UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`SAMSUNG BIOEPIS CO., LTD., CELLTRION INC,
`and BIOCON BIOLOGICS INC.,
`Petitioners,
`
`v.
`
` REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`Patent No. 11,253,572
`
`Inter Partes Review No. IPR2023-008841
`
`MOTION TO FILE CONFIDENTIAL DOCUMENTS UNDER
`SEAL PURSUANT TO 37 C.F.R. §§ 42.14 AND 42.54
`
`1 IPR2024-00260 and IPR2024-00298 are joined with IPR2023-00884.
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`SAMSUNG BIOEPIS CO., LTD., CELLTRION INC,
`and BIOCON BIOLOGICS INC.,
`Petitioners,
`
`v.
`
` REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`Patent No. 11,253,572
`
`Inter Partes Review No. IPR2023-008841
`
`MOTION TO FILE CONFIDENTIAL DOCUMENTS UNDER
`SEAL PURSUANT TO 37 C.F.R. §§ 42.14 AND 42.54
`
`1 IPR2024-00260 and IPR2024-00298 are joined with IPR2023-00884.
`
`
`
`IPR2023-00884
`
`Pursuant to 35 U.S.C. § 316(a)(1) and 37 C.F.R. §§ 42.14 and 42.54, Patent
`
`Owner Regeneron Pharmaceuticals, Inc. moves to seal the following exhibits
`
`and references to confidential information within these exhibits and in the Patent
`
`Owner's Response:
`
`Exhibit
`2063
`
`Description
`Declaration of George Yancopoulos
`
`2064
`
`2067
`
`2069
`
`2070
`
`2072
`
`2073
`
`2075
`
`2076
`
`Declaration of Karen Chu
`Expert Declaration of Richard Manning, PhD and Attachments C-1
`through Y-4
`Regeneron, “Bayer Alliance Internal Kick-Off Meeting,” 11/2006
`Regeneron, Email from Terifay to Yancopoulos et. al, 3/22/2007
`with attached slides
`Regeneron, CLEAR-IT-2 results, sent by Powchik to Yancopoulos
`3/22/2007
`Regeneron, CLEAR-IT-2 results and analysis, sent by Yancopoulos
`to Schleifer 3/22/2007
`Regeneron, Email from Yancopoulos to Jody, 4/2007
`
`Regeneron, VIEW Protocol, 5/2007
`
`2141
`
`2142
`
`2143
`
`2092 Metadata Exhibit
`American Society of Retina Specialists, “2015 Preferences and
`Trends (PAT) Survey,” c. 2015
`American Society of Retina Specialists, “2016 Preferences and
`Trends (PAT) Survey,” c. 2016
`Regeneron, “DME Market Assessment,” 8/2014
`Regeneron, “Q2 2020 Performance Update Wet AMD, DME,
`MEfRVO & DR w/out DME,” 7/2020
`American Society of Retina Specialists, “2009 Preferences and
`Trends Membership Survey,” c. 2009
`Regeneron, “DME Market Assessment Q1 2015,” 4/2015
`
`2144
`
`2147
`2162
`
`1
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`
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`IPR2023-00884
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`
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`
`
`Exhibit
`2163
`
`Description
`Regeneron, “DME Market Assessment Q1 2016,” 4/2016
`
`2164
`
`2165
`
`2166
`
`2167
`
`2168
`
`2169
`
`2170
`
`2171
`
`2172
`
`2173
`
`2174
`
`2175
`
`2176
`
`2177
`
`2178
`
`2179
`
`2180
`
`2181
`
`Regeneron, “DME Market Assessment Q1 2017,” 5/2017
`
`Regeneron, “DME Market Assessment Q1 2018,” 5/2018
`
`Regeneron, “DME Market Assessment Q2 2015,” 8/2015
`
`Regeneron, “DME Market Assessment Q2 2016,” 8/2016
`
`Regeneron, “DME Market Assessment Q2 2017,” 7/2017
`
`Regeneron, “DME Market Assessment Q2 2018,” 7/2018
`
`Regeneron, “DME Market Assessment Q3 2015,” 11/2015
`
`Regeneron, “DME Market Assessment Q3 2016,” 10/2016
`
`Regeneron, “DME Market Assessment Q3 2017,” 10/2017
`
`Regeneron, “DME Market Assessment Q4 2014,” 1/2015
`
`Regeneron, “DME Market Assessment Q4 2015,” 2/2016
`
`Regeneron, “DME Market Assessment Q4 2016,” 1/2017
`
`Regeneron, “DME Market Assessment Q4 2017,” 2/2018
`
`Regeneron, “DME Market Assessment Wave 3, Q3 2014
`Regeneron, “DME Market Assessment, Benchmark Wave,”
`11/8/2013
`Regeneron, "Physician ATU: Q1 2015," 4/2015
`
`Regeneron, "Physician ATU: Q2 2015," 7/2015
`
`Regeneron, "Physician ATU: Q3 2014," 11/2014
`
`
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`2
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`IPR2023-00884
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`Exhibit
`2182
`
`Description
`Regeneron, "Physician ATU: Q3 2015," 11/2015
`
`2183
`
`2184
`
`2185
`
`2186
`
`2187
`
`2188
`
`2189
`
`2190
`
`2191
`
`2192
`
`2193
`
`2194
`
`2195
`
`2196
`
`2197
`
`2198
`
`2199
`
`2214
`
`Regeneron, "Physician ATU: Q4 2014," 1/2015
`
`Regeneron, "Physician ATU: Q4 2015," 1/2016
`
`Regeneron, "Physician ATU: Wave 2," 2/2013
`
`Regeneron, "Physician ATU: Wave 4," 8/6/2013
`
`Regeneron, "Physician ATU: Wave 5," 11/2013
`
`Regeneron, "Physician ATU: Wave 6," 1/2014
`
`Regeneron, "Physician ATU: Wave 7," 4/2014
`
`Regeneron, "Physician ATU: Wave 8," 8/2014
`Regeneron, “Q1 2019 Performance Update Wet AMD, DME, &
`MEfRVO,” 5/2019
`Regeneron, “Q1 2020 Performance Update Wet AMD, DME,
`MEfRVO & DR w/out DME,” 4/2020
`Regeneron, “Q2 2019 Performance Update Wet AMD, DME,
`MEfRVO & DR w/out DME,” 8/2019
`Regeneron, “Q3 2018 Performance Update Wet AMD, DME, &
`MEfRVO,” 11/2018
`Regeneron, “Q3 2019 Performance Update Wet AMD, DME,
`MEfRVO & DR w/out DME,” 11/2019
`Regeneron, “Q3 2020 Performance Update Wet AMD, DME,
`MEfRVO & DR w/out DME,” 11/2020
`Regeneron, "Q4 2018 Performance Update Wet AMD, DME, &
`MEfRVO," 2/2019
`Regeneron, “Q4 2019 Performance Update Wet AMD, DME, &
`MEfRVO,” 1/2020
`Regeneron, “Q4 2020 Performance Update Wet AMD, DME,
`MEfRVO & DR w/out DME,” 1/29/2021
`Regeneron, “US Eylea P&L LTD,” 12/2021
`
`
`
`3
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`IPR2023-00884
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`
`
`Exhibit
`2215
`
`Description
`Regeneron, "Wet AMD Physician ATU: Q1 2016," 4/2016
`
`2216
`
`2217
`
`2218
`
`2219
`
`2220
`
`2221
`
`2222
`
`2223
`
`2224
`
`2225
`
`2232
`
`2238
`
`Regeneron, "Wet AMD Physician ATU: Q1 2017," 4/2017
`
`Regeneron, "Wet AMD Physician ATU: Q1 2018," 5/2018
`
`Regeneron, "Wet AMD Physician ATU: Q2 2016," 8/2016
`
`Regeneron, "Wet AMD Physician ATU: Q2 2017," 7/2017
`
`Regeneron, "Wet AMD Physician ATU: Q2 2018," 7/2018
`
`Regeneron, "Wet AMD Physician ATU: Q3 2016," 10/2016
`
`Regeneron, "Wet AMD Physician ATU: Q3 2017," 10/2017
`
`Regeneron, "Wet AMD Physician ATU: Q4 2016," 1/2016
`
`Regeneron, "Wet AMD Physician ATU: Q4 2017," 1/2018
`Regeneron, “Wave 1 2021 Performance Update Wet AMD, DME,
`MEfRVO, and DR w/out DME,” 9/2021
`Regeneron, Eylea Gross & Net Sales P&L YTD, c.2021
`
`Vestrum, Anti-VEGF Category Sales Shares, c. 2/2022
`
`I.
`
`DOCUMENTS TO BE SEALED AND REASONS FOR SEALING
`
`The standard governing the Board’s determination of whether to grant a
`
`motion to seal is “good cause.” Arctic Cat, Inc. v. Polaris Indus. Inc., No.
`
`IPR2017-00433, 2018 WL 1145910, at *1 (P.T.A.B. Feb. 27, 2018) (quoting 37
`
`C.F.R. § 42.54). “The moving party bears the burden of showing that the relief
`
`requested should be granted, and establishing that information sought to be sealed
`
`
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`4
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`
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`IPR2023-00884
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`
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`
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`is confidential information.” Askeladden LLC v. Verify Smart Corp., No. IPR2017-
`
`00726, 2017 WL 4763581, at *1 (P.T.A.B. Oct. 18, 2017).
`
`The documents, exhibits, and portions of exhibits that Patent Owner seeks to
`
`file under seal meet the “good cause” standard. In each instance, the material is
`
`either the confidential information of a third party, or else contains confidential
`
`business information or confidential analyses that could cause competitive harm to
`
`Patent Owner if disclosed publicly. Pursuant to Paragraph 5(A)(ii) of the Board’s
`
`default protective order, redacted copies of the Patent Owner Response and
`
`exhibits 2063, 2064, 2067, 2070, 2092, 2214, and 2232 are being filed publicly.
`
`A. Confidential Commercial and Financial Documents of Patent
`Owner
`Exhibits 2143, 2144, 2162–2199, 2214–2225, and 2232 contain Patent
`
`Owner’s confidential financial and sales information and confidential surveys and
`
`analyses. The information contained in these exhibits is not publicly available and
`
`would cause competitive harm to Patent Owner if disclosed on the public docket.
`
`Public release of these documents and information could benefit Patent Owner’s
`
`competitors and would therefore cause competitive harm to Patent Owner.
`
`B.
`
`Patent Owner’s Clinical Development Processes and Strategic
`Decision Making
`Exhibits 2069, 2070, 2073, and 2075 contain Patent Owner’s internal
`
`correspondence and presentations from 2006-2007 related to Regeneron’s
`
`
`
`5
`
`
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`
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`IPR2023-00884
`
`
`
`
`
`development of aflibercept, and in particular to the design of aflibercept clinical
`
`trials. These documents reveal non-public aspects of Patent Owner’s strategic
`
`decision making in the development of Eylea®, including its commercial and
`
`regulatory strategies. Public release of these details could cause competitive harm
`
`to Patent Owner by giving its competitors knowledge of its clinical research
`
`operations. Patent Owner produced many of these documents in its district court
`
`litigation against Mylan and Biocon, and designated them “CONFIDENTIAL” as
`
`defined by the protective order in that case.
`
`Exhibit 2092 contains the first pages of confidential documents relating to
`
`Regeneron’s development of aflibercept. This document also reveals non-public
`
`aspects of Patent Owner’s strategic decision making, and public release could
`
`cause competitive harm to Patent Owner. Patent Owner produced many of these
`
`documents in its district court litigation against Mylan and Biocon, and designated
`
`them “CONFIDENTIAL” as defined by the protective order in that case.
`
`C.
`Patent Owner’s Confidential Clinical Trial Protocols and Results
`Exhibits 2072 and 2073 contain detailed internal results of Patent Owner’s
`
`CLEAR-IT-2 clinical trial results. They reveal details of the trial protocol, results,
`
`and data analysis that have not been made public. Public release of these details
`
`could cause competitive harm to Patent Owner.
`
`Exhibit 2076 is a detailed clinical trial protocol for the VIEW trial. It reveals
`
`
`
`6
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`
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`IPR2023-00884
`
`
`
`
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`non-public details about Patent Owner’s clinical trial protocol, data analysis, and
`
`the product used in the clinical trial, and it implicates Patent Owner’s commercial
`
`and regulatory strategies. Public release of these details could cause competitive
`
`harm to Patent Owner by giving its competitors knowledge of its clinical research
`
`operations. As reflected on the first page, this document was designated as
`
`confidential to the Institutional Review Board and those involved in the conduct of
`
`the clinical trial.
`
`D. Other Confidential Commercial and Financial Documents
`Exhibit 2238 contains confidential financial information that is compiled and
`
`provided by third party data provider, Vestrum Health (“Vestrum”). These
`
`documents include data analysis related to Patent Owner’s activities in connection
`
`with Eylea®. The information contained in these exhibits is not publicly available
`
`and would cause competitive harm to Patent Owner and Vestrum if disclosed on
`
`the public docket.
`
`Exhibits 2141, 2142, and 2147 contain confidential information obtained
`
`from the American Society of Retina Specialists (ASRS). These documents
`
`include compiled survey information from ASRS member retina specialists. Only
`
`members of ASRS have access to this information and the documents themselves
`
`include restrictions on their publication. The information contained in these
`
`exhibits is not publicly available and may cause competitive harm if disclosed on
`
`
`
`7
`
`
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`
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`IPR2023-00884
`
`
`
`
`
`the public docket.
`
`E.
`
`Briefing and Declarations Including or Describing Confidential
`Information
`The Patent Owner Response relies on Exhibit 2067, which is the Expert
`
`Declaration of Richard Manning, PhD (“Manning Declaration”). Dr. Manning is
`
`an expert economist retained by Patent Owner who opines on commercial success.
`
`Dr. Manning relies on Patent Owner’s confidential information in his declaration,
`
`and the confidential exhibits described above. Attachments C-1 through Y-4
`
`contain either confidential information from the exhibits below or confidential
`
`non-public analyses. Patent Owner moves to seal the specific portions of the
`
`Patent Owner Response and Manning Declaration that reveal this confidential
`
`information.
`
`The Patent Owner Response also relies on Exhibits 2064 and 2063, which
`
`are the Declaration of Dr. George Yancopoulos and the Declaration of Karen Chu.
`
`These declarations discuss non-public aspects of Patent Owner’s strategic decision
`
`making in the development of Eylea® as well as details of the clinical trial
`
`protocols, results, and data analysis that have not been made public. They discuss
`
`contents of the confidential exhibits described above. Patent Owner moves to seal
`
`the specific portions of the Patent Owner Response, Yancopoulos Declaration, and
`
`Chu Declaration that reveal this confidential information.
`
`
`
`8
`
`
`
`
`
`IPR2023-00884
`
`
`
`
`
`II.
`
`PROTECTIVE ORDER
`
`Regeneron filed an unopposed Motion for Protective Order requesting entry
`
`of the Board’s default protective order, Ex.2059, on August 25, 2023. See Paper 8.
`
`The Protective Order was entered on January 8, 2024. See Paper 25.
`
`III. CERTIFICATION
`
`Pursuant to 37 CFR § 42.54, Patent Owner certifies that it has conferred with
`
`Petitioners regarding this motion to seal. Petitioners do not object to the motion.
`
`
`
`Dated: February 23, 2024
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`By /Adam R. Brausa/
`Adam R. Brausa, Reg. No. 60,287
`MORRISON & FOERSTER LLP
`425 Market Street
`San Francisco, California 94105
`Tel: (415) 268-6053
`ABrausa@mofo.com
`
`
`Counsel for Patent Owner
`
`
`
`
`9
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`
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`IPR2023-00884
`
`
`
`
`
`Certificate of Service (37 C.F.R. § 42.6(e)(4))
`
`I hereby certify that the attached MOTION TO FILE CONFIDENTIAL
`
`DOCUMENTS UNDER SEAL PURSUANT TO 37 C.F.R. §§ 42.14 AND 42.54
`
`was served as of the below date on the Petitioners via e-mail (by agreement) to the
`
`following counsel of record:
`
`
`
`
`
`Raymond N. Nimrod (Reg. No. 31,987)
`Matthew A. Traupman (Reg. No. 50,832)
`Elliot Choi (pro hac vice)
`Zachariah Summers (pro hac vice)
`Sarah Cork (pro hac vice to be applied for)
`Landon Andrew Smith (Reg. No. 79,248)
`QUINN EMANUEL URQUHART
`& SULLIVAN, LLP
`51 Madison Ave., 22nd Floor
`New York, NY 10010
`General Tel: (212) 849-7000
`Direct Tel: (212) 849-7322
`Fax: (212) 849-7100
`raynimrod@quinnemanuel.com
`matthewtraupman@quinnemanuel.com
`elliotchoi@quinnemanuel.com
`zachsummers@quinnemanuel.com
`landonsmith@quinnemanuel.com
`qe-samsungbioepis@quinnemanuel.com
`
`Paul J. Molino (Reg. No. 45,350)
`William A. Rakoczy (pro hac vice to be filed)
`Deanne M. Mazzochi (Reg. No. 50,158)
`Heinz J. Salmen (pro hac vice to be filed)
`Jeff A. Marx (Reg. No. 56,977)
`Eric R. Hunt (pro hac vice to be filed)
`Neil B. McLaughlin (Reg. No. 70,810)
`Lauren M. Lesko (pro hac vice to be filed)
`
`10
`
`
`
`
`
`IPR2023-00884
`
`L. Scott Beall (Reg. No. 52,601)
`Thomas H. Ehrich (Reg. No. 67,122)
`Steven J. Birkos (Reg. No. 65,300)
`Jake R. Ritthamel (pro hac vice to be filed)
`Rakoczy Molino Mazzochi Siwik LLP
`6 West Hubbard Street
`Chicago, IL 60654
`MYL_REG_IPR@rmmslegal.com
`
`Lora Green (Reg. No. 43,541)
`Yahn-Lin Chu (Reg. No. 75,946)
`Robert Cerwinski (to be admitted pro hac vice, pending)
`Aviv Zalcenstein (to be admitted pro hac vice, pending)
`Brigid Morris (to be admitted pro hac vice, pending)
`Gemini Law LLP
`40 W 24th Street, Suite 6N
`New York, NY 10010
`Tel.: 917-915-8832
`Email: lgreen@geminilaw.com
`Email: fchu@geminilaw.com
`Email: rcerwinski@geminilaw.com
`Email: azalcenstein@geminilaw.com
`Email: bmorris@geminilaw.com
`
`Dated: February 23, 2024
`
` /Adam R. Brausa/
`Adam R. Brausa, Reg. No. 60,287
`
`11
`
`
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