throbber
Page'l
`
`Redacted — Subject to Protective Order
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`————————————————————————————
`
`TORRENT PHARMACEUTICALS LIMITED
`and
`
`APOTEX,
`
`INC. AND MYLAN PHARMACEUTICALS,
`
`INC. ,
`
`Petitioners,
`
`vs.
`
`NOVARTIS AG AND MITSUBISHI PHARMA CORP. ,
`
`—————————————————————————————
`
`Patent Owners.
`
`Case IPR2014—00784
`
`Case IPR2015—00518
`
`Patent 8,324,283 B2
`
`————————————————————————————
`
`One Broadway
`New York, New York
`
`June 24, 2015
`
`9:30 a.m.
`
`1 2
`
`3%
`
`4:
`
`5 .
`6
`
`'7
`
`83
`
`9
`
`10
`
`11
`
`12.
`
`13‘
`
`14
`
`15
`
`16
`
`17%
`
`18'
`
`19:
`
`’
`
`** HIGHLY CONFIDENTIAL **
`
`203
`21:
`DEPOSITION OF JOEL w. HAY, Ph.D., held
`221
`23: at the abovewmentioned time and place, before
`
`24. Randi Friedman,
`
`a Registered Professional
`
`25; Reporter, within and for the State of New York.
`
`
`212—279-9424
`
`Vefitext Lega} Solutions
`www.veritext.com
`
`Man 3 491363
`DEPOSITION
`
`ammT
`
`Pefifian for Inter Panes Reveiw
`or us. Patent 3,324,233
`mm:
`
`TORRENT-1107
`
`Page 1 of 164
`
`Biogen Exhibit 2211
`Mylan v. Biogen
`IPR 2018-01403
`
`Page 1 of 164
`
`Biogen Exhibit 2211
`Mylan v. Biogen
`IPR 2018-01403
`
`

`

`APPEARANCES:
`
`Page 2
`
`\mm
`
`KENYON & KENYON, LLP
`
`Attorneys for Torrent Pharmaceuticals
`Limited
`
`One Broadway
`
`New York, New York 10004
`BY:
`PAUL M. RICHTER
`
`, JR.,
`
`ESQ.
`
`CROWELL MORING
`
`Attorneys for Apotex
`
`,
`
`Inc.
`
`1001 Pennsylvania Avenue,
`
`NW
`
`Washington, D.C. 20004
`
`BY:
`
`DEBORAH H. YELLIN,
`
`ESQ.
`
`PERKINS COIE
`
`Attorneys for Mylan Pharmaceuticals,
`Inc.
`
`700 13th Street, NW,
`
`Suite 600
`
`Washington, D.C. 200
`
`05
`
`BY:
`
`BRANDON M. WHITE,
`
`ESQ.
`
`WILMER CUTLER PICKERING HALE
`
`AND DORR, LLP
`
`Attorneys for Novartis AG
`7 World Trade Center
`
`250 Greenwich Street
`
`New York, New York 1000?
`
`BY:
`
`ROBERT W. TRENCHARD,
`
`ESQ.
`
`STEPHANIE LIN,
`
`ESQ.
`
`
`
`
`
`obLONH
`
`Ul
`
`CD
`
`10
`
`12;
`13;
`14;
`
`15;
`
`16;
`
`17;
`18;
`19;
`
`20;
`
`21;
`
`22
`
`23:
`
`24;
`25;
`
`212—279—9424
`
`Veritext Legal Solutions
`www.veritext.c01n
`
`212-490-3430
`
`Page 2 of 164
`
`Page 2 of 164
`
`

`

`Page 3
`
`m-dmmeJNI-J
`
`STIPULATIONS
`
`IT IS HEREBY STIPULATED, by and between
`
`the attorneys for the respective parties hereto,
`
`that:
`
`All rights provided by the C.P.L.R.,
`
`and Part 221 of the Uniform Rules for the Conduct
`
`of Depositions,
`
`including the right to object to
`
`any question, except as to the form, or to move
`
`10
`
`to strike any testimony at this examination is
`
`ll:
`
`reserved; and in addition,
`
`the failure to object
`
`12?
`
`13;
`
`14?
`
`15%
`
`163
`
`17
`
`18%
`I195
`
`20
`
`21
`
`22
`
`23‘
`
`24
`
`25
`
`to any question or to move to strike any
`
`testimony at this examination shall not be a bar
`
`‘or a waiver to make such motion at, and is
`
`reserved to,
`
`the time of this action.
`
`This deposition may be sworn to by the
`
`witness being examined before a Notary Public
`
`other than the Notary Public before whom this
`
`examination was begun, but the failure to do so
`
`or to return the original of this deposition to
`
`counsel, shall not be deemed a waiver or the
`
`rights provided by Rule 3116, C.P.L.R., and shall
`
`be controlled thereby.
`
`)
`
`The filing of the original of this
`
`deposition is waived.
`
`212-279—9424
`
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`www.veritext.com
`
`2 12490—3430
`
`Page 3 of 164
`
`Page 3 of 164
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`

`

`2
`
`3
`4 %
`
`5
`
`5:
`
`7 g
`8 3
`9 g
`10 I
`
`11:
`
`*‘k'k
`
`JOEL W. HAY, Ph.D.,
`the witness
`herein, having been duly sworn, was examined
`
`and testified as follows:
`
`***
`
`EXAMINATION
`
`BY MR. TRENCHARD:
`Q
`Good morning, Dr. Hay.
`A
`Good morning.
`
`Q
`
`I'm sure you've gone over some of
`
`12% these before in other depositions, but a few
`13 ? pointers.
`If, as I'm going,
`I mess up a
`141 question, you don't understand it in some way or
`
`15; other, please don‘t hesitate to ask me to try and
`
`16% fix it; okay?
`
`173
`
`183
`
`A
`
`Q
`
`Okay.
`
`If at any time you need a break,
`
`I'm
`
`19! perfectly happy to let you have a break.
`
`20% Normally I try to break roughly every hour, plus
`215 or minus; okay?
`22;
`A
`Okay.
`23;
`Q
`But, you know, if you need it in the
`24% interim for whatever reason,
`I'm happy to
`25 i
`accommodate you.
`
`
`212—279-9424
`
`Veritext Legal Solutions
`www.veritext.com
`
`212_490_3430
`
`Page 4 of 164
`
`Page 4 of 164
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`

`

`Page 5
`
`J. Hay, Ph.D.
`
`w Highly Confidential
`
`A
`
`Presumably as long as a question isn't
`
`pending.
`
`Q
`
`Exactly.
`
`I may ask you,
`
`indeed,
`
`to
`
`sit for two questions or three questions if I‘m
`
`not done with a line, but it's not going to be
`
`anything more than that; okay?
`
`Are you on any medications today that
`
`would cloud your memory or comprehension?
`
`A
`
`Q
`
`No.
`
`So why don't we just start by getting
`
`right into it.
`
`I'm going to show you Torrent
`
`Exhibit 1041. And if you can just page through
`
`that, and confirm that that is your Declaration
`
`in this IPR,
`
`I would appreciate it.
`
`A
`
`Q
`
`It appears to be.
`
`So how much time did you spend on this
`
`Declaration?
`
`A
`
`Q
`
`A
`
`Q
`
`On the Declaration?
`
`Uh—huh.
`
`Probably about 80, 90 hours.
`
`When were you first retained to work
`
`mummthI-I
`
`I-lOED
`11?
`
`12
`
`13;
`
`16
`
`1 1
`
`3%
`19:
`20;
`
`23:1
`
`for Torrent?
`
`24
`
`25%
`
`A
`
`April or May some time.
`
`Of this year?
`Q
`
`
`Veritext Legal Solutions
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`
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`
`212-279-9424
`
`Page 5 of 164
`
`Page 5 of 164
`
`

`

`
`
`Page 6
`
`J. Hay, Ph.D.
`
`— Highly Confidential
`
`Of this year.
`
`Have you ever worked for Torrent
`
`A
`
`Q
`
`before?
`
`A
`
`I don‘t specifically know.
`
`You know,
`
`I've been involved in a few generic patent
`
`challenge cases, and they may have been a
`
`co—defendant or something on one of the cases.
`
`I
`
`don't recall.
`
`Q
`
`Have you ever worked for Kenyon
`
`
`
`before?
`
`A
`
`Kenyon, again ——
`
`MR. RICHTER: Objection to form.
`
`THE WITNESS:
`
`“— again,
`
`they may
`
`have been counsel for one of the
`
`co—defendants on something. That's as much
`
`as I can recall.
`
`BY MR. TRENCHARD:
`
`Q
`
`Who first contacted you about working
`
`on this case?
`
`A
`
`Q
`
`I believe it was Vince Galluzzo.
`
`And how many patent cases have you
`
`worked on as an expert?
`
`mU’libUJNH
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19?
`
`204
`
`22%
`
`23
`
`243
`:
`
`25
`
`E
`i
`
`A
`
`I don‘t specifically recall. Fifteen
`
`to 20.
`
`
`212—279—9424
`
`Veritext Legal Soiutions
`vnvmhverfiextconl
`
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`
`Page 6 of 164
`
`Page 6 of 164
`
`

`

`mdmmbUNH
`
`103.
`
`11
`
`J. Hay, Ph.D.
`
`— Highly Confidential
`
`Q
`
`Have they all been in the
`
`pharmaceutical area?
`
`A
`
`Q
`
`Yes.
`
`In your Declaration, at the end of it,
`
`there is an appendix.
`
`The very last group of
`
`pages are a list of cases in which you've given
`testimony; have I got that right?
`
`A
`
`Q
`
`Yeah,
`
`the past four years.
`
`Past four years. Could you just check
`
`off for me which of these cases was a case
`
`123
`
`involving a dispute over a patent?
`
`
`
`16%
`175
`
`18
`
`mi
`20%
`
`21
`
`22:
`
`23_
`
`24,
`
`A
`
`Well, it's my understanding that all
`
`these cases,
`
`to the best of my knowledge, are
`
`covered under Protective Orders, so I can‘t
`
`really tell you what
`
`the cases are about.
`
`Q
`
`Right.
`
`I don't want to know any of
`
`the details about the patent, but just whether
`
`they‘re patent cases or something else.
`
`MR. RICHTER:
`
`Can you just tell me
`
`which page you're 0n?
`
`MR. TRENCHARD:
`
`Sure.
`
`It‘s the
`
`last —~ on my copy, it's the last bunch of
`
`pages.
`
`They actually begin on Page 1
`
`to
`
`page five.
`
`
`Go to the very last page and
`
`212—279-9424
`
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`
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`
`Page 7 of 164
`
`Page 7 of 164
`
`

`

`
`
`Page 8
`
`
`
`1
`
`2 T
`
`3 1
`4 3
`
`5
`
`J. Hay, Ph.D.
`
`- Highly Confidential
`
`then work your way forward.
`
`Thanks.
`MR. RICHTER:
`THE WITNESS: Without going into
`
`the details of the case,
`
`I guess it's hard
`
`for me to say to what extent they are or are
`6 g
`not patent cases.
`7 ;
`BY MR. TRENCHARD:
`8 g
`Q
`Okay. Well,
`9 g
`10% narrower question.
`11%
`'
`Do you know which of these cases
`12% involved an allegation by the plaintiff that the
`
`then, how about a
`
`133 defendant was infringing a patent?
`
`14;
`
`15 3
`
`A
`
`Q
`
`Could you repeat the question, please?
`
`Sure. Which of these cases involved
`
`16% an allegation by the plaintiff that the defendant
`
`1? i was infringing a patent?
`
`18%
`1
`
`A
`
`Probably the first one on the top of
`
`19% Page 2.
`
`The second one on Page 2.
`
`The third one
`
`20 ‘
`on Page 2.
`Probably the fourth one on Page 2.
`21 ‘ Maybe the last one on Page 3.
`The fourth one on
`
`22; Page 4. And the last two.
`
`
`
`Q
`
`Thank you very much.
`
`So have I got it
`
`right that in each of those cases, you worked for
`
`the defendants' attorneys?
`
`
`212279—9424
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`
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`Page 8 of 164
`
`Page 8 of 164
`
`

`

`J. Hay, Ph.D.
`
`— Highly Confidential
`
`MR. RICHTER: Objection to form.
`
`THE WITNESS:
`
`It says in this
`
`listing who I worked for.
`
`BY MR. TRENCHARD:
`
`Q
`
`Okay.
`
`So to the extent it says that
`
`you worked for the defense attorneys, that's what
`
`you remembered of it; right?
`
`A
`
`Q
`
`Yeah.
`
`Could we just talk about the first one
`
`on Page 2, Teva v. Perrigo; do you see that one?
`
`A
`
`Q
`
`Uh—huh.‘
`
`I'm sorry.
`
`I'm going to have to ask
`
`you when you answer questions,
`
`that you use yes
`
`or no rather than grunts; okay?
`
`A
`
`Q
`
`Okay.
`
`So speaking about that one, again,
`
`I
`
`don't want you to get into the details of the
`
`cases at all,
`
`so keep your answers general.
`
`Is Perrigo,
`
`in your View, a generic
`
`drug manufacturer?
`
`A
`
`Q
`
`I don't recall.
`
`I have the same question with respect
`
`to the next one with Fresenius.
`
`You see that
`
`
`
`there?
`
`(IOaJO'iU'lsb-UJNH
`
`10:
`
`11;
`
`12§
`
`13%
`
`14
`
`15
`
`16:
`
`17:
`
`18%
`
`19'
`20;
`
`21;
`
`22:
`23%
`24?
`25;
`
`212~279—9424
`
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`www.veritext.com
`
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`
`Page 9 of 164
`
`Page 9 of 164
`
`

`

`
`
`Page 10
`
`J. Hay, Ph.D.
`
`u Highly Confidential
`
`Yes
`
`Is Fresenius a generic drug
`
`A
`
`Q
`
`manufacturer?
`
`A
`
`Q
`
`I don't recall.
`
`And on the next one, Watson
`
`Laboratories,
`
`is that a generic drug
`
`manufacturer?
`
`A
`
`I believe it's got a generic division.
`
`I don‘t know it‘s 100 percent generic.
`
`Q
`
`Do you know if the dispute in that
`
`case involved a generic drug?
`
`A
`
`I believe I'm covered under a
`
`Protective Order in that case.
`
`I'd be happy to
`
`give you the names of the attorneys.
`
`They can
`
`tell you what you need to know.
`
`Q
`
`To your knowledge,
`
`is the Complaint in
`
`that case filed under seal?
`
`A
`
`Q
`
`I don‘t recall.
`
`Are you under a Protective Order in
`
`the other two cases we just talked about, Teva v.
`
`Perrigo and Cadence v. Fresenius?
`
`A
`
`Q
`
`As far as I know.
`
`Turning to the bottom of Page 3,
`
`the
`
`(demnb-UJNH
`
`10:
`
`113
`
`123
`
`13
`
`14
`
`15
`
`17
`
`18:;
`
`193
`
`20,
`
`21
`
`22
`
`23
`
`24;
`
`25%
`is Impax a generic
`Impax case,
`Takeda'v.
`
`
`212—279-9424
`
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`
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`
`Pagelllof164
`
`Page 10 of 164
`
`

`

`mph-DJNI-l
`
`m
`
`CROWN]
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`23
`
`24
`
`25
`
`22E
`
`
`
`J. Hay, Ph.D.
`
`- Highly Confidential
`
`drug—maker?
`
`A
`
`Q
`
`I don't recall:
`
`Then on Page 4,
`
`the Warner Chilcott v.
`
`Teva case,
`
`that's the fourth one down,
`
`I think.
`
`Is the Teva Pharmaceuticals USA that's
`
`named as a defendant there a generic drug—maker?
`
`A
`
`Q
`
`Which case;
`
`I‘m scrry?
`
`Warner Chilcott,
`
`the Teva
`
`Pharmaceuticals?
`
`A
`
`Q
`
`Yes.
`
`Is the Teva Pharmaceuticals USA that's
`
`listed there a generic drug?
`
`A
`
`Q
`
`I think they have a generic division.
`
`Do you know if that defendant is a
`
`generic drug maker or also makes branded drugs?
`
`A
`
`Q
`
`I don't know.
`
`And then with respect to the last two
`
`which are La Roche and some others, v. Watson and
`
`some others -—
`
`Q
`
`—- that's the same Watson we talked
`
`about before that you said you thought was a
`
`generic drug-maker; right?
`
`il
`i1
`think Watson has a generic
`I
`Well,
`A
`E
`
`
`212—279-9424
`
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`
`Page110f164
`
`Page 11 of 164
`
`

`

`Page 12
`
`J. Hay, Ph.D.
`
`— Highly Confidential
`
`division.
`
`Q
`
`Okay. Have you ever testified on
`
`behalf of a branded drug—maker in support of a
`
`patent?
`
`MR. RICHTER: Objection,
`
`form.
`
`THE WITNESS: Yes.
`
`BY MR. TRENCHARD:
`
`Q
`
`A
`
`Q
`
`How many times?
`
`I don't specifically recall.
`
`Do you recall in general
`
`terms how
`
`many times?
`
`A
`
`Q
`
`Between 5 and 10.
`
`And how many times have you testified
`
`in support of an argument that a patent owned by
`
`a generic —— sorry, a branded drug—maker was
`
`invalid as obvious?
`
`MR. RICHTER: Objection,
`
`form.
`
`THE WITNESS:
`
`I don't specifically
`
`recall.
`
`BY MR. TRENCHARD:
`
`Q
`
`A
`
`Q
`
`Do you have a general recollection?
`
`Sorry?
`
`Do you have a general recollection?
`
`A
`More than 15. And in this line of
`
`
`mmmm'
`
`i
`.
`
`mswaH
`
`10%
`
`12;
`
`13:
`
`14%
`
`15
`
`16:
`
`17
`
`18
`
`19
`
`20;
`
`21:
`
`22
`
`
`
`23;
`
`24
`
`25
`
`212—279—9424
`
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`Page120f164
`
`Page 12 of 164
`
`

`

`J. Hay, Ph.D.
`
`— Highly Confidential
`
`litigation, as in most of my lines of where I am
`
`involved as a legal expert, if I don't agree with
`
`the viewpoints of the attorneys that present the
`
`case to me,
`
`I don't take the case.
`
`Q
`
`In how many patent cases have you
`
`given testimony on the subject of the commercial
`
`success of a product, as that term is used in
`
`your Declaration here?‘
`
`A
`
`I don't «u could you repeat the
`
`question, please?
`
`Q
`
`‘Sure.
`
`How many patent cases have you
`
`given testimony on the subject of commercial
`
`mdeTnh-UJNH
`
`12
`
`13;
`
`14,
`
`success of a product as that term is used in your
`
`15{
`16$
`
`19%
`202
`
`21
`
`22*
`
`23%
`24?
`25%
`
`Declaration in this proceeding?
`
`MR, RICRTER: Objection,
`
`form.
`
`THE WITNESS:
`
`I don't specifically
`
`recall. Certainly more than 20.
`
`BY MR. TRENCHARD:
`
`Q
`
`Have you published any peer review
`
`articles on the subject of commercial success?
`
`A
`
`Well,
`
`I certainly published
`
`peer—reviewed articles that relate to issues of
`
`commercial success.
`
`Have you published any articles about
`Q
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`Page 14
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`1 -
`2 2
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`3 g
`
`J. Hay, Ph.D.
`— Highly Confidential
`how one should analyze commercial success from an
`
`economic point of View in a patent case?
`
`4 3
`A
`Well,
`I
`think a lot of what I
`5 ‘ published has elements of that.
`
`6 g
`
`Q
`
`Have you published any articles in
`
`7 i which that was the primary subject?
`8 g
`'
`MR. RICHTER: Objection to form.
`9 g
`THE WITNESS:
`I don't specifically
`10%
`I may have, but nothing comes to
`recall.
`11%
`mind. We could go through my CV and see if
`12 g
`anything pops into my mind.
`13;
`BY MR. TRENCHARD:
`
`How would you describe the area of
`Q
`14;
`economics in which you have expertise?
`15 i
`‘
`A
`Well, I‘d say my area of expertise
`163
`17% relates to economic theory and methods and
`18% empirical approaches as applied to generally
`
`19g
`
`speaking topics related to health and
`
`20j pharmaceutical, both industries, markets and
`
`21
`
`22
`
`products, and a lot of what I do relates to
`
`assessing the value of different pharmaceutical
`
`233 products. But I mean,
`
`that‘s one string of my
`
`
`
`research.
`
`It's not the only one.
`
`And by "value," do you mean the cost
`Q
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`Page 15
`
`J. Hay, Ph.D.
`
`— Highly Confidential
`
`2 % effectiveness of those products?
`3 5
`A
`That certainly is one way to
`4 E characterize economic value.
`
`5 i
`
`6 ’
`
`Q
`
`We'll talk about that subject later.
`
`Returning to your Declaration, Exhibit
`
`7 ‘ A, we were just talking about a piece of it which
`
`8 3
`
`listed some cases.
`
`9 i
`Can you just take a look and confirm
`10% that that's a current version of your CV?
`
`11
`
`12;
`
`A
`
`Q
`
`Well, it‘s a CV as of June 4th.
`
`Have there been any material changes
`
`13;
`
`since then that you would like to make to the CV
`
`14:
`
`to bring it up to date?
`
`Probably a few more publications and
`A
`15%
`16$ presentations.
`1??
`Q
`Okay.
`
`A
`Q
`
`That's about it.
`18%
`Thank you.
`Okay. That's helpful.
`19%
`And you're a professor at the
`20%
`21% University of Southern California;
`is that right?
`22?
`A
`Yes.
`23;
`Q
`And you have an economics degree,
`24% right,
`
`Ph.D.?
`
`
`
`25
`
`Yes .
`A
`
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`
`
`mummthI—I
`
`\D
`
`10
`
`ll
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`J. Hay, Ph.D.
`
`— Highly Confidential
`
`Q'
`
`And that's from Yale?
`
`A
`
`Q
`
`right?
`
`Yes.
`
`And you don‘t have a medical degree;
`
`A
`
`No, although I taught in the School of
`
`Pharmacy for 25 years.
`
`Q
`
`A
`
`What did you teach?
`
`Biostatistics. Health policy. Health
`
`economics.
`
`Pharmaceueconomics.
`
`How to read the
`
`medical literature.
`
`Q
`
`You don‘t teach chemistry or
`
`formulation or anything like that; right?
`
`A
`
`Q
`
`doctor?
`
`No.
`
`You‘ve never treated a patient as a
`
`A
`
`Not formally, no.
`
`I‘ve given advice
`
`to people, but, no, I've never treated anybody.
`
`Q
`
`A
`
`Q
`
`What sort of advice have you given?
`
`Go see your doctor.
`
`Often excellent advice.
`
`So how much of your time is devoted to
`
`your work as a professor at USC versus
`
`consulting?
`
`25:
`
`1
`
`A
`Well, it varies, but, you know,
`I
`
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`Page 17
`
`QmUIIbWNH
`
`10
`
`11%
`12%
`
`13
`
`14
`
`15%
`16%
`
`13
`
`19
`
`20
`
`23%
`24%
`
`J. Hay, Ph.D.
`
`- Highly Confidential
`
`follow the University Faculty Handbook
`
`Guidelines, which are that you're allowed to do
`
`consulting one day a week, you know. That
`
`doesn't,
`
`like -- you know, for example in this
`
`case,
`
`I'm actually here in New York on this case
`
`for two days,
`
`so I don‘t follow it to the
`
`absolute letter, but I stay within the
`
`guidelines.
`
`Q
`
`And of your consulting work, how much
`
`of it is litigation consulting?
`
`A
`
`Again, it varies, but it could be —-
`
`sometimes it's less than half.
`
`Sometimes it's
`
`more than half.
`
`Q
`
`And other than litigation consulting,
`
`what sort of consulting work do you do?
`
`A
`
`I do consulting for u" typically for
`
`pharmaceutical companies that are in the process
`
`of developing products or evaluating products
`
`that they already have.
`
`I've done consulting for
`
`the U.S. Federal Government as described in my
`Declaration.
`The Centers for Disease Control.
`
`The National Institutes of Health.
`
`The
`
`Department of Health and Human Services Agencies
`
`for healthcare, research and quality. County of
`
`WW .“WM
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`0040301»me
`
`Page 18
`
`J. Hay, Ph.D.
`
`- Highly Confidential
`
`Sacramento. State of California. State of
`
`Texas.
`
`I‘ve done consulting for lots of
`
`different federal, state,
`
`local agencies. World
`
`Bank. Hong Kong —— what was it? The Hong Kong
`
`Medical Executives Association.
`
`You know,
`
`lots
`
`of different things.
`
`Q
`
`What sort of consulting do you provide
`
`to pharma companies with regard to their
`
`products?
`
`A
`
`It varies, but a lot of times I'm
`
`asked to look at appropriate ways to develop
`
`marketing messages for drugs, and to assess the
`
`value of drugs that either they have in the
`
`pipeline or on the market.
`
`Q
`
`A
`
`Have you ever worked for Novartis?
`
`Probably.
`
`I can‘t think of any major
`
`pharmaceutical company that I haven't provided
`
`some type of advisory or consulting to, but I
`
`don't specifically recall an assignment for
`
`Novartis.
`
`Q
`
`How about Mitsubishi Tanabe
`
`Pharmaceutical Company?
`
`A
`
`Not that I can recall.
`
`I'm sorry.
`Q
`
`
`You said you don't
`
`
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`Page 19
`
`MdmmthH
`
`[.1OKD
`
`11?
`
`12
`
`13?
`
`14?
`
`
`1?6
`
`18?
`
`19?
`
`20
`
`21:?
`
`22
`
`23?
`
`24?
`
`J. Hay, Ph.D.
`
`— Highly Confidential
`
`remember of any particular assignment for
`
`Novartis; right?
`
`A
`
`Q
`
`That‘s correct.
`
`Are you familiar with what a
`
`securities analyst is?
`
`A
`
`Q
`
`analyst?
`
`A
`
`Q
`
`formally?
`
`day.
`
`A
`
`Q
`
`A
`
`Q
`
`Yes.
`
`Have you ever worked as a securities
`
`Not formally.
`
`How about something other than
`
`Well,
`
`I evaluate my portfolio every
`
`So you're your own securities analyst?
`
`Yes.
`
`In connection with your own portfolio,
`
`do you ever read security analyst reports?
`
`A
`
`Occasionally. More in the context of
`
`legal cases.
`
`Q
`
`Returning to the subject of your work
`
`on providing opinions on commercial success,
`
`just
`
`to ground us again, your recollection is that
`
`you've given opinions on commercial success more
`
`than 20 times; right?
`
`
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`

`

`J. Hay, Ph.D.
`
`— Highly Confidential
`
`As I recall.
`
`And how many of those cases did you
`
`A
`
`Q
`
`conclude that commercial success with respect to
`
`a product had been shown?
`
`MR. RICHTER: Objection,
`
`form.
`
`THE WITNESS:
`
`Probably between 5
`
`and 10 times;
`
`I don't specifically recall.
`
`BY MR. TRENCHARD:
`
`Q!
`
`And the remaining times you reached
`
`the opposite conclusion?
`
`A
`
`I don't recall what conclusion I
`
`reached in all the cases.
`
`Q
`
`Did you ever conclude that it was
`
`impossible to determine one way or another
`
`whether a product was a commercial success?
`
`MR. RICHTER: Objection,
`
`form.
`
`THE WITNESS: That's possible.
`
`I
`
`don't specifically recall that, but I may
`
`have.
`
`BY MR. TRENCHARD:
`
`Q
`
`A
`
`Q
`
`A
`
`You don‘t have a law degree; right?
`
`No.
`
`Okay. You're not a member of any Bar?
`
`Any Bar?
`
`
`Veritext Legal Solutions
`“MN“Lverfiextconl
`
`“WWW
`212~490-3430
`
`mummthI—I
`
`10%
`
`11?
`
`mg
`
`14;
`
`15'?
`16%
`
`18%
`
`20%
`
`22%
`
`23
`
`24%
`
`25%
`
`212—279-9424
`
`Page 20 of 164
`
`Page 20 of 164
`
`

`

`mU‘lnhLdNH
`
`10
`
`12
`
`.14
`
`173
`183
`
`193
`203
`
`233
`
`243
`
`Q
`
`A
`
`Q
`
`J. Hay, Ph.D.
`
`— Highly Confidential
`
`Yeah.
`
`Not a legal Bar, no.
`
`I'm not talking about Cheers.
`
`So in connection with the subject of
`
`commercial success, you understand that there's
`
`something called a nexus element; right?
`
`A
`
`Q
`
`That‘s my understanding, yes.
`
`How many times have you concluded in
`
`your work on commercial success that there was no
`
`nexus between the patent at issue and the
`
`product's commercial success?
`
`MR. RICHTER: Objection to form.
`
`THE WITNESS:
`
`I don't specifically
`
`recall.
`
`It-depends on the case and it
`
`
`
`depends on my burden.
`
`BY MR. TRENCHARD:
`
`Q
`
`What do you mean by, it depends on
`
`your burden?
`
`A
`
`Well,
`
`I don't have to affirmatively
`
`conclude nexus or affirmatively conclude no nexus
`
`in all cases.
`
`Q
`
`A
`
`Why not?
`
`Because it depends on what my burden
`
`25?
`is in each case. At least that's my
`
`
`212—279—9424
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`
`Page210f164
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`

`

`consulting with multiple lawyers,
`
`both for
`
`and
`
`Yeah,
`
`it's
`
`Page 22
`
`mUldh-LIJNP‘
`
`J.
`
`Hay, Ph.D.
`
`— Highly Confidential
`
`understanding.
`
`on?
`
`Q
`
`A
`
`And what is that understanding based
`
`It's based on what I've read.
`
`It's
`
`based on my experience in all these various cases
`
`that we‘ve been talking about.
`
`It's based on
`
`ms!
`9 E against defendants and plaintiffs.
`10% based on all the work I've done.
`11%
`Q
`So what is your understanding about
`E
`12: who has the burden to show nexus?
`form.
`13:
`MR. RICHTER: Objection,
`14 g
`THE WITNESS: Well, it's my
`15%
`understanding that typically for the kinds
`16%
`of cases we're talking about where the
`17;.
`plaintiffs are challenging the defendants
`183
`and claiming that the patent has validity
`19%
`because of secondary considerations of
`20%
`non—obviousness, such as commercial success
`213
`or long-felt need,
`that it‘s the burden of
`22%
`the plaintiffs to establish that there is a
`
`23
`24g
`25;
`
`nexus between the claims of the patent and
`whatever indicia of commercial success are
`that make sense.
`
`
`
`
`212-279—9424
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`Page 23
`
`mqmmbwma—I
`
`J. Hay, Ph.D.
`
`_ Highly Confidential
`
`BY MR. TRENCHARD:
`
`Q
`
`Okay.
`
`Turn to Page 7 of your.
`
`Declaration, Paragraph 19.
`
`Do you see that is there where it
`
`says, "I understand that patent owners have the
`
`burden to show the existence of secondary
`
`considerations of non—obviOusness"; do you see
`
`that?
`
`1oi
`
`A
`
`Q
`
`Yes.
`
`From where did you get that
`
`
`
`12
`
`understanding?
`
`Mi
`15i
`
`16i
`
`18i
`19i
`20i
`
`22
`
`24
`
`A
`
`Same answer I gave earlier.
`
`It‘s -—
`
`as we've established I've worked on, you know,
`
`dozens of these kinds of generic patent challenge
`
`cases, and so I've read a lot of stuff about
`
`this.
`
`I've discussed these issues at great
`
`length in many of these cases with counsel.
`
`I've
`
`been challenged in depositions and other
`
`testimony in many of these cases by opposing
`
`counsel. And that's my general understanding.
`
`Q
`
`Okay. This section that we're talking
`
`about in your Declaration, Relevant Legal
`
`Concepts, Roman Numeral III; do you see that?
`
`A
`
`Yes.
`
`
`
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`

`Page 24
`
`J. Hay, Ph.D.
`
`- Highly Confidential
`
`Q
`
`Did you write this section or did
`
`somebody else?
`
`MR. RICHTER: Objection to form.
`
`THE WITNESS:
`
`I don‘t specifically
`
`recall who wrote the words.
`
`I certainly am
`
`quite happy that it's consistent with my
`
`understanding.
`
`BY MR. TRENCHARD:
`
`Q
`
`Did you, when preparing this
`
`Declaration, discuss the question addressed in
`
`Paragraph 19 of who has what burden with counsel
`
`in this case?
`
`MR. RICHTER: Objection,
`
`form.
`
`THE WITNESS: Well,
`
`I think
`
`implicitly —— implicitly we did.
`
`I don't
`
`know if we did explicitly.
`
`mutt-DON!“
`
`01
`
`03-4
`
`10%
`
`11
`
`12‘j
`
`13}
`
`14
`
`15
`
`16
`
`17
`
`182
`
`BY MR. TRENCHARD:
`
`19%
`
`20%
`
`21%
`
`22%
`
`23
`
`24%
`
`25
`
`Q
`
`What do you mean by "implicitly"?
`
`MR. RICHTER: Objection,
`
`form.
`
`Just on the question of privilege, Bob,
`
`you're not asking for the substance?
`
`MR. TRENCHARD: No, no. You're
`
`absolutely right.
`
`I‘m asking about
`
`implicitly.
`
`
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`
`Page240fl64
`
`Page 24 of 164
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`

`

`mummwaI—I
`
`10%
`11%
`
`12%
`13%
`14%
`
`16%
`
`17
`
`18%
`19%
`
`20%
`
`23%
`2.;
`25%
`
`J. Hay, Ph.D,
`
`— Highly Confidential
`
`BY MR. TRENCHARD:
`
`Q
`
`Paul is absolutely right.
`
`I don‘t
`
`want to know the substance of the back and forth
`
`you had with counsel.
`
`A '
`
`You know,
`
`this is my general
`
`understanding,
`
`I think before I came into this
`
`case, of how these cases operate, and I don't
`
`think anything I said to counsel or anything
`
`counsel said to me dissuaded me from this
`
`opinion.
`
`Q
`
`Okay.
`
`Is the question of who has the
`
`burden with respect to secondary considerations
`
`referred to in your Paragraph 19 an important
`
`input to your opinion in the rest -- opinions,
`
`sorry,
`
`in the rest of your Declaration?
`
`MR. RICHTER: Objection to form.
`
`THE WITNESS: Could you repeat the
`
`question, please?
`
`BY MR. TRENCHARD:
`
`
`
`Q
`
`Sure.
`
`Is the question of who has the
`
`burden with respect to secondary considerations
`
`referred to in your Paragraph 19 an important
`
`input to your opinions in the rest of your
`
`Declaration?
`
`
`
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`
`
`J. Hay, Eh.D.
`
`- Highly Confidential
`
`A
`
`Well, it's certainly one of the
`
`elements of how I conduct my analysis.
`
`Q
`
`A
`
`How does it affect your analysis?
`
`Well, it leads to issues of whether or
`
`not I have to affirmatively prove or disprove
`
`certain things as opposed to point out that the
`
`opposing expert in this case, Dr. Blackburn,
`
`failed to prove or failed to establish certain
`
`things.
`
`Q
`
`So if you had the burden to
`
`affirmatively prove things, would any part of
`
`your Declaration be different?
`
`MR. RICHTER: Objection,
`
`form.
`
`THE WITNESS: That's an incomplete
`
`hypothetical.
`
`I'd have to know everything
`
`else that went into that counter—factual
`
`hypothetical.
`
`BY MR. TRENCHARD:
`
`Q
`
`A
`
`What else would you need to know?
`
`Why we would be doing something that
`
`deviates from what
`
`I understand to be established
`
`case law for these kinds of cases.
`
`Q
`
`Okay. There was an assumption in one
`
`ODHJOWU‘Ith-LAJNH
`
`10%
`113
`
`12;
`13%
`14%
`
`16%
`
`183
`
`19%
`
`20
`
`21;
`
`23%
`
`
`
`of my earlier questions that I actually should
`
`
`212-279w9424
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`O‘sU‘lnbLONH
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`-J
`
`
`
`11
`
`13?
`142
`
`152
`162
`
`192
`202
`212
`
`232
`242
`
`J. Hay, Ph.D.
`
`- Highly Confidential
`
`establish.
`
`Who retained you in this case?
`
`A
`
`I believe it‘s all of the
`
`co-petitioners.
`
`Q
`
`Can you walk me through how you
`
`drafted your report? Who wrote the first draft?
`
`MR. RICHTER: Objection,
`
`form.
`
`THE WITNESS: Well,
`
`I‘m not sure
`
`that there was a completed first draft, you
`
`know.
`
`I worked with my assistant. We put
`
`together an outline. We assigned different
`
`components to be either her primary
`
`responsibility or my primary responsibility.
`
`We put together words, and that constituted
`
`the first draft.
`
`BY MR. TRENCHARD:
`
`Q
`
`An outline, okay.
`
`And you sent that outline to counsel;
`
`is that how it worked?
`
`A
`
`I don't recall when we sent the first
`
`thing to counsel.
`
`I simply don't recall.
`
`Q
`
`A
`
`Q
`
`And who's your assistant?
`
`Shraddha Chaugule.
`
`' Spelled the usual way?
`
`212-279-9424
`
`Veritext Legai Solutions
`www.veritext.com
`
`212-490-3430
`
`Page270f164
`
`Page 27 of 164
`
`

`

`Page 28
`
`J. Hay, Ph.D.
`
`_ Highly Confidential
`
`A
`
`Yeah.
`
`S-H—R—A—D—Dmfl—A,
`
`CHHHAHUHGHUHLHE.
`
`Q
`
`What materials did you review in
`
`preparing your Declaration?
`
`A
`
`I mean,
`
`I
`
`think all of —— anything
`
`that I can remember is stated as a footnote, and
`
`also I
`
`think was included as an exhibit to my
`
`report.
`
`Q
`
`Okay.
`
`So you don't remember anything
`
`other than what you cite in your report as being
`
`reviewed in connection with your Declaration?
`
`A
`
`I mean, not specifically to the
`
`report. Certainly I have decades of experience
`
`that is sort of in the back of my mind when I do
`
`these things, so, you know,
`
`I'm not going there
`
`with a tabula rasa, but these are the things I
`
`can remember citing.
`
`Q'
`
`In terms of documents specific to this
`
`case, that's what I was talking about.
`
`A
`
`Q
`
`Yes, that's what I Can recall.
`
`How did you gather the materials that
`
`you cite in your opinion?
`
`MR. RICHTER: Objection form.
`
`the standard
`I mean,
`THE WITNESS:
`
`
`WNH
`GUI-h-
`
`10%
`
`12é
`
`13‘
`
`14
`
`153
`
`16%
`
`19
`
`20%
`
`21
`
`22
`
`23
`
`24
`
`'25
`
`2124799424
`
`Veritext Legal Solutions
`www.veritext.co1n
`
`212-490-3430
`
`Page280fl64
`
`Page 28 of 164
`
`

`

`Page 29
`
`— Highly Confidential
`J. Hay, Ph.D.
`way that I do research, you know, both for
`legal cases and academic research,
`I
`look
`
`for what I'm interested.
`
`I use Google
`
`searches.
`
`I use searches on other
`
`databases.
`I search electronic records at
`the USC library.
`Those kinds of things. Or
`
`my assistant does it as well.
`
`1;
`2 2
`3 5
`
`4 ‘
`
`5 ‘
`
`6 3
`7 ‘
`
`8 4
`
`9
`
`BY MR . TRENCHARD:
`
`Did counsel give you the Declaration
`Q
`102
`11: of Dr. Blackburn?-
`125
`A
`I believe so, yeah.
`
`13 3
`Q
`And did you also receive exhibits that
`14 3 were in this proceeding already from counsel?
`15 §
`A
`I believe I received Dr. Blackburn's
`
`16, exhibits.
`Are you okay if I call the patent that
`17%
`Q
`18% we're talking about in this case,
`the 283 patent?
`19;
`A
`Fine with me.
`20%
`Q
`Have you reviewed the 283 patent?
`21;
`A
`Yeah, I‘ve certainly looked at it.
`I'm
`22%
`Q
`Just for the interest of clarity,
`23; handing you what's been marked as Torrent Exhibit
`24% 1001.
`253
`
`Is that the patent you reviewed? You
`
`
`
`Veritext Legal Solutions
`www.veritext.com
`
`W
`212-490-3430
`
`212-279-9424
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`Page290fl64
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`
`

`

`
`
`OO-de'Fnh-wNH
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22f
`
`23
`
`24;
`
`Page 30
`
`J. Hay, Ph.D.
`
`— Highly Confidential
`
`can take a few minutes to take a look at it if
`
`you need to.
`
`A
`
`Q
`
`It appears to be, yeah.
`
`You've heard of the drug called
`
`Gilenya; right?
`
`A
`
`Q
`
`Yes.
`
`Is it your understanding that Gilenya
`
`is an embodiment of this patent?
`
`MR. RICHTER: Objection to form.
`
`Outside the scope.
`
`THE WITNESS: Well,
`
`I guess it's
`
`my understanding that petitioners claim that
`
`this patent doesn't have validity, so I
`
`don't know how ~~ you know, if the patent's
`
`invalid,
`
`I don't know how it can embody an
`
`invalid patent.
`
`BY MR. TRENCHARD:
`
`Q
`
`Assuming the patent were valid, was it
`
`your understanding that this patent covers
`
`Gilenya?
`
`MR. RICHTER: Objection to form.
`
`Outside the.scope.
`
`THE WITNESS:
`
`You know,
`
`that
`
`sounds like a kind of a strange
`
`
`212-279-9424
`
`Veritext Legal Solutions
`www.veritext.com
`
`212—490-3430
`
`Page300f164
`
`Page 30 of 164
`
`

`

`J. Hay, Ph.D.
`
`— Highly Confidential
`
`counter-factual or hypothetical, because if
`
`something that is not true is to be assumed
`
`true,
`
`then somehow we have to look at what
`
`else happens in the world. And, again, it
`
`seems like an incomplete hypothetical.
`
`BY MR. TRENCHARD:
`
`Q
`
`A
`
`What's incomplete about it?
`
`I mean, you're asking me to assume
`
`that the patent is valid, even though I
`
`think the
`
`whole point of this hearing process in front of
`
`the PTAB is exactly that the petitioners assert
`
`that the patent is not valid; okay.
`
`So you're
`
`asking me
`
`to assume that what they say is
`
`incorrect.
`
`And then the questiOn is, well, so
`
`what —— other than all the things about this
`
`patent that they assume are incorrect are
`
`actually correct that would then lead this patent
`
`to be validated.
`
`So I just have to know more
`
`about what those other things are.
`
`Q
`
`Okay.
`
`Say in this case the Board of
`
`Patent Appeals rejects the petition and says that
`
`the patent is valid.
`
`(DulmU‘lnb-UJNH
`
`105
`
`11
`
`123
`
`13‘
`
`14;
`
`153
`
`
`
`16
`
`17
`
`18
`
`19
`
`20
`
`213
`
`22
`
`233
`
`243
`
`Is it your understanding that Gilenya
`
`
`212-279-9424
`
`Veritext Legal Solutions
`“nvuhverfiextconl
`
`212-490-343

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