`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`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
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`1 IPR2024-00260 and IPR2024-00298 are joined with IPR2023-00884.
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`
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`IPR2023-00884
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`Pursuant to 35 U.S.C. § 316(a)(1) and 37 C.F.R. §§ 42.14 and 42.54, Patent
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`Owner Regeneron Pharmaceuticals, Inc. moves to seal the following exhibits
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`and references to confidential information within these exhibits and in the Patent
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`Owner's Response:
`
`Exhibit
`2063
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`Description
`Declaration of George Yancopoulos
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`2064
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`2067
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`2069
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`2070
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`2072
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`2073
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`2075
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`2076
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`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
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`Regeneron, VIEW Protocol, 5/2007
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`2141
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`2142
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`2143
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`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
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`2144
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`2147
`2162
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`1
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`IPR2023-00884
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`Exhibit
`2163
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`Description
`Regeneron, “DME Market Assessment Q1 2016,” 4/2016
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`2164
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`2165
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`2166
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`2167
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`2168
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`2169
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`2170
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`2171
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`2172
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`2173
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`2174
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`2175
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`2176
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`2177
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`2178
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`2179
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`2180
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`2181
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`Regeneron, “DME Market Assessment Q1 2017,” 5/2017
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`Regeneron, “DME Market Assessment Q1 2018,” 5/2018
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`Regeneron, “DME Market Assessment Q2 2015,” 8/2015
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`Regeneron, “DME Market Assessment Q2 2016,” 8/2016
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`Regeneron, “DME Market Assessment Q2 2017,” 7/2017
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`Regeneron, “DME Market Assessment Q2 2018,” 7/2018
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`Regeneron, “DME Market Assessment Q3 2015,” 11/2015
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`Regeneron, “DME Market Assessment Q3 2016,” 10/2016
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`Regeneron, “DME Market Assessment Q3 2017,” 10/2017
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`Regeneron, “DME Market Assessment Q4 2014,” 1/2015
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`Regeneron, “DME Market Assessment Q4 2015,” 2/2016
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`Regeneron, “DME Market Assessment Q4 2016,” 1/2017
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`Regeneron, “DME Market Assessment Q4 2017,” 2/2018
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`Regeneron, “DME Market Assessment Wave 3, Q3 2014
`Regeneron, “DME Market Assessment, Benchmark Wave,”
`11/8/2013
`Regeneron, "Physician ATU: Q1 2015," 4/2015
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`Regeneron, "Physician ATU: Q2 2015," 7/2015
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`Regeneron, "Physician ATU: Q3 2014," 11/2014
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`Exhibit
`2182
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`Description
`Regeneron, "Physician ATU: Q3 2015," 11/2015
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`2183
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`2184
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`2185
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`2186
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`2187
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`2188
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`2189
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`2190
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`2191
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`2192
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`2193
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`2194
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`2195
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`2196
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`2197
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`2198
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`2199
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`2214
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`Regeneron, "Physician ATU: Q4 2014," 1/2015
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`Regeneron, "Physician ATU: Q4 2015," 1/2016
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`Regeneron, "Physician ATU: Wave 2," 2/2013
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`Regeneron, "Physician ATU: Wave 4," 8/6/2013
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`Regeneron, "Physician ATU: Wave 5," 11/2013
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`Regeneron, "Physician ATU: Wave 6," 1/2014
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`Regeneron, "Physician ATU: Wave 7," 4/2014
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`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
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`Exhibit
`2215
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`Description
`Regeneron, "Wet AMD Physician ATU: Q1 2016," 4/2016
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`2216
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`2217
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`2218
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`2219
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`2220
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`2221
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`2222
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`2223
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`2224
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`2225
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`2232
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`2238
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`Regeneron, "Wet AMD Physician ATU: Q1 2017," 4/2017
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`Regeneron, "Wet AMD Physician ATU: Q1 2018," 5/2018
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`Regeneron, "Wet AMD Physician ATU: Q2 2016," 8/2016
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`Regeneron, "Wet AMD Physician ATU: Q2 2017," 7/2017
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`Regeneron, "Wet AMD Physician ATU: Q2 2018," 7/2018
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`Regeneron, "Wet AMD Physician ATU: Q3 2016," 10/2016
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`Regeneron, "Wet AMD Physician ATU: Q3 2017," 10/2017
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`Regeneron, "Wet AMD Physician ATU: Q4 2016," 1/2016
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`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
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`Vestrum, Anti-VEGF Category Sales Shares, c. 2/2022
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`I.
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`DOCUMENTS TO BE SEALED AND REASONS FOR SEALING
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`The standard governing the Board’s determination of whether to grant a
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`motion to seal is “good cause.” Arctic Cat, Inc. v. Polaris Indus. Inc., No.
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`IPR2017-00433, 2018 WL 1145910, at *1 (P.T.A.B. Feb. 27, 2018) (quoting 37
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`C.F.R. § 42.54). “The moving party bears the burden of showing that the relief
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`requested should be granted, and establishing that information sought to be sealed
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`is confidential information.” Askeladden LLC v. Verify Smart Corp., No. IPR2017-
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`00726, 2017 WL 4763581, at *1 (P.T.A.B. Oct. 18, 2017).
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`The documents, exhibits, and portions of exhibits that Patent Owner seeks to
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`file under seal meet the “good cause” standard. In each instance, the material is
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`either the confidential information of a third party, or else contains confidential
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`business information or confidential analyses that could cause competitive harm to
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`Patent Owner if disclosed publicly. Pursuant to Paragraph 5(A)(ii) of the Board’s
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`default protective order, redacted copies of the Patent Owner Response and
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`exhibits 2063, 2064, 2067, 2070, 2092, 2214, and 2232 are being filed publicly.
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`A. Confidential Commercial and Financial Documents of Patent
`Owner
`Exhibits 2143, 2144, 2162–2199, 2214–2225, and 2232 contain Patent
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`Owner’s confidential financial and sales information and confidential surveys and
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`analyses. The information contained in these exhibits is not publicly available and
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`would cause competitive harm to Patent Owner if disclosed on the public docket.
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`Public release of these documents and information could benefit Patent Owner’s
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`competitors and would therefore cause competitive harm to Patent Owner.
`
`B.
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`Patent Owner’s Clinical Development Processes and Strategic
`Decision Making
`Exhibits 2069, 2070, 2073, and 2075 contain Patent Owner’s internal
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`correspondence and presentations from 2006-2007 related to Regeneron’s
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`development of aflibercept, and in particular to the design of aflibercept clinical
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`trials. These documents reveal non-public aspects of Patent Owner’s strategic
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`decision making in the development of Eylea®, including its commercial and
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`regulatory strategies. Public release of these details could cause competitive harm
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`to Patent Owner by giving its competitors knowledge of its clinical research
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`operations. Patent Owner produced many of these documents in its district court
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`litigation against Mylan and Biocon, and designated them “CONFIDENTIAL” as
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`defined by the protective order in that case.
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`Exhibit 2092 contains the first pages of confidential documents relating to
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`Regeneron’s development of aflibercept. This document also reveals non-public
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`aspects of Patent Owner’s strategic decision making, and public release could
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`cause competitive harm to Patent Owner. Patent Owner produced many of these
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`documents in its district court litigation against Mylan and Biocon, and designated
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`them “CONFIDENTIAL” as defined by the protective order in that case.
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`C.
`Patent Owner’s Confidential Clinical Trial Protocols and Results
`Exhibits 2072 and 2073 contain detailed internal results of Patent Owner’s
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`CLEAR-IT-2 clinical trial results. They reveal details of the trial protocol, results,
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`and data analysis that have not been made public. Public release of these details
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`could cause competitive harm to Patent Owner.
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`Exhibit 2076 is a detailed clinical trial protocol for the VIEW trial. It reveals
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`non-public details about Patent Owner’s clinical trial protocol, data analysis, and
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`the product used in the clinical trial, and it implicates Patent Owner’s commercial
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`and regulatory strategies. Public release of these details could cause competitive
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`harm to Patent Owner by giving its competitors knowledge of its clinical research
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`operations. As reflected on the first page, this document was designated as
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`confidential to the Institutional Review Board and those involved in the conduct of
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`the clinical trial.
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`D. Other Confidential Commercial and Financial Documents
`Exhibit 2238 contains confidential financial information that is compiled and
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`provided by third party data provider, Vestrum Health (“Vestrum”). These
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`documents include data analysis related to Patent Owner’s activities in connection
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`with Eylea®. The information contained in these exhibits is not publicly available
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`and would cause competitive harm to Patent Owner and Vestrum if disclosed on
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`the public docket.
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`Exhibits 2141, 2142, and 2147 contain confidential information obtained
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`from the American Society of Retina Specialists (ASRS). These documents
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`include compiled survey information from ASRS member retina specialists. Only
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`members of ASRS have access to this information and the documents themselves
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`include restrictions on their publication. The information contained in these
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`exhibits is not publicly available and may cause competitive harm if disclosed on
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`the public docket.
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`E.
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`Briefing and Declarations Including or Describing Confidential
`Information
`The Patent Owner Response relies on Exhibit 2067, which is the Expert
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`Declaration of Richard Manning, PhD (“Manning Declaration”). Dr. Manning is
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`an expert economist retained by Patent Owner who opines on commercial success.
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`Dr. Manning relies on Patent Owner’s confidential information in his declaration,
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`and the confidential exhibits described above. Attachments C-1 through Y-4
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`contain either confidential information from the exhibits below or confidential
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`non-public analyses. Patent Owner moves to seal the specific portions of the
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`Patent Owner Response and Manning Declaration that reveal this confidential
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`information.
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`The Patent Owner Response also relies on Exhibits 2064 and 2063, which
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`are the Declaration of Dr. George Yancopoulos and the Declaration of Karen Chu.
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`These declarations discuss non-public aspects of Patent Owner’s strategic decision
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`making in the development of Eylea® as well as details of the clinical trial
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`protocols, results, and data analysis that have not been made public. They discuss
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`contents of the confidential exhibits described above. Patent Owner moves to seal
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`the specific portions of the Patent Owner Response, Yancopoulos Declaration, and
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`Chu Declaration that reveal this confidential information.
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`II.
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`PROTECTIVE ORDER
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`Regeneron filed an unopposed Motion for Protective Order requesting entry
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`of the Board’s default protective order, Ex.2059, on August 25, 2023. See Paper 8.
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`The Protective Order was entered on January 8, 2024. See Paper 25.
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`III. CERTIFICATION
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`Pursuant to 37 CFR § 42.54, Patent Owner certifies that it has conferred with
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`Petitioners regarding this motion to seal. Petitioners do not object to the motion.
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`
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`Dated: February 23, 2024
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`Respectfully submitted,
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`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
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`Certificate of Service (37 C.F.R. § 42.6(e)(4))
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`I hereby certify that the attached MOTION TO FILE CONFIDENTIAL
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`DOCUMENTS UNDER SEAL PURSUANT TO 37 C.F.R. §§ 42.14 AND 42.54
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`was served as of the below date on the Petitioners via e-mail (by agreement) to the
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`following counsel of record:
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`
`
`
`
`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
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`IPR2023-00884
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`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
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`11
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