`Filed: May 12, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`LUPIN LTD. and LUPIN PHARMACEUTICALS INC.,
`Petitioners
`
`v.
`
` SENJU PHARMACEUTICAL CO., LTD.,
`Patent Owner
`_________________
`Case IPR2015-01099 (Patent 8,669,290 B2)
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`PATENT OWNER’S MOTION FOR OBSERVATION
`REGARDING CROSS-EXAMINATION OF
`REPLY WITNESSES DR. M. JAYNE LAWRENCE, Ph.D.
`AND IVAN T. HOFMANN, CPA/CFF, CLP
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`Case IPR2015-01099 (Patent 8,669,290 B2)
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`Patent Owner Senju Pharmaceutical Co., Ltd. et al. (“Senju”), submits this
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`Patent Owner’s Motion for Observation Regarding Cross-Examination of Dr. M.
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`Jayne Lawrence and Mr. Ivan T. Hofmann, pursuant to the Scheduling Order,
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`Paper No. 10 (filed October 27, 2015), and the Joint Stipulation Adjusting Due
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`Dates 1, 2 & 4, Paper No. 16 (filed January 6, 2016).
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`Observation #1 - In Ex. 2342, at 10:21-11:11, Dr. Lawrence acknowledged
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`that it was her prior testimony that she had never been qualified by any court or by
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`the U.S. Patent and Trademark Office as an expert in chemistry. At 11:12-20, Dr.
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`Lawrence testified that she is not an expert in medicinal chemistry, organic
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`chemistry, or antioxidant chemistry. See also EX2342, 9:11-14:10, 16:3-23:10
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`(additional testimony on Dr. Lawrence’s background and qualifications). This
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`testimony is relevant to the statements and conclusions in Dr. Lawrence’s reply
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`declaration, Ex. 1094, ¶¶ 31, 33, 36-37, 48-49, 51-52, 73, n.5, regarding and
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`relying on chemistry, and in Petitioners’ Reply1 at pp. 1, 6-9. This testimony is
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`relevant to the weight and understanding to be given to Dr. Lawrence’s statements
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`and conclusions in her declaration because it establishes her lack of qualification to
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`testify on the subject matter for which she has offered opinions.
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`Observation #2 - In Ex. 2342, at 179:20-180:1, when asked whether the
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`1 Petitioners’ Reply (“Reply”) is Paper No. 32, filed April 22, 2016.
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`Case IPR2015-01099 (Patent 8,669,290 B2)
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`claimed formulations of the ’290, ’131, ’813, and ’606 patents contain metals or
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`metal cations, Dr. Lawrence testified: “They contain sodium cation.” See also
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`EX2342, 179:11-19 (on how metals and metal cations differ). This testimony is
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`relevant to the statements in Dr. Lawrence’s reply declaration, Ex. 1094, ¶ 31, n.5,
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`regarding the alleged teachings in the Merck Index (EX1096) and Remington: The
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`Science and Practice of Pharmacy (1995) (EX1051) that tyloxapol is “oxidized by
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`metals,” and the corresponding arguments in the Reply at p. 7. This testimony is
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`relevant because it establishes that the alleged teachings of the Merck Index and
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`Remington are inapplicable to the ’290, ’131, ’813, and ’606 patents (the “patents-
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`at-issue”) because the claimed formulations contain metal cations, not metals.
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`Observation #3 - In Ex. 2342, at 180:21-181:8, Dr. Lawrence testified as
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`follows: “Q. . . . The claimed formulations of the ’290, ’131, ’813, and ’606
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`patents are not formulated for nasal administration; correct? A. That’s my
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`understanding, yes. Q. The claimed formulations of the ’290, ’131, ’813, and ’606
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`patents are not formulated for pharyngeal administration; correct? A. Yes, I
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`believe that’s -- yes, that’s correct.” See also EX2342, 180:2-5 (the patents-at-
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`issue are formulated for ophthalmic administration). This testimony is relevant to
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`the statements regarding the alleged behavior of tyloxapol in liquid preparations
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`for nasal and/or pharyngeal applications in Dr. Lawrence’s reply declaration, Ex.
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`1094, ¶ 31, n.5, and in the Reply at p. 7. 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 patents-at-
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`issue because
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`the claimed
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`formulations are
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`formulated
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`for ophthalmic
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`administration, not nasal or pharyngeal administration.
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`Observation #4 - In Ex. 2342, at 32:17-33:5, Dr. Lawrence agreed that
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`Ogawa (EX1010) “identified the formulations of examples 6, 7, and 8 as not
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`forming red insoluble matters and described them as stable, excellent for a long
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`period of time” and testified that the formulations of Ogawa examples 6, 7, and 8
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`did “not [have any problems with instability or degradation] under the conditions
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`tested.” See also EX2342, 62:22-64:3. At 33:6-34:2, Dr. Lawrence further
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`testified: “Q. In your view, the Ogawa ’225 patent solved bromfenac’s stability
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`problem by showing that, under the conditions of examples 6, 7, and 8, the
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`formulations were stable; correct? . . . THE WITNESS: The patent states under the
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`one condition that the formulations were tested for. That is 60 degrees, say, at four
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`weeks. It calls the formulations excellently stable.” This testimony is relevant to
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`the statements in Dr. Lawrence’s reply declaration, Ex. 1094, ¶¶ 22, 26-27, 31, 37-
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`42, and in the Reply at pp. 1-9. This testimony is relevant to the weight and
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`understanding to be given to Dr. Lawrence’s declaration statements regarding the
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`alleged motivation of a person of ordinary skill in the art (“POSA”) “to substitute
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`tyloxapol for polysorbate 80” in Ogawa’s example 6.
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`Observation #5 - In Ex. 2342, at 221:2-14, Dr. Lawrence testified that Doi
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`(EX2030) “does not” teach the use of tyloxapol in any formulation. At 222:1-4,
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`when asked if the alkylphenols of the Doi patent all contain an OH group directly
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`attached to the phenyl ring, Dr. Lawrence testified “[t]hat is correct.” And when
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`asked whether she agreed with the prior testimony of Dr. Laskar2 that “[t]he OH
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`group [in tyloxapol] is not directly attached [to the phenyl ring],” Dr. Lawrence
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`testified that “I think the average structure looks like that” and that she had not
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`done any testing to confirm that any individual tyloxapol molecules would have a
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`free hydroxyl on the ring. EX2342, 224:18-225:9. This testimony is relevant to
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`the statements in Dr. Lawrence’s reply declaration, Ex. 1094, ¶¶ 32-33, and in the
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`Reply at pp. 6-7. This testimony is relevant to the weight and understanding to be
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`given Dr. Lawrence’s opinion that Doi teaches a “class of compounds to which
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`tyloxapol belongs,” because Doi does not teach the use of tyloxapol and the
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`alkylphenols disclosed by Doi are structurally different from tyloxapol.
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`Observation #6 - In Ex. 2342, at 181:11-186:17, Dr. Lawrence agreed that
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`the ’956 application (EX1097) and WO ’610 (EX1098) concern “a method and
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`composition for treatment” “of snoring, sleep apnea, or sudden infant death
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`syndrome and for improvement of nasal breathing” “by nasal and/or pharyngeal
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`2 Dr. Laskar is the expert for the Petitioner in separate, but related, IPR proceedings
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`involving the same family of patents.
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`administration” and “use tyloxapol as an active pharmaceutical ingredient,”
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`whereas “the ’290, ’131, ’813, and ’606 patents do not use tyloxapol as an active
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`pharmaceutical ingredient.” Dr. Lawrence also testified, at 186:19-191:1, that the
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`’956 application and WO ’610 disclose preferred doses, in weight per volume
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`percent, of: 1 percent to 10 percent for treatment of snoring; 1 percent to 15
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`percent for treatment of sleep apnea; 0.5 percent to 15 percent for improvement of
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`sleep pattern, increase of alertness, and improvement of breathing; and 0.05
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`percent to 1 percent for treatment of sudden infant death syndrome. See also
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`EX2342, 191:3-14 (on whether “[t]he approach that the ’956 application and the
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`WO 610 reference took is different from the approach that the inventors of the
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`’290, ’131, ’813, and ’606 patents took when formulating the claimed aqueous
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`liquid preparations of those patents”: “They’re formulating for different route of
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`administration. So some things are bound to be different.”). This testimony is
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`relevant to the statements in Dr. Lawrence’s reply declaration, Ex. 1094, ¶ 31, n.5,
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`and in the Reply at p. 7. This testimony is relevant to the weight and
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`understanding to be given to Dr. Lawrence’s opinion that “[t]he prior art also
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`teaches that tyloxapol is . . . an antioxidant,” because it illustrates that there are
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`differences between the formulations in the references Dr. Lawrence cited for this
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`proposition and those claimed in the patents-at-issue, which render the teachings of
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`the ’956 application and WO ’610 irrelevant.
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`Observation #7 - In Ex. 2342, at 194:1-195:3, Dr. Lawrence testified that
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`Kennedy (EX1100) is “not directed to ophthalmic formulations,” and agreed that it
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`does not teach benzalkonium chloride (“BAC”), bromfenac, or any commercially
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`marketed NSAID. At 195:117-196:2, when asked whether the approach that
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`Kennedy took is different from the approach that the inventors of the patents-at-
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`issue took, Dr. Lawrence stated “Yes, I don’t believe that the authors specifically –
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`yes. It is different.” At 195:11-16, Dr. Lawrence agreed that a stated object of
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`Kennedy was “to provide a method to inhibit oxidant chemical reactions caused by
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`partially reduced O2 species,” which she testified are not included in the claimed
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`formulations of the patents-at-issue. EX2342, 234:20-235:2. This testimony is
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`relevant to the statements in Dr. Lawrence’s reply declaration, Ex. 1094, ¶¶ 31, 37,
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`n.5, and in the Reply at pp. 4, 7. This testimony is relevant to the weight and
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`understanding to be given to Dr. Lawrence’s statements regarding tyloxapol’s
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`alleged antioxidant properties because it illustrates that there are differences
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`between the formulations disclosed in Kennedy, which Dr. Lawrence cites for this
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`proposition, and those claimed in the patents-at-issue, which render the teachings
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`of Kennedy irrelevant. This testimony is also relevant to the weight and
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`understanding to be given to Dr. Lawrence’s assertion that “it was known that
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`tyloxapol inhibits the oxidation caused by oxygen based species” 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 patents-at-issue.
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`Observation #8 - In Ex. 2342, at 198:1-199:6, Dr. Lawrence testified that
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`Ghio 1994 (EX1102) “does not teach bromfenac” and agreed that it “does not
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`teach any NSAID,” “does not teach benzalkonium chloride,” and “does not
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`disclose any ophthalmic formulations.” At 200:10-201:5, she testified: “Q. Just to
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`be clear, the approach the Ghio 1994 reference took is different from the approach
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`that the inventors of the ’290, ’131, ’813, and ’606 patents took when formulating
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`the claimed aqueous liquid preparations of those patents; correct? . . . THE
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`WITNESS: Sorry. My understanding is they’re looking at different things, yes.”
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`See also EX2342, 199:7-200:9 (agreeing that Ghio 1994 “deals with protection
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`against lung injury from partially reduced oxygen species”). This testimony is
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`relevant to the statements in Dr. Lawrence’s reply declaration, Ex. 1094, ¶¶ 31, 33,
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`37, n.5, and in the Reply at p. 7, particularly to the weight and understanding to be
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`given to Dr. Lawrence’s reliance on Ghio 1994 as allegedly “suggesting that
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`tyloxapol is an antioxidant” because it illustrates the differences between the
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`formulations disclosed in Ghio 1994 and those claimed in the patents-at-issue and
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`further demonstrates that Ghio 1994 is not relevant to the claimed subject matter
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`because partially reduced O2 species are not identified in the patents-at-issue.
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`Observation #9 - In Ex. 2342, at 167:8-12, Dr. Lawrence testified: “Q. You
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`never conducted any testing in connection with your opinions in this case; correct?
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`. . . THE WITNESS: No, I have not conducted experiments.” At 192:6-193:11,
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`after being shown Dr. Laskar’s testimony, Dr. Lawrence testified: “Q. . . . Do you
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`agree with Dr. Laskar that the ’956 application and the WO 610 reference do not
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`disclose any actual data showing any antioxidant effects of tyloxapol? A. I
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`thought I just answered that question when you asked me myself. I said I don’t
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`believe it does.” This testimony is relevant to the statements in Dr. Lawrence’s
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`reply declaration, Ex. 1094, ¶¶ 31, 33, 37, n.5, and in the Reply at pp. 5-9. This
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`testimony is relevant to the weight and understanding to be given to Dr.
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`Lawrence’s statements and conclusions regarding tyloxapol allegedly being a
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`“potent antioxidant” and having an “antioxidant property” because it establishes
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`that Dr. Lawrence did not conduct any experiments to support her conclusions,
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`instead relying on references that, as discussed above, describe different
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`formulations from those of the patents-at-issue and that further do not provide any
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`supporting data.
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`Observation #10 - In Ex. 2342, at 109:17-111:21, when shown Dr. Laskar’s
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`testimony and asked whether she agreed with Dr. Laskar that “there is nothing
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`explicit in the prior art concerning the interaction of bromfenac and benzalkonium
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`chloride,” Dr. Lawrence testified “ . . . I agree with Dr. Laskar, I haven’t seen
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`anything explicit.” See also EX2342, 111:22-112:5 (has not seen anything
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`reporting the solubility of any complex between bromfenac and BAC). At 112:7-
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`113:19, Dr. Lawrence testified: “Q. You, likewise, have conducted no test to
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`determine whether bromfenac itself actually interacts with benzalkonium chloride
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`to form a turbid or hazy drug product and diminish the antimicrobial preservative
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`effectiveness of the benzalkonium chloride; correct? A. I’ve done no experiment,
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`no . . . .” See also EX2342, 113:20-115:21 (did not review any spectroscopic data
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`to determine whether bromfenac interacts with BAC). This testimony is relevant
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`to the statements in Dr. Lawrence’s reply declaration, Ex. 1094, ¶¶ 13, 22, 24, 26-
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`28, 30-31, 35, 37, 40, 43-53, and in the Reply at pp. 1, 4-5, 8-12. This testimony is
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`relevant to the weight and understanding to be given to Dr. Lawrence’s broad
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`statements and conclusions regarding BAC allegedly forming complexes with
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`acidic NSAIDs such as bromfenac because she testified that she has not seen any
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`evidence to support her conclusion that such an interaction occurs between BAC
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`and bromfenac, and she did not conduct any experiments or review any
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`spectroscopic data to substantiate her conclusion.
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`Observation #11 - In Ex. 2342, at 39:10-40:12, Dr. Lawrence
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`acknowledged that when previously asked: “Q. No complex would form between
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`bromfenac and the methyl or ethyl parabens in the formulations of the Ogawa
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`patent, correct?” she testified “[c]orrect.” See also EX2342, 38:15-22 (agreeing
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`that the formulation of example 7 of the Ogawa ’225 patent uses a combination of
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`methylparaben and ethylparaben instead of BAC). At 40:13-42:10, Dr. Lawrence
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`testified, regarding the FDA-approved package insert for sulfacetamide sodium
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`ophthalmic solution, USP, 10 percent (EX2328), as follows: “Q. The ophthalmic
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`solution disclosed in Exhibit 2328 contains the preservative methylparaben;
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`correct? A. That’s what it says here.” At 42:15-46-17, Dr. Lawrence agreed that
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`the 2000 edition of the Handbook of Pharmaceutical Excipients (EX1168) states
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`that “[m]ethylparaben is widely used as an antimicrobial preservative in . . .
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`pharmaceutical formulations” and acknowledged that she previously testified that
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`it further states that “parabens are effective over a wide pH range and have a broad
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`spectrum of antimicrobial activity.” See EX2342, 52:8-16 (agreeing that “[a]s of
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`2003, the two most common references a formulator would have looked to in
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`identifying excipients for pharmaceutical formulations would have been the 2000
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`edition of the Handbook of Pharmaceutical Excipients and the FDA’s GRAS list”);
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`EX2342, 52:17-55:1 (regarding the excipients listed in the FDA’s GRAS list,
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`including methylparaben). Moreover, at 106:9-109:16, after being impeached with
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`her prior testimony, Dr. Lawrence conceded she used the term “hindsight” to
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`describe her opinions, at least with respect to the POSA’s alleged preference to
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`modify a formulation to remove any incompatibility issue with BAC rather than
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`use a different preservative. This testimony is relevant to the statements in Dr.
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`Lawrence’s reply declaration, Ex. 1094, ¶¶ 24, 64-68, and in the Reply at pp. 15-
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`16. This testimony is relevant to the weight and understanding to be given to Dr.
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`Lawrence’s declaration statements regarding the POSA’s alleged motivation to
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`select Ogawa example 6 instead of Ogawa example 7, the POSA’s alleged
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`preference to modifying the formulation to remove any incompatibility rather than
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`use a different preservative, and the alleged lack of viability of using parabens as
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`preservatives instead of BAC.
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`Observation #12 - In Ex. 2342, at 95:5-96:13, Dr. Lawrence acknowledged
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`that, in prior testimony regarding Yanni (EX1007), when asked: “Q. In your
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`opinion, the Yanni ’034 patent teaches that to achieve penetration, high
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`concentrations of bromfenac might be needed, and the Yanni ’034 patent uses this
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`as a starting point for formulation with esters and amides; correct?” she answered:
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`“They used that, yes. They used that for their starting point, that’s correct.” See
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`also EX2342, 99:16-19 (testifying that the Yanni ’034 patent discloses “a number”
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`of other compounds in table 1 besides bromfenac); EX2342, 90:3-91:17
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`(acknowledging that she previously testified that “[t]he statement [that Yanni]
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`described an ophthalmic formulation of bromfenac derivatives and esters, I
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`believe, is true”); EX2342, 92:7-10 (agreeing that “[t]he claimed formulations of
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`the ’290, ’131, ’813, and ’606 patents do not use bromfenac derivatives and
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`esters”). At 84:20-87:21, Dr. Lawrence agreed that Yanni teaches that “[r]elatively
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`high concentrations” of benzoylphenylacetic acids “are often needed to achieve
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`corneal penetration rates sufficient
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`to provide effective
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`intraocular drug
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`concentrations” and that “[s]uch high drug concentrations are generally not
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`desirable as they may provoke ocular irritation and discomfort,” and further agreed
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`that bromfenac is a benzoylphenylacetic acid. This testimony is relevant to the
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`statements in Dr. Lawrence’s reply declaration, Ex. 1094, ¶¶ 14-15, and in the
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`Reply at pp. 9-12. This testimony is relevant to the weight and understanding to be
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`given to Dr. Lawrence’s assertion that “a POSA in 2003 would have been
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`motivated to formulate an ophthalmic preparation containing bromfenac” and her
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`reliance on Yanni as teaching an alleged superiority of bromfenac over diclofenac.
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`Observation #13 - In Ex. 2342, at 120:6-122:13, Dr. Lawrence testified that
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`the prior art regarding diclofenac
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`is relevant
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`to bromfenac ophthalmic
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`formulations, acknowledging her reliance on prior art regarding diclofenac in
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`providing her opinion “[i]n response to what Dr. Davies and Dr. Williams
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`commented on.” At 122:21-124:2, Dr. Lawrence testified that Bowman (EX1111)
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`teaches that diclofenac and BAC “were unexpectedly compatible” in an aqueous
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`liquid preparation for ophthalmic use. This testimony is relevant to the statements
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`in Dr. Lawrence’s reply declaration, Ex. 1094, ¶¶ 13, 22, 24, 26-28, 30-31, 35, 37,
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`40, 43-53, and in the Reply at pp. 1, 4-5, 8-12. This testimony is relevant to the
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`weight and understanding to be given to Dr. Lawrence’s broad statements and
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`conclusions regarding BAC allegedly forming complexes with acidic NSAIDs
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`such as bromfenac because it reflects that the prior art does not support her
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`conclusion with respect to an alleged formation of a complex between BAC and an
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`NSAID.
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`Observation #14 - In Ex. 2342, at 146:8-148:18, Dr. Lawrence, after being
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`impeached with her prior testimony, conceded that Sallmann (EX1021) teaches the
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`use of tyloxapol as a solubilizer, not a stabilizer. At 118:5-11, Dr. Lawrence
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`further admitted that with respect to aqueous liquid preparations, the concepts of
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`stability and solubility are not synonymous at all. Consequently, at 149:6-150:16,
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`after further impeachment, Dr. Lawrence conceded that Sallmann’s approach
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`differs from the approach the inventors of the patents-at-issue took when
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`formulating the claimed aqueous liquid preparations of those patents. This
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`testimony is relevant to the statements in Dr. Lawrence’s reply declaration, Ex.
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`1094, ¶¶ 10, 28-42, and in the Reply at pp. 1, 3-9. This testimony is relevant to the
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`weight and understanding to be given to Dr. Lawrence’s declaration statements
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`regarding the alleged motivation of a POSA to combine Sallmann with Ogawa.
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`Observation #15 - In Ex. 2343, at 58:19-59:9, when asked whether he had
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`any experience administering, designing, or evaluating the pharmaceutical
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`formulations that are disclosed and claimed in the patents-at-issue, Mr. Hofmann
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`testified “[n]ot from any technical perspective.” See also EX2343, 13:16-14:13
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`(not an expert in any field of medicine), 20:17-21:19 (not a technical expert in
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`methods of using pharmaceutical products or an “in any technical way” an expert
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`in pharmaceutical formulations, ophthalmic formulations, or the manufacture of
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`pharmaceuticals), 88:6-7 (not a “clinician” or “technical expert”). This testimony
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`is relevant to the statements in Mr. Hofmann’s reply declaration, Ex. 1122, ¶¶ 25-
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`27, 42, 59-60, 62, 69-70, 72-80, 86-87, 99, 102, and 110, particularly the weight
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`and understanding to be given to Mr. Hofmann’s opinions as stated therein,
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`because Mr. Hofmann lacks the relevant technical or medical expertise or
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`experience to provide these opinions.
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`Observation #16 - In Ex. 2343, at 88:20-90:14, when asked the percentage
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`of Prolensa® sales are the result of “marketing and promotion efforts,” the alleged
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`“life-cycle management strategy,” and “coupon programs,” Mr. Hofmann failed to
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`provide values, instead testifying that he did not have a “quantitative percentage.”
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`This testimony is relevant to the statements in Mr. Hofmann’s reply declaration,
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`Ex. 1122, ¶¶ 61, 81-120, and in the Reply at pp. 21-22. This testimony is relevant
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`to the weight and understanding to be given to Mr. Hofmann’s assertion that the
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`performance of Prolensa® is attributable to various extrinsic factors unrelated to the
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`patents-at-issue.
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`Date: May 12, 2016
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`By: /Bryan C. Diner/
`Bryan C. Diner, Lead Counsel
`Registration No. 32,409
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`Counsel for Patent Owner Senju
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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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`
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`OWNER’S MOTION FOR OBSERVATION REGARDING CROSS-
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`EXAMINATION OF REPLY WITNESSES DR. M. JAYNE LAWRENCE,
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`PH.D. AND IVAN T. HOFMANN, CPA/CFF, CLP, was served on May 12,
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`2016, via email directed to counsel of record for the Petitioner at the following:
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`Deborah Yellin
`dyellin@crowell.com
`
`Jonathan Lindsay
`jlindsay@crowell.com
`
`Teresa Stanek Rea
`TRea@crowell.com
`
`Chiemi Suzuki
`CSuzuki@crowell.com
`
`
`
`
`Dated: May 12, 2016
`
`
`
`
`
`/Bradley J. Moore/
`Bradley J. Moore
`Litigation Legal Assistant
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`
`
`
`16