Transcript of the Testimony of M. Jayne Lawrence
`
`Date: February 29, 2016
`
`Case: Senju Pharmaceutical Co., LTD., et al. v. Lupin, LTD., and Lupin
`Pharmaceutical, Inc.,
`
`Ace—Federa| Reporters, Inc.
`Phone: 202-347-3700
`Fax: 202-737-3638
`Email: info@acefederai.com
`Internet: www.acefedera|.com
`
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`SENJU EXHIBIT 2327
`Lupin v Senju,
`iI’R2915-01097, IPRZUIS-(31099,
`IPRZOIS-01100 & IPRZUIS-01105
`
`

`
`M. Jayne Lawrence
`
`February 29, 2016
`
`Senju Pharznaceutical Co., LTD., et :11. v. Lupin, LTD., and Lupin Pl1a1*maceu1ica], Inc.,
`
`UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF NEW JERSEY
`
`SENJU PHARMACEUTICAL CO., LTD.,
`
`PAUSCH & LOMB INCORPORATED, and
`
`PAUSCH & LOMB PHARMA HOLDINGS CoRP.,
`
`Plaintiffs,
`
`C.A. Nos.
`1:l4—Cv~OO667—JBS~KMW
`
`:l4—cv—04149—JBS-KMW
`
`v.
`
`LUPIN, LTD. and LUPIN
`
`:14—cv—05144»JBs—RMw
`
`PHARMACEUTICALS,
`
`INC.,
`
`:14~cv—00335—JBs—KMw
`
`Defendants.
`
`INNOPHARMA LICENSING,
`
`:1§—CV-06893-JBS-KMW
`
`INC.,INNOPHARMA LICENSING,
`
`:14-CV-03240-JBS—KMW
`
`LLC,
`
`INNOPHARMA,
`
`INC.,
`
`INNOPHARMA, LLC,
`
`Defendants.
`
`VIDEOTAPED DEPOSITION of M.
`
`JAYNE LAWRENCE, Ph.D.
`
`February 29, 2016
`9:06 a.m.
`
`Goodwin Procter, LLP
`
`53 State Street
`Boston, Massachusetts
`
`Reporter: Michael D. O'Connor, RMR, CRR, CBC, CCP
`
`5
`E
`
`E
`
`E
`E
`
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`E
`
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`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`

`
`M. Jayne Lawrence
`
`February 29, 20 i 6
`
`Senju Pliarmaceuticai Co., LTD., et al. v. Lupin, LTD., and Lupin Pharmaceuticai, lnc._.
`
`Page 2
`
`VIDEOTAPED DEPOSITION of M. JAYNE
`LAWRENCE, Ph.D., taken pursuant to Notice, held
`at the Law Offices of Goodwin Procter, LLP, 53
`State Street, Boston, Massachusetts, on Monday,
`Februaly 29, 2016, at 9:06 a.1n., before Michael
`D. O'Connor, RMR, CRR, CBC, CCP, and a Notary
`Public.
`
`APPEARANCES (Cont'd):
`
`ATTORNEYS FOR INNOPHARMA DEFENDANTS:
`ALSTON & BIRD, LLP
`4721 Emperor Boulevard, Suite 400
`Durham, Nonh Carolina 27703
`(919) 862-2200
`BY: JITENDRA MALIK, Ph.D.
`
`jitty.1naiik@alston.com
`
`Also Present: Shawn Budd, Videographer
`
`APPEARANCES:
`
`I N D E,‘ X
`
`ATTORNEYS FOR PLAINTIFFS:
`FINNEGAN, HENDERSON, FARABOW, GARRETT &
`DUNNER, LLP
`
`Deposition of: Direct Cross Redirect Recross
`M_ JAYNE, LAWRENCE: Ph_D,
`By Mr_ Hagford
`1 1
`
`Page 5
`
`901 New York Avenue, NW.
`Washington, D.C. 20001
`(202) 408-4000
`BY: JUSTIN 3- HASFORD. ESQ
`BY: TERRENCE KIM, ESQ.
`JU50H-heSf01'd@fi11Heg3fl-eem
`ferrenee-kim@fiImegan-eem
`
`ATTORNEYS FOR LUPIN LTD AND LUPIN
`PHARMACEUTICALS, ENC-I
`GOODWIN PROCTER, LLP
`The New York Times Building
`520 Eighth Avenue
`New York, New York 10013
`(212) 459-7236
`3Yi DANIEL P- MARGOUS, Ph-D
`dinargolis@goodwinprocter.com
`
`E X H I B I T S
`
`Page
`No_
`Exhibit 25 Deposition transcript of M.
`Jayne Lawrence, Ph.D., dated
`9/4/14
`12
`Exhibit 26 Deposition transcript of M.
`Jayne Lawrence, Ph.D., dated
`2/ 16/ 1 6
`I4
`
`14 Exhibit 27 Document entitled "Opening
`15
`Expert Report of M. Jayne
`16
`16
`Lawrence, Ph.D."
`17 Exhibit 28 US. Patent No. 8,129,431
`18 Exhibit 29 U.S. Patent No. 8,669,290
`19 Exhibit 30 U.S. Patent No. 8,754,131
`20 Exhibit 31 US. Patent No. 8,871,813
`21 Exhibit 32 U.S. Patent No. 8,927,606
`22
`
`Ix)»-‘C>\DOO~JG\Ln-hbJl\)>—-©\OGO‘-1ChLIIJ=.L>JI\J:—A
`
`|x_)[\)[~.J»—-»--.«t—a»—A»—->-—-:-»—»—»—-.-
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`2 (Pages 2 to 5)
`
`202-347-3700
`
`

`
`M. Jayne Lawrence
`
`Februaiy 29, 2016
`
`Senju Pharmaceutical Co., LTD, et al. v. Lupin, LTD., and Lupin Pharmaceutical, 1nc.,
`
`.pl_;.)1\_)»#(:)\D0O'--..'lO\LJ'I.I§(.¢J[\)>---
`
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`
`EXI-I1BlTS(Cont'd)
`Page
`No.
`Exhibit 33 FDA—approved package insert
`for Alphagan P, entitled,
`"Center for Drug Evaluation
`and Research"
`78
`89
`Exhibit 34 U.S. Patent No. 4,910,225
`95
`Exhibit 35 Fu reference EP 0306984/X1
`10}
`Exhibit 36 U.S. Patent No. 5,603,929
`106
`Exhibit 37 U.S. Patent No. 5,558,876
`107
`Exhibit 38 U.S. Patent No. 5,891,913
`Exhibit 39 Document entitled “Responsive
`Expert Report of M. Jayne
`Lawrence Ph.D. Regarding
`Secondary Considerations"
`Exhibit 40 U.S. Patent No. 9,144,609
`Exhibit 41 Document entitled, "Reply
`Expert Report of M. Jayne
`Lawrence Ph.D. Regarding
`invalidity"
`150
`
`135
`
`148
`
`EXHIBiTS(Cont'd)
`Page
`No.
`Exhibit 49 Ghio reference , entitled,
`"Tyloxapol inhibits NF-kB and
`Cytokine Release, Scavenges
`I-IOCI, and Reduces Viscosity
`204
`of Cystic Fibrosis Sputum"
`Exhibit 50 Remington document entitled,
`"Remington, The science and
`Proctice of Pharmacy, 22nd
`Edition"
`209
`Exhibit 51 Edwards and Prausnitz
`reference, entitled "Predicted
`Permeability of Cornea to
`Topical Drugs"
`
`222
`
`Exhibit 52 Schick reference, entitled
`"Nonionic Surfactants"
`229
`
`EXHiBITS(Cont'd)
`Page
`No.
`Exhibit 53 Redenti reference, entitled
`"Cyclodextrin Complexes of
`Salts of Acidic Drugs,
`Thermodynamic Properties,
`Structural Features, and
`Pharmaceutical Applications“ 234
`
`175
`
`1 2 3 4 5 6 7 8 9 0 1
`
`EXI-1IB1TS(Cont'd)
`Page
`No.
`Exhibit 42 DeRuiter reference, entitled,
`“Non-Steroidai Antiinflammatory
`Drugs (NSADs)"
`167
`Exhibit 43 U.S. Patent No. 5,475,034
`Exhibit 44 Eyjolfsson reference, entitled,
`"Diclofenac Sodium: Oxidative
`Degradation in Solution and
`Solid State"
`179
`
`._..._.._. Ix) Exhibit 45 Gu reference, entitled, "Light
`
`Degradation ofKetorolac
`Tromethamine"
`
`1 81
`
`Exhibit 46 U.S. Patent No. 6,165,445
`Exhibit 47 Handbook of Pharmaceuticai
`
`183
`
`192
`Excipients, Third Edition
`Exhibit 48 Document entitled, "Remington:
`The Science and Practice of
`
`Pharmacy"
`
`200
`
`[\.J[\_)[\_)i~—->—-»-—--II:-—I>—I----Ai—-I
`
`i\J>—‘CD\OOO'--JCJNUIJRUJ
`
`866-928-6509
`
`Ace~Federal Reporters, inc.
`
`-,~,.-,, 4'4:/»««'.12:4v'i .-M, V4'I:( we-,-,::,.,,=.(.~.. ,~.,.m,-,-.:.:,,~7.. a..9’...a.»....,.x:/«Maw.-;..;,.)«.1-,
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`
`3 (Pages 6 to 9)
`
`202-347-3700
`
`

`
`M. .layne Lawrence
`
`February 29, 2016
`
`Senju Pharmaceutical C0,, LTD., et al. v. Lupin, LTD., and Lupin Pharmaceutical, Inc.,
`
`Page 10
`
`Page 12
`
`\DOO--.]O'\'1J1-ll‘-LJJl\J>—‘
`
`P R O C E E D I N G S
`VIDEOGRAPI-IER: We are on the record.
`
`This is the videographer speaking, Shawn Budd,
`with Ace Federal Reporters. Today's date is
`February 29, 2016, and the time is 9:06 a.m.
`We are here in Boston, Massachusetts
`to take the video deposition of Dr. layne
`Lawrence in the matter of Senju Pharmaceutical
`Company, et al. versus Lupin Limited and Lupin
`Pharmaceuticals, inc.
`Would counsel please introduce
`themselves.
`MR. HASFORD: Justin Hasford from
`Finnegan on behalf of the Plaintiffs. With me
`here is my colleague, Terrence Kim.
`MR. MARGOLIS: Dan Margolis from
`Goodwin Procter for Lupin.
`MR. MALIK: J itendra Malik, law firm
`of Alston & Bird, for the Innopharrna Defendants.
`VIDEOGRAPHER: Would the court
`reporter please swear in the witness.
`M. JAYNE LAWRENCE, Ph.D.
`
`understand a question that I ask, please let me
`know. If you answer a question, I will assume
`that you understood the question.
`Is that okay?
`A. Yes.
`
`Q. Is there any reason why you cannot
`testify truthfully and accurately today?
`A. No.
`MR. MALIK: Counsel, not to
`interrupt, but our stipulation, an objection by
`one Defendant is an objection to all?
`MR. I-IASFORD: So stipulated.
`I'm handing the court reporter what
`I've asked to be marked as Lawrence Exhibit 25.
`For the record, Lawrence Exhibit 25 is a copy of
`the transcript of the testimony of M. Jayne
`Lawrence, dated September 4, 2015 in this case.
`(Document marked as Exhibit 25
`for identification)
`Q. Are you the M. Jayne Lawrence who
`provided sworn testimony in this case on
`September 4, 2015 that was transcribed in
`
`'
`
`Page 1 I
`
`having been satisfactorily identified by the
`production of her driver's license, and duly
`sworn by the Notary Public, was examined and
`testified as follows:
`DIRECT EXAMINATION
`BY MR. I-IASFORD:
`Q. Good morning, Dr. Lawrence.
`A. Good morning.
`Q. Would you please state your name and
`address for the record.
`A. Yes. It's Margaret Jayne Lawrence,
`62 Wellington Road, Ashford, Middlesex, UK.
`Q. Let me tell you how today's
`deposition will proceed.
`I represent the
`Plaintiffs in this case. Today I will ask you a
`series of questions, and I would ask that you
`answer my questions truthfully and accurately.
`If you need a break, just let me
`know, but if I have asked a question, I would ask
`that you please first answer the question and
`then we can take a break.
`If for any reason you do not
`
`Lawrence Exhibit 25?
`A.
`I am.
`Q. Turn, if you would, to Page 17 in the
`small numbered pages. It's going to be Page 5 in
`the large numbered pages. Let me direct your
`attention to Page 17, Line 13.
`I asked you a question, "Let me tell
`I
`you how today's deposition will proceed.
`represent the Plaintiff in this case. Today I
`will ask you a series of questions, and I would
`ask that you answer my questions truthfully and
`accurately.
`"If you need a break, just let me
`know, but if I have asked a question I would ask
`that you first answer the question and then we
`can take a break.
`"If for any reason you do not
`understand a question that I ask, please let me
`know. If you answer a question, I will assume
`that you understood the question. Is that okay?"
`You answered "Yes." Then I asked a question, "Is
`there any reason why you cannot testify
`.~..-_...~.:..-....»=-,,(,.,.~.-,~». .--as-.»..~..~«;.-t.-,~ rm,-,..”.,-,,.~. 1,....,..-,..at-_,.;t.=-..~..~.a....,.:a..e.,n,.,~,.s..l ,-.,;,,-»N,,;a\..,-.,~_’,_,,_;.,,,.,_.m,,_.,_,,,,,,.,_,_,,,,__ ,_,,_,,,_,._.,,,_.,_ ,_,_ ,.
`
`,M;
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`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`4 (Pages 10 to 13)
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`202-3476700
`
`

`
`M. Jayne Lawrence
`
`February 29, 2016
`
`Senju Pharmaceutical Co._. LTD., et al. v. Lupin, LTD., and Lupin Pharmaceutical, Inc.,
`
`\DOO--—'lO\U1-I>-L».)[\J>—-
`
`\DOO'--JCHUI-llLoJl\J>—‘
`
`truthfully and accurately today," and you
`answered "No."
`
`Do you see that?
`A. ido.
`
`Q. Then you proceeded to provide
`truthful and accurate testimony, correct?
`MR. MARGOLIS: Objection. Vague and
`compound.
`A.
`I provided my testimony as truthfuliy
`and accurately as I could, yes.
`Q. You can put that aside.
`MR. HASFORD: I'm handing the court
`reporter what I've asked to be marked as Lawrence
`Exhibit 26. For the record, Lawrence Exhibit 26
`
`is a copy of the transcript of patent owners
`cross examination of M. Jayne Lawrence, Ph.D.,
`taken Tuesday, February 16, 2016 in the parallel
`IPR proceedings to this case.
`(Document marked as Exhibit 26
`for identification)
`Q. Are you the M. Jayne Lawrence, Ph.D.,
`who provided sworn testimony in the parallel
`
`today," and you answered, “No."
`Do you see that?
`I do.
`
`A.
`
`Q. And you proceeded to provide truthful
`and accurate testimony, correct?
`MR. MARGOLIS: Objection. Vague and
`compound.
`A.
`I believe I provided truthful and
`accurate testimony, yes.
`Q. You can put that aside.
`MR. HASFORD: I'm handing the court
`reporter what I'd ask to be marked as Exhibit 27.
`For the record, Lawrence Exhibit 27 is entitled
`“Opening Expert Report of M. Jayne Lawrence,
`Ph.D.'‘
`
`_
`5
`
`(Document marked as Exhibit 27
`for identification)
`Is Lawrence Exhibit 27 your opening
`Q.
`report in this case?
`A. Yes, it is.
`Q. Please turn to Exhibit A.
`A. Yes.
`
`Page 15
`
`Page 17
`
`patent oftice IPR proceedings to this case on
`February 16, 20I6 that was transcribed in
`Lawrence Exhibit 26?
`A. Iam.
`
`I
`
`Q. Take a look, if you would, at Page
`11. Let me direct your attention to Line 17.
`asked you:
`I represent the patent
`"Question:
`owner Senju in these IPR proceedings. Today I
`will ask you questions, and all that I. ask is
`that you answer my questions truthfully and
`accurately.
`"If you need a break, just let me
`know, but if a question is pending, please first
`answer the question and then we can take a break.
`If for any reason you do not understand a
`question that I ask, please let me know. If you
`answer a question, I will assume that you
`
`answered, "Yes." Then I asked:
`"Question: Is there any reason why
`you cannot testify truthfully and accurately
`
`Q. Is Exhibit A to your opening report a
`copy of your curriculum vitae?
`A. It is.
`
`Q. Piease look at the section entitled
`"Education and Awards."
`A. Yes.
`
`Q. Are you a member of the American
`Chemical Society?
`A. No, I'm not.
`Q. Are you a member of the Royal Society
`of Chemistry?
`A.
`I was a member of the Royai Society
`of Chemistry, but I let that membership drop
`because I couldn't afford all of my memberships.
`Q. When were you last a member of the
`Royal Society of Chemistry?
`A. In the 1980s, I believe -— no, I
`honestly don't remember. I'd be guessing.
`quite a while ago.
`Q. Do you remember approximately how
`long ago you were last a member of the Royal
`
`It's
`
`Society of Chemistry?
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`5 (Pages 14 to 17)
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`202-347-3700
`
`

`
`M. Jayne Lawrence
`
`Februaiy 29, 2016
`
`Senju Pharmaceutical Co., LTD., et al. v. Lupin, LTD., and Lupin Pharmaceutical, Inc.,
`
`\OOO"-JU\Ln-F-'-‘-L.IJI\)o—-
`
`\-O00‘-JONLH-I2-L->Jl\3*—‘
`
`A. No.
`
`Q. Have you ever earned any degrees in
`chemistry?
`MR. MARGOLIS: Objection. Vague.
`A. No, I have not been awarded a degree
`in chemistry, but my degree in pharmacy contained
`a considerable amount of chemistry when I did it,
`and many -- and I was awarded a membership of the
`Royal Society of Chemistry because of my
`knowledge in chemistry at that time.
`So I think they acknowledged I had a
`good understanding of chemistry.
`Q. Have you ever earned any degrees in
`chemistry?
`MR. MARGOLIS: Objection. Asked and
`answered.
`A. As I said before, I have a degree in
`pharmacy, and that degree in pharmacy was
`recognized by the Royai Society of Chemistry as
`being applicable for membership in the '80s.
`Q. Have you ever actually earned any
`degrees in chemistiy?
`
`answered.
`A. While I have not been awarded a
`
`degree in chemistry, but my undergraduate
`pharmacy degree and my Ph.D. were considerabiy
`chemical based.
`
`,
`
`’;
`
`Q. Okay. That wasn't my question. Have
`you ever earned a Master's degree in chemistry‘?
`MR. MARGOLIS: Objection. Asked and
`answered.
`A.
`I don't have any Master's degree.
`Q. Have you ever earned a Ph.D. degree
`in chemistry?
`MR. MARGOLIS: Objection. Asked and
`answered.
`Q. You may answer.
`A. The title of my Ph.D., if I recail,
`was Synthesis and Testing of Aqueous Surfactant
`Solutions, I believe, or very similar.
`Q. You identify on your curriculum vitae
`that you earned a Ph.D. in pharmacy.
`Do you see that?
`I did a Ph.D. in the pharmacy
`
`A.
`
`MR. MARGOLIS: Objection. Asked and
`answered.
`
`department at Manchester University; that is
`correct.
`
`Page :9
`
`Page 21
`
`MR. MALIK: Asked and answered.
`A. My Ph.D. was purely chemical.
`Q. Have you ever earned any degrees that
`state "chemistry" on them‘?
`MR. MARGOLIS: Objection. Asked and
`answered.
`A. My degree —— I have a registration as
`a pharmaceutical chemist. As a pharmacist, your
`registration was as a pharmaceutical chemist.
`So...
`
`Q. That wasn't my question, Doctor. Let
`me ask it this way.
`Have you ever earned a Bachelor's
`degree in chemistry?
`MR. MARGOLIS: Objection. Vague.
`Asked and answered.
`A. No, I have not.
`Q. Have you ever earned a Master's
`degree in chemistry?
`
`Q. Do you identify on your curriculum
`vitae any Ph.D. degree in chemistry?
`MR. MARGOLIS: Objection. Vague.
`Q. You may answer.
`A. My Ph.D. was undertaken in the
`Department of Pharmacy, but it is registered in
`the -- in official records at that time as being
`a Ph.D. in colloid chemistry.
`Q. You do not indicate on your —— strike
`that and try again.
`You do not indicate on your
`curriculum vitae that you have earned any degrees
`in chemistry, correct?
`MR. MARGOLIS: Objection. Vague.
`Asked and answered.
`Q. You may answer.
`A. I do not put the titie of my Ph.D.
`down on this CV, no.
`Q. Okay. Have you ever held any faculty
`positions in chemistry?
`
`,
`
`i
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`
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`6 (Pages i8 to 21)
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`202-347-3700
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`

`
`M. Jayne Lawrence
`
`Senju Pharmaceutical Co., LTD., et al. v. Lupin, LTI)., and Lupin Pharmaceutical, Inc.,
`
`Page 22
`
`MR. MARGOLIS: Objection. Vague.
`A. That's very vague. I've been --
`Q. Well, let me ask it this way. Have
`you ever held any faculty positions in any
`chemistry department?
`A. No. But I have been invited for
`
`interviews for readerships in Imperial Chemistry
`Department, which is one of the top departments
`of chemistry in the U.K.
`Q. Did they extend you any kind of offer
`based on those interviews?
`
`A. The head of the department of
`chemistry at UCL, which is gained as a leading
`chemistry department, spoke to me and told me
`that I was exactly the sort of person they
`wanted, but they already had somebody in mind.
`So I think I was considered an
`
`appropriate person for that department.
`Q. Have you ever actually been extended
`any kind of offer of employment from any
`chemistry department?
`A.
`I don't believe I have, but this is a
`
`February 29, 20 I 6
`
`Page 24
`
`MR. HASFORD: Sorry, Jitty.
`Q. Have you ever held yourself out as an
`expert in medicinal chemistry‘?
`A. I'm not an expert in medicinal
`chemistry, no.
`Q. Have you ever held yourself out as an
`expert in organic chemistry?
`MR. MARGOLIS: Objection. Vague.
`I have a very good knowledge of
`A.
`organic chemistry, because I used it in my Ph.D.
`to make my molecules, and I use it in my
`undergraduate teaching.
`So I have more than the person
`skiiled in the arts knowledge.
`Q. Have you ever held yourself out to
`the public as an expert in organic chemistry?
`MR. MARGOLIS: Objection. Vague.
`I have never publicly —- assuming,
`A.
`you mean, the general public, held myself out as
`an expert in organic chemistry?
`Q. Are you an expert in FDA regulatory
`law?
`
`,
`
`,
`
`2
`
`Page 23
`
`Page 25
`
`misunderstanding of what a pharmacy degree
`entails.
`
`MR. MALIK: Counselor, let her finish
`her answer.
`
`MR. I-IASFORD: Okay. She‘s being
`nonresponsive. You can plainly see that she's
`being nonresponsive. So if she keeps this up,
`we're going to have to get the magistrate on the
`line.
`
`MR. MARGOLIS: She's answered the
`
`questions. They're vague.
`MR. HASFORD: No, they're not vague,
`Dan, and you know they're not vague.
`MR. MARGOLIS: You're asking
`chemistry general issues, and she's struggling to
`understand what that means.
`MR. HASFORD: She has a Ph.D. in
`
`chemistry. I've got a degree in chemistry. We
`all sitting at this table understand what,
`chemistry is.
`MR. MALIK: Nuclear science
`
`engineering.
`
`MR. MARGOLIS: Objection. Vague.
`..
`I am not an expert in FDA regulatory
`A.
`law. Although, I have a good working knowledge
`of regulation of medicines regulation.
`Q. Have you ever been qualified by any
`Court or any body as an expert in any regulatory
`law?
`
`MR. MARGOLES: Objection. Calls for
`a legal conclusion.
`A.
`I don't know, I don't believel have
`been ever.
`
`Q. Have you ever practiced FDA
`regulatory law?
`A. I've never practiced FDA regulatory
`
`law.
`
`Q. Have you ever consulted for any party
`on any issue of FDA regulatory law?
`A. No, I've never consulted for any
`party on FDA iaw, reguiatory law.
`Q. Are you an expert in U.S. marketing
`of drug products?
`A. No, I'm not an expert in U.S.
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`7 (Pages 22 to 25)
`
`202-347-3700
`
`

`
`M. Jayne Lawrence
`
`February 29, 2016
`
`Senju Pharmaceutical Co., LTD.. et al. v. Lupin, LTD., and Lupin Pharmaceutical, Inc.,
`
`Page 26
`
`\O00--}G\Lv"I-llL>JI\..)I-—-
`
`marketing ofdrug products.
`Q. Have you ever conducted any research
`on any product containing a paraben?
`A. Have I conducted any --
`Q.
`I can repeat. Have you ever
`conducted any research on any product containing
`a paraben?
`A.
`I beiieve I have when I was an
`
`undergraduate student. That's my research
`project.
`Q. When did you last conduct research on
`product containing a paraben?
`A. It would be back in -- I really can't
`remember whether I've done any other research.
`But my project was back in the late '70s.
`Q. Have you ever conducted any research
`on any ophthalmic product containing a paraben?
`A.
`I haven't conducted any research,
`because I've not particularly favored
`preservatives.
`Q. Have you ever formulated any
`ophthalmic product containing a paraben?
`
`I have not, and I probably would not,
`A.
`because I'm not particularly good with
`preservatives.
`Q. Have you ever consulted for any party
`regarding the use of a paraben?
`A. No, I don't believe I have consulted
`for any party regarding the use of parabens.
`Q. Have you ever fonnulated any
`bromfenac product?
`A.
`I have not formulated any bromfenac
`product, but I have formulated products
`containing non-steroidai antiinflammatories.
`Q. Just to be clear, have you ever
`forrnuiatecl any bromfenac product‘?
`MR. MARGOLIS: Objection. Asked and
`answered.
`
`A. As I said, I haven't formulated and
`
`bromfenac product, but I am familiar formulating
`products containing NSAIDS.
`Q. Have you ever measured the solubility
`
`A. While I have not measured the
`
`solubility of the complex form between
`benzalkonium chloride and bromfenac, I would
`expect from my knowledge it to be very insoluble.
`Q. That wasn't my question. Have you
`ever measured the solubility of any complex
`between bromfenac and benzalkoniuin chloride?
`
`MR. MARGOLiS: Objection. Asked and
`answered.
`
`Q. You may answer.
`A. As I said, I haven't measured the
`solubility of the complex form between bromfenac
`and benzalkonium chloride ~—
`
`Q.
`
`Is the solubility ofany --
`MR. MARGOLIS: Counsei, please don't
`interrupt her.
`MR. I-IASFORD: She can't refuse to
`
`answer my question.
`MR. MARGOLIS: She's answered your
`question.
`MR. I-IASFORD: No. She can't refuse
`
`to answer my question.
`
`Page 29
`
`‘~DO<J'--.JO\UI-ll‘-U->I\)>—*
`
`MR. MARGOLIS: She has to answer it
`
`as accurately as she can, and that's what she's
`trying to do.
`MR. HASFORD: The question does not
`call for her to be nonresponsive.
`MR. MARGOLIS: She's being perfectly
`responsive.
`MR. HASFORD: Okay. Well, let me ask
`a different question.
`MR. MARGOLIS: Can she continue with
`her answer‘?
`MR. HASFORD:
`
`I'd like to ask a
`
`2
`
`f
`
`different question.
`MR. MARGOLIS: Are you withdrawing
`the previous question‘?
`MR. HASFORD: No, I'm not withdrawing
`the previous question.
`MR. MARGOLIS: Then please allow her
`to finish her answer.
`
`Q. Did you have anything else to
`provide?
`A.
`I think you have to repeat the
`.i... ...-.w.-....w~.«,.--.e-.-
`.. .-.-. ..._..-..,.... .-, ,. VA-.--...-,--M..:..-.-..--. ...«»,-:.¢.,.w.-1. »'K s\k",«\/E»'\»~k,,.,.,_.._,-; _;.,_..,,,.,,__.,-M,,.,,,.,W,mM, m.mM_,‘,‘,3
`
`»--..-.w..(.,-.e.«..«..-,.-sum i-,-...~.w.~..~.... ....-.«c-.-.-:.---
`
`«
`
`.-.... 4.-W-.-.
`
`s.-.’.«.....».
`
`866-928-6509
`
`Ace-Federai Reporters, Inc.
`
`8 (Pages 26 to 29)
`
`202-347-3700
`
`

`
`M. Jayne Lawrence
`
`February 29, 2016
`
`Senju Pharmaceutical Co., LTD._. et al. v. Lupin, LTD., and Lupin Pharmaceutical. inc.,
`
`\OC>‘:>~—-JO\l./I-ii‘-LaJl\-3'-*
`
`question again, please.
`Q. Okay.
`Is the solubility of any
`complex between bromfenac and benzalkonium
`chloride reported in any reference?
`A. Was that the question you asked?
`Q. No. I'm asking you a different
`question now.
`Is the solubility of any compiex
`between bromfenac and benzalkonium chloride
`
`00*-—IlO‘\U‘:-l‘—‘-lJJE-3~—‘
`
`reported in any reference?
`MR. MARGOLIS: Objection. Lacks
`foundation.
`
`Q. You may answer.
`A.
`I have not seen the solubility of the
`complex form between bromfenac and benzalkonium
`chloride reported in the literature. That
`doesn't mean it doesn't exist.
`i haven't seen
`it.
`
`‘
`
`reported in any reference?
`MR. MARGOLIS: Just to be clear, are
`you not going to allow her to finish her answer
`that she was previously giving when you
`interrupted her?
`MR. HASFORD: No. I'm asking her a
`different question now.
`MR. MARGOLIS: Are you withdrawing
`the previous question?
`
`the previous question.
`MR. MARGOLIS: Can you allow her to
`finish her answer to the previous question?
`
`Q. Are you aware of any bromfenac
`product, other than Prolensa, that ever was
`forrnulated at a pH of 7.8?
`MR. MARGOLIS: Objection. Lacks
`foundation.
`
`A. Could you repeat the question,
`please?
`Q. Certainly. Are you aware of any
`bromfenac product, other than Proiensa, that ever
`has been formulated at a pH of 7.8‘?
`MR. MARGOLIS: Same objection.
`A. That's a very difficult question to
`answer, because there are products in the
`
`Page 31
`
`Page 33
`
`MR. HASFORD: If she has anything
`further to provide.
`MR. MARGOLIS: Can the court reporter
`please read back the prior question and her
`answer before she was cut off.
`
`(Reporter read back pending question)
`A. As I believe 1 said, no, I have not
`measured the solubility of the complex form
`between benzalkonium chloride and bromfenac. But
`
`9
`
`based on my knowledge, I wouid expect it to be
`very insoluble.
`Q. Have you ever actually measured the
`solubility of any complex between bromfenac and
`benzalkoniuni chloride?
`
`MR. MARGOLIS: Objection. Asked and
`answered.
`
`A. As I thought I said, I have not
`measured the soiubility between the complex form
`between benzalkonium chloride and bromfenac. But 19
`
`i expect it to be insoluble.
`Q.
`Is the solubility of any complex
`between bromfenac and benzaikonium chloride
`
`literature, there are exarnpies in the patent
`literature of formulations being formulated at
`different pHs.
`Q. Are you personally aware of any
`bromfenac product, other than Prolensa, that ever
`has been formuiated at a pH of 7.8?
`A. Perhaps you could clarify what you
`mean by "personally"?
`Q. Do you understand what it means to be
`personally aware of something?
`A. That's what I'm asking. Perhaps you
`could just clarify that for me, please.
`Q. Do you have any personal knowledge?
`Do you understand that?
`A. What becomes personal knowledge, is
`that knowledge from the literature?
`Q. Knowledge from any source. So I'll
`ask the question again.
`Do you have any personal knowledge of
`any bromfenac product, other than Prolensa, that
`ever has been formulated at a pH of 7.8?
`
`,
`
`i‘
`
`MR. MARGOLIS: Objection. Lacks
`
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`
`Ace-Federal Reporters, Inc.
`
`9 (Pages 30 to 33)
`
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`
`--
`
`-
`
`...(_».,x..-=a.»s..,,»......a..=. ,,-.;.--. .=,
`
`-. -, \...;,-/. m... ..z .. .-..,-..:: ...-
`
`-;.;, A4
`
`..,..';.'./, W,-.¢., ,»,_,, ,5>¢--\('/-gfig/,\b.3,_'\4,__§,_=:§~ _,..,,_,.,_,,N._MM__,.,,_,,,,,,;,
`
`

`
`M. Jayne Lawrence
`
`February 29, 2016
`
`Senju Pharmaceutical Co., LTD._. et al. v. Lupin, LTD., and Lupin Pharmaceutical, lnc.,
`
`\OOO-.3C;‘\Lh.3LLaJl\.)>—-
`
`foundation. Vague.
`A. If my understanding of "personal
`knowledge" is correct, there are products in the
`patent literature that formulated at different
`pHs.
`Q. How many different possible
`concentrations of tyloxapol exist between 0.02
`weight per volume percent and 0.15 weight per
`volume percent for use in an aqueous liquid
`preparation?
`MR. MARGOLIS:
`hypothetical.
`A. Are you asking me as a formulator?
`Q. Yes.
`MR. MARGOLIS: Foundation.
`
`incomplete
`
`A. In theory, there are an infinite
`number of possibilities. But in practice as a
`formulator, you wouldn't be as stupid as to use
`that infinite number of possibilities. You would
`obviously narrow that range down.
`Q. Would the use of esters or amides of
`bromfenac remove any incompatibility issues with
`
`\.D0O'---LIONUI-J5-LvJl\J---*
`
`greatly. So I realiy can't comment.
`Q. How expensive is tyloxapol as
`compared to polysorbate 80?
`MR. MARGOLIS: Objection. Lacks
`foundation.
`
`A. Again, it's very difficult to answer,
`because there are different grades of these
`surfactants. Polysorbate, certainly in Sigma,
`goes from very cheap to much more expensive,
`depending on the grade. And, of course, that's
`not a commercial supplier for the pharmaceutica
`industry.
`Q. Has your scientific research focused
`on formulating drugs for administration to
`patients?
`MR. MARGOLIS: Objection. Vague.
`A. Could you repeat the question,
`please?
`Q. Certainly. Has your scientific
`research focused on formulating drawings for
`administration to patients?
`MR. MARGOLIS: Same objection.
`
`benzalkonium chloride?
`
`MR. MARGOLiS: Incomplete
`hypothetical. Foundation.
`Q. You may answer.
`A. It's very difficult to answer,
`because there isn't a full amount of information.
`
`it would depend upon, for example, the pH of the
`solution, whether it ester hydrolyzes, et cetera.
`So it's not possible to answer that.
`Q. How expensive is tyioxapol compared
`to octoxynoi-40?
`MR. MARGOLIS: Objection. Lacks
`foundation. Outside the scope.
`A. It's very hard to say.
`i have bought
`Triton, which is octoxynol-9 and tyloxapol, and
`there wasn't a huge amount of difference in
`price.
`Q. Do you remember what that difference
`in price was?
`A. The problem is, it was bought fi'om a
`commercial source, Sigma, not from an industry,
`
`Page 37
`
`A. Yes, it has.
`Q. Take a look, if you would, at the IPR
`deposition transcript that's in front of you.
`It's Lawrence Exhibit 26. Let me direct your
`attention to Page 92.
`In particular, let me
`direct your attention to Line 20.
`I asked you,
`“Have you conducted any bench testing in
`connection with your opinions in this case," and
`there was an objection, and you answered, "No.
`Pvejust read scientific papers."
`That testimony would apply to both
`your opinions in the parallel IPR proceedings an
`your opinions in these District Court cases,
`correct?
`A. Correct.
`
`Q. Okay. You can put that document
`aside.
`
`Are you familiar with the IUPAC gold
`
`book?
`
`A. No, I‘m not.
`
`Q. Are you familiar with the pH scale?
`A.
`I am famiiiar with the pH scale.
`uvZ‘,«‘,z.‘a'»L:,'«)1Lm'-t)«‘1.A«ut(’~',E./r\‘J\#V‘o"»Cm\71€:‘.?72
`
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`
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`
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`
`202-347-3700
`
`

`
`M. Jayne Lawrence
`
`February 29, 2016
`
`Senju Pharmaceutical Co., LTD., et ai. v. Lupin, LTD., and Lupin Pharmaceutical, Inc.,
`
`Page 33
`
`K000‘-JC\LlI-1'3-U->i\.)>-—‘
`
`Is pH measured on a linear scale or a
`Q.
`logarithmic scale?
`MR. MARGOLIS: Objection. Vague.
`Incomplete hypothetical.
`A. It's usually measured on a
`logarithmic scale.
`Q. If two formulations differ by 0.5 pH
`units, how large a difference on a linear scale
`does this reflect?
`
`\DOG‘--JO‘\U1J>~L;Ji\J---*
`
`Q. What is your understanding of
`biological data?
`A. It's to do with animals, microbes,
`microorganisms. It's a whole plethora.
`Q. Under what circumstances would
`formulators rely on biological data in making
`formulation decisions?
`
`MR. MARGOLIS: Objection. Lacks
`foundation.
`
`A. You're testing my knowledge of
`antilogs at the moment, but it's less than the
`order of magnitude.
`Q. Do you need a calculator?
`A. It's less than the order of
`
`magnitude.
`Q. How much less than the order of
`magnitude?
`A.
`I cannot recall without antilocking
`the number. I'm sorry.
`Q. Have you ever used Lipinski's rules
`in formulating an aqueous liquid preparation?
`MR. MARGOLIS: Objection. Lacks
`
`foundation.
`
`I teach Lipinsl<i's rules to
`A.
`undergraduate students at King's College.
`Q. Have you ever used Lipinski's rules
`in formulating an aqueous liquid preparation‘?
`A. Can I clarify, Lipinski‘s rules are
`not usually used for formulation. They are used
`by medicinal chemists to predict whether a drug
`is likely to be absorbed.
`Q.
`Is tyloxapoi a nonionic surfactant?
`A. Tyloxapol is a nonionic surfactant.
`Q. Is benzalkonium chloride an
`antimicrobial conservative compound?
`A. Amongst other things, yes.
`Q. Do formulators rely on biological
`data in making formulation decisions?
`MR. MARGOLIS: Objection. Incomplete
`hypothetical. Calls for speculation.
`MR. MALIK: Foundation.
`
`I
`I don't have enough information.
`A.
`don't understand in this context why what you
`mine by "biological"?
`
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`-«.-mm»,-.w.-mz-,;.§
`
`MR. MALIK: Vague and ambiguous.
`A. It's a really difficult question to
`answer without some guidance.
`Q. Do you know the circumstances under
`which a formulator would rely on biological data
`in making a formulation decision?
`MR. MARGOLIS: Objection. Lacks
`foundation. Calls for speculation.
`MR. MALIK: Incomplete hypothetical.
`A. It's so broad, that question, it is
`very difficult to answer without you giving me
`more guidance.
`Q. What additional information would you
`
`Page 4:
`
`need to answer that question?
`A. Well, for example, what stage of the
`development process you are at, whether you've
`gone through clinical trials, what the
`formulation is intended for.
`
`Q. Have you ever relied on biological
`data in making formulation decisions?
`MR. MALIK: Vague and ambiguous.
`Foundation.
`
`Q. You may answer.
`A.
`I believe every forinulator will be
`aware of certain biological data when they're
`formulating, yes.
`Q. Do formulators rely on chemical
`stability data in making formulation decisions?
`MR. MARGOLIS: Objection. Calls for
`speculation.
`MR. MALIK: Incomplete hypothetical.
`A. Again, that would depend at what
`stage of the deveiopment process t