IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
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`Paper No. ____
`Filed: April 29, 2016
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`LUPIN LTD. and LUPIN PHARMACEUTICALS INC., INNOPHARMA
`LICENSING, INC., INNOPHARMA LICENSING LLC, INNOPHARMA
`INC., INNOPHARMA LLC, MYLAN PHARMACEUTICALS INC., and
`MYLAN INC.
`Petitioner
`v.
`
` SENJU PHARMACEUTICAL CO., LTD.
`Patent Owner
`__________________
`Case IPR2015-01097 (Patent 8,754,131 B2) 1
`Case IPR2015-01100 (Patent 8,927,606 B1) 2
` Case IPR2015-01105 (Patent 8,871,813 B2) 3, 4
`__________________
`
`PATENT OWNER’S OBJECTIONS
`UNDER 37 C.F.R. § 42.64(B)(1)
`
`
`
`
`1 Case IPR2016-00089 has been joined with this proceeding.
`
`2 Case IPR2016-00091 has been joined with this proceeding.
`
`3 Case IPR2016-00090 has been joined with this proceeding.
`
`4 A word-for-word identical paper has been filed in each proceeding identified in
`
`the heading.
`
`
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`
`
`
`
`
`
`
`
`
`
`
`
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`
`
`
`
`Paper No. ____
`Filed: April 29, 2016
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`LUPIN LTD. and LUPIN PHARMACEUTICALS INC., INNOPHARMA
`LICENSING, INC., INNOPHARMA LICENSING LLC, INNOPHARMA
`INC., INNOPHARMA LLC, MYLAN PHARMACEUTICALS INC., and
`MYLAN INC.
`Petitioner
`v.
`
` SENJU PHARMACEUTICAL CO., LTD.
`Patent Owner
`__________________
`Case IPR2015-01097 (Patent 8,754,131 B2) 1
`Case IPR2015-01100 (Patent 8,927,606 B1) 2
` Case IPR2015-01105 (Patent 8,871,813 B2) 3, 4
`__________________
`
`PATENT OWNER’S OBJECTIONS
`UNDER 37 C.F.R. § 42.64(B)(1)
`
`
`
`
`1 Case IPR2016-00089 has been joined with this proceeding.
`
`2 Case IPR2016-00091 has been joined with this proceeding.
`
`3 Case IPR2016-00090 has been joined with this proceeding.
`
`4 A word-for-word identical paper has been filed in each proceeding identified in
`
`the heading.
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Patent Owner objects to Exhibits 1094
`
`and 1122, served with Petitioners’ Reply (Paper Nos. 35 & 37 (Confidential
`
`Version)). Patent Owner objects to Exhibit 1094 (Reply Declaration of M. Jayne
`
`Lawrence, Ph.D.) because portions of the Exhibit lack relevance (FRE 402), as
`
`they exceed the proper scope of Petitioners’ Reply. 37 C.F.R. § 42.23(b) states
`
`“[a] reply may only respond to arguments raised in the corresponding . . . patent
`
`owner response.” As explained in the Trial Practice Guide, “new evidence
`
`necessary to make out a prima facie case for [] unpatentability” and “new evidence
`
`that could have been presented in a prior filing” are improper. 77 Fed. Reg. 48767.
`
`“[A] reply that raises a new issue or belatedly presents evidence will not be
`
`considered and may be returned.” Id. For instance, paragraphs 29, 31-33, 37-38,
`
`40, and 80, as well as footnote 5, of Exhibit 1094 are all directed to new testimony
`
`from Dr. Lawrence that tyloxapol is allegedly an antioxidant (¶¶ 31-33, 37-38, and
`
`footnote 5); the specific NSAIDs diclofenac and ketorolac are allegedly subject to
`
`oxidative degradation (¶ 31); tyloxapol is allegedly less toxic to the ocular
`
`membranes (¶ 29); and that too much non-ionic surfactant, specifically polysorbate
`
`80, allegedly reduces the effectiveness of benzalkonium chloride (¶ 80). That
`
`Petitioner knew bromfenac degraded by oxidation and that this new testimony
`
`regarding the alleged use of an antioxidant could have been previously presented is
`
`
`
`2
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`confirmed and recognized in Dr. Lawrence’s initial declaration (EX1005), where at
`
`¶ 66(e) it states that stabilizers, such as antioxidants, are added to ophthalmic
`
`formulations to decrease the decomposition of the active ingredient and that
`
`Ogawa Example 6 uses the stabilizer sodium sulfite (EX1005, ¶186, last sentence),
`
`a well-known antioxidant.
`
`Patent Owner further objects to Exhibit 1094 because of the prejudice
`
`resulting from Patent Owner’s inability to respond to the untimely evidence and
`
`arguments therein (FRE 403). As explained above, at least paragraphs 29, 31-33,
`
`37-38, 40, 80, and footnote 5, of Exhibit 1094, containing Dr. Lawrence’s new
`
`testimony, exceed the proper scope of Petitioners’ Reply and are thus irrelevant,
`
`untimely, prejudicial, and objectionable under FRE 402 and FRE 403.
`
`Patent Owner further objects to Exhibit 1094 under FRE 702 and 37 C.F.R.
`
`§ 42.65 because the opinions offered by Dr. Lawrence in her reply declaration,
`
`specifically at least paragraphs 31, 33, 36-37, 48-49, 51-52, and 73, and footnote 5,
`
`evidence a complete lack of expertise in organic or medicinal chemistry and thus
`
`Dr. Lawrence is not qualified by knowledge, skill, experience, training or
`
`education necessary to form an opinion. Patent Owner further objects to Exhibit
`
`1174 and 1176, upon which Dr. Lawrence relies on for her unqualified opinions in
`
`
`
`3
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`paragraphs 36 and 48, as irrelevant, untimely, prejudicial and objectionable under
`
`FRE 402 and FRE 403.
`
`Patent Owner objects to Exhibit 1122 (Reply Declaration of Ivan Hofmann)
`
`under FRE 702 and 37 C.F.R. § 42.65 because the opinions offered by Ivan
`
`Hofmann in his reply declaration, specifically at least paragraphs 25-27, 42, 59-60,
`
`62, 69-70, 72-80, 86-87, 99, 102, and 110, discuss subject matter beyond
`
`economics for which Mr. Hofmann is not qualified by knowledge, skill, experience,
`
`training or education necessary to form an opinion.
`
`Patent Owner also objects to Exhibits 1096, 1097, 1098, 1100, 1101, 1102,
`
`1172, and 1173, which Dr. Lawrence discusses in detail in Exhibit 1094 in
`
`paragraphs 31, 33 and 37, and footnote 5, in support of her new testimony that
`
`tyloxapol is allegedly an antioxidant. Patent Owner further objects to Exhibit 1169,
`
`which Dr. Lawrence discusses in paragraph 29 of Exhibit 1094, in support of her
`
`new testimony that tyloxapol is allegedly less toxic to ocular membranes. Patent
`
`Owner further objects to Exhibits 1170 and 1171, which Dr. Lawrence discusses in
`
`Exhibit 1094 in paragraph 31, in support of her new testimony that the specific
`
`NSAIDs diclofenac and ketorolac are allegedly subject to oxidative degradation.
`
`Exhibits 1096, 1097, 1098, 1100, 1101, 1102, 1169, 1170, 1171, 1172, and 1173
`
`all lack relevance (FRE 402), as they exceed the proper scope of Petitioners’ Reply.
`
`
`
`4
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`See 37 C.F.R. § 42.23(b); 77 Fed. Reg. 48767. Patent Owner further objects to
`
`these Exhibits because of the prejudice resulting from Patent Owner’s inability to
`
`respond to the untimely evidence therein (FRE 403).
`
`Patent Owner objects to Exhibits 1107, 1108, and 1109, which Petitioners
`
`use to allegedly support a new argument in Petitioners’ Reply (Paper Nos. 32 &
`
`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
`
`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
`
`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
`
`allegedly informed the person of ordinary skill in the art that lower levels of
`
`surfactant would be effective and expected. Exhibits 1107, 1108, 1109, 1179, and
`
`1180 lack relevance (FRE 402), as they exceed the proper scope of Petitioners’
`
`Reply. See 37 C.F.R. § 42.23(b); 77 Fed. Reg. 48767. Patent Owner further
`
`objects to these Exhibits because of the prejudice resulting from Patent Owner’s
`
`inability to respond to the untimely evidence therein (FRE 403).
`
`Dated: April 29, 2016
`
`
`
`
`
`
`
`By: /Bryan C. Diner/
`
`Bryan C. Diner, Lead Counsel
`Reg. No. 32,409
`
`
`
`
`
`
`
`
`5
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`
`Justin J. Hasford, Back-up Counsel
`Reg. No. 62,180
`Joshua L. Goldberg, Back-up Counsel
`Reg. No. 59,369
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, L.L.P.
`901 New York Ave. NW
`Washington, DC 20001-4413
`Telephone: (202) 408-4000
`
`Counsel for Patent Owner
`
`
`
`
`
`6
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing Patent
`
`Owner’s Objections Under 37 C.F.R. § 42.64(B)(1) were served on April 29,
`
`2016, via email directed to counsel of record for the Petitioner at the following:
`
`Deborah Yellin
`DYellin@crowell.com
`
`Jonathan Lindsay
`JLindsay@crowell.com
`
`Teresa Stanek Rea
`TRea@crowell.com
`
`Chiemi Suzuki
`CSuzuki@crowell.com
`
`Jitendra Malik
`jitty.malik@alston.com
`
`Bryan Skelton, Ph.D.
`Bryan.skelton@alston.com
`
`Lance Soderstrom
`Lance.soderstrom@alston.com
`
`Hitetada James Abe
`James.abe@alston.com
`
`Joseph M. Janusz
`Joe.janusz@alston.com
`
`
`
`
`7
`
`
`
`
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`Date: April 29, 2016
`
`/Lisa C. Hines/
`Lisa C. Hines
`Litigation Clerk
`Finnegan, Henderson, Farabow, Garrett &
`Dunner, LLP
`
`
`
`
`
`
`
`8
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