Paper No. ____
`Filed: April 11, 2016
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`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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`PATENT OWNER’S REPLY IN SUPPORT OF ITS
`MOTION TO EXCLUDE EVIDENCE UNDER 37 C.F.R. § 42.64(c)
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`1IPR2015-01871 has been joined with this proceeding.
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` SENJU PHARMACEUTICAL CO., LTD.,
`Patent Owner
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`_________________
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`Case IPR2015-00903 (Patent 8,129,431 B2)1
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`Filed: April 11, 2016
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`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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`PATENT OWNER’S REPLY IN SUPPORT OF ITS
`MOTION TO EXCLUDE EVIDENCE UNDER 37 C.F.R. § 42.64(c)
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`1IPR2015-01871 has been joined with this proceeding.
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` SENJU PHARMACEUTICAL CO., LTD.,
`Patent Owner
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`_________________
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`Case IPR2015-00903 (Patent 8,129,431 B2)1
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`Case IPR2015-00903 (Patent 8,129,431 B2)
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`TABLE OF CONTENTS
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`Dr. Laskar Is Not Qualified to Offer Opinions on Organic or
`Medicinal Chemistry, and Those Opinions Should Thus Be Excluded .......... 1
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`Dr. Laskar’s Reply Declaration and Supporting Exhibits Exceed the
`Proper Scope of Petitioner’s Reply under 37 C.F.R. § 42.23(b), Lack
`Relevance under FRE 402 and are Prejudicial Under FRE 403 ..................... 3
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`I.
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`II.
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`III. Dr. Laskar’s Testimony on Redirect After Consultation with
`Petitioner’s Counsel Should Be Excluded ....................................................... 5
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`IV. Conclusion ....................................................................................................... 5
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`ii
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`Case IPR2015-00903 (Patent 8,129,431 B2)
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`Dr. Laskar candidly conceded on cross examination that he is not an expert
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`in medicinal or organic chemistry, including antioxidant chemistry. (EX2272 at
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`20:17-21:5.) Dr. Laskar further conceded that the formulations of the ’431 patent
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`(EX1001) as well as the formulations of Yasueda (EX1012) that contain tyloxapol
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`“do not contain any traditional antioxidant or compound that functions in an
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`antioxidant capacity.” (EX2272 at 68:20-69:7.) Dr. Laskar’s candid concessions
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`eviscerate his credibility and render all of his testimony regarding chemistry issues,
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`including his unsupported assertions that tyloxapol allegedly is an antioxidant in
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`the ophthalmic formulations at issue, irrelevant as a matter of law. The Board
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`accordingly should grant Patent Owner’s motion to exclude.
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`I. Dr. Laskar Is Not Qualified to Offer Opinions on Organic or Medicinal
`Chemistry, and Those Opinions Should Thus Be Excluded
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`Dr. Laskar readily admits that he is not an expert in medicinal or organic
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`chemistry, including antioxidant chemistry. (EX2272, 20:17-21:5.) This should
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`end the inquiry. Yet Dr. Laskar nonetheless attempts to testify about matters
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`within these highly complex, specialized chemistry fields in which he admits he is
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`not an expert. The Board thus should exclude Dr. Laskar’s opinions in these areas.
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`Petitioner half-heartedly attempts to salvage Dr. Laskar’s testimony by
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`relying on dicta in Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356
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`(Fed. Cir. 2008), and arguing that Dr. Laskar is a person of ordinary skill in the
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`1
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`Case IPR2015-00903 (Patent 8,129,431 B2)
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`pharmaceutical sciences. This misses the point entirely. Dr. Laskar admittedly has
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`no qualifications in the pertinent chemical arts, including antioxidant chemistry,
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`and the holding of Sundance makes clear that his testimony on these issues is thus
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`inadmissible as a matter of law. Id. at 1364 (reversing district court and excluding
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`unqualified expert testimony, noting “[n]or may a witness not qualified in the
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`pertinent art testify as an expert on obviousness, or any of the underlying technical
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`questions, such as the nature of the claimed invention, what a prior art reference
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`discloses, or whether the asserted claims read on the prior art reference”).
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`While the Board has recognized that it “need not find a complete overlap”
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`between an expert’s qualifications and the field of endeavor, CaptionCall, LLC v.
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`Ultratech, Inc., IPR2013-00550, Paper 57 at 11, the Federal Circuit in Sundance
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`makes clear that an expert may not offer an opinion in an area in which the expert
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`lacks qualification. Petitioner’s reliance on Motorola Mobility, LLC v. Intellectual
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`Ventures I, LLC, CBM2015-00004, Paper 33, is likewise misplaced, because in
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`that case, an expert in electrical engineering having experience in computer
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`programming was found to “align sufficiently” with claims directed to software for
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`use on a user station. Id. at 10. Dr. Laskar, in contrast, admittedly has no expertise
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`in medicinal or organic chemistry, including the antioxidant chemistry issues about
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`which he opines. Accordingly, Dr. Laskar’s opinions involving medicinal and
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`organic chemistry, including antioxidant chemistry, should be excluded.
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`2
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`Case IPR2015-00903 (Patent 8,129,431 B2)
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`II. Dr. Laskar’s Reply Declaration and Supporting Exhibits Exceed the
`Proper Scope of Petitioner’s Reply Under 37 C.F.R. § 42.23(b), Lack
`Relevance Under FRE 402 and Are Prejudicial Under FRE 403
`Petitioner spends a full eight pages of its opposition inaccurately contending
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`that Dr. Laskar’s opinions should be admitted because they allegedly establish that
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`tyloxapol is an antioxidant in ophthalmic formulations. Petitioner is entirely
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`wrong. Notwithstanding that Dr. Laskar admittedly has no expertise to offer these
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`new opinions, Dr. Laskar candidly conceded on cross examination that these new
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`opinions are not even accurate. Indeed, Dr. Laskar admitted that the formulations
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`of the ’431 patent (EX1001) as well as the formulations of Yasueda (EX1012) that
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`contain tyloxapol “do not contain any traditional antioxidant or compound that
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`functions in an antioxidant capacity.” (EX2272 at 68:20-69:7 (emphasis added).)
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`Dr. Laskar’s candid concession wholly undermines his credibility and establishes
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`the irrelevance—and thus inadmissibility—of his opinions to the contrary.
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`Faced with this fatal concession, Petitioner does not deny that neither its
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`petition nor Dr. Laskar’s opening declaration mentions any alleged antioxidant
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`properties of tyloxapol or any alleged motivation to substitute tyloxapol for
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`polysorbate 80 in Ogawa (EX1004) based on any purported antioxidant properties.
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`Rather, Petitioner wholly mischaracterizes Dr. Laskar’s first cross examination, in
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`which Dr. Laskar only referred to BHT and EDTA as antioxidants and never once
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`referred to tyloxapol as an antioxidant. (EX2114 at 157:2-22, 160:18-162:20.)
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`3
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`Case IPR2015-00903 (Patent 8,129,431 B2)
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`Petitioner repeatedly disparages Dr. Davies, suggesting that he allegedly
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`should have “looked up” whether tyloxapol is an antioxidant. Paper 66 at 7, 11.
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`Dr. Davies did just that, and Dr. Davies confirmed that tyloxapol does not have
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`any antioxidant properties in ophthalmic formulations such as those of the ’431
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`patent, distinguishing the new references on which Dr. Laskar relies. (EX2272 at
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`134:15-139:19.) Tellingly, Dr. Laskar never asked Petitioner’s counsel if Dr.
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`Davies had expressed any such opinions contradicting Dr. Laskar’s unsupported
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`opinions regarding the oxidation properties of tyloxapol. (Id. at 139:14-19.)
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`Petitioner further blatantly mischaracterizes the prior art, inaccurately stating
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`that the art allegedly “teaches that tyloxapol falls in the class of alkylphenol
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`compounds” of Doi (EX2025). Paper 66 at 6. Nothing could be further from the
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`truth. Indeed, Dr. Laskar candidly concedes that the alkylphenol compounds of
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`Doi contain an –OH group directly attached to their phenyl ring—hence their
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`“phenol” designation—whereas tyloxapol does not. (EX2272 at 47:2-4, 91:9-15.)
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`And Dr. Laskar freely admits that “tyloxapol is not included as an excipient in any
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`of the example formulations” of Doi (id. at 90:13-19), further underscoring the
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`unreliability and thus inadmissibility of his baseless opinions to the contrary.
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`Petitioner additionally contends that Dr. Laskar 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. Paper No. 66 at 8. Petitioner completely ignores that
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`4
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`Case IPR2015-00903 (Patent 8,129,431 B2)
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`Patent Owner moves to exclude Dr. Laskar’s new antioxidant argument and
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`evidence precisely because Petitioner never provided in its petition or in Dr.
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`Laskar’s initial declaration any motivation why a POSA would substitute tyloxapol
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`for polysorbate 80 in Ogawa based on any alleged antioxidant properties. This
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`new argument on motivation, which is a necessary element of Petitioner’s case-in-
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`chief, accordingly is an improper reply argument and should be excluded.
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`III. Dr. Laskar’s Testimony on Redirect After Consultation with
`Petitioner’s Counsel Should Be Excluded
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`Patent Owner does not move to exclude Dr. Laskar’s testimony on redirect
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`because of coaching by Petitioner’s counsel, nor does Patent Owner “implicit[ly]
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`suggest[]”, Paper 66 at 14, that such coaching may have occurred. Rather, Patent
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`Owner’s argument is that Dr. Laskar was non-responsive and inconsistent during
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`cross-examination, yet freely talkative on redirect after the break. As a result, Dr.
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`Laskar’s redirect testimony should be excluded as prejudicial under FRE 403.
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`IV. Conclusion
`For the reasons discussed herein and in Patent Owner’s opening brief, Patent
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`Owner respectfully requests that the Board grant its motion to exclude.
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`Date: April 11, 2016
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`By: /Bryan C. Diner/
`Bryan C. Diner, Lead Counsel
`Registration No. 32,409
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`5
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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 REPLY IN SUPPORT OF ITS MOTION TO EXCLUDE UNDER
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`37 C.F.R. § 42.64(C) was served on April 11, 2016, via email directed to counsel
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`of record for the Petitioner at the 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
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`Shannon Lentz
`slentz@crowell.com
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`/Bradley J. Moore/
`Bradley J. Moore
`Litigation Legal Assistant
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
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`Dated: April 11, 2016
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`6
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