`Filed: May 12, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`LUPIN LTD. and LUPIN PHARMACEUTICALS INC.
`Petitioner,
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD.
`Patent Owner.
`
`__________________
`
`IPR2015-01097 (US Patent No. 8,751,131)
`IPR2015-01099 (US Patent No. 8,669,290)
`IPR2015-01100 (US Patent No. 8,927,606)
`IPR2015-01105 (US Patent No. 8,871,813)1
`__________________
`
`
`
`PATENT OWNER’S MOTION TO EXCLUDE
`UNDER 37 C.F.R. § 42.64(C)
`
`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. 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
`
`Dr. Lawrence’s Opinions and Testimony Regarding any Issue of
`Organic or Medicinal Chemistry Should Be Excluded Under FRE 702 ......... 2
`
`A.
`
`B.
`
`Senju Timely Objected to and Challenged Dr. Lawrence’s
`Qualifications During Cross Examination ............................................ 2
`
`Dr. Lawrence Is Not Qualified to Offer Opinions on Chemistry,
`or Challenge Those Opinions of Senju’s Qualified Expert .................. 2
`
`II.
`
`Portions of the Reply Declaration of Dr. Lawrence and New
`Accompanying Exhibits Should be Excluded Under FRE 402 and 403 ......... 8
`
`A.
`
`B.
`
`Senju Timely Objected to the Lawrence Reply Declaration and
`Accompanying Exhibits, Upon Which Petitioner Relied ..................... 8
`
`Dr. Lawrence’s Reply Declaration and Supporting Exhibits
`Exceed the Scope of Petitioner’s Reply under 37 C.F.R. §
`42.23(b) ................................................................................................. 9
`
`1.
`
`2.
`
`Paragraphs 31-33, 37-38, and footnote 5 of EX1094 and
`EX1096-1098, EX1100-1102, and EX1172-1173 ...................... 9
`
`EX1107, EX1108, and EX1109 ................................................10
`
`C.
`
`The Portions of Dr. Lawrence’s Reply Declaration and
`Supporting Exhibits Identified Above Lack Relevance under
`FRE 402 and Are Prejudicial Under FRE 403 ....................................11
`
`III. Mr. Hofmann’s Opinions and Testimony Should Be Excluded Under
`FRE 702 .........................................................................................................12
`
`A.
`
`Senju Timely Objected to and Challenged Mr. Hofmann’s
`Qualifications During Cross Examination ..........................................12
`
`B. Mr. Hofmann Is Not Qualified to Opine Beyond Economics ............12
`
`IV. Conclusion .....................................................................................................15
`
`
`
`
`
`ii
`
`
`
`
`
`Pursuant to 37 C.F.R. §§ 42.64(c) and 42.61(a), and the Federal Rules of
`
`Evidence, Patent Owner Senju moves to exclude three categories of evidence filed
`
`by Petitioners. First, Senju moves to exclude the Reply Declaration of M. Jayne
`
`Lawrence, Ph.D. (EX1094), specifically at least paragraphs 31, 33, 36-37, 48-49,
`
`51-52, and 73, and footnote 5, allegedly supporting EX1174 and 1176, and the
`
`related testimony of Dr. Lawrence (EX2342), because Dr. Lawrence completely
`
`lacks expertise in organic or medicinal chemistry and, thus, she is not qualified by
`
`knowledge, skill experience, training or education necessary to form an opinion
`
`under FRE 702. Second, Senju moves to exclude paragraphs 31-33, 37-38, as well
`
`as footnote 5 of EX1094, and allegedly supporting EX1096-1098, 1100-1102,
`
`1107-1109, and 1172-1173, because these exhibits lack relevance under FRE 402,
`
`as they exceed the proper scope of Petitioner’s Reply under 37 C.F.R. § 42.23(b),
`
`and because they are prejudicial under FRE 403 to Senju, as Senju is unable to
`
`respond to the new arguments contained to them. Finally, Senju moves to exclude
`
`the Reply Declaration of Ivan T. Hofmann (EX1122) in its entirety because of Mr.
`
`Hofmann’s improper behavior during cross examination, and specifically at least
`
`paragraphs 25-27, 42, 59-60, 62, 69-70, 72-80, 86-87, 99, 102, and 110, and the
`
`related testimony of Mr. Hofmann (EX2343), because he also provides opinions on
`
`technical and medical matters for which he is not qualified by knowledge, skill,
`
`experience, training or education necessary to form an opinion under FRE 702.
`
`
`
`1
`
`
`
`I.
`
`Dr. Lawrence’s Opinions and Testimony Regarding any Issue of
`Organic or Medicinal Chemistry Should Be Excluded Under FRE 702
`A.
`
`Senju Timely Objected to and Challenged Dr. Lawrence’s
`Qualifications During Cross Examination
`
`Senju timely objected to EX1094, specifically paragraphs 31, 33, 36-37, 48-
`
`49, 51-52, and 73, and footnote 5, under FRE 702 and 37 C.F.R. § 42.65 in
`
`objections filed and served April 29, 2016.2 Further, during Dr. Lawrence’s two
`
`cross-examinations (EX2316, 31:3-43:8; 141:15-142:2; EX2342, 9:11-14:10; 16:3-
`
`23:10; 263:21-264:10), Senju extensively challenged and objected to Dr.
`
`Lawrence’s lack of qualifications necessary to form an opinion under FRE 702.
`
`B. Dr. Lawrence Is Not Qualified to Offer Opinions on Chemistry, or
`Challenge Those Opinions of Senju’s Qualified Expert
`
`In her Reply Declaration, Dr. Lawrence offers opinions on organic and
`
`medicinal chemistry issues to argue that the instituted claims are allegedly obvious
`
`and to challenge the declarative evidence on secondary considerations submitted
`
`by Patent Owner. As she even readily admits, Dr. Lawrence completely lacks
`
`expertise in organic and medicinal chemistry—the central technology of this
`
`proceeding. Accordingly, Dr. Lawrence’s opinions should be excluded.
`
`Dr. Lawrence was cross-examined twice during this proceeding, and each
`
`time, Patent Owner explored her complete lack of relevant expertise. At the outset,
`
`2 (Paper 40 in IPR2015-1097, IPR2015-01100, and IPR2015-01105, and Paper 39
`
`in IPR2015-1099.)
`
`
`
`2
`
`
`
`Dr. Lawrence held herself out to be an expert in “the field of formulation and drug
`
`delivery, specifically pharmaceutical formulation for oral and parenteral use . . .”
`
`(EX1094, ¶ 4.) She is not a medical doctor and has never practiced medicine or
`
`prescribed medication to a patient (EX2316, 31:6-11; EX2342, 13:11-15). Further,
`
`Dr. Lawrence is no longer an active pharmacist, having not dispensed a drug in the
`
`last 20 years (EX2316, 34:17-20; EX2342, 13:19-21), and she has never dispensed
`
`any bromfenac product. (EX2316, 34:21-35:2; EX2342, 13:22-14:2.) She has
`
`never formulated any marketed drug product or any product for treating an
`
`inflammatory disease of the eye and never conducted any research on any
`
`bromfenac product. (EX2316, 35:3-5; 35:11-18; EX2342, 16:3-17; 14:3-5.)
`
`Dr. Lawrence’s formal education is in pharmacy, not chemistry. (EX2342,
`
`12:22-13:5; EX1005, ¶ 5.) She has never held a faculty position in any chemistry
`
`department. (EX1005, ¶ 7.) She is not a member of the American Chemical
`
`Society and has never published anything in the Journal of the American Chemical
`
`Society. (EX2316, 39:5-22; EX2342, 11:21-12:21.) Dr. Lawrence has only ever
`
`filed two patent applications, and neither is relevant to the ’290, ’131, ’831, or ’606
`
`patents. (EX2316, 42:7-43:8; E2342, 22:11-23:10.) After an extensive review of
`
`her credentials during her cross examinations, Dr. Lawrence readily admitted that
`
`she is not an expert in medicinal chemistry, organic chemistry, or antioxidant
`
`chemistry and that she had never been qualified by any court or the U.S.P.T.O. as
`
`
`
`3
`
`
`
`an expert in chemistry. (EX2316, 40:1-5; EX2342, 9:16-11:20.) Tellingly, in a
`
`moment of candor, Dr. Lawrence wondered out loud if her chemistry was “rusty.”
`
`(EX2316, 289:3-4.) Thus, with respect to the central issues Dr. Lawrence and
`
`Petitioners have raised in this proceeding, Dr. Lawrence has no experience or
`
`expertise whatsoever, and therefore she is unqualified to provide expert testimony.
`
`Dr. Lawrence not only is unqualified to offer her own opinions but also is
`
`unqualified to challenge the opinions of Patent Owner’s expert Dr. Davies. For
`
`example, Dr. Lawrence contends that the compound tyloxapol is an “alkylphenol,”
`
`like those disclosed in the Doi patent (EX2030). (EX1094, ¶ 33.) A phenol,
`
`however, is by definition a compound having one or more hydroxyl (-OH) groups
`
`attached to a phenyl ring. Tyloxapol is therefore by definition not an alkylphenol
`
`and is not taught by Doi, contrary to Dr. Lawrence’s opinions. When asked
`
`whether tyloxapol contains an OH group directly attached to the phenyl ring, Dr.
`
`Lawrence could not provide a straight answer, and simply responded: “It might
`
`do.” (EX2342, 222:17-21.) When also asked whether tyloxapol contains one OH
`
`group at the very end of each R group, which the chemical structure of tyloxapol
`
`depicted in Dr. Lawrence’s reply declaration clearly establishes, Dr. Lawrence
`
`responded: “Not necessarily.” (EX2342, 222:10-16.) Worse still, Dr. Lawrence’s
`
`testimony with respect to these matters of basic chemistry directly conflicts with
`
`Petitioners’ other expert in separate, but related, IPR proceedings for the same
`
`
`
`4
`
`
`
`family of patents, Dr. Laskar, who testified that tyloxapol does not contain an OH
`
`group directly attached to the phenyl ring and that tyloxapol does contain one OH
`
`group at the end of each R group. (EX2342, 222:22-225:9; EX2331, 46:21-47:4.)
`
`Moreover, Dr. Lawrence’s reliance on a series of wholly irrelevant
`
`references that teach the use of tyloxapol in biological systems to prevent biologic
`
`injury (see EX1097-1098, EX1100-EX1102, EX1172) further establishes that Dr.
`
`Lawrence is unqualified to offer opinions regarding organic or medicinal chemistry.
`
`As Dr. Davies explained in the parallel district court litigation regarding
`
`the ’290, ’131, ’831, and ’606 patents, bromfenac is subject to oxidation in
`
`aqueous ophthalmic solutions in the presence of oxygen (O2). (EX2344.) EX1100,
`
`EX1172, and EX1101 cited by Dr. Lawrence study the ability of tyloxapol to
`
`prevent biologic injury from “partially reduced O2 species,” which are not oxygen.
`
`(EX2344, at ¶ 29.) “Partially reduced O2 species” are simply not present in the
`
`claimed bromfenac ophthalmic solutions of the ’290, ’131, ’813, and ’606 patents,
`
`as Dr. Lawrence acknowledged. (EX2342, 234:20-235:2.) Dr. Davies further
`
`explained that the Ghio article (EX1102) similarly studies the use of tyloxapol in
`
`biological systems to “inhibi[t] activation of the transcription factor nuclear factor-
`
`kappa B . . .,” as well as tyloxapol’s ability to serve as an antioxidant for hydroxyl
`
`radicals, generated in the presence of ferrous ions, and hypochlorous acid,
`
`generated from ‘leukocyte myeloperoxidase.” (EX2344, at ¶ 29.) Hydroxy
`
`
`
`5
`
`
`
`radicals and hypochlorous acid are also not oxygen and are similarly not present in
`
`the claimed bromfenac ophthalmic solutions of the ’290, ’131, ’813, and ’606
`
`patents, as Dr. Lawrence again acknowledged. (Id.; EX2342, 234:6-18.) These
`
`references are therefore not relevant to bromfenac’s oxidative degradation, and
`
`nothing in these references establishes that tyloxapol would behave as an
`
`antioxidant for O2 in an aqueous solution of bromfenac. (EX2344, at ¶ 29.)
`
`Indeed, if tyloxapol did inhibit O2, its administration as a therapeutic agent by
`
`aerosol treatment to the lungs as in EX1101 (see 3:2-5) would be potentially fatal
`
`in vivo. In sum, it is not surprising that Dr. Lawrence’s opinions in her Reply
`
`Declaration (EX1094) are inconsistent with the opinions offered by Dr. Davies, an
`
`undisputed expert in organic and medicinal chemistry.
`
`To qualify as an expert, a witness must have “knowledge, skill, experience,
`
`training, or education” relevant to the evidence or facts at issue. Fed. R. Evid. 702.
`
`In addition, an expert must be more than simply “qualified” in any discipline. The
`
`expert must be qualified in the subject matter about which he or she proposes to
`
`testify. See Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1362
`
`(Fed. Cir. 2008) (expert who may have been qualified to testify as to patent office
`
`procedures not qualified to testify on patent validity because of a lack of
`
`experience and training in the pertinent art). The Federal Circuit has stated that
`
`
`
`6
`
`
`
`“[a]dmitting testimony from a [witness], with no skill in the pertinent art, serves
`
`only to cause mischief and confuse the factfinder.” Sundance, 550 F.3d at 1362.
`
`Under Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 597 (1993) and
`
`Fed. R. Evid. 702, courts and the Board are charged with a “gatekeeping role,” the
`
`objective of which is to ensure that expert testimony admitted into evidence is both
`
`reliable and relevant. Because Dr. Lawrence, by her own admission, has no
`
`training or experience in organic or medicinal chemistry, which is the very subject
`
`matter Dr. Lawrence and Petitioners have placed at issue in this proceeding, her
`
`opinions fail to comply with Fed. R. Evid. 702. Dr. Lawrence plainly lacks both
`
`the knowledge and experience required for the opinions she provides in EX1094.
`
`Dr. Lawrence’s purported expertise in the fields of formulation and drug
`
`delivery does not now qualify her as an expert in chemistry. See Extreme
`
`Networks, Inc. v. Enterasys Networks, Inc., 395 F. App’x 709, 715 (Fed. Cir. 2010)
`
`(“General experience in a related field may not suffice when experience and skill
`
`in specific product design are necessary to resolve patent issues.”) Indeed, during
`
`Dr. Lawrence’s first cross examination, Petitioners’ counsel repeatedly objected to
`
`questions relating to chemistry, such as the three-dimensional structures and
`
`chemical structures of NSAIDS, as “outside the scope” of Dr. Lawrence’s
`
`expertise. (E.g., EX2316, 90:5-13; 92:8-14; 101:9-102:3; 169:9-17.) Yet now,
`
`Petitioners rely on Dr. Lawrence’s opinions on these and other chemistry issues,
`
`
`
`7
`
`
`
`despite their previous objection that these issues were “outside the scope” of Dr.
`
`Lawrence’s expertise. (EX1094, ¶¶ 36, 48-49, 51-52.) Because she is unqualified,
`
`Dr. Lawrence’s opinions expressed in EX1094, specifically at least paragraphs 31,
`
`33, 36-37, 48-49, 51-52, and 73, footnote 5, and EX1174 and EX1176 regarding
`
`organic or medicinal chemistry are unreliable, cannot assist the trier of fact as Fed.
`
`R. Evid. 702 requires, should be afforded no weight, and should be excluded.
`
`II.
`
`Portions of the Reply Declaration of Dr. Lawrence and New
`Accompanying Exhibits Should be Excluded Under FRE 402 and 403
`A.
`
`Senju Timely Objected to the Lawrence Reply Declaration and
`Accompanying Exhibits, Upon Which Petitioner Relied
`
`In objections filed and served on April 29, 2016, Senju objected to EX1094,
`
`specifically ¶¶ 31, 33, and 37, and footnote 5, and allegedly supporting EX1096-
`
`1098, 1100-1102, and 1172-1173, under FRE 402 and 403 as being directed to
`
`improper new testimony from Dr. Lawrence that tyloxapol allegedly is an
`
`antioxidant.3 Senju further objected to Exhibits 1107-1109, under FRE 402 and
`
`403, which Petitioners use to allegedly support a new argument in Petitioners’
`
`Reply that a POSA would expect switching polysorbate 80 with tyloxapol to
`
`improve preservative efficacy because polysorbate 80 allegedly was known to
`
`neutralize BAC. Id.
`
`
`3 (Paper 40 in IPR2015-1097, IPR2015-01100, and IPR2015-01105, and Paper 39
`
`in IPR2015-1099.)
`
`
`
`8
`
`
`
`B. Dr. Lawrence’s Reply Declaration and Supporting Exhibits
`Exceed the Scope of Petitioner’s Reply under 37 C.F.R. § 42.23(b)
`1.
`
`Paragraphs 31-33, 37-38, and footnote 5 of EX1094 and
`EX1096-1098, EX1100-1102, and EX1172-1173
`
`In its Reply, Petitioner relies upon the Lawrence Reply Declaration
`
`(EX1094) for an entirely new argument for why a POSA allegedly would have
`
`reason to modify Ogawa in view of Sallmann, relying on eight new references.4 In
`
`EX1094, Dr. Lawrence posits, for the first time, that:
`
`And, to the extent that Drs. Davies and Williams are
`correct, a POSA would have been even more motivated
`to use tyloxapol in a bromfenac formulation as a POSA
`would have been aware of the studies suggesting that
`tyloxapol is an antioxidant.
`
`(EX1094, ¶ 31(emphasis added).) In Dr. Lawrence’s opening declaration
`
`(EX1005), her first cross examination, and the Petition, however, not once did Dr.
`
`Lawrence or Petitioners argue that a POSA would replace polysorbate 80 with
`
`tyloxapol because tyloxapol allegedly is an antioxidant. This is an entirely new
`
`argument, to which Patent Owner has had no opportunity to respond. In
`
`connection with this new argument, Dr. Lawrence discusses eight new references
`
`
`4 (Reply, Paper 38 in IPR2015-1099 at 7, Paper 37 in IPR2015-1097, IPR2015-
`
`1105, and IP2015-1100 at 7.)
`
`
`
`9
`
`
`
`in detail, blatantly mischaracterizing each reference. (See EX1094, ¶¶ 31-33, 37-
`
`38, and fn. 5; EX1096-1098, EX1100-1102, and EX1172-1173.)
`
`Moreover, Petitioners knew that bromfenac degraded by oxidation and this
`
`new testimony regarding the alleged use of an antioxidant could have been
`
`previously presented. Indeed, Dr. Lawrence’s initial declaration at ¶ 66(e)
`
`(EX1005) states that stabilizers, such as antioxidants, are added to ophthalmic
`
`formulations to decrease the decomposition of the active ingredient and that
`
`Ogawa Example 6 uses the stabilizer sodium sulfite (EX1005, ¶186, last sentence),
`
`a well-known antioxidant. Petitioner’s failure to address a known issue until the
`
`Reply round of submissions plainly warrants exclusion.
`
`EX1107, EX1108, and EX1109
`
`2.
`In its Reply, Petitioner argues for the first time that a POSA allegedly would
`
`expect that switching polysorbate 80 with tyloxapol would improve preservative
`
`efficacy because polysorbate 80 allegedly was known to neutralize BAC. 5
`
`Petitioner sets forth three new references in connection with this new argument.
`
`(EX1107-1109.) Patent Owner has had no opportunity to respond to this entirely
`
`new argument relating to alleged motivation to combine, and accordingly this new
`
`argument should be excluded.
`
`5 (Reply, Paper 38 in IPR2015-1099 at 5, Paper 37 in IPR2015-1097, IPR2015-
`
`1105, and IP2015-1100 at 5.)
`
`
`
`10
`
`
`
`C. The Portions of Dr. Lawrence’s Reply Declaration and
`Supporting Exhibits Identified Above Lack Relevance under FRE
`402 and Are Prejudicial Under FRE 403
`
`Paragraphs 31-33, 37-38, as well as footnote 5 of EX1094 and Exhibits
`
`1096-1098, 1100-1102, 1107-1109, and 1172-1173 described above should be
`
`excluded because they lack relevance under FRE 402, as they exceed the proper
`
`scope of Petitioner’s Reply under 37 C.F.R. § 42.23(b). Arguments in support of a
`
`reply “may only respond to arguments raised in the corresponding . . . patent owner
`
`response.” Id. As explained in the Trial Practice Guide, “new evidence necessary
`
`to make out a prima facie for [] unpatentability” and “new evidence that could
`
`have been presented in a prior filing” are improper. 77 Fed. Reg. 48767. “[A]
`
`reply that raises a new issue or belatedly presents evidence will not be considered
`
`and may be returned.” Id. Indeed, “[i]t is of the utmost importance that petitioners
`
`in the IPR proceedings adhere to the requirement that initial petition identify ‘with
`
`particularity’ the ‘evidence that supports the grounds for the challenge to each
`
`claim.’” Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., No. 15-1639 at
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`16 (Fed. Cir. May 9, 2016). Moreover, these portions of EX1094 and the exhibits
`
`listed above should be excluded under FRE 403 because they were first presented
`
`at the Reply stage and Patent Owner is prejudiced by being unable to respond to
`
`the untimely evidence and arguments therein.
`
`
`
`11
`
`
`
`III. Mr. Hofmann’s Opinions and Testimony Should Be Excluded Under
`FRE 702
`A.
`
`Senju Timely Objected to and Challenged Mr. Hofmann’s
`Qualifications During Cross Examination
`
`Senju timely objected to EX1122, specifically paragraphs 25-27, 42, 59-60,
`
`62, 69-70, 72-80, 86-87, 99, 102, and 110, under FRE 702 and 37 C.F.R. § 42.65 in
`
`its April 29, 2016, objections.6 Further, during Mr. Hofmann’s cross-examination
`
`on his Reply Declaration (EX2343, 10:5-16:6; 20:17-25:1; 39:4-17; 55:6-59:9;
`
`109:15-110:4), Senju challenged and objected to Mr. Hofmann’s improper
`
`behavior and lack of qualifications necessary to form an opinion under FRE 702.
`
`B. Mr. Hofmann Is Not Qualified to Opine Beyond Economics
`In his declaration in support of the Reply, Mr. Hofmann offers opinions on
`
`technical and medical matters to support his contention that there is allegedly no
`
`nexus between the claimed inventions of the ’290, ’131, ’813, and ’606 patents and
`
`commercial success. Mr. Hofmann, however, completely lacks the relevant
`
`technical or medical expertise or experience
`
`to provide
`
`these opinions.
`
`Accordingly, and as discussed below, Mr. Hofmann’s opinions should be excluded.
`
`During his cross-examination, Patent Owner explored Mr. Hofmann’s lack
`
`of relevant technical and medical expertise, but he refused to answer straight-
`
`
`6 (Paper 40 in IPR2015-1097, IPR2015-01100, and IPR2015-01105, and Paper 39
`
`in IPR2015-1099.)
`
`
`
`12
`
`
`
`forward questions, and as a result, was repeatedly impeached. (EX2343, 11:13-
`
`13:6; 13:16-14:19; 23:10-25:1; 55:9-56:7; 57:6-13; 95:12-96:6; 106:16-110:4.)
`
`Despite his defiance, Mr. Hofmann acknowledged that he had no technical
`
`expertise
`
`in pharmaceutical
`
`formulations, ophthalmic
`
`formulations,
`
`the
`
`manufacture of pharmaceuticals, methods of using pharmaceuticals, and FDA
`
`regulations. (EX2343, 20:17-22:11.) He further acknowledged that he 1) is not a
`
`“medical expert,” “legal expert” or “technical expert,” 2) has no expertise in
`
`chemistry, 3) has never formulated or conducted research on a pharmaceutical
`
`product, 4) has never prescribed medicine or treated an inflammatory disease of the
`
`eye, 5) has never tested Prolensa®, 6) has never been qualified as an expert in
`
`clinical benefits of pharmaceutical products, 7) has never practiced pharmacy, and
`
`8) has never conducted or participated a clinical study. (EX2343, 11:13-13:5;
`
`13:10-14:13; 14:20-15:9; 15:21-16:6; 23:10-15; 39:15-17; 57:6-58:6; 87:10-12;
`
`88:6-11; 105:4-13.) Indeed, Mr. Hofmann’s formal education is limited to a
`
`bachelor’s degree in business administration. (EX2343, 10:10-11:6.)
`
`Despite his repeated admissions that he was not a technical or medical
`
`expert, Mr. Hofmann provides opinions directly on these issues. For example, Mr.
`
`Hofmann opines that the efficacy of Prolensa® is attributable to the bromfenac
`
`molecule (EX1122, ¶¶ 72-24), opines that the safety and efficacy of Prolensa is not
`
`improved over Bromday® (EX1122, ¶¶ 75-79), and opines on the prescribing
`
`
`
`13
`
`
`
`practices of physicians and patient compliance (EX1122, ¶¶ 62, 80, 86, 102). Mr.
`
`Hofmann has absolutely no qualifications, by education or experience, to provide
`
`opinions on these technical and medical issues. Moreover, Mr. Hofmann did not
`
`even speak with any of the technical experts to gain an understanding of the
`
`technical or medical issues relevant to the ’290, ’131, ’813, and ’606 patents.
`
`(EX1122, ¶ 5; EX2343, 52:8-13.) Instead, he simply “[p]erformed independent
`
`research on various topics and issues.” Id.; see Forest Labs., Inc. v. Ivax
`
`Pharmaceuticals, Inc., 438 F.Supp. 2d 479, 495 (D. Del. 2006) (rejecting
`
`economic expert testimony where economist did not consult with any physicians in
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`preparing his opinions).
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`Mr. Hofmann further asserts in his Reply Declaration that various “other
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`extrinsic factors” contribute to the commercial success of Prolensa®. (EX1122, ¶¶
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`81-120). But when asked during his cross-examination what percentage of sales
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`was the result of these “other extrinsic factors,” Mr. Hofmann could not provide an
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`answer. (EX2343, 89:2-90:21.) Such haphazard analysis falls well short of the
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`standard set forth in Rule 702. See Forest Labs., 438 F.Supp. 2d at 495 (rejecting
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`economic expert testimony where economist could not determine what percentage
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`of pharmaceutical sales were due to “other factors”). Indeed, multiple courts have
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`found Mr. Hofmann’s analysis lacking, unreliable, and have rejected his opinions.
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`(EX2343, 35:3-37:21; 41:11-43:18; 45:20-48:15.) Further, while working as an
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`audit manager for Deloitte, Mr. Hofmann was part of an auditing team that was
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`later investigated by the SEC. (EX2343, 25:6-33:20; 60:3-68:17.) During that
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`SEC investigation, Mr. Hofmann provided testimony against the lead partner, who
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`was ultimately sanctioned by the SEC for failing to comply with certain disclosure
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`requirements. Id. And throughout his cross examination, Mr. Hofmann defiantly
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`refused to answer even basic questions, in one instance launching into a page-and-
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`a-half-long diatribe when simply asked whether a particular judicial opinion
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`identified him. (EX2343, 46:10-48:8.)
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`Because Mr. Hofmann is unqualified and not credible, his opinions
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`expressed in EX1122, specifically at least paragraphs 25-27, 42, 59-60, 62, 69-70,
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`72-80, 86-87, 99, 102, and 110, are unreliable, irrelevant, and cannot assist the trier
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`of fact as Fed. R. Evid. 702 requires and should be afforded no weight.
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`Accordingly, the Board should exclude his testimony from evidence given his
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`improper behavior and admitted lack of technical and medical expertise.
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`IV. Conclusion
`For the reasons set forth above, Patent Owner respectfully requests that the
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`Board grant this Motion to Exclude.
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`Date: May 12, 2016
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`Respectfully submitted,
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`By: /Bryan C. Diner/
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`Bryan C. Diner, Lead Counsel
`Reg. No. 32,409
`Counsel for Patent Owner
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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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`Owner’s Motion to Exclude was filed on May 12, 2016, and served via email
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`directed to counsel of record for the Petitioner at the following:
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`Deborah Yellin
`dyellin@crowell.com
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`Jonathan Lindsay
`jlindsay@crowell.com
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`Teresa Stanek Rea
`TRea@crowell.com
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`Chiemi Suzuki
`CSuzuki@crowell.com
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`Jitendra Malik
`jitty.malik@alston.com
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`Bryan Skelton, Ph.D.
`Bryan.skelton@alston.com
`
`Lance Soderstrom
`Lance.soderstrom@alston.com
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`Hitetada James Abe
`James.abe@alston.com
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`Joseph M. Janusz
`Joe.janusz@alston.com
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`Dated: May 12, 2016
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`/Bradley J. Moore/
`Bradley J. Moore
`Litigation Legal Assistant
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP