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.,
`
`)))
`~L[ · ff~f~~l
`
`Ace-Federal Reporters, Inc.
`Phone: 202-347-3700
`Fax: 202-737-3638
`Email: info@acefederal.com
`Internet: www .acefederal.com
`
`Page 1 of 132
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`SENJU EXHIBIT 2140
`LUPIN v. SENJU
`IPR2015-01099
`
`

`
`M. Jayne Lawrence
`
`Senju Pharmaceutical Co., LTD., et al. v. Lupin, LTD., and Lupin Pharmaceutical, Inc.,
`
`September 4, 2015
`
`Page I
`
`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
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`SENJU PHARMACEUTICAL CO.,
`LTD., BAUSCH & LOMB
`INCORPORATED, and BAUSCH
`& LOMB PHARMA HOLDINGS CORP.,
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`Plaintiffs,
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`Civil Action Nos.:
`1:14-cv-00667-JBS-KMW
`1:14-cv-04149-JBS-KMW
`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,
`INNOPHARMA,
`INC., INNOPHARMA,
`LLC, MYLAN PHARMACEUTICALS,
`INC., and MYLAN INC.,
`Defendants.
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`-
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`Civil Action Nos.:
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`1:14-cv-06893-JBS-KMW
`1:15-cv-03240-JBS-KMW
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`X
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`Deposition of:
`
`M. JAYNE LAWRENCE, Ph.D.
`
`September 4, 2015
`New York, New York
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`866-928-6509
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`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Page 2 of 132
`
`

`
`M. Jayne Lawrence
`
`Senju Pharmaceutical Co., LTD., et a!. v. Lupin, LTD., and Lupin Phmmaceutical, Inc.,
`
`September 4, 2015
`
`Page 4
`
`APPERANCES (CONTINUED):
`
`ALSTON & BIRD, LLP
`Attorneys for Defendant Innopharma
`333 South Hope Street, 16th Floor
`Los Angeles, California 90071
`BY: H. JAMES ABE, ESQ.
`(213) 576-1000 (Telephone)
`(213) 576-1100 (Fax)
`james.abe@alston.com
`
`Also Present:
`Thomas Del Vecchio (Videographer)
`
`Page 2
`VIDEOTAPED DEPOSITION ofM. JAYNE LAWRENCE, 1
`1
`2
`2 Ph.D., taken pursuant to Notice, held at the law
`3
`3 offices ofGOODWlN PROCTER, LLP, 620 Eighth Avenue,
`4 26th floor, New York, New York, I 0018-1405, on
`4
`5 Friday, September 4, 2015, at 8:00a.m. before
`5
`6 JEANNETTE MCCORMICK, a Certified Sh01ihand Reporter,
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`7 and a Notary Public.
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`Page 3
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`I A P P E A RANCE S:
`INDEX
`EXAMINATION BY
`2
`FINNEGAN, HENDERSON, FARABOW, GARRETT 2 WITNESS
`3
`& DUNNER, LLP
`3 M. JAYNE LAWRENCE, Ph.D.
`4
`Attorneys for Plaintiffs
`4
`MR. HAS FORD
`5
`90 I New York A venue, NW
`5
`EXHIBITS
`Washington, D.C. 20001-44I3
`6
`6
`7
`BY: JUSTIN J. HASFORD, ESQ.
`7 LAWRENCE
`8
`BRYAN C. DINER, ESQ.
`8 NUMBER
`9
`(202) 408-4000 (Telephone)
`9
`10
`10 Exhibit I Declaration ofM. Jayne
`(202) 408-4400 (Fax)
`II
`justin.hasford@finnegan.com
`11
`Lawrence, Ph.D. and
`I 2
`I2
`bryan.diner@finnegan.com
`Appendices and Exhibits
`13
`13
`I4
`14 Exhibit 2 "Models for Intestinal Drug
`I5
`Absorption", Wood & Lawrence
`15
`I6
`I 6
`(I 99 I) Journal of Biopharmaceutical
`I7
`17
`Sciences (pgs. 147-1 72)
`I8
`18
`(Publication No. 5 on CV)
`I9
`19
`20
`20
`21
`21
`22
`22
`
`DESCRIPTION
`
`GODWIN PROCTER, LLP
`Attorneys for Defendant Lupin
`The New York Times Building
`620 Eighth A venue
`New York, New York 10018-1405
`BY: DANIEL P. MARGOLIS, ESQ.
`(2I2) 8I3-8800 (Telephone)
`(2I2) 355-3333 (Fax)
`dmargolis@goodwinprocter.com
`
`I 7
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`Page 5
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`PAGE
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`PAGE
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`I 8
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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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`Page 3 of 132
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`

`
`M. Jayne Lawrence
`
`Senju Pharmaceutical Co., LTD., et al. v. Lupin, LTD., and Lupin Pham1aceutical, Inc.,
`
`Paee 6
`
`September 4, 2015
`
`Page 8 IJ
`
`DESCRIPTION
`
`PAGE
`
`EXHIBITS
`I
`2 LAWRENCE
`3 NUMBER
`4
`5 Exhibit 3 "Effect of diclofenac sodium
`and disodium
`6
`ethylenediaminetetraacetate on
`7
`electrical parameters ofthe
`8
`mucosal membrane and their
`9
`10
`relation to the permeability
`11
`enhancing effects in the rat
`12
`jejunum" by Yamashita, et al,
`13
`in the J. Pharm. Pharmacal.
`14
`1987, volume 39, pages 621 to 626 208
`15
`16 Exhibit4 U.S. Patent No. 8,192,755 B2
`17 Exhibit 5 U.S. Patent Application
`Publication No. 2013/0210878 A 1
`18
`19
`20
`21
`22
`
`232
`
`237
`
`EXHIBITS
`1
`2 LAWRENCE
`3 NUMBER
`DESCRIPTION
`4 Exhibit 6 "Structural Investigations of
`5
`the Monolayers and Vesicular
`Bilayers Formed by a Novel Class
`6
`7
`ofNonionic Surfactant" in the
`"Chemical Aspects of Drug
`8
`9
`Delivery System," (pgs. 65-76)
`(Book Chapters No.6 on CV)
`10
`I 1
`12 Exhibit 7 "Neutron Scattering in
`13
`Pharmaceutical Sciences" in
`14
`"Applications ofNeutron
`15
`Scattering to Soft Condensed
`16
`Matter," (pgs. 325-356)
`17
`(Book Chapters No. 7 on CV)
`18 Exhibit 8 "Molecular Modelling of
`19
`Surfactant Vesicles" in
`20
`"Synthetic Surfactant
`21
`Vesicles," (pgs. 9-23)
`22
`(Book Chapters No. 8 on CV)
`
`Page 7
`
`PAGE
`
`240
`
`257
`
`259
`
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`II
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`20
`21
`22
`
`EXHIBITS
`LAWRENCE
`NUMBER
`DESCRIPTION
`Exhibit 9 "Recent Advances in
`Microemulsions as Drug
`Delivery Vehicles" in
`"Nanoparticulates as Drug
`Carriers," (pgs. 125-171)
`(Book Chapters No. 14 on CV)
`Exhibit I 0 "Drug Delivery Systems:
`Neutron Scattering Studies" in
`"Encyclopedia of Pharmaceutical
`Technology," (pgs. 1049-1070)
`(Book Chapters No. 15 on CV)
`Exhibit 11 "New Medicines, Better
`Medicines, Better Use of
`Medicines," (120 pgs.)
`(Other Outputs No. 12 on CV)
`
`11
`
`I,
`PAGEil
`I
`I'
`I,
`1: ll
`
`262
`
`11
`
`265
`
`267
`
`Page 9
`
`PAGE
`
`EXHIBITS
`LAWRENCE
`DESCRIPTION
`NUMBER
`Exhibit 12 "Association Characteristics
`of Synthetic Non-ionic
`Surfactants in Aqueous Solution"
`in "Physical Chemistry in
`Condensed Phases," (pgs. 1903-191 0)
`(Articles in Academic Journals
`No. I on CV)
`279
`
`Exhibit 13 "Effect of Structural
`Variations ofNon-ionic
`Surfactants on Micellar
`Prope1ties and Solubilization:
`Smfactants with Semi-Polar
`Hydrophobes" in "Journal of
`Pharmacy & Pharmacology,"
`(pgs. 585-589) (Articles in
`Academic Journals No. 2 on CV)
`
`281
`
`ll li
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`866-928-6509
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`Page 4 of 132
`
`

`
`M. Jayne Lawrence
`
`Senju Pharmaceutical Co., LTD., et al. v. Lupin, LTD., and Lupin Pharmaceutical, Inc.,
`
`September 4, 2015
`
`Page 12
`
`EXHIBITS
`LAWRENCE
`DESCRIPTION
`NUMBER
`Exhibit 14 "Analysis and Modelling of the
`Structures of Beta-Cyclodextrin
`Complexes" in "BBA, Biochimica
`et Biophysica Acta, (pgs. 27-36)
`(A1ticles 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)
`
`I
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`Page 10
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`PAGE 3
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`285
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`Page II
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`EXHIBITS
`LAWRENCE
`DESCRIPTION
`NUMBER
`PAGE
`Exhibit 18 "Microemulsions as Drug Delivery
`Vehicles" in "Current Opinion in
`Colloid & Interface Science,"
`(pgs. 826-832) (Articles in
`Academic Journals No. 18 on CV)
`295
`Exhibit 19 "Aggregation & Surface Properties
`of Synthetic Double-Chain Non-Ionic
`Surfactants in Aqueous Solution in
`"Journal of Pharma & Pharmacology,
`Volume 49, May 1997 (pgs. 594-600)
`(Articles in Academic Journals
`No. 20 on CV)
`297
`
`Page 13
`
`EXHIBITS
`LAWRENCE
`DESCRIPTION
`NUMBER
`Exhibit 16 "Surfactant Systems:
`Microemulsions and Vesicles as
`Vehicles for Drug Delivery" in
`"European Journal of Drug
`Metabolism & Pharmacokinetics,
`1994, No. 3, (pgs. 257-269)
`(Atticles in Academic Journals
`No. 12 on CV)
`288
`
`1
`2
`3
`4
`5
`6
`7
`8
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`10
`11
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`13 Exhibit 17 "The Formation, Characterization
`& Stability ofNon-Ionic
`14
`15
`Surfactant Vesicles" in "STP
`16
`Pharma Sciences." (Pgs. 49-60)
`17
`(Articles in Academic Journals
`18
`292
`No. 16 on CV)
`19
`20
`21
`22
`
`....
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`. . .
`
`··--'---'·--=--
`
`-___ -
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`EXHIBITS
`LAWRENCE
`NUMBER
`DESCRIPTION
`PAGE
`Exhibit 20 "Physicochemical & Solubilization
`Prope1ties ofN,N-Dimethyl-N(cid:173)
`(3-Dodecylcarbonyloxypropyl)
`amineoxide: A Biodegradable
`Nonionic Surfactant" in "Journal
`of Phmmaceutical Sciences,"
`(pgs. 798-806) (Articles in
`Academic Journals No. 33 on CV)
`
`1
`2
`PAGE 3
`4
`5
`6
`7
`8
`9
`10
`II
`12
`13 Exhibit 21 "Toxicological Evaluation of
`14
`Mixtures ofNonionic Surfactants,
`Alone & in Combination with Oil"
`15
`16
`in "Journal of Pharmaceutical
`17
`Sciences," (pgs. 859-868 (Articles
`18
`in Academic Journals No. 47 on CV) 304
`19
`20
`21
`22
`
`299
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`Page 5 of 132
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`

`
`M. Jayne Lawrence
`
`September 4, 2015
`
`Senju Pharmaceutical Co., LTD., et al. v. Lupin, LTD., and Lupin Pharmaceutical, Inc.,
`
`Page 14
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`Page 16
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`PAGE
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`EXHIBITS
`LAWRENCE
`DESCRIPTION
`NUMBER
`Exhibit 22 "Fonnulation of Electrically
`Conducting Microemulsion-Based
`Organogels" in "International
`Joumal of Pharmaceutics"
`(pgs. 65-83 (A1ticles in Academic
`Joumals No. 49 on CV)
`305
`Exhibit 23 "Molecular Dynamics Simulations
`ofthe Interfacial & Structural
`Prope1ties of
`Dimethyldodecylamine-N-Oxide
`Micelles" in "Langmuir, The ACS
`Journal of Surfaces & Colloids"
`(pgs. 546-553 (Articles in 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 (Aiticles in
`Academic Journals No. 102 on CV)
`
`312
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`2
`3
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`5
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`II
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`
`••
`
`.:
`
`The court reporter today is Jeannette
`08:11:53
`McCormick with the firm of Ace-Federal
`08:11:57
`Reporters. My name is Thomas Del Vecchio. I
`08:12:00
`am the legal video specialist representing
`08:12:04
`Ace-Federal Reporters, 1625 1 Street,
`08:12:06
`08:12:12
`Northwest, Washington, D.C., 20006.
`Will counsel identify themselves and who
`08:12:17
`they represent.
`08:12:19
`08:12:20
`MR. BASFORD: Justin Has ford of Finnegan
`on behalf of plaintiffs Senju and Bausch &
`08:12:21
`Lomb.
`08:12:21
`MR. DINER: Bryan Diner of Finnegan,
`also on behalf of plaintiffs Scnju and Bausch
`& Lomb.
`08: 12:31
`MR. MARGOLIS: Dan Margolis from Goodwin
`Procter for the Lupin defendants.
`08:12:33
`MR. ABE: James Abe of Alston & Bird for
`08:12:36
`the lnnopharma defendants.
`08:12:38
`08:12:4
`THE VIDEOGRAPHER: Thank you. Now, will
`the court reporter please swear in or affirm
`08:12:43
`the witness.
`08:12:45
`M. JAYNE LAWRENCE, Ph.D.,
`
`08:12:25
`08:12:27
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`08:12:31
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`Page 15
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`Page 17
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`08:10:1
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`PROCEEDINGS
`THE VIDEOGRAPHER: Good moming. We are
`now going on the record. Please note that
`08:10:16
`08: I 0:20
`microphones are sensitive and may pick up
`08: I 0:22
`whispering and private conversations. Please
`08: I 0:25
`turn off all telephones or place them away
`from the microphones as they can interfere
`08:10:29
`with the video deposition audio.
`08:10:32
`08: I 0:34
`Recording will continue until parties
`agree to go off the record.
`08:10:36
`The deponent today is Dr. Jayne Lawrence
`08:10:38
`08: I 0:42
`in the matter of Senju Pharmaceutical
`08: I 0:48
`Company, Ltd, et al, plaintiffs, versus
`Lupin, Ltd, et al, 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
`08:11:13
`Jersey.
`08:11:23
`This deposition is being taken at the
`08:11:23
`08: II :25
`office of Goodwin Procter, the New York Times
`Building, 620 Eighth Avenue, New York, New
`08:11:30
`York, 10018. The time is approximately 8:12
`08:11:33
`a.m. Today is Friday, September 4, 2015.
`08:11:44
`
`08:13:02
`
`having been first duly swom
`testified as follows:
`2
`EXAMINATION
`3
`4 BY MR. HASFORD:
`08:12:57
`5
`Q. Good morning, Dr. Lawrence.
`08:12:57
`A. Good morning.
`6
`08:13:01
`7
`Q. Would you please state your name and address
`8
`for the record.
`08: 13:04
`08:13:04
`9
`A. Yes. Dr. Margaret Jayne Lawrence of 62
`08:13:08
`10 Wellington Road, Ashford, Middlesex, UK.
`II
`Q. How many times have you been deposed before?
`08:13:1
`12
`A. This is my first time.
`08:13:14
`13
`Q. Let me tell you how today's deposition will
`08:13:16
`14 proceed. I represent the plaintiffs in this case.
`08:13:18
`15 Today I will ask you a series of questions, and I
`08:13:20
`16 would ask that you answer my questions truthfully
`08:13:23
`17 and accurately.
`08:13:25
`18
`If you need a break, just let me know, but if 08:13:26
`I have asked a question I would ask that you first
`19
`08:13:29
`20 answer the question and then we can take a break.
`08:13:31
`21
`If for any reason you do not understand a
`08:13:34
`22 question that I ask, please let me know. If you
`08:13:36
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`Ace-Federal Reporters, Inc.
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`5 (Pages 14 to 1 7)
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`202-347-3700
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`Page 6 of 132
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`

`
`M . .Jayne Lawrence
`
`September 4, 2015
`
`Senju Pharmaceutical Co., LTD., et al. v. Lupin, LTD., and Lupin Pharmaceutical, Inc.,
`
`Page 18
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`Page 20
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`08:13:38
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`answer a question, I will assume that you understood
`I
`08:13:40
`the question. Is that okay?
`2
`A. Yes.
`08:13:42
`3
`08:13:42
`Q. Is there any reason why you cannot testify
`4
`truthfully and accurately today?
`08:13:45
`5
`A. No.
`08:13:46
`6
`MR. HASFORD: I'm handing the court
`08:13:49
`7
`reporter what I've asked to be marked as
`8
`08:13:50
`Lawrence Exhibit I.
`08:13:52
`9
`For the record, Lawrence Exhibit I is
`08:13:53
`10
`the Declaration of Jayne Lawrence, Ph.D., and
`08:13:55
`II
`Appendices and Exhibits.
`08:13:59
`12
`(Whereupon, Plaintiffs Deposition
`08:14:30
`13
`Exhibit No. Lawrence I was marked for
`08:14:31
`14
`Identification.)
`08:14:33
`15
`Q. Is Lawrence Exhibit 1 your claim construction
`16
`17 declaration, appendices and exhibits in this case?
`18
`A. Yes.
`08:14:45
`Q. Please tum to page 25. Does your signature
`19
`08:14:46
`08:14:54
`20 appear on page 25 of your claim construction
`21
`declaration for this case?
`08:14:57
`A. It does.
`22
`08:14:58
`
`08:14:33
`08:14:37
`
`08:15:47
`08:15:49
`08: 15:54
`08:15:56
`
`question again?
`I
`08:15:44
`Q. Certainly. In what areas do you consider
`2
`08:15:44
`3 yourself an expert?
`08:15:46
`4
`MR. MARGOLIS: Same objection.
`5
`THE WITNESS: In terms of scientific
`6
`activities? In terms of professional
`7
`activities? Could you please clarify a bit
`8
`more?
`08:15:58
`Q. In what areas do you hold yourself out as an
`9
`I 0 expert?
`08: 16:0 I
`08:16:01
`II
`MR. MARGOLIS: Objection. Vague.
`08:16:06
`12
`THE WITNESS: It depends what-- I find
`13
`that a very difficult question to answer
`08:16: I 0
`14
`because you could be expert in lots of areas
`08:16:12
`15
`and that's why I ask for clarification.
`08: 16: 15
`16
`Q. In what scientific areas do you consider
`08:16:17
`17 yourself an expert?
`08:16:19
`18
`A. Okay. I --
`08:16:20
`08:16:20
`19
`MR. MARGOLIS: Objection. Vague.
`20
`Q. You may answer.
`08:16:21
`21
`A. Do you mean an expert in the context ofthis
`08:16:23
`22 particular case?
`08:16:35
`
`08:15:58
`
`Page 19
`
`Page 21
`
`08:14:58
`Q. Who prepared your claim construction
`1
`2 declaration for this case?
`08:15:00
`3
`A. I did.
`08:15:02
`08:15:03
`4
`Q. Take a look, if you would, at Appendix A. Is
`08:15:13
`5 Appendix A to your claim construction declaration a
`copy of your cun·iculum vitae?
`08:15:16
`6
`7
`A. It is.
`08:15:18
`08:15:19
`Q. Does your curriculum vitae list your relevant
`8
`9 professional experience?
`08:15:22
`A. It does.
`10
`08:15:23
`II
`Q. In what areas do you consider yourself an
`12 expert?
`08:15:26
`MR. MARGOLIS: Objection. Vague.
`13
`08:15:27
`14 BY MR. HASFORD:
`08:15:30
`Q. You may answer.
`15
`08:15:30
`16
`MR. ABE: Counsel, will we agree that if 08:15:32
`17
`counsel for Lupin objects it will apply for
`08:15:35
`18
`Innopharma as well?
`08:15:39
`19
`MR. HASFORD: Sure. We can agree to
`that.
`20
`08:15:41
`21
`MR. ABE: Thank you. Please proceed.
`THE WITNESS: Could you just repeat the
`22
`
`08:15:24
`
`08:15:40
`
`08:15:42
`08:15:43
`
`I
`2
`3
`4
`5
`6
`7
`8
`9
`10
`II
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`08:16:36
`
`08:16:44
`
`Q. What's your understanding of an expert,
`Doctor?
`08: 16:44
`A. An expert is a person who has knowledge in a
`particular area.
`08:16:48
`08:16:49
`Q. Okay. And I'm asking the question based on
`08: I 6:51
`your understanding. So I will ask it again. In
`08:16:53
`what areas do you consider yourself an expert?
`08:16:56
`MR. MARGOLIS: Objection. Vague.
`THE WITNESS: I think to answer that
`08:17:06
`question I'm going to have to qualify the
`08:17:08
`08: 17:12
`pat1icular areas I'm talking about because I
`have expe11ise in several areas.
`08: 17:15
`Q. What areas?
`08:17:17
`A. I have expertise in respect to professional
`08:17:19
`activities where I'm chair of-- I'm sony-- where
`08:17:27
`I'm Chief Scientist for Royal Pharmaceutical
`08: 17:30
`Society, and so I have expertise, and sunounding my
`08: 17:36
`08:17:43
`activities as a chief scientist in that context. I
`obviously have expertise smTounding my activities
`08:17:47
`08:17:50
`as an academic in King's College, London.
`Q. Are you an expert in any other areas?
`08:17:56
`08:18:00
`MR. MARGOLIS: Objection. Vague.
`
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`
`

`
`M. Jayne Lawrence
`
`September 4, 2015
`
`Senju Pharmaceutical Co., LTD., et al. v. Lupin, LTD., and Lupin Phammceutical, Inc.,
`
`Page 22
`
`Page 24
`
`08:20:04
`Q. What other areas?
`I
`08:18:02
`Q. You may answer.
`I
`2
`08:20:06
`A. Getting-- that's incredibly vague and
`A. I do find that really, really hard to answer.
`08:18:06
`2
`08:20:12
`3 probably not relevant to this particular case. For
`I can give you an expertise if you tell me what
`08:18:09
`3
`example, I'm an expert on neutron scattering, but
`08:20:15
`4
`4 particular areas you are referring to.
`08: 18: II
`it's probably irrelevant for this particular case.
`5
`5
`Q. I'm asking you for your understanding. In
`08:18:13
`08:20:20
`Q. Well, I'm asking you the question and, you
`6
`what other areas do you hold yourself out as an
`08:18:17
`08:20:24
`6
`08:20:2
`know, I'm not asking you to try to detennine what's
`expert?
`7
`08:18:20
`7
`relevant or not relevant for the case.
`08:20:31
`8
`08:18:20
`MR. MARGOLIS: Objection. Vague.
`8
`Are you an expert in any other areas?
`08:20:33
`08:18:36 9
`THE WITNESS: Well, I'm going to answer
`9
`I 0
`A. I consider I have expertise in a number of
`08:20:59
`it this way. I have expertise in a number of 08: 18:38
`10
`II
`scientific disciplines. I have expertise in
`08:18:42
`other areas, yes. For example, I'm a recognized
`08:21 :02
`II
`expert on neutron scattering.
`08:21 :09
`12
`respect to my professional activities
`08:18:47
`12
`Q. And you just said that. What other areas
`08:21: 12
`regarding my work at Pharmaceutical Society.
`08: 18:54 13
`13
`14 besides neutron scattering?
`08:21: 15
`14
`I think my main -- my main two areas of
`08:18:56
`08:19:0 I
`A. 1 think I'm expert in promoting of
`08:21:18
`15
`expertise.
`15
`Q. Take a look at paragraph 5 of your
`08:21 :23
`16 phmmaceutical science.
`08:19:02
`16
`08:21 :25
`Q. Any other areas?
`08: 19:05
`17 declaration on page two.
`17
`A. I'll qualify that, promoting to the public
`08:21:27
`08:19:11
`18
`A. Which is headed?
`18
`08:19:13
`Q. It's going to be page 2 of your declaration.
`and other scientists. Can I look at my CV?
`08:21:32
`19
`19
`Q. Oh, please.
`08:21:40
`20
`A. Yes.
`08:19:13
`20
`08:19: 16
`21
`Q. Paragraph 5 under Qualifications. I don't
`21
`A. I consider I'm an expert teacher with respect
`22
`think you're on the right page.
`22
`to pharmaceutical science. I've been given awards
`08:19: 19
`
`08:21:48
`08:21:54
`
`1'
`
`
`i"
`
`Page 23
`
`Page 25
`
`1
`1
`08:22:00
`for that activity.
`08:19:20
`A. I'm son-y.
`2
`08:22:02
`I consider I'm an expert researcher, which
`2
`08:19:21
`Q. It's your declaration.
`3
`08:22:06
`includes an expert in the areas you highlighted.
`08:19:22
`A. Son-y. Paragraph 5?
`3
`08:22: I 0
`Q. Any other areas?
`Q. So, I still don't believe you're on the right
`08:19:26
`4
`4
`page. It's your declaration, not your curriculum
`A. Archaeology. Hobby.
`08:22: 14
`08:19:28
`5
`5
`Q. Anything else?
`08:22:22
`6
`vitae.
`08:19:31
`6
`A. It's vet)' hard to answer when asked are you
`A. I'm son-y. Five did you say?
`08:19:31
`Page 5?
`7
`7
`8
`8
`an expert in, not knowing what the point of the
`Q. Page 2, paragraph 5.
`08:19:37
`9
`question is.
`08:22:44
`9
`A. Page 2. Okay.
`08:19:39
`10
`08:22:45
`Q. Well, let me ask it this way. Are you an
`Q. It says, "I am an expert in the field of
`08:19:40
`10
`11
`expert in the field of pharmacy?
`08:22:47
`11
`fmmulation and drug delivet-y, specifically
`08:19:42
`12 pharmaceutical formulation for oral and parenteral
`08:19:44 12
`08:22:48
`A. Yes.
`Q. Have you ever practiced pharmacy?
`08:19:48
`13 use (i.e., non-oral, including intravenous
`13
`14
`intramuscular, nasal, respiratm-y and ophthalmic),
`08:22:51
`A. Yes.
`08: 19:52
`14
`15
`including aqueous liquid preparations."
`08:19:57
`15
`08:22:51
`Q. When did you last practice pharmacy?
`Do you see that?
`08:19:58
`16
`16
`08:22:53
`A. I'm a practicing pharmacist.
`Q. When did you last dispense a medication to a
`08:22:55
`A. Yes.
`08:19:59
`17
`17
`08:19:59
`Q. Do you hold yourself out to the public as an
`18 patient?
`08:22:58
`18
`08:20:0 I
`08:22:58i,
`19
`A. Dispense medication? Probably 20 years ago.
`19 expet1 in any other areas?
`20
`A. In other areas?
`08:20:02
`Q. Are you an expert in phmmacology?
`08:23:10
`20
`21
`Q. Correct.
`08:20:03
`21
`A. No.
`08:23:12
`22
`22
`A. Yes.
`08:20:04
`Q. Are you an expert in phannacokinetics?
`
`08:22:37
`08:22:40
`
`08:22:49
`
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`
`Page 8 of 132
`
`

`
`M. Jayne Lawrence
`
`September 4, 2015
`
`Senju Pharmaceutical Co., LTD., et al. v. Lupin, LTD., and Lupin Pharmaceutical, Inc.,
`
`Page 26
`
`Page 28
`
`08:23:18
`MR. MARGOLIS: Objection. Vague.
`I
`Q. You may answer.
`08:23:19
`2
`A. I have -- I have a good level of expertise in
`08:23:23
`3
`08:23:28
`4
`that.
`Q. Have you ever held yourself out to the public
`08:23:29
`5
`as an expert in pharmacokinetics?
`08:23:31
`6
`08:23:33
`A. No.
`7
`Q. Have you ever held yourself out to the public
`08:23:33
`8
`as an expert in pharmacodynamics?
`08:23:36
`9
`MR. MARGOLIS: Objection. Vague.
`08:23:40
`10
`Q. You may answer.
`08:23:41
`II
`A. I have not.
`12
`08:23:44
`Q. Are you an expert in ophthalmology?
`08:23:45
`13
`MR. MARGOLIS: Objection. Vague.
`14
`08:23:52
`Q. You may answer.
`08:23:54
`15
`A. I'm an expert in parenteral formulations of
`08:23:57
`16
`17 which ophthalmology -- ophthalmic formulations as
`08:24:01
`18 well.
`08:24:06
`Q. Have you ever held yourself out to the public
`08:24:06
`19
`20 as an expert in ophthalmology?
`08:24:09
`MR. MARGOLIS: Objection. Vague.
`21
`08:24:1I
`THE WITNESS: No.
`22
`08:24:I2
`
`I
`2
`3
`4
`5
`6
`7
`8
`9
`10
`II
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`IJ
`
`08:25:17
`
`A. As a pharmacist in the UK, that is not your
`role.
`08:25:21
`Q. Is that a "no"?
`08:25:22
`A. In the UK, that would not be the role of a
`pharmacist.
`08:25:26
`Q. Have you ever dispensed any bromfenac product
`to a patient?
`08:25:30
`A. No.
`08:25:32
`Q. Have you ever dispensed any product
`08:25:33
`containing tyloxapol to a patient?
`08:25:35
`1\. Yes.
`08:25:38
`Q. What product?
`08:25:39
`A. Exosurf.
`08:25:40
`08:25:42
`Q. You may have to spell that for the reporter.
`08:25:45
`A. E-X-0-S-U-R-F.
`Q. What is Exosurf?
`08:25:50
`A. It's a product for respiratory distress
`08:25:52
`syndrome in pre-term infants.
`08:25:59
`Q. Is that an ophthalmic product?
`08:26:03
`A. It's not an ophthalmic product. I have
`08:26:06
`dispensed many ophthalmic products.
`08:26:08
`Q. Have you ever dispensed an ophthalmic product
`08:26: II
`
`Page 27
`
`Page 29
`
`08:24:13
`Q. Are you an expert in any field of medicine?
`1
`2
`08:24:17
`MR. MARGOLIS: Objection. Vague.
`3
`08:24:19
`THE WITNESS: Medicine is a huge area.
`08:24:25
`And what are you covering? Are you covering
`4
`pharmaceutical medicine?
`08:24:27
`5
`Q. Have you ever held yourself out to the public
`08:24:29
`6
`08:24:3I
`as an expert in any field of medicine?
`7
`MR. MARGOLIS: Objection. Vague.
`08:24:34
`8
`THE WITNESS: I am a Registered
`9
`08:24:37
`Practicing Pharmacist in the UK.
`08:24:39
`10
`Q. Have you ever--
`II
`08:24:42
`A. So, I am not a medic.
`12
`08:24:43
`Q. Well, when you say--
`13
`08:24:47
`A. So, I would not claim to practice medicine.
`14
`08:24:48
`Q. Have you ever prescribed medication to a
`15
`08:24:53
`16 patient?
`08:24:56
`17
`A. No.
`08:24:58
`Q. Have you ever treated an inflammatory disease
`18
`19 of the eye?
`08:25:02
`20
`A. No.
`08:25:06
`21
`Q. Have you ever administered any bromfenac
`08:25: II
`22 product to a patient?
`
`containing tyloxapol to a patient?
`08:26:16
`I
`A. Undoubtedly.
`2
`08:26:I6
`Q. Which one?
`08:26:I7
`3
`A. Many products contain tyloxapol. As a
`4
`5 pharmacist, I have dispensed most ophthalmic
`6 preparations.
`08:26:32
`08:26:32
`7
`Q. What ophthalmic product containing tyloxapol
`8 have you dispensed to a patient?
`08:26:36
`A. As a phannacist, it is not normal you read
`08:26:37
`9
`I 0
`the list of excipients.
`08:26:40
`II
`Q. Sitting here today, can you name any
`08:26:41
`12 ophthalmic product containing tyloxapol that you
`08:26:43
`13 have dispensed to a patient?
`08:26:46
`14
`A. No.
`08:26:52
`08:26:53
`15
`Q. Are you aware that the acronym EDT A stands
`I6
`for ethylenediaminetetraacetic acid?
`08:26:59
`08:27:02
`17
`A. I am.
`08:24:59 18
`Q. Have you ever administered any product
`19 containing EDTA or any salt or anion of EDTA to a
`20 patient?
`08:27: II
`08:25:06 21
`A. Undoubtedly, yes.
`08:27:12
`22
`Q. Which product?
`08:27:14
`
`08:26:19
`08:26:28
`
`08:27:02
`08:27:04
`
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`Page 9 of 132
`
`

`
`M. Jayne Lawrence
`
`September 4, 20 I 5
`
`Senju Pharmaceutical Co., LTD., et al. v. Lupin, LTD., and Lupin Pharmaceutical, Inc.,
`
`Page 30
`
`Page 32
`
`08:27:21
`
`A. Eye drops that contain it.
`1
`08:27:15
`Q. Which eye drops?
`2
`08:27:17
`08:27:19
`A. I don't recall.
`3
`Q. Have you ever conducted any research on any
`4
`5 bromfenac product?
`08:27:25
`08:27:27
`6
`MR. MARGOLIS: Objection. Vague.
`7
`Q. You may answer.
`08:27:28
`8
`A. On a bromfenac product, no.
`08:27:38
`Q. Have you ever conducted any research on any
`08:27:40
`9
`10 product containing tyloxapol?
`08:27:42
`II
`A. Yes.
`08:27:45
`12
`Q. What product?
`08:27:45
`13
`A. Exosurf, for example.
`08:27:47
`14
`Q. Any others?
`08:27:52
`15
`A. Formulations I have unde1iaken research in my
`16 own laboratory.
`08:27:59
`Q. Which fonnulations?
`08:28:00
`17
`A. That I have made up in my own laboratory.
`08:28:01
`18
`Q. How did you make a fmmulation in your
`08:28:04
`19
`laboratory containing tyloxapol?
`20
`08:28:07
`A. That is a ve1y vague question. I have used
`08:28:1 I
`21
`22
`tyloxapol much in my research.
`08:28:16
`
`Q. Have you ever conducted any research on any
`1
`2 product containing EDTA or any salt or anion of
`3 EDT A?
`08:29:45
`A. Yes.
`08:29:45
`4
`5
`Q. What product?
`08:29:45
`6
`A. It's tl·equently -- it's a compound that is
`08:29:48
`frequently used in academic research for a variety
`08:29:53
`7
`8 ofpurposes.
`08:29:58
`9
`Q. When did you last use EDT A in your academic
`I 0
`research?
`08:30:02
`A. Personally, a while ago. My research group,
`11
`I 2 all the time. So, I don't know how that answers
`13 your question.
`08:30:14
`14
`Q. No. Thank you for clarifying.
`08:30:14
`When personally did you last use EDT A in your
`08:30:16
`08:27:55 15
`16 academic research?
`08:30: 19
`A. Probably about five years ago.
`08:30:22
`17
`Q. When personally did you last use tyloxapol in
`08:30:37
`18
`19 your academic research?
`08:30:39
`A. Very recently.
`08:30:42
`20
`Q. Do you remember how recently?
`08:30:45
`21
`A. Probably last year or so.
`08:30:47
`22
`
`08:29:37
`08:29:40
`
`08:29:58.
`
`08:30:03
`08:30:08
`
`Page 31
`
`Page 33
`
`08:30:52
`
`08:31:00
`08:31:02
`08:31:02
`
`Q. Is bromfenac a water-soluble hydrophilic
`Q. What did you use it for?
`08:28:18
`drug?
`08:31:00
`2
`08:28:20
`A. To make a variety of formulations, of types
`2
`MR. MARGOLIS: Objection. Vague.
`3
`3 offormulations.
`08:28:24
`THE WITNESS: Can I ask you to clarity
`08:28:25 4
`Q. Why did you use tyloxapol in the fmmulations
`4
`that? Do you mean the free acid or do you
`5
`that you made in your laboratory?
`08:28:28
`5
`08:31:04
`mean the salt?
`08:28:30
`6
`6
`MR. MARGOLIS: Objection. Vague.
`08:31:05
`Q. Well, let me ask it this way. Is the sodium
`7
`Compound.
`08:28:31
`7
`Q. You may answer.
`08:31:07
`salt ofbromfenac a water-soluble hydrophilic drug?
`08:28:32
`8
`8
`A. I used it for several reasons. For example,
`08:28:35
`9
`9
`A. It is.
`08:31:12
`it is accepted pharmaceutically.
`I 0
`08:31:13
`Q. Would a solution containing tyloxapol in
`I 0
`08:28:40
`Q. What other reasons?
`II
`I I water be considered a water-based surfactant system?
`08:31:16
`08:28:42
`12
`MR. MARGOLIS: Objection. Vague.
`08:31:19
`08:28:45
`A. It's a non-ionic surfactant.
`12
`13
`THE WITNESS: Sony. Repeat the
`08:31 :23
`13
`08:28:51
`Q. What other reasons?
`14
`question?
`08:31:25
`14
`A. It is well-known to solubilize drugs. To
`08:28:53
`08:31 :25
`15
`Q. Certainly. I will repeat the question.
`solubilize, S-0-L-U-B-I-L-I-S-E, or Z-E.
`08:29:05
`15
`Would a solution containing tyloxapol in
`16
`Q. Any other reasons?
`08:29:07
`08:31:27
`16
`A. It's -- it stabilizes many formulations.
`08:31:30
`I 7 water be considered a water-based surfactant system?
`17
`08:29:09
`18
`Q. What do you mean by "it stabilizes many
`08:29:26
`18
`MR. MARGOLIS: Objection. Vague.
`08:31:34
`THE WITNESS: It is vague because you
`19
`08:31:37
`19
`formulations"?
`08:29:29
`A. It depends on the formulation you're looking
`20
`don't give enough information as to regards
`08:31:43
`20
`to how much tyloxapol or what else is in
`at, how it acts, but it is used to formulate many
`21
`08:31 :45
`2 I
`22
`08:31 :49
`there. So it's very --it's difficult to
`22 preparations.
`08:29:35
`
`08:29:29
`08:29:3 I
`
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`
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`
`-----.
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`,_ -- ~~
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`-- __ , ___ ~ '- -
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`Page 10 of 132
`
`

`
`M. Jayne Lawrence
`
`September 4, 2015
`
`Senju Pharmaceutical Co., LTD., et al. v. Lupin, LTD., and Lupin Pharmaceutical, Inc.,
`
`Page 34
`
`Page 36
`
`08:33:48
`
`I
`concentration, that would depend on what you would
`do next.
`08:33:50
`08:31:52 2
`Q. Would that be considered a water-based
`3
`surfactant system?
`08:33:53
`4
`MR. MARGOLIS: Objection. Vague.
`5
`THE WITNESS: Again, it depends on what
`6
`the definition of based is.
`08:34:04
`7
`Q. Would that be considered an aqueous
`08:34:06
`8
`surfactant system?
`08:34:09
`9
`08:34:11
`MR. MARGOLIS: Objection. Vague.
`10
`II
`08:34:13
`THE WITNESS: It would depend on the
`relative-- depending on the relative
`08:34:15
`12
`proportions of surfactant and water.
`08:34:16
`13
`Q. If the water is in the greater propmiion,
`08:34:18
`14
`15 would that be an aqueous surfactant system?
`08:34:21
`A. VeL
`16
`08:~:24
`17
`Q. Are you an expert in clinical testing?
`18
`A. No. I would consider myself somebody of
`19 ordinary skill in the art.
`08:34:35
`08:34:36
`20
`Q. Have you ever conducted any clinical testing
`21 with a pharmaceutical product?
`08:34:39
`A. When you mean conduct, again, that's very
`22
`08:34:47
`
`I
`08:31:52
`answer.
`2
`Q. How would you make a water-based surfactant
`system with tyloxapol?
`08:31:56
`3
`4
`A. Can I ask for clarification?
`08:31:57
`5
`08:31:59
`Q. Sure.
`A. What do you mean by water-based?
`08:32:00
`6
`7
`08:32:01
`Q. What's your understanding of water-based?
`08:32:03
`A. I don't know. I'm asking for clarification.
`8
`08:32:06
`Q. Have you ever used the term water-based?
`9
`08:32:09
`A. It's not a frequently used term -- a term I
`10
`frequently use, no.
`08:32:12
`11
`Q. Have you ever used it in any of your
`08:32: 13
`12
`13 publications?
`08:32:15
`14
`A. I don't know. I don't remember every single
`15 publication I've had.
`08:32:24
`Q. Would a solution containing tyloxapol in
`16
`08:32:25
`17 water be considered an aqueous surfactant system?
`08:32:28
`08:32:31
`18
`MR. MARGOLI