throbber
Case IPR2015-01097; IPR2015-1099; IPR2015-01100; IPR2015-01105
`Lawrence, Ph.D., M. Jayne
`February 16, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`1
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`LUPIN LTD. and LUPIN PHARMACEUTICALS INC.,
` Petitioner
` v.
` SENJU PHARMACEUTICAL CO., LTD.,
` Patent Owner
` ________________________
` Case IPR2015-01097 (Patent 8,754,131 B2)
` Case IPR2015-01099 (Patent 8,669,290 B2)
` Case IPR2015-01100 (Patent 8,927,606 B1)
` Case IPR2015-01105 (Patent 8,871,813 B2)
`
` PATENT OWNER'S CROSS-EXAMINATION OF
` M. JAYNE LAWRENCE, PH.D.
` Washington, D.C.
` Tuesday, February 16, 2016
`
`Reported by: Linda S. Kinkade RDR CRR RMR RPR CSR
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`PAGE 1 OF 403
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`SENJU EXHIBIT 2316
`LUPIN v SENJU
`IPR2015-01100
`
`

`
`Case IPR2015-01097; IPR2015-1099; IPR2015-01100; IPR2015-01105
`Lawrence, Ph.D., M. Jayne
`February 16, 2016
`
`2
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` The following is the transcript of the
`videotaped cross-examination of M. Jayne Lawrence,
`Ph.D. held at the offices of:
`
` Crowell & Moring LLP
` 1001 Pennsylvania Avenue, NW
` Washington, DC 20004
`
` Taken pursuant to applicable Rules of Civil
`Procedure, before Linda S. Kinkade, Registered
`Diplomate Reporter, Certified Realtime Reporter,
`Registered Professional Reporter, Registered Merit
`Reporter, and Certified Shorthand Reporter, as
`licensed by the State of California, and Notary
`Public, as commissioned by the District of
`Columbia.
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`Case IPR2015-01097; IPR2015-1099; IPR2015-01100; IPR2015-01105
`Lawrence, Ph.D., M. Jayne
`February 16, 2016
`
`3
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`APPEARANCES:
`
`On Behalf of Petitioner:
` Crowell & Moring LLP
` By: Chiemi D. Suzuki
` 590 Madison Avenue
` 20th Floor
` New York, New York 10022
` 212.803.4050
` csuzuki@crowell.com
`
`- and -
`
` Crowell & Moring LLP
` By: Deborah H. Yellin
` By: Shannon Lentz
` 1001 Pennsylvania Avenue, NW
` Washington, DC 20004
` 202.624.2947
` dyellin@crowell.com
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`Case IPR2015-01097; IPR2015-1099; IPR2015-01100; IPR2015-01105
`Lawrence, Ph.D., M. Jayne
`February 16, 2016
`
`4
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`APPEARANCES (continued):
`
`On Behalf of Patent Owner:
` Finnegan, Henderson, Farabow, Garrett &
` Dunner, LLP
` By: Justin J. Hasford
` By: Bradley Moore
` 901 New York Avenue, NW
` Washington, DC 20001
` 202.408.4000
` justin.hasford@finnegan.com
` bradley.moore@finnegan.com
`
`Also Present:
` Patrick Graham, Video Specialist
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`Case IPR2015-01097; IPR2015-1099; IPR2015-01100; IPR2015-01105
`Lawrence, Ph.D., M. Jayne
`February 16, 2016
`
`5
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` INDEX OF EXAMINATION
`
` EXAMINATION of JAYNE LAWRENCE, Ph.D. PAGE
` BY MR. HASFORD 11
` BY MS. SUZUKI 338
`
` E X H I B I T S
`NO. DESCRIPTION PAGE
`Exhibit 1001 U.S. Patent No. 8,669,290 150
` [Senju]
`Exhibit 1005 Declaration of M. Jayne 13
` Lawrence, Ph.D.
`Exhibit 1006 Clinics & Drug Therapy 2000 The 112
` Future of Osteoporosis Treatment
` in Primary Care "The Hara
` Reference"
`Exhibit 1007 U.S. Patent No. 5,475,034 98
` [Yanni]
`Exhibit 1010 U.S. Patent No. 4,910,225 146
` [Ogawa]
`Exhibit 1011 U.S. Patent No. 6,107,343 184
` [Sallmann]
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`Case IPR2015-01097; IPR2015-1099; IPR2015-01100; IPR2015-01105
`Lawrence, Ph.D., M. Jayne
`February 16, 2016
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`Exhibit 1012 U.S. Patent No. 5,603,929 [Desai] 241
`Exhibit 1013 U.S. Patent No. 5,558,876 [Desai] 135
`Exhibit 1014 European Patent Application 151
` 0 306 984 [Syntex | Fu]
`Exhibit 1015 Schott: Comparing the Surface
` Chemical Properties and the
` Effect of Salts on the Cloud
` Point of a Conventional Nonionic
` Surfactant, Octoxynol 9 (Triton
` X-100), and of its Oligomer,
` Tyloxapol (Triton WR-1339)
`Exhibit 1021 U.S. Patent No. 5,891,913 182
` [Sallmann]
`Exhibit 1022 U.S. Patent No. 6,274,609 221
` [Yasueda]
`Exhibit 1027 International Publication 138
` No. WO 94/15597 [Wong]
`Exhibit 1028 Regev: Aggregation Behavior of 173
` Tyloxapol, a Nonionic Surfactant
` Oligomer, in Aqueous Solution
`Exhibit 1035 U.S. Patent No. 6,638,976 288
` [Gamache]
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`www.hendersonlegalservices.com
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`Case IPR2015-01097; IPR2015-1099; IPR2015-01100; IPR2015-01105
`Lawrence, Ph.D., M. Jayne
`February 16, 2016
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`Exhibit 1036 International Publication 246
` No. WO 02/13804
`Exhibit 1039 U.S. Patent No. 5,597,560 274
` [Bergamini]
`Exhibit 1040 U.S. Patent No. 6,071,904 [Ali] 268
`Exhibit 1042 Journal of Pharmaceutical 248
` Sciences January 1961
`Exhibit 1051 Remington: The Science and 255
` Practice of Pharmacy, Volume II
`Exhibit 1054 Curriculum Vitae 30
`Exhibit 1064 U.S. Patent No. 5,504,113 143
` [Lucero]
`Exhibit 1065 U.S. Patent No. 5,747,061 [Amselem] 191
`Exhibit 1066 Modern Pharmaceutics, Fourth 250
` Edition, Revised and Expanded
` [Banker and Rhodes]
`Exhibit 1071 U.S. Patent No. 5,540,930 [Guy] 266
`Exhibit 1073 U.S. Patent No. 6,440,964 292
` [Cagle]
`Exhibit 2132 Transcript of the Testimony of 25
` M. Jayne Lawrence dated
` September 4, 2015
`
`202-220-4158
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`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
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`Case IPR2015-01097; IPR2015-1099; IPR2015-01100; IPR2015-01105
`Lawrence, Ph.D., M. Jayne
`February 16, 2016
`
`8
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`Exhibit 2133 "Notice of Retraction" from the 27
` journal Drug Metabolism &
` Disposition
`Exhibit 2134 Court of Appeals for the Federal 79
` Circuit's opinion in Allergan v.
` Sandoz, case number 2014-1275,
` decided on August 4th, 2015
`Exhibit 2135 Eastern District of Texas Trial 129
` Court Opinion in Allergan v. Sandoz
`Exhibit 2137 Transcript of Bench Trial Before 299
` the Honorable Judge T. John
` Ward, August 4, 2011
`Exhibit 2138 U.S. District Court for the 162
` Northern District of
` California's opinion in Syntex,
` et al. v. Apotex, et al., case
` number 01-02214, 2006 U.S.
` District LEXIS 36089 decided on
` June 2nd, 2006
`Exhibit 2140 Transcript of the Testimony of 16
` M. Jayne Lawrence dated
` September 4, 2015
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`Case IPR2015-01097; IPR2015-1099; IPR2015-01100; IPR2015-01105
`Lawrence, Ph.D., M. Jayne
`February 16, 2016
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`9
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`Exhibit 2253 Opening Expert Report of M. 281
` Jayne Lawrence, Ph.D. (Redacted)
`Exhibit 2264 Patent Owner's Amended Notice of 12
` Cross-Examination of Dr. Jayne
` Lawrence
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`Case IPR2015-01097; IPR2015-1099; IPR2015-01100; IPR2015-01105
`Lawrence, Ph.D., M. Jayne
`February 16, 2016
`
` P R O C E E D I N G S
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`10
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` VIDEO SPECIALIST: Here begins disc 1 in
`the video deposition of Dr. Jayne Lawrence taken in
`the matter of Lupin Limited and Lupin
`Pharmaceuticals, Inc., v. Senju Pharmaceuticals
`Company, Limited, in the United States Patent and
`Trademark Office, case numbers IPR2015-01097,
`IPR2015-01099, IPR2015-01100, IPR2015-01105.
` Today's date is February 16th, 2016. The
`time is 9:53. This deposition is being held at
`1001 Pennsylvania Ave., northwest, Washington, DC
`20004. The court reporter is Linda Kinkade, the
`videographer is Patrick Graham, both are presenting
`on behalf of Henderson Reporting.
` Will counsel and others please introduce
`themselves and state whom they represent.
` MR. HASFORD: Justin Hasford of Finnegan
`on behalf of Patent Owner. I'm also here with my
`colleague Bradley Moore, also of Finnegan.
` MS. SUZUKI: Chiemi Suzuki from Crowell &
`Moring for the Lupin parties. With me also from
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`Case IPR2015-01097; IPR2015-1099; IPR2015-01100; IPR2015-01105
`Lawrence, Ph.D., M. Jayne
`February 16, 2016
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`Crowell & Moring are Shannon Lentz and Deborah
`Yellin.
` VIDEO SPECIALIST: Will the court
`reporter please swear in the witness.
` M. JAYNE LAWRENCE, Ph.D.,
` Having been first duly sworn, was thereafter
`examined and testified as follows:
` CROSS-EXAMINATION
`BY MR. HASFORD:
` Q. Good morning, Dr. Lawrence.
` A. Good morning.
` Q. Would you please state your name and
`address for the record?
` A. It's Margaret Jayne Lawrence, 62
`Wellington Road, Ashford, Middlesex, TW15 3RJ,
`England.
` Q. Doctor, I represent the Patent 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
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`202-220-4158
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`www.hendersonlegalservices.com
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`Case IPR2015-01097; IPR2015-1099; IPR2015-01100; IPR2015-01105
`Lawrence, Ph.D., M. Jayne
`February 16, 2016
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`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?
` A. Yes.
` Q. Is there any reason why you cannot
`testify truthfully and accurately today?
` A. No.
` MR. HASFORD: For the record, I'm handing
`Dr. Lawrence and Lupin's counsel copies of Exhibit
`2264 entitled Patent Owner's Amended Notice of
`Cross-Examination of Dr. Jayne Lawrence.
` (Exhibit 2264 was marked for
`identification.)
` MR. HASFORD: Counsel, can we stipulate
`that Dr. Lawrence is here today pursuant to Exhibit
`2264?
` MS. SUZUKI: We can.
`BY MR. HASFORD:
` Q. Okay. You can put that aside, doctor.
` MR. HASFORD: Counsel, can we also
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`www.hendersonlegalservices.com
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`Case IPR2015-01097; IPR2015-1099; IPR2015-01100; IPR2015-01105
`Lawrence, Ph.D., M. Jayne
`February 16, 2016
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`stipulate that the questions I ask unless otherwise
`stated apply equally to IPR2015-01097,
`IPR2015-01099, IPR2015-01100 and IPR2015-01105?
` MS. SUZUKI: We can.
` MR. HASFORD: Let the record reflect that
`we hereby invoke the rule on witnesses pursuant to
`Federal Rules of Evidence pursuing -- prohibiting
`showing the transcript of this cross-examination or
`discussing any of its contents with Dr. Paul Laskar
`or any other InnoPharma witness in connection with
`any IPR proceeding involving Prolensa.
` For the record, I'm handing Dr. Lawrence and
`Lupin's counsel copies of Exhibit 1005 entitled
`Declaration of M. Jayne Lawrence, Ph.D.
` (Exhibit 1005 was marked for
`identification.)
`BY MR. HASFORD:
` Q. Is Exhibit 1005 your declaration
`concerning U.S. Patent Nos. 8,669,290, 8,754,131,
`8,871,813 and 8,927,606?
` A. It is.
` Q. If I refer to U.S. Patent Nos. 8,669,290,
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`Case IPR2015-01097; IPR2015-1099; IPR2015-01100; IPR2015-01105
`Lawrence, Ph.D., M. Jayne
`February 16, 2016
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`8,754,131, 8,871,813 and 8,927,609 as the '290,
`'131, '813 and '606 patents respectively, will you
`understand what I mean?
` A. Yes, I will.
` MS. SUZUKI: Counsel, I believe you said
`'609 for the last patent, and it's '606.
` MR. HASFORD: Okay. Yeah, I meant '606.
`BY MR. HASFORD:
` Q. If I refer to the '290, '131, '813 and
`'606 patents collectively as the patents at issue,
`will you understand what I mean?
` A. I will.
` Q. Please turn to the last page of your
`declaration. Do you see the electronic signature
`on the last page of your declaration?
` A. I do.
` Q. Your declaration bears an electronic
`signature instead of an inked signature, correct?
` A. It does.
` Q. You did not actually write your
`declaration for these IPR proceedings, correct?
` MS. SUZUKI: Objection to form.
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`202-220-4158
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`www.hendersonlegalservices.com
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`Case IPR2015-01097; IPR2015-1099; IPR2015-01100; IPR2015-01105
`Lawrence, Ph.D., M. Jayne
`February 16, 2016
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`BY MR. HASFORD:
` Q. You may answer.
` A. I don't understand what you mean by
`"write."
` Q. Did you actually physically write your
`declaration for these IPR proceedings?
` MS. SUZUKI: Objection to form.
` THE WITNESS: If you meant I typed every
`word, no, but every word in there are my -- my
`understanding of the particular case, and I stand
`by them.
`BY MR. HASFORD:
` Q. Your declaration is dated April 21st,
`2015, correct?
` A. Yes.
` Q. The first patents -- strike that and try
`again.
` The first documents you considered in
`connection with your opinions in these cases were
`the patents at issue, correct?
` MS. SUZUKI: Objection to form.
` THE WITNESS: I believe so.
`
`202-220-4158
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`www.hendersonlegalservices.com
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`Case IPR2015-01097; IPR2015-1099; IPR2015-01100; IPR2015-01105
`Lawrence, Ph.D., M. Jayne
`February 16, 2016
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`BY MR. HASFORD:
` Q. From whom did you obtain the documents
`you considered in connection with your opinions in
`these IPR proceedings?
` A. Sorry. Could you just repeat that
`slightly slower?
` Q. Certainly. From whom did you obtain the
`documents you considered in connection with your
`opinions in these IPR proceedings?
` MS. SUZUKI: Objection to form.
`BY MR. HASFORD:
` Q. You may answer.
` A. I considered a large number of documents
`for these particular proceedings, some of which
`were obtained by counsel, a number of them, quite a
`lot, obtained by myself.
` MR. HASFORD: For the record, I'm handing
`Dr. Lawrence and Lupin's counsel copies of Exhibit
`2140 entitled Transcript of the Testimony of M.
`Jayne Lawrence dated September 4, 2015.
` (Exhibit 2140 was marked for
`identification.)
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`PAGE 16 OF 403
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`Case IPR2015-01097; IPR2015-1099; IPR2015-01100; IPR2015-01105
`Lawrence, Ph.D., M. Jayne
`February 16, 2016
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`BY MR. HASFORD:
` Q. Is Exhibit 2140 the transcript of your
`sworn testimony in connection with the parallel
`district court proceedings involved in the patents
`at issue?
` MS. SUZUKI: Objection to form.
` THE WITNESS: It looks like it. I
`obviously don't have time to read it over, but I
`assume it is.
`BY MR. HASFORD:
` Q. Turn to page 135, and let me direct your
`attention to lines 16 through 22.
` A. I'm sorry. 135?
` Q. Yeah, page 135. It's -- it's the small
`number. There's large numbers and small numbers.
` A. Yes.
` Q. Are you at page 135, lines 16 through 22?
` A. So I'm at page 135.
` Q. Do you see lines 16 through 22?
` A. Okay. Yes.
` Q. It says:
` "Q. From whom did you obtain the
`
`202-220-4158
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`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`PAGE 17 OF 403
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`Case IPR2015-01097; IPR2015-1099; IPR2015-01100; IPR2015-01105
`Lawrence, Ph.D., M. Jayne
`February 16, 2016
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` documents that you considered in
` connection with your opinions in
` this case?"
` A. Mm-hmm.
` Q. And then there was an objection. And
`then I said, "You may answer." And you answered,
`"The attorneys."
` That was your sworn testimony, correct?
` A. Yes.
` Q. You may put that aside for now.
` A. That's taking it out of context. I'm
`sorry.
` Q. You never qualified your testimony in
`connection with this deposition, correct?
` A. Because I obviously didn't realize you
`were meaning the whole documents.
` Q. Okay. The exact question that I asked
`you was: "From whom did you obtain the documents
`that you considered in connection with your
`opinions in this case?" And the exact answer that
`you gave was "the attorneys," correct?
` A. I would like to read the text that went
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`PAGE 18 OF 403
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`Case IPR2015-01097; IPR2015-1099; IPR2015-01100; IPR2015-01105
`Lawrence, Ph.D., M. Jayne
`February 16, 2016
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`before that to put it into context because we were
`talking about patents, I believe.
` So the patents I obtained from the
`attorneys. A large number of the other documents I
`obtained through my own searching and my own work.
` Q. Okay. You never qualified your testimony
`when I asked you at your deposition, did you,
`doctor.
` MS. SUZUKI: Objection, asked and
`answered.
`BY MR. HASFORD:
` Q. You may answer.
` A. As I said, I would have to read the whole
`text to see the context in which it was -- that
`statement was made to be able to answer that
`appropriately.
` Q. The next question I asked was --
` A. Can --
` Q. -- "and in your previous answer
` when you said the patents
` themselves with the whole
` specifications were the documents
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`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`PAGE 19 OF 403
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`Case IPR2015-01097; IPR2015-1099; IPR2015-01100; IPR2015-01105
`Lawrence, Ph.D., M. Jayne
`February 16, 2016
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` you considered first, in connection
` with your opinions in this case,
` you're referring to the
` patents-in-suit, correct?"
` And you answered, "I am." That was your
`testimony, correct?
` A. I'm sorry. I didn't hear the beginning
`part of that question.
` Q. I read you page 136, lines 1 through 6 of
`your transcript. Do you see that?
` A. That only supports, I believe, what I
`said that we were talking specifically about
`patents, not the other documents, not the whole
`documents.
` Q. And in a previous answer you testified
`that you obtained the documents that you considered
`in connection with your opinions in the case from
`the attorneys, correct?
` MS. SUZUKI: Objection, form, asked and
`answered.
` THE WITNESS: I would really need to read
`the transcript rather than taking one particular
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`PAGE 20 OF 403
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`
`Case IPR2015-01097; IPR2015-1099; IPR2015-01100; IPR2015-01105
`Lawrence, Ph.D., M. Jayne
`February 16, 2016
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`sentence out of context like that. I'm sorry.
`BY MR. HASFORD:
` Q. How did you go about formulating your
`obviousness opinions for these IPR proceedings?
` A. Before I took on the case, I did a lot of
`reading and searching myself and formulated my own
`opinion before I -- I took on the case.
` Q. Please turn to page 49 of your
`declaration, and let me direct your attention to
`page 120. I apologize. Paragraph 120.
` A. Turn to page what?
` Q. Please turn to page 49 of your
`declaration, and let me direct your attention to
`paragraph 120.
` A. Sorry. I'm --
` Q. It's your declaration, not your
`testimony.
` A. Okay. 49?
` Q. 49.
` A. Okay.
` Q. And let me direct your attention to
`paragraph 120.
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
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`PAGE 21 OF 403
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`
`Case IPR2015-01097; IPR2015-1099; IPR2015-01100; IPR2015-01105
`Lawrence, Ph.D., M. Jayne
`February 16, 2016
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` A. Yes.
` Q. It states:
` "There are three applications in
` the chain leading to the '290
` patent: (1) U.S. Application No.
` 10/525,006 ('the '006
` application'), which issued as the
` '431 patent."
` Do you see that?
` A. I do.
` Q. Are you aware that the '431 patent is in
`the same patent family as the '290, '131, '813 and
`'606 patents?
` MS. SUZUKI: Objection to form.
` THE WITNESS: I understand they're in the
`same family, yes.
`BY MR. HASFORD:
` Q. You also submitted a separate declaration
`to The U.S. Patent and Trademark Office concerning
`the '431 patent, correct?
` A. Yes.
` MS. SUZUKI: Objection to form.
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`PAGE 22 OF 403
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`Case IPR2015-01097; IPR2015-1099; IPR2015-01100; IPR2015-01105
`Lawrence, Ph.D., M. Jayne
`February 16, 2016
`
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`BY MR. HASFORD:
` Q. We're not going to mark this as an
`exhibit, but I will hand you a copy of that
`separate declaration.
` Please turn to page 2, and let me direct
`your attention to the last full sentence on the
`page. It states:
` I note that I agree in all material
` respects with the analysis and
` opinions set forth by the
` petitioner InnoPharma's expert,
` Dr. Laskar, in the declaration that
` was submitted in the InnoPharma IPR
` and share the same opinions below.
` You wrote that in your declaration, correct?
` A. I did.
` Q. The next sentence states:
` I also note that I agree in all
` material respects with the analysis
` and opinions set forth by
` petitioner Metrics expert
` Dr. Kompella.
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`PAGE 23 OF 403
`
`
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`

`
`Case IPR2015-01097; IPR2015-1099; IPR2015-01100; IPR2015-01105
`Lawrence, Ph.D., M. Jayne
`February 16, 2016
`
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` You wrote that in your declaration, correct?
` A. I did.
` Q. You may put that document aside.
` Doctor, what does it mean for an author to
`retract a scientific journal publication?
` MS. SUZUKI: Objection to form.
` THE WITNESS: To be honest with you, I
`don't know because I've never done it.
`BY MR. HASFORD:
` Q. If an author retracts a scientific
`journal publication because it included falsified
`data, what does that say about the credibility of
`the author's statements to the scientific
`community?
` MS. SUZUKI: Objection to form.
` THE WITNESS: There's not enough
`information to answer that. It would depend why
`they were falsified.
`BY MR. HASFORD:
` Q. Have you ever retracted a journal
`publication because it included falsified data?
` A. No.
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`PAGE 24 OF 403
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`
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`

`
`Case IPR2015-01097; IPR2015-1099; IPR2015-01100; IPR2015-01105
`Lawrence, Ph.D., M. Jayne
`February 16, 2016
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` Q. Would you typically rely on the opinions
`of a scientist who has retracted journal
`publications that have included falsified data?
` MS. SUZUKI: Objection to form.
` THE WITNESS: That's not sufficient
`information as to -- as to why. I couldn't answer.
` MR. HASFORD: For the record, I'm handing
`Dr. Lawrence and Lupin's counsel copies of Exhibit
`2132, which is entitled "Retraction:
`Sclera-Choroid-RPE Transport of Eight Beta-Blockers
`in Human, Bovine, Porcine, Rabbit, and Rat Models"
`from the journal of Investigative Ophthalmology &
`Visual Science.
` (Exhibit 2132 was marked for
`identification.)
`BY MR. HASFORD:
` Q. It states: "Retraction of
`Sclera-Choroid-RPE Transport of Eight Beta-Blockers
`in Human, Bovine, Porcine, Rabbit and Rat Models,"
`by Rajendra S. Kadam, Narayan P.S. Cheruvu, Henry
`F. Edelhauser, and Uday B. Kompella, and then it
`has a citation, and then it goes on to say:
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`PAGE 25 OF 403
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`
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`Case IPR2015-01097; IPR2015-1099; IPR2015-01100; IPR2015-01105
`Lawrence, Ph.D., M. Jayne
`February 16, 2016
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` "A scientific misconduct
` investigation by University of
` Colorado Denver (Anschutz Medical
` Campus) concluded that this paper
` contains falsified and/or
` fabricated data. Specifically,
` Figures 1 and 3: Some LC-MS peak
` areas in the beta-blocker transport
` data reported in these figures were
` falsified to create smooth
` monotonic transport curves with
` smaller error bars.
` Tables 2, 3; Figures 2, 4, 5, 7, 8
` and 10: All use the primary
` transport data from curves in
` Figures 1 and 3, hence, the
` analyses reported will all be
` contaminated by falsified data from
` Figure 1 and/or Figure 3.
` The university recommended the
` paper be retracted from publication
` and the editor-in-chief, David C.
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`PAGE 26 OF 403
`
`
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`

`
`Case IPR2015-01097; IPR2015-1099; IPR2015-01100; IPR2015-01105
`Lawrence, Ph.D., M. Jayne
`February 16, 2016
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` Beebe, agreed. The paper is
` therefore being retracted by ARVO
` from IOVS."
` Do you see that?
` A. I do.
` Q. You can put that document aside.
` MR. HASFORD: For the record, I am
`handing Dr. Lawrence and Lupin's counsel copies of
`Exhibit 2133, which is entitled "Notice of
`Retraction" from the journal Drug Metabolism &
`Disposition.
` (Exhibit 2133 was marked for
`identification.)
`BY MR. HASFORD:
` Q. Take a look at page 4, the last page, it
`says:
` "Notice of Retraction regarding
` Kadam RS, Vooturi SK, Kompella UB,
` Immunohistochemical and functional
` characterization of peptide,
` organic cation, neutral and basic
` amino acid, and monocarboxylate
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`PAGE 27 OF 403
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`
`
`

`
`Case IPR2015-01097; IPR2015-1099; IPR2015-01100; IPR2015-01105
`Lawrence, Ph.D., M. Jayne
`February 16, 2016
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` drug transporters in human ocular
` tissues."
` And then there's a citation. It says:
` "The University of Colorado and
` authors have requested that this
` article be withdrawn due to data
` integrity problems with some
` LC-MS/MS peak areas in Figure 10
` (A-D) and Figure 11 (A-C). The
` data were found to be falsified to
` improve the differences or
` kinetics." Drug Metabolism
` Disposition has retracted this
` article.
` Do you see that?
` A. Yes, I do.
` Q. You may put that aside.
` Before today were you aware that
`Dr. Kompella, on whose opinions you've testified
`you have relied, retracted multiple journal
`publications because they included falsified data?
` MS. SUZUKI: Objection to form.
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`PAGE 28 OF 403
`
`
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`

`
`Case IPR2015-01097; IPR2015-1099; IPR2015-01100; IPR2015-01105
`Lawrence, Ph.D., M. Jayne
`February 16, 2016
`
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` THE WITNESS: As it stands, the
`retraction -- lots of people retract papers. I've
`never done one personally, but lots of people do.
`I would have to understand the reason why. I do
`know in the last one a couple of the authors were
`involved in that retraction. So it could be a
`post-doc. It doesn't necessarily mean the author
`is misbehaving.
`BY MR. HASFORD:
` Q. Just to be clear, before today were you
`aware that Dr. Kompella, on whose opinions you've
`testified you have relied, retracted multiple
`journal publications because they included
`falsified data?
` MS. SUZUKI: Objection to form, asked and
`answered.
`BY MR. HASFORD:
` Q. You may answer.
` A. If I answer, it's a fairly meaningless
`statement because lots of people retract papers
`because they find subsequently there are errors in
`the data. So I'd have to understand the reason
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`PAGE 29 OF 403
`
`
`
`

`
`Case IPR2015-01097; IPR2015-1099; IPR2015-01100; IPR2015-01105
`Lawrence, Ph.D., M. Jayne
`February 16, 2016
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`why.
` Q. Before today were you aware that he
`retracted those papers because they included
`falsified data?
` MS. SUZUKI: Objection to form, asked and
`answered.
`BY MR. HASFORD:
` Q. You may answer.
` A. I can't make a judgment on those papers,
`so, no, I wasn't aware, but I cannot make a
`judgment on the papers, and the reason why I would
`be taking it out of context.
` MR. HASFORD: For the record, I am
`handing Dr. Lawrence and Lupin's counsel copies of
`Exhibit 1054.
` (Exhibit 1054 was marked for
`identification.)
`BY MR. HASFORD:
` Q. Is Exhibit 1054 a copy of your curriculum
`vitae?
` A. It is, yes.
` Q. Your curriculum vitae lists your relevant
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`PAGE 30 OF 403
`
`
`
`

`
`Case IPR2015-01097; IPR2015-1099; IPR2015-01100; IPR2015-01105
`Lawrence, Ph.D., M. Jayne
`February 16, 2016
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`professional experience, correct?
` A. It does.
` Q. You are not an expert in ophthalmology,
`correct?
` A. No, I'm not an expert.
` Q. You do not practice medicine and have
`never prescribed medication to a patient,

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