`Tel: 571-272-7822
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`
`
`Paper No. 105
`Entered: July 13, 2022
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`REGENERON PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`NOVARTIS PHARMA AG, NOVARTIS TECHOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owner.
`_____________
`
`IPR2021-00816
`Patent 9,220,631 B2
`______________
`
`Before ERICA A. FRANKLIN, ROBERT L. KINDER, and
`JAMIE T. WISZ, Administrative Patent Judges.
`
`KINDER, Administrative Patent Judge.
`
`
`
`
`
`ORDER
`Granting Petitioner’s Motion to Seal
`37 C.F.R. §§ 42.14 and 42.54
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`IPR2021-00816
`Patent 9,220,631 B2
`
`Introduction
`
`I.
`Petitioner Regeneron Pharmaceuticals, Inc. (“Petitioner” or
`“Regeneron”) filed a Motion to Seal portions of Petitioner’s Reply to Patent
`Owner’s Response (“Petitioner’s Reply”), portions of Petitioner’s
`Opposition to Patent Owner’s Contingent Motion to Amend (“MTA
`Opposition”), portions of Exhibits 1100–1102, 1105–1107, 1109, 1172,
`12071–1208, and 1210 that rely on confidential business information. Paper
`71, 1 (“Pet. Mot.”). Petitioner also moves to seal the entirety of Exhibits
`1112–1114, 1116–1128, 1130–1162, 1167–1168, 1185, 1203, 1205–1206,
`1211, 1213, 1215–1226, 1248–1249, and 1254–1256. Id.
`For the reasons set forth below, Petitioner’s Motion to Seal is granted.
`II. Motion to Seal Legal Standard
`“There is a strong public policy for making all information filed in a
`
`quasi-judicial administrative proceeding open to the public.” Garmin Int’l v.
`Cuozzo Speed Techs., LLC, IPR2012–00001, slip op. at 1–2 (PTAB Mar. 14,
`2013) (Paper 34). 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. § 326(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; see also Argentum
`Pharms. LLC v. Alcon Res., Ltd., IPR2017-01053, Paper 27 at 3–4 (PTAB
`Jan. 19, 2018) (Informative) (describing the “good cause” standard). The
`moving party bears the burden of showing that the relief requested should be
`granted. 37 C.F.R. § 42.20(c). That includes showing that the information
`
`
`1 Exhibit 1207 was filed only as “Board and Parties Only” with no
`corresponding redacted version.
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`2
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`Patent 9,220,631 B2
`is truly confidential, and that such confidentiality outweighs the strong
`public interest in having an open record. See Argentum, Paper 27 at 3–4
`(“[A] movant to seal must demonstrate adequately that (1) the information
`sought to be sealed is truly confidential, (2) a concrete harm would result
`upon public disclosure, (3) there exists a genuine need to rely in the trial on
`the specific information sought to be sealed, and (4), on balance, an interest
`in maintaining confidentiality outweighs the strong public interest in having
`an open record.”).
`
`III. Petitioner’s Motion to Seal
`In its Motion to Seal, Petitioner contends that the documents it seeks
`to seal contain truly confidential information. Pet. Mot. 2 (“The information
`that Regeneron seeks to seal is either Regeneron’s confidential research and
`development information, Regeneron’s confidential commercial and
`financial information, Novartis’s confidential research and development
`information, or third party confidential information.”). Petitioner also attests
`a concrete harm would result for Regeneron, Novartis, or third parties upon
`public disclosure of the information. Id. at 2 (stating that “Public disclosure
`of Regeneron’s, Novartis’s or third party confidential information would
`competitively harm Regeneron’s, Novartis’s, and/or third parties’ business
`prospects and put these companies at a competitive disadvantage relative to
`other similarly positioned companies in the same industry”).
`We find Petitioner’s showing persuasive in establishing good cause to
`seal the identified documents.
`1. Petitioner’s Reply and Opposition to MTA
`Regeneron seeks to seal the portions of Petitioner’s Reply and
`Opposition to MTA that discuss confidential information in the exhibits that
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`Regeneron currently seeks to seal. Pet. Mot. 2–3. Petitioner relies on
`reasons provided for certain exhibits, alleging “there is good cause to seal
`the portions of the Reply and Opposition to MTA that include confidential
`information appearing in at least Exhibits 1100–1102, 1105, 1107, 1112–
`1114, 1116–1128, 1130–1162, 1167–1168, 1172, 1185, 1203, 1205–1208,
`1211, 1213, 1215-1220, 1222–1226, 1248–1249, 1254–1256.” Id. at 3.
`For the reasons set forth more below, we determine that Petitioner
`establishes good cause for redacting the information it seeks to keep
`confidential in the Petitioner’s Reply and Opposition to MTA. The
`information redacted is truly confidential, would result in harm if disclosed,
`is pertinent to the ongoing trial, and maintaining confidentiality outweighs
`the strong public interest in having an open record. As such, Petitioner has
`established good cause for sealing Petitioner’s Reply and Opposition to
`MTA.
`2. Exhibit 1100 (Agalloco Declaration)
`Regeneron seeks to seal portions of Exhibit 1100, which is a
`declaration from Petitioner’s expert witness, James Agalloco. Petitioner
`asserts that portions of Exhibit 1100 describe and include Genentech’s and
`Novartis’s confidential development and research information and that the
`information is necessary to address issues related to the alleged obviousness
`of the claims of the ’631 patent. Pet. Mot. 3. Further, portions of Exhibit
`1100 describe exhibits filed by Novartis under seal as well as exhibits
`designated by third party Genentech as Confidential in co-pending litigation.
`Id. Petitioner further contends that “Novartis has asserted that similar
`confidential and proprietary research and development information of
`Novartis and Genentech, if publicly disclosed, would substantially harm
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`Novartis’s and Genentech’s competitive positions in the prefilled syringe
`industry.” Id. (citing Paper 38, 9–13).
`Based on this evidence and argument, we are persuaded that the
`redacted information does not appear to unreasonably impede the public’s
`understanding of the record. We are sufficiently persuaded that Petitioner’s
`showing establishes good cause for redacting the information it seeks to
`keep confidential in Exhibit 1100.
`3. Exhibit 1101 (Sawyer Declaration)
`Regeneron seeks to seal portions of Exhibit 1101, which is a
`declaration from Petitioner’s expert witness, Dr. Gregory Sawyer. Pet.
`Mot. 4. Petitioner asserts that portions of Exhibit 1101 describe and include
`Novartis’s and third-party Vetter’s confidential research and development
`information as well as exhibits filed by Novartis under seal. Id. Regeneron
`relies on such information to support its argument regarding alleged
`invalidity of Novartis’s proposed substitute claims. Id. Petitioner further
`contends that Novartis has asserted that similar confidential and proprietary
`research and development information of Novartis and its third-party
`business partners, if publicly disclosed, would substantially harm Novartis’s
`and it’s third party business partner’s competitive positions in the prefilled
`syringe industry. Id. (citing Paper 38, 4, 13).
`Based on this evidence and argument, we are persuaded that the
`redacted information does not appear to unreasonably impede the public’s
`understanding of the record. We are sufficiently persuaded that Petitioner’s
`showing establishes good cause for redacting the information it seeks to
`keep confidential in Exhibit 1101.
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`4. Exhibit 1102 (Graham Declaration)
`Regeneron seeks to seal portions of Exhibit 1102, which is a
`declaration from Petitioner’s fact witness, Dr. Kenneth Graham. Pet. Mot. 5.
`Petitioner asserts that portions of Exhibit 1102 describe and include
`Regeneron’s and third-party Steris’s confidential development and research
`information. Id. Petitioner further contends that the confidential and
`proprietary research and development information of Regeneron and Steris,
`if publicly disclosed, would substantially harm Regeneron’s and Steris’s
`competitive positions in the pre-filled syringe industry and provide
`competitors with valuable information regarding confidential research and
`development projects. Id. at 5–6 (citing Ex. 1002 ¶ 16).
`Based on this evidence and argument, we are persuaded that the
`redacted information does not appear to unreasonably impede the public’s
`understanding of the record. We are sufficiently persuaded that Petitioner’s
`showing establishes good cause for redacting the information it seeks to
`keep confidential in Exhibit 1102.
`5. Exhibit 1105 (Koller Reply Declaration)
`Regeneron seeks to seal portions of Exhibit 1105, which is a
`declaration from Petitioner’s expert witness, Horst Koller. Pet. Mot. 6.
`Petitioner asserts that portions of Exhibit 1105 describe and include
`Novartis’s confidential development and research information. Id.
`Petitioner also asserts that other portions of Exhibit 1105 describe and
`include confidential development, research, and regulatory information from
`Bausch and Beckon Dickinson, which those parties designated as
`confidential in co-pending litigation. Id. Regeneron relies on such
`information either to address the alleged obviousness of the claims of the
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`’631 patent, or to support its argument regarding alleged invalidity of
`Novartis’s proposed substitute claims. Petitioner further contends that the
`proprietary research and development information, if publicly disclosed,
`would substantially harm Novartis, Bausch, and Beckon Dickson’s
`competitive positions in the pre-filled syringe industry. Id. at 6–7 (citing
`Paper 38, 12–13).
`Based on this evidence and argument, we are persuaded that the
`redacted information does not appear to unreasonably impede the public’s
`understanding of the record. We are sufficiently persuaded that Petitioner’s
`showing establishes good cause for redacting the information it seeks to
`keep confidential in Exhibit 1105.
`6. Exhibit 1106 (Kiss Reply Declaration)
`Regeneron seeks to seal portions of Exhibit 1106, which is a
`declaration from Petitioner’s expert witness, Dr. Szilárd Kiss. Pet. Mot. 7.
`Petitioner asserts that portions of Exhibit 1106 describe and include
`Novartis’s confidential research and development information. Id.
`Petitioner also asserts that other portions of Exhibit 1106 describe and
`include exhibits filed by Novartis under seal. Id. Regeneron relies on such
`information to address the alleged obviousness of the claims of the ’631
`patent. Petitioner further contends that similar confidential and proprietary
`research and development information of Novartis, if publicly disclosed,
`would substantially harm Novartis’s competitive positions in the pre-filled
`syringe industry. Id. at 7 (citing Paper 38, 10, 12).
`Based on this evidence and argument, we are persuaded that the
`redacted information does not appear to unreasonably impede the public’s
`understanding of the record. We are sufficiently persuaded that Petitioner’s
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`showing establishes good cause for redacting the information it seeks to
`keep confidential in Exhibit 1106.
`7. Exhibit 1107 (Cameron Declaration)
`Regeneron seeks to seal portions of Exhibit 1107, which is a
`declaration from Petitioner’s expert witness, Lisa Cameron. Pet. Mot. 8.
`Petitioner asserts that portions of Exhibit 1107 describe and include
`Regeneron’s, Novartis’s, and Genentech’s confidential financial and
`commercial information. Id. Petitioner also asserts that other portions of
`Exhibit 1107 describe exhibits filed by Novartis under seal, and exhibits
`designated as confidential by third party Genentech that were produced in
`co-pending litigation. Id. Regeneron relies on such confidential financial
`information to support its argument regarding secondary considerations and
`nexus to the claims of the ’631 patent. Id. Petitioner further contends that
`confidential and proprietary financial and commercial information of
`Novartis, Regeneron and Genentech, if publicly disclosed, would
`substantially harm their competitive position in the pre-filled syringe
`industry. Id. at 7 (citing Paper 38, 9–13).
`Based on this evidence and argument, we are persuaded that the
`redacted information does not appear to unreasonably impede the public’s
`understanding of the record. We are sufficiently persuaded that Petitioner’s
`showing establishes good cause for redacting the information it seeks to
`keep confidential in Exhibit 1107.
`8. Exhibits 1109, 1172, 1207–1208, 1210–1211, 1213 (IPR Deposition
`Transcripts)
`Regeneron seeks to seal either portions or the entirety of 1109, 1172,
`1207–1208, 1210–1211, and 1213, which are cross-examination deposition
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`transcripts of Novartis witnesses taken in this IPR proceeding. Pet. Mot. 8–
`9. Petitioner asserts that each of Exhibits 1109, 1172, 1207–1208, 1210–
`1211, and 1213 contain confidential information from exhibits filed by
`Novartis under seal. Id. at 9. Petitioner also asserts that other portions of
`these exhibits relate to declaration testimony discussing information that the
`Board has deemed confidential and proper for sealing. Id. As such,
`Petitioner contends that good cause exists to seal portions of Exhibits 1109,
`1172, 1207–1208, 1210, and the entirety of Exhibits 1211 and 1213. Id.
`Based on this evidence and argument, we are persuaded that the
`redacted information does not appear to unreasonably impede the public’s
`understanding of the record. We are sufficiently persuaded that Petitioner’s
`showing establishes good cause for redacting and sealing the information it
`seeks to keep confidential in these exhibits. Further, Petitioner has provided
`good cause for sealing the entirety of Exhibits 1211 and 1213.
`Petitioner did not file a public redacted version of Exhibit 1207.
`Petitioner must file a redacted version of Exhibit 1207 within seven days of
`this Order or provide an email clarifying why Exhibit 1207 should be sealed
`in its entirety.
`9. Exhibits 1158–1161 (ITC Deposition Transcripts)
`Regeneron seeks to seal Exhibits 1158–1161, which are deposition
`transcripts of Novartis fact witnesses taken in related International Trade
`Commission (“ITC”) investigation regarding the ’631 patent. Pet. Mot. 9–
`10. Petitioner asserts that each of Exhibits 1158–1161 were marked
`confidential and subject to the protective order entered into in the ITC
`action. Id. at 9. Petitioner relies on these deposition transcripts to rebut
`Novartis’s arguments concerning the claims of the ’631 patent, and to
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`support its arguments concerning the alleged unpatentability of Novartis’s
`proposed substitute claims. Id. at 9–10. Petitioner alleges good cause exists
`to seal the exhibits because the transcripts contain confidential and propriety
`research and development information of Novartis and Novartis has made
`claims of competitive detriment should they be disclosed. Id. at 10 (citing
`Paper 38, 10, 12).
`Based on this evidence and argument, we are persuaded that Petitioner
`has provided good cause for sealing the entirety of Exhibits 1158–1161.
`10. Exhibits 1112–1114, 1116–1125, 1127–1128, 1130–1136, 1203,
`1217, 1222–1226, 1254 (Novartis Confidential Documents)
`Regeneron seeks to seal Exhibits 1112–1114, 1116–1125, 1127–1128,
`1130–1136, 1203, 1217, 1222–1226, and 1254, which are Novartis’s internal
`documents containing its confidential and proprietary research,
`development, manufacture, and business information. Pet. Mot. 10. Most of
`the exhibits are confidential Novartis internal memorandum and
`presentations discussing the development and specifications of Lucentis
`PFS. Id. at 11. Petitioner asserts that each of these exhibits were subject to
`the protective order entered into in the ITC action and the protective order
`required that these documents only be accessible by outside counsel. Id. at
`10. Petitioner notes that the parties to this IPR proceeding have agreed to
`modify the protective order in this action to extend the same level of
`protection for these documents as was provided in the ITC action. Id. (citing
`Ex. 2323).
`Based on this evidence and argument, we are persuaded that Petitioner
`has provided good cause for sealing the entirety of Exhibits 1112–1114,
`1116–1125, 1127–1128, 1130–1136, 1203, 1217, 1222–1226, and 1254.
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`11. Exhibits 1137–1140, 1142–1157, 1185, 1205, 1248–1249 (Regeneron
`Confidential Documents)
`Regeneron seeks to seal Exhibits 1137–1140, 1142–1157, 1185, 1205,
`and 1248–1249, which are Regeneron’s internal documents containing its
`confidential and proprietary research, manufacture, regulatory, financial, and
`business information. Pet. Mot. 11. Petitioner asserts that each of these
`exhibits were subject to the protective order entered into in the ITC action
`and the protective order required that these documents only be accessible by
`outside counsel. Id. at 11–12. Petitioner notes that the parties to this IPR
`proceeding have agreed to modify the protective order in this action to
`extend the same level of protection for these documents as was provided in
`the ITC action. Id. at 12 (citing Ex. 2323).
`Based on this evidence and argument, we are persuaded that Petitioner
`has provided good cause for sealing the entirety of Exhibits 1137–1140,
`1142–1157, 1185, 1205, and 1248–1249.
`12. Exhibits 1126, 1167–1168 (Vetter Confidential Documents)
`Regeneron seeks to seal Exhibits 1126 and 1167–1168, which consist
`of Vetter GmbH’s (“Vetter”) internal documents produced in the ITC action.
`Pet. Mot. 13. These exhibits contain Vetter’s confidential and proprietary
`development and research information. Id. Petitioner asserts that each of
`these exhibits were subject to the protective order entered into in the ITC
`action and the protective order required that these documents only be
`accessible by outside counsel. Id. Petitioner notes that the parties to this
`IPR proceeding have agreed to modify the protective order in this action to
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`extend the same level of protection for these documents as was provided in
`the ITC action. Id. (citing Ex. 2323).
`Based on this evidence and argument, we are persuaded that Petitioner
`has provided good cause for sealing the entirety of Exhibits 1126 and 1167–
`1168.
`13. Exhibits 1162, 1215–1216, 1218 (Becton Dickinson Confidential
`Documents)
`Regeneron seeks to seal Exhibits 1162, 1215–1216, and 1218, which
`are Beckon Dickinson & Co.’s (“BD”) internal documents containing BD’s
`confidential and proprietary development, research, and sales information.
`Pet. Mot. 14. Petitioner asserts that each of these exhibits were subject to
`the protective order entered into in the ITC action and the protective order
`required that these documents only be accessible by outside counsel. Id.
`Petitioner notes that the parties to this IPR proceeding have agreed to modify
`the protective order in this action to extend the same level of protection for
`these documents as was provided in the ITC action. Id. (citing Ex. 2323).
`Based on this evidence and argument, we are persuaded that Petitioner
`has provided good cause for sealing the entirety of Exhibits 1162, 1215–
`1216, and 1218.
`14. Exhibits 1219–1221 (Becton Dickinson Confidential Documents)
`Regeneron seeks to seal Exhibits 1219–1221, which are Bausch
`Health Co. Inc.’s (“Bausch”) internal documents containing Bausch’s
`confidential and proprietary development, research, and regulatory
`information. Pet. Mot. 15. Petitioner asserts that each of these exhibits were
`subject to the protective order entered into in the ITC action and the
`protective order required that these documents only be accessible by outside
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`counsel. Id. Petitioner notes that the parties to this IPR proceeding have
`agreed to modify the protective order in this action to extend the same level
`of protection for these documents as was provided in the ITC action. Id.
`(citing Ex. 2323).
`Based on this evidence and argument, we are persuaded that Petitioner
`has provided good cause for sealing the entirety of Exhibits 1219–1221.
`15. Exhibit 1141 (Steris Confidential Document)
`Regeneron seeks to seal Exhibit 1141, which is an internal
`development report containing Steris Co.’s (“Steris”) confidential and
`proprietary development and research information relating to Elyea PFS.
`Pet. Mot. 16. Petitioner asserts that this exhibit was subject to the protective
`order entered into in the ITC action and the protective order required that
`this document only be accessible by outside counsel. Id. Petitioner notes
`that the parties to this IPR proceeding have agreed to modify the protective
`order in this action to extend the same level of protection for this document
`as was provided in the ITC action. Id. (citing Ex. 2323).
`Based on this evidence and argument, we are persuaded that Petitioner
`has provided good cause for sealing the entirety of Exhibit 1141.
`16. Exhibit 1206 (Genentech Confidential Document)
`Regeneron seeks to seal Exhibit 1206, which is an internal
`presentation that contains Genentech, Inc.’s (“Genentech”) confidential and
`proprietary development and research information relating to Lucentis PFS.
`Pet. Mot. 16–17. Petitioner asserts that this exhibit was subject to the
`protective order entered into in the ITC action and the protective order
`required that this document only be accessible by outside counsel. Id. at 17.
`Petitioner notes that the parties to this IPR proceeding have agreed to modify
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`the protective order in this action to extend the same level of protection for
`this exhibit as was provided in the ITC action. Id. (citing Ex. 2323).
`Based on this evidence and argument, we are persuaded that Petitioner
`has provided good cause for sealing the entirety of Exhibit 1206.
`17. Exhibit 1255–1256 (Gilead Confidential Documents)
`Regeneron seeks to seal Exhibits 1255–1256, which are confidential
`financial documents containing sales information of Macugen PFS. Pet.
`Mot. 17. Petitioner asserts that public disclosure of the information in
`Exhibit 1255–1256 would lead to exposure of Gilead’s business models,
`thus harming Gilead, a third party. Id.
`Based on this evidence and argument, we are persuaded that Petitioner
`has provided good cause for sealing the entirety of Exhibits 1255–1256.
`
`
`IV. Order
`
`Accordingly, it is:
`ORDERED that Petitioner’s Motion to Seal (Paper 71) is granted, and
`the unredacted versions of Petitioner’s Reply (Paper 72), Petitioner’s MTA
`Opposition (Paper 74), Exhibits 1100–1102, 1105–1107, 1109, 1172, 1207–
`1208, 1210 and Exhibits 1112–1114, 1116–1128, 1130–1162, 1167–1168,
`1185, 1203, 1205–1206, 1211, 1213, 1215–1226, 1248–1249, and 1254–
`1256 shall remain under seal; and
`FURTHER ORDERED that Petitioner must file a redacted version of
`Exhibit 1207 within seven days of this Order or provide an email clarifying
`why Exhibit 1207 should be sealed in its entirety.
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`FOR PETITIONER:
`
`Anish Desai
`Elizabeth Weiswasser
`Christopher Pepe
`WEIL, GOTSHAL & MANGES LLP
`anish.desai@weil.com
`elizabeth.weiswasser@weil.com
`christopher.pepe@weil.com
`
`
`
`
`For PATENT OWNER:
`
`Elizabeth Holland
`Nicholas Mitrokostas
`William G. James
`ALLEN & OVERY LLP
`elizabeth.holland@allenovery.com
`nicholas.mitrokostas@allenovery.com
`william.james@allenovery.com
`
`
`Linnea Cipriano
`Duncan Greenhalgh
`Joshua Weinger
`GOODWIN PROCTER LLP
`lcipriano@goodwinlaw.com
`dgreenhalgh@goodwinlaw.com
`jweinger@goodwinprocter.com
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