), so as to provide the thrust of Patent Owner’s argument
`without compromising the underlying confidential business information.
`We ordered Patent Owner to file the Stipulated Protective Order to
`which the parties had agreed. Paper 35, 3. Patent Owner filed the so-ordered
`Stipulated Protective Order on February 15, 2017. Paper 36.
`The parties subsequently filed a series of papers and exhibits under seal,
`with accompanying motions to seal and redacted public versions, in
`accordance with the terms of the Stipulated Protective Order. The motions are
`uncontested except for one motion to seal, addressed separately below.
`The following chart summarizes the motions to seal and the confidential
`papers and exhibits that are the subject of the motions.
`Motion to Seal Paper
`Description
`Number
`
`45
`
`Papers and Exhibits
`Subject to Sealing
`Paper 43 (MTA Opp.)
`Ex. 1042 (Tate Depo.
`Tr.)
`Ex. 1043 (Seth Reply
`Dec.),
`Ex. 1044 (McSorley
`Dec.),
`Ex. 1054,
`Ex. 1065,
`
`Petitioner’s Motion to
`Seal Opposition to
`Contingent Motion to
`Amend (“MTA”)
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`
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`2
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`IPR2016-00712
`Patent 8,927,592 B2
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`54
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`56
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`62
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`65
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`74
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`76
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`83
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`88
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`
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`Exs. 1069–1072,
`Ex. 1074,
`Ex. 1079, and
`Exs. 1089–1090
`Paper 53 (MTA Reply)
`Ex. 2258 (Seth Depo.
`Tr. April 14, 2017
`(referencing sealed Ex.
`2182))
`Ex. 2211 (FDA Meeting
`Minutes of June 28,
`2006 meeting with
`Sanofi-Aventis)
`Ex. 2261 (McSorley
`Depo. Tr. April 19,
`2017)
`Paper 64 (referencing
`Ex. 1042 (Tate Depo.
`Tr.) and Ex. 2261
`(McSorley Depo. Tr.))
`Paper 72 (referencing
`Exs. 1042 (Tate Depo.
`Tr.), 2149, 2170–2171,
`2179, and 2261
`(McSorely Depo. Tr.))
`Paper 77 (referencing
`Ex. 1042 (Tate Depo.)
`and Ex. 1044
`(McSorley Dec.))
`
`Paper 81 (referencing
`Ex. 1044 (McSorley
`Dec.) and Ex. 2261
`(McSorley Depo. Tr.))
`
`Paper 89 (referencing
`Ex. 1042 (Tate Depo.
`Tr.) and Papers 64 and
`72)
`
`Patent Owner’s Motion
`to Seal MTA Reply and
`Ex. 2258
`
`Patent Owner’s Motion
`to Seal Ex. 2211
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`Patent Owner’s Motion
`to Seal Ex. 2261
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`Petitioner’s Motion to
`Seal Petitioner’s Motion
`to Exclude Evidence
`
`Patent Owner’s Motion
`to Seal Patent Owner’s
`Opp. to Petitioner’s
`Motion to Exclude.
`
`Petitioner’s Motion to
`Seal Petitioner’s Opp.
`To Patent Owner’s Mot.
`To Exclude Exs. 1089
`and 1090
`Patent Owner’s Motion
`to Seal Patent Owner’s
`Observations on Cross-
`Examination of Robert
`McSorley
`Petitioner’s Motion to
`Seal Reply in Support
`of Motion to Exclude
`Evidence
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`3
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`IPR2016-00712
`Patent 8,927,592 B2
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`91
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`97
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`Paper 92 (referencing
`Ex. 1044 (McSorley
`Dec.), Ex. 1065, Ex.
`1068, Ex. 1071, and Ex.
`2261 (McSorley Depo.
`Tr.))
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`
`
`Petitioner’s Motion to
`Seal Petitioner’s
`Response to Patent
`Owner’s Observations
`on Cross-Examination
`of Robert McSorely
`Patent Owner’s Brief in
`Support of Petitioner’s
`Motion to Seal Patent
`Owner’s Confidential
`Information (Paper Nos.
`45, 65, 76, 88, 91)
`
`The record for an inter partes review shall be made available to the
`public, except as otherwise ordered, and a document filed with a motion to
`seal shall be treated as sealed until the motion is decided. 35 U.S.C.
`§ 316(a)(1); 37 C.F.R. § 42.14. The standard for granting a motion to seal is
`“good cause.” 37 C.F.R. § 42.54. There is a strong public policy that favors
`making information filed in inter partes review proceedings open to the
`public. See Garmin Int’l v. Cuozzo Speed Techs., LLC, Case IPR2012-00001,
`slip op. at 1–2 (PTAB Mar. 14, 2013) (Paper 34) (discussing Board standards
`applied to motions to seal). The moving party bears the burden of showing
`that the relief requested should be granted. 37 C.F.R. § 42.20(c).
`Satisfaction of the burden requires a showing that the information is
`truly confidential, and that such confidentiality outweighs the strong public
`interest in having an open record. See Garmin at 3. In the instant case, Patent
`Owner asserts that, if made public, the aforementioned highly sensitive
`business information could cause competitive harm to Patent Owner. Paper
`97, 5.
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`IPR2016-00712
`Patent 8,927,592 B2
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`A. Uncontested Motions to Seal
`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 Patent Owner 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 Patent Owner’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
`Patent Owner 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 Patent Owner in Exhibits
`1065, 1068-1072, 1074, and 1079. See id. at 2, 4–5.
`On May 2, 2017, Patent Owner filed a motion to seal the transcript of
`the deposition of Mr. McSorley (Exhibit 2261) because, inter alia, the
`transcript discusses Patent Owner’s confidential business information from
`internal marketing documents. Paper 62, 2–3. Also on May 2, 2017,
`Petitioner filed a motion to 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, 1. The parties subsequently exchanged
`redactions to the deposition transcripts of Mr. Tate and Mr. McSorley, with
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`IPR2016-00712
`Patent 8,927,592 B2
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`public versions of those documents being filed on May 9–10, 2017. Papers 69
`and 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, 2171
`and 2179, and/or other documents produced by Patent Owner under the
`Stipulated Protective Order. Paper 74, 3–4; Paper 76, 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, 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 1044), which are the subject of pending motions
`to seal. Paper 83, 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), Patent Owner 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, 1.
`After consideration of the Motions, we are persuaded that Patent
`Owner has established good cause for sealing the documents identified in the
`uncontested motions to seal (Paper Nos. 45, 56, 62, 65, 74, 76, 83, 88, and
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`IPR2016-00712
`Patent 8,927,592 B2
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`91). We further adopt Patent Owner’s statements of fact and argument, with
`supporting evidence and citations, as our own. See e.g., Paper 97, 5–9.
`Therefore, the uncontested motions to seal (Paper Nos. 45, 56, 62, 65, 74,
`76, 83, 88, and 91) are granted.
`B. Contested Motion to Seal (Papers 54, 58, 71)
`Patent Owner seeks to seal portions of the MTA Reply that discuss
`sealed Exhibit 2182. Paper 54, 3. Patent Owner seeks to maintain the
`confidentiality of Exhibit 2182 because it contains highly sensitive clinical
`research information regarding the clinical trial of Jevtana®, as set out in our
`original Order (Paper 35) sealing Exhibit 2182. Id. at 3–4. Patent Owner
`also seeks to seal one sentence at page 135 of Exhibit 2258, the April 14,
`2017 Deposition Transcript of Dr. Rahul Seth. Id. at 4–5. During the
`deposition, Dr. Seth was questioned on Exhibit 2182. See, e.g., Ex. 2258,
`135.
`
`We are persuaded by Patent Owner’s argument that the information in
`Ex. 2182 is sufficiently sensitive that, if made public, it could cause
`competitive harm to Aventis by giving direct competitors knowledge of
`Paatent Owner’s clinical research operations. Patricia Matthews, the clinical
`trial manager for the phase III TROPIC study, explained that Exhibit 2182 is
`an internal document provided to clinical study investigators setting forth
`information that should be included in their institutions’ “informed consent
`forms,” which are separate documents. Ex. 2234 ¶¶ 1, 2, 4–5. Patent Owner
`is correct that, contrary to Petitioner’s argument (Paper 58, 3) Ms. Matthews
`did not testify that Exhibit 2182 itself was provided to patients, nor did she
`testify as to what specific language from within that document was included
`in any informed consent form. Id. In addition, the public version of the
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`IPR2016-00712
`Patent 8,927,592 B2
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`MTA Reply has been redacted so that the thrust of the underlying evidence
`can still be reasonably discerned. Greene’s Energy Grp., LLC v. Oil States
`Energy Servs., LLC, IPR2014-00216, Paper 27 at 5 (PTAB Sept. 23, 2014).
`We agree that the public’s interest in knowing Patent Owner’s clinical
`research information is relatively low, and is outweighed by Patent Owner’s
`interest in keeping it confidential. Therefore, Patent Owner’s motion to seal
`Ex. 2182 is granted.
`With regard to the single sentence on page 135 of Dr. Seth’s
`Deposition transcript (Ex. 2258), however, we are not persuaded by Patent
`Owner’s argument. We agree with Petitioner that it appears that the specific
`content quoted from Exhibit 2182 by Dr. Seth on page 135 of his transcript
`is not confidential information. For example, the public record in this case is
`clear that patients in the TROPIC Study were offered a pretreatment regimen
`comprising “a corticosteroid, [such as] dexamethasone, an H2 blocker, such
`as ranitidine, as well as an antihistamine.” Ex. 1041 at 207:3–208:17; see
`also Ex. 2055, 1050 (2010 publication describing pretreatment regimen).
`Dr. Sartor testified publicly that this pretreatment regimen “was in the
`[TROPIC] protocol for a fact” and that “it wouldn’t surprise me if it was…in
`the consent form” as well. Ex. 1041, 217:1-8.
`It is also public knowledge today (and was public knowledge before
`the priority date) that potential side effects of cabazitaxel include nausea,
`vomiting, and allergic reactions. Ex. 1010, 1548 (patients receiving
`cabazitaxel received anti-allergy “premedication 30 min before study drug
`administration”); id. at 1548 (“In case of nausea/vomiting, patients could
`receive preventive antiemetic treatment in compliance with the conventional
`antiemetic protocol of the center….”); id. at 1550 (listing nausea and
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`IPR2016-00712
`Patent 8,927,592 B2
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`vomiting among the “most frequent nonhematological AEs” observed for
`cabazitaxel and reporting that one patient was withdrawn from the study
`because of a “grade 4 allergic reaction at cycle 2”); id. at 1550 & Table 2
`(reporting hypersensitivity reaction in 6% of cabazitaxel patients and severe
`hypersensitivity reaction in 4% of cabazitaxel patients); id. at 1551
`(reporting that the “most frequent grade 3/4 non-hematological” adverse
`event was “allergic reaction (4%)”); Ex. 2055, 1152 (reporting nausea and
`vomiting as adverse events of cabazitaxel treatment); id. at 1153 (publishing
`that “Cabazitaxel hypersensitivity reactions were prevented by use of the
`prescribed prophylactic regimen.”); Ex. 2067, 1 (Jevtana label disclosing
`“Premedication Regimen” and “Warning and Precautions…Severe
`hypersensitivity reactions can occur. Premedicate with corticosteroids and
`H2 antagonists.”). Thus, the information Patent Owner seeks to redact from
`Dr. Seth’s deposition is public information.
`Therefore, Patent Owner’s motion to seal Ex. 2258, 135 is denied.
`C. Conclusion
`The parties are reminded that confidential information subject to a
`protective order ordinarily becomes public 45 days after final judgment in a
`trial. Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,761 (Col.
`1) (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. Id. After final judgment in a trial, a party may
`file a motion to expunge confidential information from the record prior to
`the information becoming public. See 37 C.F.R. § 42.56.
`In consideration of the foregoing, it is:
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`IPR2016-00712
`Patent 8,927,592 B2
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`ORDERED that the uncontested motions to seal (Paper Nos. 45, 56, 62,
`65, 74, 76, 83, 88, and 91) are granted;
`FURTHER ORDERED that Patent Owner’s motion to seal Ex. 2182 is
`granted;
`FURTHER ORDERED that Patent Owner’s motion to seal Ex. 2258,
`135 is denied.
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`IPR2016-00712
`Patent 8,927,592 B2
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`FOR PETITIONER:
`
`Steven W. Parmelee
`Michael T. Rosato
`Jad A. Mills
`Matthew R. Reed
`Wendy L. Devine
`Nellie J. Amjadi
`WILSON SONSINI GOODRICH & ROSATI
`sparmelee@wsgr.com
`mrosato@wsgr.com
`jmills@wsgr.com
`mreed@wsgr.com
`wdevine@wsgr.com
`namjadi@wsgr.com
`
`
`FOR PATENT OWNER:
`
`Dominic A. Conde
`Whitney L. Meier
`William E.
`Solander
`Joshua I. Rothman
`FITZPATRICK CELLA HARPER & SCINTO
`dconde@fchs.com
`wmeier@fchs.com
`wsolander@fchs.com
`jrothman@fchs.com
`
`
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`11
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