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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`REGENERON PHARMACEUTICALS,INC.,
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`Petitioner
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`Vv.
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`NOVARTIS PHARMA AG,
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`NOVARTIS TECHNOLOGYLLC,
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`NOVARTIS PHARMACEUTICALS CORPORATION,
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`Patent Owners
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`Case IPR2020-1318
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`Patent 9,220,631
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`DECLARATION OF JEFFREY SALLING IN SUPPORT OF NOVARTIS’S
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`PATENT OWNER PRELIMINARY RESPONSE
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`Novartis Exhibit 2062.001
`Regeneron v. Novartis, IPR202 1-008 16
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`Novartis Exhibit 2062.001
`Regeneron v. Novartis, IPR2021-00816
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`I.
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`INTRODUCTION
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`1.
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`I, Jeffrey Salling, have personal knowledgeofthe facts set forth in
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`this Declaration and am competentto testify concerning the same.
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`2.
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`Tam employed by Novartis Services Inc. in East Hanover, N.J. I have
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`been Global Director of eDiscovery & Senior Legal Counsel at Novartis since
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`April 2019. In this position, I oversee Novartis’s global discovery operations, to
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`ensure compliance with discovery obligations consistent with applicable rules.
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`3. BACKGROUND
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`4.
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`Novartis Pharma AG, Novartis Pharmaceuticals Corporation, and
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`Novartis Technology LLC(collectively, “Novartis”) were previously involved in
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`litigation concerning U.S. Patent 9,220,631 in ITC Investigation No. 337-TA-1207
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`(“ITC Investigation”). Novartis file systems maintain Novartis electronic files
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`created and stored by Novartis employees.
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`5.
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`File systems are maintained by Novartis Information Technology(IT)
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`whichis the infrastructure upon which the metadata is supported.
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`6.
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`Based on my understanding and experience, metadata is data about
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`the data (for example, creation date, modified date, etc.). Metadata is generated
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`contemporaneously with the creation, modification, or movementof the electronic
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`files with which they are associated.
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`7.
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`Metadata includes information such as the file name and modified
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`Novartis Exhibit 2062.002
`Regeneron v. Novartis, IPR202 1-008 16
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`Novartis Exhibit 2062.002
`Regeneron v. Novartis, IPR2021-00816
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`date for an electronic document. The modified date reflects the date on which the
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`document waslast modified or changed, such as by changingthe file name or
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`altering its contents.
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`8.
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`The metadata associated with each electronicfile is created and stored
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`in the ordinary course of business at Novartis.
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`9.
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`Novartis documents were collected from Novartis file systems for
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`production in the ITC Investigation. This collection of data was inclusive ofthe
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`associated metadata. A numberof these documents (and metadata) were produced
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`to Regeneron Pharmaceuticals Inc. (“Regeneron”) in the ITC Investigation.
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`10.
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`Each page of each document produced to Regeneron in the ITC
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`Investigation was stamped with a unique identifier referred to as a Bates number.
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`The Bates numberappearsin the lowerright corner of each page of each produced
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`document. For Novartis’ production to Regeneron in the ITC Investigation,
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`Novartis employed Bates numbers beginning with the Bates prefix
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`“NOVITC(CH)” or “NOVITC(US).”
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`II. Documents Produced by Novartis in the ITC
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`11.
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`Exhibit 2126 is a document bearing Bates number
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`NOVITC(CH)00054063, which was among the documents collected from the
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`Novartis file system and produced to Regeneron in connection with the ITC
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`Investigation.
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`I have examined Exhibit 2126, and aside from the redactions, which
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`Novartis Exhibit 2062.003
`Regeneron v. Novartis, IPR202 1-008 16
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`Novartis Exhibit 2062.003
`Regeneron v. Novartis, IPR2021-00816
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`were applied at the direction of Novartis’ outside Swiss counsel to comply with
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`Swiss data protection law, I have confirmedthat this Exhibit is a PDF ofthe native
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`file “20120320 Novartis Pre-Filled Syringes (NVS).pdf.” I have personal
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`knowledge of the metadata associated with the native file “20120320 Novartis Pre-
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`Filled Syringes (NVS).pdf,” which reflects that it has a “Modified Date” of March
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`27, 2012. These metadata were generated and maintained by Novartis in the
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`ordinary course of business.
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`12.
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`Exhibit 2128 is a document bearing Bates number
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`NOVITC(CH)00167663, which was among the documents collected from the
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`Novartis file system and produced to Regeneron in connection with the ITC
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`Investigation.
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`I have examined Exhibit 2128, and aside from the redactions, which
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`were applied at the direction of Novartis’ outside Swiss counsel to comply with
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`Swiss data protection law, I have confirmedthat this Exhibit is a PDF ofthe native
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`file “RPO1098A Development Report.pdf.” I have personal knowledge of the
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`metadata associated with the native file “RP01098A Development Report.pdf,”,
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`whichreflects that it has a “Modified Date” of March 26, 2013. These metadata
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`were generated and maintained by Novartis in the ordinary course of business.
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`13.
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`Exhibit 2129 is a document bearing Bates number
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`NOVITC(CH)00168961, which was among the documents collected from the
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`Novartis file system and produced to Regeneron in connection with the ITC
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`Novartis Exhibit 2062.004
`Regeneron v. Novartis, IPR202 1-008 16
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`Novartis Exhibit 2062.004
`Regeneron v. Novartis, IPR2021-00816
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`Investigation.
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`I have examined Exhibit 2129, and aside from the redactions, which
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`were applied at the direction of Novartis’ outside Swiss counsel to comply with
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`Swiss data protection law, I have confirmed that this Exhibit is a PDF ofthe native
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`file “Comparison Vetter Puurs syringes rap ID.pdf.” I have personal knowledge of
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`the metadata associated with the native file “Comparison Vetter Puurs syringes rap
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`ID.pdf,” which reflects that it has a “Modified Date” of December 20, 2019. These
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`metadata were generated and maintained by Novartis in the ordinary course of
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`business.
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`14.
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`Exhibit 2130 is a document bearing Bates number
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`NOVITC(CH)00169036, which was among the documents collected from the
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`Novartis file system and produced to Regeneron in connection with the ITC
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`Investigation.
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`I have examined Exhibit 2130, and aside from the redactions, which
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`were applied at the direction of Novartis’ outside Swiss counsel to comply with
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`Swiss data protection law, I have confirmed that this Exhibit is a PDF ofthe native
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`file “LucentisPFSDesignReview_Section_610aug06xl.ppt.” I have personal
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`knowledgeof the metadata associated with the native file
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`“LucentisPFSDesignReview_Section_6_10aug06xl.ppt,” which reflects that it
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`has a “Modified Date” of August 10, 2006. These metadata were generated and
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`maintained by Novartis in the ordinary course of business.
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`15.
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`Exhibit 2131 is a document bearing Bates number
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`Novartis Exhibit 2062.005
`Regeneron v. Novartis, IPR202 1-008 16
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`Novartis Exhibit 2062.005
`Regeneron v. Novartis, IPR2021-00816
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`NOVITC(CH)00170304, which was among the documents collected from the
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`Novartis file system and produced to Regeneron in connection with the ITC
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`Investigation.
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`I have examined Exhibit 2131, and aside from the redactions, which
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`were applied at the direction of Novartis’ outside Swiss counsel to comply with
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`Swiss data protection law, I have confirmed that this Exhibit is a PDF ofthe native
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`file “090095a985da60fc_7008027P35M_966_1.doc.” I have personal
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`knowledgeof the metadata associated with the native file
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`“090095a985da60fc_7008027P35M_966_1.doc,” which reflects that it has a
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`“Modified Date” of January 28, 2019. These metadata were generated and
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`maintained by Novartis in the ordinary course of business.
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`16.
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`Exhibit 2136 is a document bearing Bates number
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`NOVITC(CH)00217349, which was among the documents collected from the
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`Novartis file system and produced to Regeneron in connection with the ITC
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`Investigation.
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`I have examined Exhibit 2136, and aside from the redactions, which
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`were applied at the direction of Novartis’ outside Swiss counsel to comply with
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`Swiss data protection law, I have confirmed that this Exhibit is a PDF ofthe native
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`file “Lucentis GNE PFS — Tech. Eval. final Sept. 2006.doc.” I have personal
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`knowledge of the metadata associated with the native file “Lucentis GNE PFS —
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`Tech. Eval. final Sept. 2006.doc,” which reflect that it has a “Modified Date” of
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`January 9, 2009. These metadata were generated and maintained by Novartis in
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`Novartis Exhibit 2062.006
`Regeneron v. Novartis, IPR202 1-008 16
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`Novartis Exhibit 2062.006
`Regeneron v. Novartis, IPR2021-00816
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`

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`the ordinary course of business.
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`17.
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`Exhibit 2137 is a document bearing Bates number
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`NOVITC(CH)00217646, which was among the documentscollected from the
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`Novartis file system and produced to Regeneron in connection with the ITC
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`Investigation. I have examined Exhibit 2137, and aside from the redactions, which
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`were applied at the direction of Novartis’ outside Swiss counsel to comply with
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`Swiss data protection law, I have confirmed that this Exhibit is a PDF ofthe native
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`file “[UnnamedPresentation].” I have personal knowledgeof the metadata
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`associated with the native file “[Unnamed Presentation],” which reflects that it has
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`a “Modified Date” of December 4, 2008. These metadata were generated and
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`maintained by Novartis in the ordinary course of business.
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`18.
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`Exhibit 2138 is a document bearing Bates number
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`NOVITC(CH)00217650, which was among the documents collected from the
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`Novartis file system and produced to Regeneron in connection with the ITC
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`Investigation. I have examined Exhibit 2138, and aside from the redactions, which
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`were applied at the direction of Novartis’ outside Swiss counsel to comply with
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`Swiss data protection law, I have confirmedthat this Exhibit is a PDF ofthe native
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`file “[UnnamedPresentation].” I have personal knowledge of the metadata
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`associated with the native file “[Unnamed Presentation],” which reflects that it has
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`a “Modified Date” of December 4, 2008. These metadata were generated and
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`Novartis Exhibit 2062.007
`Regeneron v. Novartis, IPR202 1-008 16
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`Novartis Exhibit 2062.007
`Regeneron v. Novartis, IPR2021-00816
`
`

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`maintained by Novartis in the ordinary course of business.
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`19.
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`Exhibit 2139 is a document bearing Bates number
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`NOVITC(CH)00810847, which was among the documents collected from the
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`Novartis file system and produced to Regeneron in connection with the ITC
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`Investigation.
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`I have examined Exhibit 2139, and aside from the redactions, which
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`were applied at the direction of Novartis’ outside Swiss counsel to comply with
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`Swiss data protection law, I have confirmed that this Exhibit is a PDF ofthe native
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`
`file “QOS_drug-product-syringe.pdf.” I have personal knowledge of the metadata
`
`
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`
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`
`
`associated with the native file “QOS_drug-product-syringe.pdf,” which reflects
`
`
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`that it has a “Modified Date” of May 13, 2013. These metadata were generated
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`and maintained by Novartis in the ordinary course of business.
`
`
`
`20.
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`
`Exhibit 2140 is a document bearing Bates number
`
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`NOVITC(CH)00874056, which was among the documents collected from the
`
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`
`
`
`
`
`
`
`Novartis file system and produced to Regeneron in connection with the ITC
`
`
`
`Investigation.
`
`
`
`
`
`
`
`
`
`
`
`
`
`I have examined Exhibit 2140, and aside from the redactions, which
`
`
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`
`
`
`
`
`
`
`
`
`
`
`were applied at the direction of Novartis’ outside Swiss counsel to comply with
`
`
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`
`
`
`
`
`
`
`
`
`
`
`
`
`Swiss data protection law, I have confirmed that this Exhibit is a PDF ofthe native
`
`
`
`
`
`
`
`
`
`
`
`
`file “Lucentis PFS update - NSO IFB — June 16_2011-final-revised2.ppt.” I have
`
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`personal knowledge of the metadata associated with the native file “Lucentis PFS
`
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`
`
`
`
`
`
`
`
`
`update — NSO IFB — June 16_2011-final-revised2.ppt,” which reflect that it has a
`
`Novartis Exhibit 2062.008
`Regeneron v. Novartis, IPR202 1-008 16
`
`Novartis Exhibit 2062.008
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`
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`“Modified Date” of June 15, 2011. These metadata were generated and maintained
`
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`by Novartis in the ordinary course of business.
`
`
`
`21.
`
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`
`
`Exhibit 2144 is a document bearing Bates number
`
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`NOVITC(CH)01498292, which was among the documents collected from the
`
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`
`
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`
`
`Novartis file system and produced to Regeneron in connection with the ITC
`
`
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`
`
`
`
`
`
`
`
`Investigation. I have examined Exhibit 2144, and aside from the redactions, which
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`were applied at the direction of Novartis’ outside Swiss counsel to comply with
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Swiss data protection law, I have confirmed that this Exhibit is a PDF ofthe native
`
`
`
`
`
`
`
`
`
`
`
`
`
`file “Lucentis PFS Project Review — GPT November 15_2011 — Main deck.ppt.” I
`
`
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`
`
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`
`
`
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`
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`have personal knowledge of the metadata associated with the native file “Lucentis
`
`
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`
`
`
`
`
`
`PFS Project Review — GPT November 15_2011 — Main deck.ppt,” whichreflects
`
`
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`that it has a “Modified Date” of November 11, 2011. These metadata were
`
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`
`
`
`
`
`
`
`
`generated and maintained by Novartis in the ordinary course of business.
`
`
`
`22.
`
`
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`
`
`Exhibit 2145 is a document bearing Bates number
`
`
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`
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`
`
`NOVITC(CH)01863737, which was among the documents collected from the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Novartis file system and produced to Regeneron in connection with the ITC
`
`
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`
`
`
`
`
`
`
`
`
`
`
`Investigation. I have examined Exhibit 2145, and aside from the redactions, which
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`were applied at the direction of Novartis’ outside Swiss counsel to comply with
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Swiss data protection law, I have confirmed that this Exhibit is a PDF ofthe native
`
`
`
`
`
`
`
`
`
`
`
`
`
`file “Lucentis PFS — IPT meeting — March 19th 2007_CS.ppt.” I have personal
`
`
`
`Novartis Exhibit 2062.009
`Regeneron v. Novartis, IPR202 1-008 16
`
`Novartis Exhibit 2062.009
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`knowledge of the metadata associated with the native file “Lucentis PFS — IPT
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`meeting — March 19th 2007_CS.ppt,” whichreflect that it has a “Modified Date”
`
`
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`
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`
`
`of March 15, 2007. These metadata were generated and maintained by Novartis in
`
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`
`
`the ordinary course of business.
`
`
`
`23.
`
`
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`
`
`Exhibit 2146 is a document bearing Bates number
`
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`
`
`NOVITC(CH)01863785, which was among the documentscollected from the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Novartis file system and produced to Regeneron in connection with the ITC
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Investigation. I have examined Exhibit 2146, and aside from the redactions, which
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`were applied at the direction of Novartis’ outside Swiss counsel to comply with
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Swiss data protection law, I have confirmed that this Exhibit is a PDF ofthe native
`
`
`
`
`
`
`
`
`
`
`
`
`
`file “Novartis Vetter Disclosure to Bayer Healthcare 01 April~.pdf.” I have
`
`
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`
`
`
`
`
`
`personal knowledge of the metadata associated with the native file “Novartis
`
`
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`
`
`
`
`
`
`
`
`
`
`
`
`Vetter Disclosure to Bayer Healthcare 01 April~.pdf,” which reflects that it has a
`
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`
`
`
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`
`
`“Modified Date” of April 1, 2014. These metadata were generated and maintained
`
`
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`
`
`by Novartis in the ordinary course of business.
`
`
`
`24.
`
`
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`
`
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`
`
`
`Exhibit 2147 is a document bearing Bates number
`
`
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`
`
`NOVITC(CH)01906307, which was among the documents collected from the
`
`
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`
`
`
`
`
`
`
`
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`
`
`Novartis file system and produced to Regeneron in connection with the ITC
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Investigation. I have examined Exhibit 2147, and aside from the redactions, which
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`were applied at the direction of Novartis’ outside Swiss counsel to comply with
`
`
`
`Novartis Exhibit 2062.0010
`Regeneron v. Novartis, IPR202 1-008 16
`
`Novartis Exhibit 2062.0010
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`
`Swiss data protection law, I have confirmed that this Exhibit is a PDF ofthe native
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`file “ASP CDA.pdf.” I have personal knowledge of the metadata associated with
`
`
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`
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`
`
`
`
`
`
`
`
`
`the native file “ASP CDA.pdf,” which reflects that it has a “Modified Date” of
`
`
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`
`
`
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`
`
`
`March 19, 2009. These metadata were generated and maintained by Novartis in
`
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`
`
`the ordinary course of business.
`
`
`
`25.
`
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`
`
`Exhibit 2150 is a document bearing Bates number
`
`
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`
`
`NOVITC(CH)02929814, which was among the documents collected from the
`
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`
`
`
`
`
`
`
`
`
`
`Novartis file system and produced to Regeneron in connection with the ITC
`
`
`
`Investigation.
`
`
`
`
`
`
`
`
`
`
`
`
`
`I have examined Exhibit 2150, and aside from the redactions, which
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`were applied at the direction of Novartis’ outside Swiss counsel to comply with
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Swiss data protection law, I have confirmed that this Exhibit is a PDFofthe native
`
`
`
`
`
`
`
`
`
`
`
`
`
`file “7008027P83MB967_17.pdf.” I have personal knowledgeof the metadata
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`associated with the native file “7008027P83MB967_17.pdf,” which reflect that
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`it has a “Modified Date” of September 3, 2019. These metadata were generated
`
`
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`
`
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`
`
`
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`
`
`and maintained by Novartis in the ordinary course of business.
`
`
`
`26.
`
`
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`
`
`
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`
`
`Exhibit 2254 is a document bearing Bates number
`
`
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`
`
`
`
`
`NOVITC(CH)00885630, which was among the documents collected from the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Novartis file system and produced to Regeneron in connection with the ITC
`
`
`
`Investigation.
`
`
`
`
`
`
`
`
`
`
`
`
`
`I have examined Exhibit 2254, and aside from the redactions, which
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`were applied at the direction of Novartis’ outside Swiss counsel to comply with
`
`
`
`Novartis Exhibit 2062.0011
`Regeneron v. Novartis, IPR202 1-008 16
`
`Novartis Exhibit 2062.0011
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`
`Swiss data protection law, I have confirmed that this Exhibit is a PDF ofthe native
`
`
`
`
`
`
`
`
`
`
`file “Lucentis PFS_Technical Review_2012_0216.” I have personal knowledge
`
`
`
`
`
`
`
`
`
`
`
`
`
`of the metadata associated with the native file “Lucentis PFS_Technical
`
`
`
`
`
`
`
`
`
`
`
`
`
`Review_20120216,” whichreflects that it has a “Modified Date” of February 16,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`2012. These metadata were generated and maintained by Novartis in the ordinary
`
`
`
`
`
`course of business.
`
`
`
`27.
`
`
`
`
`
`
`
`
`
`Exhibit 2166 is a document bearing Bates number
`
`
`
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`
`
`
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`
`
`
`
`NOVITC(US)00389194, which was among the documents collected from the
`
`
`
`
`
`
`
`
`
`
`
`
`Novartis file system and produced to Regeneron in connection with the ITC
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Investigation. I have examined Exhibit 2166 and I have confirmedthatthis
`
`
`
`
`
`
`
`
`
`
`
`
`
`Exhibit is a PDF ofthe native file “Brolucizumab Global Forecast incl PFS
`
`
`
`
`
`
`
`
`
`
`
`analysis - October 18th 2016.pptx.” I have personal knowledge of the metadata
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`associated with the native file “Brolucizumab Global Forecast incl PFS analysis -
`
`
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`
`
`
`
`
`
`
`
`
`October 18th 2016.pptx,” whichreflects that it has a “Modified Date” of October
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`18, 2016. These metadata were generated and maintained by Novartis in the
`
`
`
`
`
`
`ordinary course of business.
`
`
`
`28.
`
`
`
`
`
`
`
`
`
`Exhibit 2167 is a document bearing Bates number
`
`
`
`
`
`
`
`
`
`
`
`
`NOVITC(US)00394737, which was among the documents collected from the
`
`
`
`
`
`
`
`
`
`
`
`
`Novartis file system and produced to Regeneron in connection with the ITC
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Investigation. I have examined Exhibit 2167 and I have confirmedthat this
`
`Novartis Exhibit 2062.0012
`Regeneron v. Novartis, IPR202 1-008 16
`
`Novartis Exhibit 2062.0012
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`
`
`
`
`
`
`
`Exhibit is a PDF ofthe native file
`
`
`
`
`
`
`
`“Ophthalmology.zip?Ophthalmology\RTH258\Competitive Landscape\Retina CI
`
`
`
`
`
`
`
`
`
`
`
`Review - Feb19.pdf.” I have personal knowledge of the metadata associated with
`
`
`
`
`
`
`the native file “Ophthalmology.zip?Ophthalmology\RTH258\Competitive
`
`
`
`
`
`
`
`
`
`
`
`
`Landscape\Retina CI Review - Feb19.pdf,” whichreflects that it has a “Modified
`
`
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`
`
`
`
`
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`
`
`
`Date” of February 25, 2019. These metadata were generated and maintained by
`
`
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`
`
`Novartis in the ordinary course of business.
`
`
`
`29.
`
`
`
`
`
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`
`
`
`Exhibit 2168 is a document bearing Bates number
`
`
`
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`
`
`
`
`
`
`
`NOVITC(US)00395564, which was among the documents collected from the
`
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`
`
`
`
`
`
`
`
`
`Novartis file system and produced to Regeneron in connection with the ITC
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Investigation. I have examined Exhibit 2168 and I have confirmedthatthis
`
`
`
`
`
`
`
`
`
`Exhibit is a PDF ofthe native excelfile
`
`
`
`
`
`
`
`“Ophthalmology.zip?Ophthalmology\RTH258\Forecast\workspace\rth forecast
`
`
`
`
`
`
`
`
`
`
`scenario scratch\20171204BrolucizumabnAMDUS_Yr6-8 zerodout for
`
`
`
`
`
`
`
`
`
`
`
`
`namd.xlsm.” I have personal knowledge of the metadata associated with the native
`
`
`
`
`
`
`file “Ophthalmology.zip?Ophthalmology\RTH258\Forecast\workspace\rth forecast
`
`
`
`
`
`
`
`
`
`
`scenario scratch\20171204BrolucizumabnAMD_US_Yr6-8 zerodout for
`
`
`
`
`
`
`
`
`
`
`
`
`namd.xlsm,” which reflects that it has a “Modified Date” of December6, 2017.
`
`
`
`30.
`
`
`
`
`
`
`
`
`
`Exhibit 2169 is a document bearing Bates number
`
`
`
`
`
`
`
`
`
`
`
`NOVITC(US)00395565, which was among the documents collected from the
`
`
`
`Novartis Exhibit 2062.0013
`Regeneron v. Novartis, IPR202 1-008 16
`
`Novartis Exhibit 2062.0013
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`Novartis file system and produced to Regeneron in connection with the ITC
`
`
`
`Investigation.
`
`
`
`
`
`
`
`
`
`
`
`
`I have examined Exhibit 2169 and I have confirmed thatthis
`
`
`
`
`
`
`
`
`
`
`
`Exhibit is a PDF ofthe native excelfile
`
`
`
`
`
`
`
`“Ophthalmology.zip?Ophthalmology\RTH258\Forecast\workspace\rth forecast
`
`
`
`
`
`
`
`
`
`scenario scratch\20171205BrolucizumabnAMD_US.XLSM..”I havepersonal
`
`
`
`
`
`
`
`
`
`
`
`
`knowledgeof the metadata associated with the native file
`
`
`
`
`
`
`
`“Ophthalmology.zip?Ophthalmology\RTH258\Forecast\workspace\rth forecast
`
`
`
`
`
`scenario scratch\20171205BrolucizumabnAMD_US.XLSM,”whichreflects that
`
`
`
`
`
`
`
`
`
`
`it has a “Modified Date” of December 6, 2017.
`
`
`
`31.
`
`
`
`
`
`
`
`
`
`Exhibit 2170 is a document bearing Bates number
`
`
`
`
`
`
`
`
`
`
`
`NOVITC(US)00507243, which was among the documents collected from the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Novartis file system and produced to Regeneron in connection with the ITC
`
`
`
`Investigation.
`
`
`
`
`
`
`
`
`
`
`
`
`I have examined Exhibit 2170 and I have confirmed thatthis
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Exhibit is a PDF ofthe native file “Lucentis PFS 0.5mg Impact.pptx.” I have
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`personal knowledgeof the metadata associated with the native file “Lucentis PFS
`
`
`
`
`
`
`
`
`
`
`
`
`
`0.5mg Impact.pptx,” which reflects that it has a “Modified Date” of November17,
`
`
`
`2019.
`
`
`
`32.
`
`
`
`
`
`
`
`
`
`Exhibit 2171 is a document bearing Bates number
`
`
`
`
`
`
`
`
`
`
`
`NOVITC(US)00697489, which was among the documents collected from the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Novartis file system and produced to Regeneron in connection with the ITC
`
`
`
`Novartis Exhibit 2062.0014
`Regeneron v. Novartis, IPR202 1-008 16
`
`Novartis Exhibit 2062.0014
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`Investigation. I have examined Exhibit 2171 and I have confirmed that this
`
`
`
`
`
`
`
`
`
`
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`Exhibit is a PDF ofthe native file “PFS Research_US RS Panel May 2020.pptx.” I
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`have personal knowledge of the metadata associated with the native file “PFS
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`Research_US RS Panel May 2020.pptx,” which reflects that it has a “Modified
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`Date” of May 13, 2020.
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`33.
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`Exhibit 2172 is a document bearing Bates number
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`NOVITC(US)00718202, which was among the documents collected from the
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`Novartis file system and produced to Regeneron in connection with the ITC
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`Investigation. I have examined Exhibit 2172 and I have confirmedthat this
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`Exhibit is a PDF ofthe native file “Situation Assessment 2019 02 24 CW.pptx.” I
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`have personal knowledge of the metadata associated with the native file “Situation
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`Assessment 2019 02 24 CW.pptx,” whichreflects that it has a “Modified Date” of
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`February 25, 2019.
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`it. DECLARATION
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`34.
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`Thereby declare that all statements made herein of my own
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`knowledge are true andthat all statements made on information andbelief are
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`believed to be true. I further declare that all of my statements are made with the
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`knowledge that willful false statements are punishable by fine or imprisonment, or
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`both, under Section 1001 of Title 18 of the United States Code.
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`Novartis Exhibit 2062.0015
`Regeneron v. Novartis, IPR202 1-008 16
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`Novartis Exhibit 2062.0015
`Regeneron v. Novartis, IPR2021-00816
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`DN:dc=com, dc=novartis,
`Sada | | i ng
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`Dated:_1/18/2022 By: Jeffrey itrepn 17:09:08-05'00"
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`Jeffrey Salling
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`Digitally signed bySalling Jeffrey
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`ou=people, ou=GR,
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`serialNumber=2157089, cn=Salling
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`Novartis Exhibit 2062.0016
`Regeneron v. Novartis, IPR202 1-008 16
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`Novartis Exhibit 2062.0016
`Regeneron v. Novartis, IPR2021-00816
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`