throbber
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.
`
`
`
`IPR2015-01097 (Patent 8,754,131)
`IPR2015-01099 (Patent 8,669,290)
`IPR2015-01100 (Patent 8,927,606)
`IPR2015-01105 (Patent 8,871,813)
`
`
`PETITIONERS’ OPPOSITION TO PATENT OWNER’S MOTION FOR
`OBSERVATION REGARDING CROSS-EXAMINATION OF
`REPLY WITNESSES DR. M. JAYNE LAWRENCE, Ph.D.
`AND IVAN T. HOFMANN, CPA/CFF, CLP1
`
`                                                            
`1 A word-for-word identical paper has been 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. Each of these joined proceedings includes Petitioners
`InnoPharma Licensing, Inc., InnoPharma Licensing LLC, InnoPharma Inc., Mylan
`Pharmaceuticals Inc., and Mylan Inc. (collectively, “InnoPharma”) in addition to
`the parties identified above.
`
`

`
`Pursuant to the Scheduling Order (Paper No. 10 at 4), Petitioners file their
`
`Opposition to Patent Owner’s Motion for Observation Regarding Cross-
`
`Examination of Dr. M. Jayne Lawrence and Mr. Ivan T. Hofmann.
`
`Patent Owner’s Motion for Observation mischaracterizes the testimony of
`
`Dr. Lawrence and Mr. Hofmann, and further includes several arguments to the
`
`merits, which is an improper use of the Motion for Observation as a vehicle to
`
`make arguments in sur-reply. Regardless, those arguments to the merits, which
`
`ultimately fail to contradict any of Petitioner’s positions in this proceeding, further
`
`show why Patent Owner’s Motion to Exclude Under 37 C.F.R. § 42.64(C) (Paper
`
`No. 46) is without merit. Accordingly, the Board should expunge or give no
`
`weight to Patent Owner’s purported observations.
`
`Response to Observation #1: Patent Owner’s observation is not relevant
`
`and mischaracterizes Dr. Lawrence’s Reply Declaration and testimony. Dr.
`
`Lawrence offered statements and conclusions in her Reply Declaration (EX1094)
`
`that are well within her qualifications, which include: a PhD in Pharmacy,
`
`EX1005, ¶ 3; prior expert qualification in the field of formulation and drug
`
`delivery, EX1094, ¶¶ 4-5; acting Head of the Pharmaceutical Biophysics Group of
`
`the Institute of Pharmaceutical Science at Kings College, and previously the Chief
`
`Scientist at the Royal Pharmaceutical Society, EX1005, ¶¶ 7-8; professor at Kings
`
`College of multiple courses related to physical chemistry of micelles, physical
`
`1
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`

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`chemistry of emulsions and biopharmaceutics and bio-pharmacy, EX1054 at 7; and
`
`publications in the field of physical and colloid chemistry. Id. at 8.
`
`Dr. Lawrence is also more than qualified under Patent Owner’s own
`
`definition of a POSA by Patent Owner’s “chemistry” expert, Dr. Davies: someone
`
`with at least a Bachelor’s degree in a field of science which includes
`
`“pharmaceutical sciences or a related discipline with about three to five years of
`
`work experience in this area, or a comparable level of education and training.”
`
`EX2105, ¶ 41. Dr. Lawrence is similarly more than qualified under the definition
`
`given by Patent Owner’s formulation expert, Dr. Williams. See EX2082 at 45.
`
`Response to Observation #2: Patent Owner mischaracterizes Dr.
`
`Lawrence’s testimony. The testimony cited by Patent Owners is in response to
`
`“preliminary questions” vaguely directed to general differences between metals
`
`and metal cations, and therefore is not related directly to the teachings in the Merck
`
`Index and Remington. See EX2342, 179:4-180:1. Patent Owner omits the
`
`testimony that is directly related to the patents-at-issue, which is consistent with
`
`Dr. Lawrence’s opinion that tyloxapol has antioxidant properties. Id. at 180:4-10.
`
`Patent Owner also omits Dr. Lawrence’s testimony that “a person of skill in the art
`
`would expect an antioxidant to interact with [partially reduced oxygen species],
`
`with these partially reduced species.” EX2342, 228:7-9. This testimony is
`
`relevant to whether an antioxidant such as tyloxapol would be oxidized by an
`
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`oxidizing agent (i.e., oxygen), much like the statements in the Merck Index and
`
`Remington that tyloxapol is “oxidized by metals.” EX1096, 1751; EX1051, 1415.
`
`Furthermore, Patent Owner’s allegation is not a proper distinction of the
`
`general teaching in the Merck Index and Remington, which provide a more
`
`generalized teaching that tyloxapol has antioxidant properties. EX1096, 1751;
`
`EX1051, 1415; EX1114, 114:6-16; EX1094, ¶¶31, n.5. If tyloxapol were not an
`
`antioxidant, and instead were an oxidizing agent (which it is not), then it would not
`
`be oxidized by oxidizing agents. Whether or not the sodium in bromfenac sodium
`
`is in cation form or not has no relevance to Dr. Lawrence’s analysis.
`
`Response to Observation #3: Patent Owner’s observation is misleading,
`
`not relevant, and mischaracterizes Dr. Lawrence’s testimony. First, Patent Owner
`
`cites to vague questions seeking legal conclusions whether a prior art is relevant in
`
`view of the preamble of the claims. EX2342, 180:2-5; 180:21-181:8. Second,
`
`Patent Owner omits testimony that the specifications of the ’290, ’131, ’813 and
`
`’606 patents discuss nasal drops. Id. at 181: 10-15. This testimony is relevant to
`
`whether nasal formulations would have been relevant to a POSA. Dr. Lawrence
`
`also testified that references directed to lung and nasal formulations show that
`
`tyloxapol is a good antioxidant. Id. at 192: 16-21; 203:2-15. Third, while Patent
`
`Owner’s observation implies it, Patent Owner tellingly never questioned Dr.
`
`Lawrence if nasal and pulmonary formulations are relevant to ophthalmic
`
`3
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`formulations.
`
`Patent Owner’s own expert’s testimony also contradicts Patent’ Owner’s
`
`improper legal conclusion, stating that inhalation and nasal formulations have the
`
`same characteristics as ophthalmic formulations. EX1099, 20:13-21. As noted,
`
`Patent Owner omits that the ’290, ’131, ’606 and ’813 patents, as well as Ogawa
`
`similarly involve nasal formulations. EX1001, 4:10-13, 11:48-51; EX1002, 4 :8-
`
`11, 11 :48-54, EX1003, 43:56-59, 11:11-17;EX1004, 4:60-62, 10:64-11:10,
`
`Example 10.
`
`Response to Observation #4: Patent Owner mischaracterizes Dr.
`
`Lawrence’s testimony and is not relevant. Testimony regarding the general
`
`stability of the examples of Ogawa is unrelated to whether a POSA would be
`
`motivated to replace polysorbate 80. Also, the cited portions of Dr. Lawrence’s
`
`testimony relate to what the Ogawa reference discloses—specifically whether the
`
`Ogawa reference identifies the formulations of Examples 6, 7, and 8 as not forming
`
`red insoluble matters and describes them as “stable, excellent for a long period of
`
`time”—not what Dr. Lawrence’s own opinions on the matter are. See EX2342,
`
`62:22-64:2. Patent Owner instead omits Dr. Lawrence’s testimony about her own
`
`opinions. When asked if the formulation of Example 6 of Ogawa did not exhibit
`
`significantly greater stability than the formulations of examples 7 or 8, Dr.
`
`Lawrence testified, “I would look at those formulations, and to me, example 6 gave
`
`4
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`the greater stability of the formulation. And for that reason, it would be the first
`
`formulation I would consider.” Id. at 35:21-36:2. When asked the question again,
`
`Dr. Lawrence stated, “[i]t clearly has a greater amount of residue, and as I’ve
`
`explained, coupled with other information, a person of ordinary skill in the art
`
`would make a decision as to which formulation was of interest to them by looking
`
`at the patent in the context with the broader picture.” Id. at 37:1-7. This testimony
`
`is relevant to whether a POSA would be motivated to address the issue of insoluble
`
`complexes forming between bromfenac and BAC in Example 6 of Ogawa.
`
`Response to Observation #5: Patent Owner’s observation mischaracterizes
`
`the testimony of Dr. Lawrence. The testimony “It might do” does not indicate
`
`ignorance whether tyloxapol contains an OH group directly attached to the phenyl
`
`ring, but that the answer depends on the context. EX2342 at 222:10-21. Patent
`
`Owner omits that Dr. Lawrence tried to elaborate on her answer in the deposition,
`
`but Patent Owner interrupted and did not allow her to finish or provide context to
`
`her answer. EX2342, 222:17-223:3. Patent Owner also omits Dr. Lawrence’s
`
`eventual explanation, when given the chance, that she assumed that Dr. Laskar’s
`
`testimony referred to the average structure of a polymeric molecule, i.e., monomers
`
`strung together, which would have molecules with no ethyoxylate on them. Id. at
`
`224:3-7. Dr. Lawrence further testified, “if you look at the individual molecules
`
`[monomers] that comprise tyloxapol, there are undoubtedly molecules of free
`
`5
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`

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`hydroxyl on the ring”. Id. at 225:1-5.
`
`This testimony is consistent with Dr. Lawrence’s testimony in her Reply
`
`declaration and references cited therein. As she testified in her Reply declaration,
`
`EX1102 explains that tyloxapol “retains functional groups to the original alcohol
`
`monomer, and these may confer its antioxidant capacity”, i.e., that the antioxidant
`
`capacity of tyloxapol stems from “functional groups [retained] of the original
`
`alcohol monomer,” an oxygen atom conjugated to a phenyl ring. The system of an
`
`oxygen atom conjugated to a phenyl ring would be capable of accepting electrons
`
`from a radical species. EX1094, ¶33; EX1102 at 1221-22. This testimony is
`
`relevant to whether a POSA would understand tyloxapol to “retain[] functional
`
`groups to the original alcohol monomer” and that “tyloxapol is within the
`
`aklylphenols disclosed by Doi for ophthalmic preparations.” EX1094, ¶33.
`
`Response to Observation #6: Patent Owner’s observation mischaracterizes
`
`the testimony of Dr. Lawrence. Patent Owner omits testimony that a number of
`
`surfactants are both excipients and active ingredients. EX2342, 185:8-14. Patent
`
`Owner also omits testimony that it is the surfactant properties of tyloxapol that are
`
`exploited by these references as an active ingredient. Id. at 185:16-186:7. Dr.
`
`Lawrence testified that the ‘956 application and the WO 610 reference use
`
`tyloxapol as an active ingredient as they are “using its ability to act as a surfactant
`
`in this context” and “they’re exploiting its surfactant properties as an active
`
`6
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`

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`ingredient. So not having a pharmacological effect in the way that you would
`
`normally anticipate for an active ingredient.” Id. at 185:16-186:7.
`
`Patent Owner’s observation also relies on a vague question, the answer to
`
`which Dr. Lawrence would have no way of knowing: how the approach that the
`
`‘956 application and the WO 610 application took is different from the approach
`
`that the inventors of the ‘290, ‘131. ‘606 and ‘813 patents took when formulating
`
`the claimed formulations. Dr. Lawrence answered the best she could, not being an
`
`inventor of any of the patents or references cited in the question: “I have real
`
`difficulty with the word—the phrase ‘different approach.’ They’re formulating for
`
`a different route of administration. Some things are bound to be different.” Id. at
`
`191:3-14. This testimony is relevant to whether the ‘956 application and WO 610
`
`application use the surfactant properties of tyloxapol. As also discussed in
`
`response to Observation #3, Patent Owner’s own expert’s testimony contradicts
`
`this observation. Dr. Williams testified that inhalation and nasal formulations have
`
`the same characteristics as ophthalmic formulations. EX1099, 20:13-21.
`
`Response to Observation #7: Patent Owner’s observation is not relevant
`
`and it mischaracterizes Dr. Lawrence’s testimony. First, Dr. Lawrence does not
`
`cite to the Kennedy reference (EX1100) as teaching NSAIDs, including
`
`bromfenac, or BAC, and does not cite to Kennedy as taking the same approach as
`
`the inventors of the patents-at-issue in preparing the claimed aqueous formulations.
`
`7
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`

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`Dr. Lawrence relies on Kennedy as one of multiple references relevant to whether
`
`a POSA would know that tyloxapol inhibits the oxidation caused by oxygen based
`
`species (i.e., it is an antioxidant). EX1094, ¶37, citing EX 1100, 1:27-61; EX
`
`1101, 2:38-50; EX 1102 at 1221-1222). As discussed with respect to Observations
`
`#3 and 6, Patent Owner’s expert agrees the formulations in Kennedy would have
`
`relevance to the present claims. EX1099, 20:13-21.
`
`Second, Patent Owner mischaracterizes the testimony of Dr. Lawrence with
`
`regard to whether partially reduced oxygen species are included in the claimed
`
`formulations of the patents at issue. When asked this question, Dr. Lawrence
`
`answered, “[n]ot by deliberate addition,” indicating that partially reduced oxygen
`
`species are not on the list of ingredients. This testimony is limited to whether such
`
`partially reduced oxygen species are disclosed in the patents-at-issue, not whether
`
`Dr. Lawrence believes they are present in the claimed formulations. EX2342,
`
`234:20-235:2. This understanding is confirmed by Dr. Lawrence’s testimony just
`
`moments before Patent Owner’s cited response. When asked if the claimed
`
`formulations include hypochlorous acid, Dr. Lawrence stated, “I’m certain it’s not
`
`in the list of ingredients.” Id. at 271:6-11.
`
`Response to Observation #8: Patent Owner’s observation mischaracterizes
`
`Dr. Lawrence’s testimony. Patent Owner omits Dr. Lawrence’s testimony that she
`
`and Dr. Williams agreed that looking at art relating to nasal formulations is
`
`8
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`

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`relevant. EX2342, 180:10-15 (noting that the specification of the ’290, ’131, ’606,
`
`and ’813 patents discuss its formulations being used for nasal drops); EX1094, n.5;
`
`EX 1099, 20:13-21. Dr. Lawrence also testified that tyloxapol was known to have
`
`antioxidant properties in a general sense. EX2342, 191:16-192:5, 203:10-15;
`
`EX1094, ¶¶ 31-33 37, n. 5. This testimony is relevant to whether the antioxidant
`
`properties of tyloxapol apply to the present situation.
`
`Response to Observation #9: Patent Owner’s observation mischaracterizes
`
`Dr. Lawrence’s testimony. The observation incorrectly suggests that there is no
`
`data to support the recognition in the prior art that tyloxapol is an antioxidant, but
`
`omits Dr. Lawrence’s testimony on this exact point. Dr. Lawrence testified to the
`
`data in Yasueda and Ghio 1996 (EX1173) that shows tyloxapol’s antioxidant
`
`properties and polysorbate 80’s oxidation properties. EX2342, 203:10-15;
`
`EX1094, ¶ 31, 33, n. 5. Dr. Lawrence’s testimony is supported by experimental
`
`data indicating tyloxapol’s antioxidant properties. Id.
`
`Response to Observation #10: Patent Owner’s observations
`
`mischaracterize Dr. Lawrence’s Reply Declaration and testimony. Dr. Lawrence
`
`explained that Fu provides experimental data showing BAC complexes with acidic
`
`NSAIDs. EX1094, ¶¶ 35, 37. This testimony is relevant to whether a POSA
`
`would have known of the complexation issue because several references report the
`
`issue with respect to different acidic NSAIDs (which bromfenac is) and BAC, and
`
`9
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`

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`several references report the issue with respect to anions (which bromfenac is at
`
`the relevant pH) and BAC. Petitioner Reply (1099), Paper 38 at 9-10; Reply (-
`
`1097), Paper 37 at 9-10; Reply (-1100), Paper 37 at 9-10 and Reply (-1105), Paper
`
`37 at 9-10. Patent Owner also omits contradictory testimony and exhibits. Dr.
`
`Williams testified that a POSA would have taken such teachings in the prior art at
`
`“face value.” EX1104, 81:4. The ’290, ’131, ’606, and ’813 patents expressly
`
`discuss this same issue. EX1001, 1:62-2:3; EX1002, 1:51-67; EX1003, 1:48-63;
`
`EX1004, 1:48-63. And Patent Owner’s exhibits show that bromfenac and BAC
`
`complex. EX2098, 30 (“[B]romfenac sodium forms insoluble complexes due to
`
`the addition of quaternary ammonium salt and becomes cloudy.”).
`
`Response to Observation #11: Patent Owner’s observations
`
`mischaracterize Dr. Lawrence’s testimony. Patent Owner omits Dr. Lawrence’s
`
`testimony that a POSA would have focused on Example 6 of Ogawa and not
`
`Example 7. Id. at 35:21-36:2, 37:1-7. Patent Owner also omits Dr. Lawrence’s
`
`testimony that parabens are not preferred preservatives. EX2342, 40:17-19 (noting
`
`that methylparaben is “used in relatively few ophthalmic preparations”), 45:10-12
`
`(noting that parabens are “hydrolyzed at pH 8”, so “you wouldn’t normally use
`
`them at pH 8”); EX1094, ¶¶ 24, 66 (noting that a POSA “would know that
`
`parabens are undesirable for use as a preservative in an ophthalmic formulation”
`
`because “parabens are not stable and degrade at pH values around 8,” and that
`
`10
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`“parabens are not as effective preservatives as BAC”). Dr. Lawrence further
`
`testified that a POSA “would be concerned that methyl and methylparabens [would
`
`be] solubilized in the polysorbate 80,” providing a reason why a POSA would not
`
`look to use methylparabens as a preservative in a formulation. EX2342, 39:5-9.
`
`Moreover, Dr. Lawrence testified that BAC is used in far more ophthalmic
`
`preparations than any other preservative. EX2342, 58:9-10; EX1094, ¶¶ 64, 67, n.
`
`9.
`
`Dr. Lawrence was not impeached, but was asked a vague question that failed
`
`to define a time period: “Is it still your opinion that a POSA would have found it
`
`preferable to modify a formulation or remove any incompatibility issues of
`
`benzalkonium chloride?” EX2342, 108:4-8. Dr. Lawrence reasonably asked for
`
`clarification about whether Patent Owner was referring to Dr. Lawrence’s opinions
`
`as of 2016 or looking back to 2003. EX2342, 108:10-13. In that question, she
`
`used the word “hindsight” as a non-lawyer with a lay meaning of the word, not in a
`
`legal sense. Moreover, Dr. Lawrence testified that she “did not use hindsight” and
`
`that she “put [herself] back to the time 2003 and looked at it objectively then.”
`
`EX2342, 109:1-3. And that “[w]hile I read the word “hindsight” there, it wasn’t
`
`meant in the context that you’ve interpreted it as and that was very clear from my
`
`testimony. Any opinions I’ve made are stated with an expert – as a person of
`
`ordinary skill in the art in 2003.” EX2326, 79:12-16.
`
`11
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`

`
`Response to Observation #12: Patent Owner’s observations
`
`mischaracterize Dr. Lawrence’s testimony. Patent Owner omits testimony that
`
`Yanni does not disparage the use of bromfenac, as it teaches that it is effective in
`
`treating ocular inflammation . EX1094, ¶14. Patent Owner also omits testimony
`
`that Yanni teaches that diclofenac is somewhat less effective both in vitro and in
`
`vivo than bromfenac. EX1094, ¶15.
`
`Response to Observation #13: Patent Owner’s observations mischaracterize Dr.
`
`Lawrence’s testimony. Patent Owner omits testimony that the prior art regarding
`
`diclofenac is relevant to bromfenac ophthalmic formulations: “it was known at the
`
`time that these drugs did degrade. So in that respect, it[’]s relevant.” EX2342 at
`
`122:5-7. When directly asked whether the prior art directed to diclofenac is
`
`relevant to bromfenac ophthalmic formulations, Dr. Lawrence stated “Dr. Davies
`
`and Dr. Williams comments that neither of these drugs [bromfenac and diclofenac]
`
`are susceptible to degradation, and they are using it to downplay the relevance of
`
`Sallmann and Fu.” EX2342 at 122:2-5.
`
`Patent Owner’s observation also omits contradictory testimony and exhibits.
`
`Dr. Lawrence testified that a POSA would expect complexes to form between
`
`BAC and acidic NSAIDs, and the experimental data in the art showing BAC
`
`complexes with acidic NSAIDs. EX1094, ¶¶ 35, 37. Several references report the
`
`issue with respect to different acidic NSAIDs (which bromfenac is) and BAC, and
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`12
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`several references report the issue with respect to anions (which bromfenac is at
`
`the relevant pH) and BAC. Petitioner Reply, Paper 38 (-1099) Paper 37 (-1097, -
`
`1100, -1105) at 9-10. Patent Owner’s own expert Dr. Williams testified that a
`
`POSA would have taken such teachings in the prior art at “face value.” EX1104,
`
`81:4. The ’290, ’131, ’606, and ’813 patents discuss this same issue. EX1001,
`
`1:62-2:3; EX1002, 1:51-67; EX1003, 1:48-63; EX1004, 1:48-63. Patent Owner’s
`
`exhibits also show that bromfenac and BAC are complex. EX2098, 30
`
`(“[B]romfenac sodium forms insoluble complexes due to the addition of
`
`quaternary ammonium salt and becomes cloudy.”). This testimony, data, and
`
`reference are relevant to whether a POSA would have known of complexation.
`
`Response to Observation #14: Patent Owner’s observations
`
`mischaracterize Dr. Lawrence’s testimony. Dr. Lawrence was not impeached and
`
`Patent Owner omits testimony showing this lack of impeachment. Dr. Lawrence
`
`testified that while Sallmann “uses the word solubilizer,” (EX2326, 393:5) a POSA
`
`would understand that “it’s using the word ‘solubilizer’ just to mean surfactants,
`
`and that is clear from the compositions of the formulations.” EX2342, 146:14-17.
`
`This is consistent with prior testimony that Sallmann “uses” the word solubilizer.
`
`EX2326, 393:5. Further, Dr. Lawrence did not testify that Sallmann “teaches the
`
`use of tyloxapol as a solubilizer, not a stabilizer,” as Patent Owner alleges. Dr.
`
`Lawrence’s testimony that the concepts of solubility and stability (in general) are
`
`13
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`different concepts does not change this fact.
`
`Response to Observation #15: Patent Owner’s observation is not relevant
`
`and mischaracterizes the scope of Mr. Hofmann’s Reply Declaration. Mr.
`
`Hofmann is not a technical expert, nor does he claim to be. See, e.g., EX1122,
`
`¶ 25, n.27. Mr. Hofmann is an expert in economic and market analysis, including
`
`analysis of objective indicia of nonobviousness, in the pharmaceutical industry.
`
`Id., ¶¶ 11-14; EX2343 at 13:19-22, 21:3-5, 21:12-15. None of the opinions
`
`proffered by Mr. Hofmann require that he be a technical expert because he did not
`
`provide technical or medical opinions, including in the cited paragraphs of the
`
`Reply Declaration mischaracterized by Patent Owner. Those paragraphs directly
`
`respond to the Declaration of John Jarosz, Patent Owner’s economic expert, see,
`
`e.g., EX1122, ¶¶ 42, 72-80, 86-87, 102, 110, and are economics-based and not
`
`opinions on technical matters, see, e.g., id., ¶¶ 42, 62, 69-70, 86-87, 102, 110.
`
`Patent Owner also mischaracterizes as “technical opinions” Mr. Hofmann’s
`
`assumptions or “understandings” that underlie his economic opinions. See, e.g.,
`
`id., ¶¶ 25-27, 59-60, 69-70, 72-80, 99, 102, 110. The Reply Declaration states that
`
`these assumptions come from other sources, such as the National Eye Institute
`
`website. See id., ¶¶ 25-26, nn.28-29. Patent Owner also omits that it did not
`
`inquire about the source of these “understandings,” that Mr. Hofmann previously
`
`testified as to their source in a related matter, and that Patent Owner’s own
`
`14
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`economic expert, Mr. Jarosz, relied on similar technical assumptions. EX1181,
`
`9:24-10:22, 165:24-166:20; EX2334, 13:1-14:17; EX1182 , 172:21-25.
`
`Response to Observation #16: Patent Owner’s observation
`
`mischaracterizes Mr. Hofmann’s Reply Declaration and testimony. The Reply
`
`Declaration provides a qualitative analysis of Prolensa®’s marketing and
`
`promotion efforts, life-cycle management strategy, and coupon programs.
`
`EX1122, ¶¶ 60-62, 67-70, 82-85, 88, 91, 93-96, 104-105. Patent Owner omits that
`
`Mr. Hofmann repeatedly referred Patent Owner to his Reply Declaration for such
`
`analyses. EX2343 at 89:5-8, 89:12-13, 89:21-22, 90:9-10. Patent Owner also
`
`omits Mr. Hofmann’s testimony that the “entirety”—i.e., 100%—of Prolensa®
`
`sales can be explained by marketing and promotion efforts, life-cycle management
`
`strategy, and coupon programs. EX2343 at 89:13-16. Patent Owner omits that
`
`Prolensa® never reached the sales of the previous bromfenac drug, Bromday® and
`
`thus has not demonstrated any incremental commercial performance beyond the
`
`existing bromfenac franchise. EX1122 at ¶¶ 67-68. Finally, Patent Owner’s
`
`observation omits that Patent Owner’s own economic expert, Mr. Jarosz, did not
`
`provide or attempt to provide a quantitative analysis regarding the promotional
`
`efforts’ contribution to the performance of Prolensa® like that sought by Patent
`
`Owner from Mr. Hofmann. EX1182, 23:9-23.
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`May 18, 2016
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`
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`Respectfully submitted,
`
`
`
` /Deborah Yellin/
`Deborah H. Yellin
`Reg. No. 45,904
`CROWELL & MORING LLP
`Intellectual Property Group
`P.O. Box 14300
`Washington, DC 20044-4300
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`CERTIFICATION OF SERVICE
`
`The undersigned hereby certifies that the foregoing document entitled
`
`PETITIONERS’ OPPOSITION TO 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 electronically via email on May 18, 2016 to Patent
`
`Owner’s counsel of record and counsel of record for Petitioners InnoPharma at the
`
`following:
`
`Patent Owner
`Bryan.Diner@finnegan.com
`Justin.Hasford@finnegan.com
`Joshua.Goldberg@finnegan.com
`Petitioners InnoPharma
`Jitty.malik@alston.com
`bryan.skelton@alston.com
`James.abe@alston.com
`Lance.soderstrom@alston.com
`Joe.janusz@alston.com
`Respectfully submitted,
`
`
` /Shannon M. Lentz/
`Shannon M. Lentz, Reg. No. 65,382
`CROWELL & MORING LLP
`Intellectual Property Group
`P.O. Box 14300
`Washington, DC 20044-4300
`
`17
`
`
`May 18, 2016

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