throbber
Redacted - Subject to Protective Order
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`3
`Beateee
`
`1 2
`
`5.
`6
`
`7
`ga
`
`9
`
`16
`
`11
`
`W200
`
`130
`
`14
`
`15.
`
`TORRENT PHARMACEUTICALS BIMITED
`and
`
`APOTEX,
`
`INC. AND MYLAN PHARMACEUTICALS,
`Petitioners,
`
`INC.,
`
`vs,
`
`NOVARTIS AG AND MITSUBISHI PHARMA CORP.,
`
`een eee eee eee eeee
`
`Patent Owners.
`
`Case IPR2014-00784
`
`Case IPR2015-00518
`
`Patent 8,324,283 B2
`
`1600RR
`
`17,
`
`18 ©
`19°
`
`One Broadway
`New York, New York
`
`June 24, 2015
`
`9:30 a.m.
`
`** HIGHLY CONFIDENTIAL **
`
`20
`21
`DEPOSITION OF JOEL W. HAY, Ph.D., held
`22.
`23. at the above-mentioned time and place, before
`24, Randi Friedman,
`a Registered Professional
`
`25 Reporter, within and for the State of New York.
`
` :
`
`:
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`Page 1 of 164
`
`TORRENT -1107 PRO & BINS
`EXHIBIT
`
`Petition for inter Partes Reveiw
`OF U.S.Patent 8,324,283
`Exhibit
`
`DEPOSITION
`
`Biogen Exhibit 2211
`Mylanv. Biogen
`IPR 2018-01403
`
`Page 1 of 164
`
`Biogen Exhibit 2211
`Mylan v. Biogen
`IPR 2018-01403
`
`

`

`1 2
`
`30
`4
`
`5
`
`6
`
`7 8 9
`
`10,
`|
`11)
`12,
`130
`14)
`|
`15)
`
`16.
`
`17
`18)
`19°
`
`20.
`
`21.
`2
`22,
`:
`230
`24
`
`25.
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`Page 2 of 164
`
`APPEARANCES:
`
`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. 20005
`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 10007
`BY:
`ROBERT W. TRENCHARD,
`STEPHANIE LIN, ESQ.
`
`ESQ.
`
`
`
`
`
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`

`

`o4TOUWF&FWwWNYFF
`
`Page 3
`
`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
`
`11.
`
`12.
`
`13°
`14°
`15.
`16
`17.
`18
`19°
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`reserved; and in addition,
`
`the failure to object
`
`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.
`
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`

`oa1HOUW&®WwWNHNF&
`
`1owo
`11
`120
`13.
`14.
`
`xk
`
`ok
`
`*
`
`JOEL W. HAY, Ph.D.,
`
`the witness
`
`herein, having been duly sworn, was examined
`
`and testified as follows:
`
`xk
`
`k
`
`&
`
`EXAMINATION
`
`BY MR. TRENCHARD:
`
`Q
`
`A
`
`Q
`
`Good morning, Dr. Hay.
`
`Good morning.
`
`I'm sure you've gone over some of
`
`these before in other depositions, but a few
`
`pointers.
`
`If, as I'm going,
`
`I mess up a
`
`question, you don't understand it in some way or
`
`other, please don't hesitate to ask me to try and
`
`I'm
`
`15 |
`16
`fix it; okay?
`|
`A
`Okay.
`18°
`Q
`If at any time you need a break,
`| perfectly happy to let you have a break.
`| Normally I try to break roughly every hour, plus
`
`17
`
`19
`
`20.
`
`or minus; okay?
`
`A
`
`Q
`
`Okay.
`
`But, you know, if you need it in the
`
`24
`
`interim for whatever reason,
`
`I'm happy to
`
`25
`
`accommodate you.
`
`
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`

`

`J. Hay, Ph.D.
`
`- Highly Confidential
`
`A
`
`Presumably as long as a question isnit
`
`pending.
`
`9
`
`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
`
`o
`
`A
`
`Q
`
`On the Declaration?
`
`Uh-huh.
`
`Probably about 80, 90 hours.
`
`When were you first retained to work
`
`oo1DOWWF&FWwWNHEF
`
`owo
`11
`
`12
`
`13
`
`16
`
`1 1
`
`8
`19°
`20 |
`
`23.
`
`for Torrent?
`
`24
`
`25)
`
`A
`
`April or May some time.
`
`Of this year?
`Q
`
`
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`
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`

`

`
`
`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
`I believe it was Vince Galluzzo.
`
`Q
`
`And how many patent cases have you
`
`worked on as an expert?
`
`nAUO&®FWNHNFF
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20.
`
`22
`23.
`24)
`
`25
`
`|
`
` A
`
`to 20.
`
`I don't specifically recall. Fifteen
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`

`

`ao47+OoOF&WHDFF
`
`10
`
`11
`
`12.
`
`
`
`15)
`16
`17.
`18
`19°
`
`20
`
`21
`
`22
`
`230
`
`24 |
`
`255
`
`J. Hay, Ph.D.
`
`- Highly Confidential
`
`Q
`
`Have they all been in the
`
`pharmaceutical area?
`
`A
`
`Qo
`
`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
`
`involving a dispute over a patent?
`
`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 on?
`
`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
`
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`

`
`
`Page 8
`
`J. Hay, Ph.D.
`
`- Highly Confidential
`
`then work your way forward.
`
`MR. RICHTER:
`
`Thanks.
`
`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
`
`
`
`not patent cases.
`
`BY MR. TRENCHARD:
`
`aoaTAHOoeeWDHB
`
`then, how about a
`
`Okay. Well,
`Q
`9 |
`10. narrower question.
`11
`'
`Do you know which of these cases
`12.
`involved an allegation by the plaintiff that the
`13 defendant was infringing a patent?
`
`14 —
`
`15
`
`A
`
`9
`
`Could you repeat the question, please?
`
`Sure. Which of these cases involved
`
`16 an allegation by the plaintiff that the defendant
`17 | was infringing a patent?
`18)
`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 i 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
`
` the defendants' attorneys?
`
`right that in each of those cases, you worked for
`
`
`
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`

`

`oO1HFoOFFWNHN
`
`10
`11)
`
`12,
`13
`
`14
`
`15
`
`16.
`
`17.
`18)
`
`19°
`20
`
`21,
`22
`
`23
`24
`25
`
`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,
`or no rather than grunts; okay?
`
`that you use yes
`
`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?
`
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`
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`

`

`
`
`Page 10
`
`J. Hay, Ph.D.
`
`- Highly Confidential
`
`A
`
`Q
`
`Yes.
`
`Is Fresenius a generic drug
`
`manufacturer?
`
`A
`
`Q
`
`I don't recall.
`
`And on the next one, Watson
`
`Laboratories,
`
`is that a generic drug
`
`manufacturer?
`
`oo~~OOOF&eWwWNHNfF
`
`A
`
`I believe it's got a generic division.
`
`10.
`
`I don't know it's 100 percent generic.
`
`li
`
`12
`
`13
`
`14
`
`15
`
`17
`
`18
`
`19 |
`
`20-
`
`21
`
`22
`
`23
`
`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
`
`As far as I know.
`
`24.
`25.
`is Impax a generic
`Impax case,
`Takeda v.
`
`
`Q
`
`Turning to the bottom of Page 3,
`
`the
`
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`
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`

`oOFFWWNHF
`o6oO-~!I
`
`Co
`
`11.
`
`12
`
`13
`
`14
`
`15
`
`J. Hay, Ph.D.
`
`- Highly Confidential
`
`drug-maker?
`
`A
`
`Qo
`
`Io 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
`
`9
`
`Which case;
`
`I'm sorry?
`
`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
`
`16 :
`
`generic drug maker or also makes branded drugs?
`
`L7
`
`18
`
`19.
`
`20.
`
`21
`
`22.
`
`
`
`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 --
`
`A
`
`Q
`
`Yes.
`
`-- that's the same Watson we talked
`
`about before that you said you thought was a
`
`generic drug-maker; right?
`
`23
`
`24
`
`25
`
`I think Watson has a generic
`Well,
`A
`
`
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`

`wo&WwNHFF
`
`10.
`
`12.
`13.
`14
`
`15
`
`16_
`
`17
`
`18
`
`19
`
`20 |
`
`21
`
`22
`
`23
`
`24
`
`
`
`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
`
`QO
`
`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
`
`
`—
`
`|
`|
`
`25
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`

`oanFInoWw&WNHF
`
`12
`
`13 .
`14.
`15
`16
`
`19°
`20
`
`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 -- could you repeat the
`
`question, please?
`
`Q
`
`sure.
`
`How many patent cases have you
`
`given testimony on the subject of commercial
`
`success of a product as that term is used in your
`
`Declaration in this proceeding?
`
`MR, RICHTER: Objection,
`
`form.
`
`THE WITNESS:
`
`I don't specifically
`
`recall. Certainly more than 20.
`
`BY MR. TRENCHARD:
`
`Q
`
`Have you published any peer review
`
`21
`
`articles on the subject of commercial success?
`
`22.
`
`23
`24
`25°
`
`A
`
`Well,
`
`I certainly published
`
`peer-reviewed articles that relate to issues of
`
`commercial success.
`
`Q
`
`Have you published any articles about
`
`
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`Page 14
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`J. Hay, Ph.D.
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`- Highly Confidential
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`how one should analyze commercial success from an
`
`economic point of view in a patent case?
`
`A
`
`Well,
`
`I
`
`think a lot of what I
`
`published has elements of that.
`
`Q
`
`Have you published any articles in
`
`which that was the primary subject?
`
`MR. RICHTER: Objection to form.
`
`THE WITNESS:
`
`I don't specifically
`
`recall.
`
`=I may have, but nothing comes to
`
`mind. We could go through my CV and see if
`
`anything pops into my mind.
`
`BY MR. TRENCHARD:
`
`Q
`
`How would you describe the area of
`
`economics in which you have expertise?
`|
`A
`Well, I'd say my area of expertise
`
`relates to economic theory and methods and
`
`empirical approaches as applied to generally
`
`speaking topics related to health and
`
`pharmaceutical, both industries, markets and
`
`products, and a lot of what I do relates to
`
`assessing the value of different pharmaceutical
`
`products. But I mean, that's one string of my
`
`research.
`
`It's not the only one.
`
`nonUF&WwWNHFF
`
`10
`11
`12
`
`13
`
`14
`15
`
`16
`
`19.
`20.
`
`21
`
`22
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`23.
`
`
`
`And by "value," do you mean the cost
`Q
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`Page 15
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`J. Hay, Ph.D.
`- Highly Confidential
`2 ! effectiveness of those products?
`3 :
`A
`That certainly is one way to
`4 : characterize economic value.
`5 |
`Q
`We'll talk about that subject later.
`6
`Returning to your Declaration, Exhibit
`
`7 #.A, we were just talking about a piece of it which
`
`listed some cases.
`8 !
`Can you just take a look and confirm
`9
`10 that that's a current version of your CV?
`
`11
`
`12,
`
`A
`
`Q
`
`Weill, 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
`
`Probably a few more publications and
`
`to bring it up to date?
`14.
`A
`15.
`16 presentations.
`17
`Q
`Okay.
`18)
`A
`That!
`19°
`Q
`Okay.
`
`s about it.
`
`That's helpful.
`
`Thank you.
`
`And you're a professor at the
`
`of Southern California;
`
`is that right?
`
`
`
`Yes.
`
`And you have an economics degree,
`
`Ph.D.?
`
`21 University
`22
`A
`23.
`Q
`24 xight,
`250
`z
`
`Yes.
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`oo4THUW&®WBNHNHP
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`Oo
`
`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
`
`10,
`
`economics.
`
`Pharmaco-economics.
`
`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
`
`oO
`
`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?
`I
`Well, it varies, but, you know,
`A
`
`
`| | |
`
`|
`|
`|
`
`13
`
`14
`
`15
`
`16
`
`17
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`18
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`19
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`20
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`21
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`22
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`23
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`24
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`25
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`Page 17
`
`J. Hay, Ph.D.
`
`- Highly Confidential
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`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
`
`so I don't follow it to the
`for two days,
`absolute letter, but I stay within the
`
`guidelines.
`
`Q
`
`And of your consulting work, how much
`
`of at 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 -- 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
`
`qamnUWF&FWwWNHFP
`
`10
`
`11.
`12.
`
`13
`
`14
`
`15
`16
`
`18 |
`
`19
`20
`
`23 |
`240
`
`for healthcare, research and quality. County of
`
`eenarnia
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`Veritext Legal Solutions
`Wwww.veritext.com
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`oTIomFF&WwWDNFF
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`Page 18
`
`J. Hay, Ph.D.
`
`~- Highly Confidential
`
`Sacramento. State of California. State of
`
`Texas.
`
`I've done consuiting 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.
`9
`
`
`You said you don't
`
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`ooJFHOOFF&F|WNHNFF
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`-Oo
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`11)
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`Page 19
`
`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
`
`Yes.
`
`Have you ever worked as a securities
`
`Not formally.
`
`How about something other than
`
`12
`
`formally?
`
`13 |
`
`14.
`
` 15
`
`16
`
`18°
`19°
`
`20
`
`21.
`
`22
`
`230
`
`day.
`
`A
`
`Qo
`
`A
`
`Q
`
`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,
`to ground us again, your recollection is that
`
`just
`
`24)
`
`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:
`
`Qo
`
`And the remaining times you reached
`
`the opposite conclusion?
`
`A
`
`I don't recall what conclusion Tf
`
`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 eee
`
`www.veritext.com
`
`212-490-3430
`
`aoFTmHOWyeWwWNHFF
`
`10.
`
`11
`
`13
`
`14
`
`15
`16
`
`18
`
`20.
`
`22.
`23°
`24
`255
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`

`noOo&WNHFF
`
`J. Hay, Ph.D.
`
`- Highly Confidential
`
`Qo
`
`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
`That's my understanding, yes.
`
`Q
`
`How many times have you concluded in
`
`10
`
`your work on commercial success that there was no
`
`nexus between the patent at issue and the
`
`12°
`
`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
`
`14
`
`17
`18
`19°
`
`20.
`
`23.
`24.
`
`
`
`25
`is in each case. At least that's my
`
`
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`

`nawo&®FWwWDH
`
`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 ta
`
`oo~J
`consulting with mu
`9 | against defendants
`10 based on ail the w
`11 |
`Q
`So what
`
`liking about.
`
`It's based on
`
`ltiple lawyers,
`
`both for
`
`and
`
`and plaintiffs.
`
`Yeah,
`
`it's
`
`ork I've done.
`
`is your understanding about
`
`12, who has the burden
`
`to show nexus?
`
`13°
`
`14
`15
`16
`17
`18°
`19
`20
`21
`22
`23
`24.
`25.
`
`MR.
`
`RICHTER: Objection,
`
`form.
`
`THE WITNESS: Well, it's my
`understanding that typically for the kinds
`of cases we're talking about where the
`plaintiffs are challenging the defendants
`and claiming that the patent has validity
`because of secondary considerations of
`non-obvicusness, such as commercial success
`or long-felt need,
`that it's the burden of
`the plaintiffs to establish that there is a
`nexus between the claims of the patent and
`whatever indicia of commercial success are
`that make sense.
`
`
`
`
`
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`o4oOOo&WYHBPR
`
`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-obviocusness"; do you see
`
`that?
`
`10.
`
`A
`
`Q
`
`Yes.
`
`From where did you get that
`
`12
`
`understanding?
`
`
`
`A
`
`Same answer I gave earlier.
`
`It's --
`
`14
`15.
`
`as we've established I've worked on, you know,
`
`dozens of these kinds of generic patent challenge
`
`16
`
`cases, and so I've read a lot of stuff about
`
`18
`
`19°
`
`20
`
`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.
`
`22.
`
`Q
`
`Okay. This section that we're talking
`
`about in your Declaration, Relevant Legal
`
`24
`
`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,
`
`If
`
`think
`
`implicitly -- implicitly we did.
`
`I don't
`
`know if we did explicitly.
`
`BY MR. TRENCHARD:
`
`0
`
`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.
`
`
`oTfmWWNh
`oOwTMH
`
`10
`
`11.
`
`12.
`13)
`
`14
`
`15
`
`16
`
`17.
`
`18 :
`
`19°
`
`20
`
`21,
`
`22.
`
`23
`
`24
`
`25
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`ao~AoOOF&WwWNHFF
`
`10.
`11
`12,
`13°
`14
`
`16—
`
`17
`
`18.
`
`19
`
`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?
`
`20.
`
`BY MR. TRENCHARD:
`
`
`
`Qo
`
`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?
`
`
`23
`24
`25
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`J. Hay, Ph.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.
`
`Qo
`
`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
`
`ooFmOOFeWwWNHNFF
`
`10—
`11
`
`12—
`
`13,
`
`14,
`
`16
`
`18
`19.
`
`20
`
`21.
`
`23
`
`
`
`of my earlier questions that I actually should
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`11
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`13°
`14
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`15_
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`16.
`
`19°
`20 |
`
`21
`
`23
`
`24
`
`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 recail when we sent the first
`
`thing to counsel.
`
`I simply don't recall.
`
`Q
`
`And who's your assistant?
`
`Shraddha Chaugule.
`
`Spelled the usual way?
`
`212-279-9424
`
`Veritext Legal Solutions
`WWw.veritext.com
`
`212-490-3430
`
`Page 27 of 164
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`Page 28
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`WwNNFF
`aouo&
`
`10.
`
`12.
`
`13
`
`J. Hay, Ph.D.
`
`- Highly Confidential
`
`A
`
`Yeah.
`
`S-H-R-A-D-D-H-A,
`
`C~H-A~U-G-U-L-E.
`
`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
`
`Iomean, not specifically to the
`
`14
`
`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.
`
`Qo
`
`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:
`
`
`Veritext Legal Solutions
`WWw.veritext.com
`
`212-490-3430
`
`15 |
`
`16.
`
`19
`
`20.
`
`21
`
`22
`
`23
`
`24
`
`25
`
`212-279-9424
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`

`i
`2 |
`3 :
`
`4
`
`5
`
`6
`7 |
`8
`
`- 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.
`
`9 BY MR. TRENCHARD:
`
`Did counsel give you the Declaration
`Q
`10°
`11 of Dr. Blackburn?
`12
`A
`I believe so, yeah.
`
`13 |
`Q
`And did you also receive exhibits that
`14 | were in this proceeding already from counsel?
`15 :
`A
`FT 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.
`25
`
`Is that the patent you reviewed? You
`Veritext Legal Solutions
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`www.veritext.com
`212-490-3430
`
`
`
`212-279-9424
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`Page 29 of 164
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`

`aoaonWFF&FWwWNHF
`
`10
`
`11
`
`12
`
`13
`
`14
`
`i5
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22,
`
`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
`
`Qo
`
`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
`
`Veritext Legal Solutions
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`
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`

`oc~~tOOo&FWHNHNKF
`
`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
`
`10 |
`
`that the patent is valid, even though I
`
`think the
`
`11,
`
`whole point of this hearing process in front of
`
`12.
`
`13.
`
`140
`
`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
`
`15)
`
`
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`220
`
`230
`24.
`
`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.
`
`Is it your understanding that Gilenya
`
`
`212-279-9424
`
`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
`Page 31 of 164
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`Page 31 of 164
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`

`
`
`Page 32
`
`1
`
`2
`3 :
`4 |
`5 |
`6 |
`7 |
`8 :
`9 ,
`10.
`11.
`12
`13.
`14 |
`15
`16
`
`17
`18
`19°
`
`20,
`21 |
`
`J. Hay, Ph.D.
`
`= Highly Confidential
`
`form.
`
`is covered by this p

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