SENJU EXHIBIT 2140
`LUPIN v SENJU
`IPR2015-01105
`
`PAGE 1 OF 132
`
`

`
`M. .|ayne L:1wr{:ncc
`
`Seplemberd, 2015
`
`Scnju Ph:1rm:1ceLItit:al C0,, I.TD., cl al. V. Lupin, L'|'D., and Lupin Phalmacuulical. Inc.,
`
`UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF NEW JERSEY
`
`SENJU PHARMACEUTICAL CO.,
`
`LTD., BAUSCH & LOMB
`
`INCORPORATED, and BAUSCH
`
`& LOMB PHARMA HOLDINGS CORP.,
`
`Civil Action Nos.:
`
`l:14-Cv-U0667—JBS-KMW
`1:14-CV-04149*JBS~KMW
`
`Plaintiffs,
`
`1:14-cv—05144—JBS—KMW
`
`1:15-CV-00335-JBS~KMW
`
`_VS_
`
`LUPIN, LTD., and LUPIN
`
`PHARMACEUTICALS,
`
`INC.,
`
`Defendants.
`
`INNOPHARMA LICENSING,
`
`INC.,
`
`INNOPHARMA LICENSING, LLC,
`
`Civil Action NOS.:
`
`INNOPHARMA,
`
`INC.,
`
`INNOPHARMA,
`
`LLC, MYLAN PHARMACEUTICALS,
`
`1:l4—cv—06893~JBS—KMW
`
`INC., and MYLAN INC.,
`
`1:15-cv-03240-JBS-KMW
`
`Defendants.
`
`Deposition of:
`
`M.
`
`JAYNE LAWRENCE, Ph.D.
`
`September 4, 2015
`
`New York, New York
`
`,
`I
`
`
`
`......=..._._._.__:._..4._....;M._«...-.-....«.M.............:..-.
`
`i
`
`866-928-6509
`
`Ace—Federal Reporters, Inc.
`
`202-347-3700
`
`PAGE 2 OF 132
`
`PAGE 2 OF 132
`
`

`
`M. Jayne Lzlwrence
`
`September4, 20l5
`
`Senju Pharniaceutieal C0,, LTD. et a]. V. L.upil‘l, LTD-. find 1.|.Ipin Pliarmaceulical. |nc:..
`
`APPERANCES (CONTINUED):
`
`ALSTON & BIRD, LLP
`Attorneys for Defendant lnnopharma
`333 Smith Hgpe Street, ]5[h F100;-
`Los Angeles, California 900?‘!
`BY: H. JAMES ABE, ESQ.
`(213) 5764000 (Telephone)
`(213) 576-] I00 (Fax)
`jarnes.abe@alslon.co1n
`
`I 2 3 4
`
`5
`
`6 7 8
`
`Also Present:
`
`Thomas Del Veeehio (Videographer)
`
`Page 2
`
`VIDIEOTA PED DEPOSITION OIM. .|/-\YNI~i I..AWRl-ENCE.
`
`Ph.D., taken pursuant to Notice, held at the law
`offices ol‘GOODWIN I’ROC'l‘l.-IR. LLP, 620 Eighth Avenue,
`26th Floor, New York. New York, IOOI8-I405, on
`
`Fiiday, Seplentber 4. 2(Jl5. at 8:00 am. before
`JEANNl?.TTli MCCORMICK, a-Certified Slmrthand Reporter,
`and a Notary Public.
`
`APPEARANCES:
`
`INDEX
`
`Page 3
`
`FINNEGAN, HENDERSON, FARABOW. GARRETT
`& DUNNER, LLP
`Attorneys for Plaintiffs
`901 New York Avenue, NW
`Washington, DC. 20001-4413
`BY: JUSTIN J. HASFORD, ESQ‘
`BRYAN C. DINER, ESQ.
`(202) 408-4000 (Telephone)
`(202) 408-4400 (Fax)
`justin.hasford@finneganeom
`
`bryan.diner@,finnegan.com
`
`EXAMINATION BY
`WITNESS
`M. JAYNE LAWRENCE, Ph.D.
`MR. HASFORD
`
`I7
`
`E X H I B I T S
`LAWRENCE
`NUMBER
`
`DESCRIPTION
`
`Exhibit I Declaration ofM. Jayne
`Lawrence, Ph.D. and
`
`Appendices and Exhibits
`
`GODWIN PROCTER, LLP
`Attorneys for Defendant Lupin
`The New York Times Building
`620 Eighth Avenue
`New York, New York 10018-1405
`BY: DANIEL P. MARGOLIS, ESQ.
`(212) 8]3~8800 (Telephone)
`(212) 355-3333 (Fax)
`
`dmargolis@goodwinprocter.com
`
`"Models for Intestinal Drug
`Exhibitl
`Absorption", Wood & Lawrence
`(1991) Journal of'Biopharn1aeeutical
`Sciences (pgs. 147-] 72)
`(Publication No. 5 on CV)
`
`206
`
`fi:."5~.ooo-.:o\<.n-I:-team-—
`
`13
`
`14
`15
`16
`I?
`I8
`19
`20
`2]
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`PAGE 3 OF 132
`
`2 (Pages 2 to 5}
`
`202-347-3700
`
`PAGE 3 OF 132
`
`

`
`M. Jayne Lawrence
`
`September 4, ZUI5
`
`Scnju PI1:1t'm3Ct!llliC2ll Co., LTD., et al. v. Lupin, LTD., and Lupin Pliaimaccutical, lnc..
`
`OO--.JG\L.I1-bL..-JI\-J—-
`
`E X H I B I T S
`LAWRENCE
`
`NUMBER
`
`DESCRIPTION
`
`Exhibit 3 "Effect of diclofenac sodium
`and disodium
`
`ethyleuediaminetetraacetate on
`electrical parameters of the
`mucosa] membrane and their
`
`relation to the permeability
`enhancing effects in the rat
`jejunum" by Yamashita, et al,
`in the J. Pharm. Pharmacol.
`
`I987, volume 39, pages 621 to 626
`
`208
`
`Exl1ibit4 U.S. Patent No. 8,192,755 B2
`Exhibit 5 U.S. Patent Application
`Publication No. 20l3f02l0878 Al
`
`232
`
`237
`
`E X H I 13 IT S
`LAWRENCE
`DESCRIPTION
`NUMBER
`Exhibit 9 "Recent Advances in
`
`Microemulsions as Drug
`Delivery VeI1icles" in
`"Nanoparticulates as Drug
`Carriers," (pgs. I25-I'll)
`(Book Chapters No. 14 on CV)
`Exhibit I0 "Drug Delivery Systems:
`Neutron Scattering Studies" in
`"Encyclopedia of Pharmaceutical
`Technology," (pgs. I049-l 070)
`(Book Chapters No. 15 on CV)
`Exhibit I
`I "New Medicines, Better
`Medicines, Better Use of
`Medicines," (120 pgs.)
`(Other Outputs No. 12 on CV)
`
`GEG§:E.~oeo-..1crxL;1.e.uaM—
`
`[>.,_1;\_3|-_)._._._._.
`
`I‘-J'—'$"‘-«DOO--.'|C'\
`
`E X H I B I T S
`LAWRENCE
`NUMBER
`
`DESCRIPTION
`
`"Structural Investigations of
`Exhibit 6
`the Monolayers and Vesicular
`Bilayers Formed by a Novel Class
`ofhlonionic Surfactant" in the
`
`"Chemical Aspects of Drug
`Delivery System," (pgs. 65-26)
`(Book Chapters No. 6 on CV)
`
`240
`
`"Neutron Scattering in
`Pharmaceutical Sciences" in
`
`“Applications ofNeutron
`Scattering to Soft Condensed
`Matter," (pgs. 325-356)
`(Book Chapters No. 7 on CV)
`Exhibit 3
`"Molecular Modelling of
`Surfactant Vesicles" in
`"Synthetic Surfactant
`Vesicles," (pgs. 9-23)
`(Book Chapters No. 8 on CV)
`
`KC-‘DO-u.lO\Lh-L‘-LnJt~J—
` Exhibit?’
`
`E X H I B I T S
`LAWRENCE
`DESCRIPTION
`NUMBER
`Exhibit 12 "Association Characteristics
`
`of Synthetic Non-ionic
`Surfactants in Aqueous Solution"
`in “Physical Chemistry in
`Condensed Phases," (pgs. 1903-1910)
`(Articles in Academic Journals
`No.
`I on CV)
`279
`
`Exhibit I3 "Effect of Structural
`Variations ofNon—ionic
`
`Surfactants on Micellar
`Properties and Solubilization:
`Surfactants with Semi-Polar
`Hyclrophobes" in "Journal of
`Phanuacy & Pharmacology,"
`(pgs. 585-S89) (Articles in
`Academic Journals No. 2 on CV)
`
`281
`
`'
`3
`.
`
`g
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`3 (Pages 6 to 9}
`
`202-347-3700
`
`PAGE 4 OF 132
`
`PAGE 4 OF 132
`
`

`
`M. Jayne Lawrence
`
`September 4, 2015
`
`Scnju Pharmaceutical Co., [.'|'D., et al. v. Lupin, I."l'D., and Lupin Pliarmaceutical. Inc..
`
`I
`
`EXHIBITS
`LAWRENCE
`2
`3 NUMBER
`
`PAGE
`DESCRIPTION
`4 Exhibit 18 "Microemulsions as Drug Delivery
`Vehicles" in "Culrent Opinion in
`Colloid & Interface Science,"
`
`8
`
`(pgs. 826-832) (Articles in
`Academic Journals No. [8 on CV)
`295
`9 Exhibit 19 "Aggregation & Surface Propenies
`10
`of Synthetic Double—Chain Non-Ionic
`ll
`Surfactants in Aqueous Solution in
`I2
`"Journal ofPhar111a & Pharmacology.
`I3
`Volume 49, May 199? (pgs. S94-600)
`l4
`(Articles in Academic Journals
`l5
`No. 20 on CV)
`29?
`l6
`l7
`
`l8
`I9
`20
`21
`22
`
`\C'-‘%---JE3'\L)'\-l'>-LnJI\..‘I—-
`
`EXHIBITS
`
`LAWRENCE
`
`PAGE
`DESCRIPTION
`NUMBER
`Exhibit 20 "Physicochemical & Solubiliaation
`Properties ofN,N-Dimethyl-N-
`(3-Dodecylcarbonyloxypropyl)
`amineoxide: A Biodegradable
`Nonionic Surfactant" in "Journal
`
`’
`
`ofPhan'nac-eutical Sciences,"
`(pgs. 798-806) (Articles in
`
`Academic Journals No. 33 on CV)
`
`299
`
`E X ll 1 B I T S
`LAWRENCE
`
`NUMBER
`
`DESCRIPTION
`
`PAGE
`
`Exhibit I4 "Analysis and Modelling ofthe
`Structures of Bcta—Cyclodextrin
`Complexes" in "BBA, Biochimica
`et Biophysica Acta, (pgs. 27-36)
`(Articles in Academic Journals
`No. 8 on CV)
`283
`
`Exhibit I5 "Surfactant Systems: Their
`Use in Drug Delivery" in
`"Chemical Society Reviews,"
`(pgs. 4|?-424) (Articles in
`Academic Journals No. 9 on CV)
`
`285
`
`EXHIBITS
`LAWRENCE
`NUMBER
`
`DESCRIPTION
`
`Exhibit 16 "Surfactant Systems:
`Microemulsions and Vesicles as
`
`Vehicles for Drug Delivery“ in
`“European Journal of Drug
`Metabolism & Phannacokinetics,
`I994, No. 3, (pgs. 25?-26.9)
`(Articles in Academic Journals
`No. 12 on CV)
`288
`
`I 2 3 4
`
`I0
`I]
`I2
`13
`14
`
`15
`16
`
`I7
`18
`I9
`20
`21
`22
`
`l 2 3 4 5 6 7 3 9
`
`Exhibit I? "The Formation, Characterization
`& Stability of'Non-Ionic
`Surfactant Vesicles" in "STP
`
`Pharrna Sciences." (Pgs. 49-60)
`(Articles in Academic Journals
`No. 16 on CV)
`292
`
`Exhibit 21 "Toxicological Evaluation of
`Mixtures ofNonionic Surfactants,
`Alone & in Combination with Oil"
`in "Journal of Pharmaceutical
`
`Sciences," (pgs. 859-868 (Articles
`in Academic Journals No. 47 on CV) 304
`
`366-928-6509
`
`Ace—Federa| Reporters, Inc.
`
`4 (Pages I0 to 13}
`
`202-347-3700
`
`PAGE 5 OF 132
`
`PAGE 5 OF 132
`
`

`
`M. Jayne Lawrence
`
`Senju Pl1nt'rnacet|tica1C0., LTD.. et al. v. Lupin, LTD.. and Lupin Pha1'maceutica|. Inr:..
`
`September 4, 2015
`
`Page I 6
`
`DO‘-.1C\U't-13L.»-ll‘-J‘—'
`
`E X H 1 B 1 T S
`LAWRENCE
`NUMBER
`
`DESCRIPTION
`
`Exhibit 22 "Formulation of Electrically
`Conducting Microernulsion-Baserl
`Organogels" in "International
`Journal of Pharmaceutics"
`
`(pgs. 65-83 (Articles in Academic
`Journals No. 49 on CV)
`305
`Exhibit 23 "Molecular Dynamics Simulations
`of the Interfacial & Structural
`
`Properties of
`Dimethyldodecylarnine-N-Oxide
`Micelles" in "Langmuir, The ACS
`Journal of Surfaces & Colloids"
`
`(pgs. 546-553 (Articles in Academic
`Journals No. 8?‘ on CV)
`308
`Exhibit 24 "Microernu1sion-Based Media as
`
`Novel Drug Delivery Systems" in
`"Advanced Drug Delivery Reviews"
`(pgs. 175-193 (Articles in
`Academic Journals No. 102 on CV)
`
`312
`
`Page 15
`
`P R O C F. E D I N G S
`
`08:10:l
`
`THE VIDEOGRAPHERI Good morning. We are
`now going on the record. Please note that
`08:10:16
`microphones are sensitive and may pick up
`08:10:20
`whispering and private conversations. Please
`08:10:22
`turn off all telephones or place them away
`08:10:25
`08:10:29
`from the microphones as they can interfere
`08:10:32
`with the video deposition audio.
`08:10:34
`Recording will continue until parties
`08:10:36
`agree to go off the record.
`03:10:38
`The deponenr today is Dr. Jayne Lawrence
`in the matter of Senju Pharmaceutical
`08:10:42
`Company, Ltd, at al, plaintiffs, versus
`08:10:48
`Lupin, Ltd, et a1, defendants. Civil Action
`08:10:52
`Number 1:14-CV-0066?, in the United States
`08:11:00
`District Court for the District of New
`08:1 1:13
`
`08:1 1:23
`Jersey.
`This deposition is being taken at the
`oilice of Goodwin Procter, the New York Times
`
`Building, 620 Eighth Avenue, New York, New
`York, 10018. The time is approximately 8:12
`a.m. Today is Friday, September 4, 2015.
`
`08:1 1:23
`08:1 1:25
`08:11:30
`03:1 1:33
`0831 1 :44
`
`[Q.—.—.—..—..............__._
`
`
`
`g¢.__.a\t,_;1_J;.L,.a[\_)._ifi_g\5t¢c.__;g-\._n;,L,,,,_;_gt:ioa~..:a~Ln.r~_Laar.i—-
`
`The court reporter today is Jeannette
`McCormick with the firm ol'Ace-Federal
`
`08:1 1:53
`08:1 1:5?
`
`Reporters. My name is'i‘|tntnas 1)c| Veechio.
`am the legal video specialist representing
`Ace-Fedentl Reporters, 1625 I Street,
`Northwest, Washington], D.C'., 20006.
`Will cmtnsel identify themselves and who
`they represent.
`08:12:19
`08:12:20
`MR. IIASFORD: Justin llasford of Finnegan
`on bclialfofplaintitfs Senju and Bauseh &
`08: 12:21
`l_.omb.
`08:12:21
`
`08:12:00
`1
`08:12:04
`08:12:06
`08:12: 12
`08:12:17
`
`MR. DINER: Bryan [Jitter of Finnegan,
`also on behallefplaintiffs Senju and Bauseh
`3: Lom|:t.
`08:12:31
`
`08:12:25
`08:12:27
`
`MR. MARGOLIS: Dan Margolis from Goodwin
`Procter for the Lupin defendants.
`08:12:33
`MR. ABE: James Abe ofAlston & Bird for
`08:12:36
`
`03:12:31 :-
`
`08:12:38
`the Innopharma defendants.
`THE VIDEOGRAPHER: Thank you. Now, will
`08:12:43
`lhe court reporter please swear in or afiimt
`the witness.
`08:12:45
`
`_
`
`08: 12:4
`
`M. JAYNE LAWRENCE, Phil,
`
`having been first duly sworn
`testified as follows:
`EXAMINATION
`
`BY MR. I-IASFORD:
`
`03:12:57
`
`08:12:57
`Q. Good morning, Dr. Lawrence.
`08:13:01
`A. Good morning.
`Q. Would you please state your name and address
`for the record.
`08:13:04
`
`08:13:02 __
`
`A. Yes. Dr. Margaret Jayne Lawrence of62
`
`08:13:04
`
`08:13:08
`Wellington Road, Ashford, Middlesex, UK.
`Q. How many times have you been deposed before?
`08: 13:1 .
`A. This is my first time.
`08:13:14
`Q. Let me tell you how today's deposition will
`proceed.
`I represent the plaintiffs in this case.
`Today 1 will ask you at series ofquestions, and I
`would ask that you answer my questions truthfully
`and accttralely.
`08:13:25
`Ifyou need a break,just let me know, but if
`1 have asked a question 1 would ask that you first
`answer the question and then we can take a break.
`If for any reason you do not ulidcrstand a
`question that 1 ask, please let me know.
`lfyou
`
`08:13:26
`08:13:29
`08:13:31
`08:13:34
`08:13:36
`
`03:13:16
`08:13:18
`08:13:20
`03:13:23
`
`866-928-6509
`
`Aee—Federal Reporters, Inc.
`
`5 (Pages 14 to 1'?)
`202-347-3700
`
`PAGE 6 OF 132
`
`PAGE 6 OF 132
`
`

`
`M. Jayne Lawrence
`
`September 4, 2015
`
`Senju Pharrnaceutical Co._,
`
`|.TD., et al. v. Lupin, LTD._, and Lupin Pliarniaceutical, lnc.,
`
`19(6--|O'\L.i'|-1‘-‘-La-JP‘-1*
`
`answer :1 question, 1 will assume that you understood
`the question.
`Is that okay?
`08:13:40
`A. Yes.
`08:13:42
`
`Page I 8
`
`08:13:38
`
`08:13:42
`is there any reason why you cannot testify
`Q.
`trutlt1'ul|y and accurately today?
`08:13:45
`A. No.
`
`08:13:46
`
`08:13:49
`l'm handing the court
`MR. IIASFORD:
`08:13:50
`reporter what We asked to be marked as
`Lawrence Exhibit 1.
`08:13:52
`
`For the record, Lawrence Exhibit 1 is
`
`08: 13:53
`
`08:13:55
`the Declaration oflaync Lawrence, Ph.D., and
`Appendices and Exhibits.
`08:13:59
`(whereupon, P|ainti11‘s Deposition
`08:14:30
`1£x11ibitNo. Lawrence 1 was marked for
`08:14:31
`
`Identification.)
`
`08:14:33
`
`Q. 15 Lawrence Exhibit 1 your claim construction
`declaration, appendices and exhibits in this case?
`A. Yes.
`08:14:45
`
`08:14:33
`08:14:37
`
`Q. Please tum to page 25. Does your signature
`appear on page 25 ofyour claim construction
`declaration for this case?
`08:14:57
`A.
`11 does.
`08:14:58
`
`08:14:46
`
`08:14:54
`
`Page 19
`
`Q. Who prepared your claim construction
`declaration for this case’?
`A.
`I did.
`
`08:14:58
`08:15:00
`08:15:02
`
`08:15:03
`15
`Q. Take a look, ifyou would, at Appendix A.
`08:15:13
`Appendix A to your claim construction declaration at
`copy ofyour curriculum vitae?
`08:15:16
`A.
`11 is.
`
`08:15:18
`
`08:15:19
`Q. Does your curriculum vitae list your relevant
`professional experience?
`08:15:22
`A. It does.
`08:15:23
`
`Q. In what areas do you consider yourselfan
`expert‘?
`08:15:26
`MR. MARGOLIS: Objection. Vague.
`BY MR.1-IASFORD:
`
`08:15:24
`
`08:15:27
`08:15:30
`
`08:15:30
`Q. You may answer.
`MR. ABE: Counsel, will we agree that if
`08:15:32
`counsel for Lupin objects it will apply for
`08:15:35
`lnnophanna as well?
`08:15:39
`MR. 1-IASFORD: Sure. We can agree to
`that.
`08:15:41
`
`08:15:40
`
`MR, ABE: Thank you. Please proceed.
`T1-11:". WITNESS: Could you just repeat the
`
`08:15:42
`08:15:43
`
`08:15:44
`question again?
`Q. Ccttainly.
`In what areas do you consider
`yourst:|1'an expert?
`08:15:46
`MR. M!\RG()L.lS: Same objection.
`THE WITNESS:
`lo terms o1‘ scientific
`
`activities? In terms ofprofessional
`activities? Could you please clarify a hit
`more?
`08:15:58
`
`Page 20
`
`08:15:44
`
`08:15:47
`
`08:15:49
`08:15:54
`08:15:56
`
`08:15:58
`
`In what areas do you hold yourself out as an
`Q.
`expert‘?
`08:16:01
`MR. MARGOIJS: Objection. Vague.
`08:16:01
`THE WITNESS:
`It depends what --1 tind
`08:16:06
`that a very clifficult question to answer
`08:16:10
`because you could be expert in lots ofareas
`08:16:12
`and that's why 1 ask for clarification.
`08:16:15
`
`08:16:17
`Q. 1n what scientific areas do you consider
`yourself an expert?
`08:16:19
`A. Okay.
`I-—
`08:16:20
`MR. MARGOLIS: Objection. Vague.
`Q. You may answer.
`08:16:21
`A. Do you mean an expert in the context ofthis
`particular case?
`08:16:35
`
`08:16:23
`
`08:16:20
`
`Q. W11at‘s your understanding ofan expert,
`Doctor?
`08: 16:44
`
`A. An expert is a person who has knowledge in a
`particular area.
`08:16:48
`Q. Okay. And l'm asking the question based on
`your understanding. So I will ask it again. In
`what areas do you consider yoursetfan expert?
`MR. MARGOLIS: Objection. Vague.
`THE WITNESS:
`I think to answer that
`
`08:16:44
`
`08:16:49
`08:16:51
`08:16:53
`08:16:56
`08:17:06
`
`08:17:08
`question I'm going to have to quali Fy the
`08:17:12
`particular areas I’m talking about because 1
`have expertise in several areas.
`08:17:15
`Q. What areas?
`08:17:17
`A.
`1 have expertise in respect to professional
`activities where l'm chair of -- I‘rn sony -- where
`l'm Chief" Scientist for Royal Pharmaceutical
`08:17:36 '1
`Society, and so 1 have expertise, and surrounding my
`activities as a chief scientist in that context.
`1
`08:17:43
`
`08:17:19
`08:17:27
`08:17:30
`
`obviously have expertise surrounding my activities
`as an academic in King's College, London.
`Q. Are you an expert in any other areas?
`MR. MARGOLIS: Objection. Vague.
`
`03:17:47 9
`08:17:50
`08:17:56
`08:18:00
`
`866928-6509
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`PAGE 7 OF 132
`
`6(Pages18to21)
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`202-347-3700
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`PAGE 7 OF 132
`
`

`
`M. Jayne Lawrence
`
`Scnju Pharmaceutical Co., LTD., ct al. v. Lupin, LTD., and Lupin Pharmaceutical, |rtc.,
`
`Page 2?.
`
`September 4, 2015
`
`Page 24 Z
`
`Q. What other areas‘!
`A. {jetting — that's incredibly vague and
`
`08:20:04
`08:20:06
`08:20:12
`
`(18:20: 15
`08:20:20
`
`probably not relevant to this particular case. For
`example, I'm an expert on neutron scattering, but
`it‘s probably i rrclcvant for this particttlar case.
`08:20:24
`Q. Well. I'm asking you the question and, you
`08:2lJ:2
`know, I'm not asking you to try to determine what's
`08:20:31
`relevant or not relevant for the case.
`08:20:33
`
`Are you an expert in any other areas‘?
`A.
`I consider 1 have expertise in a number of
`08:2] :02
`other areas. yes. For example, I'm a recognized
`expert on neutron scattering.
`08:21:09
`Q. And you just said that. What other areas
`08:21:12
`besides neutron scattering?
`08:21:15
`.
`A.
`1 think 1'tn expert in promoting of
`08:21:18
`pltarmaeeutical science.
`08:21:23
`Q. Any other areas?
`08:21:25
`A. 1'l1qua1iFy that, promoting to the public
`08:21 :27
`and other scientists. Can 1 look at my CV?
`08:21:32
`Q. Oh, please.
`08:21:40
`A.
`1 consider1'm an expert teacher with respect
`
`08:20:59
`
`08:21:48
`08:21:54
`
`Page 25
`
`to pharmaceutical science. I've been given awards
`
`08 :22 :00
`for that activity.
`1 consider I'm an expert researcher, which
`includes an expert in the areas you highlighted.
`Q. Any other areas?
`08:22: 10
`A. Archaeology. Hobby.
`08:22: 14
`Q. Anything else?
`08:22:22
`A.
`it's very hard to answer when asked are you
`
`08:22:02
`08:22:06
`
`08:22:37
`08:22:40
`
`an expert in, not knowing what the point ofthe
`question is.
`08:22:44
`Q. Well, let me ask it this way. Are you an
`expert in the field of pharmacy?
`. Yes.
`
`08:22:48
`
`08:22:45
`
`08:22:47
`
`. Have you ever practiced pharmacy?
`. Yes.
`08:22:51
`
`08:22:49
`
`. When did you last practice pharmacy?
`.
`I‘m a practicing pharmacist.
`08:22:53
`. When did you last dispense a medication to a
`patient?
`08:22:58
`A. Dispense medication? Probably 20 years ago.
`Q. Are you an expert in pharmacology?
`A. No.
`08:23:12
`
`08:22:51
`
`:
`
`08:22:55
`
`08:22:58 '2
`03:23:10
`-
`
`Q. Are you an expert in pharmacokinetics?
`
`08:23:12
`
`HDGCI--.'IONl.I\r-12-bJ|*J—'
`
`~._a‘'
`
`.— Ix.)
`
`._.—-bid
`
`3 3 E
`
`:
`\-D
`_t
`l\-?3
`N —-
`l\-Ji‘-3
`
`0'€I-~.1U'\Lri-hl.aJI--)—-
`
`20
`21
`22
`
`Q. You may a|1swer_
`A.
`1 do find that really, really hard to answer.
`1 can give you an expertise ifyou tell me vvltat
`particular areas you are referring to.
`In
`Q.
`I'm asking you for your understanding.
`what other areas do you hold yourscl1'out as on
`08:18:20
`expert‘?
`
`08:18:02
`08:18:06
`08:18:09
`
`08:18:| 1
`08: 18:13
`08:18: 17
`
`08:18:20
`MR. MARGOLIS: Objection. Vague.
`08:18:}
`THE WITNESS: Well, I'm going to answer
`it this way.
`1 have expertise in a number of
`08:18:38
`scientific disciplines.
`1 have expertise in
`08:18:42
`08:18:47
`respect to my professional activities
`regarding my work at Pharmaceutical Society.
`I think my main -- my main two areas of
`expertise.
`08:19:01
`Q. Take a look at paragraph 5 of your
`declaration on page two.
`A. Which is headed?
`
`08:19:02
`
`08:19:05
`08:19:11
`
`08:18:54
`08:18:56
`
`Q. Its going to be page 2 ofyour declaration.
`A. Yes.
`08:19:13
`
`08:19:13
`
`08:19:16
`Q. Paragrap1I5 under Qualifications. [don't
`think you're on the right page.
`t18:19:19
`
`08:19:20
`I'm sorry.
`A.
`08:19:21
`lt'S your declaration.
`Q.
`08:19:22
`A. Sorry. Paragraph 5'?
`Q. So, 1 still don't believe you're on the right
`08:19:26
`page.
`It's your declaration, not your curriculum
`08:19:28
`vitae.
`08:19:31
`
`08: I 9:31
`08:19:32
`08:19:39
`08: 19:40
`
`I‘m sorry. Five did you say? Page 5?
`A.
`Q. Page 2, paragraph 5.
`A. Page 2. Okay.
`Q.
`It says, "I am an expert in the field of
`08:19:42
`formulation and drug delivery, specifically
`08:19:44
`phannaeetrtical fonnulation for oral and parenteral
`use (i.e., non-oral, including intravenous
`08:19:48
`intramuscular, nasal, respiratory and ophthaltrtic],
`08:19:52
`including aqueous liquid preparations."
`08:19:57
`Do you see that?
`08:19:58
`A. Yes.
`08:19:59
`
`08:19:59
`Q. Do you hold yourscifout to the public as an
`expert in any other areas?
`08:20:01
`A.
`ln other areas?
`08:20:02
`
`E\DGO'~--.tO‘‘\L!l«I‘-‘-LoJl'\J'—'
`
`_.
`
`5 G E E S —
`
`---..1
`-
`—- O0
`6
`
`Q. Correct.
`A. Yes.
`
`08:20:03
`08:20:04
`
`866-928-6509
`
`Ace—Federal Reporters, lnc.
`
`'? {Pages 22 to 25)
`
`202-347-3700
`
`PAGE 8 OF 132
`
`PAGE 8 OF 132
`
`

`
`M. Jayne Lawrence
`
`Senju Pharmaceutical C0,, I.TD., et al. v. Lupin, LTD., and Lupin Pharmaeettlicul. 1nc.,
`
`September 4, 2015
`
`Page 28 .
`
`A. As a pharmacist in the UK, that is not your
`role.
`03:25:21
`
`08:25:17
`
`08:25:22
`15 that a "nt1"'.’
`Q.
`A. 1n the UK, that would not he the role ofa
`
`08:25:24
`
`08:25:26
`pharmacist.
`Q. Have you ever dispensed any hrotnfenac product
`to a patient‘?
`08:25:30
`A. No.
`08:25:32
`
`_
`08:25:22 I
`
`Q. Have you ever dispensed any product
`containing tyloxapol to a patient‘?
`A. Yes.
`
`08:25:33
`08:25:35
`
`. What product‘?
`. Exosurl.
`
`08:25:38
`08:25:39
`08:25:40
`
`08:25:42
`. You may have to spell that for the reporter.
`. E-X-0-S-U-R-F.
`08:25:45
`. What is Exosurt?
`08:25:50
`
`it's a product for respiratory distress
`.
`syndrome in pro-term infants.
`Q.
`is that an ophthalmic product?
`A. 1t‘s not an ophthalmic product.
`
`1 have
`
`08:25:52
`08:25:59
`08:26:03
`
`08:26:06
`
`_
`08:26:08
`dispensed many oplithalmie products.
`Q. Have you ever dispensed an ophthalmic product
`08:26:11 I
`
`Page 2‘)
`
`08:26: 16
`containing tyloxapol to a patient‘?
`08:26:16
`A. Undoubtedly.
`08:26:]?
`Q. Which one?
`A. Many products contain tyloxapol. As at
`pharmacist, 1 have dispensed most ophthalmic
`preparations.
`08:26:32
`08:26:32
`Q. What ophthalmic product containing tyloxapol
`have you dispensed to a patient‘?
`08:26:36
`A. As a pharmacist, it is not normal you read
`08:26:32
`the list ofexcipients.
`08:26:40
`Q. Sitting here today, can you name any
`ophthalmic product containing tyloxapol that you
`have dispensed to a patient?
`08:26:46
`A. No.
`08:26:52
`08:26:53
`Q. Are you aware that the acronym EDTA stands
`For ethylenediaminetetraacetie acid?
`08:26:59
`A. lam.
`
`08:26:19
`08:26:28
`
`08:26:41
`
`08:26:43
`
`_
`
`08:27:02
`
`E\-G-‘JO-~lCl‘-I.-it-ht.-Jr\J—'
`
`5 S E
`
`.— Ln
`-- Ch
`
`——DU‘-J
`NM-—.::\.-.>
`
`In.)M}
`
`DO--IGNLII-fl-(.1-|'l‘J4—'
`
`Page 26
`
`MR. MARGOLIS: Objection. Vague.
`Q. You may answer.
`08:23:19
`A.
`l have -- 1 have a good level ofexpertise in
`08:23:23
`that.
`08:23:28
`
`08:23:18
`
`08:23:29
`Q. Have you ever held yourself out to the public
`as an expert in phannacoltittctics?
`08:23:31
`A. No.
`
`08:23:33
`
`Q. Have you ever held yoursclfout to the public
`as an expert in pharmacodytianiics?
`MR. MARGOLIS: Objection. Vague.
`08:23:41
`Q. You may answer.
`A
`.
`I have not.
`08:23:44
`
`08:23:33
`08:23:36
`08:23:40
`
`Q. Are you an expert in ophthalmology?
`MR. MARGOLIS: Objection. Vague.
`Q. You may answer.
`08:23:54
`
`08:23:45
`
`08:23:52
`
`I'm an exp:-it in parenteral fonnulations of
`A.
`which ophthalmology -- ophthaltnic formulations as
`well.
`08:24:06
`
`08:23:53’
`08:24:01
`
`08:24:06
`Q. Have you ever held yourselfout to the public
`as an expert in ophthalmology?
`08:24:09
`MR. MARGOIJS: Objection. Vague.
`08:24:] 1
`THE WITNESS: No.
`08:24:12
`
`Page 2}‘
`
`08:24:13
`08:24:17
`
`Q. Are you an expert in any field ofmedieine?
`MR. MARGOLIS: Objection. Vague.
`08:24:19
`THE WITNESS: Medicine is a huge area.
`08:24:25
`And what are you covering? Are you covering
`phannaceutical medicine?
`08:24:27
`Q. Have you ever held yourselfout to the public
`08:24:29
`as an expert in any field of medicine‘?
`08:24:31
`
`08:24:34
`MR. MARGOLIS: Objection. Vague.
`08:24:37
`THE WITNESS:
`1 am a Registered
`08:24:39
`Practicing Pharmacist in the UK.
`08:24:42
`. Have you ever --
`08:24:43
`. So, I am not a medic.
`08:24:47
`. Well, when you say -—
`. So, 1 would not claim to practice medicine.
`08:24:48
`. Have you ever prescribed medication to 3
`08:24:53
`patient?
`08:24:56
`A. No.
`08:24:58
`
`\DOO'--.lO"t‘Jl-H-<..nJl"*J—'
`
`E .
`
`_.
`
`S S E G E S
`
`._. DO
`
`l-lave you ever treated an inflammatory disease
`0.
`of the eye?
`08:25:02
`A. No.
`08:25:06
`
`Q. Have you ever administered any bromfenac
`product to a patient?
`
`08:24:59
`
`08:25:06
`
`21
`22
`
`Q. Have you ever administered any product
`containing EIDTA or any salt or anion nt‘EDTA to a
`patient’?
`08:27:11
`A. Undoubtedly, yes.
`08:27:12
`Q. Which product‘?
`08:2't:t4
`
`03:27:02
`
`03:27:04 ‘_
`
`866-928-6509
`
`Ace-Federal Reportets, lnc.
`
`PAGE 9 OF 132
`
`8 ( Pages 26 to 29)
`
`202-347-3200
`
`PAGE 9 OF 132
`
`

`
`M. Jayne Lawrence
`
`September 4, 2015
`
`Senju Pl1armaceutica1Co.. LT['J., et a1. V. Lupin, LTD., and Lupin Pliarmaceuiieal. Inc.
`
`Q. Have you ever conducted any research on any
`product containing EDTA or any salt or anion o1‘
`EDT/\'?
`08:29:45
`A. Yes.
`08:29:45
`
`Page 32
`
`08:29:37
`08:29:40
`
`'
`
`08:29:45
`Q. What product?
`A.
`It's frequently —~ it's a compound that is
`08:29:48
`fnequenlly used in academic researelt for a variety
`08:29:53
`of purposes.
`08:29:58
`Q. When did you inst use EDTA in your academic
`research‘?
`08:30:02
`
`08:29:13 =
`
`A. Personally, a while ago. My research group,
`all the time. So, 1 don't know how that answers
`
`08:30:03
`08:30:08
`
`08:30:14
`your question.
`08:30:14
`Q. No. Thank you for clarifying.
`When personally did you last use EDTA in your
`08:30: 16
`academic research?
`08:30: 19
`
`A. Probably about five years ago.
`
`08:30:22
`
`08:30:37
`Q. When personally did you last use tyloxapol in
`your academic research’?
`08:30:39
`A. Very recently.
`08:30:42
`Q. Do you remember how recently‘?
`A. Probably last year or so.
`
`08:30:45
`08:30:47
`
`Q. Is bromfenac a water-soluble hydrophilic
`drug‘?
`08:31:00
`MR. MARGQLIS: Objection. Vague.
`THE WITNESS: Can I ask you to clarify
`that? Do you mean the free acid or do you
`mean the salt?
`08:31:04
`
`Page 33
`
`08:30:52
`
`08:31:00
`08:31:02
`08:31:02
`
`Q. Well, let me ask it this way.
`
`ls the sodium 08:31:05
`
`08:31 :07
`
`salt of bromfenac a water-soluble hydrophilic drug’?
`A.
`It is.
`03:31:12
`08:31:13
`Q. Would :1 solution containing tyloxapol in
`water he considered a water-based surfactant system?
`08:31:16
`MR. MARGOLIS: Objection. Vague.
`08:31:19
`THE WITNESS: Sorry. Repeat the
`08:31 :23
`question’?
`08:31 :25
`Q. Certainly.
`twill repeat the question.
`Would a solution containing tyloxapol in
`
`08:31:25
`08:31:27
`
`08:31 :30
`water he considered a water-based surfactant system?
`08:31:34
`MR. MARGOLIS: Objection. Vague.
`08:31:37
`THE WITNESS:
`It is vague because you
`08:31 :43
`don't give enough infonnation as to regards
`08:31 :45
`to how much tyloxapol or what else is in
`there. So it's very -- it's difficult to
`08:31 :49
`
`I
`
`I
`
`.5
`
`:5-DOD--IG'~UI.b-L-Jl\J—'
`
`E G _
`
`..—-U143
`
`S -
`
`- --I
`_. OD
`_. \D
`In-JG
`
`N I
`
`x}IN}
`
`E\DO1:I--lG'\U\-h.La-II‘-J—-
`
`E E E G
`
`.— UN
`
`3 E _
`
`\-D
`
`.
`
`A. Eye drops that contain it.
`Q. Which eye drops‘?
`A.
`ldon'tieca|1.
`
`(18:27: 15
`08:27:17
`08:27:19
`
`Q. Have you ever conducted any research on any
`bromfenuc product‘?
`08:27:25
`MR. MARGOLIS: Objection, Vague.
`Q. You may answer.
`08:27:28
`A. On El bromfenac product, no.
`08:27:38
`Q. Have you ever conducted any research on any
`08:27:40
`product containing tyloxapol?‘
`08:23:42
`. Yes.
`
`08:27:21
`
`08:27:27
`
`08:27:45
`
`08:27:45
`. What product‘?
`08:27:47
`. Exosurf, for example.
`08:27:52
`. Any others?
`. Formulations I have undertaken research in my
`own laboratory.
`08:27:59
`Q. Which fonnulations?
`08:28:00
`A. That 1 have made up in my own laboratory.
`08:28:01
`Q. How did you make a 1'orn1ulation in your
`08:28:04
`laboratory containing tyloxapol?
`08:28:07
`A. That is a very vague question.
`08:28:11
`
`I have used
`
`08:27:55
`
`lyloxapol much in my research.
`
`08:28: 1 6
`
`Page 31
`
`08:28:18
`Q. What did you use it for‘?
`A. To make a variety of formulations, of types
`08:28:20
`offormulations.
`08:28:24
`
`08:28:25
`Q. Why did you use tyioxapol in the formulations.
`that you made in your laboratory?
`08:28:28
`MR. MARGOLIS: Objection. Vague.
`08:28:30
`Compound.
`08:28:31
`Q. You may answer.
`08:28:32
`
`08:28:35
`A. Iused it for several reasons. For example,
`it is accepted phunnaeeutically.
`08:28:40
`Q. What other reasons’?
`08:28:42
`A. It's a non-ionie surfactant.
`08:28:45
`
`08:28:51
`Q. What other reasons?
`A.
`It is well—known to solubilize drugs. To
`08:28:53
`solubilize, S-0-L-U-B-1-L—l-S—E, or Z—E.
`08:29:05
`Q. Any other reasons‘?
`08:29:07
`A.
`It's -- it stabilizes many formulations.
`08:29:09
`
`Q. What do you mean by "it stabilizes many
`forrnulations"?
`08:29:29
`A.
`ll depends on the formulation you're looking
`at, how it acts, but it is used to fonnulate many
`preparations.
`08:29:35
`
`08:29:26
`
`08:29:29
`08:29:31
`
`tXt--!t'.'hUI-1l:.L.LJI\-?‘—-
`
`866-928-6509
`
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`
`9 (Pages 30 to 33)
`
`202-347-3700
`
`PAGE 10 OF 132
`
`PAGE 10 OF 132
`
`

`
`M. Jayne L.a\vI‘cnee
`
`September 4, 2015
`
`Senjlt Pharrnaccutical Co.. LTD.. ct al. v. Lupin, l.TD., and Lupin Pliarrnaceutical, lnc.,
`
`answer.
`
`08:31:52
`
`Q. How \\«'t‘.Il.| Id you make :1 \vatcr—based surfactant
`08:31 :56
`system with tyloxapol?
`08:31 :57
`A. Cart 1 ask for clarification‘?
`. Sure.
`
`Page 34
`
`08:31:52
`
`08:31:59
`Q
`A. What do you mean by water-based?
`Q. What's your understanding of water-based?
`.
`1 don't know.
`I'm asking For clarification.
`. Have you ever used the term watcr-based?
`08:32:09
`A. It's not a frequently used term -- a teI'm 1
`08:32:12
`frequently use, no.
`Q. Have you ever used it in any ofyour
`publications?
`08:32: 1 5
`A. Idoo't know.
`ldon‘t remember every single
`08:32:24
`publication I've had.
`Q. Would a solution containing tyloxapol in
`water be considered an aqueous surfactant system?
`MR. MARGOLIS: Objection. Vague.
`08:32:32
`’I'|-11:". WITNESS: Again, you need to tell me
`08:32:34
`how much water and tyloxapol there are to
`08:32:37
`answer that question. I'm sorry.
`08:32:37
`Q. Why does it matter how much water and
`
`08:32:00
`08:32:01
`
`08:32:03
`08:32:06
`
`08:32:13
`
`08:32:17
`
`08:32:25
`08:32:28
`08:32:31
`
`A Q
`
`\2IOfl'-I5‘\U'I-D-L-|lNJ—
`
`concentration, that would depend on what you would
`do next.
`08:33:50
`
`Q. Would that he considered a water-based
`surfactant system’?
`08:33:53
`MR. MARGOLIS: Objection. Vogue.
`THE WITNESS: Again, it depends on what
`lhe detinition of based is.
`08:34:04
`08:34:06
`
`08:33:51
`
`08:33:55
`08:34:00
`
`Q. Would that be considered an aqueous
`08:34:09
`surt'aetnnt system?
`08:34:11
`MR. MARGOLIS: Objection. Vague.
`08:34:13
`THE WITNESS:
`It would depend on the
`08:34:15
`relative -- depending on the relative
`08:34:16
`proportions of surfactant and water.
`Q. 1f the water is in the greater proportion,
`would that be an aqueous surfactant system?
`A. Yes.
`08:34:24
`
`08:34:18
`08:34:2I
`
`Q. Are you an expert in clinical testing?
`A. No.
`1 would consider myself somebody of
`08:34:35
`ordinary skill in the art.
`08:34:36
`Q. Have you ever conducted any clinical testing
`08:34:39
`with a pharrnaeeutical product’?
`03:34:47
`A. When you mean conduct, again, that's very
`
`08:34:26
`08:34:33
`
`vague because have 1 led a clinical trial, have I
`designed a clinical trial, have I analyzed a
`clinical trial? That's not -
`
`08:35:00
`
`Page 3'1’
`
`.
`
`08:34:54
`08:34:58
`
`08:35:02
`Q. Have you ever [ed any clinical testing on a
`pharmaceutical product?
`08:35:05
`A. No.
`08:35:06
`
`08:35:06
`Q. Have you ever designed any clinical testing
`on a pharmaceutical product‘?
`08:35:09
`A. No.
`
`08:35:10
`
`Q. Are you an expert in statistics or
`biostatistics?
`
`08:35:10
`08:35: 12
`
`08:35:15
`08:35:21
`08:35:23
`08:35:24
`
`MR. MARGOLIS: Objection. Vague.
`THE WITNESS:
`I have a good
`understanding ofstatistics.
`Q. Do you hold yourselfto the public as an
`08:35:26
`expert in statistics or biostatistics‘?
`08:35:30
`A. No, lwould not.
`Q. Are you an expert in the U.S. Pharmacopeia
`03:35:31
`criteria for antimicrobial etlectiveness?
`03:35:35
`08:35:39
`
`MR. MARGOLIS: Obicction. Vague.
`THE WITNESS:
`I'm very aware ofxvhat the
`criteria are.
`08:35:48
`
`0s:35:4
`
`'
`_
`
`08:32:39
`
`Page 35
`
`08:32:42
`
`08:32:45
`
`tyloxapol are there‘?
`A. Because you still haven't answered really
`what based is. So. when you say water-based, ifyott
`can clarify that, please?
`08:32:49
`Q. No.
`I asked a difTerent question.
`08:32:51
`asked -
`
`1
`08:32:53
`
`08:32:53
`1 can't answer if you're talking about
`A.
`08:32:56
`water-based and it's not clarified. So I can't
`08:32:58
`
`answer. Sorry.
`
`08:33:00
`08:33:03
`08:33:06
`
`Q. Okay. How would you make an aqueous
`surfactant system using tyloxapol‘?
`MR. MARGOLIS: Objection. Vague.
`08:33:09
`Q. You may answer.
`08:33:12
`A. The only way I can answer that is to make
`some assumptions.
`08:33:15
`Q. Please do.
`08:33:16
`A. Assuming you want a predominantly
`water-based -~ water to be there in the biggest
`amount, largest amount, which I assume is what you
`are trying to say by based, you would add water, a
`known amount of water, to a pre-weighed amount of
`tyloxapol. and depending upon the particular
`
`08:33: 1 7
`08:33:25
`08:33:28
`08:33:31
`
`08:33:45
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`[0 (Pages 34 to 37)
`202-347-3700
`
`PAGE 11 OF 132
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`PAGE 11 OF 132
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`

`
`M. Jayne Lawrence
`
`September 4, 2015
`
`Scnju Pharmaceutical Co., L"['D.. et :11. v. Lupin, LTD., and Lupin Pharrnaceutictrl. Inc.,
`
`Q. Do you hold yoursel f as an expert in the U .53.
`Plrarrnacopcia criteria for anti rrricrobial
`ellcctiveness?
`
`08:35:56
`
`08:35:49
`08:35:52
`
`Page 38
`
`MR. MAR(iOl.lS: Objection. Vague.
`THE WITNESS:
`I am unclear what an
`
`08:35:57
`
`08:35:58
`08:35:59
`08:36:02
`
`expert would need to do ttndcr those --
`somebody would need to do under those
`circunrstances to be an expert.
`Q. 1-lave you ever conducted any tests rrreasuring
`antimicrobial effectiveness according to