Paper No. ____
`Filed: March 31, 2016
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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., and MYLAN INC.,
`LUPIN LTD., and LUPIN PHARMACEUTICALS, INC.,
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`Petitioners
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`v.
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` SENJU PHARMACEUTICAL CO., LTD.,
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`Patent Owner.
`_________________
`Case IPR2015-00903 (Patent 8,129,431 B2)1
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`PATENT OWNER’S MOTION FOR OBSERVATION
`REGARDING CROSS-EXAMINATION OF
`REPLY WITNESSES DR. PAUL A. LASKAR, Ph.D.
`AND IVAN T. HOFMANN, CPA/CFF, CLP
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`1 IPR2015-01871 has been joined with this proceeding.
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`Filed: March 31, 2016
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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., and MYLAN INC.,
`LUPIN LTD., and LUPIN PHARMACEUTICALS, INC.,
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`Petitioners
`
`v.
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` SENJU PHARMACEUTICAL CO., LTD.,
`
`Patent Owner.
`_________________
`Case IPR2015-00903 (Patent 8,129,431 B2)1
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`PATENT OWNER’S MOTION FOR OBSERVATION
`REGARDING CROSS-EXAMINATION OF
`REPLY WITNESSES DR. PAUL A. LASKAR, Ph.D.
`AND IVAN T. HOFMANN, CPA/CFF, CLP
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`1 IPR2015-01871 has been joined with this proceeding.
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`IPR2015-00903 (Patent 8,129,431 B2)
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`Patent Owner Senju Pharmaceutical Co., Ltd. et al. (“Senju”), submits this
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`Motion for Observation Regarding Cross-Examination of Dr. Paul A. Laskar and
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`Mr. Ivan T. Hofmann, pursuant to the Scheduling Order (Paper No. 17, filed Aug.
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`7, 2015), and Joint Stipulation to Extend Due Dates 1, 2, 4 & 5 (Paper No. 29, filed
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`Dec. 10, 2015).
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`Observation #1
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`In Ex. 2272, at 20:17-22, Dr. Laskar testified that “I have not held myself as
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`an expert in [medicinal or organic chemistry], only in pharmaceutical development
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`and formulation development.” See also EX2272, 14:22-25:7 (additional
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`testimony on Dr. Laskar’s background and qualifications). This testimony is
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`relevant to the statements and conclusions in Dr. Laskar’s reply declaration, Ex.
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`1104, ¶¶ 2-38, regarding and relying on the use of chemistry, and in Petitioner’s
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`Reply2 at pp. 3, 5-6, 12-14. This testimony is relevant to the weight and
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`understanding to be given to Dr. Laskar’s statements and conclusions in his
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`declaration because it establishes his lack of qualification to testify on the subject
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`matter for which he has offered opinions in his reply declaration.
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`Observation #2
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`In Ex. 2272, at 68:20-69:7, Dr. Laskar testified that the formulations of the
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`’431 and ’290 patents as well as the formulations of Yasueda (EX1012) that
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`2Petitioner’s Reply is Paper No. 49, filed March 18, 2016.
`1
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`IPR2015-00903 (Patent 8,129,431 B2)
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`contain tyloxapol “do not contain any traditional antioxidant or compound that
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`functions in an antioxidant capacity.” This testimony is relevant to the statements
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`and conclusions in Dr. Laskar’s reply declaration, Ex. 1104, ¶¶ 4-34, and in
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`Petitioner’s Reply at pp. 12-14. The testimony is relevant to the weight and
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`understanding to be given to Dr. Laskar’s statements and conclusions because his
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`testimony that tyloxapol is not a “traditional antioxidant or compound that
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`functions in an antioxidant capacity” contradicts the statements throughout ¶¶ 4-34
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`of his declaration regarding tyloxapol allegedly being an antioxidant and having
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`“antioxidant properties.”
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`Observation #3
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`In Ex. 2272, at 29:14-20, when asked whether the claimed formulations of
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`the ’431 and ’290 patents contain metals or metal cations, Dr. Laskar testified:
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`“Specifically, the claims refer to salts, of which -- and I recall predominantly
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`sodium salts. And so, therefore, the sodium is present as the sodium cation.” See
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`also EX2272, 29:14-20 (on how metals and metal cations differ). This testimony
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`is relevant to the statements in Dr. Laskar’s reply declaration, Ex. 1104, ¶¶ 21-22,
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`regarding the alleged teachings in the Merck Index (EX1089) and Remington: The
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`Science and Practice of Pharmacy (19th Ed.) (EX1106) that tyloxapol is “oxidized
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`by metals,” and corresponding arguments in Petitioner’s Reply at pp. 13-14. This
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`testimony is relevant because it establishes that the alleged teachings of the Merck
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`IPR2015-00903 (Patent 8,129,431 B2)
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`Index and Remington are inapplicable to the ’431 and ’290 patents because the
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`claimed formulations contain metal cations, not metals.
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`Observation #4
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`In Ex. 2272, at 32:17-33:1, when asked whether the claimed formulations of
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`the ’431 and ’290 patents are formulated for nasal administration, Dr. Laskar
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`testified: “The claims themselves, as I recall, do not refer to routes of
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`administration other than ophthalmic.” At 33:3-9, he testified that “[t]he
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`formulations as -- in the claims [of the ’431 and ’290 patents] do not explicitly
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`indicate their use for pharyngeal administration.” This testimony is relevant to the
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`statements regarding the alleged behavior of tyloxapol in liquid preparations for
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`nasal and/or pharyngeal applications in Dr. Laskar’s reply declaration, Ex. 1104, ¶¶
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`23-27, and in Petitioner’s Reply at pp. 12-14. This testimony is relevant because it
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`establishes that the alleged behavior of tyloxapol in liquid preparations for nasal
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`and/or pharyngeal applications is irrelevant to the subject matter of the ’431 and
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`’290 patents because the claimed formulations are formulated for ophthalmic
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`administration, not nasal or pharyngeal administration.
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`Observation #5
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`In Ex. 2272, at 37:18-38:3, Dr. Laskar testified that Fu (EX1011) “does not
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`explicitly use the word ‘tyloxapol.’” At 38:4-46:10, Dr. Laskar acknowledged that
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`in prior testimony he stated that: (1) “[Fu] does not mention tyloxapol by name”;
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`IPR2015-00903 (Patent 8,129,431 B2)
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`(2) “[Octoxynol 40 and tyloxapol] do have different structures”; (3) “[Octoxynol 9
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`and tyloxapol] do have different chemical structures”; and (4) based on Schott
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`(EX1024), “ I’m sure that -- that a polymer chemist would -- would say that
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`[tyloxapol is] not a true oligomer [of Octoxynol 9].” This testimony is relevant to
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`the statements in Dr. Laskar’s reply declaration, Ex. 1104, ¶¶ 2-3, and in
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`Petitioner’s Reply at p. 6. This testimony is relevant to the weight and
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`understanding to be given to the statements regarding tyloxapol allegedly “fall[ing]
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`within the disclosure of Fu,” because Dr. Laskar testified that tyloxapol is not
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`expressly disclosed in Fu and that there are differences between tyloxapol and the
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`surfactants that Fu actually discloses.
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`Observation #6
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`In Ex. 2272, at 52:14-17, Dr. Laskar testified that Octoxynol 9 and p-
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`(1,1,3,3-tetramethylbutyl) phenol “differ structurally.” At 98:8-11, Dr. Laskar
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`testified that “p-(1,1,3,3-tetramethylbutyl) phenol is the original alcohol monomer
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`from which tyloxapol is made.” This testimony is relevant to the statements in Dr.
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`Laskar’s reply declaration, Ex. 1104, ¶¶ 2-3, n.4, and in Petitioner’s Reply at p. 6,
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`regarding Fu’s alleged inclusion of tyloxapol. This testimony is relevant to the
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`weight and understanding to be given to Dr. Laskar’s opinion that tyloxapol
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`allegedly is an oligomer of Octoxynol 9 (EX1104, n.4; see also EX1003, ¶¶ 36, 70,
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`105-106), because Dr. Laskar testified that the monomeric unit of tyloxapol differs
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`IPR2015-00903 (Patent 8,129,431 B2)
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`from Octoxynol 9.
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`Observation #7
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`In Ex. 2272, at 56:22-57:8, Dr. Laskar testified that “as Dr. Davis writes in
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`this paragraph, I would say that in his last sentence, as he says, a person of
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`ordinary skill would not replace polysorbate.” See also EX2272, 57:10-14 (stating
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`that Dr. Davies “did not opine” that the stability of bromfenac solutions in Ogawa
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`can be improved by replacing polysorbate 80). This testimony is relevant to the
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`statements in Dr. Laskar’s reply declaration, Ex. 1104, ¶¶ 4-5, and in Petitioner’s
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`Reply at p. 6. This testimony is relevant to the weight and understanding to be
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`given to Dr. Laskar’s characterization of the testimony of Patent Owner’s experts,
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`because, contrary to the statements in his reply declaration at ¶¶ 4-5, Dr. Laskar
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`testified that Dr. Davies did not opine that there was a motivation to replace the
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`polysorbate 80 in Ogawa’s Example 6 or that doing so would improve the stability
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`of the bromfenac solutions in Ogawa.
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`Observation #8
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`In Ex. 2272, at 59:16-60:6, Dr. Laskar testified, regarding Ogawa (EX1004):
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`“Example 6, 7, and 8 all appear to be precipitate or turbidity particulate matter free
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`and have acceptable residual amounts of bromfenac. Q. Just to be clear, the Ogawa
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`patent solved bromfenac’s stability problem using the formulations of Example 6,
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`7, and 8, correct? DR.MALIK: Asked and answered. THE WITNESS: I believe
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`IPR2015-00903 (Patent 8,129,431 B2)
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`that’s what I said.” See also EX2272, 60:7-19 (Dr. Laskar testifying that he has
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`opined that the inventors in Ogawa succeeded in stabilizing bromfenac and that
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`Ogawa states that the formulations of Examples 6, 7 and were “stable, excellent for
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`a long period of time”). At 60:20-61:2, Dr. Laskar testified that “Ogawa does not
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`mention the use of tyloxapol, as I recall.” See also EX2073 at 61:3-10 (Dr. Laskar
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`testifying that, despite his focus on Example 6, Ogawa discloses “a number of
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`other examples”). At 62:3-21, Dr. Laskar also testified that the ’431 and ’290
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`patents “appear to have identified an issue that Ogawa had not perceived.” This
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`testimony is relevant to the statements in Dr. Laskar’s reply declaration, Ex. 1104,
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`¶¶ 4-5, and in Petitioner’s Reply at p. 12. This testimony is relevant to the weight
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`and understanding to be given to Dr. Laskar’s declaration statements regarding the
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`alleged motivation of a person of ordinary skill in the art “to replace polysorbate
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`80 with an alternative non-ionic surfactant (i.e., tyloxapol).”
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`Observation #9
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`In Ex. 2272, at 64:2-65:3, Dr. Laskar testified, regarding Yasueda (EX1012):
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`“The Yasueda patent deals with a different molecule than bromfenac, yes. So
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`pranlukast. Q. The Yasueda patent does not teach the use of any NSAID, correct?
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`A. No. Pranlukast is not an NSAID.” At 65:4-68:3, Dr. Laskar acknowledged that
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`in prior testimony he testified: “Q. To be clear, pranlukast and bromfenac are
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`different chemical compounds, correct? A. I believe that’s what I said” and further
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`agreed that “Pranlukast contains an amide group where bromfenac does not contain
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`an amide group.” At 69:20-70:9, Dr. Laskar testified that “the duration of
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`[Yasueda’s stability] testing differed. It was two weeks in the case of Yasueda and
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`four weeks in the case of the ’431 patent.” Dr. Laskar further testifed, at 70:11-
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`71:1, that formulations A and B in Tables 4 and 5 of Yasueda “use[] 4 grams per
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`100 mils of tyloxapol.” See also EX2272, 71:22-74:10 (regarding Yasueda’s
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`preferred concentration of tyloxapol). This testimony is relevant to the statements
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`in Dr. Laskar’s reply declaration, Ex. 1104, ¶¶ 6, 30-32, and in Petitioner’s Reply
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`at p. 14. This testimony is relevant to the weight and understanding to be given to
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`Dr. Laskar’s reliance on the experimental data and alleged teachings of Yasueda
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`because Yasueda deals with a different, non-NSAID active ingredient, different
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`stability test conditions, and a different amount of tyloxapol than the claimed
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`formulations of the ’431 and ’290 patents.
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`Observation #10
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`In Ex. 2272, at 90:13-19, Dr. Laskar testified that “tyloxapol is not included
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`as an excipient in any of the example formulations” of Doi (EX2025). At 91:9-15,
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`Dr. Laskar testified that at least several of the alkylphenols disclosed in Doi “do, in
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`fact have free phenolic residues.” Dr. Laskar further testified, at 47:2-4, that “the
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`OH group [in tyloxapol] is not directly attached” to the phenyl ring. This
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`testimony is relevant to the statements in Dr. Laskar’s reply declaration, Ex. 1104,
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`IPR2015-00903 (Patent 8,129,431 B2)
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`¶¶ 15-20, and in Petitioner’s Reply at pp. 12-14. This testimony is relevant to the
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`weight and understanding to be given to Dr. Laskar’s opinion that “to the skilled
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`artisan, tyloxapol is within the alkylphenols disclosed by Doi,” because Doi does
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`not teach the use of tyloxapol and the alkylphenols disclosed by Doi are
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`structurally different from tyloxapol.
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`Observation #11
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`In Ex. 2272, at 103:21-105:9, Dr. Laskar agreed that the ’956 application
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`(EX1105) and WO ’610 (EX1148) “concern a method and composition for
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`treatment of snoring, sleep apnea, or sudden infant death syndrome and for
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`improvement of nasal breathing by nasal and/or pharyngeal administration” and
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`“used tyloxapol as an active ingredient,” whereas Dr. Laskar testified that “[i]n the
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`’431 and ’290 patent, tyloxapol is not identified as an active pharmaceutical
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`ingredient.” Dr. Laskar further testified, at 105:10-108:20, that the ’956
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`application and WO ’610 disclose preferred doses, in weight by volume, of: “1
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`percent to 10 percent” for treatment of snoring; “1 percent to 15 percent” for
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`treatment of sleep apnea; 0.5 percent to 15 percent for improvement of sleep
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`pattern, increase in alertness, and improvement of breathing; and 0.05 percent to 1
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`percent for treatment of sudden infant death syndrome. See also EX2272, 108:21-
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`110:17 (“The approach taken by the ’431, ’290 patents attempt to answer different
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`questions than what the ’610 patent attempts to respond to. So that they are, in fact,
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`IPR2015-00903 (Patent 8,129,431 B2)
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`different.”). This testimony is relevant to the statements in Dr. Laskar’s reply
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`declaration, Ex. 1104, ¶¶ 23-25, and in Petitioner’s Reply at pp. 12-14. This
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`testimony is relevant to the weight and understanding to be given to Dr. Laskar’s
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`opinion that “the ’956 application and WO ’610 teach that [tyloxapol] is an
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`antioxidant” because it illustrates that there are differences between the
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`formulations disclosed therein and those claimed in the ’431 and ’290 patents,
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`which render the teachings of the ’956 application and WO ’610 irrelevant.
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`Observation #12
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`In Ex. 2272, at 126:20-127:10, Dr. Laskar testified that Kennedy (EX1092)
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`“does not teach bromfenac” and agreed that it does not teach any NSAID or
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`benzalkonium chloride. See also EX2272, 127:11-129:1 (Dr. Laskar
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`acknowledging that petitioner’s expert in the parallel district court cases, Dr.
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`Heathcock, testified that Kennedy does not disclose any ophthalmic formulation).
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`At 129:2-130:8, Dr. Laskar testified that “[t]he goal . . . of the ’431 and ’290
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`patents, is -- differs from the goal of the Kennedy patent” and agreed that a stated
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`object of Kennedy was “to provide a method to inhibit oxidant chemical reactions
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`caused by partially reduced O2 species,” which he testified “differ[] from the
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`oxygen molecule” and are “not explicitly identified” in the claimed formulations.
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`EX2272, 32:2-7. This testimony is relevant to the statements in Dr. Laskar’s reply
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`declaration, Ex. 1104, ¶¶ 26-28, and in Petitioner’s Reply at pp. 13-14. This
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`9
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`IPR2015-00903 (Patent 8,129,431 B2)
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`testimony is relevant to the weight and understanding to be given to Dr. Laskar’s
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`statements regarding Kennedy’s discussion of tyloxapol’s alleged antioxidant
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`properties because it illustrates that there are differences between the formulations
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`disclosed in Kennedy and those claimed in the ’431 and ’290 patents, which render
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`the teachings of the Kennedy irrelevant. This testimony is also relevant to the
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`weight and understanding to be given to Dr. Laskar’s assertion that “a skilled
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`artisan would find Kennedy’s discussion of the detrimental impact of oxygen
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`radicals (which would include partially reduced O2 species) and the antioxidant
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`ability of tyloxapol to limit such radicals to be relevant” because it further
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`demonstrates that any such discussion in Kennedy is not relevant to the claimed
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`subject matter given that partially reduced O2 species are not identified in the
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`claimed formulations of the ’431 and ’290 patents.
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`Observation #13
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` In Ex. 2272, at 131:9-132:15, Dr. Laskar agreed that Ghio (EX1093) “does
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`not teach bromfenac,” “does not teach any NSAID,” “does not teach benzalkonium
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`chloride,” and “does not teach any ophthalmic formulations” and testified that “the
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`question that the ’431 and ’290 patents attempt to answer differs from the question
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`and need that the ’760 patent [Ghio] is directed to.” At 132:17-133:9, Dr. Laskar
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`testified agreeing that Ghio “describes how alkylaryl polyether alcohol polymers
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`are useful as antioxidants in blocking oxidant reactions and biologic injury from
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`0
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`IPR2015-00903 (Patent 8,129,431 B2)
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`partially reduced O2 species.” This testimony is relevant to the statements in Dr.
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`Laskar’s reply declaration, Ex. 1104, ¶ 30, and in Petitioner’s Reply at p. 14. This
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`testimony is relevant to the weight and understanding to be given to Dr. Laskar’s
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`reliance on Ghio as allegedly “discuss[ing] tyloxapol’s antioxidant properties”
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`because it illustrates the differences between the formulations disclosed in Ghio
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`and those claimed in the ’431 and ’290 patents and further demonstrates that any
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`such discussion in Ghio is not relevant to the claimed subject matter because
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`partially reduced O2 species are not identified in the ’431 and ’290 patents.
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`Observation #14
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`In Ex. 2272, at 140:9-20, Dr. Laskar testified that it “is a general philosophy
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`of formulation” that a formulator would want to try to use the minimum number of
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`excipients possible to accomplish the goal for the particular formulation. This
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`testimony is relevant to the statements in Dr. Laskar’s reply declaration, Ex. 1104,
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`¶ 33, and in Petitioner’s Reply at p. 14. The testimony is relevant to the weight
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`and understanding to be given to Dr. Laskar’s opinions in his declaration that “the
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`addition of tyloxapol to Ogawa Example 6 would not mean that the skilled artisan
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`would have removed other components (e.g., the antioxidant sodium sulfite)”
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`because those statements conflict with the goals of a formulator.
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`Observation #15
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`In Ex. 2272, at 154:8-14, Dr. Laskar testified: “Q. You never conducted any
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`IPR2015-00903 (Patent 8,129,431 B2)
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`testing to determine whether tyloxapol would have antioxidant properties in
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`aqueous liquid preparations of bromfenac, such as the aqueous liquid preparations
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`of the ’431 and ’290 patents, correct? A. I’ve not conducted any such experimental
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`activities.” At 110:9-17, Dr. Laskar testified: “Q. The ’956 application and the
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`WO 610 reference do not disclose any actual data showing any antioxidant effects
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`of tyloxapol, correct? A. Not that I recall at the moment, having seen anything of
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`that nature. Q. Okay. A. It doesn’t – it makes a statement about tyloxapol having
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`those attributes as opposed to reporting data.” This testimony is relevant to the
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`statements in Dr. Laskar’s reply declaration, Ex. 1104, ¶¶ 4-34, and in Petitioner’s
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`Reply at pp. 12-14. The testimony is relevant to the weight and understanding to
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`be given to Dr. Laskar’s statements and conclusions regarding tyloxapol allegedly
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`being an antioxidant and having “antioxidant properties” because it establishes that
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`Dr. Laskar did not conduct any experiments to support his conclusions and instead
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`relied on statements from references that, as discussed above, describe different
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`formulations from those of the ’431 and ’290 patents and further do not provide
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`any supporting data.
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`Observation #16
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`In Ex. 2272, at 160:20-163:3, Dr. Laskar acknowledged that he previously
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`testified: “Q. Just to be clear, in your declarations in these IPR proceedings, you
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`have cited no specific evidence that bromfenac itself actually interacts with
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`IPR2015-00903 (Patent 8,129,431 B2)
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`benzalkonium chloride to form a turbid or hazy drug product and diminish the
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`antimicrobial effectiveness of the benzalkonium chloride, correct? THE
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`WITNESS: There is -- there is nothing explicit concerning the interaction of
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`bromfenac and benzalkonium chloride.” At 163:5-8, Dr. Laskar testified: “Q. You
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`have conducted no test to determine whether bromfenac itself actually interacts
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`with benzalkonium chloride, correct? A. I have not,” and at 163:12-18, he testified:
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`“Q. You have not reviewed any spectroscopic or spectrometric data to determine
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`whether bromfenac itself actually interacts with benzalkonium chloride, correct?
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`A. I’d be interested to know what sort of spectrometric information might indicate
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`that, but no, I have not.” This testimony is relevant to the statements in Dr.
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`Laskar’s reply declaration, Ex. 1104, ¶¶ 35-38, and in Petitioner’s Reply at pp. 2,
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`5-6. The testimony is relevant to the weight and understanding to be given to Dr.
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`Laskar’s broad statements and conclusions in his declaration regarding
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`benzalkonium chloride allegedly forming complexes with acidic NSAIDs such as
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`bromfenac because, as he previously testified, he did not cite any specific evidence
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`to support his conclusion that such an interaction occurs between benzalkonium
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`chloride and bromfenac, and he did not conduct any experiments or review any
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`spectroscopic or spectrometric data to substantiate his conclusions.
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`Observation #17
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`In Ex. 2273 at 213:5-218:8, Mr. Hofmann testified that “I think that’s right”
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`that non head-to-head data can be indirectly compared, “yes” you would compare
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`them to a common benchmark /vehicle/placebo, and Prolensa® had a “slightly
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`better” and “higher” differentials than Bromday® as reported in B&L’s Cataract
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`Discussion Group. See EX1152, EX2226. This testimony is relevant to statements
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`Mr. Hofmann’s reply declaration, Ex. 1150, ¶ 70, because he claimed Bromday,
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`not Prolensa, produced better results.
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`Observation #18
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`In Ex. 2273, e.g., at 192:13-17, Mr. Hofmann testified that he learned
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`“technical” information from others, including counsel, at 99:4-9, that it is
`
`“[c]orrect” that there are “differences in formulations as between Prolensa® . . . and
`
`Xibrom® or Bromday®,” and at 121:10-122:1 that “[i]t appears that those attributes
`
`of the formulation . . . appear in” marketing documents, and, at 183:15-183:12, that
`
`“[s]ure” that “there’s a lot more information” in materials communicated to doctors
`
`than what he cited in Ex. 1150. See also 16:3-17:13, 18:3-19:16, 20:3-6, 24:8-
`
`25:4, 26:5-27:4, 39:11-40:1, 40:6-41:4, 48:18-49:19, 95:4-96:7, 99:4-101:16,
`
`102:10-22, 107:12-108:19, 109:14-20, 110:4-11, 110:19-111:2, 117:1-10, 118:4-
`
`119:3, 121:10-122:1, 124:22-125:8, 125:21-126:8, 128:5-18, 130:11-15, 136:10-
`
`15, 146:18-20, 147:20-148:6, 150:2-152:2, 161:8-162: 22, 164:10-22, 165:18-
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`166:21, 168:8-173:1, 175:17-176:3, 182:15-183:12, 184:18-185:10, 188:13-189:5,
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`190:8-20, 192:13-21, 204:1-206:4. This testimony is relevant to the statements in
`
`4
`
`
`
`
`
`
`
`IPR2015-00903 (Patent 8,129,431 B2)
`
`
`Mr. Hofmann’s reply declaration, Ex. 1150, ¶¶ 19, 26, 52, 63-67, 72-73, 79, and
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`90-96, because marketing messages for Prolensa® mention its attributes, as
`
`opposed to Xibroms or Bromday’s, related to the claims of the patents-at-issue.
`
`Observation #19
`
`In Ex. 2273 at 51:22-54:5, e.g., the witness testified regarding Mr. Jarosz’s
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`understanding, in ¶¶ 84-85 of Ex. 2130 under the heading “Causal Nexus,” of
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`tyloxapol’s role in affecting Prolensa®’s pH level, reduced surfactant
`
`concentration, and lower bromfenac concentration. See also 16:3-17:13, 33:18-
`
`34:7, 39:11-40:1-41:4, 48:18-54:5, 55:7-18, 62:10-18. This testimony is relevant
`
`to statements in Mr. Hofmann’s reply declaration, Ex. 1150, n.101, and in
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`Petitioner’s Reply at p. 23, because Mr. Jarosz does opine on nexus of commercial
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`success specific to the patents-at-issue.
`
`By: /Bryan C. Diner/
`Bryan C. Diner, Lead Counsel
`Registration No. 32,409
`Justin J. Hasford, Backup Counsel
`Registration No. 62,180
`Finnegan, Henderson, Farabow, Garrett
`& Dunner, LLP
`901 New York Avenue NW
`Washington, DC 20001
`
`Attorneys for Patent Owner Senju
`Pharmaceutical Co., Ltd.
`
`
`
`5
`
`
`
`Date: March 31, 2016
`
`
`
`
`
`
`
`
`
`
`
`IPR2015-00903 (Patent 8,129,431 B2)
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing PATENT
`
`
`
`OWNER’S MOTION FOR OBSERVATION REGARDING CROSS-
`
`EXAMINATION OF REPLY WITNESSES DR. PAUL A. LASKAR, PH.D.
`
`AND IVAN T. HOFMANN, CPA/CFF, CLP, was served on March 31, 2016,
`
`via email directed to counsel of record for the Petitioner who have executed the
`
`Acknowledgment Form of the Stipulated Protective Order:
`
`Jitendra Malik, Ph.D
`Jitty.malik@alston.com
`
`Lance Soderstrom
`Lance.soderstrom@alston.com
`
`Hitetada James Abe
`James.abe@alston.com
`
`Deborah Yellin
`dyellin@crowell.com
`
`Jonathan Lindsay
`jlindsay@crowell.com
`
`Shannon Lentz
`slentz@crowell.com
`
`
`
`
`
`/Bradley J. Moore/
`Bradley J. Moore
`Litigation Legal Assistant
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`
`6
`
`
`Dated: March 31, 2016
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing re-designated
`
`Patent Owner’s Motion for Observation Regarding Cross-Examination of
`
`Reply Witnesses Dr. Paul A. Laskar, Ph.D. and Ivan T. Hofmann, CPA/CFF,
`
`CLP was served on July 29, 2016, via email directed to counsel of record for the
`
`Petitioner at the following:
`
`Jitendra Malik
`jitty.malik@alston.com
`
`Lance Soderstrom
`lance.soderstrom@alston.com
`
`Hidetada James Abe
`james.abe@alston.com
`
`Bryan Skelton
`bryan.skelton@alston.com
`
`Joseph Janusz
`joe.janusz@alston.com
`
`Deborah Yellin
`dyellin@crowell.com
`
`Jonathan Lindsay
`jlindsay@crowell.com
`
`Shannon Lentz
`slentz@crowell.com
`
`
`
`
`
`
`
`Date: July 29, 2016
`
`
`
`
`
`
`
`
`
`
`
`/Bradley J. Moore/
`Bradley J. Moore
`Litigation Legal Assistant
`Finnegan, Henderson, Farabow, Garrett &
`Dunner, LLP
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