Paper No. __
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`INNOPHARMA LICENSING, INC., INNOPHARMA LICENSING LLC,
`INNOPHARMA INC., INNOPHARMA LLC,
`MYLAN PHARMACEUTICALS INC., MYLAN INC., LUPIN LTD., and LUPIN
`PHARMACEUTICALS, INC.,
`Petitioner,
`
`v .
`
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`Patent Owner.
`__________________
`
`Case IPR2015-00903 (Patent 8,129,431)1
`__________________
`
`Filed: April 6, 2016
`__________________
`
`Petitioner’s Opposition to Patent Owner’ Motion to Exclude
`Under 37 C.F.R. § 42.64(c)
`
`
`
`
`
`1 IPR2015-01871 has been joined with IPR2015-00903.
`
`
`
`

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`
`
`TABLE OF CONTENTS
`
`I.
`
`Dr. Laskar is Qualified to Opine as an Expert in this Proceeding in
`Compliance with Fed. R. Evid. 702 ................................................................ 1
`
`A. Dr. Laskar Possesses the Qualifications of a POSA even under
`Patent Owner’s Definition ..................................................................... 2
`
`B.
`
`Patent Owner’s Attack on the Substance of Dr. Laskar’s
`Opinions Lacks Merit and is in Violation of the Board’s Own
`Rules ...................................................................................................... 5
`
`II.
`
`Dr. Laskar’s Reply Declaration And Supporting Exhibits are
`Admissible Under the Board’s and the Federal Rules .................................... 8
`
`A. Dr. Laskar’s Statements Relating to Tyloxapol’s Antioxidant
`Properties are a Direct Rebuttal to the Patent Owner’s Wrong
`Statement that Tyloxapol is an Oxidant ................................................ 9
`
`B.
`
`From the Beginning Patent Owner has Interjected Issues
`Relating to Oxidative Degradation ......................................................10
`
`III. Exhibits 1075, 1076, and 1098 Are Within the Proper Scope of a
`Reply ..............................................................................................................12
`
`IV. Patent Owner’s Arguments Regarding Excluding Dr. Laskar’s
`Redirect are Unjustified .................................................................................13
`
`V.
`
`Conclusion .....................................................................................................15
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`
`
`i
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`

`
`
`
`Cases
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Burton v. R.J. Reynolds Tobacco Co.,
`183 F. Supp. 2d 1308 (D. Kan. 2002) ................................................................... 4
`
`Captioncall, LLC v. Ultratec, Inc., IPR2013-00550, Paper No. 57
`(PTAB, Mar. 3, 2015) ........................................................................................... 1
`
`Chicago Mercantile Exchange, Inc., CBM2014-00114, Paper 35
`(PTAB, Aug. 18, 2015) ....................................................................................... 13
`
`Google Inc. and Apple Inc. v. Jongerius Panoramic Tech., LLC,
`IPR2013-00191, Paper 48 (PTAB, Feb. 6, 2014) ............................................... 14
`
`K40 Elecs., LLC v. Escort, Inc., IPR2013-00203, Paper 46 (PTAB
`Aug. 27, 2014) .................................................................................................... 14
`
`Laird Techs., Inc. v. Graftech Int’l Holdings, Inc.., IPR2014-00025,
`Paper No. 45 (PTAB, Mar. 25, 2015) ................................................................... 8
`
`Liberty Mutual Ins. Co. v. Progressive Casualty Ins. Co., CMB2012-
`00002, Paper No. 66 (PTAB, Jan. 23, 2014) ........................................................ 5
`
`Motorola Mobility, LLC v. Intellectual Ventures I, LLC, CMB2015-
`00004, Paper No. 33 11 (PTAB, Mar. 21, 2016) .................................................. 3
`
`Organik Kimya AS v. Rohm and Haas Co., IPR2014-00185, Paper 25
`(Aug. 21, 2014) ................................................................................................... 14
`
`Square, Inc. v. Unwired Planet, LLC,
`Case CBM2014-00156, Paper 40 (PTAB Dec. 22, 2015) .......................... 4, 8, 14
`
`Sundance, Inc. v. DeMonte Fabricating Ltd.,
`550 F.3d 1356 (Fed. Cir. 2008) ........................................................................ 1, 2
`
`Other Authorities
`
`37 C.F.R. § 42.64 ..................................................................................................... 15
`
`37 C.F.R. § 42.64(c) ............................................................................................... 1, 5
`
`
`
`ii
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`
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`77 Fed. Reg. 48756 .................................................................................................. 14
`77 Fed. Reg. 48756 ................................................................................................ .. 14
`
`Fed. R. Evid. 702 ................................................................................................... 1, 4
`Fed. R. Evid. 702 ................................................................................................. .. 1, 4
`
`iii
`iii
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`Pursuant to the Scheduling Order (Papers 17 at 4), Petitioner files its
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`Opposition to Patent Owner’s Motion to Exclude under 37 C.F.R. § 42.64(c).
`
`I.
`
`DR. LASKAR IS QUALIFIED TO OPINE AS AN EXPERT IN THIS
`PROCEEDING IN COMPLIANCE WITH FED. R. EVID. 702
`
`This panel has already found that “Dr. Laskar has significant experience in
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`the development and assessment of ophthalmic preparations” and that Dr. Laskar
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`has “the requisite familiarity with ophthalmic preparations to opine on the views of
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`a [POSA].” Decision to Institute, Paper 15 at 4, n.1. Furthermore, this panel has
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`already found Dr. Laskar’s testimony “credible and persuasive.” Id.
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`Yet, Patent Owner asserts that Dr. Laskar is somehow not qualified, ignoring
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`the fact that Dr. Laskar squarely falls within the definition of a POSA, including the
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`definition offered by Dr. Davies— Patent Owner’s own expert. Given Dr. Laskar
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`meets Dr. Davies’ definition, Patent Owner has completely failed to prove that Dr.
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`Laskar is not a person “qualified in the pertinent art.” Sundance, Inc. v. DeMonte
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`Fabricating Ltd., 550 F.3d 1356, 1363-64 (Fed. Cir. 2008); Captioncall, LLC v.
`
`Ultratec, Inc., IPR2013-00550, Paper No. 57, 10-11, n.4 (PTAB, Mar. 3, 2015)
`
`(distinguishing jury trials and stating the Board, “sitting as a non-jury tribunal with
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`administrative and technical expertise, is well-positioned to determine and assign
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`appropriate weight to evidence presented”).
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`1
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`

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`
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`A. Dr. Laskar Possesses the Qualifications of a POSA even under
`Patent Owner’s Definition
`
`Dr. Laskar has nearly 34 years of experience in formulating drug products
`
`and is still actively involved in this field. EX2272 at 22:1-4; EX 1053. Dr. Laskar
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`has a Ph.D. in Pharmaceutical Sciences, a Master’s of Science in Pharmacy and has
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`two (2) Bachelor’s degrees—one in Pharmacy, and another in “General Science
`
`(Chemistry, Biology).” EX1003 at ¶ 14. And unlike Patent Owner’s expert Dr.
`
`Davies, Dr. Laskar has actually worked with tyloxapol prior to his involvement in
`
`this proceeding and formulated preparations that include the NSAIDs (i.e.,
`
`diclofenac). EX2114 at 29:13-22, 30:18-21. Moreover, Dr. Laskar has been
`
`qualified by a court as an expert in the area of ophthalmic preparations. EX2114 at
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`31:21-25. Yet, Patent Owner claims that Dr. Laskar is not a POSA because Dr.
`
`Laskar’s allegedly “has no training or experience in organic or medicinal chemistry”
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`and “completely lacks expertise in organic and medicinal chemistry—the central
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`technology of this proceeding.” See Patent Owner’s Motion to Exclude, Paper 59 at
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`2, 7. Patent Owner’s assertions are meritless.
`
`Dr. Laskar is “qualified in the pertinent art,” Sundance, 550 F.3d at 1363-64,
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`even under Patent Owner’s definition of a POSA, which does not require a
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`background limited to organic or medicinal chemistry. Indeed, Dr. Davies, Patent
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`Owner’s own expert, states a POSA would have at least a Bachelor’s degree in a
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`field of science which includes “pharmaceutical sciences or a related discipline
`
`
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`2
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`
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`with about three to five years of work experience in this area, or a comparable level
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`of education and training.” EX2105, ¶ 41. As stated above, Dr. Laskar holds a
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`Ph.D. is pharmaceutical sciences. Accordingly, Patent Owner’s Motion is
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`contradicted by its own definition of a POSA. Dr. Laskar also is qualified under Dr.
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`Williams’s definition of a POSA. EX2082, ¶ 41 (“[A POSA] . . . would have at least
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`a Bachelor’s degree in fields such as pharmaceutical chemistry, chemistry, or a
`
`related discipline with about three to five years of work experience in this area, or
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`a comparable level of education and training.”); see also Patent Owner’s Response
`
`at 6.
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`In addition to Dr. Laskar’s rigorous educational training, Dr. Laskar has
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`nearly 34 years of experience formulating drug products. EX1003 at ¶¶ 13-16;
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`EX2272 at 22:1-4. Notably, Dr. Laskar has over ten years of experience at Allergan,
`
`Inc., which is a pharmaceutical company specializing in ophthalmic drug products;
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`nearly ten years of experience in management-level roles at Santen, Inc. where he
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`was responsible, inter alia, for ophthalmic formulation development and a variety
`
`of pharmaceutical testing; and several years’ experience as Senior Director of
`
`Pharmaceutical Development at a Merck-owned company where he filled a variety
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`of roles including supervision of formulation development. EX1003 at ¶¶ 13-16.
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`Even a cursory inspection of Dr. Laskar’s CV shows his wealth of experience in the
`
`subject matter of these patents. EX1053.
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`
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`3
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`
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`Accordingly, Dr. Laskar possesses the amount of education and work
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`experience that far exceeds the amount allegedly required even under Patent
`
`Owner’s definition of a POSA making him qualified to testify from the perspective
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`of a POSA. Accordingly, Dr. Laskar’s “qualifications align sufficiently with the
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`challenged subject matter . . . such that his knowledge is helpful in understanding
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`the evidence and determining facts in issue.” Motorola Mobility, LLC v. Intellectual
`
`Ventures I, LLC, CMB2015-00004, Paper No. 33, at 10-11 (PTAB, Mar. 21, 2016)
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`(refusing to disqualify an expert under Fed. R. Evid. 702).
`
`The balance of Patent Owner’s arguments attempting to persuade the Board
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`that Dr. Laskar is not a POSA are irrelevant. That Dr. Laskar is not a physician or
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`that since it has been some time since Dr. Laskar was a practicing pharmacist (and
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`further argument that Dr. Laskar is not a POSA because he has not dispensed certain
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`products as a pharmacist), are irrelevant since neither parties’ definition of a POSA
`
`contains such requirement. EX2082 at ¶ 41. Furthermore, Dr. Laskar’s alleged lack
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`of recent publications, recent presentations, and research experience on specific
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`products does not disqualify him as an expert. As the Board can appreciate, the fact
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`that Dr. Laskar has not published everything in his 34 year career is not surprising,
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`presumably because of the confidential nature of Dr. Laskar’s industrial work, nor
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`is there any requirement that he do so. Burton v. R.J. Reynolds Tobacco Co., 183 F.
`
`Supp. 2d 1308, 1315 (D. Kan. 2002) (“the fact that [an expert] has not published
`
`
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`4
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`
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`articles on the [subject matter] does not disqualify [him] from testifying about [the
`
`subject matter]”.).
`
`B.
`
`Patent Owner’s Attack on the Substance of Dr. Laskar’s Opinions
`Lacks Merit and is in Violation of the Board’s Own Rules
`
`The instant Motion represents yet another instance of Patent Owner’s
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`disregard for the Board’s directives denying a sur-reply. See EX1154. Just as Patent
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`Owner attempted to improperly backdoor sur-reply evidence into the record during
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`Dr. Laskar’s cross-examination, (See Paper 56), Patent Owner has used the instant
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`Motion as a vehicle by which to introduce similar arguments in violation of the
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`purpose of 37 C.F.R. § 42.64(c). Liberty Mutual Ins. Co. v. Progressive Casualty
`
`Ins. Co., CMB2012-00002, Paper No. 66, 61-62 (PTAB, Jan. 23, 2014) (holding that
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`“a motion to exclude . . . is not an opportunity to file a sur-reply, and also is not a
`
`mechanism to argue that a reply contains new arguments”).
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`For example, Patent Owner cloaks various arguments that it would have
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`included in a sur-reply in its Motion by manufacturing attacks on Dr. Laskar’s Reply
`
`Declaration (EX1104). Patent Owner’s attacks on Dr. Laskar rely on hearsay quotes
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`from its own expert’s reply report from a parallel district court proceeding, which
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`are not evidence of record and should be expunged from the record. See, e.g. Paper
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`59 at 5-6.
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`Moreover, Patent Owner’s attacks on the credibility of Dr. Laskar’s opinion
`
`are baseless. Patent Owner manufactures issues with a variety of Dr. Laskar’s well-
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`5
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`reasoned and properly-supported positions by misconstruing Dr. Laskar’s
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`statements. For example, Dr. Laskar stated that “[t]yloxapol belongs to the
`
`alkylphenol class of compounds because it is made from the alkylphenol p-(1,1,3,3-
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`tetramethybutyl) phenol also referred to p-tertiary-octylphenol,” (EX1104 at ¶ 17
`
`(emphasis added)), which is consistent with Dr. Davies’s testimony characterizing
`
`tyloxapol as being substituted octylphenols that has chains of polyoxyethylated
`
`groups, thus falling in the family of octylphenol surfactants that are ethoxylated. See
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`EX1061, 193:7-10, 193:22-194:11; EX1080, 56:10-57:1.
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`Indeed the prior art discusses tyloxapol as having an octylphenol nucleus or
`
`teaches that tyloxapol falls in the class of alkylphenol compounds. EX1091, 1:45-
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`61; EX1089, 9902, EX1106, 1415; EX1094, 1221:2:2-1222:1:1; see also EX1045,
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`1:33-34 (“Using an alkylphenol-formaldehyde-ethylene oxide condensation product
`
`such as Triton WR-1339 . . . .”). Indeed, the patent-at-issue, itself, describes
`
`tyloxapol as an “alkyl aryl polyether alcohol type polymer.” EX1001, 2:35-36.
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`Dr. Laskar’s opinion that polysorbate 80 is an oxidizing agent whereas
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`tyloxapol is an antioxidant is also supported by the facts.2 Dr. Laskar testified in his
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`first cross-examination that polysorbate 80 was known to contain peroxides (giving
`
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`2 Dr. Laskar never agreed that “polysorbate 80 is an antioxidant,” which is a
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`mischaracterization of Dr. Laskar’s opinions. Paper 59 at 5.
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`6
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`it its oxidant properties) whereas tyloxapol does not suffer from the same liability,
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`testifying in fact that it is an antioxidant. EX2114, 107:2-5, 157:18-22, 183:3-7;
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`EX1104 at ¶¶5-7. As an experienced formulator, Dr. Laskar was aware of this
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`property of polysorbate 80, and Dr. Laskar in his reply declaration merely pointed
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`out Dr. Davies’s agreed with him with respect to at least polysorbate 80. EX1104 at
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`¶¶ 4-5. Dr. Laskar’s testimony that tyloxapol has antioxidant properties is credible
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`and based on prior art references and experimental data on point that directly discuss
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`tyloxapol’s antioxidant properties. EX1104 at ¶ 10; EX2272, 78:18-20.
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`Indeed, Patent Owner’s argument only magnifies the unreliable opinion Dr.
`
`Davies provides in support of his assertion that tyloxapol is an oxidant. Dr. Davies
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`relies on Donbrow (EX2097), which does not relate to tyloxapol and focuses on
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`polysorbate 20. See EX1104 at ¶ 11; EX2272, 81:14- 82:7. Similarly, Dr. Davies
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`relies on Emanuel (EX2120), which also does not relate to tyloxapol and relates to
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`non-aqueous solvent systems. See EX2272 at 167:5-168:4; EX1104 at ¶ 11-13, n.
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`7. Since Dr. Davies has never worked with tyloxapol, EX10691 at 48:19-21, it is
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`not surprising he is not aware of the properties of tyloxapol. To the extent Dr. Davies
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`simply did not know (as he clearly does not), he should have done what any other
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`POSA would have done, looked it up. The antioxidant properties of tyloxapol are
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`well known. See EX1061, 48:19-21. In sum, Patent Owner’s Motion must be denied
`
`as Patent Owner does not meet the high burden of proof as “the Board, sitting as a
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`7
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`non-jury tribunal with administrative expertise, is well-positioned to determine and
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`assign appropriate weight to the evidence presented” without resorting to formal
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`exclusion. Laird Techs., Inc. v. Graftech Int’l Holdings, Inc.., IPR2014-00025,
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`Paper No. 45, 41-42 (PTAB, Mar. 25, 2015).
`
`II. DR. LASKAR’S REPLY DECLARATION AND SUPPORTING
`EXHIBITS ARE ADMISSIBLE UNDER THE BOARD’S AND THE
`FEDERAL RULES
`
`
`
`Dr. Laskar’s Reply Declaration (EX1104, specifically ¶¶ 4-34) and supporting
`
`exhibits (EX1089, EX1092, EX1093, EX1105, EX1106, EX1091, EX1094, and
`
`EX1148) are admissible because they are relevant and in direct response to Patent
`
`Owner’s principle theory of the purported non-obviousness of the claims—that a
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`POSA would have known bromfenac degrades by oxidative degradation and thus
`
`would have used an antioxidant—and associated factual allegations (e.g., that
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`polysorbate 80 and tyloxapol are both oxidizing agent). Dr. Laskar does nothing
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`more than respond to Patent Owner’s experts’ arguments thereto, thus making Dr.
`
`Laskar’s Reply Declaration and supporting exhibits entirely proper.
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`Indeed, Patent Owner admits as much in its Motion, asserting that Dr. Laskar
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`“is unqualified to challenge the opinions of Patent Owner’s expert Dr. Davies” and
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`further comparing Dr. Laskar’s opinions with those of Dr. Davies. Motion to
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`Exclude at 4-6; see Square, Inc. v. Unwired Planet, LLC, Case CBM2014-00156,
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`Paper 40 at 35 (PTAB Dec. 22, 2015) (“Under our rules, Petitioner may respond in
`
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`8
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`its Reply to the arguments or evidence, or both, presented in the Patent Owner
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`Response.”). It is axiomatic that since Dr. Laskar—by Patent Owner’s own
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`admission—is responding to Patent Owner’s expert Dr. Davies’s opinions and
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`evidence about the oxidizing properties of tyloxapol (Motion to Exclude, Paper 59
`
`at 4-6), any reply evidence responding to those points is proper.
`
`A. Dr. Laskar’s Statements Relating to Tyloxapol’s Antioxidant
`Properties are a Direct Rebuttal to the Patent Owner’s Wrong
`Statement that Tyloxapol is an Oxidant
`
`Patent Owner’s principle theory rests on tyloxapol’s impact on the oxidative
`
`degradation of bromfenac, i.e., whether tyloxapol is an oxidant or an antioxidant.
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`(Motion to Exclude, Paper 59 at 4-6). Dr. Laskar’s Reply Declaration and
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`supporting exhibits relating to tyloxapol’s antioxidant properties were in direct
`
`response to Patent Owner’s assertions: (1) that bromfenac degrades by oxidation;
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`(2) that a POSA would have used antioxidants to stabilize bromfenac; and (3) that
`
`tyloxapol generates peroxides and is thus an oxidizer. Patent Owner’s Response at
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`14, 20-22, 27-28, 39, 42. In fact, Dr. Laskar’s testimony and supporting exhibits are
`
`in direct response to the Patent Owner’s experts’ allegations that tyloxapol generates
`
`peroxides and thus is an oxidizer, and a POSA would not use tyloxapol for a
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`bromfenac formulation. See, e.g., EX2105 at ¶ 72; EX2082 at ¶ 114; EX2025;
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`EX2097; EX2120.
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`9
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`After discovering that its expert is incorrect that tyloxapol is an oxidant (which
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`is not surprising since Patent Owner’s Dr. Davies has never worked with tyloxapol,
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`EX10691 at 48:19-21, unlike Petitioner’s Dr. Laskar), and that tyloxapol is in fact
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`an antioxidant, Patent Owner asks the Board to exclude all Petitioner’s contradicting
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`evidence. The problem Patent Owner now faces is that if the Board accepts the
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`wealth of prior art describing tyloxapol as an antioxidant (as Dr. Laskar testified
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`when he was deposed during his first deposition), then the claims at issue would be
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`obvious under Patent Owner’s own theory. EX1104 at ¶¶ 15-20; EX2114 at 157:13-
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`22. Dr. Laskar’s testimony in his Reply Declaration and the exhibits thereto should
`
`not be excluded for merely rebutting Patent Owner’s incorrect assertion that
`
`tyloxapol is an oxidant, when clearly it is not.
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`B.
`
`From the Beginning Patent Owner has Interjected Issues Relating
`to Oxidative Degradation
`
`
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`The issues surrounding these arguments raised by Patent Owner were so
`
`prevalent that the Board included a discussion of it in its Decision to Institute.
`
`See Decision to Institute, Paper 15 at 11 (discussing whether polysorbate 80 plays a
`
`role in oxidative degradation of bromfenac), 14 (discussing whether a POSA would
`
`recognize that bromfenac degraded via oxidation). Indeed, from the beginning,
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`Patent Owner had made the argument central to its theory of the case—that a POSA
`
`would not expect tyloxapol to prevent bromfenac’s oxidative degradation. Patent
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`Owner’s Preliminary Response, Paper 11 at 7-9, 20-23, 25-27, 31-32, 43, 48-49.
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`10
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`Patent Owner’s experts (Dr. Williams and Dr. Davies) have repeatedly
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`discussed the oxidation degradation of bromfenac and the impact of tyloxapol’s
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`properties. See EX2082 (Dr. Williams) at ¶¶ 44-47, 88, 97, 100, 103, 111, 114, 116-
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`17, 121-23, 131, 133-34, 146-47, 161, 183, 184. See EX2105 (Dr. Davies) at ¶¶ 37,
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`70-72, 98. Patent Owner has also offered exhibits in supports of its theory. EX2120
`
`at 393-94; EX2097 at 1678; see also EX2114 at 156:6-157:22, 183:17. And as
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`mentioned above, this theory remained in Patent Owner Response. Patent Owner’s
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`Response, Paper 34 at 17-23, 27-28, 31, 35.
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`Throughout this proceeding, Patent Owner has relentlessly pursued the theory
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`that a POSA would not expect tyloxapol to prevent bromfenac’s oxidative
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`degradation problem, because tyloxapol would allegedly contribute to the oxidative
`
`degradation. However, the lynchpin of Patent Owner’s entire theory rested on a
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`person (Dr. Davies) who has never worked with tyloxapol speculating that tyloxapol
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`was an oxidant by relying on references that did not even discuss tyloxapol, rather
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`than doing what any POSA would have done if they did not know—look it up.
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`Petitioner’s Reply was the first opportunity for Petitioner to directly address
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`that factually incorrect assumption that Patent Owner has made in this proceeding
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`i.e., that tyloxapol is an oxidant. Rather than entertaining Dr. Davies musings about
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`tyloxapol, even though Petitioner’s expert testified at his first deposition that
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`tyloxapol was an antioxidant (presumably due to his prior work with tyloxapol),
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`11
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`Petitioner and Dr. Laskar simply provided the Board with the prior art on point
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`discussing tyloxapol’s antioxidant properties. Without an opportunity for Petitioner
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`to correct the record, the Board would have to render a decision based on an incorrect
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`record and without having an opportunity to verify whether Patent Owner’s
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`allegation that tyloxapol is an oxidant, when in truth, the exact opposite is true, i.e.
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`a wealth of references explain that tyloxapol is an antioxidant.
`
`Dr. Laskar’s Reply Declaration and the supporting exhibits (EX1089,
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`EX1092, EX1093, EX1105, EX1106, EX1091, EX1094, and EX1148) correct the
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`factual record. Dr. Laskar’s response shows that Patent Owner’s assertion that
`
`tyloxapol is an oxidant is incorrect—it is precisely the opposite. EX1104 at ¶ 7. Dr.
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`Laskar’s response is supported by various prior art references showing that tyloxapol
`
`is an antioxidant (including references that provide experimental data verifying
`
`tyloxapol’s antioxidant properties). See EX1089 at 9902; EX1106 at 1415, EX1092
`
`at 4:46-56 (teaching that tyloxapol is a “potent antioxidant”); EX1093 at 2:38-50
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`(teaching how alkylaryl polyether alcohol polymers are useful as antioxidants in
`
`blocking oxidant reactions); EX1105 at ¶ [0032]; EX1148 at 6:25-28. Again, Dr.
`
`Laskar’s arguments were used to correct the record and is properly the subject of a
`
`Reply. Therefore, Patent Owner’s motion should be denied.
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`III. EXHIBITS 1075, 1076, AND 1098 ARE WITHIN THE PROPER SCOPE
`OF A REPLY
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`12
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`Patent Owner seeks to exclude EX1075, EX1076, and EX1098, alleging that
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`they relate to new arguments first raised on reply that are beyond the scope of a
`
`reply. Exhibits 1075, 1076, and 1098 are within the scope of a reply because they
`
`respond to arguments raised in the Patent Owner’s response. EX1075 and EX1076
`
`are both prior art publications that reflect the knowledge of a POSA that polysorbate
`
`80 neutralizes the preservative effectiveness of BAC. EX1098 references EX1075
`
`as Reference 6 and illustrates how a POSA would have understood EX1075. These
`
`exhibits respond directly to Patent Owner’s arguments that “[t]yloxapol also
`
`unexpectedly maintained preservative efficacy –
`
`i.e., prevented microbial
`
`contamination – as compared to polysorbate 80” and that “no prior art discloses or
`
`suggests that tyloxapol would have had a more favorable effect than polysorbate 80
`
`on preservative efficacy.” (Patent Owner’s Response, Paper 34 at 2, 54). Exhibits
`
`1075, 1076, and 1098 are precisely the prior art that suggests that the preservative
`
`efficacy of BAC would be improved by using a surfactant other than polysorbate 80.
`
`Since these exhibits directly respond to arguments raised in Patent Owner’s
`
`response, they are within the scope of Petitioner’s reply. See Chicago Mercantile
`
`Exchange, Inc., CBM2014-00114, Paper 35, 60 (PTAB, Aug. 18, 2015) (considering
`
`new reply exhibits that responded to arguments raised in Patent Owner response).
`
`IV. PATENT OWNER’S ARGUMENTS REGARDING EXCLUDING DR.
`LASKAR’S REDIRECT ARE UNJUSTIFIED
`
`
`
`13
`
`

`
`
`
`Patent Owner motion to exclude Dr. Laskar’s redirect is meritless. Motion to
`
`Exclude, Paper 59 at 12. Although the Testimony Guidelines state that ‘[o]nce the
`
`cross-examination of a witness has commenced, and until cross-examination of the
`
`witness has concluded,” counsel may not, for example, “suggest to the witness the
`
`manner in which any questions should be answered,” 77 Fed. Reg. 48756, 48772
`
`(emphasis added), the Board has stated “[t]he prohibition does not exist, however,
`
`during the time frame between conclusion of cross-examination and start of re-
`
`cross.” Organik Kimya AS v. Rohm and Haas Co., IPR2014-00185, Paper 25 at 2-3
`
`(Aug. 21, 2014); Google Inc. and Apple Inc. v. Jongerius Panoramic Tech., LLC,
`
`IPR2013-00191, Paper 48 at 3 (PTAB, Feb. 6, 2014) (explaining that counsel is
`
`“permitted to confer with the witness before redirect examination begins.”).
`
`
`
`Patent Owner conveniently does not mention that Dr. Laskar testified that
`
`other than being informed of the general areas where he might be questioned,
`
`“[t]here was no indication given to me or suggestion to me of how I should respond
`
`to that. I was given some time to ponder those general areas and consider how I
`
`might respond.” EX2114 at 265:15-20. Indeed, the reference “general areas,”
`
`indicates Dr. Laskar was not even given the specific questions he would be asked.
`
`EX2114 at 265:14-16. Patent Owner’s implicit suggestion that Dr. Laskar was
`
`coached during the break, given the recess between cross-examination and redirect
`
`
`
`14
`
`

`
`
`
`was less than twelve minutes (EX 2114 at 258:6-7), and he was not given any
`
`specific questions or answers, is baseless.
`
`
`
`To the extent Patent Owner believes Dr. Laskar was unresponsive, Patent
`
`Owner has failed to show that it timely objected to any answer by Dr. Laskar Patent
`
`Owner deems non-responsive. 37 C.F.R. § 42.64; see, e.g., K40 Elecs., LLC v.
`
`Escort, Inc., IPR2013-00203, Paper 46 at 4-5 (PTAB Aug. 27, 2014). Patent Owner
`
`does not provide any specific citation to the transcript where Patent Owner
`
`specifically objected to Dr. Laskar’s testimony after Dr. Laskar provided it for being
`
`non-responsive. Id.
`
`V.
`
` CONCLUSION
`
`For the foregoing reasons, Petitioner respectfully requests that Patent Owner’s
`
`motion to exclude be denied.
`
`
`
`Date: April 6, 2016
`
`
`
`
`
`RESPECTFULLY SUBMITTED,
`
`ALSTON & BIRD LLP
`
`
`
`/Jitendra Malik/
`Jitendra Malik (Reg. No. 55823)
`
`Lead Attorney for Petitioners InnoPharma
`Licensing, Inc., InnoPharma Licensing
`LLC, InnoPharma Inc., InnoPharma LLC,
`Mylan Pharmaceuticals Inc., and Mylan
`Inc.
`
`
`
`
`
`15
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`

`
`
`
`
`
`CERTIFICATION OF SERVICE
`
`Pursuant to 37 C.F.R. §§ 42.6(e), 42.8(b)(4) and 42.105, the undersigned
`
`certifies that on the 6th day of April, 2016, a complete copy of the foregoing
`
`Petitioner’s Reply to Patent Owner’s Response to Petition and all supporting exhibits
`
`were served via email on counsel of record for the Patent Owner:
`
`Senju Pharmaceutical Co., Ltd., et al.
`
`Bryan C. Diner
`bryan.diner@finnegan.com
`
`Justin J. Hasford
`justin.hasford@finnegan.com
`
`Joshua L. Goldberg
`Joshua.goldberg@finnegan.com
`
`
`
`
`Date: April 6, 2016
`
`
`
`Respectfully submitted,
`
`Alston & Bird LLP
`
`By: /Jitendra Malik/
`
`Jitendra Malik, Ph.D.
`Reg. No. 55823
`Alston & Bird LLP
`4721 Emperor Blvd., Suite 400
`Durham, NC 27703-8580
`jitty.malik@alston.com
`
`Bryan Skelton, Ph.D.
`Reg. No. 50893
`Alston & Bird LLP
`4721 Emperor Blvd., Suite 400
`Durham, NC 27703-8580
`
`

`
`bryan.skelton@alston.com
`
`Lance Soderstrom
`Reg. No. 65405
`Alston & Bird LLP
`90 Park Avenue
`15th Floor
`New York, NY 10016-1387
`lance.soderstrom@alston.com
`
`Hidetada James Abe
`Reg. No. 61,182
`Alston & Bird LLP
`333 South Hope Street
`16th Floor
`Los Angeles, CA 90071
`james.abe@alston.com
`
`Joseph M. Janusz (Reg. No. 70396)
`ALSTON & BIRD LLP
`101 S. Tryon Street, Suite 4000
`Charlotte, NC 28205
`Telephone: 704-444-1000
`Fax: 704-444-1111
`joe.janusz@alston.com
`
`Attorneys for Petitioners InnoPharma
`Licensing, Inc., InnoPharma Licensing LLC,
`InnoPharma Inc., InnoPharma LLC, Mylan
`Pharmaceuticals Inc., and Mylan Inc.
`
`
`
`Deborah H. Yellin (Reg. No. 45,904)
`Crowell & Moring LLP
`Intellectual Property Group
`1001 Pennsylvania Avenue, N.W.
`Washington, DC 20004-2595
`Telephone No.: (202) 624-2947
`Facsimile No.: (202) 628-5116
`DYellin@Crowell.com
`
`2
`
`
`
`
`
`

`
`
`
`
`
`
`Jonathan Lindsay (Reg. No. 45,810)
`Crowell & Moring LLP
`Intellectual Property Group
`3 Park Plaza, 20th Floor
`Irvine, CA 92614-8505
`Telephone No.: (949) 798-1325
`Facsimile No.: (949) 263-8414
`JLindsay@Crowell.com
`
`Shannon Lentz (Reg. No. 65,382)
`Crowell & Moring LLP
`Intellectual Property Group
`1001 Pennsylvania Ave, N.W.
`Washington, DC 20004-2595
`Telephone No.: (202)624-2897
`Facsimile No.: (202) 628-5116
`SLentz@Crowell.com
`
`Attorneys for Petitioners Lupin Ltd. and
`Lupin Pharmaceuticals, Inc.
`
`3