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 TO EXCLUDE1
`
`
`
`
`                                                            
`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.
`
`
`
`i
`
`

`
`TABLE OF CONTENTS
`
`TABLE OF CONTENTS
`
`
`
`DR. LAWRENCE IS WELL-QUALIFIED TO OFFER THE OPINIONS
`I.
`DR. LAWRENCE IS WELL-QUALIFIED TO OFFER THE OPINIONS
`I.
`IN HER REPLY DECLARATION ........................................................................... 1
`IN HER REPLY DECLARATION ......................................................................... ..l
`
`II.
`
`DR. LAWRENCE’S REPLY DECLARATION AND THE EXHIBITS
`
`DR. LAWRENCE’S REPLY DECLARATION AND THE EXHIBITS
`II.
`THERETO ARE WITHIN THE SCOPE OF DR. LAWRENCE’S REPLY ............ 4
`
`THERETO ARE WITHIN THE SCOPE OF DR. LAWRENCE’S REPLY .......... ..4
`
`III. MR. HOFMANN IS WELL-QUALIFIED TO OFFER HIS OPINIONS
`III.
`MR. HOFMANN IS WELL-QUALIFIED TO OFFER HIS OPINIONS
`AND TESTIMONY ON ECONOMIC MATTERS RELATED TO THE
`AND TESTIMONY ON ECONOMIC MATTERS RELATED TO THE
`PHARMACEUTICAL MARKET AND RELATED FACTORS ........................... 10
`
`PHARl\/IACEUTICAL MARKET AND RELATED FACTORS ......................... ..lO
`
`A. Mr. Hofmann Is Not a Technical Expert and Does Not Claim to Be One .. 11
`A.
`l\/Ir. Hofmann Is Not a Technical Expert and Does Not Claim to Be One ..ll
`
`B. Mr. Hofmann Fully Answered All Questions Asked, Except When
`B.l\/Ir. Hofmann Fully Answered All Questions Asked, Except When
`Interrupted by Patent Owner, and Was Not Impeached ............................... 12
`Interrupted by Patent Owner, and Was Not Impeached ............................. .. 12
`
`C. Mr. Hofmann Provided Qualitative and Quantitative Analyses of the
`C.l\/Ir. Hofmann Provided Qualitative and Quantitative Analyses of the
`“Extrinsic Factors” That Affect Prolensa® Sales ........................................ 14
`“Extrinsic Factors” That Affect Prolensa® Sales ...................................... ..l4
`
`D. Mr. Hofmann’s Testimony Has Been Repeatedly Credited ........................ 15
`D.
`l\/Ir. Hofmann’s Testimony Has Been Repeatedly Credited ...................... ..l5
`
`IV.
`IV.
` 
`
`
`
`CONCLUSION ............................................................................................ 15
`
`CONCLUSION .......................................................................................... .. 15
`
`ii
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`

`
`Pursuant to the Scheduling Order (Paper 10 at 4), Petitioners file their
`
`Opposition to Patent Owner’s Motion to Exclude under 37 C.F.R. § 42.64(c).
`
`I.
`
`Dr. Lawrence Is Well-Qualified to Offer the Opinions in Her Reply
`Declaration
`
`Patent Owner spends six full pages arguing that Dr. Lawrence is not an
`
`“expert” in chemistry, but all six of those pages are directed to an entirely
`
`irrelevant point. The issues in this action are related to formulations and Dr.
`
`Lawrence is by any measure a highly accomplished formulation expert. Part and
`
`parcel to the field of formulation is of course an understanding of basic chemistry
`
`relating to formulations; chemistry and formulation science are not mutually
`
`exclusive. Dr. Lawrence has more than enough experience and knowledge within
`
`her formulation expertise to address any chemistry issues in this action.
`
`Dr. Lawrence has a PhD in Pharmacy, and has been an expert in the field of
`
`formulation and drug delivery since prior to 2003. EX1005, ¶3; EX1094, ¶¶4-5.
`
`She is Head of the Pharmaceutical Biophysics Group of the Institute of
`
`Pharmaceutical Science at Kings College, and has been the Chief Scientist at the
`
`Royal Pharmaceutical Society since 2007. EX1005, ¶¶7-8. At Kings College she
`
`taught multiple courses including physical chemistry of micelles, physical
`
`chemistry of emulsions and biopharmaceutics and bio-pharmacy. EX1054 at 7.
`
`She has performed research and published in the field of physical and colloid
`
`chemistry. Id. at 8.
`
`
`
`1
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`

`
`Dr. Lawrence is also qualified under Patent Owner’s own definition of a
`
`POSA. Patent Owner’s “chemistry” expert, Dr. Davies, opines that a POSA would
`
`have 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 also exceeds Dr. Williams’s definition of a POSA,
`
`See EX2082 at 45 (characterizing Dr. Lawrence’s definition of a POSA as
`
`“exaggerat[ing] the level of a” POSA).
`
`Patent Owner made no attempt to determine Dr. Lawrence’s understanding
`
`of the basic chemistry at issue here, in an apparent strategy to move to exclude on
`
`qualifications alone. See EX2342, 10:16 to 13:5. But in the related district court
`
`trial regarding the same patents and subject matter, Patent Owner substantively
`
`challenged Dr. Lawrence’s chemistry abilities. EX2326, 196:23-197:3. In
`
`response, Dr. Lawrence testified to her knowledge of chemistry, including basic
`
`chemistry and acid chemistry involved in formulation of NSAID compounds in
`
`solution. Id. at 197:4-20. Patent Owner was satisfied with Dr. Lawrence’s
`
`qualifications, and the district court recognized Dr. Lawrence as an expert
`
`“embracing the field of chemistry of NSAIDs.” Id. at 197:23-198:1, 198:7-14.
`
`Patent Owner also overly simplifies Dr. Lawrence’s testimony that tyloxapol
`
`is an “alkylphenol” in an attempt to undermine her credentials. As Dr. Lawrence
`
`
`
`2
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`

`
`explains in her Declaration and in her testimony, the issue is more nuanced,
`
`because tyloxapol’s p-(1,1,3,3-tetramethybutyl) phenol component is an
`
`alkylphenol. EX1094, ¶ 33; EX2342, 225:1-5. Patent Owner’s Motion thus acts as
`
`a de facto sur-reply on the antioxidant activity of tyloxapol. This is improper.
`
`Regardless, per Dr. Lawrence, 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. EX1094,
`
`¶33; EX1102 at 1221-22. The system of an oxygen atom conjugated to a phenyl
`
`ring would be capable of accepting electrons from a radical species, and thus
`
`would impart antioxidant activity. EX1094, ¶33; EX1102, 1221-22.
`
`This testimony does not contradict Dr. Laskar. Dr. Lawrence’s testimony
`
`“assum[ed that] Dr. Laskar [was] referring to the average structure of what’s
`
`known as a polymeric molecule. There will be molecules in there that have no
`
`ethyoxylate group on them,” in which case Dr. Laskar’s testimony and Dr.
`
`Lawrence’s testimony are consistent. EX2342, 224:3-7.
`
`Patent Owner also fails to undermine Dr. Lawrence’s credentials by
`
`characterizing certain references as “irrelevant.” Motion at 5. Dr. Lawrence cited
`
`those references because they teach that tyloxapol has antioxidant activity,
`
`rendering them relevant to the oxidative degradation of bromfenac. EX1097, ¶
`
`
`
`3
`
`

`
`[0032]; EX1098, 6:25-28; EX1100, 4:46-61; EX1101, 2:38-48; EX1102 at 1219,
`
`1221-1222; EX1172; EX1100-1102, EX1172, 4 :46-61. Despite Patent Owner’s
`
`Motion, Dr. Lawrence does not agree that partially reduced oxygen species and
`
`hypochlorous acid are not present in the claimed bromfenac ophthalmic solutions
`
`of the ’290, ’131, ’813 and ’606 patents. Rather, when asked whether the claimed
`
`formulations of the ’290, ’131, ’813 and ’606 patents include partially reduced O2
`
`species, Dr. Lawrence answered, “[n]ot by deliberate addition,” indicating that
`
`partially reduced oxygen species are not on the list of ingredients. EX2342,
`
`234:20-235:2. This testimony is limited to the disclosure of the patents-at-issue
`
`and has no bearing on whether Dr. Lawrence believes the species are present in the
`
`claimed formulations. EX2342, 234:20-235:2. And 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.
`
`II. Dr. Lawrence’s Reply Declaration and the Exhibits Thereto Are Within
`the Scope of Dr. Lawrence’s Reply
`
`Dr. Lawrence’s Reply Declaration (EX1094, specifically ¶¶ 31-33, 37-38
`
`and n.5) and supporting exhibits (EX1096-1098, EX1100-1102, and EX1172-
`
`1173) are admissible because they are relevant and in direct response to Patent
`
`Owner’s principle theory of the purported non-obviousness of the claims—that a
`
`POSA would have known that bromfenac degrades by oxidative degradation and
`
`thus would have used an antioxidant—and associated factual allegations (e.g., that
`
`
`
`4
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`

`
`polysorbate 80 and tyloxapol are both oxidizing agent). Dr. Lawrence simply
`
`responded to Patent Owner’s experts’ arguments, which is entirely proper. See
`
`Square, Inc. v. Unwired Planet, LLC, Case CBM2014-00156, Paper 40 at 35
`
`(PTAB Dec. 22, 2015) (“Under our rules, Petitioner may respond in its Reply to
`
`the arguments or evidence, or both, presented in the Patent Owner Response.”).
`
`Patent Owner admits as much in its Motion, asserting that Dr. Lawrence “is
`
`unqualified to challenge the opinions of Patent Owner’s expert Dr. Davies.”
`
`Motion at 4-6.
`
`From their very first filing, Patent Owner has pursued the theory that a
`
`POSA would not expect tyloxapol to prevent bromfenac’s oxidative degradation
`
`problem, because tyloxapol would allegedly contribute to the oxidative
`
`degradation. This theory rests on whether tyloxapol is an oxidant or an
`
`antioxidant. See Motion at 4-6. Patent Owner interjected this issue into the case
`
`first by its Preliminary Response. PO Prelim Response, IPR2015-01097, -1099, -
`
`1100, -1105, Paper 8, at 7, 9, 18-20, 22-24, 29-32, 38, 42, 45-46. The Board
`
`picked up on the issue and even included a discussion of it in its Decision to
`
`Institute. See Decision to Institute, IPR2015-01097, -1099, -1100, -1105, Paper 9
`
`at 12, 12, 10, and 9, respectively (discussing that bromfenac degraded via
`
`oxidation). Since then, Patent Owner’s experts (Drs. Williams and Davies) have
`
`repeatedly discussed the oxidation degradation of bromfenac and the impact of
`
`
`
`5
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`

`
`tyloxapol’s properties. See e.g. IPR2015-01099, EX2082, ¶¶ 55-60, 100, 109, 119-
`
`126, 133, 138, 141, 142, 158, 159, 171, 182, 231, 232; and EX2105, ¶¶ 41, 69-70,
`
`97. Patent Owner has also offered exhibits in supports of its theory. EX1094, ¶33;
`
`EX2120 at 393-94; EX2097 at 1678; see also EX2114, 156:6-157:22, 183:17.
`
`Predictably, this theory remained in the Patent Owner Response. PO Response,
`
`IPR2015-01097, Paper 23; -1099, Paper 22; -1100, Paper 23; and -1105, Paper 23
`
`at 14-18, 20-24, 26, 28, 29, 32, 53.
`
`Petitioner’s Reply was the first opportunity for Petitioner to directly address
`
`whether tyloxapol is an oxidant, and Dr. Lawrence’s Reply Declaration and
`
`supporting exhibits relating to tyloxapol’s antioxidant properties were in direct
`
`response to Patent Owner’s assertions (1) that bromfenac degrades by oxidation;
`
`and (2) that a POSA would have used antioxidants to stabilize bromfenac. PO
`
`Response, IPR2015-01097, Paper 23; -1099, Paper 22; -1100, Paper 23; and -1105,
`
`Paper 23 at 14-18, 20-24, 26, 28, 29, 32, 53. Dr. Lawrence’s testimony and
`
`supporting exhibits are also in direct response to Patent Owner’s experts’
`
`allegations that a POSA would not use tyloxapol for a bromfenac formulation,
`
`because the POSA would have instead been led to use an antioxidant, thereby
`
`implying that tyloxapol is not an antioxidant. See, e.g., IPR2015-01099, EX2105,
`
`¶ 41 and EX2082, ¶ 138; EX2030; EX2097; EX2120.
`
`Patent Owner’s problem is that the lynchpin of its entire oxidative
`
`
`
`6
`
`

`
`degradation theory rested on a person (Dr. Davies) who has never worked with
`
`tyloxapol. Dr. Davies merely speculated that tyloxapol is an oxidant by relying on
`
`references that did not even discuss tyloxapol, rather than doing what any POSA
`
`would have done if they did not know whether tyloxapol is an antioxidant—look it
`
`up. Yet Patent Owner now attempts to shield Dr. Davies and its flawed theory of
`
`the case by prohibiting Petitioners from responding at all on the issue. In this light,
`
`Patent Owner’s strategy here is clear. Patent Owner discovered after its
`
`Preliminary Response that Dr. Davies was incorrect, and tyloxapol is not an
`
`oxidant (which is not surprising since Dr. Davies has never worked with tyloxapol,
`
`EX1103, 48:19-21), but in fact is an antioxidant. Stuck with its earlier mistaken
`
`theory, Patent Owner now asks the Board to exclude all of Petitioner’s
`
`contradictory evidence
`
`Without an opportunity for Petitioner to correct the record, the Board would
`
`have to render a decision based on an incorrect record and without having an
`
`opportunity to verify whether Patent Owner’s allegation that tyloxapol is an
`
`oxidant. In truth, the exact opposite is true: there is a wealth of references to
`
`support that tyloxapol is an antioxidant. That is why rather than allowing these
`
`inaccuracies to stand, Petitioners and Dr. Lawrence provided the Board with the
`
`relevant prior art discussing tyloxapol’s antioxidant properties. Petitioners are
`
`afforded the opportunity to correct Patent Owner’s incorrect assumption that
`
`
`
`7
`
`

`
`tyloxapol is an oxidant, and Petitioners took that opportunity.
`
`To this end, Dr. Lawrence’s Reply Declaration and the supporting exhibits
`
`(EX1051, EX1095, EX1096, EX1097, EX1098, EX1100, EX1101, and EX1102)
`
`correct the factual record. Dr. Lawrence’s response shows that Patent Owner’s
`
`assertion that tyloxapol is an oxidant is incorrect—it is precisely the opposite.
`
`EX1094, ¶ 31. Dr. Lawrence’s response is supported by various prior art
`
`references showing that tyloxapol is an antioxidant (including references that
`
`provide experimental data verifying tyloxapol’s antioxidant properties). See
`
`EX1051 at 1415, EX1096 at 9902; EX1097, ¶ [0032]; EX1098, 6:25-28; EX1101,
`
`2:38-50 (teaching how alkylaryl polyether alcohol polymers are useful as
`
`antioxidants in blocking oxidant reactions); and EX1172, 4:46-61 (teaching that
`
`tyloxapol is a “potent antioxidant”). This correction of the record and response to
`
`Patent Owner’s Response are properly the subject of a Reply.
`
`Patent Owner also mischaracterizes Dr. Lawrence’s testimony. For
`
`example, Patent Owner referred Dr. Lawrence to her district court deposition
`
`testimony and asked whether Ogawa identifies the formulations of Examples 6, 7,
`
`and 8 as not forming red insoluble matters and describing them as “stable,
`
`excellent for a long period of time.” EX2327, 62:22-64:2. Patent Owner queried
`
`what the patent itself disclosed, not Dr. Lawrence’s own opinions. Id.
`
`Dr. Lawrence’s testimony also does not conflict with her position that a
`
`
`
`8
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`

`
`POSA would choose Example 6 of Ogawa, or that a POSA would be motivated to
`
`address complexation issues by substituting tyloxapol for polysorbate 80. The
`
`formulation of Ogawa Example 6 was known as a commercially viable product
`
`and was stable. EX2248, 27-28; EX2111, 2; EX2112, 2; EX1006, 2:1:3; EX1005
`
`¶ 101. The fact that the formulations of Examples, 6, 7, and 8 were all generally
`
`stable does not change the fact that Example 6 was a good formulation. Dr.
`
`Lawrence further testified that she “would look at [the formulations of Ogawa
`
`Examples 7 or 8], and to me, example 6 gave 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, she 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 consistent with Dr. Lawrence’s
`
`position that a POSA would be motivated to address the issue of insoluble
`
`complexes forming between bromfenac and BAC in Example 6 of Ogawa. See
`
`EX1094, ¶ 23.
`
`Patent Owner seeks to exclude EX1107, 1108 and 1109, alleging that they
`
`relate to new arguments first raised on reply that are beyond the scope of a reply.
`
`Exhibits 1107, 1108 and 1109 are within the scope of a reply because they respond
`
`
`
`9
`
`

`
`to arguments raised in the Patent Owner’s response. But these exhibits respond
`
`directly to Patent Owner’s arguments that “[t]yloxapol also unexpectedly
`
`maintained preservative efficacy—i.e., prevented microbial contamination—as
`
`compared to polysorbate 80” and that “no prior art discloses or suggests that
`
`tyloxapol would have had a more favorable effect than polysorbate 80 on
`
`preservative efficacy.” PO Response, IPR2015-01097, Paper 23; -1099, Paper 22;
`
`-1100, Paper 23; and -1105, Paper 23 at 2, 45. EX1107 and EX1109 are both prior
`
`art publications that reflect the knowledge of a POSA that polysorbate 80
`
`neutralizes the preservative effectiveness of BAC. EX1108 references EX1107 as
`
`Reference 6 and illustrates how a POSA would have understood EX1107. Exhibits
`
`1107, 1108 and 1109 are precisely the prior art that suggests that the preservative
`
`efficacy of BAC would be improved by using a surfactant other than polysorbate
`
`80. Since these exhibits directly respond to arguments raised in Patent Owner’s
`
`response, they are within the scope of Petitioner’s reply. See Chicago Mercantile
`
`Exchange, Inc., CBM2014-00114, Paper 35, 60 (PTAB, Aug. 18, 2015)
`
`(considering new reply exhibits that responded to arguments raised in Patent
`
`Owner response).
`
`III. Mr. Hofmann Is Well-Qualified to Offer His Opinions and Testimony
`on Economic Matters Related to the Pharmaceutical Market and
`Related Factors
`
`Patent Owner’s Motion to Exclude follows the strategy of its cross-
`
`
`
`10
`
`

`
`examination of Mr. Hofmann by desperately avoiding substance in favor of
`
`sideshow. Each of the issues raised by Patent Owner fails even basic scrutiny. In
`
`any event, Patent Owner cannot exclude Mr. Hofmann’s Reply Declaration in its
`
`entirety, because Patent Owner did not object to the Reply Declaration in its
`
`entirety. Patent Owner is limited to the paragraphs explicitly listed on pages 12
`
`and 15 of its Motion. But even then, Patent Owner’s Motion should be denied.
`
`A. Mr. Hofmann Is Not a Technical Expert and Does Not Claim to
`Be One
`
`It is hardly a secret that Mr. Hofmann is not a technical or medical expert,
`
`see, e.g., EX1122, ¶ 25, n.27, yet Patent Owner’s motion treats this fact as
`
`discovered treasure. Mr. Hofmann is an expert in economic and market analysis,
`
`including analysis of objective indicia of nonobviousness, in the pharmaceutical
`
`industry. Id., ¶¶ 11-14. Mr. Hofmann also did not “offer[] opinions on technical
`
`and medical matters,” Motion at 12, 13 (“Mr. Hofmann provides opinions directly
`
`on these issues.”), but on economic matters directly responsive to the Declaration
`
`of John Jarosz, Patent Owner’s economics expert. And Mr. Hoffman is more than
`
`qualified to provide these economic opinions. See EX1122, ¶¶ 4, 11-14.
`
`Patent Owner mischaracterizes Mr. Hofmann’s technical
`
`“understandings”—technical assumptions—as opinion itself. But as any economic
`
`expert must, Mr. Hofmann relied on these assumptions to form the basis for his
`
`economic opinions because he cannot himself opine on technical matters. See,
`
`
`
`11
`
`

`
`e.g., id., ¶¶ 25-27, 59-60, 69-70, 72-80, 99, 102, 110. This is a commonplace
`
`practice; Mr. Jarosz similarly relied on technical understandings to form the basis
`
`of his economic opinions. EX2130, ¶¶ 18, 41, 48, 50, 81, 83, 148. Interestingly,
`
`Patent Owner did not attempt to undermine Mr. Hofmann’s technical assumptions,
`
`preferring to avoid substance. Patent Owner also did not ask Mr. Hofmann where
`
`these technical assumptions came from, likely because they came from the
`
`documents explicitly cited in the footnotes to the Reply Declaration, see, e.g.,
`
`EX1122 ¶¶ 25-26 (nn.28-29), 62 (n.95), 72-80 (nn.115-27), 86 (nn.137-38), 102
`
`(nn.166-69), or because Mr. Hofmann previously testified in a related matter that
`
`they came from technical experts and Patent Owner’s documents. EX1181, 9:24-
`
`10:22, 165:24-166:20; EX2334, 13:1-14:17; see also id. at ¶¶ 11-14 (discussing
`
`Mr. Hofmann’s experience in the field). Regardless of the reason, Mr. Hofmann
`
`does not opine any of the assumptions that Patent Owner mischaracterizes as
`
`opinion in its Motion. Mr. Hofmann need not be qualified as a technical expert to
`
`competently analyze how these assumptions affect his economic opinions. Finally,
`
`the fact that Mr. Hofmann did not have any “live discussions” with the technical
`
`expert makes no difference as he still reviewed their reports and considered a large
`
`volume of Patent Owner’s documents. EX2343, 52:11-13.
`
`B. Mr. Hofmann Fully Answered All Questions Asked, Except When
`Interrupted by Patent Owner, and Was Not Impeached
`
`There is also no controversy of Mr. Hofmann “refus[ing] to answer
`
`
`
`12
`
`

`
`straightforward questions” and therefore purportedly being “repeatedly
`
`impeached.” Motion at 12-13. Each of the cited portions at the top of page 13 of
`
`Patent Owner’s Motion shows Mr. Hofmann’s willingness to answer questions and
`
`give appropriate context to those answers. None of the cited portions actually
`
`constitutes impeachment. Mr. Hofmann (1) gave the exact same answer—“no”—
`
`as his prior allegedly impeaching testimony, see EX2343, 11:13-13:6, (2) gave the
`
`same answer but simply elaborated on the topics of his expertise, see id. at 13:16-
`
`14:19, and (3) provided a responsive answer that was in no way contradictory to
`
`his previous answer, see id. at 23:10-25:1, 55:9-56:7, 57:6-13, 106:16-110:4.
`
`None of this constitutes impeachment under any competent understanding of the
`
`term. Moreover, in at least two examples cited by Patent Owner, Mr. Hofmann’s
`
`answers were limited due to third-party confidentiality. See id. at 95:12-96:6,
`
`106:16-110:4.
`
`On numerous occasions, counsel for Patent Owner interrupted Mr. Hofmann
`
`and did not allow him to fully answer the question. See, e.g., id. at 68:14-20, 89:9-
`
`20, 95:16-96:6, 101:5-10. These interruptions were not because Mr. Hofmann
`
`“defiantly refused to answer even basic questions,” Motion at 15, but because Mr.
`
`Hofmann was providing necessary context to his answers, as any expert will do.
`
`Counsel apparently did not appreciate these complete responses, clearly fishing for
`
`sound-bites. In fact, if any party at the deposition exhibited “improper behavior,”
`
`
`
`13
`
`

`
`Motion at 12, it certainly was not Mr. Hofmann. At one point, counsel for Patent
`
`Owner asked Mr. Hofmann a very broad question, EX2343, 108:5-8, to which Mr.
`
`Hofmann tried his best to answer, first explaining that there were a number of
`
`assumptions in the question with which he disagreed. Id. at 108:10-18. Mr.
`
`Hofmann then began to directly answer the question when counsel cut him off,
`
`apparently unhappy that Mr. Hofmann would “make those kinds of statements”—
`
`i.e., answer the question asked—“on the record.” Id. at 109:7-17.
`
`C. Mr. Hofmann Provided Qualitative and Quantitative Analyses of
`the “Extrinsic Factors” That Affect Prolensa® Sales
`
`Patent Owner also takes issue with Mr. Hofmann’s testimony about “other
`
`extrinsic factors.” Motion at 14. When asked “what percentage of Prolensa sales
`
`are the result of” various extrinsic factors, Mr. Hofmann on each occasion referred
`
`Patent Owner to his full Reply Declaration. EX2343, 89:5-8, 89:12-13, 89:21-22,
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`90:9-10. Mr. Hofmann also testified that the “entirety of the sales of the Prolensa
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`product”—i.e., 100%—can be attributed to those “extrinsic factors.” EX2343,
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`89:13-16. When Mr. Hofmann attempted to further define this statement, counsel
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`predictably interrupted. Id. at 89:17-20. In any event, Mr. Hofmann went far
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`beyond Patent Owner’s own economic expert, Mr. Jarosz, who did not provide or
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`even attempt to provide such a quantitative analysis of the effects of promotional
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`efforts by Patent Owner on the performance of Prolensa®. EX1182, 23:9-23,
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`158:3-22.
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`D. Mr. Hofmann’s Testimony Has Been Repeatedly Credited
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`Mr. Hofmann’s expertise has also been repeatedly credited by various
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`federal courts and institutions. EX1122, ¶¶ 13-14. While Patent Owner’s Motion
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`attempts to undermine this fact, none of the examples cited at the bottom of page
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`14 of Patent Owner’s Motion is related to Mr. Hofmann’s expertise at issue in this
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`case: objective indicia of commercial success. Additionally, Patent Owner
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`mischaracterizes the outcome of at least two of those cases. See EX2343, 37:3-38-
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`9; id. at 47:13-48:8. In the context of Mr. Hofmann’s “generally . . . favorable
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`feedback” from the courts regarding his expertise, id. at 45:15-19, the few cited
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`examples cannot undermine Mr. Hofmann’s economic opinions here.
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`Patent Owner’s discussion of the SEC investigation of Mr. Dearlove is
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`misguided. Motion at 14-15. Mr. Hofmann was not found of any wrongdoing; the
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`SEC sanctioned Mr. Dearlove, the lead audit partner, not Mr. Hofmann. EX2343
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`at 61:17-62:3, 63:3-20. In Mr. Hofmann’s favor, the SEC in fact credited his
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`testimony and called him as a witness at the hearing for Mr. Dearlove. EX2343,
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`68:9-13. Of course, Mr. Hofmann’s responses on this matter were limited due to
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`third-party confidentiality, as would be expected. EX2343, 65:20-22.
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`IV. Conclusion
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`Patent Owner’s Motion to Exclude should be denied in its entirety.
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` 
`May 18, 2016
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`Respectfully submitted,
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`
`
` /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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`16
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`CERTIFICATION OF SERVICE
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`The undersigned hereby certifies that the foregoing document entitled
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`Petitioners’ Opposition To Patent Owner’s Motion to Exclude was served
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`electronically via email on May 18, 2016 to Patent Owner’s counsel of record and
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`counsel of record for Petitioners InnoPharma at the following:
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`Patent Owner
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`Bryan.Diner@finnegan.com
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`Justin.Hasford@finnegan.com
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`Joshua.Goldberg@finnegan.com
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`Petitioners InnoPharma
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`Jitty.malik@alston.com
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`bryan.skelton@alston.com
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`James.abe@alston.com
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`Lance.soderstrom@alston.com
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`Joe.janusz@alston.com
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`Respectfully submitted,
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`
`
`/Shannon M. Lentz/
`Shannon M. Lentz, Reg. No.65,382
`CROWELL & MORING LLP
`Intellectual Property Group
`P.O. Box 14300
`Washington, DC 20044-4300
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`May 18, 2016