`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Page 1
`
`MYLAN LABORATORIES LIMITED, )
`Petitioner, ) Case IPR2016-00712
`) U.S. Patent No.
`vs.
`) 8,927,592
`AVENTIS PHARMA S.A.,
`Patent Owner. )
`
`DEPOSITION
`OF
`ROBERT McSORLEY
`April 19, 2017
`
`Reported by:
`JULIANA F. ZAJICEK, RPR, CSR
`Job No: 18558
`
`TransPerfect Legal Solutions
`depo@transperfect.com -- 212-400-8845
`
`AVENTIS EXHIBIT 2261
`Mylan v. Aventis IPR2016-00712
`
`PUBLIC VERSION
`
`
`
`Page 2
`
`The confidential deposition of ROBERT
`McSORLEY, called for examination, taken pursuant to
`the provisions of the Code of Civil Procedure and the
`Rules of the Supreme Court of the State of Illinois
`pertaining to the taking of depositions for the
`purpose of discovery, taken before JULIANA F. ZAJICEK,
`CSR 84-2604, a Certified Shorthand Reporter of the
`State of Illinois, at the Sheraton Chicago O'Hare
`Airport Hotel, Suite 706A, 6501 Mannheim Road,
`Rosemont, Illinois, on April 19, 2017, at 9:00 a.m.
`
`1 2 3 4 5 6
`
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`TransPerfect Legal Solutions
`depo@transperfect.com -- 212-400-8845
`
`PUBLIC VERSION
`
`
`
`Page 3
`
`PRESENT:
`
`ON BEHALF OF PETITIONER:
`WILSON SONSINI GOODRICH & ROSATI, P.C.
`701 Fifth Avenue, Suite 5100
`Seattle, Washington 98104
`206-883-2554
`BY: JAD A. MILLS, ESQ.
`jmills@wsgr.com
`
`ON BEHALF OF PATENT OWNER:
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, New York 10104
`212-218-2128
`BY: JOSHUA I. ROTHMAN, ESQ.
`jrothman@fchs.com
`UNA C. FAN, ESQ.
`ufan@fchs.com
`
`1
`
`2 3
`
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`TransPerfect Legal Solutions
`depo@transperfect.com -- 212-400-8845
`
`PUBLIC VERSION
`
`
`
`I N D E X
`
`Page 4
`
`WITNESS:
` ROBERT McSORELY
`EXAM BY MR. ROTHMAN.................. 6
`EXAM BY MR. MILLS.................... 198
`
`PAGE:
`
`*****
`
`E X H I B I T S
`
`MARKED FOR ID
`EXHIBIT
` No. 2256 Wells Fargo Equity Research Report 167
`Dated 6/27/13 related to J&J;
`CabRef0012609 - 617.................
` No. 2257 Wells Fargo Equity Research Report 179
`Dated 6/26/14 related to J&J;
`CabRef0012618 - 627.................
`
`1
`
`2 3
`
`4
`5
`6
`
`7 8
`
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`TransPerfect Legal Solutions
`depo@transperfect.com -- 212-400-8845
`
`PUBLIC VERSION
`
`
`
`Page 5
`
`78
`
`PREVIOUSLY MARKED EXHIBITS
`FIRST TIME REFERRED TO
`EXHIBIT
` No. 1044 Declaration of Mr. Robert McSorley 8
`attached to Exhibit 1094............
` No. 1064 Medscape article titled:
`"Ketoconazole in Advanced Prostate
`Cancer: Have Tolerability Concerns
`Been Overstated?"...................
` No. 1067 Cabazitaxel (Jevtana) National
`Drug Monograph, March 2011..........
` No. 1094 Evidentiary Declaration of
`Mr. Robert McSorley, also
`containing Exhibit 1044.............
`
`147
`
`100
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`TransPerfect Legal Solutions
`depo@transperfect.com -- 212-400-8845
`
`PUBLIC VERSION
`
`
`
`Page 6
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`(WHEREUPON, the witness was duly
`sworn.)
`ROBERT McSORELY,
`called as a witness herein, having been first duly
`sworn, was examined and testified as follows:
`EXAMINATION
`
`BY MR. ROTHMAN:
`Q.
`Good morning, Mr. McSorley.
`A.
`Good morning.
`Q.
`Have you been deposed before?
`A.
`Yes.
`Q.
`So you're familiar with the process?
`A.
`Yes.
`Q.
`I'm going to ask you some questions. I
`ask that you give verbal answers. Is that okay?
`A.
`Yes.
`Q.
`If you don't understand a question, please
`let me know.
`Is that okay?
`Yes.
`A.
`If you don't tell me that you don't
`Q.
`understand a question, I'll assume that you do
`understand it.
`Is that fair?
`
`TransPerfect Legal Solutions
`depo@transperfect.com -- 212-400-8845
`
`PUBLIC VERSION
`
`
`
`Page 7
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`It is.
`A.
`Are you on any medication that would
`Q.
`prevent you from testifying truthfully, accurately and
`completely today?
`A.
`No.
`Q.
`Is there any reason why you cannot testify
`truthfully, accurately and completely today?
`A.
`No.
`Q.
`Does the expert report that you served in
`this case contain all of your opinions regarding this
`litigation?
`A.
`I believe it does.
`Q.
`Do you want to change any of the opinions
`that are contained in your expert report as you sit
`here today?
`A.
`I can't think of any.
`Q.
`Do you believe all of the opinions in your
`report are truthful, accurate and complete?
`A.
`I do.
`Q.
`Did you do your best to ensure that the
`opinions contained in your report were truthful,
`accurate and complete at the time you served it?
`A.
`I did.
`Q.
`Did you use your best judgment in forming
`
`TransPerfect Legal Solutions
`depo@transperfect.com -- 212-400-8845
`
`PUBLIC VERSION
`
`
`
`Page 8
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`the opinions that are contained in your expert report?
`A.
`I believe I did.
`Q.
`Did you have enough time to prepare your
`expert report before you served it?
`A.
`Yes.
`Q.
`I see you have before you a copy of your
`expert report.
`Is that Exhibit 1044?
`Yes.
`A.
`We have, I think, all of the documents
`Q.
`that you've cited in your report, so if at any time
`you want to see a document to assist you in providing
`your testimony, just let me know and we should be able
`to provide that, is that okay?
`A.
`Great. Thank you.
`Q.
`Where did you get your undergraduate
`degree?
`A.
`Q.
`
`Pennsylvania State University.
`What did you get your undergraduate degree
`
`in?
`
`Accounting.
`A.
`In what year did you obtain your
`Q.
`undergraduate degree?
`A.
`1989.
`
`TransPerfect Legal Solutions
`depo@transperfect.com -- 212-400-8845
`
`PUBLIC VERSION
`
`
`
`Page 9
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`While you were at Penn State, did you take
`Q.
`any premed classes?
`A.
`No.
`Q.
`While you were at Penn State, did you take
`any pharmacy classes?
`A.
`No.
`Q.
`While you were at Penn State, did you take
`any classes about FDA regulations?
`A.
`No.
`Q.
`While you were at Penn State, did you take
`any classes on advertising or marketing?
`A.
`Yes.
`Q.
`What classes did you take?
`A.
`I believe there were marketing classes
`that were part of the undergrad general business
`administration curriculum.
`Q.
`Did those marketing classes involve
`marketing of pharmaceuticals?
`A.
`They may have.
`Q.
`What did you --
`A.
`I don't recall.
`Q.
`You don't recall?
`A.
`Right.
`Q.
`Do you rely on the -- that marketing class
`
`TransPerfect Legal Solutions
`depo@transperfect.com -- 212-400-8845
`
`PUBLIC VERSION
`
`
`
`Page 10
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`for your opinions here today?
`A.
`Not specifically, no.
`Q.
`Did you take any classes at Penn State on
`managed care companies?
`A.
`I don't believe so.
`Q.
`Did you take any classes at Penn State
`regarding formularies?
`A.
`Not that I recall.
`Q.
`What is formulary?
`A.
`It is a list of drugs that insurance
`companies or states or -- or payors in general provide
`with information on what they will reimburse and what
`they'll pay for.
`Q.
`Have you ever synthesized, modified or
`purified a chemical compound?
`A.
`No.
`Q.
`Have you ever selected a compound for
`development into a medicine?
`A.
`No.
`Q.
`Do you read about chemical compounds?
`A.
`Yes.
`Q.
`In what context do you read about chemical
`compound -- compounds?
`A.
`In my work that I've done over the last 11
`
`TransPerfect Legal Solutions
`depo@transperfect.com -- 212-400-8845
`
`PUBLIC VERSION
`
`
`
`Page 11
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`Do you consider yourself a chemistry
`
`or so years in evaluating the alleged commercial
`success and economic damages concerning pharmaceutical
`patents.
`Q.
`expert?
`I do not.
`A.
`You don't keep up on chemistry issues
`Q.
`other than with regard to the litigations you've
`worked on, is that right?
`A.
`I would say that's generally correct. We
`also consult with some pharmaceutical companies where
`we have evaluated their, for example, portfolio of
`products and assisted them with the sale of those
`products and evaluation of those products, so we do
`some work outside of the context of litigation.
`Q.
`Are you an expert in medicinal chemistry?
`A.
`No.
`Q.
`Have you ever made a pharmaceutical
`formulation?
`A.
`Have I ever?
`Q.
`Made a pharmaceutical formulation.
`A.
`No.
`Q.
`Have you ever developed a pharmaceutical
`formulation?
`
`TransPerfect Legal Solutions
`depo@transperfect.com -- 212-400-8845
`
`PUBLIC VERSION
`
`
`
`Page 12
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`No.
`A.
`Have you ever performed analytical testing
`Q.
`on a pharmaceutical formulation?
`A.
`You mean in a lab?
`Q.
`Anywhere.
`A.
`I'm not sure what you mean by that.
`Q.
`What is analytical testing?
` MR. MILLS: Objection; form.
`BY THE WITNESS:
`A.
`It could mean a lot of things. It could
`mean that we are analyzing the data relating to sales
`of IMS Health information.
`BY MR. ROTHMAN:
`Q.
`Aside from sales data, have you ever
`performed analytical testing on a pharmaceutical
`formulation?
`A.
`That -- that question suggests that I was
`in a lab, to me, you know, performing studies on how a
`chemical response to certain tests and I have not done
`that type of lab work.
`Q.
`Do you consider yourself an expert in
`pharmaceutical formulations?
` MR. MILLS: Objection; form.
`BY THE WITNESS:
`
`TransPerfect Legal Solutions
`depo@transperfect.com -- 212-400-8845
`
`PUBLIC VERSION
`
`
`
`Page 13
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`I do not.
`A.
`BY MR. ROTHMAN:
`Q.
`Do you know what a prescription for a
`medicine is?
`A.
`Yes.
`Q.
`What is it?
`A.
`It is a -- it's a -- well, physically it's
`a piece of paper or it's an entry into a computer that
`physicians or nurse practitioners generally make to
`inform a pharmacist or dispenser of medication what
`their patient should be given.
`Q.
`Have you ever written a prescription?
`A.
`I have not.
`Q.
`Have you ever treated a patient?
`A.
`I have not.
`Q.
`Have you ever counseled a patient with
`medical advice?
`A.
`No.
`Q.
`Do you consider yourself an expert in the
`medical field?
`A.
`No.
` MR. MILLS: Objection; form.
`BY THE WITNESS:
`A.
`No.
`
`TransPerfect Legal Solutions
`depo@transperfect.com -- 212-400-8845
`
`PUBLIC VERSION
`
`
`
`Page 14
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`BY MR. ROTHMAN:
`Q.
`We talked a little bit about formularies
`already, right?
`A.
`We did.
`Q.
`Have you ever worked to get a drug on a
`formulary?
`I have not.
`A.
`Have you ever worked at a formulary -- let
`Q.
`me ask a different question.
`Have you ever worked at a company that
`evaluated whether a drug should be on a formulary?
`A.
`I have not.
`Q.
`Have you had any involvement in getting
`drugs on a formulary?
`A.
`Well, you know, I would say possibly to
`the extent that the work that I've done has helped
`generic products, I get to market those products
`possibly that have been listed on a formulary.
`Q.
`I'm talking more specifically about the
`actual getting the drug on a specific formulary.
`Have you ever worked with anyone to get a
`drug onto a specific formulary?
`A.
`Where I was actually calling an insurance
`company and requesting, is that what your question is?
`
`TransPerfect Legal Solutions
`depo@transperfect.com -- 212-400-8845
`
`PUBLIC VERSION
`
`
`
`Page 15
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`Right, right, however that process
`
`Q.
`happens.
`Outside the context of litigation where I
`A.
`have assisted attorneys and generic firms primarily
`invalidate patents and get their products to market
`and I suppose onto formularies, I have not done that.
`Q.
`You've never talked to a company in an
`effort to get a drug onto a formulary, is that right?
`A.
`Not outside of what I just described.
`Q.
`And you've never been at a company that
`was -- that had a formulary and were part of
`discussions or someone else was trying to get a drug
`onto a formulary, right?
`A.
`Such as the health insurer?
`Q.
`Right.
`A.
`I have not worked for them.
`Q.
`Do you consider yourself an expert on
`formularies or managed care medicine?
` MR. MILLS: Objection; form.
`BY THE WITNESS:
`A.
`Managed care management, is that what
`you're...
`BY MR. ROTHMAN:
`Q.
`I'm trying to figure out whether you are
`
`TransPerfect Legal Solutions
`depo@transperfect.com -- 212-400-8845
`
`PUBLIC VERSION
`
`
`
`Page 16
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`an expert in the field of getting drugs onto
`formularies.
`Do you think you are?
`I wouldn't say that I'm an expert in that
`A.
`particular area, no.
`Q.
`And you are not an expert on what it takes
`to get a drug onto a formulary, right?
`A.
`I have evaluated factors that -- in the
`normal course of my work, economic factors, business
`factors, product features that attribute to the sale
`of products. And to the extent that those products
`are the subject of discussions with companies that
`have formularies, I have considered that issue.
`Q.
`But do you consider yourself an expert on
`getting drugs onto formularies?
` MR. MILLS: Objection; asked and answered.
`BY THE WITNESS:
`A.
`I consider myself an expert in evaluating
`the factors that drive sales of products. And to the
`extent that those issues overlap, I would say that
`that is part of my expertise.
`BY MR. ROTHMAN:
`Q.
`So you're -- you're an expert on what it
`takes to get a drug onto a formulary, is that what you
`
`TransPerfect Legal Solutions
`depo@transperfect.com -- 212-400-8845
`
`PUBLIC VERSION
`
`
`
`Page 17
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`are saying?
`A.
`I will go back to my previous answer. I
`mean, to the extent that the work that I do in
`evaluating business factors, economic factors, product
`features that drive sales and contribute to the sales
`of pharmaceutical products, to the extent that those
`analyses are the -- similar or the same as evaluating
`products that should be put onto a formulary, then I
`think that that expertise may overlap.
`Q.
`Do you know all of the factors that a
`formulary considers in deciding whether to put a drug
`on a formulary?
`A.
`I don't know if I know all of them. I'm
`familiar with some of them.
`Q.
`You don't know all of them, do you?
`A.
`I have considered formularies in the past
`and I understand that, for example, they consider the
`price that pharmaceutical companies charge, they
`consider the efficacy of those drugs, they consider
`side effects and safety profiles, they consider other
`competing drugs and the price of those drugs, they
`consider some of their own in-house medical experts
`and their -- their opinions and the opinions in the
`literature for that product and for that disease
`
`TransPerfect Legal Solutions
`depo@transperfect.com -- 212-400-8845
`
`PUBLIC VERSION
`
`
`
`Page 18
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`state. So there is a lot of different factors that
`formularies consider and I have addressed a lot of
`those in the work that I do.
`Q.
`Do you know if those are all of the
`factors that a formulary considers?
`A.
`There are probably other factors that I
`didn't just list -- I did not just list that
`formularies consider.
`Q.
`Are there factors that a formulary
`considers that you are not aware of?
`A.
`There may be.
`Q.
`Because you never worked at a formulary
`company, right?
`A.
`I think I answered that previously that I
`haven't.
`And you've never been involved in getting
`Q.
`a drug onto a formulary, right, aside from the
`litigation work you do, right?
`A.
`Not aside from the litigation work.
`Q.
`Have you ever evaluated whether a drug was
`properly on a formulary?
` MR. MILLS: Objection; form.
`BY THE WITNESS:
`A.
`I've never been asked to make that
`
`TransPerfect Legal Solutions
`depo@transperfect.com -- 212-400-8845
`
`PUBLIC VERSION
`
`
`
`Page 19
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`evaluation.
`BY MR. ROTHMAN:
`Q.
`Have you ever evaluated whether a drug
`should not be on a formulary?
`A.
`I have not performed that particular
`analysis.
`Have you ever evaluated the result of
`Q.
`having a drug on a formulary?
`A.
`Well, to the extent that some of my
`opinions in my -- in the previous matters I've been
`involved with have attributed formulary status to
`sales of patented pharmaceutical products, I have
`evaluated that formulary status can be a -- can
`influence pharmaceutical product sales.
`Q.
`Before working on this case, did you have
`any knowledge about Jevtana?
`Let me ask the predicate question. Do you
`know what Jevtana is?
`A.
`I do.
`Q.
`What is Jevtana?
`A.
`It is the tradename for cabazitaxel.
`Q.
`Before working on this case, did you know
`anything about Jevtana?
`A.
`No.
`
`TransPerfect Legal Solutions
`depo@transperfect.com -- 212-400-8845
`
`PUBLIC VERSION
`
`
`
`Page 20
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`You had no knowledge about Jevtana at all
`Q.
`before working on this case, is that right?
`A.
`That's correct.
`Q.
`Did you have any knowledge of metastatic
`castrate resistant prostate cancer before working on
`this case?
`I have not.
`A.
`Did you have any knowledge of prostate
`Q.
`cancer before working on this case?
`A.
`Not outside of what a, you know, typical
`50-year-old male knows of that disease.
`Q.
`So all of the knowledge that you obtained
`regarding Jevtana metastatic castrate resistant
`prostate cancer and prostate cancer generally have
`come through this litigation, right?
`A.
`I think I can agree with that.
`Q.
`You list your past testimony in
`Attachment 1 to your declaration, Exhibit 1044, right?
`A.
`That's correct.
`Q.
`And in your CV there are several cases
`that are listed on Pages 2, 3, 4 and 5 of your CV,
`right?
`A.
`Q.
`
`That's correct.
`Which of these cases dealt with commercial
`
`TransPerfect Legal Solutions
`depo@transperfect.com -- 212-400-8845
`
`PUBLIC VERSION
`
`
`
`Page 21
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`Q.
`A.
`
`success?
`Oh, well, the first one listed on Page 2,
`A.
`the second one listed on Page 2, the third one
`listed -- or the fourth one listed on Page 2, the
`fifth one listed on Page 2, the sixth one listed on
`Page 2, the seventh one listed on Page 2, the ninth
`one listed on Page 3.
`Q.
`That's Wyeth versus Anchen?
`A.
`That's correct.
`The third one listed on Page 4.
`That's Lupin versus Abbott?
`Yes.
`The seventh one listed on Page 4.
`And that's King versus Lupin.
`Q.
`And those are the ones that I recall
`A.
`testifying about commercial success as a secondary
`indication of nonobviousness.
`Now, there are other cases that are patent
`infringement cases on the -- on the CV which I address
`the economic loss associated with that -- with the
`infringement of the asserted patents and I may have
`evaluated commercial success for purposes of
`determining a reasonable royalty under
`Georgia-Pacific, but that's for a different purpose.
`
`TransPerfect Legal Solutions
`depo@transperfect.com -- 212-400-8845
`
`PUBLIC VERSION
`
`
`
`Page 22
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`Q.
`
`Great. Thank you.
`So for all of the cases that you've listed
`or identified for which you provided testimony
`concerning commercial success as a secondary indicia
`of nonobviousness, which of those cases did you
`provide an opinion that there was a commercial
`success?
`Well, I've been retained by the generic
`A.
`pharmaceutical firms in my work and I've been retained
`and have determined that there are -- that there is
`commercial success in other matters, but I have not
`provided expert testimony in those cases.
`Q.
`So in all of the cases you've identified
`that you've provided testimony concerning commercial
`success, in none of them did you opine that the
`product was a commercial success, right?
`A.
`In none of the cases that I provided
`expert testimony, that's correct.
`Q.
`I assume, because you've had no experience
`with prostate cancer before this litigation, none of
`the other litigations you've worked on dealt with a
`drug related to prostate cancer, is that right?
`A.
`That's correct.
`Q.
`Let's go back to your educational
`
`TransPerfect Legal Solutions
`depo@transperfect.com -- 212-400-8845
`
`PUBLIC VERSION
`
`
`
`Page 23
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`background.
`We talked about the -- your education at
`Penn State, right?
`A.
`We have.
`Q.
`After you graduated Penn State, did you go
`to work somewhere?
`A.
`Yes.
`Q.
`Where did you go to work?
`A.
`At a consulting firm called Peterson
`Consulting.
`Q.
`Generally what did Peterson Consulting do?
`A.
`It did a number of things, including
`litigation consulting, valuation work, some merger and
`acquisition-related consulting, insurance industry
`consulting, among other things.
`Q.
`And generally what did you do while you
`were at Peterson Consulting?
`A.
`I worked in the litigation consulting area
`and assisted more senior experts evaluate the economic
`and financial aspects of commercial litigation.
`Q.
`For how long did you work at Peterson
`Consulting?
`A.
`From 1990 to 1993.
`Q.
`Did you work on any pharmaceutical
`
`TransPerfect Legal Solutions
`depo@transperfect.com -- 212-400-8845
`
`PUBLIC VERSION
`
`
`
`Page 24
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`litigations while you were at Peterson Consulting?
`A.
`Not that I recall.
`Q.
`In 1993 did you leave Peterson Consulting
`to go to law school?
`A.
`I did.
`Q.
`In 1993, did you enroll in the University
`of Pittsburgh School of Law?
`A.
`Yes.
`Q.
`Did you go to the University of Pittsburgh
`School of Law from 1993 to 1996?
`A.
`Yes.
`Q.
`Were you a full-time student?
`A.
`Yes.
`Q.
`Did you work outside of school while you
`were at the University of Pittsburgh School of Law?
`A.
`Yes.
`Q.
`Where did you work?
`A.
`I worked for Peterson Consulting on a
`contract basis and I worked for a law firm in
`Pittsburgh called Marshall -- I'm sorry -- called
`Pietragallo Bosick & Gordon.
`Q.
`Did you do pharmaceutical litigation while
`you were at that law firm?
`A.
`No, I didn't.
`
`TransPerfect Legal Solutions
`depo@transperfect.com -- 212-400-8845
`
`PUBLIC VERSION
`
`
`
`Page 25
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`And while you were working on a contract
`Q.
`basis for Peterson Consulting while you were at law
`school, did you work on pharmaceutical litigation?
`A.
`No.
`Q.
`In law school, did you take any medical or
`premed classes?
`A.
`No.
`Q.
`While you were at law school, did you take
`any pharmacy classes?
`A.
`No.
`Q.
`Did you take any classes on FDA
`regulations?
`A.
`Not that I recall.
`Q.
`Did you take any classes on advertising or
`marketing while you were in law school?
`A.
`Not that I recall.
`Q.
`Did you take any classes on managed care
`organizations while you were in law school?
`A.
`I remember having an insurance class, but
`I don't recall if the managed care industry was part
`of that course or not.
`Q.
`Do you rely on what you learned in that
`class for your opinions here today?
`A.
`Not specifically, no.
`
`TransPerfect Legal Solutions
`depo@transperfect.com -- 212-400-8845
`
`PUBLIC VERSION
`
`
`
`Page 26
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`Did you take any classes in law school
`Q.
`related to formularies?
`A.
`No.
`Q.
`After law school, did you obtain any other
`degrees?
`No.
`A.
`Did you attend any other school in the
`Q.
`attempt to get a degree after law school?
`A.
`No.
`Q.
`So you have no other formal education
`other than Penn State and the University of Pittsburgh
`School of Law, is that right?
`A.
`That's correct.
`Q.
`Do you consider yourself an expert in
`patent law?
`A.
`Well, I've been involved in patent law
`since 1992. I've took patent class -- and
`intellectual property classes in law school, I've
`worked extensively since 1998 in intellectual property
`litigation and patent infringement cases, particularly
`in the area of damages and lost profits and reasonable
`royalties and commercial success. I have familiarity
`in those areas of patent law.
`Q.
`Do you hold yourself out as an expert in
`
`TransPerfect Legal Solutions
`depo@transperfect.com -- 212-400-8845
`
`PUBLIC VERSION
`
`
`
`Page 27
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`those areas of patent law?
`A.
`You know, I'm not retained as a legal
`expert. I'm retained as a financial and economic
`expert, but I do have familiarity with those areas of
`the law.
`So you're not -- you've not been retained
`Q.
`in this litigation as a legal expert, is that right?
`A.
`That's correct.
`Q.
`So you are not providing your opinions as
`a legal expert in this case, is that right?
`A.
`That's correct.
`Q.
`Have you ever been qualified as an expert
`in patent law?
`A.
`You mean as a legal expert?
`Q.
`Right.
`A.
`I have never been retained as a legal
`expert.
`And you've never been qualified as a legal
`Q.
`expert in a court of law, is that correct?
`A.
`That's correct.
`Q.
`Are you offering legal opinions in this
`action?
`Well, I'm offering the opinion that
`A.
`Jevtana is not a commercial success as that term has
`
`TransPerfect Legal Solutions
`depo@transperfect.com -- 212-400-8845
`
`PUBLIC VERSION
`
`
`
`Page 28
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`been defined by federal courts for purposes of
`evaluating the alleged nonobvious nature of the patent
`subject matter, but I believe that my testimony is
`based on the economic and financial aspects of the
`sale of Jevtana and not on legal issues.
`Q.
`In your report you've got a section that
`analyzes case law, is that right?
`A.
`I do.
`Q.
`And you analyzed case law in footnotes in
`your report as well, right?
`A.
`I do.
`Q.
`Did you come to those legal conclusions on
`your own with regard to what those cases stand for?
`A.
`Well, I wouldn't say entirely on my own.
`I have read those cases over the course of the last 11
`or so years that I've been involved with Hatch-Waxman
`work at different times, sometimes I have reviewed
`those cases several times. I'm familiar with them. I
`wrote my report and that is my work product, that
`section describing my understanding of the law in this
`area, but I've also had input from the attorneys that
`I've worked with, including Mr. Mills and Ms. Devine.
`Q.
`So you are relying on those communications
`for your understanding of the opinions in your report?
`
`TransPerfect Legal Solutions
`depo@transperfect.com -- 212-400-8845
`
`PUBLIC VERSION
`
`
`
`Page 29
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
` MR. MILLS: Objection; mischaracterization.
`BY THE WITNESS:
`A.
`I wouldn't say I'm relying on them. I'm
`relying on my own experience over the last 11 years.
`My own reading of those legal opinions. However, I
`have had discussions with Mr. Mills and Ms. Devine,
`who have confirmed my understanding.
`BY MR. ROTHMAN:
`Q.
`So all of the opinions in your report
`about what these cases stand for are your opinions,
`right?
`I don't know if I would say they are my
`A.
`opinions. They are my understanding. They set forth
`my understanding of what the legal standard is for
`evaluating commercial success.
`Q.
`And that legal standard is based on your
`reading of the case law, right?
`A.
`In part.
`Q.
`And what other part informed you on what
`the case law stands for?
`A.
`My work in this area over the last
`11 years, my review of other -- other opinions that
`aren't listed or discussed in the report, my review of
`literature in this area, my attendance at conferences
`
`TransPerfect Legal Solutions
`depo@transperfect.com -- 212-400-8845
`
`PUBLIC VERSION
`
`
`
`Page 30
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`that talked -- that involved Paragraph 4, litigation,
`and my communication with the people that I work with
`at Ocean Tomo who have also been involved and have
`testified in this area and have provided information
`about the legal standards in this area.
`Q.
`How did you find the cases that you cite
`in your report?
`A.
`Through a review of the Westlaw database.
`Q.
`Okay. So you did a comprehensive review
`of Westlaw with regard to the issues in your report in
`selecting the cases you rely upon?
`A.
`Not necessarily just for this report, but
`over the last 11 years I have continuously reviewed
`legal opinions on Westlaw to broaden and stay on top
`of the standards in this area.
`Q.
`Do you believe your analysis of commercial
`success with regard to the case law is complete?
`A.
`Well, it is complete for the purpose that
`I'm -- that I'm providing here in this -- in this
`report. It's not complete in that it doesn't address
`every legal opinion that has addressed this issue, but
`for purposes of my understanding of the standard that
`I'm -- that experts are supposed to consider in
`evaluating commercial success, I believe it's
`
`TransPerfect Legal Solutions
`depo@transperfect.com -- 212-400-8845
`
`PUBLIC VERSION
`
`
`
`Page 31
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`complete.
`Does your analysis of commercial success
`Q.
`include cases that go against your opinions?
`A.
`Well, it wasn't my intention to only list
`cases that are consistent with my opinion. I don't --
`I'm not aware of legal opinions that are inconsistent
`with my opinion.
`Q.
`You are not aware of any -- any case law
`that is inconsistent with the opinions you've taken in
`this case, is that your position?
`A.
`I'm not aware of any case law that
`contradicts the legal standards that are set forth in
`this section of my report.
`Q.
`Did you leave out any cases that you are
`aware of that contradicted your opinions in your
`report?
`Not that I'm aware of. If there are legal
`A.
`opinions that contradict the standards that I
`understand, I'd be happy to review them.
`Q.
`But you didn't review any of those in
`preparation of your report?
` MR. MILLS: Objection; foundation.
`BY THE WITNESS:
`A.
`I'm not aware of any, and if there were
`
`TransPerfect Legal Solutions
`depo@transperfect.com -- 212-400-8845
`
`PUBLIC VERSION
`
`
`
`Page 32
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`legal opinions that contradicted my understanding of a
`legal standard, then I certainly would have
`incorporated them into my general understanding and if
`necessary into this opinion -- or into this
`declaration in order to provide my understanding of
`the standard.
`BY MR. ROTHMAN:
`Q.
`And you obtained your understanding of the
`standard for commercial success based on your review
`of the case law, right?
` MR. MILLS: Objection; asked and answered.
`BY THE WITNESS:
`A.
`As I said, in part.
`BY MR. ROTHMAN:
`Q.
`Did your counsel tell you that there
`are -- there was a different legal standard than the
`one you were applying?
` MR. MILLS: Objection; foundation. I'm also
`going to object on the basis of work product
`privilege.
`BY THE WITNESS:
`A.
`No, they didn't.
`BY MR. ROTHMAN:
`Q.
`All right. Let's turn to your report,
`
`TransPerfect Legal Solutions
`depo@transperfect.com -- 212-400-8845
`
`PUBLIC VERSION
`
`
`
`Page 33
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`okay.
`
`opinions.
`
`A.
`Q.
`that?
`A.
`Q.
`page.
`
`Can we turn to Page 4, the summary of your
`
`Do you have that page before you?
`I do.
`There is a Paragraph 9 there. Do you see
`
`Yes.
`And there are several bullets on that
`
`Do you see that?
`I do.
`A.
`And there is -- if you look at Bullet
`Q.
`No. 1, do you see that?
`A.
`Yes.
`Q.
`If you go down one, two, three, four, five
`lines, it says:
`"Mr. Tate's market definition also fails
`to consider that both Taxotere and Jevtana were
`displaced as primary prostate cancer and metastatic
`castration-resistant prostate cancer treatments during
`the relevant time period."
`Do you see that?
`I do.
`
`A.
`
`TransPerfect Legal Solutions
`depo@transperfect.com -- 212-400-8845
`
`PUBLIC VERSION
`
`
`
`Page 34
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`Do you still agree with that opinion?
`Q.
`Yes.
`A.
`When was Jevtana a primary prostate cancer
`Q.
`and metastatic castrate resistant prostate cancer
`treatment?
` MR. MILLS: Objection; foundation.
`BY THE WITNESS:
`A.
`Well, after Jevtana was approved and
`introduced into the market in the summer of 2010, it
`and Taxotere and Lupron and a few other medications
`were regularly prescribed to treat that condition.
`BY MR. ROTHMAN:
`Q.
`So there was a time when Jevtana was a
`primary cancer and metastatic castration-resistant
`prostate cancer treatment, is that right?
`A.
`I don't know if I could agree with that
`question the way you've asked it. I understand that I
`say in my report that it was displaced as a primary
`prostate cancer treatment, but if you look at the
`prescriptions for Jevtana, even in 2010, before other
`medications came on the market, like Xtandi and
`Zytiga, the prescriptions for Jevtana were very low
`based on IMS Health information. So there -- there is
`probably never a time where Jevtana was a primary
`
`TransPerfect Legal Solutions
`depo@transperfect.com -- 212-400-8845
`
`PUBLIC VERSION
`
`
`
`Page 35
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`prostate cancer treatment since it was approved and
`introduced into the market.
`Q.
`If it was never a primary treatment, how
`could it be displaced from being a primary treatment?
`Doesn't that make your opinion incorrect?
`A.
`Yeah, I believe that statement in the
`summary of my opinion is improperly worded. Jevtana
`was never a primary prostate cancer treatment. It was
`always prescribed as a third- or fourth-line treatment
`at times and it was also prescribed as a first line
`and a se