` Filed: March 25, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`INNOPHARMA LICENSING, INC., INNOPHARMA LICENSING LLC,
`INNOPHARMA INC., INNOPHARMA LLC,
`MYLAN PHARMACEUTICALS INC., and MYLAN INC.,
`LUPIN LTD., and LUPIN PHARMACEUTICALS INC.,
`Petitioner
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`v.
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` SENJU PHARMACEUTICAL CO., LTD.,
`Patent Owner
`_________________
`Case IPR2015-00903 (Patent 8,129,431 B2)1
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`PATENT OWNER’S OBJECTIONS
`UNDER 37 C.F.R. § 42.64(B)(1)
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`1. IPR2015-01871 has been joined with this proceeding.
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`Case IPR2015-00903 (Patent 8,129,431 B2)
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`Pursuant to 37 C.F.R. § 42.64(b)(1), Patent Owner objects to Exhibit 1104,
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`served with Petitioner’s Reply (Paper No. 56). Patent Owner objects to Exhibit
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`1104 (Reply Declaration of Paul Laskar) because portions of the Exhibit lack
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`relevance (FRE 402), as they exceed the proper scope of Petitioner’s Reply. 37
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`C.F.R. § 42.23(b) states “[a] reply may only respond to arguments raised in the
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`corresponding . . . patent owner response.” As explained in the Trial Practice
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`Guide, “new evidence necessary to make out a prima facie case for []
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`unpatentability” and “new evidence that could have been presented in a prior
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`filing” are improper. 77 Fed. Reg. 48767. “[A] reply that raises a new issue or
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`belatedly presents evidence will not be considered and may be returned.” Id. For
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`instance, paragraphs 4-34 of Exhibit 1104 are all directed to new testimony from
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`Dr. Laskar that tyloxapol is allegedly an antioxidant.
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`Patent Owner further objects to Exhibit 1104 because of the prejudice
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`resulting from Patent Owner’s inability to respond to the untimely evidence and
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`arguments therein (FRE 403). As explained above, at least paragraphs 4-34 of
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`Exhibit 1104 containing Dr. Laskar’s new testimony exceed the proper scope of
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`Petitioner’s Reply and are thus irrelevant, untimely, prejudicial, and objectionable
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`under FRE 402 and FRE 403.
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`Patent Owner further objects to Exhibit 1104 under FRE 702 and 37 C.F.R.
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`§ 42.65 because the opinions offered by Dr. Laskar in his reply declaration,
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`2
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`Case IPR2015-00903 (Patent 8,129,431 B2)
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`specifically at least paragraphs 8, 10-13, and 17-19, evidence a complete lack of
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`expertise in organic or medicinal chemistry and thus Dr. Laskar is not qualified by
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`knowledge, skill, experience, training or education necessary to form an opinion.
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`Patent Owner also objects to Exhibits 1089, 1092, 1093, 1105, 1106, 1091,
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`1094, and 1148, which Dr. Laskar discusses in detail in Exhibit 1104 in paragraphs
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`19 and 23-29, in support of his new testimony that tyloxapol is allegedly an
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`antioxidant, because these Exhibits lack relevance (FRE 402), as they exceed the
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`proper scope of Petitioner’s Reply. See 37 C.F.R. § 42.23(b); 77 Fed. Reg. 48767.
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`Patent Owner further objects to these Exhibits because of the prejudice resulting
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`from Patent Owner’s inability to respond to the untimely evidence therein (FRE
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`403).
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`Patent Owner objects to Exhibits 1075, 1098, and 1076, which Petitioners
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`use to allegedly support a new argument in Petitioner’s Reply (Paper 56) that a
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`person of ordinary skill in the art would expect that switching polysorbate 80 with
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`tyloxapol would improve preservative efficacy because polysorbate 80 allegedly
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`was known to neutralize BAC. Exhibits 1075, 1098, and 1076 lack relevance
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`(FRE 402), as they exceed the proper scope of Petitioner’s Reply. See 37 C.F.R. §
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`42.23(b); 77 Fed. Reg. 48767. Patent Owner further objects to these Exhibits
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`because of the prejudice resulting from Patent Owner’s inability to respond to the
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`untimely evidence therein (FRE 403).
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`3
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`Case IPR2015-00903 (Patent 8,129,431 B2)
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`
`By: /Bryan C. Diner/
`Bryan C. Diner, Lead Counsel
`Registration No. 32,409
`Justin J. Hasford, Backup Counsel
`Registration No. 62,180
`Finnegan, Henderson, Farabow, Garrett
`& Dunner, LLP
`901 New York Avenue NW
`Washington, DC 20001
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`Attorneys for Patent Owner Senju
`Pharmaceutical Co., Ltd.
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`4
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`Date: March 25, 2016
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`Case IPR2015-00903 (Patent 8,129,431 B2)
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing PATENT
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`OWNER’S OBJECTIONS UNDER 37 C.F.R. § 42.64(B)(1) was filed on March
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`25, 2016, and served via email directed to counsel of record for the Petitioner at the
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`following:
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`Jitendra Malik, Ph.D
`Jitty.malik@alston.com
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`Bryan Skelton, Ph.D.
`Bryan.skelton@alston.com
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`Lance Soderstrom
`Lance.soderstrom@alson.com
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`Hitetada James Abe
`James.abe@alston.com
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`Joseph M. Janusz
`Joe.janusz@alston.com
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`Deborah Yellin
`dyellin@crowell.com
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`Jonathan Lindsay
`jlindsay@crowell.com
`
`Shannon Lentz
`slentz@crowell.com
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` /Ashley F. Cheung/
`Ashley F. Cheung
`Case Manager
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
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`
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`Dated: March 25, 2016
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`5
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