throbber
Case IPR2015-00902; IPR2015-00903
`Laskar, Ph.D., Paul A.
`November 4, 2015
`
`1
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` _____________________________________________________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` _____________________________________________________
`
`INNOPHARMA LICENSING, INC., INNOPHARMA LICENSING LLC,
` INNOPHARMA INC., INNOPHARMA LLC,
` MYLAN PHARMACEUTICALS INC., and MYLAN INC.,
` Petitioner
` v.
` SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC.,
` and BAUSCH & LOMB PHARMA HOLDINGS CORP.,
` Patent Owner
` _____________________________________________________
` Case IPR2015-00902 (Patent 8,669,290 B2)
` Case IPR2015-00903 (Patent 8,129,431 B2)
` _____________________________________________________
`
` VIDEOTAPED DEPOSITION OF PAUL A. LASKAR, PH.D.
` Charlotte, North Carolina
` Wednesday, November 4, 2015
`
` Reported by: Karen Kidwell, RMR, CRR
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`
`
`PAGE 1 OF 327
`
`SENJU EXHIBIT 2114
`LUPIN v SENJU
`IPR2015-01105
`
`

`
`Case IPR2015-00902; IPR2015-00903
`Laskar, Ph.D., Paul A.
`November 4, 2015
`
`2
`
` A P P E A R A N C E S
` ON BEHALF OF THE PETITIONER:
` ALSTON & BIRD LLP
` BY: JITENDRA MALIK, PH.D.
` 4721 Emperor Boulevard, Suite 400
` Durham, North Carolina 27703
` 919.862.2200
` jitty.malik@alston.com
` and
` BY: H. JAMES ABE, ESQ.
` 333 South Hope Street, Sixteenth Floor
` Los Angeles, California 90071
` 213.576.1000
` james.abe@alston.com
`
` ON BEHALF OF THE PATENT OWNER:
` FINNEGAN, HENDERSON, FARABOW, GARRETT
` & DUNNER, LLP
` BY: JUSTIN J. HASFORD, ESQ.
` BRYAN C. DINER, ESQ.
` 901 New York Avenue, NW, Suite 400
` Washington, D.C. 20001-4413
` 202.408.4000
` justin.hasford@finnegan.com
`
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`

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`Case IPR2015-00902; IPR2015-00903
`Laskar, Ph.D., Paul A.
`November 4, 2015
`
`3
`
` ALSO PRESENT:
` Bradley Moore, Litigation Clerk,
` Finnegan, Henderson, Farabow, Garrett
` & Dunner, LLP
` Bruce Weekly, Videographer
`
` VIDEOTAPED DEPOSITION OF PAUL A. LASKAR,
` PH.D., a witness called on behalf of Patent Owner,
` before Karen K. Kidwell, Notary Public, in and for
` the State of North Carolina, at Alston & Bird LLP,
` 101 South Tryon Street, Suite 4000, Charlotte, North
` Carolina, on Wednesday, November 4, 2015, commencing
` at 9:06 a.m.
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`www.hendersonlegalservices.com
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`PAGE 3 OF 327
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`

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`Case IPR2015-00902; IPR2015-00903
`Laskar, Ph.D., Paul A.
`November 4, 2015
`
`4
`
` I N D E X
` WITNESS/EXAMINATION Page
` PAUL LASKAR, PH.D.
` By Mr. Hasford 13
` By Mr. Malik 258
` Further by Mr. Hasford 263
` Further by Mr. Malik 265
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`202-220-4158
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`www.hendersonlegalservices.com
`
`PAGE 4 OF 327
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`

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`Case IPR2015-00902; IPR2015-00903
`Laskar, Ph.D., Paul A.
`November 4, 2015
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` E X H I B I T S
` Number Description Page
` Exhibit 2131 Patent Owner's Notice of .........14
` Cross-Examination of Dr. Paul
` A. Laskar, Ph.D.
` Exhibit 2132 Article Retraction ...............21
` Sclera-Choroid-RPE Transport
` of Eight Beta Blockers in
` Human, Bovine, Porcine,
` Rabbit, and Rat Models
` Exhibit 2133 Drug Metabolism and ..............22
` Disposition, Notice of
` Retraction
` Exhibit 2134 Allergan v. Sandoz, et al, .......76
` Federal Appeal's Court opinion
` Exhibit 2135 Trial Court's Opinion, ..........169
` Allergan vs. Sandoz, et al
` Exhibit 2136 Copy of transcript of bench .....172
` trial of Allergan vs. Sandoz,
` August 3, 2011, afternoon
` session
` Exhibit 2137 Copy of transcript of bench .....187
` trial of Allergan vs. Sandoz,
` August 4, 2011, afternoon
` session
`
`202-220-4158
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`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
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`

`
`Case IPR2015-00902; IPR2015-00903
`Laskar, Ph.D., Paul A.
`November 4, 2015
`
`6
`
` E X H I B I T S (Cont'd)
` Number Description Page
` Exhibit 2138 LexisNexis Court's Opinion in ..197
` Syntex, et al v. Apotex, et al.
` Exhibit 2139 Chemical Society Reviews ........222
` December 1994, Surfactant
` Systems: Their Use in Drug
` Delivery article
` Exhibit 2140 Transcript of the Testimony of ..248
` M. Jayne Lawrence September 4,
` 2015
` Exhibit 2141 Article Absorption and ..........255
` Distribution of Radioactivity
` from Suppositories Containing
` H-Benzocaine in Rats
`
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`www.hendersonlegalservices.com
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`PAGE 6 OF 327
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`

`
`Case IPR2015-00902; IPR2015-00903
`Laskar, Ph.D., Paul A.
`November 4, 2015
`
`7
`
` EXHIBITS REFERENCED
` No. Page
` Exhibit 1001 United States Patent 8,669,290 ...67
` B2 in IPR2015-00902
` Exhibit 1001 United States Patent 8,129,431 ..231
` in IPR2015-00903
` Exhibit 1002 Clinics and Drug Therapy 2000, ...47
` The Future of Osteoporosis
` Treatment in Primary Care,
` Bronuck ophthalmic solution,
` in IPR2015-00902 and
` IPR2015-00903
` Exhibit 1003 Declaration of Paul A. Laskar ....15
` in IPR2015-00903, 86 pages,
` and IPR2015-00903, 85 pages
` Exhibit 1004 United States Patent 4,910,225 ...62
` - also Exhibit 1004 in IPR
` 2015-00903
` Exhibit 1005 United States Patent .............70
` 5,603,919, also Exhibit 1005
` for IPR2015-00903
` Exhibit 1006 United States Patent 5,558,876 ...86
` for IPR 2015-00902, also
` Exhibit 1006 in IPR 2015-00903
`
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`www.hendersonlegalservices.com
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`

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`Case IPR2015-00902; IPR2015-00903
`Laskar, Ph.D., Paul A.
`November 4, 2015
`
`8
`
` EXHIBITS REFERENCED (Cont'd)
` No. Page
` Exhibit 1009 U. S. Patent 6.107,343 in IPR ...134
` 2015-00902 and also in IPR
` 2015-00903
` Exhibit 1010 Journal of Pharmaceutical .......149
` Sciences article
` Solubilization of
` Anti-inflammatory Steroids by
` Aqueous Solutions of Triton
` WR-1339 in IPR 2015-00902,
` also Exhibit 1010 in IPR
` 2015-00903
` Exhibit 1011 Patent Abridgement Australian ...103
` Patent Office AU-B-22042/88 in
` IPR 2015-00902 and IPR
` 2015-00903
` Exhibit 1012 United States Patent 6,274,609 ..153
` in IPR 2015-00902 and IPR
` 2015-00903
` Exhibit 1017 International Application, ......146
` Kapin, WO 02/13804 A2, for
` IPR2015-00902 and also Exhibit
` 1016 in IPR2015-00903
`
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`www.hendersonlegalservices.com
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`

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`Case IPR2015-00902; IPR2015-00903
`Laskar, Ph.D., Paul A.
`November 4, 2015
`
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` EXHIBITS REFERENCED (Cont'd)
` No. Page
` Exhibit 1018 Topical Nonsteroidal .............34
` Anti-inflammatory Drugs for
` Ophthalmic Use by Allan J.
` Flach, M.D., in IPR2015-00902
` and also Exhibit 1017 in
` IPR2015-00903
` Exhibit 1019 Article, Comparing the Surface ..123
` 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), in IPR2015-00902,
` also known as Exhibit 1024 in
` IPR2015-00903
` Exhibit 1020 Article Aggregation Behavior ....126
` of Tyloxapol, a Nonionic
` Surfactant Oligomer, in
` Aqueous Solution in
` IPR2015-00902 and also known
` as Exhibit 1025 in
` IPR2015-00903
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`PAGE 9 OF 327
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`

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`Case IPR2015-00902; IPR2015-00903
`Laskar, Ph.D., Paul A.
`November 4, 2015
`
`10
`
` EXHIBITS REFERENCED (Cont'd)
` No. Page
` Exhibit 1022 United States Patent 5,597,560 ...95
` for IPR2015-00902 and also
` known as Exhibit 1019 in
` IPR2015-00903
` Exhibit 1028 United States Patent 5,475,034 ...53
` for IPR2015-00902, also known
` as Exhibit 1033 in
` IPR2015-00903
` Exhibit 1035 International Application, .......97
` PCT, WO 94/15597, Wong
` reference, for IPR2015-00902,
` also known as Exhibit 1020 in
` IPR2015-00903
` Exhibit 1036 United States Patent 5,540,930 ..144
` in IPR2015-00902, also known
` as Exhibit 1038 in
` IPR2015-00903
` Exhibit 1047 Highlights of Prescribing ........38
` Information, Prolensa, in
` IPR2015-00902, also known as
` Exhibit 1050 in IPR2015-00903
`
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`

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`Case IPR2015-00902; IPR2015-00903
`Laskar, Ph.D., Paul A.
`November 4, 2015
`
`11
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` EXHIBITS REFERENCED (Cont'd)
` No. Page
` Exhibit 1049 United States Patent 6,071,904 ..204
` in IPR2015-00902, also known
` as Exhibit 1052 in
` IPR2015-00903
` Exhibit 1050 European Patent Application .....219
` 87310931.8, in IPR2015-00902
` Exhibit 1052 Curriculum Vitae of Paul A. ......24
` Laskar in IPR2015-00902
` Exhibit 1053 Curriculum Vitae of Paul A. ......25
` Laskar in IPR2015-00903
` Exhibit 1054 Declaration of M. Jayne ..........17
` Lawrence, Ph.D.
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`

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`Case IPR2015-00902; IPR2015-00903
`Laskar, Ph.D., Paul A.
`November 4, 2015
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`WEDNESDAY, NOVEMBER 4, 2015, CHARLOTTE, NORTH CAROLINA
` P R O C E E D I N G S
` -oOo-
` VIDEOGRAPHER: Stand by. This is the
` videotaped deposition of Paul A. Laskar, Ph.D.,
` in the matter of InnoPharma Licensing versus
` Senju Pharmaceutical Company, Ltd., et al, filed
` in the United States Patent Trademark Office
` before the Patent Trial and Appeal Board. Today
` is Wednesday, November the 4th, 2015. This
` deposition is being held in the offices of
` Alston & Bird, LLP, located at 101 South Tryon
` Street, Charlotte, North Carolina.
` My name is Bruce Weekly. I'm the video
` specialist. Court reporter is Karen Kidwell.
` We are on the record. The time on the monitor
` is 9:06.
` Counsel will now introduce themselves and
` whom they represent.
` MR. HASFORD: Justin Hasford of Finnegan
` on behalf of patent owner, Senju.
` MR. DINER: Brian Diner of Finnegan on
` behalf of patent owner, Senju.
` MR. MALIK: Jitendra Malik of Alston &
` Bird representing petitioner.
`
`202-220-4158
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`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
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`

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`Case IPR2015-00902; IPR2015-00903
`Laskar, Ph.D., Paul A.
`November 4, 2015
`
`13
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` MR. ABE: James Abe of Alston & Bird
` representing petitioners.
` VIDEOGRAPHER: Would the court reporter
` please swear in the witness.
` PAUL LASKAR, PH.D.
` being first duly sworn, testified as follows:
` EXAMINATION
` BY MR. HASFORD:
` Q. Good morning, Dr. Laskar.
` A. Good morning.
` Q. Would you please state your name and
` address for the record.
` A. My name is Paul Laskar. I reside at 603
` Montecito Boulevard, Napa, California.
` Q. Doctor, I represent the patent owner,
` Senju, in these IPR proceedings. Today I will ask
` you questions, and all 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 understood
` the question. Is that okay?
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`PAGE 13 OF 327
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`

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`Case IPR2015-00902; IPR2015-00903
`Laskar, Ph.D., Paul A.
`November 4, 2015
`
`14
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` A. That is.
` Q. Is there any reason why you cannot testify
` truthfully and accurately today?
` A. No.
` (Exhibit 2131 was marked for identification.)
` MR. HASFORD: For the record, I am handing
` Dr. Laskar and InnoPharma's counsel copies of
` Exhibit 2131, entitled "Patent Owner's Notice of
` Cross-examination of Dr. Paul A. Laskar, Ph.D."
` MR. MALIK: Thank you.
` MR. HASFORD: Counsel, can we stipulate
` that Dr. Laskar is here today pursuant to
` Exhibit 2131?
` MR. MALIK: Yes, we can.
` MR. HASFORD: Thank you. You can put that
` document aside, Doctor.
` Counsel, can we also stipulate that the
` questions I ask, unless otherwise stated, apply
` equally to IPR2015-00902 and IPR2015-00903?
` MR. MALIK: Yes, you can.
` MR. HASFORD: Thank you. And let the
` record reflect that we hereby invoke the rule on
` witnesses pursuant to Federal Rule of
` Evidence 615 prohibiting showing the transcript
` of this deposition or discussing any of its
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`PAGE 14 OF 327
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`

`
`Case IPR2015-00902; IPR2015-00903
`Laskar, Ph.D., Paul A.
`November 4, 2015
`
`15
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` contents with Dr. Jayne Lawrence in connection
` with any IPR proceeding involving Prolensa.
` MR. MALIK: Only thing is, Counsel, just
` to let you know, I will obviously be -- well, we
` reserve the right to inform Lupin of this fact,
` and then obviously, that's an issue between, I
` guess, Lupin and Senju, but I will inform them
` that you invoked Rule 615.
` MR. HASFORD: We understand. For the
` record, I'm handing Dr. Laskar and InnoPharma's
` counsel copies of Exhibit 1003 in IPR2015-00903
` entitled "Declaration of Paul A. Laskar, Ph.D."
` (Exhibit 1003 was previously marked for
` identification.)
` BY MR. HASFORD:
` Q. Is Exhibit 1003 in IPR2015-00903 your
` declaration concerning U.S. Patent Number 8,129,431?
` A. Yes, it is.
` Q. If I refer to U.S. Patent Number 8,129,431
` as the '431 patent, will you understand what I mean?
` A. Yes.
` Q. Please hold on to that document for a
` moment.
` MR. HASFORD: For the record, I'm handing
` Dr. Laskar and InnoPharma's counsel copies of
`
`202-220-4158
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`

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`Case IPR2015-00902; IPR2015-00903
`Laskar, Ph.D., Paul A.
`November 4, 2015
`
`16
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` Exhibit 1003 in IPR2015-00902 entitled
` "Declaration of Paul A. Laskar, Ph.D."
` MR. MALIK: Thank you, Counsel.
` BY MR. HASFORD:
` Q. Is Exhibit 1003 in IPR2015-00902 your
` declaration concerning U.S. Patent Number 8,669,290?
` A. Yes.
` Q. If I refer to U.S. Patent Number 8,669,290
` as the '290 patent, will you understand what I mean?
` A. Yes.
` Q. Please turn to the last page of each of
` your declarations. Do you see your electronic
` signature on the last page of each of your
` declarations?
` A. I do.
` Q. Your declarations bear electronic
` signatures instead of ink signatures, correct?
` A. Correct.
` Q. You did not actually write your
` declarations for these IPR proceedings, correct?
` A. I'm sorry. Would you repeat the question?
` Q. Certainly. You did not actually write
` your declarations for these IPR proceedings, correct?
` A. I certainly -- I did not do the final word
` processing of them. I did write these documents.
`
`202-220-4158
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`www.hendersonlegalservices.com
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`

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`Case IPR2015-00902; IPR2015-00903
`Laskar, Ph.D., Paul A.
`November 4, 2015
`
`17
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` Q. Are you aware that Lupin has submitted an
` IPR petition challenging the '431 patent, along with
` a declaration of Dr. Jayne Lawrence, who relies on
` your declaration in IPR2015-00903?
` A. No.
` MR. HASFORD: Can we go off the record for
` a moment?
` VIDEOGRAPHER: Stand by. We are going off
` the record. The time on the monitor is 9:11.
` (A recess transpired from 9:11 a.m. until
` 9:12 a.m.)
` VIDEOGRAPHER: Stand by. We are going on
` record. The time on the monitor is 9:12.
` BY MR. HASFORD:
` Q. Doctor, I'm handing you a copy of --
` A. Am I done with these two?
` (Exhibit 1054 was previously marked for
` identification.)
` BY MR. HASFORD:
` Q. For the time being. We'll go back to
` them.
` Handing you a copy of Dr. Lawrence's
` declaration. Turn, if you would, to page 2. And let
` me direct your attention to the second full sentence
` on that page. It says, "I have reviewed the
`
`202-220-4158
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`www.hendersonlegalservices.com
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`Case IPR2015-00902; IPR2015-00903
`Laskar, Ph.D., Paul A.
`November 4, 2015
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` materials submitted with the petition filed in the
` InnoPharma IPR including the petition itself,
` IPR2015-00903, Paper 2 in the declaration of Paul --
` Dr. Paul A. Laskar, IPR2015-00903, Exhibit 1003, the
` Board's decision instituting inter partes review,
` IPR2015-00903, paper 15, and the prior art and
` materials cited in each.
` "I have also reviewed the materials
` submitted in connection with the Metrics IPR,
` including the petition itself, second corrected
` petition, the second corrected declaration of
` Dr. Uday B. Kompella, the patent owner's preliminary
` response, and the board's decision instituting inter
` partes review. 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. I also note
` that I agree in all material respects with the
` analysis and opinion set forth by petitioner Metrics'
` expert, Dr. Kompella. Because my independent
` analysis of the claims and prior art led to the same
` conclusions as Dr. Laskar, coupled with the fact that
` the petitioner is seeking to become a party to the
` InnoPharma IPR, I have incorporated Dr. Laskar's
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`PAGE 18 OF 327
`
`

`
`Case IPR2015-00902; IPR2015-00903
`Laskar, Ph.D., Paul A.
`November 4, 2015
`
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` opinions and characterizations below as my own."
` Do you see that?
` A. I do.
` Q. Do you have any basis to disagree with
` Dr. Lawrence's opinions as they relate to the subject
` matter of '431 and '290 patents?
` MR. MALIK: Speculation and foundation.
` THE WITNESS: Inasmuch as I've not -- I've
` not seen this document, I have no idea what it
` contains so I can't respond.
` BY MR. HASFORD:
` Q. Put this aside. Please turn to page 2 of
` each of your declarations. You are relying on the
` declarations of Dr. Uday Kompella that Metrics
` submitted in IPR2014-01041 and IPR2014-01043,
` correct?
` A. As I -- as I've stated on that page, yes.
` Q. You state, "I note that I agree with the
` analysis and opinions set forth by the petitioner's
` expert, Dr. Kompella, in the declaration that was
` submitted in the Metrics IPR proceeding and share
` many of those same opinions below. Because my
` independent analysis of the claims and prior art led
` to the same conclusions as the expert in the Metrics
` IPR, I have incorporated many of his opinions and
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`PAGE 19 OF 327
`
`

`
`Case IPR2015-00902; IPR2015-00903
`Laskar, Ph.D., Paul A.
`November 4, 2015
`
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` characterizations below as my own."
` Do you see that?
` A. I do.
` Q. Doctor, what does it mean for an author to
` retract a scientific journal publication?
` A. In -- in general, a -- a retracted journal
` publication suggests that there was some erroneous
` information contained therein.
` 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?
` A. It would --
` MR. MALIK: Speculation.
` THE WITNESS: Concerning the matter at
` hand, it would suggest that whatever that
` retracted article and its contents and the
` author would not be credible relative to that
` materials -- those materials.
` BY MR. HASFORD:
` Q. You have never retracted a journal
` publication because it included falsified data,
` correct?
` A. No, I have not.
` Q. Would you typically rely on the opinions
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`PAGE 20 OF 327
`
`

`
`Case IPR2015-00902; IPR2015-00903
`Laskar, Ph.D., Paul A.
`November 4, 2015
`
`21
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` of a scientist who has retracted journal publications
` that have included falsified data?
` A. I would -- it would add a level of
` skepticism in my reading of any of that information.
` (Exhibit 2132 was marked for identification.)
` MR. HASFORD: For the record, I am handing
` Dr. Laskar and InnoPharma's counsel copies of
` Exhibit 2132 which is entitled, "Retraction:
` Sclera-Choroid-RPE Transport of Eight
` Betablockers in Human, Bovine, Porcine, Rabbit
` and Rat Models from the journal, Investigative
` Ophthalmology and Visual Science."
` It states, "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 LCMS 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.
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`PAGE 21 OF 327
`
`

`
`Case IPR2015-00902; IPR2015-00903
`Laskar, Ph.D., Paul A.
`November 4, 2015
`
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` The university recommended the paper be
` retracted from publication and the editor in
` chief, David C. Beebee agreed. The paper is
` therefore being retracted by ARVO and IOVS."
` And the author on this paper, one of the
` authors, that is, is Uday B. Kompella. Do you
` see that, Doctor?
` A. I do.
` (Exhibit 2133 was marked for identification.)
` BY MR. HASFORD:
` Q. You can put that aside for the moment.
` MR. HASFORD: For the record, I'm handing
` Dr. Laskar and InnoPharma's counsel copies of
` Exhibit 2133 which is entitled "Notice of
` Retraction from the Journal of Drug Metabolism
` and Disposition."
` MR. MALIK: Thank you.
` BY MR. HASFORD:
` Q. The last page shows Dr. Kompella's name
` and states, "The University of Colorado and authors
` have requested that this article be withdrawn due to
` data integrity problems with some LCMSMS peak areas
` in Figure 10, A through D, and Figure 11, A through
` C. The data were found to be falsified to improve
` the differences or kinetics. Drug metabolism
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`PAGE 22 OF 327
`
`

`
`Case IPR2015-00902; IPR2015-00903
`Laskar, Ph.D., Paul A.
`November 4, 2015
`
`23
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`
` disposition has retracted this article."
` And, again, that's with Dr. Kompella as an
` author. Do you see that?
` A. I do.
` Q. Before today, were you aware that
` Dr. Kompella retracted multiple journal publications
` because they included falsified data?
` MR. MALIK: Speculation. Also assumes
` facts not in evidence.
` BY MR. HASFORD:
` Q. You may answer.
` A. I was not aware.
` Q. Having been made aware that Dr. Kompella
` retracted multiple journal publications because they
` included falsified data, do you still intend to rely
` on Dr. Kompella's opinions in these IPR proceedings?
` A. Inasmuch as the -- the studies -- the --
` for the articles that have been retracted and do not
` relate to matters of formulation and inasmuch as I
` conducted my separate analyses of the information. I
` believe that there's no information that I'm aware of
` that there has been any falsification of information
` relating to drug formulation on the part of
` Dr. Kompella.
` Q. Please turn to page 12 in each of your
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`PAGE 23 OF 327
`
`

`
`Case IPR2015-00902; IPR2015-00903
`Laskar, Ph.D., Paul A.
`November 4, 2015
`
`24
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` declarations. And if it's easier, you can just focus
` on the declaration in IPR2015-00902.
` Let me direct your attention to the first
` sentence under "My Background and Qualifications."
` It states, "I am an expert in the field of
` formulations and drug delivery, specifically
` pharmaceutical formulations for ophthalmic
` administration including topical aqueous liquid
` preparations, and I have been an expert in this field
` since prior to 2003."
` In these IPR proceedings, you are not
` holding yourself out as an expert in any other field
` besides that which you have stated here, correct?
` A. That would be correct.
` MR. HASFORD: For the record, I am handing
` Dr. Laskar and InnoPharma's counsel copies of
` Exhibit 1052 in IPR2015-00902.
` (Exhibit 1052 was previously marked for
` identification.)
` BY MR. HASFORD:
` Q. Is Exhibit 1052 in IPR2015-00902 a copy of
` your curriculum vitae?
` A. Yes, it is.
` MR. HASFORD: For the record, I'm handing
` Dr. Laskar and InnoPharma's counsel copies of
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`PAGE 24 OF 327
`
`

`
`Case IPR2015-00902; IPR2015-00903
`Laskar, Ph.D., Paul A.
`November 4, 2015
`
`25
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`
` Exhibit 1053 in IPR2015-00903.
` (Exhibit 1053 was previously marked for
` identification.)
` MR. MALIK: Thank you.
` BY MR. HASFORD:
` Q. Is Exhibit 1053 in IPR2015-00903 also a
` copy of your curriculum vitae?
` A. Yes.
` Q. You can just take a look at one or the
` other. Let's start from the last page of your
` curriculum vitae and work forward.
` Let me direct your attention to the
` subheading "Other," and in particular, the first
` line. You state in your curriculum vitae that you
` are a registered pharmacist, but that you are
` inactive. Correct?
` A. Correct.
` Q. When did you last dispense a drug to a
` patient?
` A. Oh, in -- last dispense a drug to a
` patient would have been in the mid-1970s.
` Q. You have never dispensed any bromfenac
` product to a patient, correct?
` A. Not given that date, no.
` Q. You have never dispensed to a patient any
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`PAGE 25 OF 327
`
`

`
`Case IPR2015-00902; IPR2015-00903
`Laskar, Ph.D., Paul A.
`November 4, 2015
`
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` product containing tyloxapol, correct?
` A. I don't really recall.
` Q. Let me direct your attention to the
` subheading "Patents" in your curriculum vitae. Your
` curriculum vitae identifies the only two patent
` applications that you have ever submitted, correct?
` A. Yes.
` Q. One of your two patent applications is a
` U.S. patent application, and the other of your two
` patent applications is a PCT application, correct?
` MR. MALIK: Compound.
` THE WITNESS: Yes.
` BY MR. HASFORD:
` Q. Your one and only PCT application is
` directed to a method and composition for treating
` acne, correct?
` A. Yes.
` Q. The '431 and '290 patents are not related
` to methods for treating acne, correct?
` A. That is correct.
` Q. Your one and only U.S. patent application
` is directed to quinolone compositions, correct?
` A. It is.
` Q. The '431 and '290 patents are not related
` to quinolone compositions, correct?
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`PAGE 26 OF 327
`
`

`
`Case IPR2015-00902; IPR2015-00903
`Laskar, Ph.D., Paul A.
`November 4, 2015
`
`27
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` A. No, they are not.
` Q. Let me direct your attention to the
` subheading "Publications" in your curriculum vitae.
` According to your curriculum vitae, you have authored
` a total of eight publications, correct?
` A. Yes.
` Q. Your last publication issued in 1993,
` correct?
` A. Correct.
` Q. Your last publication which issued in 1993
` dealt with evaluation of sunscreen products, correct?
` A. That's correct.
` Q. You have only published one journal
` article since 1977, correct?
` A. Yes.
` Q. Let me direct your attention to the
` subheading "Presentations" in your curriculum vitae.
` According to your curriculum vitae, you have given a
` total of four presentations, correct?
` A. I have participated in four presentations,
` yes.
` Q. According to your curriculum vitae, your
` last presentation was in 1992, correct?
` A. Correct.
` Q. You have never held a faculty position
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`PAGE 27 OF 327
`
`

`
`Case IPR2015-00902; IPR2015-00903
`Laskar, Ph.D., Paul A.
`November 4, 2015
`
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