`Filed: April 29, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`__________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`__________________
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`LUPIN LTD. and LUPIN PHARMACEUTICALS INC.
`Petitioner,
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`v.
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`SENJU PHARMACEUTICAL CO., LTD.
`Patent Owner.
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`__________________
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`Case IPR2015-01099 (Patent 8,669,290 B2)
`__________________
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`PATENT OWNER’S OBJECTIONS
`UNDER 37 C.F.R. § 42.64(B)(1)
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`Case IPR2015-01099 (Patent 8,669,290)
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`Pursuant to 37 C.F.R. § 42.64(b)(1), Patent Owner objects to Exhibits 1094
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`and 1122, served with Petitioners’ Reply (Paper Nos. 32 & 34 (Confidential
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`Version)). Patent Owner objects to Exhibit 1094 (Reply Declaration of M. Jayne
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`Lawrence, Ph.D.) because portions of the Exhibit lack relevance (FRE 402), as
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`they exceed the proper scope of Petitioners’ Reply. 37 C.F.R. § 42.23(b) states
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`“[a] reply may only respond to arguments raised in the corresponding . . . patent
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`owner response.” As explained in the Trial Practice Guide, “new evidence
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`necessary to make out a prima facie case for [] unpatentability” and “new evidence
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`that could have been presented in a prior filing” are improper. 77 Fed. Reg. 48767.
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`“[A] reply that raises a new issue or belatedly presents evidence will not be
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`considered and may be returned.” Id. For instance, paragraphs 29, 31-33, 37-38,
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`40, and 80, as well as footnote 5, of Exhibit 1094 are all directed to new testimony
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`from Dr. Lawrence that tyloxapol is allegedly an antioxidant (¶¶ 31-33, 37-38, and
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`footnote 5); the specific NSAIDs diclofenac and ketorolac are allegedly subject to
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`oxidative degradation (¶ 31); tyloxapol is allegedly less toxic to the ocular
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`membranes (¶ 29); and that too much non-ionic surfactant, specifically polysorbate
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`80, allegedly reduces the effectiveness of benzalkonium chloride (¶ 80). That
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`Petitioner knew bromfenac degraded by oxidation and that this new testimony
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`regarding the alleged use of an antioxidant could have been previously presented is
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`Case IPR2015-01099 (Patent 8,669,290)
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`confirmed and recognized in Dr. Lawrence’s initial declaration (EX1005), where at
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`¶ 66(e) it states that stabilizers, such as antioxidants, are added to ophthalmic
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`formulations to decrease the decomposition of the active ingredient and that
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`Ogawa Example 6 uses the stabilizer sodium sulfite (EX1005, ¶186, last sentence),
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`a well-known antioxidant.
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`Patent Owner further objects to Exhibit 1094 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 29, 31-33,
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`37-38, 40, 80, and footnote 5, of Exhibit 1094, containing Dr. Lawrence’s new
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`testimony, exceed the proper scope of Petitioners’ Reply and are thus irrelevant,
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`untimely, prejudicial, and objectionable under FRE 402 and FRE 403.
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`Patent Owner further objects to Exhibit 1094 under FRE 702 and 37 C.F.R.
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`§ 42.65 because the opinions offered by Dr. Lawrence in her reply declaration,
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`specifically at least paragraphs 31, 33, 36-37, 48-49, 51-52, and 73, and footnote 5,
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`evidence a complete lack of expertise in organic or medicinal chemistry and thus
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`Dr. Lawrence is not qualified by knowledge, skill, experience, training or
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`education necessary to form an opinion. Patent Owner further objects to Exhibit
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`1174 and 1176, upon which Dr. Lawrence relies on for her unqualified opinions in
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`Case IPR2015-01099 (Patent 8,669,290)
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`paragraphs 36 and 48, as irrelevant, untimely, prejudicial and objectionable under
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`FRE 402 and FRE 403.
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`Patent Owner objects to Exhibit 1122 (Reply Declaration of Ivan Hofmann)
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`under FRE 702 and 37 C.F.R. § 42.65 because the opinions offered by Ivan
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`Hofmann in his reply declaration, specifically at least paragraphs 25-27, 42, 59-60,
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`62, 69-70, 72-80, 86-87, 99, 102, and 110, discuss subject matter beyond
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`economics for which Mr. Hofmann is not qualified by knowledge, skill,
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`experience, training or education necessary to form an opinion.
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`Patent Owner also objects to Exhibits 1096, 1097, 1098, 1100, 1101, 1102,
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`1172, and 1173, which Dr. Lawrence discusses in detail in Exhibit 1094 in
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`paragraphs 31, 33 and 37, and footnote 5, in support of her new testimony that
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`tyloxapol is allegedly an antioxidant. Patent Owner further objects to Exhibit
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`1169, which Dr. Lawrence discusses in paragraph 29 of Exhibit 1094, in support of
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`her new testimony that tyloxapol is allegedly less toxic to ocular membranes.
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`Patent Owner further objects to Exhibits 1170 and 1171, which Dr. Lawrence
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`discusses in Exhibit 1094 in paragraph 31, in support of her new testimony that the
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`specific NSAIDs diclofenac and ketorolac are allegedly subject to oxidative
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`degradation. Exhibits 1096, 1097, 1098, 1100, 1101, 1102, 1169, 1170, 1171,
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`1172, and 1173 all lack relevance (FRE 402), as they exceed the proper scope of
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`Case IPR2015-01099 (Patent 8,669,290)
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`Petitioners’ Reply. See 37 C.F.R. § 42.23(b); 77 Fed. Reg. 48767. Patent Owner
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`further objects to these Exhibits because of the prejudice resulting from Patent
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`Owner’s inability to respond to the untimely evidence therein (FRE 403).
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`Patent Owner objects to Exhibits 1107, 1108, and 1109, which Petitioners
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`use to allegedly support a new argument in Petitioners’ Reply (Paper Nos. 32 &
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`34) that a person of ordinary skill in the art would expect switching polysorbate 80
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`with tyloxapol to improve preservative efficacy because polysorbate 80 allegedly
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`was known to neutralize BAC. Patent Owner also objects to Exhibits 1179 and
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`1180, which Dr. Lawrence discusses in Exhibit 1094 in paragraph 80, in support of
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`her new testimony that it was allegedly understood in the art that using too much
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`non-ionic surfactant could reduce the effectiveness of BAC, which would have
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`allegedly informed the person of ordinary skill in the art that lower levels of
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`surfactant would be effective and expected. Exhibits 1107, 1108, 1109, 1179, and
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`1180 lack relevance (FRE 402), as they exceed the proper scope of Petitioners’
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`Reply. See 37 C.F.R. § 42.23(b); 77 Fed. Reg. 48767. Patent Owner further
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`objects to these Exhibits because of the prejudice resulting from Patent Owner’s
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`inability to respond to the untimely evidence therein (FRE 403).
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`Date: April 29, 2016
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`By: /Bryan C. Diner/
`Bryan C. Diner, Lead Counsel
`Registration No. 32,409
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`Case IPR2015-01099 (Patent 8,669,290)
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`Justin J. Hasford, Backup Counsel
`Registration No. 62,180
`Joshua L. Goldberg, Back-up Counsel
`Reg. No. 59,369
`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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`Case IPR2015-01099 (Patent 8,669,290)
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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 April 29, 2016,
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`and served via email directed to counsel of record for the Petitioner at the
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`following:
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`Deborah Yellin
`dyellin@crowell.com
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`Jonathan Lindsay
`jlindsay@crowell.com
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`Teresa Stanek Rea
`TRea@crowell.com
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`Chiemi Suzuki
`CSuzuki@crowell.com
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`/Lisa C. Hines/
`Lisa C. Hines
`Litigation Clerk
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, LLP
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`Date: April 29, 2016
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