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`UNITED STATES PATENT AND TRADEMARK OFFICE
`___________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________
`
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`COALITION FOR AFFORDABLE DRUGS V LLC;
`HAYMAN CREDES MASTER FUND, L.P.;
`HAYMAN ORANGE FUND SPC – PORTFOLIO A;
`HAYMAN CAPITAL MASTER FUND, L.P.;
`HAYMAN CAPITAL MANAGEMENT, L.P.;
`HAYMAN OFFSHORE MANAGEMENT, INC.;
`HAYMAN INVESTMENTS, LLC;
`NXN PARTNERS, LLC;
`IP NAVIGATION GROUP, LLC;
`J KYLE BASS, and ERICH SPANGENBERG,
`Petitioner,
`
`v.
`
`BIOGEN MA INC.,
`Patent Owner.
`
`____________________________________________
`
`Case: IPR2015-01993
`U.S. Patent No. 8,399,514
`____________________________________________
`
`BIOGEN’S OBJECTIONS TO PETITIONER’S EXHIBITS
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`Case No. IPR2015-01993
`Patent 8,399,514
`Pursuant to 37 C.F.R. § 42.64(b)(1), Patent Owner Biogen MA Inc. submits
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`the following objections to Petitioner’s Exhibit Nos. 1045, 1047, 1048, 1049, 1055,
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`1058, 1059, 1060, 1061, 1062, 1063, 1064, 1065, 1068, 1069, 1070, 1071, 1072,
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`and 1073. Biogen’s objections apply equally to Petitioner’s reliance on these
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`exhibits in any subsequently filed documents. These objections are timely, having
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`been served within five business days of Petitioner’s service of these exhibits in
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`this proceeding.
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`Exhibit 1045
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`Biogen objects to paragraphs 62-83 of Exhibit 1045 under Fed. R. Evid. 401,
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`as not relevant because they contain arguments or evidence that are outside the
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`scope of a proper reply in violation of 37 C.F.R. § 42.23(b). In particular,
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`paragraphs 62-83 advance new theories of unpatentability that were not set forth in
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`the Petition.
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`Exhibits 1047, 1048, and 1049
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`Biogen objects to Exhibits 1047, 1048, and 1049 under Fed. R. Evid. 802.
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`To the extent Petitioner relies on the contents of these Exhibits for the truth of the
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`matter asserted, Biogen objects to such contents as inadmissible hearsay (see Rule
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`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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`1
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`Exhibit 1055
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`Biogen objects to Exhibit 1055 because it is improperly stamped as Exhibit
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`Case No. IPR2015-01993
`Patent 8,399,514
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`1056.
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`Exhibit 1058
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`Biogen objects to Exhibit 1058 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
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`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. 401-403 as lacking nexus
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`to the grounds on which the Board has instituted inter partes review. In particular,
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`this Exhibit does not make any fact more or less probable than it would be without
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`the Exhibit. Moreover, this Exhibit is unfairly prejudicial, confuses the issues,
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`misleads the factfinder, and is a waste of time, as Petitioner has not established that
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`glatiramer acetate (Copaxone®) is relevant to this proceeding. Biogen also objects
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`to this Exhibit because Petitioner never relied on it in Petitioner’s Reply to
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`Biogen’s Opposition or Motion to Antedate or explained its significance. 37 C.F.R.
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`§§ 42.22(a), 42.23. Biogen also objects to this Exhibit as being outside the scope
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`of a proper reply in violation of 37 C.F.R. § 42.23(b).
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`2
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`Case No. IPR2015-01993
`Patent 8,399,514
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`Exhibit 1059
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`Biogen objects to Exhibit 1059 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
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`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. 401-403 as lacking nexus
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`to the grounds on which the Board has instituted inter partes review. In particular,
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`this Exhibit does not make any fact more or less probable than it would be without
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`the Exhibit. Moreover, this Exhibit is unfairly prejudicial, confuses the issues,
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`misleads the factfinder, and is a waste of time, as Petitioner has not established that
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`glatiramer acetate (Copaxone®) is relevant to this proceeding. Biogen also objects
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`to this Exhibit because Petitioner never relied on it in Petitioner’s Reply to
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`Biogen’s Opposition or Motion to Antedate or explained its significance. 37 C.F.R.
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`§§ 42.22(a), 42.23. Biogen also objects to this Exhibit as being outside the scope
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`of a proper reply in violation of 37 C.F.R. § 42.23(b).
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`Exhibit 1060
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`Biogen objects to Exhibit 1060 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
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`not fall under any exceptions, including those of Rules 803, 804, 805, and 807.
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`3
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`Case No. IPR2015-01993
`Patent 8,399,514
`Biogen further objects to this Exhibit under Fed. R. Evid. 401-403 as lacking nexus
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`to the grounds on which the Board has instituted inter partes review. In particular,
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`this Exhibit does not make any fact more or less probable than it would be without
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`the Exhibit. Moreover, this Exhibit is unfairly prejudicial, confuses the issues,
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`misleads the factfinder, and is a waste of time, as Petitioner has not established that
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`glatiramer acetate (Copaxone®) is relevant to this proceeding. Biogen also objects
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`to this Exhibit as being outside the scope of a proper reply in violation of 37 C.F.R.
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`§ 42.23(b).
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`Exhibit 1061
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`Biogen objects to Exhibit 1061 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
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`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 being properly
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`authenticated. Biogen also objects to this Exhibit under Fed. R. Evid. 401-403 as
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`lacking nexus to the grounds on which the Board has instituted inter partes review.
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`In particular, this Exhibit does not make any fact more or less probable than it
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`would be without the Exhibit. Moreover, this Exhibit is unfairly prejudicial,
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`confuses the issues, misleads the factfinder, and is a waste of time, as Petitioner
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`has not established that glatiramer acetate (Copaxone®) is relevant to this
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`4
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`Case No. IPR2015-01993
`Patent 8,399,514
`proceeding. In addition, this Exhibit is improperly stamped as Exhibit 1063.
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`Biogen also objects to this Exhibit as being outside the scope of a proper reply in
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`violation of 37 C.F.R. § 42.23(b).
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`Exhibit 1062
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`Biogen objects to Exhibit 1062 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
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`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 being properly
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`authenticated. Biogen also objects to this Exhibit under Fed. R. Evid. 401-403 as
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`lacking nexus to the grounds on which the Board has instituted inter partes review.
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`In particular, this Exhibit does not make any fact more or less probable than it
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`would be without the Exhibit. Moreover, this Exhibit is unfairly prejudicial,
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`confuses the issues, misleads the factfinder, and is a waste of time, as Petitioner
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`has not established that natalizumab (Tysabri®) is relevant to this proceeding.
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`Biogen also objects to this Exhibit as being outside the scope of a proper reply in
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`violation of 37 C.F.R. § 42.23(b).
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`Exhibit 1063
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`Biogen objects to Exhibit 1063 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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`5
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`Case No. IPR2015-01993
`Patent 8,399,514
`Biogen objects to such contents as inadmissible hearsay (see Rule 801) that does
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`not fall under any exceptions, including those of Rules 803, 804, 805, and 807.
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`Biogen also objects to this Exhibit under Fed. R. Evid. 401-403 as lacking nexus to
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`the grounds on which the Board has instituted inter partes review. In particular,
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`this Exhibit does not make any fact more or less probable than it would be without
`
`the Exhibit. Moreover, this Exhibit is unfairly prejudicial, confuses the issues,
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`misleads the factfinder, and is a waste of time. Biogen further objects to this
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`Exhibit because Petitioner never relied on it in Petitioner’s Reply to Biogen’s
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`Opposition or Motion to Antedate or explained its significance. 37 C.F.R. §§
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`42.22(a), 42.23. Biogen also objects to this Exhibit as being outside the scope of a
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`proper reply in violation of 37 C.F.R. § 42.23(b).
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`Exhibits 1064, 1065, 1068, 1069, 1070, 1071, and 1072
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`Biogen objects to Exhibits 1064, 1065, 1068, 1069, 1070, 1071, and 1072
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`under Fed. R. Evid. 802. To the extent Petitioner relies on the contents of these
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`Exhibits for the truth of the matter asserted, Biogen objects to such contents as
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`inadmissible hearsay (see Rule 801) that does not fall under any exceptions,
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`including those of Rules 803, 804, 805, and 807. Biogen further objects to these
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`Exhibits under Fed. R. Evid. 401-403 as lacking nexus to the grounds on which the
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`Board has instituted inter partes review. In particular, these Exhibits do not make
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`any fact more or less probable than it would be without the Exhibits. Moreover,
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`6
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`Case No. IPR2015-01993
`Patent 8,399,514
`these Exhibits are unfairly prejudicial, confuse the issues, mislead the factfinder,
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`and are a waste of time, as interferon beta-1a (Avonex® and Rebif®), fingolimod
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`(Gilenya®), teriflunomide (Aubagio®), interferon beta-1b (Betaseron®), glatiramer
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`acetate (Copaxone®), and natalizumab (Tysabri®) are not relevant to this
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`proceeding. Biogen also objects to these Exhibits because Petitioner never relied
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`on them in Petitioner’s Reply to Biogen’s Opposition or Motion to Antedate or
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`explained their significance. 37 C.F.R. §§ 42.22(a), 42.23. Biogen also objects to
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`these Exhibits as being outside the scope of a proper reply in violation of 37 C.F.R.
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`§ 42.23(b).
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`Exhibit 1073
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`Biogen objects to Exhibit 1073 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
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`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. 401-403 as lacking nexus
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`to the grounds on which the Board has instituted inter partes review. In particular,
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`this Exhibit does not make any fact more or less probable than it would be without
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`the Exhibit. Moreover, this Exhibit is unfairly prejudicial, confuses the issues,
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`misleads the factfinder, and is a waste of time. Biogen also objects to this Exhibit
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`as being outside the scope of a proper reply in violation of 37 C.F.R. § 42.23(b).
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`7
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`Dated: October 5, 2016
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`Case No. IPR2015-01993
`Patent 8,399,514
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`
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`Respectfully submitted,
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`By: / Maureen D. Queler /
`Michael J. Flibbert, Reg. No. 33,234
`Maureen D. Queler, Reg. No. 61,879
`Erin M. Sommers, Reg. No. 60,974
`Finnegan, Henderson, Farabow, Garrett
` & Dunner, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`(202) 408-4000
`
`Counsel for Patent Owner in
`IPR2015-01993
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`8
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`CERTIFICATE OF SERVICE
`The undersigned certifies that a copy of the foregoing BIOGEN’S
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`OBJECTIONS TO PETITIONER’S EXHIBITS was served electronically via
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`e-mail on October 5, 2016, in its entirety on the following:
`
`James T. Carmichael
`Carol A. Spiegel
`Carmichael IP, PLLC
`8000 Towers Crescent Drive, 13th Floor
`Tysons Corner, VA 22182
`jim@carmichaelip.com
`carol@carmichaelip.com
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`Petitioner has agreed to electronic service.
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`Dated: October 5, 2016
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`By: / Maureen D. Queler /
`Maureen D. Queler
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
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