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