`
`Meese, Claus
`
`January 20, 2015
`
`STR CT COURT
`,
`IfiLAWAR7
`
`3 PHARMA GM:
`'""s
`
`VS.
`
`C.V. No. 13-lllO(GMS)
`
`%ORATOR
`
`1
`
`' I., CONSOL
`
`AL ATTORN1
`
`Videotaped Deposition of Claus Meese
`
`Vol
`
`1
`
`Taken aL _he 0 "ices 0;:
`
`& ?mery
`Mcjermott Wii'
`AV nu
`d s N rvi ns 9 31
`1040 Brussels
`
`Tuesday, 20th January 2015
`
`At 9.49 a.m.
`
`202-220-415 8
`
`Henderson Legal Services, Inc.
`WWW.hendersonlegalservices. com
`
`Restricted Confidential - Subject to Protective Order
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1076A — Page 1
`PFEO1830530
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1076A - Page 1
`
`
`
`CONFIDENTIAL - ATTORNEYS‘ EYES ONLY
`
`Meese, Claus
`
`January 20, 2015
`
`*'.HAT.J:' OJ:' BUA NT J:'J:'S and TH‘.
`
`TN*'.SS:
`
`WH T4‘.
`
`& CASL LLB
`
`L55 Avenue o_ -he Americas
`
`ew York, New York 10036-2787
`;2.8l9.8255
`
`AWfiS S. TRAZNOR, ESQ.
`:rainor@whitecase.com
`JRGLN HASSA
`1
`
`rgen.hassa@ucb.com
`%fiCCA MCCULLOUGH
`
`N7‘i—\
`
`('
`
`WLLCLI.
`
`'. DAN1‘ , ABOT *'.X ,
`
`RAKOCHY MOTTNO IVIAHHOCH
`Six West Hubbard Street
`Suite 500
`
`S
`
`Chicago, "i'inois 60654
`3‘7.597.9 57
`SY BHONfi:
`fiR N EOR%fiS
`
`e‘orbes@rmms'egai.com
`
`Duh. JAMES, H.
`W
`£3:
`
`-IAQKR D
`AXIIN\T, VELTROP &
`1L4 Wes- 47-h SLree_
`
`Vew Yor<, New Yor< 10036
`2;2.728.2200
`
`SY PHONL: MATT MU?P{Y ISQ.
`
`mmurphy3axinn.com
`
`202-220-415 8
`
`Henderson Legal Services, Inc.
`WWW.hendersonlegalservices. com
`
`Restricted Confidential - Subject to Protective Order
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1076A — Page 2
`PFEO1830531
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1076A - Page 2
`
`
`
`CONFIDENTIAL - ATTORNEYS‘ EYES ONLY
`
`Meese, Claus
`
`January 20, 2015
`
`-.
`
`iDAi\T'I‘S , SAN
`
`fiMfiRY
`MCDERMOTT W"LL &
`227 West Monroe Street
`
`Chicago, “"inois 60606-5096
`3;2.984.58;0
`
`s;o@mwe.com
`WAN—SHON LO
`
`' OE D%E%NDANTS, WOCKHARi
`USA, LLC:
`
`KNO%%fi, MART?NS, OLSON &
`2040 Main Street
`;—:h Floor
`
`Irvine, Ca'i‘ornia 97614
`9—9.760.0404
`
`IAR?N CASS"3Y, ?SQ.
`
`karen.cassidy@k1obbe.com
`
`Also Present:
`
`Kay Hendrick — Court Reporter
`
`Simon Ritson — Videographer
`
`Andrea soyer — "nterpreter
`
`202-220-415 8
`
`Henderson Legal Services, Inc.
`WWW.hendersonlegalservices. com
`
`Restricted Confidential - Subject to Protective Order
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1076A — Page 3
`PFEO1830532
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1076A - Page 3
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`
`
`CONFIDENTIAL - ATTORNEYS‘ EYES ONLY
`
`Meese, Claus
`
`January 20, 2015
`
`"nterpre
`
`CLAUS MfifiSfi
`
`Examination by Ms Cassidy:
`
`X H
`
`3
`
`T S
`
`US L
`
`-en
`
`6,858,650
`
`US L
`
`-en
`
`7,384,980
`
`US L
`
`-en
`
`7,885,230
`
`US L
`
`-en
`
`7,985,772
`
`US L
`
`-en
`
`8,338,478
`
`Agreemen'
`
`re inventors
`
`bonus
`
`Exhibi'
`
`?nglish translation o‘ 6
`
`Exhibi'
`
`Timetable o: development
`
`o: Fesoterodine
`
`Exhibi'
`
`{istory o: SPM O07
`
`?xhibi'
`
`Tnglish Translation
`
`of 9
`
`NC? Project
`
`Tolterodine
`
`?nglish Translation
`
`of ll
`
`Chemical Development
`
`Plan Zncontinince Project
`
`202-220-415 8
`
`Henderson Legal Services, Inc.
`WWW.hendersonlegalservices. com
`
`Restricted Confidential - Subject to Protective Order
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1076A — Page 4
`PFEO1830533
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1076A - Page 4
`
`
`
`CONFIDENTIAL - ATTORNEYS‘ EYES ONLY
`
`Meese, Claus
`
`January 20, 2015
`
`Tngiish Translation
`
`of 13
`
`Second Team Meeting
`
`NCfi ncontinence
`
`Third Team Meeting
`
`NCfi ncontinence
`
`"ncontinence
`
`Project
`
`Chemical Development
`
`Plan Update 4
`
`Lab notebook
`
`PT 02075909
`
`English Translation
`
`of 19
`
`Chemical Development
`
`Plan Update 5
`
`Chemical Development
`
`Plan Update 5
`
`Team Meeting NCE
`
`Incontinence 25-6-98
`
`Team Meeting NCE
`
`Incontinence 10-8-98
`
`Team Meeting NCE
`
`Incontinence 1-10-98
`
`202-220-415 8
`
`Henderson Legal Services, Inc.
`WWW.hendersonlegalservices. com
`
`Restricted Confidential - Subject to Protective Order
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1076A —
`
`Page 5
`PFEO1830534
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1076A - Page 5
`
`
`
`CONFIDENTIAL - ATTORNEYS‘ EYES ONLY
`
`Meese, Claus
`
`January 20, 2015
`
`?uropean Patent
`
`Application 17-11-99
`
`Minutes o: Team Meeting
`
`NCfi ncontinence 29-1-99
`
`Chemical Development
`
`Plan 24-2-99
`
`NCfi ncontinence Meeting
`
`Incontinence 28-5-99
`
`Minutes o: CMC Sub Team
`
`8-10-99
`
`Analytical
`
`15-10-99
`
`Minutes o: Project
`
`SPM 909
`
`33 e-mail
`
`from
`
`A. Schuetz
`
`202-220-415 8
`
`Henderson Legal Services, Inc.
`WWW.hendersonlegalservices. com
`
`Restricted Confidential - Subject to Protective Order
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1076A — Page 6
`PFEO1830535
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1076A - Page 6
`
`
`
`CONFIDENTIAL - ATTORNEYS‘ EYES ONLY
`
`Meese, Claus
`
`January 20, 2015
`
`Tuesday, 20th January 2015
`
`THfi V DfiOGRAPHLR: Good morning,
`
`this is
`
`the beginning o: Tape One, Volume One in the
`
`deposition of Dr Claus Meese taken on 20th
`
`January 2015 at 9.49 am, as indicated on the video
`
`screen. This deposition is being taken in the
`
`matter o" P"i4er "nc. and UC3 Pharma GMBH,
`
`P'ainLi
`
`s, versus Aikem Laboratories Limited et
`
`a’, De‘endant's, case number CA13—l;lO (GMS)
`
`Consolidated, being heard in the United States
`
`District Court for the District o‘
`
`Delaware.
`
`The deposition is taking place at the
`
`"ices o: McDermott Wiii
`
`& ?mey in Qrusseis,
`
`'gium.
`
`The videographer is Simon Rutson.
`
`The
`
`Court Reporter is Kay Hendrick on behai
`
`o
`
`Henderson Legal Services.
`
`Would counsel
`
`in the room please
`
`introduce themselves and state whom they
`
`represent?
`
`MS CASSZDY: Karen Cassidy from Knobbe,
`
`Martens, Olson & 3ear representing the Wockhardt
`
`fendant's.
`
`MS LO: Wan—Shon Lo representing the
`
`202-220-415 8
`
`Henderson Legal Services, Inc.
`WWW.hendersonlegalservices. com
`
`Restricted Confidential - Subject to Protective Order
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1076A — Page 7
`PFEO1830536
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1076A - Page 7
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`
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`CONFIDENTIAL - ATTORNEYS‘ EYES ONLY
`
`Meese, Claus
`
`January 20, 2015
`
`fendants Sandoz Inc.
`
`MR HASSA:
`
`Jurgen Hassa European Patent
`
`Attorney, representing UC3.
`
`MR TRAINOR:
`
`Jin Trainor from White &
`
`Case in New York on behai
`
`o
`
`the P'ainti
`
`s
`
`P‘izer, UCR, also on beha'
`
`o
`
`the witness. With
`
`me today is my colleague Rebecca McCullough.
`
`THfi V D%OGRAPH Q: Would counsel
`
`appearing telephonically please introduce
`
`yourselves and state who you represent?
`
`MR MURRHY: Matt Murphy on behai
`
`o
`
`Axinn Veltrop & {arkrider on behal
`
`o
`
`the He‘
`
`Defendant's.
`
`MS EOR%fiS: Good morning. This isl
`
`Forbes from Rakoczy Molino Mazzochi Siwik
`
`representing Apotex Inc.
`
`THfi V 3fiOGRAPHjR: Anyone else on the
`
`”nterpreter a
`
`‘irmed.
`
`CLAUS M11
`
`having been d I
`
`testified as
`
`Examination by Ms Cassidy:
`
`Q. Good morning, Dr Meese. Could you
`
`202-220-415 8
`
`Henderson Legal Services, Inc.
`WWW.hendersonlegalservices. com
`
`Restricted Confidential - Subject to Protective Order
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1076A — Page 8
`PFEO1830537
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1076A - Page 8
`
`
`
`CONFIDENTIAL - ATTORNEYS‘ EYES ONLY
`
`Meese, Claus
`
`January 20, 2015
`
`please state your name and address for the record?
`
`A. My name is Claus Meese and my
`
`address is —— my name is Claus Meese, Kreuzberger
`
`50, 40748 Monheim, possibly 789 Monheim.
`
`Q.
`
`Dr Meese, are you represented by
`
`counsel
`
`today?
`
`MR TRAZNOR:
`
`I represent to you that we
`
`are representing the witness it he is confused by
`
`that but
`
`MS CASSZDY:
`
`Dr Meese, have you ever
`
`b
`
`n d pos d b for ?
`
`A. No, never.
`
`Q. Alright.
`
`.Are you aware o; any
`
`reason you would be unable to give full and
`
`accurate testimony today?
`
`A. No.
`
`Q.
`
`So a few ground rules for how we are
`
`going to run this deposition.
`
`I will ask you
`
`questions.
`
`The Court Reporter is here to take
`
`down the questions and your answers. Rlease make
`
`sure to give verbal responses so that the Court
`
`Reporter can take down your response and please
`
`wait Jntil the question has been completed before
`
`you answer it?
`
`A. Yes.
`
`202-220-415 8
`
`Henderson Legal Services, Inc.
`WWW.hendersonlegalservices. com
`
`Restricted Confidential - Subject to Protective Order
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1076A — Page 9
`PFEO1830538
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1076A - Page 9
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`
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`CONFIDENTIAL - ATTORNEYS‘ EYES ONLY
`
`Meese, Claus
`
`January 20, 2015
`
`Q.
`
`"" you do not understand a question
`
`please let me know otherwise I will assume that
`
`you understand?
`
`A. Okay.
`
`Q. Your attorney may object, please
`
`answer the question Jnless you are instructed not
`
`to answer by your attorney?
`
`A. Okay.
`
`Q. And i: you need to take a break just
`
`: me know and we can take a break at any time
`
`_ ii there is a question pending please answer
`
`7
`
`w
`
`tak a break?
`
`A. Okay, yes.
`
`Q. Did you do anything to prepare
`
`this deposition?
`
`A. We have had some discussions with
`
`our lawyers, and I had a look at previous document
`
`from the patent literature and our own work in
`
`order to recall everything, because some time has
`
`passed since that time.
`
`Q. Did you mee
`
`'-h anyone aside
`
`your attorney to prepare _
`
`-he deposition?
`
`A. No.
`
`Q. And did you review any documents
`
`while you were preparing ‘or this deposition?
`
`202-220-415 8
`
`Henderson Legal Services, Inc.
`WWW.hendersonlegalservices. com
`
`Restricted Confidential - Subject to Protective Order
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1076A — Page 10
`PFEO1830539
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1076A - Page 10
`
`
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`CONFIDENTIAL - ATTORNEYS‘ EYES ONLY
`
`Meese, Claus
`
`January 20, 2015
`
`A. Yes, as I mentioned before the
`
`patent literature and our own documents,
`
`the
`
`patent which we have filed in order to recall this
`
`world.
`
`Q. We are going to start with a little
`
`bit of your background. Could you please describe
`
`your education history since after high school?
`
`A. Yes,
`
`I started organic chemistry and
`
`as well as pharmaceutical chemistry and pharmacy
`
`and made my diploma and Doctor of thesis at the
`
`university of Hamburg. And afterwards, do you
`
`want me to tell what I did later on?
`
`Q. Yes, actually that was going to be
`
`my next question,
`
`so you could explain a__er you
`
`finished your formal education what your first job
`
`was?
`
`A.
`
`I have had a job at the University
`
`of Hamburg.
`
`I was a so—called assistant for the
`
`advanced chemistry student. And after that time
`
`it changed to the administration authorities of
`
`Hamburg,
`
`the Department of Environmental Affairs,
`
`and I specialized on the analytics of water,
`
`that
`
`means any kinds of water,
`
`tap water and bath
`
`water,
`
`swimming and so on. After a time
`
`I changed.
`
`202-220-415 8
`
`Henderson Legal Services, Inc.
`WWW.hendersonlegalservices. com
`
`Restricted Confidential - Subject to Protective Order
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1076A — Page 11
`PFEO1830540
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1076A - Page 11
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`
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`CONFIDENTIAL - ATTORNEYS‘ EYES ONLY
`
`Meese, Claus
`
`January 20, 2015
`
`I moved to Stuttgart and used to work in
`
`the Institute of Clinical Pharmacology,
`
`Dr Margarete Fischer—Bosch,
`
`that is a private
`
`institution sponsored by the Robert Bosch
`
`Foundation in Stuttgart. And I used to work there
`
`for 14 years and I established a chemistry
`
`department at this Institute and primarily made
`
`studies on drugs, drug metabolism,
`
`in—vitro as
`
`well as animal studies, analytics, and after that
`
`time, which ended in 1993,
`
`I moved to a
`
`pharmaceutical company, Schwarz Pharma, at that
`
`time in Monheim, Germany, and I was responsible
`
`for the Chemistry Department of this Company.
`
`In this Company I was involved in the
`
`development of new drugs and all chemistry affairs
`
`which occur in a pharmaceutical company until
`
`2007. And during that time there was a time where
`
`very many papers were published and patents were
`
`made on different issues. This is well
`
`documented.
`
`Q. And after 2007 were you employed
`
`anywhere else or did you retire at that time?
`
`A. After 2007 when I left the Company
`
`I retired.
`
`Q.
`
`Thank you.
`
`202-220-415 8
`
`Henderson Legal Services, Inc.
`WWW.hendersonlegalservices. com
`
`Restricted Confidential - Subject to Protective Order
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1076A — Page 12
`PFEO1830541
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1076A - Page 12
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`
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`CONFIDENTIAL - ATTORNEYS‘ EYES ONLY
`
`Meese, Claus
`
`January 20, 2015
`
`A. And the reason was simply that my
`
`Company was merged with UCB Pharma GMBH from
`
`Belgium, and it was clear that many changes would
`
`occur there due to process, so I decided to leave
`
`the Company.
`
`It was a smooth goodbye from this
`
`Company, so I said yes. Any more questions?
`
`Q. Are you familiar with a compound
`
`festoterodine fumarate?
`
`A. Yes, yes.
`
`I can say yes,
`
`I know
`
`this compound.
`
`Q. Did you work with festoterodine
`
`fumarate anywhere besides your employment at
`
`Schwarz?
`
`A. No, never. Never.
`
`Q. And do you understand that the
`
`r—enantiomer o_ Lhe festoterodine fumarate may
`
`also be referred to as SPM 8272?
`
`A. Yes,
`
`I know that.
`
`Q. Okay. And are you familiar with the
`
`festoterodine freebase?
`
`A. Yes,
`
`I am.
`
`Q. Did you work with that anywhere
`
`besides at Schwarz Pharma?
`
`A. No, never.
`
`Q. And do you understand that the
`
`202-220-415 8
`
`Henderson Legal Services, Inc.
`WWW.hendersonlegalservices. com
`
`Restricted Confidential - Subject to Protective Order
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1076A — Page 13
`PFEO1830542
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1076A - Page 13
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`
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`CONFIDENTIAL - ATTORNEYS‘ EYES ONLY
`
`Meese, Claus
`
`January 20, 2015
`
`r—enantiomer o_ '
`
`jreebase may also be re:
`
`to as SPM 8224?
`
`A. Yes, it's the freebase.
`
`It's
`
`freebase.
`
`8272 is the salt.
`
`Q. And are you familiar with a compound
`
`called tolterodine?
`
`A. Yes.
`
`Q. Did you work with tolterodine
`
`anywhere besides in your employment at Schwarz?
`
`A. No, never.
`
`Q. And are you familiar with a compound
`
`called 5—hydroXymethyl tolterodine?
`
`A. Yes.
`
`Q. And are you com‘ortabie i“ we re‘
`
`to this as 5—HMT throughout
`
`the deposition, wil
`
`you understand what
`
`" am re‘erring to?
`
`A. Yes.
`
`Q. And did you work with 5—LMT anywhere
`
`besides in your employment at Schwarz?
`
`A. No, never.
`
`Q.
`
`How many patents are you listed as
`
`an inventor on?
`
`A.
`
`I only remember the major patents,
`
`the priority patent which was filed in May 1998
`
`the first one. And I remember, please correct me
`
`202-220-415 8
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`Henderson Legal Services, Inc.
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`Restricted Confidential - Subject to Protective Order
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1076A — Page 14
`PFEO1830543
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1076A - Page 14
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`
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`CONFIDENTIAL - ATTORNEYS‘ EYES ONLY
`
`Meese, Claus
`
`January 20, 2015
`
`if I am wrong,
`
`in total six patents. Yeah.
`
`Q. And the six patents that you are
`
`ferring to, are these all related to derivatives
`
`_
`
`the 5—HMT metabolite?
`
`MR TRAZNOR: Objection.
`
`A. Yes.
`
`MS CASSIDY:
`
`I am going to hand you a
`
`document which will be marked as Meese Exhibit 1,
`
`and it bears 3ates numbers PT 00000001 through PT
`
`000000l9.
`
`(Exhibit
`
`1 marked ‘or identi‘ication)
`
`A. Yes, okay.
`
`Thank you.
`
`Q.
`
`Jr Meese, do you recognize this
`
`document?
`
`A. Yes.
`
`Q. And can you tell me what this
`
`document is?
`
`A.
`
`It describes new salt, stable salt
`
`and suitable salt, often metabolite they are
`
`talking of.
`
`Q. And this document is a patent
`
`bearing the number US 6858650;
`
`is that correct?
`
`A. That is right.
`
`Q.
`
`Dr Meese, you are named as a sole
`
`inventor on this patent?
`
`202-220-415 8
`
`Henderson Legal Services, Inc.
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`Restricted Confidential - Subject to Protective Order
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1076A — Page 15
`PFEO1830544
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1076A - Page 15
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`
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`CONFIDENTIAL - ATTORNEYS‘ EYES ONLY
`
`Meese, Claus
`
`January 20, 2015
`
`A. Yes.
`
`Q.
`
`Do you recall whether you dra:
`
`any portions o: this patent?
`
`A. Yes,
`
`together with the Patent
`
`Department of Schwarz Pharma.
`
`Q.
`
`So we are going to read through a
`
`couple o: sections o: this patent.
`
`I will read
`
`them out
`
`loud so that we can have the translator
`
`translate the sections as well
`
`to make it a little
`
`bit easier on you.
`
`The first section we are going
`
`to look at is column one,
`
`lines 15 through 21?
`
`MR TRAZNO : May I assist the witness
`
`with understanding '
`
`Lne numbers?
`
`MS CASSZi
`
`:
`
`lease.
`
`A.
`
`I need a magnifying glass.
`
`It is
`
`too small. Sorry.
`
`MR TRAINOR:
`
`Do you have it? Can we go
`
`—Lhe—record for a moment?
`
`THfi V 3fiOGRAP{jR:
`
`O "—Lhe—record at
`
`(o
`
`-he—record)
`
`TH? V”D?OGRA?H?R: Rack on the record at
`
`13 minutes past 10.
`
`MS CASSZDY:
`
`In column one o:
`
`the 650
`
`patent, starting at lines 15 through 2;, it reads:
`
`202-220-415 8
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`Restricted Confidential - Subject to Protective Order
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`
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`CONFIDENTIAL - ATTORNEYS‘ EYES ONLY
`
`Meese, Claus
`
`January 20, 2015
`
`"From document PCT/EP 99/O32l2 novel
`
`derivatives of 3,3—dipenylpropylamine.
`
`These are
`
`valuabie prodrugs "or
`
`the treatment o.
`
`_ urinary
`
`incontinence and other spasmodics complaints which
`
`overcome the disadvantage o:
`
`the active substances
`
`available to date, namely inadequate absorption or
`
`the active substance by biological membranes or
`
`the unfavorable metabolism of these."?
`
`A. Yes.
`
`MS CASSZDY:
`
`Dr Meese, did you help
`
`ft that paragraph?
`
`MR TRAINOR:
`
`"" you remember.
`
`A. Most primarily, as far as I remember
`
`written by the Patent Department people and the
`
`pharmacologists which gave some advice, because
`
`I just want to recall I am a chemist, and this is
`
`my focus on the whole issue.
`
`MS CASSZDY: And do you recall the time
`
`this was drafted do you agree with the statement
`
`that essentially the derivatives of the
`
`3,3—dipenylpropylamines were known?
`
`A. Derivatives were known since the
`
`MS CASSZDY: And do you recall
`
`pharmacologists who assisted in the dra'
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`202-220-415 8
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`Restricted Confidential - Subject to Protective Order
`
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`
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`CONFIDENTIAL - ATTORNEYS‘ EYES ONLY
`
`Meese, Claus
`
`January 20, 2015
`
`this patent were?
`
`MR TRAINOR: Objection.
`
`A.
`
`I can't say the name but it must be
`
`a pharmacologist from the project team.
`
`MS CASSIDY:
`
`Now,
`
`if you will look at
`
`column one, starting at line 63 through column one
`
`or column two,
`
`line 3 where it says:
`
`"Surprisingly, it has now been found
`
`that the above mentioned disadvantages can be
`
`avoided if compounds with a structure of general
`
`formula A once they have been prepared under a
`
`special reaction process are converted with a
`
`physiologically compat’ble ‘norganic or organic
`
`acid with the general
`
`formu'& HX in which X
`
`represents the respective acid residue into their
`
`respective salt with the general
`
`formula "."?
`
`A. Yes.
`
`MS CASSZDY:
`
`'
`
`could direct your
`
`attention to figure one OT the 650 patent,
`
`believe it will be one page over on your copy,
`
`back towards the front o_ the document?
`
`A. Yes.
`
`MS CASSIDY:
`
`Is the reaction depicted in
`
`figure one the special reaction process that was
`
`referred to in the section from column one o:
`
`the
`
`202-220-415 8
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`Restricted Confidential - Subject to Protective Order
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`
`
`CONFIDENTIAL - ATTORNEYS‘ EYES ONLY
`
`Meese, Claus
`
`January 20, 2015
`
`patent that we just read?
`
`MR TRAINOR: Objection.
`
`A. Yes, it's a abbreviated depiction of
`
`the transition from 1 to 2.
`
`MS CASSIDY: And for this abbrevia
`
`figure why were these particular steps selec
`
`for the abbrevia-ed jigure 1?
`
`A.
`
`Just to give an overview how we got
`
`compound 6 from 3 and then following steps from 3
`
`to 2A or 2B they are essential, and they are again
`
`shown in the following columns.
`
`MS CASSZDY: When you say that these
`
`steps are essential, do you recall whether in the
`
`'u" synthesis :h r
`
`ar oth r
`
`ss ntial steps as
`
`we"
`
`MR TRAINOR: Objection.
`
`A. Yes, certainly.
`
`The Regio specific
`
`acylation giving a compound of the formula A is
`
`certainly a crucial step, and salt formation again
`
`is a crucial step formula. We have 1, yes, on
`
`column 2.
`
`MR TRA:
`
`selective".
`
`A. Yes, Regio selective because the
`
`precursor compound Number 6 in figure 1 has two
`
`202-220-415 8
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`Restricted Confidential - Subject to Protective Order
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`
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`CONFIDENTIAL - ATTORNEYS‘ EYES ONLY
`
`Meese, Claus
`
`January 20, 2015
`
`hydroxy groups and really it was to our experience
`
`surprising that only the phenolic hydroxy groups
`
`react under certain conditions with the respective
`
`acylation agent.
`
`MR TRAINOR:
`
`That is A-C-Y-L-A-T-I
`
`am just helping her.
`
`MS CASSIDY: Why was it surprising that
`
`only the phenolic hydroxy groups reacted under
`
`certain conditions?
`
`A. We didn't expect that before,
`
`because there are two hydroxy groups available and
`
`molecule and we didn't expect a high degree of
`
`specificity.
`
`MS CASSIDY: Was this because you
`
`expected both hydroxy groups to be equally
`
`reactive?
`
`A. Yes, or less or more, but this way.
`
`Q.
`
`I
`
`am going to hand you a document
`
`that has been previously marked as Spar;
`
`Exhibit 11 and it is bearing Bates numbers PT
`
`00000020 through PT 00000052. Actually I
`
`think we
`
`are going to mark that, i: you hand that back to
`
`the Court Reporter. We will mark this as Meese
`
`Exhibit 2.
`
`(?xhibit 2 marked '
`
`=ication)
`
`202-220-415 8
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`Henderson Legal Services, Inc.
`WWW.hendersonlegalservices. com
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`Restricted Confidential - Subject to Protective Order
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1076A — Page 20
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1076A - Page 20
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`
`
`CONFIDENTIAL - ATTORNEYS‘ EYES ONLY
`
`Meese, Claus
`
`January 20, 2015
`
`Dr Meese,
`
`i:
`
`you can take a minute to
`
`look at this document and let me know i: you
`
`recognize it?
`
`A. Yes.
`
`Q.
`
`Dr Meese,
`
`what is this document that
`
`i have handed you?
`
`A.
`
`A document the American translation
`
`of our priority patent from May 12th 1998.
`
`Q. And this bears US patent Number
`
`7384980;
`
`is that correct?
`
`A. This paper here, yes.
`
`Q. Yes?
`
`A.
`
`980.
`
`Q. And you are listed as a co—inventor
`
`3engt Spar:;
`
`is that correct?
`
`A. That is correct.
`
`Q. And who is
`
`3engt Spar:?
`
`A. Bengt Sparf is a pharmacologist from
`
`Sweden who was familiar with anti—muscarinic drugs
`
`for many years and at that time he was kind of
`
`consultant for Schwarz Pharma, because this —— no,
`
`no.
`
`Q.
`
`Do you recall how
`
`Dr Spar: became
`
`involved in this project,
`
`in this paten"?
`
`MR TRA: NOR: Objection.
`
`202-220-415 8
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`WWW.hendersonlegalservices. com
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`Restricted Confidential - Subject to Protective Order
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`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1076A — Page 21
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1076A - Page 21
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`
`
`CONFIDENTIAL - ATTORNEYS‘ EYES ONLY
`
`Meese, Claus
`
`January 20, 2015
`
`A. Well, we researched CEO of Schwarz
`
`Pharma, we needed external input. At that time
`
`the whole project was initiated at Schwarz Pharma,
`
`so this expert was willing to give support.
`
`MS CASSIDY:
`
`Do you recall whether you
`
`had started work on this project prior to Dr Spar:
`
`becoming involved?
`
`A. No, we haven't done anything on this
`
`field before.
`
`MS CASSZDY: What do you understand
`
`Dr Sparf's contribition to the invention described
`
`in the 980 patent to be?
`
`MR TRA:NOR: Objection.
`
`A. Well, his contribution was primarily
`
`in the field of pharmacology and handling of
`
`anti—muscarinic drugs in human and animal studies.
`
`There was no contribution in the field of
`
`chemistry, no significant contribution.
`
`MS CASSZDY: And what do you understand
`
`your contribution to the invention described in
`
`this patent to have been?
`
`MR TRAZNOR: Objection.
`
`A.
`
`I was responsible for the chemistry,
`
`for all chemical aspects.
`
`MS CASSZDY: What do you understand the
`
`202-220-415 8
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`Henderson Legal Services, Inc.
`WWW.hendersonlegalservices. com
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`Restricted Confidential - Subject to Protective Order
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1076A — Page 22
`PFEO1830551
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1076A - Page 22
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`
`
`CONFIDENTIAL - ATTORNEYS‘ EYES ONLY
`
`Meese, Claus
`
`January 20, 2015
`
`di
`
`" r nc
`
`b :w n th 650 patent,
`
`the inventions
`
`described in the 650 patent and the invention in
`
`the 980 patent to have been?
`
`MR TRAINOR: Objection.
`
`A.
`
`650 patent,
`
`this and this one?
`
`MS CASSIDY: Yes.
`
`A.
`
`The focus in the 650 patent clearly
`
`was on the formation of stable salts, as the title
`
`says. And the 980 is a more general patent on
`
`many more aspects of drug development.
`
`Q.
`
`i
`
`am going to hand you a document
`
`which will be marked as Meese Exhibit 3, bearing
`
`3ates njmbers PT OOOOOO53 throjgh PT OOOOOO85.
`
`(Exhibit 3 marked ‘or identi‘ication)
`
`A. Does that mean we are done with
`
`these for now?
`
`Q.
`
`You can set them aside for now, we
`
`may come back to them.
`
`Do you recognize this
`
`document, Dr Meese?
`
`A. Give me a second, yes. Okay.
`
`Q.
`
`Do you recognize this document?
`
`A. Yes.
`
`Q. And i: you look in the top right
`
`corner this document is bearing the US patent
`
`number 7855230;
`
`is that correct?
`
`202-220-415 8
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`Henderson Legal Services, Inc.
`WWW.hendersonlegalservices. com
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`Restricted Confidential - Subject to Protective Order
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1076A — Page 23
`PFEO1830552
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1076A - Page 23
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`
`
`CONFIDENTIAL - ATTORNEYS‘ EYES ONLY
`
`Meese, Claus
`
`January 20, 2015
`
`A. Yes.
`
`Q. And you and Dr Spar: are named as
`
`co—inventors on this patent, correct?
`
`A. Yes.
`
`Q. And i: you could please turn to the
`
`last page,
`
`the page ending in 3ates Number 085
`
`with the column top 56?
`
`MR TRAINOR:
`
`The last page or column 56?
`
`MS CASSIDY:
`
`Column 56 which should be
`
`on the last page.
`
`MR TRA:NOR:
`
`?xhibit.
`
`" apoiogize.
`
`A.
`
`Column 56 and which number there?
`
`THfi NTfi?PRflTfi?: Which line number?
`
`MS CASSIDY: Starting at line number
`
`l7
`
`right after it says "The invention claimed is,"
`
`then the Number 1?
`
`A. Yeah.
`
`MS CASSIDY: And looking at Claim 1 what
`
`do you understand the di" r nc
`
`b tw n :h 230
`
`patent and the 980 paten' Exhibit 2,
`
`: we were
`
`just looking at to be?
`
`MR TKAINOR: Objection.
`
`"“ you have an
`
`understanding.
`
`A. Yeah. There is a clear difference
`
`202-220-415 8
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`Henderson Legal Services, Inc.
`WWW.hendersonlegalservices. com
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`Restricted Confidential - Subject to Protective Order
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1076A - Page 24
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`
`
`CONFIDENTIAL - ATTORNEYS‘ EYES ONLY
`
`Meese, Claus
`
`January 20, 2015
`
`because the focus of this claim is clearly the
`
`transdermal application of the novel derivatives,
`
`and that was absolutely new and nobody thought of
`
`that before. Not oral, but transdermal.
`
`MS CASSIDY: And what was your
`
`contribution to the invention described in this
`
`patent?
`
`MR TRAINOR: Objection.
`
`A.
`
`Simply spoken nobody thought of this
`
`transdermal application of this kind of normal
`
`compounds. Never before. And I was convinced
`
`that transdermal application has considerable
`
`advantages over oral, orally administered drug.
`
`MS CASSZDY: Okay.
`
`I am handing you a
`
`document that will be mar<ed as Meese Exhibit 4.
`
`It is a document bearing 3ates numbers PT 00000086
`
`through PT 00000ll7.
`
`(Exhibit 4 marked for identification)
`
`Do you recognize this document,
`
`Dr Meese?
`
`A. Sorry. Yes,
`
`I remember it.
`
`Q. And do you understand this document
`
`to be a patent bearing the US patent Number
`
`7985772?
`
`202-220-415 8
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`Henderson Legal Services, Inc.
`WWW.hendersonlegalservices. com
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`Restricted Confidential - Subject to Protective Order
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1076A — Page 25
`PFEO1830554
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1076A - Page 25
`
`
`
`CONFIDENTIAL - ATTORNEYS‘ EYES ONLY
`
`Meese, Claus
`
`January 20, 2015
`
`Q.
`
`You are a co—inventor on this patent
`
`;
`
`is that correct?
`
`A. Yes.
`
`Q. And what do you understand your
`
`contribution to this,
`
`to the invention in this
`
`patent to have been?
`
`MR TRAZNOR: Objection.
`
`I just object
`
`to this whole line o: questioning.
`
`These are
`
`about questions o:
`
`law. This man is here to
`
`answer questions about facts.
`
`Interpreting pa‘
`
`documents, understanding what claims mean, what
`
`the di"”erence between what one document is and
`
`another,
`
`legal documents, examine as you wish but
`
`i object to this question.
`
`A.
`
`I just want to emphasise my initial
`
`command that I was responsible for the chemistry
`
`and not for other aspects.
`
`MS CASSZDY: Okay. And based on your
`
`recollection do yo; understand —— what is your
`
`understanding is the di" r nc
`
`b tw n th 772
`
`patent and the 230 patent that we just discussed?
`
`MR TRAZNOR: Objection.
`
`A. There is one big difference.
`
`It's
`
`column 53 —— I go back again. Sorry. Sorry, but
`
`it's a couple of years ago so I have to.
`
`202-220-415 8
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`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1076A — Page 26
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1076A - Page 26
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`
`
`CONFIDENTIAL - ATTORNEYS‘ EYES ONLY
`
`Meese, Claus
`
`January 20, 2015
`
`MR TRAINOR:
`
`Can we give him the
`
`question back and can you please translate it?
`
`MS CASSIDY: Qetore you do, Dr Meese,
`
`can clarijy,
`
`-his is just based on your
`
`recollection, i: you recall what
`
`the di
`
`"erence
`
`was?
`
`A. First I see novel derivatives
`
`prepared by other methods,
`
`some experiments make
`
`polymers loaded with active drug.
`
`I can't find it
`
`now but I know there was a section for benzylic
`
`esters.
`
`Q.
`
`Dr Meese,
`
`this is just based on your
`
`recollection.
`
`I understand it has been some time
`
`since yo; have looked at this, you don't need to
`
`analyze the entire document it you don'_ want
`
`based on your recollection what you have told
`
`should be su
`
`"icient?
`
`A. Okay.
`
`I just remember novel methods
`
`and novel variance, and one of them, an enzymetic
`
`process to get the benzylic esters which could not
`
`be obtained by other methods.
`
`It was completely
`
`new, and that's what I remember right now.
`
`Q.
`
`Dr Meese,
`
`I
`
`am handing you a
`
`document bearing —— marked as Exhibit Number 5
`
`bearing 3ates numbers PT 00000118 through PT
`
`202-220-415 8
`
`Henderson Legal Services, Inc.
`WWW.hendersonlegalservices. com
`
`Restricted Confidential - Subject to Protective Order
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1076A — Page 27
`PFEO1830556
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1076A - Page 27
`
`
`
`CONFIDENTIAL - ATTORNEYS‘ EYES ONLY
`
`Meese, Claus
`
`January 20, 2015
`
`00000149.
`
`(Exhibit 5 marked
`
`‘or identi-
`
`=ication)
`
`Dr Meese,
`
`do you recognize this
`
`document?
`
`A.
`
`I will have to have a look at it
`
`first.
`
`Sorry.
`
`Yes.
`
`Q. And
`
`do you recognize this document
`
`to be a US patent bearing patent Number 8338478?
`
`A. Yes.
`
`Q. And
`
`you are listed as co—inventor on
`
`this patent along
`
`with Dr Spar:
`
`;
`
`is that correct?
`
`A. Yes.
`
`Q. And i; you recall what was your
`
`contribution to this patent?
`
`MR TRAINOR: Objection. Talking about
`
`the patent,
`
`the claims?
`
`MS CASS;
`"DY:
`
`Sorry,
`
`to the invention
`
`disclosed in this patent?
`
`A. Well, basically the processes,
`
`and
`
`I mean the chemical processes necessary to make
`
`novel derivatives but —— and I want to emphasise
`
`this, only until 2012, after that it was no longer
`
`Schwarz but UCB that was updating them.
`
`Q.
`
`Dr Meese, do you receive any
`
`fit,
`
`do employees at Schwarz receive any
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`WWW.hendersonlegalservices.com
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`Restricted Confidential - Subject to Protective Order
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1076A — Page 28
`PFEO1830557
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1076A - Page 28
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`
`
`CONFIDENTIAL - ATTORNEYS‘ EYES ONLY
`
`Meese, Claus
`
`January 20, 2015
`
`"or being named as inventors on patents?
`
`A. Not in financial terms, no.
`
`It is
`
`appreciated but that's all.
`
`Q.
`
`I
`
`am going to hand you a document
`
`which bears the 3ates number —— we will be marking
`
`as Meese Exhibit
`
`6 bearing 3ates numbers PT --
`
`sorry, Exhibit 6?
`
`MR TRAINOR:
`
`Five?
`
`MS CASSIDY:
`
`Six. Exhibit
`
`6 bearing the
`
`Jmbers PT 02019287 through PT 02019292.
`
`Exhibit
`
`6 marked ‘or identi‘ication)
`
`T am also handing you an English,
`
`a
`
`certified English translation o‘ the same document
`
`which we will be marking as