Filed on behalf of: Sarepta Therapeutics, Inc.
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`Filed: February 9, 2022
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`SAREPTA THERAPEUTICS, INC.
`Petitioner
`v.
`NIPPON SHINYAKU CO., LTD.
`&
`NATIONAL CENTER OF NEUROLOGY AND PSYCHIATRY
`Patent Owners
`______________________
`
`Case No. IPR2021-01137
`Patent No. 10,487,106
`______________________
`
`
`PETITIONER’S OBJECTIONS TO PATENT OWNERS’ EVIDENCE
`SUBMITTED WITH PATENT OWNERS’
`MOTION FOR ADDITIONAL DISCOVERY
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`Filed: February 9, 2022
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`SAREPTA THERAPEUTICS, INC.
`Petitioner
`v.
`NIPPON SHINYAKU CO., LTD.
`&
`NATIONAL CENTER OF NEUROLOGY AND PSYCHIATRY
`Patent Owners
`______________________
`
`Case No. IPR2021-01137
`Patent No. 10,487,106
`______________________
`
`
`PETITIONER’S OBJECTIONS TO PATENT OWNERS’ EVIDENCE
`SUBMITTED WITH PATENT OWNERS’
`MOTION FOR ADDITIONAL DISCOVERY
`
`
`
`
`
`
` IPR2021-01137
`Patent No. 10,487,106
`Pursuant to 37 C.F.R. § 42.64(b)(1) and the Federal Rules of Evidence
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`(“FRE”), Petitioner Sarepta Therapeutics, Inc. (“Sarepta”) submits the following
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`objections to certain exhibits submitted with Patent Owners’ Motion for Additional
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`Discovery (Paper 22). Sarepta’s objections apply equally to Patent Owners’ reliance
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`on these exhibits in any subsequently filed documents. These objections are timely
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`filed and served within five business days of service. 37 C.F.R. § 42.64(b)(1).
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`Exhibit 2054
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`To the extent Patent Owners rely on the content of Exhibit 2054 for the truth
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`of the matter asserted, Sarepta objects to Exhibit 2054 as inadmissible hearsay (see
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`FRE 801 and 802) that does not fall under any exceptions, including FRE 803, 804,
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`805, and 807. Sarepta objects to Exhibit 2054 because it lacks proper foundation or
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`authenticity under FRE 901.
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`In addition, Sarepta objects to Exhibit 2054 under FRE 401-403 as lacking
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`relevance to the instituted grounds and as a document from a different forum.
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`Because Exhibit 2054 does not reflect any knowledge of one skilled in the art at the
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`time of the alleged invention, this exhibit does not make any fact more or less
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`probable than it would be without this exhibit. Moreover, Exhibit 2054 is unfairly
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`prejudicial, confuses the issues, misleads the factfinder, and/or is a waste of time.
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`1
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` IPR2021-01137
`Patent No. 10,487,106
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`Exhibit 2055
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`To the extent Patent Owners rely on the content of Exhibit 2055 for the truth
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`of the matter asserted, Sarepta objects to Exhibit 2055 as inadmissible hearsay (see
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`FRE 801 and 802) that does not fall under any exceptions, including FRE 803, 804,
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`805, and 807. Sarepta objects to Exhibit 2055 because it lacks proper foundation or
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`authenticity under FRE 901.
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`In addition, Sarepta objects to Exhibit 2055 under FRE 401-403 as lacking
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`relevance to the instituted grounds. Because Exhibit 2055 does not reflect any
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`knowledge of one skilled in the art at the time of the alleged invention, this exhibit
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`does not make any fact more or less probable than it would be without this exhibit.
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`Moreover, Exhibit 2055 is unfairly prejudicial, confuses the issues, misleads the
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`factfinder, and/or is a waste of time.
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`Sarepta also objects to Exhibit 2055, which is a chart cited in the Motion (Mot.
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`2), because the Motion does not include this chart and its inclusion would cause the
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`Motion to exceed the permitted page limit. Accordingly, Exhibit 2055 is not properly
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`relied upon by Patent Owners.
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`Exhibit 2056
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`To the extent Patent Owners rely on the content of Exhibit 2056 for the truth
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`of the matter asserted, Sarepta objects to Exhibit 2056 as inadmissible hearsay (see
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`FRE 801 and 802) that does not fall under any exceptions, including FRE 803, 804,
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`2
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` IPR2021-01137
`Patent No. 10,487,106
`805, and 807. Sarepta objects to Exhibit 2056 because it lacks proper foundation or
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`authenticity under FRE 901.
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`In addition, Sarepta objects to Exhibit 2056 under FRE 401-403 as lacking
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`relevance to the instituted grounds. Because Exhibit 2056 does not reflect any
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`knowledge of one skilled in the art at the time of the alleged invention, this exhibit
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`does not make any fact more or less probable than it would be without this exhibit.
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`Moreover, Exhibit 2056 is unfairly prejudicial, confuses the issues, misleads the
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`factfinder, and/or is a waste of time.
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`Exhibit 2057
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`Sarepta objects to Exhibit 2057 because it lacks proper foundation or
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`authenticity under FRE 901.
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`In addition, Sarepta objects to Exhibit 2057 under FRE 401-403 as lacking
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`relevance to the instituted grounds. Because Exhibit 2057 does not reflect any
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`knowledge of one skilled in the art at the time of the alleged invention, this exhibit
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`does not make any fact more or less probable than it would be without this exhibit.
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`Moreover, Exhibit 2057 is unfairly prejudicial, confuses the issues, misleads the
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`factfinder, and/or is a waste of time.
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`Exhibit 2058
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`To the extent Patent Owners rely on the content of Exhibit 2058 for the truth
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`of the matter asserted, Sarepta objects to Exhibit 2058 as inadmissible hearsay (see
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`3
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` IPR2021-01137
`Patent No. 10,487,106
`FRE 801 and 802) that does not fall under any exceptions, including FRE 803, 804,
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`805, and 807. Sarepta further objects to Exhibit 2058 because it lacks proper
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`foundation or authenticity under FRE 901.
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`In addition, Sarepta objects to Exhibit 2058 under FRE 401-403 as lacking
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`relevance to the instituted grounds. Because Exhibit 2058 does not reflect any
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`knowledge of one skilled in the art at the time of the alleged invention, this exhibit
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`does not make any fact more or less probable than it would be without this exhibit.
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`Moreover, Exhibit 2058 is unfairly prejudicial, confuses the issues, misleads the
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`factfinder, and/or is a waste of time.
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`
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`Respectfully submitted,
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`Date: February 9, 2022
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`By: /William B. Raich/
`William B. Raich (Reg. No. 54,386)
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`4
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`IPR2021-01137
`Patent No. 10,487,106
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`CERTIFICATE OF SERVICE
`The undersigned certifies that a copy of the foregoing Petitioner’s
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`Objections to Patent Owners’ Evidence Submitted with Patent Owners’ Motion
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`for Additional Discovery was served electronically via email on February 9, 2022,
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`in its entirety on the following:
`
`Dion M. Bregman
`Alexander B. Stein
`MORGAN, LEWIS & BOCKIUS LLP
`1400 Page Mill Road
`Palo Alto, CA 94304
`NS-IPRs-Service@morganlewis.com
`
`Louis T. Nguyen
`MORGAN, LEWIS & BOCKIUS LLP
`One Market Street, Spear Street Tower
`San Francisco, CA 94105-1596
`NS-IPRs-Service@morganlewis.com
`
`Amanda S. Williamson
`Christopher J. Betti
`Guylaine Haché
`MORGAN, LEWIS & BOCKIUS LLP
`110 North Wacker Drive
`Chicago, IL 60606-1511
`NS-IPRs-Service@morganlewis.com
`guylaine.hache@morganlewis.com
`
`Patent Owner has consented to service by email.
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`Date: February 9, 2022
`
`By: /William Esper/
`William Esper
`Case Manager and PTAB Coordinator
`
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
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