Transcript of the Testimony of M. Jayne Lawrence
`
`Date: September 4, 2015
`
`Case: Senju Pharmaceutical Co., LTD., et al. v. Lupin, LTD., and Lupin
`Pharmaceutical, Inc.,
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`
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`Ace-Federal Reporters, Inc.
`Phone: 202-347-3700 7’
`Fax: 202-737-3638
`
`Email: info@acefedera|.com 3
`Internet: www.acefedera|.com 3
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`SENJU EXHIBIT 2140
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`LUPIN v. SENJU
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`IPR20l5-01 100
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`Page 1 of 132
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`M. .|:|yr1e Lawrence
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`Senju Pharmaceutical C0,, LTD.. el al. ‘v. Lupin, LTI1, and Lupin Phannaceltlical, lnc.,
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`September 4, 2015
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`UNITED STATES DISTRICT COURT
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`FOR THE DISTRICT OF NEW JERSEY
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`_ _ _ _ _ _ _ . _ _ _ _ _ __..._._____._X
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`SENJU PHARMACEUTICAL CO.,
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`LTD., BAUSCH & LOMB
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`INCORPORATED, and BAUSCH
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`& LOMB PHARMA HOLDINGS CORP.,
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`Civil Action Nos.:
`
`1:l4—cv—0O667~JBS—KMW
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`
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`1:14-CV-04149-JBS-KMW
`
`l:l4—cv~05l44-JBS—KMW
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`1:15-cv—0O335—JBS~KMW
`
`Plaintiffs,
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`
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`_Vs_
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`INC.,
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`LUPIN, LTD., and LUPIN
`
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`PHARMACEUTICALS,
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`Defendants.
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`INC.,
`INNOPHARMA LICENSING,
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`INNOPHARMA LICENSING, LLC,
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`INNOPHARMA,
`INNOPHARMA,
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`LLC, MYLAN PHARMACEUTICALS,
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`INC., and MYLAN INC.,
`Defendants.
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`INC.,
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`Civil Action NOs.:
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`
`
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`1:14-CV-06893-JBS-KMW
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`1:15-CV-03240-JBS~KMW
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`
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`Deposition of:
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`M.
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`
`
`JAYNE LAWRENCE, Ph.D.
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`September 4, 2015
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`New York, New York
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`E66-928-6509
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`Ace-Federal Reporters, Inc.
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`Page 2 of 132
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`202~347-3700
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`Page 2 of 132
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`M. Jayne I_.awrcnce
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`September 4, 20I S
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`Senju Pharmaceutical C0,. l.FD., et at. v. Lupin, L'I‘D., and Lupin I’Iian11uceutic:1I. Inc.,
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`I APPERANCES (CONTINUED):
`
`ALSTON & BIRD, LLP
`Attorneys for Defendant Innopharma
`333 South Hope Street,
`|6th F100,-
`L03 A|1gclgS, California
`BY: II. JAMES ABE, ESQ.
`(2I3) S76-I000 (Telephone)
`(213) 576-] I00 (Fax)
`james.abe@aIston.com
`
`Also Present:
`
`Thomas Del Vecchio (Videographer)
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`2 3 4
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`5
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`6 7 8
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`Page 2
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`V|I)I-IOTAPIZD DEPOSITION oI'M. JAYNE LAWRENCE.
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`Ph.D.. taken pursuant to Notice, held at the law
`
`0ITIccs OIGOODWIN PROCTER. LLP, 620 Eighth Avenue.
`2601 Floor. New York. New York. IO0I8-I405. on
`I-'n'day. September 4. 20I5. at 8:00 am. hcfore
`.IF.ANNI7I“I.I‘. MCCURMICK, I] (‘enified Shnrthanil Repnrler,
`and «1 NUWY I’Ub“¢-
`
`I APPEARANCES:
`
`I
`
`INDEX
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`Page 3
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`2
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`3
`4
`5
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`6
`7
`8
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`9
`I0
`II
`I2
`I3
`
`I4
`I5
`I6
`I7
`I8
`I9
`
`FINNEGAN, HENDERSON, FARABOW. GARRETT Z WITNESS
`
`EXAMINATION BY
`
`& DUNNER, LLP
`Attorneys for Plaintiffs
`90| New York Avenue, NW
`
`Washington, D.C. 2000I-4413
`BY: JUSTIN J. HASFORD, ESQ.
`BRYAN C. DINER, ESQ.
`
`(202) 408-4000 (Telephone)
`(202) 408-4400 (Fax)
`justin.hasford@finnegan.com
`bryan.diner@finnegan.com
`
`GODWIN PROCTER. LLP
`Attorneys for Defendant Lupin
`The New York Times Building
`620 Eighth Avenue
`New York, New York I001 8-I405
`BY: DANIEL P. MARGOLIS, ESQ.
`(2 I2) 8 I3-8800 (Telephone)
`(212) 355-3333 (Fax)
`
`I7
`
`3 M. JAYNE LAWRENCE, Ph.D.
`4
`MR. HASFORD
`5
`
`E X H I B I T S
`6
`LAWRENCE
`7
`8 NUMBER
`
`DESCRIPTION
`
`9
`IO Exhibit I Declaration of M. Jayne
`I I
`Lawrence, Ph.D. and
`I2
`Appendices and Exhibits
`I3
`
`I4 ExhibiI2 "Models for Intestinal Drug
`I5
`Absorption", Wood & Lawrence
`I6
`(I99!) .IournaI ofBinpharmaceuticaI
`I7
`Sciences (pgs. I47-I72)
`I8
`(Publication No. S on CV)
`I9
`20
`2I
`
`206
`
`dmnrgolis@goodwinprocter.com
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`22
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`866-928-6509
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`Ace-Federal Reporters, Inc.
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`2 (Pages 2 to 5)
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`202-347-3700
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`Page 3 of 132
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`

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`M. Jayne Luwrcncc
`
`September 4, 20 I 5
`
`Scnju Pharmaceutical C0,, L'I'D.. ct al. v. Lupin, LTD. and Lupin Pliamiaccutical. lnc.,
`
`ooo\io~.u~4>wt\)-
`
`E X H I B IT S
`LAWRENCE
`NUMBER
`Exhibit‘)
`
`DESCRIVFION
`"Recent Advances in
`
`Microemulsions as Drug
`Delivery Vehicles" in
`"Nanoparticulates as Drug
`(‘arrie-rs," (pgs. I25-l7l)
`(Book Chapters No. 14 on CV)
`IO Exhibit I0 "Drug Delivery Systems:
`I
`I
`Neutron Scattering Studies" in
`I2
`"Encyclopedia of Phannaceuticnl
`13
`Technology," (pgs. I049-I070)
`I4
`(Book Chapters No. 15 on CV)
`I5 Exhibit I
`I "New Medicines, Better
`I6
`Medicines, Better Use of
`
`17
`18
`I9
`
`20
`2l
`22
`
`\'700-lO\lJ'i-l>-bJt0'-
`
`Medicines," (I20 pgs.)
`(Other Outputs No. 12 on CV)
`
`E X H I B IT S
`LAWRENCE
`DESCRIPTION
`NUMBER
`Exhibit 12 "Association Characteristics
`
`of Synthetic Non—i0nic
`Surfactants in Aqueous Solution"
`in "Physical Chemistry in
`Condensed Phases," (pgs. I903— I 9 10)
`(Articles in Academic Journals
`No.
`l on CV)
`279
`
`Exhibit 13 "Effect of Structural
`Variations ofNon-ionic
`
`Surfactants on Micellar
`Properties and Solubilizationz
`Surfactants with Semi-Polar
`Hydrophobes" in "Journal of
`Pharmacy & Pharmacology."
`(pgs. 585-S89) (Articles in
`Academic Journals No. 2 on CV)
`
`28]
`
`E X H I B I T S
`LAWRENCE
`NUMBER
`
`DESCRIPTION
`
`Exhibit 3 "Effect of diclofenac sodium
`and disodium
`
`ethylenediaminetetraacetate on
`electrical parameters ofthe
`mucosal membrane and their
`relation to the permeability
`enhancing effects in the rat
`jejunum" by Yamashitn, ct nl,
`in the J. Pharm. Pharrnacol.
`I987, volume 39, pages 621 to 626
`
`208
`
`Exhibit 4 U.S. Patent No. 8,192,755 B2
`
`232
`
`Exhibit 5 U.S. Patent Application
`Publication No. 2013/0210878 Al
`
`237
`
`E X H I B IT S
`LAWRENCE
`
`NUMBER
`
`DESCRIPTION
`
`Exhibit 6 "Structural Investigations of
`the Monolaycrs and Vesicular
`Bilayers Formed by a Novel Class
`of Nonionic Surfactant" in the
`
`"Chemical Aspects of Drug
`Delivery System," (pgs. 65-76)
`(Book Chapters No. 6 on CV)
`
`Exhibit 7 "Neutron Scattering in
`Pharmaceutical Sciences" in
`
`"Applications of Neutron
`Scattering to Soft Condensed
`Matter," (pgs. 325-356)
`(Book Chapters No. 7 on CV)
`Exhibit 8
`"Molecular Modelling of
`Surfactant Vesicles" in
`"Synthetic Surfactant
`Vesicles," (pgs. 9-23)
`(Book Chapters No. 8 on CV)
`
`Fj:5'o3o\io~«ui.t>L..nr~..>—
`
`E
`
`I 2 3 4 5 6 7 8 9
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`866-928-6509
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`Ai:c-Federal Reporters, Inc.
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`3 (Pages 6 to 9)
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`202-347-3700
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`Page 4 of 132
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`

`
`M. Jayne Lawrence
`
`September 4. 2015
`
`Scnju Pharmaceutical Co., LTD.. et al. v. Lupin. l.TD.. and Lupin Pharmaceutical. Inc.
`
`E X H l 8 IT S
`LAWRENCE
`NUMBER
`
`DESCRIPTION
`
`Exhibit I4 "Analysis and Modelling ofthe
`Structures of Beta-Cyclodextrin
`Complexes" in "BBA, Biochimica
`ct Biophysica Acta, (pgs. 27-36)
`(Articles in Academic Journals
`
`No. 8 on CV)
`
`283
`
`Exhibit 15 "Surfactant Systems: Their
`Use in Drug Delivery" in
`"Chemical Society Reviews,"
`(pgs. 417-424) (Articles in
`Academic Journals No. 9 on CV)
`
`285
`
`I
`2
`
`E X H I B IT S
`LAWRFINCF.
`
`3 NUMBER
`
`DESCRIPTION
`
`PAGE ,
`
`4
`
`Exhibit I8 "Microemulsions as Drug Delivery
`Vehicles" in "Current Opinion in
`Colloid & Interface Science,"
`(pgs. 826-832) (Articles in
`295
`Academic Joumals No. I8 on CV)
`Exhibit I9 "Aggregation & Surface Properties
`of Synthetic Double—Chain Non-Ionic
`Surfactants in Aqueous Solution in
`"Joumal of Phanna & Pharmacology,
`Volume 49, May 1997 (pgs. 594-600)
`(Articles in Academic Journals
`No.20 on CV)
`297
`
`E X H I B I T S
`LAWRENCE
`NUMBER
`
`DESCRIPTION
`
`Exhibit I6 "Surfactant Systems:
`Microemulsions and Vesicles as
`
`Vehicles for Drug Delivery" in
`"European Joumal of Dmg
`Metabolism & Phannacokinetics,
`I994, No. 3, (pgs. 257-269)
`(Articles in Academic Journals
`No. I2 on CV)
`288
`
`Exhibit I7 "The Formation, Characterization
`& Stability oI‘Non-Ionic
`Surfactant Vesicles" in "STP
`
`Pharma Sciences." (Pgs. 49-60)
`(Articles in Academic Journals
`No. I6 on CV)
`292
`
`E X H I B l '1' S
`
`LAWRENCE
`NUMBER
`
`DESCRIPTION
`
`PAGE
`
`Exhibit 20 "Physicochemical & Solubilization
`Properties of N,N-Dimethyl-N-
`(3-DodecylcarbonyIoxypropyl)
`amincoxide: A Biodegradable
`Nonionic Surfactant" in "Joumal
`
`of Pharmaceutical Sciences,"
`(pgs. 798-806) (Articles in
`Academic Joumals No. 33 on CV)
`
`299
`
`Exltibit 2| "Toxicological Evaluation of
`Mixtures ofNonionic Surfactants,
`Alone & in Combination with Oil"
`in "Joumal of Pharmaceutical
`
`Sciences," (pgs. 859-868 (Articles
`in Academic Journals No. 47 on CV) 304
`
`I 2 3 -
`
`'1
`
`I 2 3 4 5 6 7 8 9
`
`866-928-6509
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`Ace-Federal Reporters, Inc.
`
`4 (Pages IO to 13)
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`202-347-3700
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`Page 5 of 132
`
`

`
`M. Jayne Lawrence
`
`Scnju l’l1urmaeeutical Co., LTD.. ct al. v. Lupin, LTD., und Lupin Pltartnaceutical. Inc...
`
`September 4. 2015
`
`Page 16
`
`OO\1D1Llt-$§LoJ1\J—'
`
`B X H 1 B IT S
`LAWRENCE
`NUMBER
`
`DESCRIPTION
`
`Exhibit 22 "Fonnulation of Electrically
`Conducting M icroemulsion-Based
`Organogels" in “International
`Journal of Pharmaceutics"
`
`(pgs. 65-83 (Anicles in Academic
`Journals No. 49 on CV)
`305
`Exhibit 23 "Molecular Dynamics Simulations
`of the lnterfacial & Structural
`
`Properties of
`Dimethyldodecylaminc-N—Oxidc
`Micelles" in "Langmuir, The ACS
`Journal of Surfaces & Colloids"
`
`(pgs. 546-553 (Articles 1n Academic
`Journals No. 87 on CV)
`308
`Exhibit 24 "Microemulsion-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
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`P R OC E E D 1 N G S
`
`08: 10:1
`
`THE VIDEOGRAPH ER: Good morning. We are
`08:10:16
`now going on the record. Please note that
`08:10:20
`microphones are sensitive nnd may pick up
`08:10:22
`whispering and private conversations. Please
`08:10:25
`turn off all telephones or place them away
`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.
`The deponent today is Dr. Jayne Lawrence
`08:10:38
`in the matter of Senju Phannaceutical
`08:10:42
`Company, Ltd, et a1, plaintiffs. versus
`08:10:48
`Lupin, Ltd, et a1, defendants, Civil Action
`08: 10:52
`Number 1:14-CV-00667, 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
`oflice 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.
`
`0821113
`
`08:1 1:25
`08:11:30
`08:11:33
`08:11:44
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`The coun reporter today is Jeannette
`McComiick with the 1irrnn1'Acc-Federal
`
`08:1 1:53
`08:1 1157
`
`Reporters. My name is Thomas Del Vecchio.
`am the legal video specialist representing
`Ace-Federal Reponers. 1625 1 Street,
`Northwest, Washington, DC.. 201106.
`Will counsel identify themselves and who
`they represent.
`08:12:19
`08:12:20
`MR. HASFORD:
`.1ustin llasford of Finnegan
`on hcha11'o1'p1ninti1Ts Senjn and Rnusch &
`08:12:21
`1. omb,
`08:12:21
`
`08:12:00
`1
`08:12:04
`08:12:06
`08:12:12
`08:12:17
`
`MR. DINER: Bryan Diner oft-‘innegan,
`also on behalf of plaintiffs Senju and Bausch
`& Lomb.
`08:12:31
`
`08:12:25
`08:12:27
`
`MR. MARGOLIS: Dan Margolis from Goodwin
`Procter for the Lupin defendants.
`08.12133
`MR. ABE: James Abe o1'A1ston & Bird for
`08:12:36
`
`08:12:31 -f
`
`08:12:38
`the lnnopharma defendants.
`THE V1D1-‘.0GRAPH1iI<: ‘thank you. Now.wi11
`08:12:43
`the coun reporter please swear in or atlinn
`the witness.
`08:12:45
`
`5
`
`08:l2:4
`
`M. JAYNE LAWRENCE, Ph.D.,
`
`having been first duly sworn
`testified as follows:
`EXAMINATION
`BY MR. HASFORD:
`
`Q. Good moniing, Dr. Lawrence.
`08:13:01
`A. Good morning.
`Q. Would you please state your name and address
`for the record.
`08:13:04
`
`08:12:57
`08:12:57
`
`08:13:02
`
`08:13:04
`08:13:08
`08:13:]
`
`A. Yes. Dr. Margaret Jayne Lawrence of 62
`Wellington Road, Ashford, Middlesex, UK.
`Q. How many times have you been deposed before?
`A. This is my lirst 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 a series of questions, and 1
`would ask that you answer my questions truth fully
`and accurately.
`08:13:25
`11' you 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.
`11' for any mason you do not understand 11
`question that 1 ask. please let me know.
`lfyou
`
`08:13:16
`08:13:18
`08:13:20
`08:13:23
`
`08:13:26
`08: 13:29
`08:13:31
`08:13:34
`08:13:36
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`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`5 (Pages 14 to 17)
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`202-347-3700
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`Page 6 of 132
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`

`
`M. Jayne Lawrence
`
`Senju Pharmaceutical Co., LTD, ct al. v. Lupin, l-'l'D., and Lupin Phannzrceutical. Inc,
`
`Page 18
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`September 4. 2015
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`Page 20
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`08:15:44
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`08:15:-'17
`08:15:49
`08:15:54
`08:15:56
`
`08:15:58 1
`1
`
`08:15:44
`question again?
`Q. Certainly.
`In what areas do you consider
`yourscl1':tn expert?
`08:15:46
`MR. MARCOLIS: Same objection.
`THE WITNESS:
`In terms 01' scientific
`activities? In terms ofprofcssional
`activitics‘? Could you please clarify it hit
`nrorc?
`08:15:58
`In what areas do you hold yourselfout as an
`Q.
`expert‘?
`08:16:01
`08:16:01
`MR. MARGOLIS: Objection. Vague.
`08:16:06
`1111*; WITNESS:
`It depends what -- l lind
`that a very dillicult question to answer
`08:16:10
`because you could be expert in lots of areas
`08:16:12
`and that's whyl ask for clarification.
`08:16:15
`Q. In what scientific areas do you consider
`08:16:17
`yourselfan expert?
`08:16:19
`A. Okay.
`I --
`08:16:20
`MR. MA RGOLIS: Objection. Vague.
`
`A. Do you mean an expert in the context 01‘ this
`particular case?
`08:16:35
`
`0.Youmayanswer.
`
`08:16:21
`
`08:13:38
`
`answer a qttcstion. 1 will assume that you understood
`lltc question.
`Is that okay?
`08:13:40
`A Yes.
`08:13:42
`08:13:42
`Q.
`Is there any reason why you cannot testify
`truthfully and accurately today?
`08:13:45
`08:13:46
`A. No.
`0821324‘)
`l'm handing the court
`MR. l-IASFORD:
`08:13:50
`rcporter what We asked to be marked as
`Lawrence iixlrihit 1.
`08:13:52
`For the record, Lawrence Exhibit 1 is
`08:13:53
`the Declaration of Jayne Lawrence, Ph.D., and
`08:13:55
`Appendices and lixhibits.
`08:13:59
`(Whercupon, Plaintiffs Deposition
`08:14:30
`Exhibit No. Lawrence 1 was marked for
`08:14:31
`Identification.)
`08:14:33
`ls Lawrence Exhibit 1 your claim construction
`Q.
`declaration, appendices and exhibits in this case?
`A. Yes.
`08:14:45
`Q. Please turn to page 25. Does your signature
`
`03: 14:33
`08:14:37
`
`08:14:46
`
`declaration for this case?
`A.
`It does.
`
`08:14:57
`08:14:58
`
`appearonpage25ofyourclaimconstruction
`
`Q. who prepared your claim construction
`declaration tor this case?
`A.
`I did.
`
`08:14:58
`08: 15:00
`08:15:02
`
`08:15:03
`Is
`Q. Take a look, i1‘ you would, at Appendix A.
`08:15:13
`Appendix A to your claim construction declaration a
`copy of your curricultrm vitae‘?
`08:15:16
`A.
`It 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
`
`In what areas do you consider yourself an
`0.
`expen?
`08:15:26
`
`08:15:24
`
`MR. MARGOLIS: Objection. Vague.
`BY MR. HASFORD:
`
`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
`lnnopharma as well?
`08:15:39
`MR. HASFORD: Sure. We can agree to
`that.
`08:15:41
`MR. ABE: Thank you. Plcasc procccd.
`'l‘1l1iWlTNESS: Could youjust rcpcat the
`
`08:15:40
`
`08:15:42
`08:15:43
`
`GEES:
`
`rgt.J...._._.._-__.——.__.Qcgg\;3.r_n_§g,)|—:)——S\DOO\IO\kIr&L;JlU-
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`22
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`Page 19
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`08:14:54
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`-____.._....__..._—oooo\ra~ur4.~.c.rro-—o\'-t°\'-‘\IO"~n-P~‘-'N-
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`Page 21
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`Q. What's your understanding ofan expert,
`Doctor’?
`08: 16:44
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`08:16:36
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`08:16:44
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`A. An expert is a person who has knowledge in a
`particular area.
`08:16:48
`08:16:49
`0. Okay. And l'm asking the question based on
`08: 16:51
`your understanding. So I will ask it again. 1n
`08:16:53
`what areas do you consider yourself an expert’?
`08:16:56
`MR. MARGOLIS: Objection. Vague.
`08:17:06
`THE WITNESS:
`1 think to answer that
`08:17:08
`question l'm going to have to qualify the
`08:17:12
`particular areas 1‘rn talking about because 1
`have expertise in several areas.
`08:17:15
`0. What areas?
`08:17:17
`
`08:17:19
`1 have expertise in respect to professional
`A.
`08:17:27
`activities where l'm chair ol'— l'm son'y -- where
`08:17:30
`l'm Chiefscientist for Royal Phannaceutical
`Society, and so 1 have expertise, and surrounding my
`08:17:36
`activities as a chief scientist in that context.
`1
`08:17:43
`obviously have expertise surrounding my activities
`08:17:47
`as an academic in King's College, London.
`08:17:50
`Q. Arc you an cxpcn in any other areas?
`08:17:56
`MR. MARGOLIS: Objection. Vague.
`08:18:00
`
`:
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`3
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`866-928-6509
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`Ace—1-‘ederal Reporters. Inc.
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`Page 7 of 132
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`6 (Pages 18 to 21)
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`202-347-3700
`
`

`
`
`
`M. Jayne Lawrence
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`
`
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`September 4, 2015
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`Senju Pharmaceutical Co., LTD.. et al. v. Lupin, L‘1'D., and Lupin Pharrnaceutical. Inc.,
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`Page 22
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`Page 24 -
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`Q. You may answer.
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`A.
`1 do find that really, really hard to answer.
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`1 can give you an expertise if you tell me what
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`particular areas you are referring to.
`08: 18:13
`I'm asking you for your understanding. In
`Q.
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`what other areas do you hold yourself out as an
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`expert’?
`08:18:20
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`MR. MARGOLIS: Objection. Vague.
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`THE WITNESS: We1l,1'.rn going to answer
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`it this way.
`1 have expertise in a number of
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`scienti fie disciplines.
`I have expertise in
`08:18:42
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`respect to my professional activities
`08:18:47
`regarding my work at Pharmaceutical Society-
`08:18:54
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`I think my main —- my main two -areas of
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`expertise.
`08:19:01
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`Q. Take a look at paragraph 5 of your
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`declaration on page two.
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`A. Which is headed?
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`Q. It's going to he page 2 of your declaration.
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`A. Yes.
`08:19:13
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`Q. "Paragraph 5 under Qualifications.
`think you're on the right page.
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`08:19:02
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`08: 19:05
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`08:19:11
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`1 don‘t
`08:19:19
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`..,"_j3C,','§ljfi:E~.:.:oo~.:to-t.n.t:.t»t~..a-—-
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`i3'.3E'~'E§E
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`08:20:04
`Q. What other areas‘?
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`A. Getting ~— that's incredibly vague and
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`08:20: 1 2
`probably not relevant to this" particular case. For
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`08:20:15
`csatttple, I'm an expefl on neuhnn scattering, but
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`it's probably irrelevant for this particular case.
`08:20:20
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`Q. Well. I'm asking you the question and, you
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`08:20:2 3
`know, I'm not asking you to try to determine what's.
`relevant or not relevant for the case.
`08:20:31
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`08:20:33
`Are you an expert in any other areas?
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`08:20:59
`I considerl have expertise in a number of
`A.
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`08:21 :02
`other areas. yes. For example, I'm a recognized
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`expert on neutron scattering.
`08:21:09
`Q. And you just said ‘that. What other areas
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`besides neutron scattering?
`08:21:15
`.
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`1 think I'm expert in promoting of
`08:21:18
`A.
`pharmaceutical science.
`08:21 :23
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`Q. Any other arm?
`08:21:25
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`A.
`1'11 qualify that, promoting to the public
`08:21:27’
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`and other scientists. Can 1 look at my CV‘?
`08:21 :32
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`Q. Oh, please.
`08:21:40
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`I consider I'm an expert teacher with respect
`A.
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`to pharmaceutical science. I've been given awards
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`08:21 :48
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`08:21:54 -
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`:E§~eeu-.:a:nu..t:»r..at-.:—
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`It
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`08:22:37‘
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`03:22:40
`I
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`08:22:45
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`08:22:47
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`for that activity.
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`1 consider [‘m an expert researcher, which
`08:22:02
`includes an expert in the areas you highlighted.
`08:22:06
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`Q. Any other areas?
`08:22:10
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`A. Archaeology. Hobby.
`08:22:14
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`08:22:22
`Q. Anything else‘?
`.lt‘s very hard to answer when asked are you
`A.
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`an expert in, not knowing what the point of the
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`question is.
`08:22:44
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`Q. Well, let me ask it this way. Are you an
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`expert in the field of phsttnacy?
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`08:22:48
`. Yes.
`. Have you ever practiced pharmacy?
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`08:22-.51
`. Yes.
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`08:22:51
`. When did you last practice pharmacy?
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`08:22:53
`_ 1'm a practicing pharmacist.
`08:22:55
`Q. When -did you last dispense a medication to :1
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`patient?
`08:22:58
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`A. Dispense medication? Probably 20 years ago.
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`Q. Are you an expert in phannacology?
`08:23:10
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`A. No.
`08:23: I 2
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`Q. Are you an expert in phannacokinetics?
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`08:23:12
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`08:19:20
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`A. 1'm sorry.
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`08:19:21
`Q. It's your deo1arah‘on..
`08:19:22
`A. Sorry. Paragraph 5‘?
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`Q. So, 1 still don't believe you're on the right
`08: 19:26
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`page. It's your declaration, not your curriculum
`08:19:28
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`vitae.
`08:19:31
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`08:I9:3l
`l‘m.so'rry. Five did you say? Page 5‘?
`A.
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`08:19:32
`Q. Page 2, paragraph 5.
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`A. Page 2'. Okay.
`08:19:39
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`08:19:40
`Q. It says, "I -am an expert in the field of
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`formulation and drug delivery, specifically
`08:19:42
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`phannacetttical fommlation for oral and parenteral
`08:19:44
`use (i.e., non-oral, including intravenous
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`intramuscular, nasal, respiratoiy and ophthalmic},
`08:19:52
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`08:19:57
`including aqueous liquid preparations."
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`08:19:58
`Do you see that?
`08:19:59
`A. Yes.
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`08:19:59
`Q_. Do you hold yourself out to the public as an
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`expert in any other areas?
`08:20:01
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`A- 1n other areas?
`08:20:02.
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`Q. Correct.
`08:20:03
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`A. Yes.
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`
`7 (Pages 22 to 25)
`
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`202-347-3700
`
`866-928-6509
`
`
`
`
`
`
`Ace-Federal Reporters, Inc.
`
`Page 8 of 132
`
`Page 8 of 132
`
`

`
`M. Jayne Lawrence
`
`September 4, 2015
`
`Senju Pharmaceutical Co._. LTD., el al. v. Lupin. LTD.. and Lupin Pharmaceutical. Inc.,
`
`Page 26
`
`MR. MARGOIIS: Objection Vague.
`Q. You may answer.
`08:23: I9
`A.
`I have - l have rt good level ofcxpertise in
`08:23:23
`that.
`08:23:28
`
`08:23:18
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`A. As a pharmacist in the UK, that is not your
`mic.
`08:25:21
`Q.
`08:25:22
`Is that a "no"?
`A.
`In the UK. that would not he the role ofa
`
`Q. Have you ever held yourself out to the public
`
`08:23:29
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`phunnucist.
`
`08:25:26
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`Page 28
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`j
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`08:25: I7
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`08:25:24
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`08:23:3|
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`as an expert in pltanrmcokinctics?
`08:23:33
`A. No.
`Q. Have you ever held yourselfuut to the public
`as an expert in pharmacodynamics?
`MR. MARGOLIS: Objection. Vague.
`Q. You may answer.
`08:23:41
`A.
`I have not.
`08:23:44
`
`08:23:33
`08:23:36
`08:23:40
`
`08:25:27 i
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`Q. Have you ever dispensed uny broml‘cn-ac product
`to n patient?
`08:25:30
`A. No.
`08:25:32
`Q. Have you ever dispensed any product
`containing tyloxapol to a patient?
`A. Yes.
`. Whnt product‘?
`
`08:25:38
`08:25:39
`
`08:25:33
`08:25:35
`
`Q. Are you an expert in ophthalmology’?
`MR. MARGOLIS: Objection. Vague.
`0. You may answer.
`082354
`
`08:23:45
`08:23:52
`
`08:25:40
`. F.xosurI'.
`08:25:42
`. You may have to spell that for the reporter.
`. E-X-0-S-U-R-F.
`08:25:45
`
`08:23:57
`08:24:01
`
`I'm an expert in parenteral fonnulations of
`A.
`which ophthalmology — ophthalmic formulations as
`well.
`08:24:06
`08:24:06
`Q. Have you ever held yourself out to the pttblic
`as an expert in ophthalmology?
`08:24:09
`MR. MARGOLIS: Objection. Vague.
`08:24:ll
`THF. WITNESS: No.
`08:24:l2
`
`08:25:50
`. What is Exosurt‘?
`08:25:52
`.
`I t's a product for respiratory distress
`08:25:59
`syndrome in pre-terrn infants.
`08:26:03
`Q.
`Is that an ophthalmic product?
`08:26:06
`I have
`A.
`It's not an ophthalmic product.
`08:26:08
`dispensed many ophthalmic products
`Q. Have you ever dispensed an ophthalmic product
`08:26:l I
`
`Page 27
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`Page 29
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`08:26: I9
`08:26:28
`
`08:26:16
`containing tyloxapol to a patient?
`08:26: I6
`A. Undoubtedly.
`08:26:l7
`Q. Which one?
`A. Many products contain tyloxapol. Asa
`phannacist, I 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
`08:26:37
`the list of excipients.
`08:26:40
`0. Sitting here today. can you name any
`ophthalmic prodttct containing tyloxapol that you
`have dispensed to a patient?
`08:26:46
`A. No.
`08:26:52
`
`08:26:41
`08:26:43
`
`0. Are you aware that the acronym EDTA stands
`08:26:53
`for ethylenediominetetraacetic acid?
`08:26:59
`A.
`I am.
`
`08:27:02
`
`E3e3Z.'6»ooo~io~uaz:.4...at~.r—
`
`G 3 \
`
`)
`
`08:24:13
`Q. Are you an expert in any field of medicine?
`08:24: I7
`MR. MARGOLIS: Objection. Vague.
`08:24: I 9
`THE WITNESS: Medicine is a huge area.
`08:24:25
`And what are you covering? Are you covering
`pharmaceutical medicine?
`08:24:27
`Q. Have you ever held yourself out to the public
`08:24:29
`as an expert in any field of medicine‘!
`08:24:3l
`MR. MARGOLIS: Objection. Vague.
`08:24:34
`THE WITNESS:
`I am a Registered
`08:24:37
`Practicing Phannaeist in the UK.
`08:24:39
`0. Have you ever --
`08:24:42
`A. So, I am not a medic.
`08:24:43
`0 Well, when you say --
`08:24:47
`A. So, I would not claim to practice medicine.
`08:24:48
`Q. Have you ever prescribed medication to :1
`08:24:53
`patient?
`08:24:56
`A. No.
`08:24:58
`
`EC,;'5:5~aao\ic«u-:>u.:~—
`
`3.
`
`Q. Have you ever treated on inflammatory disease
`
`08:24:59
`
`Q. Have you ever administered any product
`
`08:27:02
`
`‘
`
`08:25:02
`oflhc cyc?
`08:25:06
`A. No.
`Q. Have you ever administered any brotnfenac
`
`08:25:06
`
`containing EDTA or any salt or union of EDTA to 1!
`pitticttt?
`08:27:l I
`A. Undoubtedly, yes.
`08:27.l2
`
`08:27:04 I
`A
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`product to a patient?
`
`08:25:! I
`
`Q. which product‘?
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`Page 9 of 132
`
`08:27:14
`
`1
`
`8 (Pages 26 to 29)
`
`202-347-3700
`
`

`
`M. Jayne lmvrence
`
`September‘ 4, ZUI 5
`
`Scnju Plutrmuccutical Co., LTD.. et al. v. Lupin, LTD., and Lupin Pharmaceutical. lnc..
`
`Q. Have you ever conducted any research on any
`product containing EDTA or any salt or anion of
`EDTA?
`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
`frequently used in academic research for a variety
`08:29:53
`of purposes.
`08:29:58
`Q. When did you last use EDTA in your academic
`research?
`08:30:02
`
`08:29:S .
`
`A. Personally. a while ago. My research group,
`all the time. So. I don't know how that answers
`
`08:30:03
`08:30:08
`
`08:30: I4
`your question.
`08:30:]-4
`Q. No. Thank you for clmifying.
`When personally did you last use EDTA in your
`08:30. I0
`academic research?
`08:30:19
`
`A. Probably about five years ago.
`
`08:30:22
`
`U8:3t):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
`
`I(
`
`Page 33 I
`
`Q. Is bromfenuc a water—soluble hydrophilic
`dmg?
`08:31:00
`MR. MARGOLIS: 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
`
`08:30:52
`
`08:3 I200
`08:31:02
`08:3! :02
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`*
`
`Is the sodium 08:31:05
`Q. Well, let me ask it this way.
`salt ot'bromt‘enac a water-soluble hydrophilic drug?
`08:3! :07
`
`08:3l:l2
`It is.
`A.
`08:3 I : I3
`Q. Would a solution containing tyloxapol in
`water be considered a water-based surfactant system‘?
`08:31 : I6 :
`MR. MARGOLIS: Objection. Vague.
`O8:3l:l9
`THE WITNESS: Sorry. Repeat the
`08:31 :23
`question?
`08:31:25
`08:3 I :25
`Q. Certainly.
`I will repeat the question.
`08:3I:27
`Would a solution containing tyloxapol in
`water be considered a water-based surfactant system?
`08:3 I :30 I
`MR. MARGOLIS: Objection. Vague.
`08:3l:34
`THE WITNESS:
`It is vague because you
`08:31 :37
`don't give enough infomtation as to regards
`0823i :43
`to how much tyloxapol or what else is in
`08:31:45
`there. So it's very -- it's difficttlt to
`08:31 :49
`
`A. Bye drops that contain it.
`Q. Which eye drops?
`A.
`I don't recall.
`
`08:27:l5
`0B:27:I‘l
`08:27: I9
`
`08:27:2I
`
`08:27:40E~O30\lO~'JIJ.‘.Lut\I—
`
`0. Have you cvcrconductcd any research on any
`bromfenac product?
`08:27:25
`MR. MARGOLIS: Objection. Vague.
`0. You may answer.
`08:27:28
`A. On a bromfenac product. no.
`08:27:38
`Q. Have you ever conducted any research on any
`product containing tyloxapol?
`08:27:42
`. Yes.
`08:27:45
`
`08:27:27
`
`_. 10
`B
`
`_.._a Ut-3»
`
`3 \
`
`l
`
`I\)l\JI\)--—IU-GREGG
`
`JZG}Z3'.3S~coc\tosu..t:uro—-
`
`....——Q0‘
`I8
`
`08:27:45
`. What product?
`08:27:47
`. Exosurf. for example.
`08:27:52
`. Any others?
`. Formulations I have undertaken rcseatcli in my
`own laboratory.
`08:27:59
`Q. Which lonnulations?
`08:28:00
`
`08:27:55
`
`A. That I have made up in my own laboratory.
`Q. How did you make a fonnulation in your
`laboratory containing tyloxapol?
`A. That is a very vague question.
`tyloxapol much in my research.
`
`I have used
`
`08:28:0l
`08:28:04
`08:28:07
`08:28:ll
`08:28: I 6
`
`Page 3|
`
`08:28:I8
`Q. What did you use it for?
`A. To make a variety of formulations, of types
`08:28:20
`of fonuulations.
`08:28:24
`
`08:28:25
`Q. Why did you use tyloxapol in the formulations
`that you made in your laboratory?
`08:28:28
`MR. MARGOLIS: Objection. Vague.
`08:28:30
`Compound.
`082283 I
`Q. You may answer.
`08:28:32
`A.
`I used it for several reasons. For example,
`08:28:35
`it is accepted pharmaceutically.
`08:28:40
`Q. What other reasons?
`08:28:42
`A. It's a non-ionic 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-O-L-U-B-I-L-I-S-E, or Z-E.
`08:19:05
`
`Q. Any other reasons?
`A. It's -— it stabilizes many formulations.
`0. What do you mean by "it stabilizes many
`fonnulations"?
`08:29:29
`A.
`It depends on the formulation you're looking
`at, how it acts. but it is used to I'ormuIale many
`prepamtinns.
`08:29:35
`
`08:29:07
`08:29:09
`08:29:26
`
`08:29:29
`08:29:31
`
`I
`
`2 3
`
`4 5
`
`\C0O~lGU-BUN-
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`9 (Pages 30 to 33)
`
`202-347-3700
`
`Page 10 of 132
`
`

`
`M. Jaync Lawrence
`
`September 4, 2015
`
`Sen_iu Pharmaceutical Co., LTD. ct al. v. Lupin, LTD., and Lupin Pharmaceutical, Inc.,
`
`flllS\VCI'.
`
`08:31:52
`
`Q. How would you make it water-based surfactant
`08:31:56
`system with tyloxapol?
`08:31:57
`A. Can I ask for clarification?
`. Sure.
`08:31 :59
`
`0833 I :52
`
`2
`
`concentration. that would depend on what you would
`do next.
`08:33:50
`
`. What do you mean by \valcr-based?
`
`. What's your understanding of watcr-based’?
`.
`1 don't know.
`I'm asking for clarilicatiou.
`. Have you ever used the tcnn watcr~bztscd?
`.
`It's nota frequently used tcnn - a term I
`
`08:32:00
`08:32:01
`08:32:03
`
`08:32:00
`08:32:09
`
`08:32:12
`08:32:13
`
`t'requeutly use. no.
`Q. Have you ever used it in any of your
`publications‘!
`08:32:15
`A.
`1 don't know.
`1 (1nn'trcmcmbcr every single
`publication I've had.
`08:32:24
`Q. Would a solution containing tyloxapol in
`water be considered an aqueous surfactant system’!
`MR. MARGOLIS: Objection. Vague.
`08:32:32
`’I‘Hl-I WITNESS: Again, you need to tell me
`08:32:34
`how much water and tyloxapol there are to
`answer that question. I'm sorry.
`08:32:37
`Q. Why does it matter how much water and
`08:32:37
`
`08:32:17
`
`08:32:25
`08:32:28
`08:32:31
`
`Q. Would that be considered :1 watenbased
`surt‘actant system?
`08:33:53
`MR. MARGOLIS: Objection. Vague.
`T1113 WITNESS: Again, it depends on wltat
`thc definition of based is.
`08:34:04
`
`08:33:55
`08:34:00
`
`08:34:06
`
`Q. Would that b: considered an aqueous
`08:34:09
`surfactant system?
`08:34:11
`MR. MA RGOLIS: Objection. Vague.
`08:34:13
`THE WI INESS:
`It would depend on the
`relative - depending on the relative
`08:34:15
`proportions of surfactant and water.
`08:34:16
`11‘ the water is in the greater proportion,
`08:34:18
`Q.
`would that be an aqueous surfactant system?
`08:34:21
`A. Yes.
`08:34:24
`
`Q. Are you an expert in clinical testing?
`A. No.
`1 would consider mysclfsomcbody of
`ordinary skill in the art.
`08:34:35
`08:34:36
`0. [lave you ever conducted any clinical testing
`with a phannaceutical product?
`08:34:39
`08:34:47
`A. When you mean conduct. again. that's very
`
`08:34:26
`08:34:33
`
`Page 35
`
`Page 37
`
`08:32:39
`tyloxapol are there?
`08:32:42
`A. Because you still haven't answered really
`what based is. So. when you say water-based, if you
`08:32:45
`can clarify that, please?
`08:32:49
`Q. No.
`I asked a different question.
`08:32:51
`asked --
`
`1
`08:32:53
`
`I can't answer if you're talking about
`A.
`water-based and it's not clarified. So I can't
`
`08:32:53
`08:32:56
`
`08:33:00
`08:33:03
`08:33:06
`
`08:32:58
`answer. Sony.
`0. Okay. How would you make an aqueous
`surfactant system using tyloxapol?
`MR. MARGOLIS: Objection. Vague.
`Q. You may answer.
`08:33:09
`A. The only way 1 can answer that is to make
`08:33:12
`some assumptions.
`08:33:15
`Q. Please do.
`08:33:16
`A. Assuming you want a predominantly
`watcr—bascd — water to be there in the biggest
`amount, largest amount, which I assume is what you
`are trying to say by bascd. you would add water, a
`known amount ofwutcr, to a prc-wcighcd amount of
`tyluxapol. and depending upon the particular
`
`08:33:17
`08:33:25
`08:33