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`
`
`December 15, 2017
` IJK@5/:7
`9:39 a.m.
`BM,B.J.
`
`  , 1
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`5 6 7
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`Video Deposition of FRED D.
`3>9? L?A>=>?8?t'#  .
`LUBLIN, M.D., held at the offices of
`< +)+/$. ./uv9==u?tt>IA?t
`Gibson, Dunn & Crutcher LLP, 200 Park
`B 2>KA?8/ w88x(@w=Iu@++/::@G
`Avenue, New York, New York, before
`: "C8w/DF?@G/DF?@G/Kt?@
`Patricia A. Bidonde,
`a Registered
` =@>I>".)>9?89/#>A=@9
`Professional Reporter, Licensed
` @?tAA>?8v#L?@=@/+>I8A9
`Shorthand Reporter of Connecticut,
`, !u?@=u89#L?@=@?t(?88I=>Iw=/
`Certified eDepoze Court Reporter, Notary
`1 (@=>t>9 L?y(?w@=#L?@=@/?=@H
`Public of the State of New York, and
`5 wKv>I?t=u!==?tDF?@G/89
`Notary Public of the State of
`6 ?=@HwKv>I?t=u!==?t
`7 (?88I=>Iw=.
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`A P P E A R A N C E S
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`WILSON SONSINI GOODRICH & ROSATI
`z+!&!&!2&& #(*x#&!"
`Attorneys for Petitioner Apotex
`5 "==?@8HAt?@=>=>?8@"L?={
`701 Fifth Avenue
`6 7:'>t=u"C8w
`Seattle, WA 98104
`7 !==v/z"B<:1
`JAD MILLS, ESQ.
`< )FMN" $++!/!|.
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`B
`
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`WINSTON & STRAWN
` z!&x!#"z
`Attorneys for Petitioner Sun Pharmaceutical
` "==?@8HAt?@=>=>?8@!w8u@JIw=>Iv
`35 West Wacker Drive
`, ,5zA=zIG@ @>C
`Chicago,
`IL 60601
`1 (u>I?/+6:6:
`SHARICK NAQI, ESQ.
`5 )FM!*"#(%"|/!|.
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`6 }3"+(&'#(0
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`(VIA TELECONFERENCE)
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`(CONTINUED)
`""#"(!M}(& 0
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` 
`
`LEM LATTIMER, VIDEOGRAPHER
`
`, 1
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`GIBSON, DUNN & CRUTCHER
`2)!&/ x(#(*#
`Attorneys for Patent Owner
`5 "==?@8HAt?@=8=&D8@
`200 Park Avenue
`6 ::@G"C8w
`New York, NY 10166
`7 DF?@G/F:66
`ROBERT TRENCHARD, ESQ.
`< )FM#&)##(*"# /!|.
`JANE LOVE PH.D., ESQ.
`B N"+&3*. ./!|.
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`ALSO PRESENT:
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`5
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`F. Lublin
` '.+wKv>8
`P R O C E E D I N G S
` #&( 2!
`THE VIDEOGRAPHER: This is the
`, *3 &2#"*#Mu>A>A=u
`start of media labeled number 1 of the
`1 A=@=?tJ9>vKv98wJK@?t=u
`Video recorded deposition of Fred D.
`5 C>9?@I?@999L?A>=>?8?t'@9 .
`Lublin in the matter of Apotex Inc., et
`6 +wKv>8>8=uJ==@?t"L?={8I./=
`al. versus Novartis AG on
`7 v.C@AwA?C@=>A"2?8
`December 15, 2017, at approximately
`< IJK@5/:7/=LL@?{>J=vH
`9:39 a.m.
`B BM,B.J.
`My name is Lem Lattimer.
`I'm the
`: $H8J>A+J+==>J@.~J=u
`legal Video specialist from TSG
` vvC>9?ALI>v>A=t@?J!2
`Reporting.
`The court reporter is
` #L?@=>8.uI?w@=@L?@=@>A
`Patricia Bidonde from TSG reporting.
`, =@>I>)>9?89t@?J!2@L?@=>8.
`Counsels, please introduce
`1 (?w8AvA/LvA>8=@?9wI
`yourselves.
`5 H?w@AvCA.
`MR. MILLS:
`Jad Mills with the
`6 $#.$++!MN9$>vvAD>=u=u
`law firm of Wilson Sonsini Goodrich &
`7 vDt>@J?tz>vA?8!?8A>8>2??9@>Iux
`Rosati representing Apotex Inc. and
`< #?A=>@L@A8=>8"L?={8I.89
`Apotex Corp.
`B "L?={(?@L.
`MR. TRENCHARD: Robert Trenchard
`: $#.#(*"# M#?K@=@8Iu@9
`from Gibson, Dunn & Crutcher
` t@?J2>KA?8/ w88x(@w=Iu@
`representing the patent owner and the
` @L@A8=>8=uL=8=?D8@89=u
`witness, and with me is Jane Love.
`, D>=8AA/89D>=uJ>AN8+?C.
`THE VIDEOGRAPHER: Will
`the court
`1 *3 &2#"*#Mz>vv=uI?w@=
`reporter please swear the witness in.
`5 @L?@=@LvAAD@=uD>=8AA>8.
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` '.+wKv>8
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`7
`
`F. Lublin
` '.+wKv>8
`me withdraw that question.
`I'll start over,
` JD>=u9@D=u=wA=>?8.~vvA=@=?C@/
`try and give you a better question.
`, =@H89>CH?wK==@wA=>?8.
`The testimony that you've offered
`1 u=A=>J?8H=u=H?w~C?tt@9
`in your declarations is based on your
`5 >8H?w@9Iv@=>?8A>AKA9?8H?w@
`experience as a physician treating multiple
`6 {L@>8IALuHA>I>8=@=>8Jwv=>Lv
`sclerosis. Correct?
`7 AIv@?A>A.(?@@I=
`MR. TRENCHARD: Objection to
`< $#.#(*"# M&K€I=>?8=?
`
`B t?@J.
`
`
`
`You can answer.
`: F?wI88AD@.
`A.
`As a physician and a researcher,
` "."ALuHA>I>889@A@Iu@/
`in multiple sclerosis.
` >8Jwv=>LvAIv@?A>A.
`Q.
`You are not a pharmacologist.
`, |.F?w@8?=Lu@JI?v?>A=.
`Correct?
`1 (?@@I=
`A.
`I
`am not.
`5 ".J8?=.
`Q.
`I notice that you spent some time
`6 |.8?=>I=u=H?wAL8=A?J=>J
`at the Albert Einstein Center.
`7 ==u"vK@=>8A=>8(8=@.
`A.
`Yes.
`< ".FA.
`Q.
`Is that an institution that has a
`B |.A=u=8>8A=>=w=>?8=u=uA
`good reputation?
`: ??9@Lw==>?8
`MR. TRENCHARD: Objection to
` $#.#(*"# M&K€I=>?8=?
`form,
`foundation, scope.
` t?@J/t?w89=>?8/AI?L.
`You can answer.
`, F?wI88AD@.
`I
`think so.
`1 ".=u>8GA?.
`I notice that you and Dr. Guisser
`5 |.8?=>I=u=H?w89 @.2w>AA@
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`<
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`F. Lublin
` '.+wKv>8
`had that in common.
` u9=u=>8I?JJ?8.
`MR. TRENCHARD: Objection to
`, $#.#(*"# M&K€I=>?8=?
`
`1 t?@J.
`
`
`
`That's correct.
`5 ".u=~AI?@@I=.
`Q.
`Dr. Lublin, what did you do to
`6 |. @.+wKv>8/Du=9>9H?w9?=?
`prepare for your deposition today?
`7 L@L@t?@H?w@9L?A>=>?8=?9H
`MR. TRENCHARD: And I'll just
`< $#.#(*"# M"89~vv€wA=
`caution you not
`to go into the content
`B Iw=>?8H?w8?==??>8=?=uI?8=8=
`of any communications with counsel, but
`: ?t8HI?JJw8>I=>?8AD>=uI?w8Av/Kw=
`you can describe it in general terms.
` H?wI89AI@>K>=>88@v=@JA.
`A.
`I reviewed my declarations, and I
` ".@C>D9JH9Iv@=>?8A/89
`reviewed the documents that I utilized for the
`, @C>D9=u9?IwJ8=A=u=w=>v>y9t?@=u
`basis of my opinions in the declarations.
`1 KA>A?tJH?L>8>?8A>8=u9Iv@=>?8A.
`Q.
`When you say just now that you
`5 |.zu8H?wAH€wA=8?D=u=H?w
`"reviewed the documents that you utilized for
`6 ‚@C>D9=u9?IwJ8=A=u=H?ww=>v>y9t?@
`the basis of your opinions in your
`7 =uKA>A?tH?w@?L>8>?8A>8H?w@
`declarations," does that include anything that
`< 9Iv@=>?8A/‚9?A=u=>8Ivw98H=u>8=u=
`is not specifically identified in the
`B >A8?=ALI>t>IvvH>98=>t>9>8=u
`declarations themselves?
`: 9Iv@=>?8A=uJAvCA
`MR. TRENCHARD: Objection to
` $#.#(*"# M&K€I=>?8=?
`
` t?@J.
`
`You can answer.
`, F?wI88AD@.
`For preparation for today, no.
`1 ".'?@L@L@=>?8t?@=?9H/8?.
`In preparing your declarations,
`5 |.8L@L@>8H?w@9Iv@=>?8A/
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`B
`
`F. Lublin
` '.+wKv>8
`did you review any documents that are not
` 9>9H?w@C>D8H9?IwJ8=A=u=@8?=
`specifically identified in your declarations?
`, ALI>t>IvvH>98=>t>9>8H?w@9Iv@=>?8A
`A.
`Yes.
`1 ".FA.
`Q.
`What were those?
`5 |.zu=D@=u?A
`A.
`Well,
`I can't —— I'm not entirely
`6 ".zvv/I8~=;;~J8?=8=>@vH
`sure which ones are in and out. But
`in
`7 Aw@Du>Iu?8A@>889?w=.)w=>8
`preparing for my declarations,
`I reviewed
`< L@L@>8t?@JH9Iv@=>?8A/@C>D9
`documents —— well, articles relating to
`B 9?IwJ8=A;;Dvv/@=>IvA@v=>8=?
`Betaseron and the Betaseron development
`: )=A@?889=u)=A@?89Cv?LJ8=
`pathway.
` L=uDH.
`
`
`
`I
`looked for some documents on
` v??G9t?@A?J9?IwJ8=A?8
`futility analyses to see if I could find any.
`, tw=>v>=H8vHAA=?A>tI?wv9t>898H.
`And I
`looked over many of the references that
`1 "89v??G9?C@J8H?t=u@t@8IA=u=
`are mentioned in the '405 patent.
`5 @J8=>?89>8=u~1:5L=8=.
`Q.
`In preparing your declarations,
`6 |.8L@L@>8H?w@9Iv@=>?8A/
`did you read the '405 patent?
`7 9>9H?w@9=u~1:5L=8=
`A.
`I did.
`< ".9>9.
`Q.
`And when we're referring to the
`B |."89Du8D~@@t@@>8=?=u
`'405 patent, you understand that's the patent
`: ~1:5L=8=/H?ww89@A=89=u=~A=uL=8=
`at issue in this proceeding. Correct?
` =>AAw>8=u>AL@?I9>8.(?@@I=
`A.
`Yes.
` ".FA.
`Q.
`You mentioned some research you
`, |.F?wJ8=>?89A?J@A@IuH?w
`did into futility analyses, where did you look
`1 9>9>8=?tw=>v>=H8vHAA/Du@9>9H?wv??G
`to research about futility analyses?
`5 =?@A@IuK?w=tw=>v>=H8vHAA
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`F. Lublin
` '.+wKv>8
`A.
`I
`looked over articles on
` ".v??G9?C@@=>IvA?8
`clinical trials, other —— other agents in
`, Iv>8>Iv=@>vA/?=u@;;?=u@8=A>8
`multiple sclerosis.
`1 Jwv=>LvAIv@?A>A.
`Q.
`What
`time period was involved in
`5 |.zu==>JL@>?9DA>8C?vC9>8
`your investigation of other clinical trials
`6 H?w@>8CA=>=>?8?t?=u@Iv>8>Iv=@>vA
`that involved futility analyses?
`7 =u=>8C?vC9tw=>v>=H8vHAA
`MR. TRENCHARD: Objection to
`< $#.#(*"# M&K€I=>?8=?
`
`B t?@J.
`
`You can answer.
`: F?wI88AD@.
`A.
`It would go back to the first
` ".=D?wv9?KIG=?=ut>@A=
`successful clinical trial.
`So that would be
` AwIIAAtwvIv>8>Iv=@>v.!?=u=D?wv9K
`'93, 1993.
`, ~B,/BB,.
`Q.
`And when did the time period end?
`1 |."89Du89>9=u=>JL@>?989
`MR. TRENCHARD: Objection to
`5 $#.#(*"# M&K€I=>?8=?
`
`MR. TRENCHARD: Objection to
`
`6 t?@J.
`
`You can answer.
`7 F?wI88AD@.
`A.
`Current.
`< ".(w@@8=.
`Q.
`Approximately, how many clinical
`B |."LL@?{>J=vH/u?DJ8HIv>8>Iv
`trials did you look at?
`: =@>vA9>9H?wv??G=
`A.
`I don't recall.
` ".9?8~=@Ivv.
`Q.
`Of
`the clinical trials, how many
` |.&t=uIv>8>Iv=@>vA/u?DJ8H
`of those involved multiple experimental doses?
`, ?t=u?A>8C?vC9Jwv=>Lv{L@>J8=v9?AA
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`1 $#.#(*"# M&K€I=>?8=?
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`F. Lublin
` '.+wKv>8
`You can answer.
` F?wI88AD@.
`A.
`I can't give you an exact number,
`, ".I8~=>CH?w8{I=8wJK@/
`but many of them.
`1 Kw=J8H?t=uJ.
`Q.
`When we use the term
`5 |.zu8DwA=u=@J
`"experimental dose," you understand what I'm
`6 ‚{L@>J8=v9?A/‚H?ww89@A=89Du=~J
`saying what when I say that?
`7 AH>8Du=Du8AH=u=
`A.
`Yes.
`< ".FA.
`Q.
`An experimental dose in contrast
`B |."8{L@>J8=v9?A>8I?8=@A=
`to a placebo dose,
`for example.
`Is that your
`: =?LvIK?9?A/t?@{JLv.A=u=H?w@
`understanding?
` w89@A=89>8
`MR. TRENCHARD: Objection to
` $#.#(*"# M&K€I=>?8=?
`
`
`
`, t?@J.
`
`You can answer.
`1 F?wI88AD@.
`Foundation too.
`5 '?w89=>?8=??.
`You can answer.
`6 F?wI88AD@.
`Q.
`Let me withdraw the question.
`7 |.+=JD>=u9@D=uwA=>?8.
`I'll try and ask a better question.
`< ~vv=@H89AGK==@wA=>?8.
`When we're talking about an
`B zu8D~@=vG>8K?w=8
`experimental dose, you're not talking about
`: {L@>J8=v9?A/H?w~@8?==vG>8K?w=
`the placebo. Correct?
` =uLvIK?.(?@@I=
`MR. TRENCHARD: Objection to
` $#.#(*"# M&K€I=>?8=?
`
`, t?@J.
`
`You can answer.
`1 F?wI88AD@.
`Yeah,
`that's correct.
`5 ".Fu/=u=~AI?@@I=.
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`,
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`
`
`F. Lublin
` '.+wKv>8
`between giving someone a placebo and not
` K=D8>C>8A?J?8LvIK?898?=
`giving them anything.
`, >C>8=uJ8H=u>8.
`It's a different type of
`1 =~A9>tt@8==HL?t
`experiment. And use of a placebo provides
`5 {L@>J8=."89wA?tLvIK?L@?C>9A
`more valid results.
`6 J?@Cv>9@Awv=A.
`Q.
`A placebo is something that's
`7 |."LvIK?>AA?J=u>8=u=~A
`known not to have any therapeutic effect.
`< G8?D88?==?uC8H=u@Lw=>IttI=.
`Correct?
`B (?@@I=
`A.
`A placebo is an inactive agent.
`: "."LvIK?>A8>8I=>C8=.
`It's a little harder to say it doesn't have a
` =~Av>==vu@9@=?AH>=9?A8~=uC
`therapeutic effect.
` =u@Lw=>IttI=.
`Q.
`A placebo,
`for example, could be
`, |."LvIK?/t?@{JLv/I?wv9K
`a sugar pill that isn't expected to have any
`1 Aw@L>vv=u=>A8~={LI=9=?uC8H
`pharmacological effect on the attribute being
`5 Lu@JI?v?>IvttI=?8=u==@>Kw=K>8
`tested. Correct?
`6 =A=9.(?@@I=
`MR. TRENCHARD: Objection to form
`7 $#.#(*"# M&K€I=>?8=?t?@J
`and foundation.
`< 89t?w89=>?8.
`You can answer.
`B F?wI88AD@.
`A.
`Yes.
`: ".FA.
`Q.
`I may have gotten a little ahead
` |.JHuC?==8v>==vu9
`of myself, but let me ask you: Have you been
` ?tJHAvt/Kw=v=JAGH?wM*CH?wK8
`deposed before, Dr. Lublin?
`, 9L?A9Kt?@/ @.+wKv>8
`A.
`I have.
`1 ".uC.
`Q.
`So you understand,
`I believe,
`the
`5 |.!?H?ww89@A=89/Kv>C/=u
`
`TSG Reporting 877-702-9580
`  
`
 
`
`

`

`1
`
`
`
`F. Lublin
` '.+wKv>8
`rules of the deposition.
`I'll be asking you
` @wvA?t=u9L?A>=>?8.~vvKAG>8H?w
`questions. Correct?
`, wA=>?8A.(?@@I=
`A.
`Yes.
`1 ".FA.
`Q.
`You'll be giving answers to those
`5 |.F?w~vvK>C>88AD@A=?=u?A
`questions. Correct?
`6 wA=>?8A.(?@@I=
`A.
`Yes.
`7 ".FA.
`Q.
`You've done a very good job so
`< |.F?w~C9?8C@H??9€?KA?
`far, but we'll have to continue to make sure
`B t@/Kw=D~vvuC=?I?8=>8w=?JGAw@
`that we don't talk over one another so the
`: =u=D9?8~==vG?C@?88?=u@A?=u
`court reporter can take everything down.
`You
` I?w@=@L?@=@I8=GC@H=u>89?D8.F?w
`understand that?
` w89@A=89=u=
`A.
`Yes.
`, ".FA.
`Q.
`If you don't understand my
`1 |.tH?w9?8~=w89@A=89JH
`question at any point, would you tell me that
`5 wA=>?8=8HL?>8=/D?wv9H?w=vvJ=u=
`so that I know?
`6 A?=u=G8?D
`A.
`Yes.
`7 ".FA.
`Q.
`And if you don't tell me that you
`< |."89>tH?w9?8~==vvJ=u=H?w
`don't understand the question,
`then we'll
`B 9?8~=w89@A=89=uwA=>?8/=u8D~vv
`assume that you do understand the question.
`: AAwJ=u=H?w9?w89@A=89=uwA=>?8.
`Is that fair?
` A=u=t>@
`A.
`Okay.
` ".&GH.
`Q.
`Is there any reason that you
`, |.A=u@8H@A?8=u=H?w
`can't offer your best testimony today in this
`1 I8~=?tt@H?w@KA==A=>J?8H=?9H>8=u>A
`deposition?
`5 9L?A>=>?8
`
`TSG Reporting 877-702-9580
`  
`
 
`
`

`

`5
`
`
`
` '.+wKv>8
`A.
`No.
` ".?.
`Q.
`And you understand that you are
`, |."89H?ww89@A=89=u=H?w@
`obligated to tell the truth in this deposition
`1 ?Kv>=9=?=vv=u=@w=u>8=u>A9L?A>=>?8
`the same as if you were in an open court
`5 =uAJA>tH?wD@>88?L8I?w@=
`before a judge?
`6 Kt?@€w9
`A.
`Yes.
`7 ".FA.
`Q.
`Sometimes multiple —— let me
`< |.!?J=>JAJwv=>Lv;;v=J
`withdraw and start over.
`B D>=u9@D89A=@=?C@.
`Sometimes experimental designs
`: !?J=>JA{L@>J8=v9A>8A
`don't use a placebo as the control. Correct?
` 9?8~=wALvIK?A=uI?8=@?v.(?@@I=
`MR. TRENCHARD: Objection to
` $#.#(*"# M&K€I=>?8=?
`form,
`foundation.
`, t?@J/t?w89=>?8.
`You can answer.
`1 F?wI88AD@.
`A.
`Yes.
`5 ".FA.
`Q.
`An example of that a is a
`6 |."8{JLv?t=u=>A
`head—to—head trial, where a compound known to
`7 u9;=?;u9=@>v/Du@I?JL?w89G8?D8=?
`have a pharmacological therapeutic effect is
`< uCLu@JI?v?>Iv=u@Lw=>IttI=>A
`used as the control. Correct?
`B wA9A=uI?8=@?v.(?@@I=
`A.
`Yes.
`: ".FA.
`Q.
`Can you give me an example of a
` |.(8H?w>CJ8{JLv?t
`head—to—head multiple sclerosis trial of which
` u9;=?;u9Jwv=>LvAIv@?A>A=@>v?tDu>Iu
`you're familiar?
`, H?w~@tJ>v>@
`A.
`Yes.
`1 ".FA.
`Q.
`Please, go ahead.
`5 |.vA/?u9.
`
`TSG Reporting 877-702-9580
`  
`
 
`
`

`

`6
`
`F. Lublin
` '.+wKv>8
`A.
`There was recently completed
` ".u@DA@I8=vHI?JLv=9
`trials of an agent called Ocrelizumab,
`, =@>vA?t88=Ivv9&I@v>ywJK/
`O—c—r—e—l—i—z—a—m—a—b,
`I
`think, which was
`1 &;I;@;;v;>;y;;J;;K/=u>8G/Du>IuDA
`compared to Interferon.
`5 I?JL@9=?8=@t@?8.
`Q.
`What is Interferon?
`6 |.zu=>A8=@t@?8
`A.
`It's a biologic substance, one
`7 ".=~AK>?v?>IAwKA=8I/?8
`form of which is used in treating multiple
`< t?@J?tDu>Iu>AwA9>8=@=>8Jwv=>Lv
`sclerosis.
`B AIv@?A>A.
`Q.
`How long has it been used in
`: |.*?Dv?8uA>=K8wA9>8
`treating multiple sclerosis?
` =@=>8Jwv=>LvAIv@?A>A
`A.
`Since 1993.
` ".!>8IBB,.
`Q.
`How is Interferon used to treat
`, |.*?D>A8=@t@?8wA9=?=@=
`multiple sclerosis?
`1 Jwv=>LvAIv@?A>A
`Let me try and ask a better
`5 +=J=@H89AGK==@
`question.
`6 wA=>?8.
`
`
`
`What aspects of multiple
`7 zu=ALI=A?tJwv=>Lv
`sclerosis is Interferon used to treat?
`< AIv@?A>A>A8=@t@?8wA9=?=@=
`A.
`Interferon is proved to treat ——
`B ".8=@t@?8>AL@?C9=?=@=;;
`to reduce frequency of relapses in multiple
`: =?@9wIt@w8IH?t@vLAA>8Jwv=>Lv
`sclerosis and also can have an affect on
` AIv@?A>A89vA?I8uC8ttI=?8
`reducing disability accumulation.
` @9wI>89>AK>v>=HIIwJwv=>?8.
`Q.
`Is there a relationship, or does
`, |.A=u@@v=>?8Au>L/?@9?A
`reducing disability accumulation have anything
`1 @9wI>89>AK>v>=HIIwJwv=>?8uC8H=u>8
`to do with slowing progression of multiple
`5 =?9?D>=uAv?D>8L@?@AA>?8?tJwv=>Lv
`
`TSG Reporting 877-702-9580
`  
`
 
`
`

`

` '.+wKv>8
`sclerosis?
` AIv@?A>A
`
`7
`
`MR. TRENCHARD: Objection to
`, $#.#(*"# M&K€I=>?8=?
`form,
`foundation.
`1 t?@J/t?w89=>?8.
`You can answer.
`5 F?wI88AD@.
`It can.
`6 ".=I8.
`Q.
`And how can that be?
`7 |."89u?DI8=u=K
`A.
`There's two different ways that
`< ".u@~A=D?9>tt@8=DHA=u=
`individuals with multiple sclerosis worsen.
`B >89>C>9wvAD>=uJwv=>LvAIv@?A>AD?@A8.
`One is through what are called acute attacks
`: &8>A=u@?wuDu=@Ivv9Iw===IGA
`through relapses from which they don't make a
` =u@?wu@vLAAt@?JDu>Iu=uH9?8~=JG
`complete recovery.
`So there's residual
` I?JLv=@I?C@H.!?=u@~A@A>9wv
`impairment. And that can accumulate over
`, >JL>@J8=."89=u=I8IIwJwv=?C@
`time.
`1 =>J.
`
`
`
`The second is if they enter
`5 uAI?89>A>t=uH8=@
`what's called a progressive phase of the
`6 Du=~AIvv9L@?@AA>CLuA?t=u
`illness in which case,
`independent of
`7 >vv8AA>8Du>IuIA/>89L898=?t
`relapses,
`they'll gradually acquire more
`< @vLAA/=uH~vv@9wvvHIw>@J?@
`impairment or disability.
`B >JL>@J8=?@9>AK>v>=H.
`Q.
`In which way does Interferon
`: |.8Du>IuDH9?A8=@t@?8
`address slowing progression of multiple
` 99@AAAv?D>8L@?@AA>?8?tJwv=>Lv
`sclerosis?
` AIv@?A>A
`
`MR. TRENCHARD: Objection to
`, $#.#(*"# M&K€I=>?8=?
`
`1 t?@J.
`
`You can answer.
`5 F?wI88AD@.
`
`TSG Reporting 877-702-9580
`  
`
 
`
`

`

`<
`
`F. Lublin
` '.+wKv>8
`A.
`Not entirely clear. Best
` ".?=8=>@vHIv@.)A=
`evidence that it impair— —— it lessens the
`, C>98I=u=>=>JL>@;;;>=vAA8A=u
`stepwise worsening. There's some data that it
`1 A=LD>AD?@A8>8.u@~AA?J9==u=>=
`could have an affect on the more progressive
`5 I?wv9uC8ttI=?8=uJ?@L@?@AA>C
`form.
`6 t?@J.
`
`Q.
`Is it correct that Interferon
`7 |.A>=I?@@I==u=8=@t@?8
`slows the progression of multiple sclerosis,
`< Av?DA=uL@?@AA>?8?tJwv=>LvAIv@?A>A/
`in part, by reducing relapses?
`B >8L@=/KH@9wI>8@vLAA
`MR. TRENCHARD: Objection to
`: $#.#(*"# M&K€I=>?8=?
`
` t?@J.
`
`
`
`You can answer.
` F?wI88AD@.
`A.
`In part.
`, ".8L@=.
`Q.
`Interferon is a therapy that is
`1 |.8=@t@?8>A=u@LH=u=>A
`used to treat relapsing—remitting multiple
`5 wA9=?=@=@vLA>8;@J>==>8Jwv=>Lv
`sclerosis. Correct?
`6 AIv@?A>A.(?@@I=
`A.
`It's approved for treating
`7 ".=~ALL@?C9t?@=@=>8
`relapsing forms of multiple sclerosis.
`< @vLA>8t?@JA?tJwv=>LvAIv@?A>A.
`Q.
`Does that include
`B |. ?A=u=>8Ivw9
`relapsing—remitting multiple sclerosis?
`: @vLA>8;@J>==>8Jwv=>LvAIv@?A>A
`A.
`It does include
` ".=9?A>8Ivw9
`relapsing—remitting multiple sclerosis.
` @vLA>8;@J>==>8Jwv=>LvAIv@?A>A.
`Q.
`And Interferon is,
`in fact, used
`, |."898=@t@?8>A/>8tI=/wA9
`to treat relapsing—remitting multiple
`1 =?=@=@vLA>8;@J>==>8Jwv=>Lv
`sclerosis. Correct?
`5 AIv@?A>A.(?@@I=
`
`TSG Reporting 877-702-9580
`  
`
 
`
`

`

`B
`
`F. Lublin
` '.+wKv>8
`MR. TRENCHARD: Objection to
` $#.#(*"# M&K€I=>?8=?
`
`, t?@J.
`
`You can answer.
`1 F?wI88AD@.
`A.
`Yes.
`5 ".FA.
`Q.
`Interferon is,
`in fact, used to
`6 |.8=@t@?8>A/>8tI=/wA9=?
`reduce relapses in patients with
`7 @9wI@vLAA>8L=>8=AD>=u
`relapsing—remitting multiple sclerosis.
`< @vLA>8;@J>==>8Jwv=>LvAIv@?A>A.
`Correct?
`B (?@@I=
`A.
`Yes.
`: ".FA.
`Q.
`Interferon is,
`in fact, used to
` |.8=@t@?8>A/>8tI=/wA9=?
`slow the progression of relapsing—remitting
` Av?D=uL@?@AA>?8?t@vLA>8;@J>==>8
`multiple sclerosis. Correct?
`, Jwv=>LvAIv@?A>A.(?@@I=
`MR. TRENCHARD: Objection to
`1 $#.#(*"# M&K€I=>?8=?
`
`
`
`5 t?@J.
`
`You can answer.
`6 F?wI88AD@.
`It can be, yes.
`7 ".=I8K/HA.
`Q.
`In June 2006, what other
`< |.8Nw8::6/Du=?=u@
`therapeutic options were available for
`B =u@Lw=>I?L=>?8AD@C>vKvt?@
`reducing relapses in relapsing—remitting
`: @9wI>8@vLAA>8@vLA>8;@J>==>8
`multiple sclerosis patients?
` Jwv=>LvAIv@?A>AL=>8=A
`A.
`There were the various forms of
` ".u@D@=uC@>?wAt?@JA?t
`Interferon, several of them. There was
`, 8=@t@?8/AC@v?t=uJ.u@DA
`Glatiramer acetate, which was marketed as
`1 2v=>@J@I==/Du>IuDAJ@G=9A
`Copaxone, C—o—p—a—x—o—n—e.
`5 (?L{?8/(;?;L;;{;?;8;.
`
`TSG Reporting 877-702-9580
`  
`
 
`
`

`

`:
`
`F. Lublin
` '.+wKv>8
`There was a drug called
` u@DA9@wIvv9
`Novantrone which is Mitoxantrone; which was
`, ?C8=@?8Du>Iu>A$>=?{8=@?8ƒDu>IuDA
`approved for worsening forms of MS,
`so that
`1 LL@?C9t?@D?@A8>8t?@JA?t$!/A?=u=
`would include relapsing—remitting.
`5 D?wv9>8Ivw9@vLA>8;@J>==>8.
`There had been a drug called
`6 u@u9K89@wIvv9
`Tysabri, T—y—s—a—b—r—i. That was approved in
`7 HAK@>/;H;A;;K;@;>.u=DALL@?C9>8
`2004.
`It was taken off the market
`in 2005.
`< ::1.=DA=G8?tt=uJ@G=>8::5.
`Came back on the market, but
`I
`think, but I'm
`B (JKIG?8=uJ@G=/Kw==u>8G/Kw=~J
`not positive about this,
`that it was July of
`: 8?=L?A>=>CK?w==u>A/=u=>=DANwvH?t
`2006.
` ::6.
`
`
`
`Q.
`Other than Copaxone and
` |.&=u@=u8(?L{?889
`Novantrone and Tysabri, were there any other
`, ?C8=@?889HAK@>/D@=u@8H?=u@
`therapeutic options in June 2006, of which you
`1 =u@Lw=>I?L=>?8A>8Nw8::6/?tDu>IuH?w
`were aware for reducing relapses in RRMS
`5 D@D@t?@@9wI>8@vLAA>8##$!
`patients?
`6 L=>8=A
`A.
`Not that I can think of.
`7 ".?==u=I8=u>8G?t.
`Q.
`When I used the term "RRMS
`< |.zu8wA9=u=@J‚##$!
`patients," do you understand what
`I mean by
`B L=>8=A/‚9?H?ww89@A=89Du=J8KH
`that?
`: =u=
`
`A.
`I assume you mean
` ".AAwJH?wJ8
`relapsing—remitting.
` @vLA>8;@J>==>8.
`Q.
`If we use that terminology during
`, |.tDwA=u==@J>8?v?H9w@>8
`the deposition, we'll understand each other.
`1 =u9L?A>=>?8/D~vvw89@A=89Iu?=u@.
`Correct?
`5 (?@@I=
`
`TSG Reporting 877-702-9580
`  
`
 
`
`

`

`
`
` '.+wKv>8
`A.
`Sure.
` ".!w@.
`Q.
`Okay.
`Of those three options
`, |.&GH.&t=u?A=u@?L=>?8A
`that you just listed: Copaxone, Novantrone,
`1 =u=H?w€wA=v>A=9M(?L{?8/?C8=@?8/
`and Tysabri, do any of those prevent relapses?
`5 89HAK@>/9?8H?t=u?AL@C8=@vLAA
`MR. TRENCHARD: Objection to
`6 $#.#(*"# M&K€I=>?8=?
`form,
`foundation.
`7 t?@J/t?w89=>?8.
`You can answer.
`< F?wI88AD@.
`A.
`They all reduce the frequency of
`B ".uHvv@9wI=ut@w8IH?t
`relapses.
`: @vLAA.
`Q.
`Do any of those three options:
` |. ?8H?t=u?A=u@?L=>?8AM
`Copaxone, Novantrone, and Tysabri, alleviate
` (?L{?8/?C8=@?8/89HAK@>/vvC>=
`relapses?
`, @vLAA
`
`
`
`MR. TRENCHARD: Objection to
`1 $#.#(*"# M&K€I=>?8=?
`form,
`foundation.
`5 t?@J/t?w89=>?8.
`You can answer.
`6 F?wI88AD@.
`Yes.
`7 ".FA.
`Which of them?
`< |.zu>Iu?t=uJ
`All of them.
`B "."vv?t=uJ.
`Q.
`Do any of those three options
`: |. ?8H?t=u?A=u@?L=>?8A
`reduce inflammation in RRMS patients?
` @9wI>8tvJJ=>?8>8##$!L=>8=A
`MR. TRENCHARD: Objection to
` $#.#(*"# M&K€I=>?8=?
`
`, t?@J.
`
`You can answer.
`1 F?wI88AD@.
`All of them.
`5 "."vv?t=uJ.
`
`TSG Reporting 877-702-9580
`  
`
 
`
`

`

`
`
`
`
`F. Lublin
` '.+wKv>8
`Q.
`Do any of those three options
` |. ?8H?t=u?A=u@?L=>?8A
`reduce lesions in RRMS patients?
`, @9wIvA>?8A>8##$!L=>8=A
`A.
`I don't know what that means.
`1 ".9?8~=G8?DDu==u=J8A.
`Brain lesions?
`I don't know what you mean by
`5 )@>8vA>?8A9?8~=G8?DDu=H?wJ8KH
`"reduce lesions."
`6 ‚@9wIvA>?8A.‚
`Q.
`Okay. Let's start with a more
`7 |.&GH.+=~AA=@=D>=uJ?@
`basic question. What are brain lesions in
`< KA>IwA=>?8.zu=@K@>8vA>?8A>8
`RRMS patients?
`B ##$!L=>8=A
`A.
`A lesion is a pathologic
`: "."vA>?8>AL=u?v?>I
`abnormality.
`In multiple sclerosis,
`the
` K8?@Jv>=H.8Jwv=>LvAIv@?A>A/=u
`lesion is inflammatory, demyelinating, and
` vA>?8>A>8tvJJ=?@H/9JHv>8=>8/89
`neurodegenerative.
`, 8w@?98@=>C.
`Q.
`Are brain lesions symptoms of
`1 |."@K@>8vA>?8AAHJL=?JA?t
`multiple sclerosis?
`5 Jwv=>LvAIv@?A>A
`A.
`No.
`6 ".?.
`Q.
`Are brain lesions,
`the disease
`7 |."@K@>8vA>?8A/=u9>AA
`itself, multiple sclerosis?
`< >=Avt/Jwv=>LvAIv@?A>A
`A.
`Yes.
`B ".FA.
`Q.
`Do any of Copaxone, Novantrone,
`: |. ?8H?t(?L{?8/?C8=@?8/
`and Tysabri,
`reduce the appearance of new
` 89HAK@>/@9wI=uLL@8I?t8D
`lesions in RRMS patients?
` vA>?8A>8##$!L=>8=A
`A.
`Yes.
`, ".FA.
`Q.
`Do any of Copaxone, Novantrone,
`1 |. ?8H?t(?L{?8/?C8=@?8/
`or —— let me withdraw the question and start a
`5 ?@;;v=JD>=u9@D=uwA=>?889A=@=
`
`TSG Reporting 877-702-9580
`  
`
 
`
`

`

`,
`
`
`
` '.+wKv>8
`new question.
` 8DwA=>?8.
`Are any of Copaxone, Novantrone,
`, "@8H?t(?L{?8/?C8=@?8/
`or Tysabri, used to slow the progression of
`1 ?@HAK@>/wA9=?Av?D=uL@?@AA>?8?t
`RRMS patients?
`5 ##$!L=>8=A
`MR. TRENCHARD: Objection to
`6 $#.#(*"# M&K€I=>?8=?
`form,
`foundation.
`7 t?@J/t?w89=>?8.
`You can answer.
`< F?wI88AD@.
`Yes.
`B ".FA.
`Which of them?
`: |.zu>Iu?t=uJ
`All of them,
`in a fashion.
` "."vv?t=uJ

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