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`UNITED STATES PATENT AND TRADEMARK OFFICE
`___________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`
`v.
`
`
`BIOGEN MA INC.,
`Patent Owner.
`____________________________________________
`
`IPR2018-01403
`Patent No. 8,399,514
`____________________________________________
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`PATENT OWNER OBJECTIONS TO PETITIONER’S EXHIBITS
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`U.S. Patent No. 8,399,514
`IPR2018-01403
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`Pursuant to 37 C.F.R. § 42.64(b)(1), Patent Owner Biogen MA Inc.
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`(“Biogen”) submits the following objections to Mylan Pharmaceutical Inc.’s
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`(“Mylan”) Exhibit Nos. 1006, 1010-1014, 1017-1019, 1021, 1023, 1024, 1027-1033,
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`1035-1037, 1042, 1044-1047, 1049-1052, 1054, and 1055. Biogen’s objections
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`apply equally to Mylan’s reliance on these exhibits in any subsequently filed
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`documents. These objections are timely, having been served within ten business
`
`days of the Board’s decision to institute a trial in this proceeding.
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`Exhibit 1006
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`Biogen objects to Exhibit 1006 under Fed. R. Evid. 106 because this Exhibit
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`is only a portion of a larger document. Biogen also objects to this Exhibit under
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`Rule 802. To the extent Petitioner relies on the contents of this Exhibit for the truth
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`of the matter asserted, Biogen objects to such contents as inadmissible hearsay (see
`
`Rule 801) that does not fall under any exceptions, including those of Rules 803, 804,
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`805, and 807.
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`Exhibits 1010
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`Biogen objects to Exhibit 1010 under Fed. R. Evid. 802. To the extent
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`Petitioner relies on the contents of this Exhibit for the truth of the matter asserted,
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`Biogen objects to such contents as inadmissible hearsay (see Rule 801) that does not
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`fall under any exceptions, including those of Rules 803, 804, 805, and 807. Biogen
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`further objects to this Exhibit under Fed. R. Evid. 901 as not properly authenticated.
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`U.S. Patent No. 8,399,514
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`Exhibit 1011
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`Biogen objects to Exhibit 1011 under Fed. R. Evid. 802. To the extent
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`Petitioner relies on the contents of this Exhibit for the truth of the matter asserted,
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`Biogen objects to such contents as inadmissible hearsay (see Rule 801) that does not
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`fall under any exceptions, including those of Rules 803, 804, 805, and 807. Biogen
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`further objects to this Exhibit under Fed. R. Evid. 901 as not properly authenticated.
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`Exhibit 1012
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`Biogen objects to Exhibit 1012 under Fed. R. Evid. 802. To the extent
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`Petitioner relies on the contents of this Exhibit for the truth of the matter asserted,
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`Biogen objects to such contents as inadmissible hearsay (see Rule 801) that does not
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`fall under any exceptions, including those of Rules 803, 804, 805, and 807. Biogen
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`further objects to this Exhibit under Fed. R. Evid. 901 as not properly authenticated.
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`Biogen further objects to this Exhibit under Rules 602 and 701 for lack of
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`foundation, speculation, and lack of personal knowledge.
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`Exhibit 1013
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`Biogen objects to Exhibit 1013 under Fed. R. Evid. 802. To the extent
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`Petitioner relies on the contents of this Exhibit for the truth of the matter asserted,
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`Biogen objects to such contents as inadmissible hearsay (see Rule 801) that does not
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`fall under any exceptions, including those of Rules 803, 804, 805, and 807.
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`U.S. Patent No. 8,399,514
`IPR2018-01403
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`Exhibit 1014
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`Biogen objects to Exhibit 1014 under Fed. R. Evid. 802. To the extent
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`Petitioner relies on the contents of this Exhibit for the truth of the matter asserted,
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`Biogen objects to such contents as inadmissible hearsay (see Rule 801) that does not
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`fall under any exceptions, including those of Rules 803, 804, 805, and 807.
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`Exhibit 1017
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`Biogen objects to Exhibit 1017 under Fed. R. Evid. 402 for lack of relevance,
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`as well as under Rule 403 as misleading, confusing, or likely to lead to unfair
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`prejudice or waste of time. Biogen also objects to this Exhibit under Rule 802. To
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`the extent Petitioner relies on the contents of this Exhibit for the truth of the matter
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`asserted, Biogen objects to such contents as inadmissible hearsay (see Rule 801) that
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`does not fall under any exceptions, including those of Rules 803, 804, 805, and 807.
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`Exhibit 1018
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`Biogen objects to Exhibit 1018 under Fed. R. Evid. 802. To the extent
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`Petitioner relies on the contents of this Exhibit for the truth of the matter asserted,
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`Biogen objects to such contents as inadmissible hearsay (see Rule 801) that does not
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`fall under any exceptions, including those of Rules 803, 804, 805, and 807.
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`Exhibit 1019
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`Biogen objects to Exhibit 1019 under Fed. R. Evid. 402 for lack of relevance,
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`as well as under Rule 403 as misleading, confusing, or likely to lead to unfair
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`U.S. Patent No. 8,399,514
`IPR2018-01403
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`prejudice or waste of time. Biogen also objects to this Exhibit under Rule 802. To
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`the extent Petitioner relies on the contents of this Exhibit for the truth of the matter
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`asserted, Biogen objects to such contents as inadmissible hearsay (see Rule 801) that
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`does not fall under any exceptions, including those of Rules 803, 804, 805, and 807.
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`Exhibit 1021
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`Biogen objects to Exhibit 1021 under Fed. R. Evid. 402 for lack of relevance,
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`as well as under Rule 403 as misleading, confusing, or likely to lead to unfair
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`prejudice or waste of time. Biogen also objects to this Exhibit under Rule 802. To
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`the extent Petitioner relies on the contents of this Exhibit for the truth of the matter
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`asserted, Biogen objects to such contents as inadmissible hearsay (see Rule 801) that
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`does not fall under any exceptions, including those of Rules 803, 804, 805, and 807.
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`Exhibit 1023
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`Biogen objects to Exhibit 1023 under Fed. R. Evid. 402 for lack of relevance,
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`as well as under Rule 403 as misleading, confusing, or likely to lead to unfair
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`prejudice or waste of time. Biogen also objects to this Exhibit under Rule 802. To
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`the extent Petitioner relies on the contents of this Exhibit for the truth of the matter
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`asserted, Biogen objects to such contents as inadmissible hearsay (see Rule 801) that
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`does not fall under any exceptions, including those of Rules 803, 804, 805, and 807.
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`Exhibit 1024
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`Biogen objects to Exhibit 1024 under Fed. R. Evid. 402 for lack of relevance,
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`U.S. Patent No. 8,399,514
`IPR2018-01403
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`as well as under Rule 403 as misleading, confusing, or likely to lead to unfair
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`prejudice or waste of time. Biogen also objects to this Exhibit under Rule 802. To
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`the extent Petitioner relies on the contents of this Exhibit for the truth of the matter
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`asserted, Biogen objects to such contents as inadmissible hearsay (see Rule 801) that
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`does not fall under any exceptions, including those of Rules 803, 804, 805, and 807.
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`Exhibit 1027
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`Biogen objects to Exhibit 1027 under Fed. R. Evid. 402 for lack of relevance,
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`as well as under Rule 403 as misleading, confusing, or likely to lead to unfair
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`prejudice or waste of time. Biogen also objects to this Exhibit under Rule 802. To
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`the extent Petitioner relies on the contents of this Exhibit for the truth of the matter
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`asserted, Biogen objects to such contents as inadmissible hearsay (see Rule 801) that
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`does not fall under any exceptions, including those of Rules 803, 804, 805, and 807.
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`Exhibit 1028
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`Biogen objects to Exhibit 1028 under Fed. R. Evid. 402 for lack of relevance,
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`as well as under Rule 403 as misleading, confusing, or likely to lead to unfair
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`prejudice or waste of time. Biogen also objects to this Exhibit under Rule 802. To
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`the extent Petitioner relies on the contents of this Exhibit for the truth of the matter
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`asserted, Biogen objects to such contents as inadmissible hearsay (see Rule 801) that
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`does not fall under any exceptions, including those of Rules 803, 804, 805, and 807.
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`Exhibit 1029
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`Biogen objects to Exhibit 1029 under Fed. R. Evid. 106 because this Exhibit
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`is only a portion of a larger document. Biogen also objects to this Exhibit under
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`Rule 402 for lack of relevance, as well as under Rule 403 as misleading, confusing,
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`or likely to lead to unfair prejudice or waste of time. Biogen also objects to this
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`Exhibit under Rule 802. To the extent Petitioner relies on the contents of this Exhibit
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`for the truth of the matter asserted, Biogen objects to such contents as inadmissible
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`hearsay (see Rule 801) that does not fall under any exceptions, including those of
`
`Rules 803, 804, 805, and 807. Biogen further objects to this Exhibit under Fed. R.
`
`Evid. 901 as not properly authenticated.
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`Exhibit 1030
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`Biogen objects to Exhibit 1030 under Fed. R. Evid. 402 for lack of relevance,
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`as well as under Rule 403 as misleading, confusing, or likely to lead to unfair
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`prejudice or waste of time. Biogen also objects to this Exhibit under Rule 802. To
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`the extent Petitioner relies on the contents of this Exhibit for the truth of the matter
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`asserted, Biogen objects to such contents as inadmissible hearsay (see Rule 801) that
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`does not fall under any exceptions, including those of Rules 803, 804, 805, and 807.
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`Exhibit 1031
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`Biogen objects to Exhibit 1031 under Fed. R. Evid. 402 for lack of relevance,
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`as well as under Rule 403 as misleading, confusing, or likely to lead to unfair
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`U.S. Patent No. 8,399,514
`IPR2018-01403
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`prejudice or waste of time. Biogen also objects to this Exhibit under Rule 802. To
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`the extent Petitioner relies on the contents of this Exhibit for the truth of the matter
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`asserted, Biogen objects to such contents as inadmissible hearsay (see Rule 801) that
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`does not fall under any exceptions, including those of Rules 803, 804, 805, and 807.
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`Ex. 1032
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`Biogen objects to Exhibit 1032 under Fed. R. Evid. 802. To the extent
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`Petitioner relies on the contents of this Exhibit for the truth of the matter asserted,
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`Biogen objects to such contents as inadmissible hearsay (see Rule 801) that does not
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`fall under any exceptions, including those of Rules 803, 804, 805, and 807.
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`Ex. 1033
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`Biogen objects to Exhibit 1033 under Fed. R. Evid. 802. To the extent
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`Petitioner relies on the contents of this Exhibit for the truth of the matter asserted,
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`Biogen objects to such contents as inadmissible hearsay (see Rule 801) that does not
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`fall under any exceptions, including those of Rules 803, 804, 805, and 807.
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`Ex. 1035
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`Biogen objects to Exhibit 1035 under Fed. R. Evid. 802. To the extent
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`Petitioner relies on the contents of this Exhibit for the truth of the matter asserted,
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`Biogen objects to such contents as inadmissible hearsay (see Rule 801) that does not
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`fall under any exceptions, including those of Rules 803, 804, 805, and 807.
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`Ex. 1036
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`Biogen objects to Exhibit 1036 under Fed. R. Evid. 402 for lack of relevance,
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`as well as under Rule 403 as misleading, confusing, or likely to lead to unfair
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`prejudice or waste of time. Biogen also objects to this Exhibit under Rule 802. To
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`the extent Petitioner relies on the contents of this Exhibit for the truth of the matter
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`asserted, Biogen objects to such contents as inadmissible hearsay (see Rule 801) that
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`does not fall under any exceptions, including those of Rules 803, 804, 805, and 807.
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`Ex. 1037
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`Biogen objects to Exhibit 1037 under Fed. R. Evid. 402 for lack of relevance,
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`as well as under Rule 403 as misleading, confusing, or likely to lead to unfair
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`prejudice or waste of time. Biogen also objects to this Exhibit under Rule 802. To
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`the extent Petitioner relies on the contents of this Exhibit for the truth of the matter
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`asserted, Biogen objects to such contents as inadmissible hearsay (see Rule 801) that
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`does not fall under any exceptions, including those of Rules 803, 804, 805, and 807.
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`Ex. 1042
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`Biogen objects to Exhibit 1042 under Fed. R. Evid. 402 for lack of relevance.
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`Biogen also objects to this Exhibit under Rule 802. To the extent Petitioner relies
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`on the contents of this Exhibit for the truth of the matter asserted, Biogen objects to
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`such contents as inadmissible hearsay (see Rule 801) that does not fall under any
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`exceptions, including those of Rules 803, 804, 805, and 807. Biogen further objects
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`U.S. Patent No. 8,399,514
`IPR2018-01403
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`to this Exhibit under Fed. R. Evid. 901 as not properly authenticated.
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`Ex. 1044
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`Biogen objects to Exhibit 1044 under Fed. R. Evid. 802. To the extent
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`Petitioner relies on the contents of this Exhibit for the truth of the matter asserted,
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`Biogen objects to such contents as inadmissible hearsay (see Rule 801) that does not
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`fall under any exceptions, including those of Rules 803, 804, 805, and 807.
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`Ex. 1045
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`Biogen objects to Exhibit 1045 under Fed. R. Evid. 802. To the extent
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`Petitioner relies on the contents of this Exhibit for the truth of the matter asserted,
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`Biogen objects to such contents as inadmissible hearsay (see Rule 801) that does not
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`fall under any exceptions, including those of Rules 803, 804, 805, and 807.
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`Ex. 1046
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`Biogen objects to Exhibit 1046 under Fed. R. Evid. 106 because this Exhibit
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`is only a portion of a larger document.
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`Ex. 1047
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`Biogen objects to Exhibit 1047 under Fed. R. Evid. 402 for lack of relevance.
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`Biogen also objects to this Exhibit under Rule 802. To the extent Petitioner relies
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`on the contents of this Exhibit for the truth of the matter asserted, Biogen objects to
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`such contents as inadmissible hearsay (see Rule 801) that does not fall under any
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`exceptions, including those of Rules 803, 804, 805, and 807.
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`U.S. Patent No. 8,399,514
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`Ex. 1049
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`Biogen objects to Exhibit 1049 under Fed. R. Evid. 402 for lack of relevance,
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`as well as under Rule 403 as misleading, confusing, or likely to lead to unfair
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`prejudice or waste of time. Biogen also objects to this Exhibit under Rule 802. To
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`the extent Petitioner relies on the contents of this Exhibit for the truth of the matter
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`asserted, Biogen objects to such contents as inadmissible hearsay (see Rule 801) that
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`does not fall under any exceptions, including those of Rules 803, 804, 805, and 807.
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`Biogen further objects to this Exhibit under Fed. R. Evid. 901 as not properly
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`authenticated.
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`Ex. 1050
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`Biogen objects to Exhibit 1050 under Fed. R. Evid. 402 for lack of relevance.
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`Biogen also objects to this Exhibit under Rule 802. To the extent Petitioner relies
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`on the contents of this Exhibit for the truth of the matter asserted, Biogen objects to
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`such contents as inadmissible hearsay (see Rule 801) that does not fall under any
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`exceptions, including those of Rules 803, 804, 805, and 807.
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`Ex. 1051
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`Biogen objects to Exhibit 1051 under Fed. R. Evid. 402 for lack of relevance.
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`Biogen also objects to this Exhibit under Rule 802. To the extent Petitioner relies
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`on the contents of this Exhibit for the truth of the matter asserted, Biogen objects to
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`such contents as inadmissible hearsay (see Rule 801) that does not fall under any
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`U.S. Patent No. 8,399,514
`IPR2018-01403
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`exceptions, including those of Rules 803, 804, 805, and 807.
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`Ex. 1052
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`Biogen objects to Exhibit 1052 under Fed. R. Evid. 402 for lack of relevance.
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`Biogen also objects to this Exhibit under Rule 802. To the extent Petitioner relies
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`on the contents of this Exhibit for the truth of the matter asserted, Biogen objects to
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`such contents as inadmissible hearsay (see Rule 801) that does not fall under any
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`exceptions, including those of Rules 803, 804, 805, and 807.
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`Exhibit 1054
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`Biogen objects to Exhibit 1054 under Fed. R. Evid. 402 for lack of relevance,
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`as well as under Rule 403 as misleading, confusing, or likely to lead to unfair
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`prejudice or waste of time. Biogen also objects to this Exhibit under Rule 802. To
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`the extent Petitioner relies on the contents of this Exhibit for the truth of the matter
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`asserted, Biogen objects to such contents as inadmissible hearsay (see Rule 801) that
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`does not fall under any exceptions, including those of Rules 803, 804, 805, and 807.
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`Biogen further objects to this Exhibit under Rules 602 and 701 for lack of
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`foundation, speculation, and lack of personal knowledge.
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`Exhibit 1055
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`Biogen objects to Exhibit 1055 under Fed. R. Evid. 402 for lack of relevance,
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`as well as under Rule 403 as misleading, confusing, or likely to lead to unfair
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`prejudice or waste of time. Biogen also objects to this Exhibit under Rule 802. To
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`U.S. Patent No. 8,399,514
`IPR2018-01403
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`the extent Petitioner relies on the contents of this Exhibit for the truth of the matter
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`asserted, Biogen objects to such contents as inadmissible hearsay (see Rule 801) that
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`does not fall under any exceptions, including those of Rules 803, 804, 805, and 807.
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`Biogen further objects to this Exhibit under Rules 602 and 701 for lack of
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`foundation, speculation, and lack of personal knowledge, as well as under 37 C.F.R.
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`§ 1.4(d).
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`Dated: February 20, 2019
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`By: /Barbara C. McCurdy/
`Barbara C. McCurdy, Reg. No. 32,120
`Erin M. Sommers, Reg. No. 60,974
`Pier D. DeRoo, Reg. No. 69,340
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`Counsel for Patent Owner
`Biogen MA Inc.
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`CERTIFICATE OF SERVICE
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`The undersigned certifies that a copy of the foregoing Patent Owner
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`Objections to Petitioner’s Exhibits was served electronically via e-mail on
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`February 20, 2019, in its entirety on the following:
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`Brandon M. White
`Perkins Coie LLP
`700 13th St., NW, Suite 600
`Washington, D.C. 20005
`Telephone: (202) 654-6206
`E-mail: bmwhite@perkinscoie.com
`Emily Greb
`Perkins Coie LLP
`One East Main St., Suite 201
`Madison, WI 53703
`Telephone: (608) 663-7494
`E-mail: egreb@perkinscoie.com
`Petitioner has agreed to electronic service.
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`Dated: February 20, 2019
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`By: /Barbara C. McCurdy/
`Barbara C. McCurdy, Reg. No. 32,120
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`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
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