`
`PGR2019-00001
`U.S. Patent 9,856,287
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`ADELLO BIOLOGICS, LLC, APOTEX INC. and APOTEX CORP.,
`Petitioners
`
`v.
`AMGEN INC. and AMGEN MANUFACTURING, LIMITED,
`Patent Owner
`______________________
`
`Case PGR2019-00001
`Patent 9,856,287
`______________________
`
`
`
`PATENT OWNERS’ OBJECTIONS TO EVIDENCE
`UNDER 37 C.F.R. § 42.64
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`
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`PGR2019-00001
`U.S. Patent 9,856,287
`Patent Owners1 Amgen Inc. and Amgen Manufacturing, Limited
`
`
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`(collectively, “Amgen”) object under the Federal Rules of Evidence (“FRE”) and
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`37 C.F.R. § 42.64(b)(1) to the admissibility of EX1002, 1006, 1009, 1013-1016,
`
`1018-1033, 1037, 1038, and 1040-1051.
`
`The Institution Decision issued on April 19, 2019. Amgen’s objections are
`
`timely under 37 C.F.R. § 42.64(b)(1). Amgen serves Petitioner with these
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`objections to provide notice that Amgen may move to exclude EX1002, 1006,
`
`1009, 1013-1016, 1018-1033, 1037, 1038, and 1040-1051 as improper evidence.
`
`1.
`
`EX1006, 1009, 1013-1016, 1018-1033, 1038, 1040-1051 And Any
`Reference To/Reliance Thereon
`Amgen objects to EX1006, 1009, 1013-1016, 1018-1033, 1038, and 1040-
`
`1051for at least the following reasons:
`
`Petitioner has failed to authenticate EX1006, 1009, 1013-1016, 1018-1033,
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`1038, and 1040-1051 under FRE 901 (authentication) and FRE 602 (personal
`
`knowledge). Specifically, Petitioner has failed to establish that each of EX1006,
`
`
`1 Petitioners listed both Amgen Inc. and Amgen Manufacturing, Limited in the
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`caption as “Patent Owner.” Amgen Manufacturing, Limited is an exclusive
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`licensee. Nevertheless, consistent with the caption, these objections refer
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`collectively to both parties as “Patent Owners.”
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`
`
`PGR2019-00001
`U.S. Patent 9,856,287
`1009, 1013-1016, 1018-1033, 1038, and 1040-1051 is what Petitioner claims it to
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`
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`be.
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`To the extent that Petitioner relies on these documents for the truth of the
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`matter asserted, or attempts to rely on any date that may appear in EX1006, 1009,
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`1013-1016, 1018-1033, 1038, and 1040-1051 for an argument to establish public
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`accessibility as a printed publication, the material, including any date is hearsay
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`under FRE 801 (hearsay) and is inadmissible under FRE 802 (hearsay), and
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`further, any such date has not been authenticated and is inadmissible under FRE
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`901.
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`Because of these deficiencies, and Petitioner’s failure to provide any other
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`supporting evidence, Petitioner has failed to establish EX1006, 1009, 1013-1016,
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`1018-1033, 1038, and 1040-1051 are prior art printed publications. Therefore,
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`EX1006, 1009, 1013-1016, 1018-1033, 1038, and 1040-1051 are also not relevant
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`under FRE 401 to the extent they are relied on as prior art and are inadmissible
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`under FRE 402 and FRE 403.
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`2.
`
`Robinson Declaration (EX1002) And Any Reference To/Reliance
`Thereon
`Amgen objects to the Robinson Declaration for at least the following
`
`reasons:
`
`Under FRE 702 (expert testimony), Dr. Robinson’s (EX1002) opinions are
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`inadmissible because they are conclusory, do not disclose underlying facts or data
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`2
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`PGR2019-00001
`U.S. Patent 9,856,287
`in support, and are unreliable. Additionally, under FRE 401 (test for relevance),
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`
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`FRE 402 (relevance), and FRE 403 (probative value outweighed by prejudice,
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`confusing of issues, and wasting time) their opinions are irrelevant, confusing, and
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`of minimal probative value.
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`In addition, to the extent Dr. Robinson relies on EX1006, 1009, 1013-1016,
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`1018-1033, 1038, and 1040-1051 for her analysis, the Robinson Declaration is also
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`inadmissible under FRE 702 and for the reasons discussed above.
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`3.
`
`“Table of Categorized Claims For ‘287 Patent” (EX1037) And Any
`Reference To/Reliance Thereon
`Amgen objects to Petitioner’s “Table of Categorized Claims” (EX1037) for
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`at least the following reasons:
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`Exhibit 1037 is attorney argument and is therefore an improper exhibit and
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`not evidence. For example, the material is hearsay under FRE 801 (hearsay) and
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`thus inadmissible under FRE 802 (hearsay).
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`To the extent Amgen is required to raise this issue in evidentiary objections
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`in order to preserve it, Amgen further states that this Exhibit amounts to improper
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`and impermissible incorporation by reference.
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`
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`Respectfully submitted by:
`
`
`/Megan Raymond/
`
`J. Steven Baughman (Reg. No. 47,414)
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`
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`
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`Dated: May 3, 2019
`
`
`3
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`PGR2019-00001
`U.S. Patent 9,856,287
`
`Paul, Weiss, Rifkind, Wharton &
`Garrison LLP
`2001 K Street, NW
`Washington, D.C. 20006-1047
`Tel: (202) 223-7340
`Fax: (202) 403-3740
`sbaughman@paulweiss.com
`
`Megan Raymond (Reg. No. 72,997)
`Paul, Weiss, Rifkind, Wharton &
`Garrison LLP
`2001 K Street, NW
`Washington, D.C. 20006-1047
`Tel: (202) 223-7300
`Fax: (202) 403-3777
`mraymond@paulweiss.com
`
`Attorneys For Patent Owner
`
`
`
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`
`
`
`4
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`
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`CERTIFICATE OF SERVICE
`
`
`
`PGR2019-00001
`U.S. Patent 9,856,287
`
`The undersigned hereby certifies that a copy of PATENT OWNER’S
`
`OBJECTIONS TO EVIDENCE UNDER 37 C.F.R. § 42.64 has been served in its
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`entirety by causing the aforementioned document to be electronically mailed to the
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`following attorneys of record for the Petitioner listed below:
`
`Petitioner’s Counsel of Record:
`
`Teresa Stanek Rea (Reg. No. 30,427)
`Deborah H. Yellin (Reg. No. 45,904)
`Shannon Lentz (Reg. No. 65,382)
`CROWELL & MORING LLP
`Intellectual Property Group
`1001 Pennsylvania Avenue, N.W.
`Washington, DC 20004-2595
`TRea@Crowell.com
`DYellin@Crowell.com
`SLentz@Crowell.com
`
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`Dated: May 3, 2019
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`
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`
` Respectfully Submitted,
`
`/Sayem Osman/
` By:
` Sayem Osman
`
`
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`
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`5
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