UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner
`
`____________
`
`Case IPR2021-00880
`Patent No. 9,669,069 B2
`_______________
`
`PATENT OWNER’S OBJECTIONS TO
`PETITIONER’S EXHIBITS
`
`
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner
`
`____________
`
`Case IPR2021-00880
`Patent No. 9,669,069 B2
`_______________
`
`PATENT OWNER’S OBJECTIONS TO
`PETITIONER’S EXHIBITS
`
`
`
`Case IPR2021-00880
`Patent 9,669,069 B2
`
`Pursuant
`
`to 37 C.F.R. § 42.64(b)(1), Patent Owner Regeneron
`
`Pharmaceuticals, Inc. (“Patent Owner”), submits the following objections to
`
`Petitioner Mylan Pharmaceuticals Inc.’s (“Petitioner”) Exhibits 1001–1083, and any
`
`reference to and/or reliance on the foregoing. Patent Owner’s objections below
`
`apply the Federal Rules of Evidence (“FRE”) as required by 37 C.F.R. § 42.62.
`
`Exhibit 1002 - Paragraphs 31, 38, 39, 42, 58, 60, 70, 71, 73, 79, 80, 84, 125,
`
`137, 143, 155, 166, 188, 192, 194, 202, 215, and 221 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 31, 39, 44, 46, 47, 49, 50, 51, 140, 156,
`
`160-165, 167, 168, 170, 174, 177, 178, 182, 186, 198, and 219 are also 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
`
`’069 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 39, 122, 125, 137, 141, 143, 155, 188,
`
`192, 202, and 215 are further objected to under FRE 901 and FRE 802 as relying on
`
`unauthenticated and hearsay evidence. Paragraphs 31, 39, 58, 60, 61, 78, 84, 117,
`
`1
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`Case IPR2021-00880
`Patent 9,669,069 B2
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`220, and 223 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 1003 - Paragraphs 16, 17, 30, 31, 32, 34, 35, 36, 38, 40, 67, 84, 85,
`
`86, 87, 94, 97, 98 of Exhibit 1003 are 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 ’069 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 85 and 97 of Exhibit 1003 is also objected to under FRE 901 and FRE
`
`802 as relying on unauthenticated and hearsay evidence to the extent it relies on
`
`Exhibit 1078.
`
`Exhibit 1005 - Exhibit 1005 is objected to under FRE 901 because Petitioner
`
`has not demonstrated the authenticity of Exhibit 1005. It is not clear where the
`
`exhibit came from or how it was compiled
`
`Exhibit 1006 - Exhibit 1005 is objected to under FRE 901 because Petitioner
`
`has not demonstrated the authenticity of Exhibit 1005. It is not clear where the
`
`exhibit came from or how it was compiled.
`
`Exhibit 1011 - Exhibit 1011 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1011 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
`
`2
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`Case IPR2021-00880
`Patent 9,669,069 B2
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`not published before the priority date of the challenged claims of the ’069 patent
`
`(January 13, 2011).
`
`Exhibit 1014 - Exhibit 1014 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1014 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 ’069 patent
`
`(January 13, 2011). Exhibit 1014 is also objected to under FRE 901 because
`
`Petitioner has not demonstrated the authenticity of Exhibit 1014. It is not clear where
`
`the exhibit came from, how it was compiled, or what methods or metrics were used
`
`to arrive at the information in the document.
`
`Exhibit 1015 - Exhibit 1015 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1015 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 ’069 patent
`
`(January 13, 2011). Exhibit 1015 is also objected to under FRE 901 because
`
`Petitioner has not demonstrated the authenticity of Exhibit 1015. It is not clear where
`
`the exhibit came from, how it was compiled, or what methods or metrics were used
`
`to arrive at the information in the document.
`
`Exhibit 1017 - Exhibit 1017 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1017 is not relevant, and its probative value is substantially outweighed by
`
`3
`
`
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`Case IPR2021-00880
`Patent 9,669,069 B2
`
`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 ’069 patent
`
`(January 13, 2011). Exhibit 1017 is also objected to under FRE 106. Petitioner has
`
`filed what appears to be an portion from the file history of patent application no.
`
`14/972,560. 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 1017 is also objected to under FRE 901 because Petitioner
`
`has not demonstrated the authenticity of Exhibit 1017. It is not clear how it was
`
`compiled.
`
`Exhibit 1018 - Exhibit 1018 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1018 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 ’069 patent
`
`(January 13, 2011).
`
`Exhibit 1019 - Exhibit 1014 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1019 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 ’069 patent
`
`(January 13, 2011).
`
`4
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`Case IPR2021-00880
`Patent 9,669,069 B2
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`Exhibit 1024 - Exhibit 1024 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1024 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 ’069 patent
`
`(January 13, 2011). Exhibit 1024 is also objected to under FRE 106. Petitioner has
`
`filed what appears to be an incomplete excerpt from the file history of Patent
`
`Application No. 11/016,503. 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 1026 - Exhibit 1026 is objected to under FRE 901 because Petitioner
`
`has not demonstrated the authenticity of Exhibit 1030. It is not clear where the
`
`exhibit came from or how it was compiled.
`
`Exhibit 1029 - Exhibit 1029 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1029 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 ’069 patent
`
`(January 13, 2011). Exhibit 1029 is also objected to under FRE 901 because
`
`Petitioner has not demonstrated the authenticity of Exhibit 1029. It is not clear where
`
`the exhibit came from, how it was compiled, or what methods or metrics were used
`
`to arrive at the information in the document.
`
`5
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`Case IPR2021-00880
`Patent 9,669,069 B2
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`Exhibit 1030 - Exhibit 1030 is objected to under FRE 901 because Petitioner
`
`has not demonstrated the authenticity of Exhibit 1030. It is not clear where the
`
`exhibit came from or how it was compiled.
`
`Exhibit 1032 - Exhibit 1032 is objected to under FRE 901 because Petitioner
`
`has not demonstrated the authenticity of Exhibit 1032. It is not clear where the
`
`exhibit came from or how it was compiled.
`
`Exhibit 1038 - Exhibit 1038 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1038 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 ’069 patent
`
`(January 13, 2011).
`
`Exhibit 1040 - Exhibit 1040 is objected to under FRE 901 because Petitioner
`
`has not demonstrated the authenticity of Exhibit 1040. It is not clear where the
`
`exhibit came from or how it was compiled. Exhibit 1040 is also objected to under
`
`FRE 106. Petitioner has 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 1042 - Exhibit 1042 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1042 is not relevant, and its probative value is substantially outweighed by
`
`6
`
`
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`Case IPR2021-00880
`Patent 9,669,069 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 ’069 patent
`
`(January 13, 2011).
`
`Exhibit 1044 - Exhibit 1044 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1044 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 ’069 patent
`
`(January 13, 2011).
`
`Exhibit 1048 - Exhibit 1048 is objected to under FRE 901 because Petitioner
`
`has not demonstrated the authenticity of Exhibit 1048. It is not clear where the
`
`exhibit came from or how it was compiled.
`
`Exhibit 1049 - Exhibit 1049 is objected to under FRE 901 because Petitioner
`
`has not demonstrated the authenticity of Exhibit 1049. It is not clear where the
`
`exhibit came from or how it was compiled.
`
`Exhibit 1055 - Exhibit 1055 is objected to under FRE 901 because Petitioner
`
`has not demonstrated the authenticity of Exhibit 1055. It is not clear where the
`
`exhibit came from or how it was compiled.
`
`Exhibit 1060 - Exhibit 1060 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1060 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
`
`7
`
`
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`Case IPR2021-00880
`Patent 9,669,069 B2
`
`not published before the priority date of the challenged claims of the ’069 patent
`
`(January 13, 2011).
`
`Exhibit 1061 - Exhibit 1061 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1061 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 ’069 patent
`
`(January 13, 2011).
`
`Exhibit 1062 - Exhibit 1062 is objected to under FRE 901 because Petitioner
`
`has not demonstrated the authenticity of Exhibit 1062. It is not clear from the exhibit
`
`itself that WO 2012/097019 is an accurate copy of EP 2 663 325. Exhibit 1062 is
`
`also objected to under FRE 401, 402 and 403. Exhibit 1062 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 ’069 patent (January 13, 2011).
`
`Exhibit 1063 - Exhibit 1063 is objected to under FRE 901 because Petitioner
`
`has not demonstrated the authenticity of Exhibit 1063. It is not clear where the
`
`exhibit came from or how it was compiled. Exhibit 1063 is also objected to under
`
`FRE 401, 402 and 403. Exhibit 1063 is not relevant, and its probative value is
`
`substantially outweighed by the danger of confusion of the issues and misleading the
`
`8
`
`
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`Case IPR2021-00880
`Patent 9,669,069 B2
`
`fact finder because it was not published before the priority date of the challenged
`
`claims of the ’069 patent (January 13, 2011).
`
`Exhibit 1064 - Exhibit 1064 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1064 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 ’069 patent
`
`(January 13, 2011). Exhibit 1064 is also objected to under FRE 901 because
`
`Petitioner has not demonstrated the authenticity of Exhibit 1064. It is not clear where
`
`the exhibit came from or how it was compiled.
`
`Exhibit 1065 - Exhibit 1065 is objected to under FRE 401, 402 and 403.
`
`Exhibit 1065 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 ’069 patent
`
`(January 13, 2011). Exhibit 1065 is also objected to under FRE 901 because
`
`Petitioner has not demonstrated the authenticity of Exhibit 1065. It is not clear where
`
`the exhibit came from or how it was compiled.
`
`Exhibit 1066 - Exhibit 1066 is objected to under FRE 901 because Petitioner
`
`has not demonstrated the authenticity of Exhibit 1066. It is not clear where the
`
`exhibit came from or how it was compiled. Exhibit 1066 is also objected to under
`
`FRE 401, 402 and 403. Exhibit 1066 is not relevant, and its probative value is
`
`9
`
`
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`Case IPR2021-00880
`Patent 9,669,069 B2
`
`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 ’069 patent (January 13, 2011) as evidenced by the statement “Last
`
`updated: September 30, 2013.”
`
`Exhibit 1067 - Exhibit 1067 is objected to under FRE 901 because Petitioner
`
`has not demonstrated the authenticity of Exhibit 1067. It is not clear where the
`
`exhibit came from or how it was compiled. Exhibit 1067 is also objected to under
`
`FRE 401, 402 and 403. Exhibit 1067 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 ’069 patent (January 13, 2011) as evidenced by the statement “Last
`
`updated: November 5, 2013.”
`
`Exhibit 1069 - Exhibit 1069 is objected to under FRE 901 because Petitioner
`
`has not demonstrated the authenticity of Exhibit 1069. It is not clear where the
`
`exhibit came from or how it was compiled. Exhibit 1069 is also objected to under
`
`FRE 401, 402 and 403. Exhibit 1069 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 ’069 patent (January 13, 2011).
`
`10
`
`
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`Case IPR2021-00880
`Patent 9,669,069 B2
`
`Exhibit 1070 - Exhibit 1070 is objected to under FRE 901 because Petitioner
`
`has not demonstrated the authenticity of Exhibit 1070. It is not clear where the
`
`exhibit came from or how it was compiled. Exhibit 1070 is also objected to under
`
`FRE 401, 402 and 403. Exhibit 1070 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 ’069 patent (January 13, 2011).
`
`Exhibit 1071 - Exhibit 1071 is also objected to under FRE 401, 402 and 403.
`
`Exhibit 1071 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 ’069 patent
`
`(January 13, 2011).
`
`Exhibit 1072 - Exhibit 1072 is objected to under FRE 901 because Petitioner
`
`has not demonstrated the authenticity of Exhibit 1072. It is not clear where the
`
`exhibit came from or how it was compiled.
`
`Exhibit 1075 - Exhibit 1075 is objected to under FRE 901 because Petitioner
`
`has not demonstrated the authenticity of Exhibit 1075. It is not clear where the
`
`exhibit came from or how it was compiled.
`
`11
`
`
`
`Case IPR2021-00880
`Patent 9,669,069 B2
`
`Exhibit 1076 - Exhibit 1076 is objected to under FRE 901 because Petitioner
`
`has not demonstrated the authenticity of Exhibit 1076. It is not clear where the
`
`exhibit came from or how it was compiled.
`
`Exhibit 1077 - Exhibit 1077 is objected to under FRE 901 because Petitioner
`
`has not demonstrated the authenticity of Exhibit 1077. It is not clear where the
`
`exhibit came from or how it was compiled. Exhibit 1077 is also objected to under
`
`FRE 401, 402 and 403. Exhibit 1077 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 ’069 patent (January 13, 2011).
`
`Exhibit 1078 - Exhibit 1078 is objected to under FRE 901 because Petitioner
`
`has not demonstrated the authenticity of Exhibit 1078. It is not clear where the
`
`exhibit came from or how it was compiled. Exhibit 1078 is also objected to under
`
`FRE 106. Petitioner has filed what appears to be an excerpt of the Volume 121 of
`
`1972 University of Pennsylvania Law Review. 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 1079 - Exhibit 1079 is objected to under FRE 901 because Petitioner
`
`has not demonstrated the authenticity of Exhibit 1079. It is not clear where the
`
`exhibit came from or how it was compiled. Exhibit 1079 is also objected to under
`
`12
`
`
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`Case IPR2021-00880
`Patent 9,669,069 B2
`
`FRE 401, 402 and 403. Exhibit 1079 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 ’069 patent (January 13, 2011).
`
`Exhibit 1080 - Exhibit 1080 is objected to under FRE 901 because Petitioner
`
`has not demonstrated the authenticity of Exhibit 1080. It is not clear where the
`
`exhibit came from or how it was compiled. Exhibit 1080 is also objected to under
`
`FRE 401, 402 and 403. Exhibit 1080 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 ’069 patent (January 13, 2011).
`
`Exhibit 1081 - Exhibit 1081 is objected to under FRE 901 because Petitioner
`
`has not demonstrated the authenticity of Exhibit 1081. It is not clear where the
`
`exhibit came from or how it was compiled. Exhibit 1081 is also objected to under
`
`FRE 401, 402 and 403. Exhibit 1081 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 ’069 patent (January 13, 2011).
`
`Exhibit 1082 - Exhibit 1082 is objected to under FRE 901 because Petitioner
`
`has not demonstrated the authenticity of Exhibit 1082. It is not clear where the
`
`13
`
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`Case IPR2021-00880
`Patent 9,669,069 B2
`
`exhibit came from or how it was compiled. Exhibit 1082 is also objected to under
`
`FRE 1006 as an improper summary. Exhibit 1082 is also objected to under FRE 401,
`
`402 and 403. Exhibit 1082 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
`
`’069 patent (January 13, 2011).
`
`Exhibit 1083 - Exhibit 1083 is objected to under FRE 901 because Petitioner
`
`has not demonstrated the authenticity of Exhibit 1083. It is not clear where the
`
`exhibit came from or how it was compiled. Exhibit 1083 is also objected to under
`
`FRE 1006 as an improper summary. Exhibit 1083 is also objected to under FRE 401,
`
`402 and 403. Exhibit 1083 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
`
`’069 patent (January 13, 2011).
`
`Dated: November 24, 2021
`
`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.
`
`14
`
`
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`Case IPR2021-00880
`Patent 9,669,069 B2
`
`CERTIFICATE OF SERVICE
`The undersigned certifies that a copy of the foregoing PATENT OWNER’S
`
`OBJECTIONS TO PETITIONER’S EXHIBITS was served on November 24,
`
`2021, 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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