Transcript of the Testimony of Paul Laskar
`
`Date: March 25, 2016
`
`Case: Innpharma Licensing, Inc., et al. v. Senju Pharmaceutical Co.,
`LTD., et al.
`
`
`
`Ace-Federal Reporters, Inc.
`Phone: 202-347-3700
`Fax: 202-737-3638
`Email: info@acefederaI.com
`Internet: www.acefedera|.com
`
`SENJU EXHIBIT 233i
`Lupin V Senju,
`IPRZO 15-01097, IPRZGIS-01 099,
`IPR2015-01100 & IPR2015-01105
`
`

`
`Paul Laskar
`
`March 25, 2016
`
`Innpharma Licensing, Inc., et al. V. Senju Pharmaceutical CO., LTD., et al.
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Case IPR2015—00902 (Patent 8,669,290 B2)
`
`Case IPR2015—00903 (Patent 8,129,431 B2)1
`
`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.
`
`————————————————————————————————— —~)
`
`VIDEOTAPED DEPOSITION OF PAUL LASKAR, PH.D.
`
`Friday, March 25, 2016, 8:19 a.m.
`
`Charlotte, North Carolina
`
`Court Reporter: Nancy J. Martin, California CSR, RMR
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`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`»
`
`-.~.,.».......».a..~..-- -,u-n-.\,,.~-.~...y.\-.-.: »,.=. N-1»-.,..-.1-:/..«..-M ,,,):;M:,A~,,»M;-1-,~ M-.u,;_-,__.;_,,.,¢,,,;,,M\m_,,_A,_,,_,,___,,,§
`
`

`
`Paul Laskar
`
`innpharma Licensing, Inc., et ai. V. Senju Pharmaceuticai Co., LTD., et al.
`
`March 25, 2016
`
`ChLn-I‘-‘-'.aJf\J'—‘<D\DO0'~—lO\€.)I-J-‘-‘LrJI\J>—-
`
`:-»—»—-....«._.._.-;#
`
`Deposition OFPAUL LASKAR. Pl-1.13.. a witness
`called on behalfof Patent Owner, before Nancy J.
`Martin, Notary Public, in and for the state of
`Noith Carolina, at Alston & Bird, E01 South Tryon
`Street, Suite 4000, Charlotte, North Carolina, on
`
`Friday, March 25, 2016, commencing 8:19 am.
`
`-000-
`APPEARANCES
`
`t'K!-—lO\Ln-€=-bJI\J-—-
`
`ON BEHALF OF THE PATENT OWNER:
`
`FINNEGAN, HENDERSON, FARABOW, PARRABOW,
`GARRETT & DUNNER, LLP.
`JUSTIN J. I-IASFORD, ESQUIRE
`BRADLEY J. MOORE
`90} New York Avenue NW
`
`Washington, DC. 20001
`(202) 408-4000
`
`I N D E X
`WITNESS/EXAMINATION
`
`PAUL LASKAR, PHD.
`By Mi‘. Hasford
`By Dr. Malik
`
`E X H I B i T S
`
`Page
`Description
`No.
`Exhibit 2264 Patent Owner‘s Notice of
`Cross—Examination of
`
`Dr. Paul A. Laskar, Ph.D.,
`IPR2015—00902 (Patent 8,699,290 B2)
`4 pages
`Exhibit 2265 Patent Owner's Notice of
`Cross-Examination of
`
`12
`
`Dr. Paul A. Laskar, Ph.D.,
`IPR2015-00903 (Patent 8,129,431 B2)
`4 pages
`Exhibit 2266 Deposition transcript of Clayton
`Heathcock, Ph.D. taken
`
`February 19, 2016, 273 pages
`
`APPEARANCES (CONTINUED):
`
`E X I-I E B I T S
`
`ON BEHALF OF THE PETITIONER:
`
`ALSTON & BIRD LLP
`
`JITENDRA “JITTY" MALIK, PI-1.31)., ESQUIRE
`I-1. JAMES ABE, ESQUIRE
`4721 Emperor Boulevard
`Suite 400
`
`Durham, North Caroiina 27703
`(919) 862—2210
`
`ALSO PRESENT:
`
`Page
`Description
`No.
`Exhibit 2267 Reply Expert Report of
`Stephen G. Davies, D. Phi},
`25 pages
`
`Exhibit 2268 Deposition transcript of
`Robert C. Cykiert, M.D., taken
`
`February 26, 2016, 173 pages
`Exhibit 2269 Assessing Antioxidant and
`Prooxidant Activities of Phenolic
`
`Compounds, 8 pages
`Exhibit 2270 US. Patent 6,265,44 B1,
`
`BRUCE MOODY, LEGAL VIDEOGRAPI-{ER
`
`10 pages
`
`866-928-6509
`
`Ace-Federal Repofiers, Inc.
`
`2 (Pages 2 to 5)
`
`202-347-3700
`
`

`
`Paul Laskar
`
`Innpharma Licensing, Inc., et at. v. Senju Pharmaceuticai Co., LTD., et al.
`
`Page 6
`
`March 25. 2016
`
`Page 8
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`i
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`....E;"xooe-.i<:~.ut.;:.L.oro--
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`EXHIBITS
`PREVEOUSLY MARKED AND REFERENCED HEREIN
`Description
`No.
`Page
`Exhibit 1001 U.S. Patent 8,i29,43i B2,
`
`28
`
`EXI-IIBETS
`PREVIOUSLY MARKED AND REFERENCED HEREIN
`Description
`No.
`i Page
`Exhibit 1093 U.S. Patent 5,474,760,
`
`131
`
`8 pages
`Exhibit 1001 U.S. Patent 8,669,290 B2,
`10 pages
`Exhibit I004 U.S. Patent 4,910,225, 10 pages
`Exhibit 101 1 Patent Abridgment, Australian
`Patent Office, AU-B-22042/88,
`
`28
`
`59
`41
`
`31 pages
`
`12 pages
`Exhibit 1104 Reply Declaration ofPauI A.
`Laskar, Ph.D., 20 pages
`Exhibit 1105 US. Patent 2003/0053956Al,
`23 pages
`
`Exhibit 1148 International Patent Application,
`W002/058610 A1, 66 pages
`Exhibit I153 U.S. Patent 5,512,270, 11 pages
`Exhibit 2025 U.S. Patent 5,856,345, 7 pages
`Exhibit 2082 Declaration ofRobe1t O.
`
`Wiliiams III, i’h.D., 132 pages
`Exhibit 2097 Dunbrow Reference
`
`13
`
`101
`
`148
`
`174
`89
`
`83
`
`79
`
`Exhibit 2105 Declaration of Stephen G. Davies,
`D.PhiI, 56 pages
`Exhibit 21 14 Deposition transcript of Paul A.
`Laskar, November 4, 2015,
`327 pages
`
`54
`
`17
`
`E X I-I I B I T S
`PREVIOUSLY MARKED AND REFERENCED HEREIN
`
`Page 7
`
`Page
`Description
`No.
`Exhibit 1012 13.3. Patent 6,274,609 B1,
`1 1 pages
`
`63
`
`Exhibit 1019 Comparing the Surface Chemical
`Properties and the Effect of
`Salts on the Cloud Point ofa
`
`51
`
`Conventional Nonionic Surfactant,
`Octoxynol 9 (Triton X-100),
`and of Its Oligomer, Tyloxapol
`(Triton WR~1339), 7 pages
`Exhibit I052 Curricultnn Vitae of Paul A.
`Laskar, Ph.D., 4 pages
`Exhibit 1079 Deposition transcript of
`Robert 0. Williams III, Ph.D.,
`taken March 9, 2016, 39 pages
`Exhibit 1091 U.S. Patent 3,272,700,
`5 pages
`Exhibit 1092 U.S. Patent 6,165,445,
`22 pages
`
`,gv:>oe—.rc.\i.n.z>mr~a-—-
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`........
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`Page 9
`CI-IARLOTTE, NORTH CAROLINA, FRIDAY, MARCH 25, 201
`8:19 AM.
`-—oOo--
`P R 0 C E E D I N G S
`
`TI-IE VIDEOGRAPHER: We're now on the record.
`
`Piease note that the microphones are sensitive and may
`pick up whispering and private conversations. Please
`turn off all ceil phones or piace them away from the
`microphones as they can interfere with the deposition
`audio. Recording wili continue until ali parties
`agree to go off the record.
`This is the deposition of Dr. Paul A. Laskar
`in the matter oflnnopharma Licensing, iric., v. Senju
`Pharmaceuticals Company, Ltd. These are Case
`Nos. IPR20I5»00902 and lPR20E5-00903 before the Patent
`Trial and Appeal Board ofthe United States Fatent and
`Trademark Office.
`This video deposition is being taken at
`Aiston & Bird, LLP., 101 South Tryon Street,
`Suite 4000, Charlotte, North Carolina. The time is
`approximately 8: E9 a.m. Today is March 25, 2015
`(sic). The court reporter is Ms. Nancy Martin,
`
`866-928-6509
`
`Ace—Federal Reporters, Inc.
`
`3 (Pages 6 to 9)
`
`202-347-3700
`
`

`
`Paul Laskar
`
`lnnpharma Licensing, lnc._. et al. v. Senju Pharmaceutical Co._. LTD., et al.
`
`I\Ji—‘©\’DOO~.]C\<-fl-4fibJi\)>—$\D00-lO\Lh-I3-bJl\J*-4
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`pq[g;\_)._.._-...a._‘._......,....._.._..._-
`DO--.10\Ut-i>~LoJl\)-—-
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`Page 10
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`appearing on behalf of Ace Federal Reporters of
`Washington, D.C. The videographer is Bruce Moody,
`also appearing on behalf of Ace Federal Reporters of
`Washington, D.C.
`Counsel will please state their appearances
`for the record, and then the court reporter will swear
`in the witness.
`
`MR. I-IASFORD: Justin Hasford of Finnegan on
`behalf of patent owner, and with me is my colleague,
`Bradley Moore, also of Finnegan.
`DR. MALIK: Jitendra Malik ofAlston & Bird.
`
`With me is my colleague, James Abe, also of Alston &
`Bird, representing petitioner.
`
`PAUL LASKAR, PH.D.,
`having been first duty sworn,
`was examined and testified as follows:
`
`I would just like to correct.
`THE WITNESS:
`I believe you used 2015.
`I think we're 2016 this
`year.
`
`CROSSEXAMINATION
`BY MR. HASFORD:
`
`Q. Good morning, Dr. Laskar.
`A. Good morning.
`Q. Would you please state your name and address
`for the record.
`
`I reside at
`A. Sure. My name is Paul Laskar.
`603 Montecito Boulevard, Napa, California.
`Q. Doctor, I represent the patent owner, Senju,
`in these IPR proceedings. Today I wiil ask you
`questions, and all I ask is that you answer my
`questions truthfully and accurately. If you need a
`break, just iet 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 the question that I ask, please let me
`know. If you answer a question, I wiil assume that
`you understood the question.
`Is that okay?
`A.
`It is.
`
`Is there any reason why you cannot testify
`Q.
`truthfully and accurately today?
`A. No, there's no reason.
`
`March 25, 2016
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`Page I2
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`Ix.)-o\c>oo~.io\Ln.t>-uJt~.>—-o\D0°-JONUV-i=-L-Ji~>—‘
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`OO-JChUl-l5UJi\J>—-
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`MR. I-IASFORD: For the record, Pm handing
`Dr. Laskar and petitioner's counsel copies of
`Exhibits 2264 and 2265, which are Patent Owner's
`Notices of Cross-Examination of Dr. Paul A Laskar.
`
`(Deposition Exhibits 2264 and 2265
`
`were marked for identification.)
`MR. HASFORD: Counsel, can we stipulate that
`Dr. Laskar is here today pursuant to Exhibits 2264 and
`2265?
`
`i
`
`DR. MALIK: Yes.
`MR. HASFORD: Counsel, can we also stipulate
`that the questions that I ask, unless otherwise
`stated, apply equally to lPR2015-00902 and
`IPR20 1 5-00903?
`DR. MALIK: Yes. -902 and -903.
`MR. HASFORD: Let the record reflect that we
`
`hereby invoke the rule on witnesses pursuant to
`Federal Rule of Evidence 6l 5 prohibiting the showing
`of the transcript of this deposition or discussing any
`of its contents with Dr. Jayne Lawrence or any other
`witness for Lupin in connection with any
`IPR proceeding involving Prolensa.
`
`‘i
`
`Page 23
`
`DR. MALIK: And your designation is noted.
`We will follow the terms of the protective order.
`MR. I-IASFORD: Thank you.
`For the record, I'm handing Dr. Laskar and
`petitioner's counsel copies of Exhibit 1 104 entitled
`"Reply Declaration of Paul A. Laskar, Ph.D."
`(Previously marked Exhibit 1 104.)
`
`BY MR. l-IASFORD:
`Q. Is Exhibit 1104 your "REPLY DECLARATION"
`concerning U.S. Patent No. 8,129,431 and U.S. Patent
`No. 8,669,290?
`A. It certainly appears to be.
`Q. If I refer to U.S. Patent No. 8,129,431 as
`the ‘"431 patent," will you understand what I mean?
`A.
`I will.
`
`Q. Ifl refer to U.S. Patent No. 8,669,290 as
`"the '290 patent," will you understand what i mean?
`A.
`I will.
`
`Q. If 1 refer to Exhibit 1104 as your "reply
`declaration," will you understand what 1 mean?
`A. Yes, I will.
`
`Q. You did not yourself actually write your
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`4 (Pages 10 to 13)
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`202-347-3700
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`

`
`Paul Laskar
`
`lnnpharma Licensing, lnc., et al. v. Senju Pharmaceuticai Co., LTD., et al.
`
`Page I4
`
`OO‘-—'lG‘\U1-5:zL.»Jl\J--
`
`reply declaration for these IPR p1'0ceecli1'1gs; correct?
`A.
`I did not do the word processing for the
`totality of it.
`Q. Take a look, if you would, at the next
`exhibit that I'm going to hand you. For the record,
`I'm handing you, Dr. Laskar, and petitioner's counsel
`copies oflixhibit 1052 in lPR2015-00902.
`(Previously marked Exhibit 1052.)
`BY MR. i-EASFORD:
`
`\DO0*-JCNVJI-$>-LaJl\)>-*
`
`Is Exhibit 1052 in lPR2015—00902 a copy of
`Q.
`your curriculum vitae?
`A. Yes.
`
`Q. Let's start from the last page of your
`
`attention to the subheading "Other," and, in
`particular, the first fine.
`DR. MALIK: Outside the scope of his
`declaration.
`BY MR. HASFORD:
`
`Q. Let me know when you're there.
`A.
`l'm at the last page.
`Q. You are no longer an active registered
`
`pharmacist; correct?
`A. That is correct.
`DR. MALIK: Move to strike. Outside the
`
`scope.
`
`Actually, just to make things easier, in
`connection with this declaration, since it is outside
`the scope of this declaration, 1104, if you just give
`me a standing objection, iwon‘t disturb.
`MR. I-IASFORD:
`I can give you a standing
`objection. Obviously, I disagree with it, but I'll
`give you a standing objection.
`DR. MALIK: Thank you.
`BY MR. HASFORD:
`
`mid 1970’s; correct?
`
`I think that's probably correct.
`A.
`Q. You have never dispensed any bromfenac
`product to a patient; correct?
`A. That is correct.
`
`products containing tyloxapol; correct?
`A. That, I c!on‘t recall.
`
`March 25, 2016
`
`Page 16
`
`Q. Let me direct your attention to the
`subheading "Patents“ in your curricuium vitae. Please
`let me know when you are there.
`A. I'm there.
`
`Q. You have only ever submitted two patent
`applications; correct?
`A. That is correct.
`
`Q. One of your two patent applications is a U.S.
`patent application, and the other of your two patent
`appiications is a PCT application; correct?
`
`A. Yes.
`Q. Your one and only PCT application is directed
`to a method and composition for treating acne;
`correct?
`A. Yes.
`
`2
`
`i
`
`y
`
`Q. The '43] and '290 patents are not related to
`methods for treating acne; correct?
`A. Yes, that is correct.
`
`Q. Your one and only U.S. patent application is
`directed to Quinolone compositions; correct?
`A. The U.S. patent appiication is directed to
`Quinoione, ophtiiaimic product.
`
`Page 17
`
`Q. The ‘43l and '290 patents are not related to
`Quinolone compositions; correct?
`A. No. They overlap in that they're both
`ophthalmic formulation patents —- or related to
`ophthalmic formulations, I should say.
`
`MR. I-IASFORD: For the record, I am handing
`Dr. Laskar and petitioner's counsel copies of
`Exhibit 21 14, which is a transcript of the
`cross-examination of Dr. Paul A. Laskar, Ph.D. taken
`in these IPR proceedings on Wednesday, November 4,
`2015.
`
`,
`
`(Previously marked Exhibit 2E 14.)
`BY MR. HASFORD:
`
`Q. Turn, if you would, to Page 26 in
`Exhibit 21 14, and iet me direct your attention to
`Line 24.
`I ask you:
`"Q. The '43] and
`’290 patents are not
`related to quinolone
`compositions, correct?"
`MR. I-IASFORD: And you answered:
`"A. No, they are not."
`
`866-928-6509
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`5 (Pages 14 to 17)
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`202-347-3700
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`

`
`Paul Laskar
`
`lnnpharma Licensing, Inc., et al. v. Senju Pharmaceutical Co., LTD., et at.
`
`Page 18
`
`BY MR. i-IASFORD:
`
`00'--JO‘iU'I-£3-UJ1\.)-—~
`
`Q. That was the exact question that l asked you,
`and that was the exact answer that you gave; correct?
`DR. MALIK: Asked and answered.
`
`I don't recall what I verbally
`THE WETNESS:
`said, but this is -- I'm sure it is an accurate
`
`transcript. So i'm sure that's what I said.
`MR. I-IASFORD: You may put that document
`
`aside.
`
`Q. You have never filed a patent application
`involving the use of antioxidants; correct?
`A. That is correct.
`
`Q. Let me direct your attention to the
`subheading "Publications" in your curriculum vitae.
`It starts on Page 3 and continues to Page 4.
`A. lsee that.
`
`Q. You have only ever authored eight peer
`reviewed publications; correct‘?
`A. Yes, that appears to be so. Yes.
`Q. Your last publication issued in 1993;
`correct?
`A. Yes.
`
`March 25, 2016
`
`Page 20
`
`Q. The last presentation you gave was in 1992;
`correct?
`A. Yes --
`
`Q. You have never --
`A. That's correct.
`
`I apologize. You have never given a
`Q.
`presentation regarding the use of antioxidants;
`correct?
`
`A. No, l have not.
`Q. You have never held a faculty position beyond
`associate professor; correct?
`A. That is correct.
`
`Q. You have never heid a faculty position in any
`chemistry department; correct?
`A. Yes, that is correct, I've never held an
`
`academic position in the chemistry department.
`Q. You have never held yourself out to the
`public as an expert in medicinal or organic chemistry;
`correct?
`
`E
`
`1
`
`X
`
`A. That is correct. Ihave not held myself as
`an expert in those fields, only in pharmaceutical
`development and formulation development.
`
`Q. Your last publication which issued in 1993
`dealt with evaluation of sunscreen products; correct?
`A. Yes.
`
`Q. You have never held yourself out to the
`pubiic as an expert in the chemistry of antioxidants;
`correct?
`
`Page t9
`
`Page 21
`
`Q. The '43] and ‘.290 patents are not related to
`sunscreen products; correct?
`A. No, they're not related to sunscreen
`products. They're related to ophthalmic products.
`Q. You have only authored one peer reviewed
`publication since 1977; correct?
`A. Yes, that's correct.
`
`Q. You have never authored a peer reviewed
`publication regarding the use of antioxidants;
`correct?
`
`I have never authored a publication having to
`A.
`do with antioxidants.
`
`Q. Let me direct your attention to the
`subheading "Presentations" in your curriculum vitae.
`Please let me know when you are there.
`A.
`I'm there.
`
`Q. You have only ever given a total of four
`presentations; correct?
`A. That's correct.
`
`A. No, l have not held myself as an expert in
`antioxidant chemistry.
`Q. You are not familiar with the oxidative
`
`properties of diphenylmethane compounds; correct?
`A. Would you repeat the question, please.
`Q. Certainly. You are not familiar with the
`
`oxidative properties of diphenylmethane compounds;
`correct‘?
`
`I am not terribly familiar.
`A. Not explicitly.
`Q. You have provided opinions in these IPR
`proceedings on brornfenac products, yet you have never
`conducted any research on any bromfenac product;
`correct?
`
`_,
`
`\
`
`A.
`
`1 have not Conducted research on bromfenac.
`
`Q. Aside from your work in this case, you have
`never consulted for any party regarding any bromfenac
`product; correct?
`A.
`I have not consulted with anyone aside from
`this case on bromfenac expiicitly.
`
`866-928-6509
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`6 (Pages 18 to 21)
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`202-347-3700
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`

`
`Paul Laskar
`
`Ennpharma Licensing, Inc, et al. v. Senju Pharmaceuticai Co.. LTD._. et al.
`
`E\':DCo-—JCh<.h-I:~L;JIx.)-—-
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`Page 22
`
`Q. For how many years during your career did you
`formulate drug products to be marketed?
`A. Running from the present day back to 1982.
`So that would be about 34 years. 33 years and change.
`Q. You have never formulated any products
`containing bromfenac; correct?
`A.
`i believe I responded to that and indicated
`that I have not formulated bromfenac.
`
`O0"-I-JG\i-J‘:-I5-L-I-Jlxi-—‘
`
`Q. You have never formulated any marketed
`ophthalmic NSAID product containing tyloxapol;
`correct?
`
`I have not formulated any NSAID product that
`A.
`contains tyloxapol, that's correct.
`Q. Tyloxapol and polysorbate 80 both contain
`oxyethylene chains; correct?
`A. Yes, they do.
`Q. You have a bachelor of arts degree in general
`Science; correct?
`A. Yeah, that is correct.
`Q. Was your bacheior of arts degree in
`general -- I apologize. Did you have something else
`to say?
`
`A.
`have.
`
`I said yes, that is one of the degrees I
`
`Q. Was your bachelor of arts degree in general
`science different from your bachelor's degree in
`chemistry?
`A. Yes, it is different in that it lacks the
`
`required number of hours within the chemistry ma_j or to
`qualify for a chemistry degree.
`Q. You also do not have a master's degree in
`chemistry; correct?
`A. No, I have a master's degree in pharmacy.
`Q. You also do not have a Ph.D. degree in
`chemistry; correct?
`A. No. My Ph.D. degree is in pharmaceutical
`Sciences.
`
`Q. Youhave never been qualified by the patent
`office as an expert in chemistry; correct?
`A. No, I have not.
`Q. You have never been qualified by any court as
`an expert in chemistry; correct?
`A. I'm not quite sure what that means, but if
`there's a particular qualification, that would be
`
`March 25, 2016
`
`Page 24
`
`I don't have any particular court appointed
`correct.
`qualification.
`Q. You have never published anything in the
`Journai of the American Chemical Society; correct?
`A.
`i have not published in that journai.
`Q. You are not a. member of the American Chemical
`Society; correct‘?
`A. No, I am not a member of that society.
`Q. You have never consulted for the FDA;
`correct?
`
`1 have never consuited for the FDA. No, I
`A.
`have not.
`
`Q. You are not an expert in FDA regulatory law;
`correct?
`
`1 am very familiar with regulatory law, and
`A.
`I'm not exactly sure what you mean by expert in that
`context.
`
`Q. You have never been quaiified as an expert in
`FDA reguiatory law; correct?
`A. Can you enlighten me as to what sort of
`quaiification that might be?
`Q. You have never been qualified by any court or
`
`i
`
`
`
`..-t~...«n~,....a..»..;<.NW1..m.s;i..~...,..i.i...:.....i..a,...._..»...n....c»/..\,..~...i.
`
`Page 25 m.n..».n...4.
`by the patent office as an expert in FDA regulatory
`law; correct?
`A. Neither of those two organizations have
`qualified me in that regard.
`Q. You are absolutely not an expert in patent
`law; correct?
`
`I'm absolutely not an expert in patent iaw.
`A.
`Q. Are you familiar with aikyiphenols?
`A.
`I am.
`
`Q. How many different alkylphenols could
`possibly exist?
`A. Quite a number.
`Q. Do you know how many?
`A. At this moment, I would be severely
`speculating if I were to give you any number.
`Q. Are you familiar with amide, a—1n-i-d-e,
`groups?
`A.
`I am.
`
`Q. Amide groups are hydrolyzable; correct?
`A. Yes, they are, in general, hydrolyzable.
`Q. Are you familiar with free radical
`scavengers?
`
`.».....a..
`
`;
`}
`
`,u.;Au'A4u'I.\'-1;;
`
`866~928~6509
`
`Ace-Federal Reporters, Inc.
`
`7 (Pages 22 to 25)
`
`202-347-3700
`
`

`
`Paul Laskar
`
`lnnpharma Licensing, Inc._. et al. v. Senju Pharmaceutical Co., LTD., et al.
`
`March 25, 2016
`
`A.
`
`I am familiar as a formulator with free
`
`MR. HASFORD: You're welcome.
`
`(Previously marE<ed Exhibit 1001.)
`BY MR. I-IASFORD:
`
`Q. You have reviewed the '43l patent in
`connection with your opinions in this IPR proceedings;
`is that correct?
`
`i
`
`A. Yes, I have reviewed the '43} patent.
`MR. HASFORD: You can put that to the side
`for a moment. We will get back to it shortly.
`For the record, I'm handing Dr. Laskar and
`petitioner's counsel copies of Exhibit 1001 in
`IPR20i 5—00902, which is the '290 patent.
`(Previously marked Exhibit 1001.)
`DR. MALIK: Thank you.
`MR. HASFORD: You're weicome.
`BY MR. HASFORD:
`
`Q. You have reviewed the '290 patent in
`connection with your opinions in these
`IPR proceedings; correct?
`A. Yes, I have.
`Q. Please turn to the claims of the '43] and
`
`‘290 patents. The ciaims of the '43l patent begin at
`
`Column II.
`
`The claims of the '290 patent begin at
`Column 12. Please review those. Take as much time as
`you need, and let me know when you're ready.
`(The witness reviewed Exhibit 1001.)
`THE WYFNESS:
`I reviewed the claims in both
`
`E
`
`'
`
`the '290 and the '43} patents.
`BY MR. HASFORD:
`
`i'm going to ask you some questions about the
`Q.
`claim formulations of the '43l and ‘290 patents, but I
`would like to ask you some preliminary questions
`first. Okay?
`A. Okay.
`Q.
`I-low do metals differ fi‘om metal cations?
`
`DR. MALIK: Incomplete hypothetical.
`THE WITNESS: Metal cation, in as much as it
`says, "cation," means that it is a positively charged
`version of whatever element that might be, and the
`metal per se would be that element in an uncharged
`state.
`
`BY MR. HASFORD:
`
`Q. Do the claimed formulations of the '43l and
`
`E§xooo-.1cxLn.tao;1o-—-
`
`\OOO'--JO\U1-lb-LaJl\J-H
`
`radical scavengers.
`Q. Do all free radical scavengers function as
`antioxidants?
`
`A. Of those that I work with as a formuiator,
`that is —— the free radical scavengers are —— their
`purpose in the formulations for which i work are as
`antioxidants.
`
`Q. Free radicals may catalyze hydrolysis;
`correct?
`
`DR. MALIK: Incomplete hypothetical.
`THE WITNESS:
`I suppose it is remotely
`possible that that's a possibility.
`I would not --
`cannot at this point in time give you mechanistic
`discussion about how that might occur.
`BY MR. I-IASFORD:
`
`Q. Piease turn to the front page of your reply
`declaration. Preliminarily, you will note that in
`your reply declaration there are two sets of page
`
`and then a number. Do you see that?
`A.
`I do.
`
`Q. And then there's a second set of page numbers
`that is on the lower center of each page that runs one
`number behind the page numbers on the lower right-hand
`corner of each page. Do you see that?
`A.
`I see the centered numbers.
`
`Q. When I refer to page numbers in your
`declaration, I will try to refer to the centered
`numbers. Ifyou have any question, please let me
`know.
`
`A. Okay.
`Q. So let's turn back to the front page of your
`reply declaration, please. You identify the '431 and
`'290 patents on the front page of your reply
`declaration. Do you see that‘?
`A.
`I do.
`
`MR. HASFORD: For the record, I'm handing
`Dr. Laskar and petitioner's counsel copies of
`Exhibit 100] in IPR20i5-00903, which is the '43]
`patent.
`DR. MALIK: Thank you.
`
`l 2 3 4 5 6 7 8
`
`I\J-—CD\OOO‘-.JG\l.h-lLLaJI\Jr—-CD\9
`
`[\Jt\)|\_)-—»—-i—r-—->-o—-»—..nu—o......._.
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`8 (Pages 26 to 29)
`
`202-347-3700
`
`

`
`Paul Laskar
`
`lnnpharma Licensing, lnc., et al. v. Senju Pharmaceutical Co.. LTD., et al.
`
`March 25, 2016
`
`Page 32
`
`\D0O‘~JC\l.J‘|-IALaJl\J*—‘
`
`Page 30
`
`'290 patents contain metals, or do they contain metal
`cations?
`
`DR. MALIK: Calls for a legal conclusion.
`THE WITNESS: As I read the claims, the
`
`cations present are identified as being in their salt
`form, which would mean that they are in their
`positively charged form.
`BY MR. I-IASFORD:
`
`Q. Just to be clear, do the claimed formulations
`of the '43l and '290 patents contain metals, or do
`they contain metal cations?
`DR. MALIK: Calls for a legal conclusion.
`TI-IE WITNESS: Specifically, the claims refer
`to salts, of which -- and I recall preclorninantly
`sodium salts. And so, therefore, the sodium is
`present as the sodium cation.
`BY MR. I-EASFORD:
`
`Q. The claimed formulations of the
`patents—in—suit do not include a hypochlorous acid;
`correct?
`
`A. No, they do not. Hypochlorous acid is not
`present in either the claims in those two patents.
`
`Page 3]
`
`.is<..am._.o\ooo-.Jo\ua4=-usi\.)»—-
`
`>—l>—-li:th—-It-#
`
`Q. And the claimed formulations —— I apologize.
`I asked that question poorly. Let me try it again.
`The claimed formulations of the ‘43l and '290
`patents do not include hypochlorous acid; correct?
`DR. MALIK: Calls for a legal conclusion.
`TI-IE WITNESS: Hypochlorous acid is not
`present in any of the claims of those two patents.
`BY MR. I-IASFORD:
`Q. The claimed formulations of the '43] and '290
`patents do not include chromic acid; correct?
`DR. MALIK: Calls for a legal conclusion.
`TI-IE WITNESS: No, they do not contain chromic
`acid per se,
`BY MR. HASFORD:
`Q. The claimed formulations of the ‘43l and '29O
`patents do not include hydroxyl radicals; correct?
`DR. MALIK: Calls for a legal conclusion and
`
`on-.Jo\<..n-l=L.al\Jv—‘
`
`.—-@\D%'-.lCa\UI-l=-bJt\J>-
`
`_.._.
`
`BY MR. HASFORD:
`
`Q. The claimed formulations of the '43] and '290
`
`patents do not include partially reduced 02 species;
`correct?
`
`DR. MALIK: Calls fora legal conclusion.
`THE WITNESS: And for the same reason, it is
`not explicitly identified.
`BY MR. HASFORD:
`
`Q. The claimed formulations of the ‘£131 and '290
`patents are formulated for ophthalmic adrninistrationyt
`correct?
`4
`A. Yes ——
`
`DR. MALIK: Calls for a legal conclusion.
`THE WITNESS: Yes, it appears that they are
`formulated for ophthalmic use.
`BY MR. HASFORD:
`
`Q. The claimed formulations of the ‘£131 and '290
`patents are not formulated for nasal administration;
`correct‘?
`
`DR. MALIK: Calls for a legal conclusion.
`TI-IE WITNESS: The claims themselves, as I
`recall, do not refer to routes of administration other
`
`E
`
`than ophthalmic.
`BY MR. HASFORD:
`Q. The claimed formulations of the '43l and '290
`patents are not formulated for pharyngeal
`administration; correct?
`DR. MALlI(: Calls for a legal conclusion.
`THE WITNESS: The formulations as —— in the
`claims do not explicitly indicate their use for
`pharyngeal administration.
`BY MR. I-IASFORD:
`Q. The '431 and '290 patents do not involve
`light degradation; correct?
`DR. MALIK: Vague.
`THE WITNESS: There's no reference to light
`in any of the claims.
`BY MR. I-IASFORD:
`Q. Take a look, if you would, at Exhibit 21 14
`again, which is the transcript from your
`cross—examinatior1 conducted on November 4, 2015. Let
`me direct your attention to Page 113.
`In particular,
`let me direct your attention to Line 19.
`I asked you:
`AA ,,-W,-..4t-.1. .1, ...,--,...»-t. .;.-,...,~,,,m,.-,..,,t .,.». m at-'>.~¢!»~‘.-':1,.v:/.3.Fwm.~.>: t... ., '/n‘n§."1--r-it/-VI 11:4 It)‘/4'14 :-..l-..,c..,.-.,.l=...-.-.1,-.,../.. .-.2
`
`-:
`
`form
`
`
`‘THE WITNESS: The claims do not identify
`those radicals as such. Whether they're present or
` of further investigation.
`not in the actual formulations, it would be a matter
`
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`
`Ace-Federal Reporters, Inc.
`
`9 (Pages 30 to 33)
`
`202-347-3700
`
`

`
`Paul Laskar
`
`lnnpharma Licensing, lnc., et al. v. Senju Pharmaceutical Co., LTD., et al.
`
`March 25, 2016
`
`Page 36
`
`\D0O'-~—]O'\U1-l>b->E\J~—‘
`
`"Q. The different
`physical and chemical
`properties that different
`non-ionic surfactants
`
`possess in aqueous liquid
`preparations would also
`depend on the active
`pharmaceutical ingredient
`in the formulation, correct?"
`MR. HASFORD: And then there was an
`
`objection, and then you answered:
`"A. It would depend --
`I -- the -- the impact of
`whatever that active
`
`pharmaceutical ingredient
`would be on the non-ionic
`
`surfactant would, I think,
`be encompassed by those other
`excipients because the
`ionic nature, et cetera, of
`those ingredients would be
`analogous to those other
`
`excipients. And in a
`practical matter, from —— for
`ophthalmic formulations,
`essentially all ofthose
`other ingredients are there
`in really quite low
`concentrations so that
`
`their true impact and
`practical manner is
`usually minimal."
`BY MR. I-IASFORD:
`
`Q. Do you see that?
`A.
`I see that.
`
`DR. MALIK: Asked and answered. Again,
`compound.
`Imprope1' impeachment.
`BY MR. HASFORD:
`
`Q. You testified that all of the excipients in
`the claimed formulations of the ‘£133 and ’290 patents
`are present in "realiy quite low concentrations";
`correct?
`
`THE WITNESS: That's what I stated in that
`
`declaration, yes.
`BY MR. HASFORD:
`
`is it your opinion that the .02 weight per
`Q.
`volume percent concentration of tyioxapol in the
`formulations of Claim 6 and 20 of the '43l patent
`quite low concentration?
`DR. MALIK: Outside the scope of his
`deciaration. Move to strike.
`
`,
`
`THE WITNESS: In which claim are you
`referring to again?
`MR. HASFORD: Take a look, ifyou would, at
`Claims 6 and 20 of the '431 patent, and I'll ask you
`the question again.
`(The witness reviewed the document.)
`BY MR. HASFORD:
`
`Q. Tell me when you're there.
`A.
`I‘m there.
`
`Is it your opinion that the 0.02 weight per
`Q.
`volume percent concentration of tyloxapol in the
`forznuiations of Claim 6 and 20 of the '43l patent is .
`quite iow concentration?
`
`DR. MALIK: Outside the scope of his
`declaration. Move to strike.
`THE WITNESS: While in an ahsoiute sense, the
`concentration is quite low.
`.02 percent is quite low.
`That concentration from a functional perspective is
`appropriate for its use as an ophthalmic excipient.
`BY MR. I-IASFORD:
`Q. You can put that document aside. Please
`turn, if you would, back to your reply declaration.
`And let me direct your attention to Paragraph 2 on
`Page 1 of your reply declaration.
`A.
`I see it.
`Q. In the first two sentences you state, "Patent
`Owners’ experts take the position that Fu does not
`disclose tyloxapol to a skilled artisan.
`I disagree."
`Do you see that?
`A. [see it.
`
`Q. Now, in fact, Doctor, you wouid admit that
`the Fu reference does not teach the use oftyloxapol;
`correct?
`
`A. The Fu reference does not explicitly use the
`word "tyloxapol." It refers to, as 1 indicated, that
`:.«.-..»-¢.«. ..«.~.».«.::.<.,..«..«.-. rm‘ )'I\, v'»IV7,7I'l»")\'1 u-:.;.. : .:A,;.;...-4...»-u. M-M-,-.. ..,:...,. ...- . )\4\l-I\‘V»\-/‘“-fil/1‘-wyfl-V .'<-—.'«:
`....'..-..
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`in-..;.-.:.=w-..=-N-M-ax-.w..;WI».u..
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`5%
`I
`2':
`
`I
`
`366-928-6509
`
`Ace-Federai Reporters, Inc.
`
`10 (Pages 34 to 37)
`
`202-347-3700
`
`

`
`Paul Laskar
`
`lnnpharma Licensing, lnc., et al. v. Senju Pliarmaceutical Co., LTD, et al.
`
`March 25, 2016
`
`tyloxapol by name."
`BY MR. HASFORD:
`
`,
`
`5
`
`E
`
`Q. Those are the exact questions that I asked
`you, and those were the exact answers that you gave;
`correct‘?
`DR. MALIK: Maintain same objections. Also
`improper impeachment.
`THE WITNESS: Yes. Those words are, I
`
`presume, to be an accurate reflection of what I said.
`MR. HASFORD: You may put that document
`
`aside.
`Q. Please Eook at Paragraph 2 again on Page I of
`your reply declaration. Actually, strike that.
`Please look at Paragraph 3 on Page 1 of your
`reply declaration.
`A.
`I see Paragraph 3.
`Q.
`in the first sentence you state, "Tyloxapol
`falls within the series disclosed by Fu." Do you see
`that?
`A. lsee that.
`
`Q. All of the formulations indicated in the Fu
`reference utilize Octoxyncl 40; correct?
`
`A. May I see the patent?
`MR. HASFORD: Certainly.
`For the record, I'm handing Dr. Laskar and
`petitioner's counsel copies of Exhibit 10]], which is
`the Fu reference.
`
`(Previously marked Exhibit 1011.)
`DR. MALIK: Vague and ambiguous. Legal
`conclusion.
`
`(The witness reviewed Exhibit 1011.)
`THE WITNESS: May I ask you to repeat the
`question, please.
`BY MR. HASFORD:
`
`Q. Certainly. All of the formulations indicated
`in the I-‘u reference utilize Octoxynol 40; correct?
`DR. MALIK: Same objections.
`Tl-IE WITNESS: The Fu reference, with the
`exception of Example 5, document the use of
`Octoxynol 40. The Example 5 identifies compositions
`that have concentrations of between 80 and merge 52 as
`well as compositions containing OctoxynoE 40.
`BY MR. HASFORD:
`
`,
`
`5
`
`Q. Octoxynol 40 and tyloxapol have different
`
`Page 38
`
`it teaches the family, if you will, of ethoxilated
`octyiphenol surfactants with particular mold ratios
`within which tyloxapol falls.
`Q. Take a look, ifyou would, again at
`Exhibit 21 14, which is the transcript of your
`cross—examination in these IPR proceedings from
`November 4, 2015. And let me direct your attention to
`Page 104, and in particular, to Line 2. Tell me when
`you're there.
`A.
`I'm there.
`
`\OOO*-JC\(.n-&-LaJK\J'—-
`
`Q.
`
`I ask you:
`“Q. The Fu reference
`does not teach the use of
`
`tyloxapol, con-ect?"
`MR. HASFORD: And you answered:
`"A. Again in a similar
`manner, it teaches the use
`of a —— of