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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner
`
`____________
`
`Case IPR2021-00881
`Patent No. 9,254,338 B2
`_______________
`
`
`
`PATENT OWNER’S SECOND SET OF OBJECTIONS TO
`PETITIONER’S EXHIBITS
`
`
`
`

`

`Case IPR2021-00881
`Patent 9,254,338 B2
`
`
`Pursuant
`
`to 37 C.F.R. § 42.64(b)(1), Patent Owner Regeneron
`
`Pharmaceuticals, Inc. (“Patent Owner”), submits the following supplemental
`
`objections to Petitioner Mylan Pharmaceuticals Inc.’s (“Petitioner”) Exhibits 1102–
`
`1176, and any reference to and/or reliance on the foregoing including, without
`
`limitation, citations thereto in Petitioner’s Reply. Patent Owner’s objections below
`
`apply the Federal Rules of Evidence (“FRE”) as required by 37 C.F.R. § 42.62.
`
`These objections supplement Patent Owner’s Objections to Petitioner’s
`
`Exhibits, served November 24, 2021, which Patent Owner maintains.
`
`Exhibit 1102 - Exhibit 1102 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1102 is not relevant, and its probative value is substantially outweighed by
`
`the danger of confusion of the issues and misleading the fact finder because it was
`
`not published before the priority date of the challenged claims of United States
`
`Patent No. 9,254,338 (“the ’338 patent”) (January 13, 2011).
`
`Exhibit 1103 - Exhibit 1103 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1103 is not relevant, and its probative value is substantially outweighed by
`
`the danger of confusion of the issues and misleading the fact finder.
`
`Exhibit 1104 - Exhibit 1104 is objected to under FRE 901 and FRE 802 as
`
`unauthenticated and hearsay evidence. It is not clear where the exhibit came from or
`
`how it was compiled. Exhibit 1104 is also objected to under FRE 106. Petitioner has
`
`filed what appears to be an excerpt of correspondence from Volume 29 of Eye. The
`1
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`

`

`Case IPR2021-00881
`Patent 9,254,338 B2
`
`remainder of this document has not been introduced or filed by Petitioner, but in
`
`fairness ought to be considered at the same time as those pages that were provided.
`
`Exhibit 1104 is also objected to under FRE 401, 402 and 403. Exhibit 1104 is not
`
`relevant, and its probative value is substantially outweighed by the danger of
`
`confusion of the issues and misleading the fact finder because it was not published
`
`before the priority date of the challenged claims of the ’338 patent (January 13,
`
`2011).
`
`Exhibit 1105 - Exhibit 1105 is objected to under FRE 901 and FRE 802 as
`
`unauthenticated and hearsay evidence. It is not clear where the exhibit came from or
`
`how it was compiled.
`
`Exhibit 1106 - Exhibit 1106 is objected to under FRE 901 and FRE 802 as
`
`unauthenticated and hearsay evidence. It is not clear where the exhibit came from or
`
`how it was compiled. Exhibit 1106 is also objected to under FRE 401, 402 and 403.
`
`Exhibit 1106 is not relevant, and its probative value is substantially outweighed by
`
`the danger of confusion of the issues and misleading the fact finder because it was
`
`not published before the priority date of the challenged claims of the ’338 patent
`
`(January 13, 2011).
`
`Exhibit 1107 - Exhibit 1107 is objected to under FRE 901 and FRE 802 as
`
`unauthenticated and hearsay evidence. It is not clear where the exhibit came from or
`
`how it was compiled. Exhibit 1107 is also objected to under FRE 106. Petitioner has
`
`
`
`
`2
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`

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`Case IPR2021-00881
`Patent 9,254,338 B2
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`filed what appears to be an excerpt of the Volume 20 of the WHO Drug Information.
`
`The remainder of this document has not been introduced or filed by Petitioner, but
`
`in fairness ought to be considered at the same time as those pages that were provided.
`
`Exhibit 1107 is also objected to under FRE 401, 402 and 403. Exhibit 1107 is not
`
`relevant, and its probative value is substantially outweighed by the danger of
`
`confusion of the issues and misleading the fact finder.
`
`Exhibit 1112 - Exhibit 1112 is objected to under FRE 901 and FRE 802 as
`
`unauthenticated and hearsay evidence. Exhibit 1112 is not cited, discussed or
`
`authenticated by any of Petitioner’s experts. Exhibit 1112 is also objected to under
`
`FRE 106 as incomplete, to the extent that it is relied upon in purported support
`
`Petitioner’s statement that “VEGF Trap-Eye/aflibercept was publicly distributed
`
`long before 2011.” Exhibit 1112 does not provide any information about the terms
`
`and restrictions surrounding transfer of the “VEGF Trap” discussed therein, and
`
`Petitioner has not introduced or filed any information concerning such terms and
`
`restrictions. Such information in fairness ought to be considered at the same time as
`
`Exhibit 1112. Exhibit 1112 is also objected to under FRE 401, 402, and 403, to the
`
`extent it is relied upon in purported support of Petitioner’s statement that “VEGF
`
`Trap-Eye/aflibercept was publicly distributed long before 2011.” As noted, Exhibit
`
`1112 does not provide any information about the terms and restrictions surrounding
`
`transfer of the “VEGF Trap” discussed therein. Absent such information, Exhibit
`
`
`
`
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`Case IPR2021-00881
`Patent 9,254,338 B2
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`1112 is irrelevant and its probative value is substantially outweighed by the danger
`
`of confusing the issues and misleading the fact finder.
`
`Exhibit 1113 - Exhibit 1113 is objected to under FRE 106. Petitioner has filed
`
`what appears to be a chapter excerpted from a larger volume. The remainder of this
`
`document has not been introduced or filed by Petitioner, but in fairness ought to be
`
`considered at the same time as those pages that were provided.
`
`Exhibit 1114 - Patent Owner incorporates its prior objections to Exhibits 1002
`
`and 1038 to the extent that Paragraphs 2 and 5 of Exhibit 1114 purport to incorporate
`
`Exhibits 1002 and 1038. Paragraphs1 9, 11-25, 27-29, 31-40, 42, 43, 48-54, 56, 59,
`
`63, 67-74, 76, 78, 80-82, 84, 85, 88-93, 97-101, 105-116, and 118 and Appendices
`
`A and B are objected to under FRE 106 and/or FRE 1006 as relying on incomplete
`
`evidence or improper summary and/or improperly cherry-picking selective passages
`
`of a reference, while ignoring other passages in the same reference. Paragraphs 18-
`
`24, 26, 40, 56, 59, 74, 80, 81, 86, 88-90, 92, 95, and 97-118 are also objected to
`
`under FRE 401, 402, and 403 because they discuss or rely on information that is
`
`irrelevant and for which probative value is substantially outweighed by the danger
`
`of confusing the issues and misleading the fact finder, including, with respect to
`
`paragraphs 56, 59, 74, 80, 81, 86, 90, 92, 105-110, 112, and 116, information that
`
`
`1 For avoidance of doubt, as used herein, an objection to a numbered paragraph of
`an Exhibit applies equally to all footnotes to that paragraph.
`4
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`
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`

`

`Case IPR2021-00881
`Patent 9,254,338 B2
`
`was not publicly available before the priority date of the challenged claims of the
`
`’338 patent (January 13, 2011). Paragraphs 55, 56, 59, 60, 62, 67-69, 76, 77, 80-82,
`
`84, 85, 88, 90, 96, and 112 are further objected to under FRE 901 and FRE 802 as
`
`relying on unauthenticated and hearsay evidence. Paragraphs 11-38, 40, 42-44, 46-
`
`53, 55, 56, 59, 67-71, 73, 77, 78, 80, 81, 83, 85, 88-92, 95, 97-102, 117, and 118 are
`
`also objected to as improper expert testimony under FRE 702, 703, and 705 because
`
`the opinions offered therein are not based on sufficient facts or data.
`
`Exhibit 1115 - Patent Owner incorporates its prior objections to Exhibits 1003
`
`and 1061 to the extent that Paragraphs 2 and 5 of Exhibit 1115 purport to incorporate
`
`Exhibits 1003 and 1061. Paragraphs 10, 11, 13, 14, 19-29, 33, 35-38, 40, 41, 44-46,
`
`48, 50, 51, 53, 57-59, 61-63, 66-70, 73, 76, 79-82, 84, 89, and 91 are objected to
`
`under FRE 106 and/or FRE 1006 as relying on incomplete evidence or improper
`
`summary and/or improperly cherry-picking selective passages of a reference, while
`
`ignoring other passages in the same reference. Paragraphs 12-32, 37, 53, 57-59, and
`
`81 are further objected to under FRE 401, 402, and 403 to the extent they discuss or
`
`rely on information that was not publicly available before the priority date of the
`
`challenged claims of the ’338 patent (January 13, 2011), because such information
`
`is irrelevant and its probative value is substantially outweighed by the danger of
`
`confusing the issues and misleading the fact finder. Paragraphs 9, 47, 49, 50, 52, and
`
`86-92 are further objected to under FRE 401, 402, and 403 as not relevant to any
`
`
`
`
`5
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`

`

`Case IPR2021-00881
`Patent 9,254,338 B2
`
`issue in this proceeding and FRE 702 and 703 as improper expert testimony for the
`
`same reason. Paragraphs 13, 33, 41, 48, 51, 57, 58, 62, 73, 85, and 88 are further
`
`objected to under FRE 901 and FRE 802 as relying on unauthenticated and hearsay
`
`evidence. Paragraphs 6, 29, 31, 33, 46, 47, 55, 57, 60, 66, 67, 69, 72, 74-77, 82-85,
`
`87, 88, and 90-92 are further objected to as improper expert testimony under FRE
`
`702, 703, and 705 because the opinions offered therein are not based on sufficient
`
`facts or data.
`
`Exhibit 1117 - Exhibit 1117 is objected to under FRE 901 and FRE 802 as
`
`unauthenticated and hearsay evidence. It is not clear where the exhibit came from or
`
`how it was compiled. Exhibit 1117 is also objected to under FRE 1006 as an
`
`improper summary. Exhibit 1117 is also objected to under FRE 401, 402 and 403.
`
`Exhibit 1117 is not relevant, and its probative value is substantially outweighed by
`
`the danger of confusion of the issues and misleading the fact finder because it was
`
`not published before the priority date of the challenged claims of the ’338 patent
`
`(January 13, 2011).
`
`Exhibit 1118 - Exhibit 1118 is objected to under FRE 901 and FRE 802 as
`
`unauthenticated and hearsay evidence. It is not clear where the exhibit came from or
`
`how it was compiled. Exhibit 1118 is also objected to under FRE 1006 as an
`
`improper summary. Exhibit 1118 is also objected to under FRE 401, 402 and 403.
`
`Exhibit 1118 is not relevant, and its probative value is substantially outweighed by
`
`
`
`
`6
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`

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`Case IPR2021-00881
`Patent 9,254,338 B2
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`the danger of confusion of the issues and misleading the fact finder because it was
`
`not published before the priority date of the challenged claims of the ’338 patent
`
`(January 13, 2011) and because it is not cited, discussed, or relied upon in
`
`Petitioner’s Reply or in any expert declaration submitted with Petitioner’s Reply.
`
`Exhibit 1121 - Exhibit 1121 is objected to under FRE 901 and FRE 802 as
`
`unauthenticated and hearsay evidence. It is not clear where the exhibit came from or
`
`how it was compiled. Exhibit 1121 is also objected to under FRE 401, 402 and 403.
`
`Exhibit 1121 is not relevant, and its probative value is substantially outweighed by
`
`the danger of confusion of the issues and misleading the fact finder because it was
`
`not published before the priority date of the challenged claims of the ’338 patent
`
`(January 13, 2011) and because it is not cited, discussed, or relied upon in
`
`Petitioner’s Reply or in any expert declaration submitted with Petitioner’s Reply.
`
`Exhibit 1122 - Exhibit 1122 is objected to under FRE 901 and FRE 802 as
`
`unauthenticated and hearsay evidence. It is not clear where the exhibit came from or
`
`how it was compiled. Exhibit 1122 is also objected to under FRE 1006 as an
`
`improper summary. Exhibit 1122 is also objected to under FRE 401, 402 and 403.
`
`Exhibit 1122 is not relevant, and its probative value is substantially outweighed by
`
`the danger of confusion of the issues and misleading the fact finder because it was
`
`not published before the priority date of the challenged claims of the ’338 patent
`
`(January 13, 2011).
`
`
`
`
`7
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`

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`Case IPR2021-00881
`Patent 9,254,338 B2
`
`
`Exhibit 1123 - Exhibit 1123 is objected to under FRE 901 and FRE 802 as
`
`unauthenticated and hearsay evidence. It is not clear where the exhibit came from or
`
`how it was compiled.
`
`Exhibit 1124 - Exhibit 1124 is objected to under FRE 901 and FRE 802 as
`
`unauthenticated and hearsay evidence. It is not clear where the exhibit came from or
`
`how it was compiled. Exhibit 1124 is also objected to under FRE 1006 as an
`
`improper summary. Exhibit 1124 is also objected to under FRE 401, 402 and 403.
`
`Exhibit 1124 is not relevant, and its probative value is substantially outweighed by
`
`the danger of confusion of the issues and misleading the fact finder because it was
`
`not published before the priority date of the challenged claims of the ’338 patent
`
`(January 13, 2011) and because it is not cited, discussed, or relied upon in
`
`Petitioner’s Reply or in any expert declaration submitted with Petitioner’s Reply.
`
`Exhibit 1125 - Exhibit 1125 is objected to under FRE 901 and FRE 802 as
`
`unauthenticated and hearsay evidence. It is not clear where the exhibit came from or
`
`how it was compiled. Exhibit 1125 is objected to under FRE 106. Petitioner has filed
`
`what appears to be an excerpt from the preface to a larger volume. The remainder of
`
`this document has not been introduced or filed by Petitioner, but in fairness ought to
`
`be considered at the same time as those pages that were provided.
`
`Exhibit 1126 - Exhibit 1126 is objected to under FRE 901 and FRE 802 as
`
`unauthenticated and hearsay evidence. It is not clear where the exhibit came from or
`
`
`
`
`8
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`

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`Case IPR2021-00881
`Patent 9,254,338 B2
`
`how it was compiled. Exhibit 1126 is also objected to under FRE 106. Petitioner has
`
`filed what appears to be a section excerpted from a larger volume. The remainder of
`
`this document has not been introduced or filed by Petitioner, but in fairness ought to
`
`be considered at the same time as those pages that were provided.
`
`Exhibit 1127 - Exhibit 1127 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1127 is not relevant, and its probative value is substantially outweighed by
`
`the danger of confusion of the issues and misleading the fact finder because it was
`
`not published before the priority date of the challenged claims of the ’338 patent
`
`(January 13, 2011). Exhibit 1127 is also objected to under FRE 106. Petitioner has
`
`filed what appears to be an portion from the file history of patent application no.
`
`10/009,852. The remainder of the file history has not been introduced or filed by
`
`Petitioner, but in fairness ought to be considered at the same time as those pages that
`
`were provided.
`
`Exhibit 1128 - Exhibit 1128 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1128 is not relevant, and its probative value is substantially outweighed by
`
`the danger of confusion of the issues and misleading the fact finder because it was
`
`not published before the priority date of the challenged claims of the ’338 patent
`
`(January 13, 2011). Exhibit 1128 is also objected to under FRE 106. Petitioner has
`
`filed what appears to be an portion from the file history of United States Patent No.
`
`7,070,959. The remainder of the file history has not been introduced or filed by
`
`
`
`
`9
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`

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`Case IPR2021-00881
`Patent 9,254,338 B2
`
`Petitioner, but in fairness ought to be considered at the same time as those pages that
`
`were provided. Exhibit 1128 is also objected to under FRE 901 and FRE 802 as
`
`unauthenticated and hearsay evidence. It is not clear how it was compiled.
`
`Exhibit 1130 - Exhibit 1130 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1130 is not relevant, and its probative value is substantially outweighed by
`
`the danger of confusion of the issues and misleading the fact finder because it was
`
`not published before the priority date of the challenged claims of the ’338 patent
`
`(January 13, 2011).
`
`Exhibit 1131 - Exhibit 1131 is objected to under FRE 901 and FRE 802 as
`
`unauthenticated and hearsay evidence. It is not clear where the exhibit came from or
`
`how it was compiled. Exhibit 1131 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1131 is not relevant, and its probative value is substantially outweighed by
`
`the danger of confusion of the issues and misleading the fact finder because it was
`
`not published before the priority date of the challenged claims of the ’338 patent
`
`(January 13, 2011).
`
`Exhibit 1133 - Exhibit 1133 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1133 is not relevant, and its probative value is substantially outweighed by
`
`the danger of confusion of the issues and misleading the fact finder because it was
`
`not published before the priority date of the challenged claims of the ’338 patent
`
`(January 13, 2011).
`
`
`
`
`10
`
`

`

`Case IPR2021-00881
`Patent 9,254,338 B2
`
`
`Exhibit 1134 - Exhibit 1134 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1134 is not relevant, and its probative value is substantially outweighed by
`
`the danger of confusion of the issues and misleading the fact finder because it was
`
`not published before the priority date of the challenged claims of the ’338 patent
`
`(January 13, 2011).
`
`Exhibit 1135 - Exhibit 1135 is objected to under FRE 901 and FRE 802 as
`
`unauthenticated and hearsay evidence. It is not clear where the exhibit came from or
`
`how it was compiled.
`
`Exhibit 1137 - Paragraphs 21, 37, 40, 70-72, 78-83, 91-92, 94, 96 (footnote
`
`154), and 98 are objected to under FRE 106 and/or FRE 1006 as relying on
`
`incomplete evidence or improper summary and/or improperly cherry-picking
`
`selective passages of a reference, while ignoring other passages in the same
`
`reference. Paragraphs 21, 29, 34, 57, 59-66, 68-74, 86, 87, 88, 89, 97, and 98 are
`
`further objected to under FRE 401, 402, and 403 because they discuss or rely on
`
`information that is irrelevant and for which probative value is substantially
`
`outweighed by the danger of confusing the issues and misleading the fact finder
`
`including, with respect to paragraphs 21, 29, 34, 97, and 98, information that was
`
`not publicly available before the priority date of the challenged claims of the ’338
`
`patent (January 13, 2011). Paragraphs 21, 24-25, 28-39, 44, 47, 49-54, 58-61, 63-68,
`
`72-74, 85-89, and 97 are further objected to under FRE 901 and FRE 802 as relying
`
`
`
`
`11
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`

`

`Case IPR2021-00881
`Patent 9,254,338 B2
`
`on unauthenticated and hearsay evidence. Paragraphs 36, 38-39, 41, 44-48, 52-53,
`
`55, 58-59, 63, 65, 69, 72, 74, 77-78, 86-89, and 93 are further objected to as improper
`
`expert testimony under FRE 702, 703, and 705 because the opinions offered therein
`
`are not based on sufficient facts or data.
`
`Exhibit 1138 - Exhibit 1138 is objected to under FRE 901 and FRE 802 as
`
`unauthenticated and hearsay evidence. It is not clear where the exhibit came from or
`
`how it was compiled. Exhibit 1138 is also objected to under FRE 802 as inadmissible
`
`hearsay.
`
`Exhibit 1139 - Exhibit 1139 is objected to under FRE 901 and FRE 802 as
`
`unauthenticated and hearsay evidence. It is not clear where the exhibit came from or
`
`how it was compiled. Exhibit 1139 is also objected to under FRE 401, 402 and 403.
`
`Exhibit 1139 is not relevant, and its probative value is substantially outweighed by
`
`the danger of confusion of the issues and misleading the fact finder because it was
`
`not published before the priority date of the challenged claims of the ’338 patent
`
`(January 13, 2011).
`
`Exhibit 1140 - Exhibit 1140 is objected to under FRE 901 and FRE 802 as
`
`unauthenticated and hearsay evidence. It is not clear where the exhibit came from or
`
`how it was compiled. Exhibit 1140 is also objected to under FRE 401, 402 and 403.
`
`Exhibit 1140 is not relevant, and its probative value is substantially outweighed by
`
`the danger of confusion of the issues and misleading the fact finder because it was
`
`
`
`
`12
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`

`

`Case IPR2021-00881
`Patent 9,254,338 B2
`
`not published before the priority date of the challenged claims of the ’338 patent
`
`(January 13, 2011).
`
`Exhibit 1141 - Exhibit 1141 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1141 is not relevant, and its probative value is substantially outweighed by
`
`the danger of confusion of the issues and misleading the fact finder because it was
`
`not published before the priority date of the challenged claims of the ’338 patent
`
`(January 13, 2011). Exhibit 1141 is also objected to under FRE 802 as inadmissible
`
`hearsay.
`
`Exhibit 1142 - Exhibit 1142 is objected to under FRE 901 and FRE 802 as
`
`unauthenticated and hearsay evidence. It is not clear where the exhibit came from or
`
`how it was compiled. Exhibit 1142 is also objected to under FRE 401, 402 and 403.
`
`Exhibit 1142 is not relevant, and its probative value is substantially outweighed by
`
`the danger of confusion of the issues and misleading the fact finder because it was
`
`not published before the priority date of the challenged claims of the ’338 patent
`
`(January 13, 2011).
`
`Exhibit 1143 - Exhibit 1143 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1143 is not relevant, and its probative value is substantially outweighed by
`
`the danger of confusion of the issues and misleading the fact finder because it was
`
`not published before the priority date of the challenged claims of the ’338 patent
`
`(January 13, 2011).
`
`
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`13
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`Case IPR2021-00881
`Patent 9,254,338 B2
`
`
`Exhibit 1144 - Exhibit 1144 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1144 is not relevant, and its probative value is substantially outweighed by
`
`the danger of confusion of the issues and misleading the fact finder because it was
`
`not discussed in the Petitioner Reply (Paper 61) and Petitioner’s expert
`
`acknowledges that it has “nothing to do with ‘[m]ethods for treating eye disorders
`
`using VEGF antagonists.’” (Ex. 1114 ¶21).
`
`Exhibit 1153 - Exhibit 1153 is objected to under FRE 901 and FRE 802 as
`
`unauthenticated and hearsay evidence. It is not clear where the exhibit came from or
`
`how it was compiled. Exhibit 1153 is also objected to under FRE 401, 402 and 403.
`
`Exhibit 1153 is not relevant, and its probative value is substantially outweighed by
`
`the danger of confusion of the issues and misleading the fact finder.
`
`Exhibit 1154 - Exhibit 1154 is objected to under FRE 901 and FRE 802 as
`
`unauthenticated and hearsay evidence that Petitioner is improperly offering into
`
`evidence to prove the truth of the matter asserted. Exhibit 1154 is also objected to
`
`under FRE 401, 402 and 403. Exhibit 1154 is not relevant, and its probative value is
`
`substantially outweighed by the danger of confusion of the issues and misleading the
`
`fact finder because it contains nothing more than uncorroborated allegations made
`
`in a legal pleading.
`
`Exhibit 1155 - Exhibit 1155 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1155 is not relevant, and its probative value is substantially outweighed by
`
`
`
`
`14
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`Case IPR2021-00881
`Patent 9,254,338 B2
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`the danger of confusion of the issues and misleading the fact finder because it was
`
`not published before the priority date of the challenged claims of the ’338 patent
`
`(January 13, 2011).
`
`Exhibit 1156 - Exhibit 1156 is objected to under FRE 106. Petitioner has filed
`
`what appears to be a draft label excerpted from BLA 125387/S-051. The remainder
`
`of the BLA has not been introduced or filed by Petitioner, but in fairness ought to be
`
`considered at the same time as those pages that were provided. Exhibit 1156 is also
`
`objected to under FRE 901 because Petitioner has not demonstrated the authenticity
`
`of Exhibit 1156.
`
`Exhibit 1158 - Exhibit 1158 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1158 is not relevant, and its probative value is substantially outweighed by
`
`the danger of confusion of the issues and misleading the fact finder because it was
`
`not published before the priority date of the challenged claims of the ’338 patent
`
`(January 13, 2011).
`
`Exhibit 1159 - Exhibit 1159 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1159 is not relevant, and its probative value is substantially outweighed by
`
`the danger of confusion of the issues and misleading the fact finder because it was
`
`not published before the priority date of the challenged claims of the ’338 patent
`
`(January 13, 2011).
`
`
`
`
`15
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`Case IPR2021-00881
`Patent 9,254,338 B2
`
`
`Exhibit 1160 - Exhibit 1160 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1160 is not relevant, and its probative value is substantially outweighed by
`
`the danger of confusion of the issues and misleading the fact finder because it was
`
`not published before the priority date of the challenged claims of the ’338 patent
`
`(January 13, 2011).
`
`Exhibit 1161 - Exhibit 1161 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1161 is not relevant, and its probative value is substantially outweighed by
`
`the danger of confusion of the issues and misleading the fact finder because it was
`
`not published before the priority date of the challenged claims of the ’338 patent
`
`(January 13, 2011).
`
`Exhibit 1162 - Exhibit 1162 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1162 is not relevant, and its probative value is substantially outweighed by
`
`the danger of confusion of the issues and misleading the fact finder because it was
`
`not published before the priority date of the challenged claims of the ’338 patent
`
`(January 13, 2011).
`
`Exhibit 1163 - Exhibit 1163 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1163 is not relevant, and its probative value is substantially outweighed by
`
`the danger of confusion of the issues and misleading the fact finder because it was
`
`not published before the priority date of the challenged claims of the ’338 patent
`
`(January 13, 2011).
`
`
`
`
`16
`
`

`

`Case IPR2021-00881
`Patent 9,254,338 B2
`
`
`Exhibit 1164 - Exhibit 1164 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1164 is not relevant, and its probative value is substantially outweighed by
`
`the danger of confusion of the issues and misleading the fact finder because it was
`
`not published before the priority date of the challenged claims of the ’338 patent
`
`(January 13, 2011).
`
`Exhibit 1165 - Exhibit 1165 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1165 is not relevant, and its probative value is substantially outweighed by
`
`the danger of confusion of the issues and misleading the fact finder because it was
`
`not published before the priority date of the challenged claims of the ’338 patent
`
`(January 13, 2011).
`
`Exhibit 1167 - Exhibit 1167 is objected to under FRE 901 and FRE 802 as
`
`unauthenticated and hearsay evidence. It is not clear where the exhibit came from or
`
`how it was compiled.
`
`Exhibit 1168 - Exhibit 1168 is objected to under FRE 901 and FRE 802 as
`
`unauthenticated and hearsay evidence. It is not clear where the exhibit came from or
`
`how it was compiled.
`
`Exhibit 1170 - Exhibit 1170 is objected to under FRE 901 and FRE 802 as
`
`unauthenticated and hearsay evidence. It is not clear where the exhibit came from or
`
`how it was compiled. Exhibit 1170 is also objected to under FRE 401, 402 and 403.
`
`Exhibit 1170 is not relevant, and its probative value is substantially outweighed by
`
`
`
`
`17
`
`

`

`Case IPR2021-00881
`Patent 9,254,338 B2
`
`the danger of confusion of the issues and misleading the fact finder. Exhibit 1170 is
`
`also objected to under FRE 106. Petitioner has filed what appears to be an excerpt
`
`from a third-party website. The remainder of the website content has not been
`
`introduced or filed by Petitioner, but in fairness ought to be considered at the same
`
`time as those pages that were provided.
`
`Exhibit 1171 - Exhibit 1171 is objected to under FRE 106. Petitioner has filed
`
`what appears to be an excerpt from the website https://eylea.us. The remainder of
`
`the content from that website has not been introduced or filed by Petitioner, but in
`
`fairness ought to be considered at the same time as those pages that were provided.
`
`Exhibit 1173 - Exhibit 1173 is objected to under FRE 901 and FRE 802 as
`
`unauthenticated and hearsay evidence that Petitioner is improperly offering into
`
`evidence to prove the truth of the matter asserted. Exhibit 1173 is also objected to
`
`under FRE 401, 402 and 403. Exhibit 1173 is not relevant, and its probative value is
`
`substantially outweighed by the danger of confusion of the issues and misleading the
`
`fact finder because it contains nothing more than uncorroborated allegations made
`
`in a legal pleading.
`
`Exhibit 1174 - Exhibit 1174 is objected to under FRE 901 and FRE 802 as
`
`unauthenticated and hearsay evidence that Petitioner is improperly offering into
`
`evidence to prove the truth of the matter asserted. It is not clear where the exhibit
`
`came from or how it was compiled. Exhibit 1174 is also objected to under FRE 401,
`
`
`
`
`18
`
`

`

`Case IPR2021-00881
`Patent 9,254,338 B2
`
`402 and 403. Exhibit 1174 is not relevant, and its probative value is substantially
`
`outweighed by the danger of confusion of the issues and misleading the fact finder.
`
`Exhibit 1176 - Exhibit 1176 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1176 is not relevant, and its probative value is substantially outweighed by
`
`the danger of confusion of the issues and misleading the fact finder because it is not
`
`cited, discussed, or relied upon in Petitioner’s Reply or in any expert declaration
`
`submitted with Petitioner’s Reply.
`
`
`
`
`
`Dated: June 6, 2022
`
`Respectfully Submitted,
`
`/s/ Deborah E. Fishman
`Deborah E. Fishman (Reg. No. 48,621)
`3000 El Camino Real #500
`Palo Alto, CA 94304
`
`
`Counsel for Patent Owner,
`Regeneron Pharmaceuticals, Inc.
`
`
`
`
`
`19
`
`

`

`Case IPR2021-00881
`Patent 9,254,338 B2
`
`
`CERTIFICATE OF SERVICE
`The undersigned certifies that a copy of the foregoing PATENT OWNER’S
`
`SECOND OBJECTIONS TO PETITIONER’S EXHIBITS was served on June
`
`6, 2022, via e-mail at the following email addresses:
`
`MYL_REG_IPR@rmmslegal.com
`paul@ rmmslegal.com
`wrakoczy@ rmmslegal.com
`hsalmen@ rmmslegal.com
`nmclaughlin@rmmslegal.com
`
`/s/ Deborah E. Fishman
`Deborah E. Fishman (Reg. No. 48,621)
`3000 El Camino Real #500
`Palo Alto, CA 94304
`
`Counsel for Patent Owner,
`Regeneron Pharmaceuticals, Inc.
`
`
`i
`
`
`
`
`
`
`
`
`
`
`
`
`
`

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