throbber
Paper No. _____
`Dated: May 12, 2016
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`LUPIN LTD. and LUPIN PHARMACEUTICALS INC., INNOPHARMA
`LICENSING, INC., INNOPHARMA LICENSING LLC, INNOPHARMA
`INC., INNOPHARMA LLC, MYLAN PHARMACEUTICALS INC., and
`MYLAN INC.,
`Petitioners,
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD.,
`Patent Owner.
`
`__________________
`
`IPR2015-01097 (US Patent No. 8,751,131)
`IPR2015-01100 (US Patent No. 8,927,606)
` IPR2015-01105 (US Patent No. 8,871,813)1
`__________________
`
`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
`
`
`
`
`1 The word-for-word identical paper is filed in each proceeding identified in the
`
`heading. IPR2016-00089 has been joined with IPR2015-01097; IPR2016-00091
`
`has been joined with IPR2015-01100; and IPR2016-00090 has been joined with
`
`IPR2015-01105. Unless otherwise noted, citations to exhibits and papers herein
`
`apply with equal force to those filed in each proceeding identified in the heading.
`
`

`
`Case Nos. IPR2015-01097; IPR2015-01100; IPR2015-01105
`
`Patent Owner Senju Pharmaceutical Co., Ltd. et al. (“Senju”), submits this
`
`Patent Owner’s Motion for Observation Regarding Cross-Examination of Dr. M.
`
`Jayne Lawrence and Mr. Ivan T. Hofmann, pursuant to the Scheduling Order,
`
`Paper No. 10 (filed October 27, 2015), and the Joint Stipulation Adjusting Due
`
`Dates 1, 2 & 4, Paper No. 16 (filed January 6, 2016).
`
`Observation #1 - In Ex. 2342, at 10:21-11:11, Dr. Lawrence acknowledged
`
`that it was her prior testimony that she had never been qualified by any court or by
`
`the U.S. Patent and Trademark Office as an expert in chemistry. At 11:12-20, Dr.
`
`Lawrence testified that she is not an expert in medicinal chemistry, organic
`
`chemistry, or antioxidant chemistry. See also EX2342, 9:11-14:10, 16:3-23:10
`
`(additional testimony on Dr. Lawrence’s background and qualifications). This
`
`testimony is relevant to the statements and conclusions in Dr. Lawrence’s reply
`
`declaration, Ex. 1094, ¶¶ 31, 33, 36-37, 48-49, 51-52, 73, n.5, regarding and
`
`relying on chemistry, and in Petitioners’ Reply2 at pp. 1, 6-9. This testimony is
`
`relevant to the weight and understanding to be given to Dr. Lawrence’s statements
`
`and conclusions in her declaration because it establishes her lack of qualification to
`
`testify on the subject matter for which she has offered opinions.
`
`Observation #2 - In Ex. 2342, at 179:20-180:1, when asked whether the
`
`2 Petitioners’ Reply (“Reply”) is Paper No. 35 in IPR2015-01097, IPR2015-01100,
`
`and IPR2015-01105. All were filed April 22, 2016.
`
`
`
`2
`
`

`
`Case Nos. IPR2015-01097; IPR2015-01100; IPR2015-01105
`
`claimed formulations of the ’290, ’131, ’813, and ’606 patents contain metals or
`
`metal cations, Dr. Lawrence testified: “They contain sodium cation.” See also
`
`EX2342, 179:11-19 (on how metals and metal cations differ). This testimony is
`
`relevant to the statements in Dr. Lawrence’s reply declaration, Ex. 1094, ¶ 31, n.5,
`
`regarding the alleged teachings in the Merck Index (EX1096) and Remington: The
`
`Science and Practice of Pharmacy (1995) (EX1051) that tyloxapol is “oxidized by
`
`metals,” and the corresponding arguments in the Reply at p. 7. This testimony is
`
`relevant because it establishes that the alleged teachings of the Merck Index and
`
`Remington are inapplicable to the ’290, ’131, ’813, and ’606 patents (the “patents-
`
`at-issue”) because the claimed formulations contain metal cations, not metals.
`
`Observation #3 - In Ex. 2342, at 180:21-181:8, Dr. Lawrence testified as
`
`follows: “Q. . . . The claimed formulations of the ’290, ’131, ’813, and ’606
`
`patents are not formulated for nasal administration; correct? A. That’s my
`
`understanding, yes. Q. The claimed formulations of the ’290, ’131, ’813, and ’606
`
`patents are not formulated for pharyngeal administration; correct? A. Yes, I
`
`believe that’s -- yes, that’s correct.” See also EX2342, 180:2-5 (the patents-at-
`
`issue are formulated for ophthalmic administration). This testimony is relevant to
`
`the statements regarding the alleged behavior of tyloxapol in liquid preparations
`
`for nasal and/or pharyngeal applications in Dr. Lawrence’s reply declaration, Ex.
`
`1094, ¶ 31, n.5, and in the Reply at p. 7. This testimony is relevant because it
`
`
`
`3
`
`

`
`Case Nos. IPR2015-01097; IPR2015-01100; IPR2015-01105
`
`establishes that the alleged behavior of tyloxapol in liquid preparations for nasal
`
`and/or pharyngeal applications is irrelevant to the subject matter of the patents-at-
`
`issue because
`
`the claimed
`
`formulations are
`
`formulated
`
`for ophthalmic
`
`administration, not nasal or pharyngeal administration.
`
`Observation #4 - In Ex. 2342, at 32:17-33:5, Dr. Lawrence agreed that
`
`Ogawa (EX1010) “identified the formulations of examples 6, 7, and 8 as not
`
`forming red insoluble matters and described them as stable, excellent for a long
`
`period of time” and testified that the formulations of Ogawa examples 6, 7, and 8
`
`did “not [have any problems with instability or degradation] under the conditions
`
`tested.” See also EX2342, 62:22-64:3. At 33:6-34:2, Dr. Lawrence further
`
`testified: “Q. In your view, the Ogawa ’225 patent solved bromfenac’s stability
`
`problem by showing that, under the conditions of examples 6, 7, and 8, the
`
`formulations were stable; correct? . . . THE WITNESS: The patent states under the
`
`one condition that the formulations were tested for. That is 60 degrees, say, at four
`
`weeks. It calls the formulations excellently stable.” This testimony is relevant to
`
`the statements in Dr. Lawrence’s reply declaration, Ex. 1094, ¶¶ 22, 26-27, 31, 37-
`
`42, and in the Reply at pp. 1-9. This testimony is relevant to the weight and
`
`understanding to be given to Dr. Lawrence’s declaration statements regarding the
`
`alleged motivation of a person of ordinary skill in the art (“POSA”) “to substitute
`
`tyloxapol for polysorbate 80” in Ogawa’s example 6.
`
`
`
`4
`
`

`
`Case Nos. IPR2015-01097; IPR2015-01100; IPR2015-01105
`
`Observation #5 - In Ex. 2342, at 221:2-14, Dr. Lawrence testified that Doi
`
`(EX2030) “does not” teach the use of tyloxapol in any formulation. At 222:1-4,
`
`when asked if the alkylphenols of the Doi patent all contain an OH group directly
`
`attached to the phenyl ring, Dr. Lawrence testified “[t]hat is correct.” And when
`
`asked whether she agreed with the prior testimony of Dr. Laskar3 that “[t]he OH
`
`group [in tyloxapol] is not directly attached [to the phenyl ring],” Dr. Lawrence
`
`testified that “I think the average structure looks like that” and that she had not
`
`done any testing to confirm that any individual tyloxapol molecules would have a
`
`free hydroxyl on the ring. EX2342, 224:18-225:9. This testimony is relevant to
`
`the statements in Dr. Lawrence’s reply declaration, Ex. 1094, ¶¶ 32-33, and in the
`
`Reply at pp. 6-7. This testimony is relevant to the weight and understanding to be
`
`given Dr. Lawrence’s opinion that Doi teaches a “class of compounds to which
`
`tyloxapol belongs,” because Doi does not teach the use of tyloxapol and the
`
`alkylphenols disclosed by Doi are structurally different from tyloxapol.
`
`Observation #6 - In Ex. 2342, at 181:11-186:17, Dr. Lawrence agreed that
`
`the ’956 application (EX1097) and WO ’610 (EX1098) concern “a method and
`
`composition for treatment” “of snoring, sleep apnea, or sudden infant death
`
`syndrome and for improvement of nasal breathing” “by nasal and/or pharyngeal
`
`3 Dr. Laskar is the expert for the Petitioner in separate, but related, IPR proceedings
`
`involving the same family of patents.
`
`
`
`5
`
`

`
`Case Nos. IPR2015-01097; IPR2015-01100; IPR2015-01105
`
`administration” and “use tyloxapol as an active pharmaceutical ingredient,”
`
`whereas “the ’290, ’131, ’813, and ’606 patents do not use tyloxapol as an active
`
`pharmaceutical ingredient.” Dr. Lawrence also testified, at 186:19-191:1, that
`
`the ’956 application and WO ’610 disclose preferred doses, in weight per volume
`
`percent, of: 1 percent to 10 percent for treatment of snoring; 1 percent to 15
`
`percent for treatment of sleep apnea; 0.5 percent to 15 percent for improvement of
`
`sleep pattern, increase of alertness, and improvement of breathing; and 0.05
`
`percent to 1 percent for treatment of sudden infant death syndrome. See also
`
`EX2342, 191:3-14 (on whether “[t]he approach that the ’956 application and the
`
`WO 610 reference took is different from the approach that the inventors of
`
`the ’290, ’131, ’813, and ’606 patents took when formulating the claimed aqueous
`
`liquid preparations of those patents”: “They’re formulating for different route of
`
`administration. So some things are bound to be different.”). This testimony is
`
`relevant to the statements in Dr. Lawrence’s reply declaration, Ex. 1094, ¶ 31, n.5,
`
`and in the Reply at p. 7. This testimony is relevant to the weight and
`
`understanding to be given to Dr. Lawrence’s opinion that “[t]he prior art also
`
`teaches that tyloxapol is . . . an antioxidant,” because it illustrates that there are
`
`differences between the formulations in the references Dr. Lawrence cited for this
`
`proposition and those claimed in the patents-at-issue, which render the teachings of
`
`the ’956 application and WO ’610 irrelevant.
`
`
`
`6
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`

`
`Case Nos. IPR2015-01097; IPR2015-01100; IPR2015-01105
`
`Observation #7 - In Ex. 2342, at 194:1-195:3, Dr. Lawrence testified that
`
`Kennedy (EX1100) is “not directed to ophthalmic formulations,” and agreed that it
`
`does not teach benzalkonium chloride (“BAC”), bromfenac, or any commercially
`
`marketed NSAID. At 195:117-196:2, when asked whether the approach that
`
`Kennedy took is different from the approach that the inventors of the patents-at-
`
`issue took, Dr. Lawrence stated “Yes, I don’t believe that the authors specifically –
`
`yes. It is different.” At 195:11-16, Dr. Lawrence agreed that a stated object of
`
`Kennedy was “to provide a method to inhibit oxidant chemical reactions caused by
`
`partially reduced O2 species,” which she testified are not included in the claimed
`
`formulations of the patents-at-issue. EX2342, 234:20-235:2. This testimony is
`
`relevant to the statements in Dr. Lawrence’s reply declaration, Ex. 1094, ¶¶ 31, 37,
`
`n.5, and in the Reply at pp. 4, 7. This testimony is relevant to the weight and
`
`understanding to be given to Dr. Lawrence’s statements regarding tyloxapol’s
`
`alleged antioxidant properties because it illustrates that there are differences
`
`between the formulations disclosed in Kennedy, which Dr. Lawrence cites for this
`
`proposition, and those claimed in the patents-at-issue, which render the teachings
`
`of Kennedy irrelevant. This testimony is also relevant to the weight and
`
`understanding to be given to Dr. Lawrence’s assertion that “it was known that
`
`tyloxapol inhibits the oxidation caused by oxygen based species” because it further
`
`demonstrates that any such discussion in Kennedy is not relevant to the claimed
`
`
`
`7
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`

`
`Case Nos. IPR2015-01097; IPR2015-01100; IPR2015-01105
`
`subject matter given that partially reduced O2 species are not identified in the
`
`claimed formulations of the patents-at-issue.
`
`Observation #8 - In Ex. 2342, at 198:1-199:6, Dr. Lawrence testified that
`
`Ghio 1994 (EX1102) “does not teach bromfenac” and agreed that it “does not
`
`teach any NSAID,” “does not teach benzalkonium chloride,” and “does not
`
`disclose any ophthalmic formulations.” At 200:10-201:5, she testified: “Q. Just to
`
`be clear, the approach the Ghio 1994 reference took is different from the approach
`
`that the inventors of the ’290, ’131, ’813, and ’606 patents took when formulating
`
`the claimed aqueous liquid preparations of those patents; correct? . . . THE
`
`WITNESS: Sorry. My understanding is they’re looking at different things, yes.”
`
`See also EX2342, 199:7-200:9 (agreeing that Ghio 1994 “deals with protection
`
`against lung injury from partially reduced oxygen species”). This testimony is
`
`relevant to the statements in Dr. Lawrence’s reply declaration, Ex. 1094, ¶¶ 31, 33,
`
`37, n.5, and in the Reply at p. 7, particularly to the weight and understanding to be
`
`given to Dr. Lawrence’s reliance on Ghio 1994 as allegedly “suggesting that
`
`tyloxapol is an antioxidant” because it illustrates the differences between the
`
`formulations disclosed in Ghio 1994 and those claimed in the patents-at-issue and
`
`further demonstrates that Ghio 1994 is not relevant to the claimed subject matter
`
`because partially reduced O2 species are not identified in the patents-at-issue.
`
`Observation #9 - In Ex. 2342, at 167:8-12, Dr. Lawrence testified: “Q. You
`
`
`
`8
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`

`
`Case Nos. IPR2015-01097; IPR2015-01100; IPR2015-01105
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`never conducted any testing in connection with your opinions in this case;
`
`correct? . . . THE WITNESS: No, I have not conducted experiments.” At 192:6-
`
`193:11, after being shown Dr. Laskar’s testimony, Dr. Lawrence testified: “Q. . . .
`
`Do you agree with Dr. Laskar that the ’956 application and the WO 610 reference
`
`do not disclose any actual data showing any antioxidant effects of tyloxapol? A. I
`
`thought I just answered that question when you asked me myself. I said I don’t
`
`believe it does.” This testimony is relevant to the statements in Dr. Lawrence’s
`
`reply declaration, Ex. 1094, ¶¶ 31, 33, 37, n.5, and in the Reply at pp. 5-9. This
`
`testimony is relevant to the weight and understanding to be given to Dr.
`
`Lawrence’s statements and conclusions regarding tyloxapol allegedly being a
`
`“potent antioxidant” and having an “antioxidant property” because it establishes
`
`that Dr. Lawrence did not conduct any experiments to support her conclusions,
`
`instead relying on references that, as discussed above, describe different
`
`formulations from those of the patents-at-issue and that further do not provide any
`
`supporting data.
`
`Observation #10 - In Ex. 2342, at 109:17-111:21, when shown Dr. Laskar’s
`
`testimony and asked whether she agreed with Dr. Laskar that “there is nothing
`
`explicit in the prior art concerning the interaction of bromfenac and benzalkonium
`
`chloride,” Dr. Lawrence testified “ . . . I agree with Dr. Laskar, I haven’t seen
`
`anything explicit.” See also EX2342, 111:22-112:5 (has not seen anything
`
`
`
`9
`
`

`
`Case Nos. IPR2015-01097; IPR2015-01100; IPR2015-01105
`
`reporting the solubility of any complex between bromfenac and BAC). At 112:7-
`
`113:19, Dr. Lawrence testified: “Q. You, likewise, have conducted no test to
`
`determine whether bromfenac itself actually interacts with benzalkonium chloride
`
`to form a turbid or hazy drug product and diminish the antimicrobial preservative
`
`effectiveness of the benzalkonium chloride; correct? A. I’ve done no experiment,
`
`no . . . .” See also EX2342, 113:20-115:21 (did not review any spectroscopic data
`
`to determine whether bromfenac interacts with BAC). This testimony is relevant
`
`to the statements in Dr. Lawrence’s reply declaration, Ex. 1094, ¶¶ 13, 22, 24, 26-
`
`28, 30-31, 35, 37, 40, 43-53, and in the Reply at pp. 1, 4-5, 8-12. This testimony is
`
`relevant to the weight and understanding to be given to Dr. Lawrence’s broad
`
`statements and conclusions regarding BAC allegedly forming complexes with
`
`acidic NSAIDs such as bromfenac because she testified that she has not seen any
`
`evidence to support her conclusion that such an interaction occurs between BAC
`
`and bromfenac, and she did not conduct any experiments or review any
`
`spectroscopic data to substantiate her conclusion.
`
`
`
`Observation #11 - In Ex. 2342, at 39:10-40:12, Dr. Lawrence
`
`acknowledged that when previously asked: “Q. No complex would form between
`
`bromfenac and the methyl or ethyl parabens in the formulations of the Ogawa
`
`patent, correct?” she testified “[c]orrect.” See also EX2342, 38:15-22 (agreeing
`
`that the formulation of example 7 of the Ogawa ’225 patent uses a combination of
`
`
`
`10
`
`

`
`Case Nos. IPR2015-01097; IPR2015-01100; IPR2015-01105
`
`methylparaben and ethylparaben instead of BAC). At 40:13-42:10, Dr. Lawrence
`
`testified, regarding the FDA-approved package insert for sulfacetamide sodium
`
`ophthalmic solution, USP, 10 percent (EX2328), as follows: “Q. The ophthalmic
`
`solution disclosed in Exhibit 2328 contains the preservative methylparaben;
`
`correct? A. That’s what it says here.” At 42:15-46-17, Dr. Lawrence agreed that
`
`the 2000 edition of the Handbook of Pharmaceutical Excipients (EX1168) states
`
`that “[m]ethylparaben is widely used as an antimicrobial preservative in . . .
`
`pharmaceutical formulations” and acknowledged that she previously testified that
`
`it further states that “parabens are effective over a wide pH range and have a broad
`
`spectrum of antimicrobial activity.” See EX2342, 52:8-16 (agreeing that “[a]s of
`
`2003, the two most common references a formulator would have looked to in
`
`identifying excipients for pharmaceutical formulations would have been the 2000
`
`edition of the Handbook of Pharmaceutical Excipients and the FDA’s GRAS list”);
`
`EX2342, 52:17-55:1 (regarding the excipients listed in the FDA’s GRAS list,
`
`including methylparaben). Moreover, at 106:9-109:16, after being impeached with
`
`her prior testimony, Dr. Lawrence conceded she used the term “hindsight” to
`
`describe her opinions, at least with respect to the POSA’s alleged preference to
`
`modify a formulation to remove any incompatibility issue with BAC rather than
`
`use a different preservative. This testimony is relevant to the statements in Dr.
`
`Lawrence’s reply declaration, Ex. 1094, ¶¶ 24, 64-68, and in the Reply at pp. 15-
`
`
`
`11
`
`

`
`Case Nos. IPR2015-01097; IPR2015-01100; IPR2015-01105
`
`16. This testimony is relevant to the weight and understanding to be given to Dr.
`
`Lawrence’s declaration statements regarding the POSA’s alleged motivation to
`
`select Ogawa example 6 instead of Ogawa example 7, the POSA’s alleged
`
`preference to modifying the formulation to remove any incompatibility rather than
`
`use a different preservative, and the alleged lack of viability of using parabens as
`
`preservatives instead of BAC.
`
`
`
`Observation #12 - In Ex. 2342, at 95:5-96:13, Dr. Lawrence acknowledged
`
`that, in prior testimony regarding Yanni (EX1007), when asked: “Q. In your
`
`opinion, the Yanni ’034 patent teaches that to achieve penetration, high
`
`concentrations of bromfenac might be needed, and the Yanni ’034 patent uses this
`
`as a starting point for formulation with esters and amides; correct?” she answered:
`
`“They used that, yes. They used that for their starting point, that’s correct.” See
`
`also EX2342, 99:16-19 (testifying that the Yanni ’034 patent discloses “a number”
`
`of other compounds in table 1 besides bromfenac); EX2342, 90:3-91:17
`
`(acknowledging that she previously testified that “[t]he statement [that Yanni]
`
`described an ophthalmic formulation of bromfenac derivatives and esters, I
`
`believe, is true”); EX2342, 92:7-10 (agreeing that “[t]he claimed formulations of
`
`the ’290, ’131, ’813, and ’606 patents do not use bromfenac derivatives and
`
`esters”). At 84:20-87:21, Dr. Lawrence agreed that Yanni teaches that “[r]elatively
`
`high concentrations” of benzoylphenylacetic acids “are often needed to achieve
`
`
`
`12
`
`

`
`Case Nos. IPR2015-01097; IPR2015-01100; IPR2015-01105
`
`corneal penetration rates sufficient
`
`to provide effective
`
`intraocular drug
`
`concentrations” and that “[s]uch high drug concentrations are generally not
`
`desirable as they may provoke ocular irritation and discomfort,” and further agreed
`
`that bromfenac is a benzoylphenylacetic acid. This testimony is relevant to the
`
`statements in Dr. Lawrence’s reply declaration, Ex. 1094, ¶¶ 14-15, and in the
`
`Reply at pp. 9-12. This testimony is relevant to the weight and understanding to be
`
`given to Dr. Lawrence’s assertion that “a POSA in 2003 would have been
`
`motivated to formulate an ophthalmic preparation containing bromfenac” and her
`
`reliance on Yanni as teaching an alleged superiority of bromfenac over diclofenac.
`
`
`
`Observation #13 - In Ex. 2342, at 120:6-122:13, Dr. Lawrence testified that
`
`the prior art regarding diclofenac
`
`is relevant
`
`to bromfenac ophthalmic
`
`formulations, acknowledging her reliance on prior art regarding diclofenac in
`
`providing her opinion “[i]n response to what Dr. Davies and Dr. Williams
`
`commented on.” At 122:21-124:2, Dr. Lawrence testified that Bowman (EX1111)
`
`teaches that diclofenac and BAC “were unexpectedly compatible” in an aqueous
`
`liquid preparation for ophthalmic use. This testimony is relevant to the statements
`
`in Dr. Lawrence’s reply declaration, Ex. 1094, ¶¶ 13, 22, 24, 26-28, 30-31, 35, 37,
`
`40, 43-53, and in the Reply at pp. 1, 4-5, 8-12. This testimony is relevant to the
`
`weight and understanding to be given to Dr. Lawrence’s broad statements and
`
`conclusions regarding BAC allegedly forming complexes with acidic NSAIDs
`
`
`
`13
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`

`
`Case Nos. IPR2015-01097; IPR2015-01100; IPR2015-01105
`
`such as bromfenac because it reflects that the prior art does not support her
`
`conclusion with respect to an alleged formation of a complex between BAC and an
`
`NSAID.
`
`
`
`Observation #14 - In Ex. 2342, at 146:8-148:18, Dr. Lawrence, after being
`
`impeached with her prior testimony, conceded that Sallmann (EX1021) teaches the
`
`use of tyloxapol as a solubilizer, not a stabilizer. At 118:5-11, Dr. Lawrence
`
`further admitted that with respect to aqueous liquid preparations, the concepts of
`
`stability and solubility are not synonymous at all. Consequently, at 149:6-150:16,
`
`after further impeachment, Dr. Lawrence conceded that Sallmann’s approach
`
`differs from the approach the inventors of the patents-at-issue took when
`
`formulating the claimed aqueous liquid preparations of those patents. This
`
`testimony is relevant to the statements in Dr. Lawrence’s reply declaration, Ex.
`
`1094, ¶¶ 10, 28-42, and in the Reply at pp. 1, 3-9. This testimony is relevant to the
`
`weight and understanding to be given to Dr. Lawrence’s declaration statements
`
`regarding the alleged motivation of a POSA to combine Sallmann with Ogawa.
`
`
`
`Observation #15 - In Ex. 2343, at 58:19-59:9, when asked whether he had
`
`any experience administering, designing, or evaluating the pharmaceutical
`
`formulations that are disclosed and claimed in the patents-at-issue, Mr. Hofmann
`
`testified “[n]ot from any technical perspective.” See also EX2343, 13:16-14:13
`
`(not an expert in any field of medicine), 20:17-21:19 (not a technical expert in
`
`
`
`14
`
`

`
`Case Nos. IPR2015-01097; IPR2015-01100; IPR2015-01105
`
`methods of using pharmaceutical products or an “in any technical way” an expert
`
`in pharmaceutical formulations, ophthalmic formulations, or the manufacture of
`
`pharmaceuticals), 88:6-7 (not a “clinician” or “technical expert”). This testimony
`
`is relevant to the statements in Mr. Hofmann’s reply declaration, Ex. 1122, ¶¶ 25-
`
`27, 42, 59-60, 62, 69-70, 72-80, 86-87, 99, 102, and 110, particularly the weight
`
`and understanding to be given to Mr. Hofmann’s opinions as stated therein,
`
`because Mr. Hofmann lacks the relevant technical or medical expertise or
`
`experience to provide these opinions.
`
`Observation #16 - In Ex. 2343, at 88:20-90:14, when asked the percentage
`
`of Prolensa® sales are the result of “marketing and promotion efforts,” the alleged
`
`“life-cycle management strategy,” and “coupon programs,” Mr. Hofmann failed to
`
`provide values, instead testifying that he did not have a “quantitative percentage.”
`
`This testimony is relevant to the statements in Mr. Hofmann’s reply declaration,
`
`Ex. 1122, ¶¶ 61, 81-120, and in the Reply at pp. 21-22. This testimony is relevant
`
`to the weight and understanding to be given to Mr. Hofmann’s assertion that the
`
`performance of Prolensa® is attributable to various extrinsic factors unrelated to the
`
`patents-at-issue.
`
`
`Date: May 12, 2016
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`
`
`By: /Bryan C. Diner/
`Bryan C. Diner, Lead Counsel
`Registration No. 32,409
`
`Counsel for Patent Owner Senju
`15
`
`

`
`Case Nos. IPR2015-01097; IPR2015-01100; IPR2015-01105
`
`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. M. JAYNE LAWRENCE,
`
`PH.D. AND IVAN T. HOFMANN, CPA/CFF, CLP, was served on May 12,
`
`2016, via email directed to counsel of record for the Petitioner at the following:
`
`Deborah Yellin
`dyellin@crowell.com
`
`Jonathan Lindsay
`jlindsay@crowell.com
`
`Teresa Stanek Rea
`TRea@crowell.com
`
`Chiemi Suzuki
`CSuzuki@crowell.com
`
`Jitendra Malik
`jitty.malik@alston.com
`
`Bryan Skelton, Ph.D.
`Bryan.skelton@alston.com
`
`Lance Soderstrom
`Lance.soderstrom@alston.com
`
`Hitetada James Abe
`James.abe@alston.com
`
`Joseph M. Janusz
`Joe.janusz@alston.com
`
`
`16
`
`
`
`
`
`

`
`Case Nos. IPR2015-01097; IPR2015-01100; IPR2015-01105
`
`Dated: May 12, 2016
`
`
`
`
`
`
`
`
`
`/Bradley J. Moore/
`Bradley J. Moore
`Litigation Legal Assistant
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`
`17

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