`
`
`__________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`__________
`
`
`REGENERON PHARMACEUTICALS, INC.,
`Petitioner
`
`v.
`
`NOVARTIS PHARMA AG,
`NOVARTIS TECHNOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owners
`
`__________
`
`
`Case IPR2020-1318
`Patent 9,220,631
`
`__________
`
`
`DECLARATION OF JEFFREY SALLING IN SUPPORT OF NOVARTIS’S
`PATENT OWNER PRELIMINARY RESPONSE
`
`
`
`
`
`1
`
`Novartis Exhibit 2062.001
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`
`
`I.
`
`INTRODUCTION
`1.
`I, Jeffrey Salling, have personal knowledge of the facts set forth in
`
`this Declaration and am competent to testify concerning the same.
`
`2.
`
`I have worked at Novartis in East Hanover as Global Director of
`
`eDiscovery & Senior Legal Counsel as of April 2019. In this position I oversee
`
`our global discovery operations, to ensure compliance with discovery obligations
`
`consistent with applicable rules.
`
`II. BACKGROUND
`
`3.
`
`Novartis file systems maintain Novartis electronic files created and
`
`stored by Novartis employees.
`
`4.
`
`File systems are maintained by Novartis Information Technology (IT)
`
`which is the infrastructure upon which the metadata is supported.
`
`5.
`
`Based on my understanding and experience, metadata is data about
`
`the data (for example, creation date, modified date). The metadata is generated
`
`contemporaneously with the creation, modification, or movement of the electronic
`
`files they are associated with.
`
`6.
`
`The metadata associated with each electronic file is created and stored
`
`in the ordinary course of business.
`
`III. ANALYSIS OF METADATA FOR EXHIBIT 2063
`
`7.
`
`Novartis Pharma AG, Novartis Pharmaceuticals Corporation, and
`
`
`
`2
`
`Novartis Exhibit 2062.002
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Novartis Technology LLC (collectively, “Novartis”) were previously involved in
`
`litigation concerning U.S. Patent 9,220,631 in ITC Investigation No. 337-TA-1207
`
`(“ITC Investigation”). Novartis documents related to its Lucentis® prefilled
`
`syringe product were collected from Novartis file systems for production in the
`
`ITC Investigation. This collection of data was inclusive of the associated
`
`metadata. A number of these documents (and metadata) were produced to
`
`Regeneron Pharmaceuticals Inc. (“Regeneron”) in the ITC Investigation.
`
`8.
`
`The native PowerPoint file “Lucentis Project Review_2011 10
`
`05a.pptx,” along with the associated metadata, was among the documents collected
`
`from the Novartis file system in connection with the ITC Investigation.
`
`9.
`
`I have examined Exhibit 2063, and aside from the redactions, which
`
`were applied at the direction of Novartis’s outside Swiss counsel to comply with
`
`Swiss data protection law, I have confirmed that this Exhibit is a PDF of the native
`
`PowerPoint file “Lucentis Project Review_2011 10 05a.pptx.”
`
`10.
`
`I have personal knowledge of the metadata associated with the native
`
`PowerPoint file “Lucentis Project Review_2011 10 05a.pptx.” Exhibit 2065 truly
`
`and correctly reports metadata associated with the native PowerPoint file “Lucentis
`
`Project Review_2011 10 05a.ppx” as it exists in Novartis’s file systems and was
`
`generated and stored in the ordinary course of Novartis’s business.
`
`11.
`
`The file extension .pptx from the filename in metadata in Exhibit 2065
`
`3
`
`Novartis Exhibit 2062.003
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`shows that “Lucentis Project Review_2011 10 05a.pptx” is a Microsoft PowerPoint
`
`slide deck. The modified date reflects the date on which the document was last
`
`modified or changed and indicates that the modified date was October 10, 2011.
`
`
`
`4
`
`Novartis Exhibit 2062.004
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`IV. DECLARATION
`12.
`I hereby declare that all statements made herein of my own
`
`knowledge are true and that all statements made on information and belief are
`
`believed to be true. I further declare that all of my statements are made with the
`
`knowledge that willful false statements are punishable by fine or imprisonment, or
`
`both, under Section 1001 of Title 18 of the United States Code.
`Salling
`l' NOVARTIS
`Jeffrey
`Dated: ____________________ By: ____________________________
`
`
`
`
`
`
`
`
` Jeffrey Salling
`
`Digitally signed by Salling Jeffrey
`DN: dc=com, dc=novartis,
`ou=people, ou=GR,
`serialNumber=2157089,
`cn=Salling Jeffrey
`Date: 2021.07.28 13:59:23 -04'00'
`
`5
`
`Novartis Exhibit 2062.005
`Regeneron v. Novartis, IPR2021-00816
`
`
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