`Filed: May 23, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
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`LUPIN LTD. and LUPIN PHARMACEUTICALS INC.
`Petitioners,
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD.
`Patent Owner.
`
`__________________
`
`IPR2015-01097 (US Patent No. 8,751,131)
`IPR2015-01099 (US Patent No. 8,669,290)
`IPR2015-01100 (US Patent No. 8,927,606)
`IPR2015-01105 (US Patent No. 8,871,813)1
`__________________
`
`
`
`PATENT OWNER’S REPLY IN SUPPORT OF ITS MOTION TO
`EXCLUDE EVIDENCE UNDER 37 C.F.R. § 42.64(c)
`
`1 The word-for-word identical paper is filed in each proceeding identified in the
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`heading. IPR2016-00089 has been joined with IPR2015-01097; IPR2016-00091
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`has been joined with IPR2015-01100; and IPR2016-00090 has been joined with
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`IPR2015-01105.
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` Each of
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`these
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`joined proceedings
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`includes Petitioners
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`InnoPharma Licensing, Inc., InnoPharma Licensing LLC, InnoPharma Inc., Mylan
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`Pharmaceuticals Inc., and Mylan Inc. (collectively, “InnoPharma”) in addition to
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`the parties identified above.
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`
`
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`I.
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`II.
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`TABLE OF CONTENTS
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`Dr. Lawrence Is Not Qualified to Offer Opinions on Organic or
`Medicinal Chemistry, and Those Opinions Should Thus Be Excluded .......... 1
`
`Dr. Lawrence’s Reply Declaration and Supporting Exhibits Exceed
`the Proper Scope of Petitioners’ Reply, Lack Relevance and Are
`Prejudicial ........................................................................................................ 3
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`III. Mr. Hofmann is Not Credible Or Qualified to Provide Any Opinions ........... 5
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`IV. Conclusion ....................................................................................................... 5
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`
`
`ii
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`
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`I.
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`Dr. Lawrence Is Not Qualified to Offer Opinions on Organic or
`Medicinal Chemistry, and Those Opinions Should Thus Be Excluded
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`On multiple occasions, Dr. Lawrence has candidly admitted that she is not
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`an expert in organic chemistry or medicinal chemistry, including antioxidant
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`chemistry. (EX2342, 9:16-11:20; EX2326, 411:7-16.) In a moment of candor, Dr.
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`Lawrence herself characterized her chemistry as “rusty.” (EX2316, 289:3-4.) She
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`was also completely incapable of answering basic chemistry questions regarding
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`the chemical structure of tyloxapol, which was depicted in her own reply
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`declaration. (EX2342, 222:10-21.) Dr. Lawrence’s forthright concessions and
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`inability to answer basic questions eviscerate her credibility and render all her
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`testimony regarding chemistry issues, including her unsupported assertions that
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`tyloxapol is allegedly an antioxidant in the ophthalmic formulations at issue,
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`irrelevant as a matter of law. Her admissions alone should end the inquiry. Yet Dr.
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`Lawrence attempts to testify about matters within these highly complex,
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`specialized chemistry fields, in particular antioxidant chemistry, in which she
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`admits she is not an expert. Accordingly, the Board should exclude Dr.
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`Lawrence’s opinions in these areas or, at the very least, afford them little weight.
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`Petitioners half-heartedly attempt to salvage Dr. Lawrence’s deficient
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`testimony by arguing that she is a person of ordinary skill in the art of
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`pharmaceutical sciences. Whether she is an expert in pharmaceutical sciences
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`misses the point entirely, because the skilled person encompasses multiple skills,
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`
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`1
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`
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`which also encompasses chemistry, particularly organic and medicinal chemistry.
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`The question thus is whether she is an expert in a subject matter directly at issue in
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`these proceedings—medicinal and organic chemistry—not a person of ordinary
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`skill in pharmaceutical sciences. Dr. Lawrence admittedly has no qualifications in
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`the pertinent chemical arts, including antioxidant chemistry, and the holding of
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`Sundance, Inc. v. DeMonte Fabricating Ltd. makes clear that her testimony on
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`these issues is thus inadmissible as a matter of law. 550 F.3d 1356, 1364 (Fed. Cir.
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`2008).
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`Petitioners falsely assert that Patent Owner made no effort to determine Dr.
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`Lawrence’s understanding of the chemistry issues in these proceedings. To the
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`contrary, Patent Owner extensively questioned Dr. Lawrence on organic and
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`medicinal chemistry issues and, not surprisingly, found that she completely lacks
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`expertise in these areas. (E.g., EX2342, 222:10-21.) She could not even answer
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`simple questions regarding tyloxapol’s chemical structure. (Id.) Indeed, it has
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`been Petitioners, not Patent Owner, who have repeatedly attempted to shield Dr.
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`Lawrence from organic and medicinal chemistry issues. During cross examination,
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`Petitioners repeatedly objected to questions about these issues as “outside the
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`scope.” (EX2316, 90:5-13; 92:8-14; 101:9-102:3; 169:9-17.) And in the district
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`court trial, Petitioners purposely limited Dr. Lawrence’s testimony to “very, very
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`
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`2
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`
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`basic chemistry” 2 not organic or medicinal chemistry. (EX2326, 196:19-22;
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`197:23-198:5.) Dr. Lawrence admittedly has no expertise in medicinal or organic
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`chemistry, including the antioxidant chemistry issues about which she opines.
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`Accordingly, Dr. Lawrence’s opinions involving medicinal and organic chemistry,
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`including antioxidant chemistry, should be excluded or afforded little weight.
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`II. Dr. Lawrence’s Reply Declaration and Supporting Exhibits Exceed the
`Proper Scope of Petitioners’ Reply, Lack Relevance and Are Prejudicial
`Petitioners devote eight pages of their opposition inaccurately contending
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`that Dr. Lawrence’s opinions should be admitted because they allegedly establish
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`that tyloxapol is an antioxidant in ophthalmic formulations. Petitioners are wrong.
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`Notwithstanding Dr. Lawrence’s lack of expertise to offer these new opinions, she
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`acknowledged
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`that partially reduced O2 species, hydroxyl radicals, and
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`hypochlorous acid are not oxygen and are not present in the ophthalmic
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`formulations claimed in the patents at issue. (EX2342, 234:6-18; 234:20-253:2.)
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`All the references on which Dr. Lawrence now relies for her brand new opinions
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`discuss the use of tyloxapol to prevent biologic injury from these compounds and
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`are therefore completely irrelevant to bromfenac’s oxidative degradation caused by
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`O2. Dr. Lawrence’s candid concessions wholly undermine her credibility and
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`2 Patent Owner never expressed satisfaction with Dr. Lawrence’s qualifications
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`with respect to medicinal and organic chemistry. (EX2326, 197:23-198:1.)
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`
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`3
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`
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`confirm the irrelevance, and thus inadmissibility, of her opinions.
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`
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`Neither the Petition nor Dr. Lawrence’s opening declaration mentions any
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`alleged antioxidant properties of tyloxapol or any alleged motivation to substitute
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`tyloxapol for polysorbate 80 in Ogawa based on any purported antioxidant
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`properties. Instead, because they did not counter proffer a chemistry expert, they
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`resort to disparaging Dr. Davies—an actual expert in organic and medicinal
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`chemistry—suggesting that he should have looked up whether tyloxapol is an
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`antioxidant. Dr. Davies did just that and confirmed that tyloxapol does not have
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`any antioxidant properties in the ophthalmic formulations of the patents at issues,
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`distinguishing the new references on which Dr. Lawrence relies. (EX2344, ¶ 29.)
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`Petitioners additionally contend that Dr. Lawrence merely replies to Patent
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`Owner’s responsive arguments that a POSA would know that bromfenac degrades
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`by oxidative degradation. They completely ignore that Patent Owner moves to
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`exclude Dr. Lawrence’s new antioxidant argument and evidence precisely because
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`Petitioners never provided in its petition or in Dr. Lawrence’s initial declaration
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`any motivation why a POSA would substitute tyloxapol for polysorbate 80 in
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`Ogawa based on any alleged antioxidant properties. Moreover, Petitioners and Dr.
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`Lawrence knew that bromfenac degraded by oxidation, and thus could have
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`presented this argument in their petition. Their attempt to present a new argument
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`on motivation, which is a necessary element of their case-in-chief, is entirely
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`4
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`improper and should not be countenanced. Thus, Petitioners’ new motivation
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`argument that they attempt to disguise as a “reply argument” should be excluded.
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`III. Mr. Hofmann is Not Credible Or Qualified to Provide Any Opinions
`As Petitioners admit, Mr. Hofmann has absolutely no technical or medical
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`expertise. Petitioners try to brush these issues aside, however, by asserting that he
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`was merely providing his “technical understandings,” not opinions. This is simply
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`untrue, as evidenced by Mr. Hofmann’s reply declaration. (E.g., EX1122, ¶¶ 72-
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`80.) Moreover, Mr. Hofmann’s improper behavior during cross examination is
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`plainly evident from the transcript. (E.g., EX2343, 46:10-48:8.) Indeed, Mr.
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`Hofmann repeatedly refused to answer questions and was repeatedly impeached.
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`(Id. at 11:13-13:6; 13:16-14:19; 23:10-25:1; 55:9-56:7; 57:6-13; 95:12-96:6;
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`106:16-110:4.) His opinions have been repeatedly disregarded and discredited by
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`district courts. (Id. at 35:3-37:21; 41:11-43:18; 45:20-48:17). In sum, Mr.
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`Hofmann wholly lacks credibility and technical expertise to provide any opinions
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`in these proceedings. Accordingly, Mr. Hofmann’s opinions should be excluded.
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`IV. Conclusion
`Patent Owner respectfully requests the Board grant its Motion to Exclude.
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`Date: May 23, 2016
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`5
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`Respectfully submitted,
`
`By: /Bryan C. Diner/
`
`Bryan C. Diner, Lead Counsel
`Reg. No. 32,409
`Counsel for Patent Owner
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`
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`
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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 Reply In Support of its Motion to Exclude Evidence Under 37 C.F.R.
`
`§ 42.64(c) was filed on May 23, 2016, and served via email directed to counsel of
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`record for the Petitioners at the following:
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`
`
`
`
`Deborah Yellin
`dyellin@crowell.com
`
`Jonathan Lindsay
`jlindsay@crowell.com
`
`Teresa Stanek Rea
`TRea@crowell.com
`
`Chiemi Suzuki
`CSuzuki@crowell.com
`
`Shannon Lentz
`Slentz@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
`
`
`
`
`
`
` /Bradley J. Moore/
`Bradley J. Moore
`Litigation Legal Assistant
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`
`
`Dated: May 23, 2016