DeForest McDuff, Ph.D.
`September 1, 2016
`
`Page 1
`
`Page 3
`
`------------------- I N D E X -------------------
`WITNESS EXAMINATION BY PAGE
`DeFOREST McDUFF, Ph.D. MR. OLSON 6
` MR. HARE 76
`
`1
`
`2
`
`3
`
`4
`
`5 6 7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`-------------------------------------------X
`
`AMERIGEN PHARMACEUTICALS LIMITED,
`
` Petitioner,
`
` -against-
`
`JANSSEN ONCOLOGY, INC.,
`
` Patent Owner.
`
`Case IPR2016-00286
`
`-------------------------------------------X
`
` 787 Seventh Avenue
`
` New York, New York
`
` September 1, 2016
`
` 9:02 a.m.
`
` DEPOSITION of DeFOREST McDUFF, Ph.D.,
`
`taken before Sadie L. Herbert, a Registered
`
`Professional Reporter and Notary Public of the
`
`States of New York and New Jersey.
`
` THE MCS GROUP, INC.
`
` 1601 Market Street, 8th Floor
`
` Philadelphia, PA 19103
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`---------------- E X H I B I T S ----------------
`JANSSEN DESCRIPTION FOR I.D.
`Exhibit 2032 Patent Owner's Notice
` of Deposition of
` DeForest McDuff, Ph.D. 5
`Exhibit 2033 Press Release, 1/26/16 28
`Exhibit 2034 Press Release, 1/21/14 32
`Exhibit 2035 Press Release, 1/20/15 33
`Exhibit 2036 Press Release, 4/20/04 46
`PREVIOUSLY MARKED
`AMERIGEN PAGE
`Exhibit 1001 US Patent 8,822,438 35
`Exhibit 1002 Declaration of Scott R.
` Serels, M.D. 37
`Exhibit 1005 US Patent 5,604,213 48
`Exhibit 1008 Applicant's 7/3/12
` Response 60
`Exhibit 1012 Applicant's 6/4/13
` Response 63
`
`Page 2
`
`Page 4
`
`25
`
` (215) 405-8178
`
`----------- PREVIOUSLY MARKED EXHIBITS ----------
`
`AMERIGEN DESCRIPTION PAGE
`
`Exhibit 1013 Notice of Allowance and
`
` Fee(s) Due 70
`
`Exhibit 1017 Declaration of DeForest
`
` McDuff, Ph.D. 9
`
`Exhibit 1065 Zytiga Label 39
`
`JANSSEN
`
`Exhibit 2013 Press Release , 5/22/96 45
`
` (EXHIBITS TO BE PRODUCED)
`
`A P P E A R A N C E S:
`
`MCNEELY, HARE & WAR LLP
`ON BEHALF OF PETITIONER
` 12 Roszel Road
` Suite C104
` Princeton, New Jersey 08540
`BY: WILLIAM D. HARE, ESQ.
` Phone 347.400.1154
` Bill@miplaw.com
`
`SIDLEY AUSTIN LLP
`ON BEHALF OF PATENT OWNER
` 787 Seventh Avenue
` New York, New York 10019
`BY: S. ISAAC OLSON, ESQ.
` Phone 212.839.5696
` Iolson@sidley.com
`
`ALSO PRESENT:
` JENNIFER REDA, Johnson & Johnson
` DAVID SHERECK, Videographer
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`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
`
`25
`
`THE MCS GROUP, INC.
`
`1 (Pages 1 to 4)
`
`JANSSEN EXHIBIT 2111
`Amerigen v. Janssen IPR2016-00286
`
`

`
`DeForest McDuff, Ph.D.
`September 1, 2016
`
`Page 5
`
`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
`
`25
`
` P R O C E E D I N G S
` (Janssen Exhibit 2032, Patent
` Owner's Notice of Deposition of
` DeForest McDuff, Ph.D., was
` pre-marked for identification.)
` THE VIDEOGRAPHER: Okay. This
` is -- sorry.
` The time is approximately
` 9:02 a.m. This is the video --
` today's date is Thursday,
` September 1st, 2016. This is the
` video deposition of Dr. DeForest
` McDuff, Ph.D. in the matter of
` Amerigen Pharmaceuticals versus
` Janssen Oncology, Incorporated.
` Case Number is IPR2016-00286, in
` the United States Patent and
` Trademark Office.
` My name is David Shereck,
` certified legal videographer with
` Shereck Video, in association with
` Deitz Reporting of Rockville
` Centre, New York.
` We're located today at the
` office of Sidley Austin, LLP at
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`state on the record that I've marked the
`notice of deposition that we served for
`Dr. McDuff as Janssen Exhibit 2032. Set
`that there, but we don't really need to do
`anything with it.
` Could you please state your full
`name for the record.
` A Robert DeForest McDuff.
` Q Have you had your deposition taken
`before today?
` A Yes.
` Q Approximately how many times?
` A Around 20 or 25.
` Q Were any of those prior depositions
`in patent proceedings?
` A Yes.
` Q How many?
` A I would have to look to get you an
`exact figure. I would ballpark, more than
`15.
` Q Of those 15, were any of those
`depositions in inter partes review
`proceedings?
` A No.
` Q Approximately how many of those
`
`Page 8
`
`Page 6
`
` 787 Seventh Avenue, New York,
` New York.
` Will counsels please voice
` identify yourselves and whom you
` represent.
` MR. OLSON: Isaac Olson with
` Sidley Austin representing Patent
` Owner, Janssen Oncology, Inc.
` MR. HARE: Bill Hare, McNeely,
` Hare & War, representing Amerigen
` Pharmaceuticals, Limited.
` MS. REDA: Jennifer Reda
` representing Janssen Oncology.
` THE VIDEOGRAPHER: Thank you.
` The court reporter today is
` Sadie Herbert, also with Deitz
` Reporting. Would you please swear
` in the witness.
`DeFOREST McDUFF, Ph.D., the witness herein,
` having first been duly sworn by a Notary
` Public of the State of New York, was
` examined and testified as follows:
` CROSS-EXAMINATION
`BY MR. OLSON:
` Q Before we start. I'd just like to
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`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
`
`25
`
`prior depositions in patent proceedings
`involved pharmaceutical products?
` A I would have to go back and look to
`get an exact figure. Sitting here, I would
`estimate around ten.
` Q And of those ten, did -- did any of
`those ten depositions involve anticancer
`treatments?
` A I don't believe so.
` Q Did you testify as an expert
`witness in those prior proceedings?
` A Yes.
` Q Have you testified at trial?
` A Yes.
` Q Approximately how many times have
`you testified at trial?
` A I believe it has been six times.
` Q And those six times, were those in
`patent proceedings?
` A Some were; some were not.
` Q Approximately how many were in
`patent proceedings?
` A I would think of four of them as
`patent proceedings and one of them related
`to patent valuation methodologies, though
`
`THE MCS GROUP, INC.
`
`2 (Pages 5 to 8)
`
`

`
`DeForest McDuff, Ph.D.
`September 1, 2016
`
`Page 9
`
`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
`
`25
`
`not a patent proceeding as I would think of
`it.
` Q What was the -- the general issue
`presented in that case that -- involving
`patent valuation?
` A It was a bankruptcy hearing where
`the plaintiff was seeking a remedy based on
`a patent portfolio valuation.
` Q Okay. Now, if you don't understand
`a question I ask today, please let me know.
`If you do not do so, can I assume that you
`understand the question?
` A Okay.
` Q Okay.
` (Amerigen Exhibit 1017,
` Declaration of DeForest McDuff,
` Ph.D., having been previously
` marked, was introduced into the
` record.)
` Q If you could please look at what's
`previously been marked as Amerigen
`Exhibit 1017.
` Do you recognize this document?
` A (Document review.)
` Yes, it appears to be the
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Q Did you write your declaration
`yourself?
` A Yes.
` Q About how much time in total did
`you spend in the preparation of your
`declaration?
` A I don't have a specific figure.
`It's probably more than 30 hours, probably
`less than 60. And hours were also spent by
`members of my staff working at my direction.
` Q Okay. Who from your staff worked
`on the preparation of this declaration?
` A I would have to go back and look,
`though I believe Mr. Matthew Brundage was a
`primary person working on this. Possibly,
`as well, Mr. Ryan Andrews.
` Q Other than Mr. Brundage and
`Mr. Andrews, do you recall anyone else who
`worked on the preparation of your
`declaration?
` A I don't believe so.
` Q Approximately how much time did you
`spend reviewing materials for your
`declaration?
` A Would you mind clarifying what you
`
`Page 12
`
`Page 10
`
`declaration I submitted in December of 2015.
` Q Okay. So Amerigen Exhibit 1017 is
`your December 4th, 2015 declaration; is that
`correct?
` A It appears to be, yes.
` Q When did you last review your
`declaration?
` A Most recently, yesterday.
` Q When were you first approached
`about getting involved in this case?
` A Sometime in the middle of 2015.
` Q Do you recall who approached you?
` A Mr. Hare.
` Q How many in-person meetings did you
`have with your attorneys related to the
`preparation of this declaration?
` A Related to the preparation of the
`declaration, none.
` Q Did you have teleconferences with
`the attorneys representing Amerigen related
`to the preparation of this declaration?
` A Yes.
` Q Approximately how many?
` A I don't recall specifically.
`Perhaps around three to six.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`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
`
`25
`
`mean?
` Q Sure -- well, I'll give you a
`better question.
` The -- you said that you spent
`approximately 30 to 60 hours preparing your
`declaration. Was that 30 to 60 hours
`drafting the declaration or 30 to 60 hours
`overall?
` A I had in mind more of an overall
`amount, so that would include my research,
`analysis, discussions with my staff,
`drafting the declaration, things of that
`nature.
` Q Okay. Approximately how much of
`the 30 to 60 hours spent in the preparation
`of the declaration was spent on research
`related to the declaration?
` A I don't remember specifically.
` Q Approximately how much time did you
`spend drafting the declaration?
` A I don't have a specific
`recollection or a breakdown for you. I
`think of it as a process that involves all
`of those activities and don't separately
`track them.
`
`THE MCS GROUP, INC.
`
`3 (Pages 9 to 12)
`
`

`
`DeForest McDuff, Ph.D.
`September 1, 2016
`
`Page 13
`
`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
`
`25
`
` Q How much in total expert fees have
`you billed on this matter?
` A I believe it's around 80,000, more
`or less.
` Q Would you please turn to
`Attachment A-1 of your declaration.
` A Okay.
` Q Do you recognize Attachment A-1?
` A Yes.
` Q Attachment A-1 is your CV; correct?
` A As of December 2015, yes.
` Q When did you last update your CV?
` A Last week, maybe even earlier this
`week.
` Q Do you consider Attachment A-1 to
`be generally reflective of your professional
`background?
` A (Document review.)
` I do, although, I do have more
`cases and testimony that has occurred since
`December 2015, and I would also include
`those as part of my professional background.
` Q And what are those additional
`cases?
` A There are a number of them. I'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
`
`25
`
`mind sitting here.
` Q All right.
` A There have, of course, been some
`depositions and trial testimony that would
`be updated on the items listed in my expert
`testimony.
` Another case that comes to mind is
`CH2O versus Maris in the Central District of
`California relating to patent damages.
` Q Okay. Any others that you can
`think of?
` A Not sitting here.
` Q Okay. Your current position is
`vice presidency -- vice president of
`Intensity Corporation; correct?
` A Yes.
` Q You state that you are an expert in
`applied business economics; correct?
` A Yes.
` Q You're not a medical doctor;
`correct?
` A Correct.
` Q And you don't have a Ph.D. in
`pharmacology, biochemistry or a related
`discipline; correct?
`
`Page 16
`
`Page 14
`
`not sure I could remember all of them
`sitting here, yet if you'd like, I'd be
`happy to try to remember some.
` Q Sure.
` A One is a case relating to the
`evaluation of the drug MULTAQ or the
`compound dronedarone in the District of
`Delaware, an evaluation of commercial
`success.
` Another is an evaluation of
`commercial success relating to the drug
`AMPYRA, compound is aminopyridine.
` Q Is the AMPYRA case in federal
`court?
` A I believe so, yes.
` Q Do you know which district it's in?
` A It's in the District of Delaware.
` Q Delaware.
` A Another case is Art Cohen and
`plaintiffs similarly situated versus
`Donald J. Trump in the Southern District of
`California relating to class action damages.
` There may be a few others.
` Q Okay.
` A Those are the ones that come to
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`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
`
`25
`
` A Correct.
` Q And you don't have a Ph.D. in
`pharmaceutical sciences; is that correct?
` A Correct.
` Q Would you turn to Attachment A-2 in
`your declaration.
` A I'm there.
` Q And this is a list of materials
`considered, reviewed or relied upon; is that
`correct?
` A Yes.
` Q Who provided you with the materials
`that are listed in Attachment A-2?
` A Some of the materials were provided
`by Mr. Hare and some of the materials I and
`members of my staff, working at my
`direction, collected in our research.
` Q Can you identify for me the
`references that you identified -- you and
`your staff identified independent of your
`attorneys?
` A I believe my staff and I identified
`the patents listed on Page 1. And then
`Mr. Hare pointed me to the versions of those
`that existed within this proceeding. And my
`
`THE MCS GROUP, INC.
`
`4 (Pages 13 to 16)
`
`

`
`DeForest McDuff, Ph.D.
`September 1, 2016
`
`Page 17
`
`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
`
`25
`
`staff and I identified the items listed
`under research materials from Pages 2 to 4.
` Q Who prepared Attachment A-2?
` A Members of my staff working at my
`direction.
` Q Turn to Attachment B-1 of
`Amerigen 1017.
` Do you recognize Attachment B-1?
` A Yes.
` Q What is Attachment B-1?
` A As described here in the title, it
`is a summary of prosecution filings for the
`'438 patent.
` Q How was Attachment B-1 prepared?
` A It was prepared based on review of
`the documents indicated in the source column
`and a description of those items was
`generated and recorded in the description
`column. And of course, the date was
`recorded in the date column.
` Q Who prepared Attachment B-1?
` A A member of my staff working at my
`direction.
` Q How were the source documents
`listed in the source column identified?
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Q Who prepared Attachment B-2?
` A Members of my staff working at my
`direction.
` Q Zytiga is the only drug listed in
`Attachment B-2 that is indicated for the
`treatment of prostate cancer; correct?
` A I would have to go back and look.
` Q Did you consider whether any of the
`drugs listed in Attachment B-2 were
`indicated for the treatment of prostate
`cancer in the preparation of your
`declaration?
` A I know that some of them are not,
`yet I'm just not sure sitting here whether
`all of them are not.
` Q Other than Zytiga, none of the
`other drugs listed in Attachment B-2 are
`oral drugs; correct?
` A I would have to go back and look.
` Q So sitting here today, you don't
`know whether the other drugs listed in
`Attachment B-2 are taken orally or given by
`injection?
` A I believe at least some of them are
`given by injection. I'm not sure sitting
`
`Page 20
`
`Page 18
`
` A I'm not sure I understand. Would
`you mind clarifying.
` Q Sure.
` Who identified the source documents
`that are listed in the source column of
`Attachment B-1?
` A I believe these were identified
`based on my and my staff's review of those
`documents. That's what I recall.
` Q Are you or any of the members of
`your staff trained patent attorneys?
` A No.
` Q Would you turn to Attachment B-2 of
`your declaration.
` Do you recognize Attachment B-2?
` A Yes.
` Q What is Attachment B-2?
` A Attachment B-2 is a list of some of
`the top selling oncology drugs.
` Q How was Attachment B-2 prepared?
` A It was prepared based on research
`on this topic and identification of the
`source listed under notes and sources. And
`then information from that source was put in
`table form.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`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
`
`25
`
`here whether all of them are. That may be
`true.
` Q Can you identify which of the drugs
`listed in Attachment B-2 you believe are
`administered by injection?
` A The only one that comes to mind
`where I have seen confirmation that it's
`given by injection is Herceptin.
` Q In the preparation of your
`declaration in Attachment B-2, did you
`consider the different modes of
`administration for these drugs?
` A It is one thing I thought about,
`yes.
` Q In Attachment B-2, you have
`compared Zytiga to non-prostate cancer and
`non-oral drugs; is that correct?
` A It is true, as we've been
`discussing, that some or all of these drugs
`are non-prostate cancer or non-oral.
` Q Can you identify any of the drugs
`listed in Attachment B-2, other than Zytiga,
`that are indicated for the treatment of
`prostate cancer?
` A I can't name any sitting here.
`
`THE MCS GROUP, INC.
`
`5 (Pages 17 to 20)
`
`

`
`DeForest McDuff, Ph.D.
`September 1, 2016
`
`Page 21
`
`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
`
`25
`
` Q Can you turn to Attachment B-3 of
`Amerigen Exhibit 1017.
` Do you recognize Attachment B-3?
` A Yes.
` Q What is Attachment B-3?
` A Attachment B-3 is a summary of
`sales, units and pricing for some drugs
`indicated for MCRPC prostate cancer
`treatment.
` Q How was Attachment B-3 prepared?
` A It was prepared based on review of
`the IML -- IMS health data cited under notes
`and sources. And those data were summarized
`in a table.
` Q Who prepared Attachment B-3?
` A Members of my staff working at my
`direction.
` Q And the drugs listed in
`Attachment B-3 are Zytiga, Xtandi and
`Jevtana; correct?
` A Yes.
` Q Do you recall how -- or why Xtandi
`and Jevtana were selected as comparators
`with Zytiga?
` A Because my understanding is that
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`opinion on that one way or the other.
` Q Commercial success can be proven by
`evidence of significant levels of sales;
`correct?
` A That also strikes me as a legal
`conclusion. As an economist, I wouldn't
`necessarily agree with that, no, not
`exclusively.
` Q Are level of -- is the level of
`sales a consideration in a commercial
`success analysis?
` A Yes, it frequently is.
` Q A decrease in the level of sales
`does not mean that a drug ceased to be
`commercially successful; correct?
` A Not necessarily, no.
` Q Now, commercial success can also be
`proven by evidence of significant levels of
`market share; is that correct?
` A Again, that strikes me as a legal
`determination, yet, as I think of it as an
`economist, market share is one factor that
`one can evaluate in an analysis of
`commercial success.
` Q A decrease in market share does not
`
`Page 24
`
`Page 22
`
`they also have approval for MCRP prostate
`cancer treatment.
` Q And MCRPC is an abbreviation for
`metastatic castration resistant prostate
`cancer; correct?
` A Yes, that's my understanding.
` Q Are Xtandi or Jevtana listed in
`Attachment B-2?
` A No.
` Q Commercial success is relevant to a
`determination of whether a patent is not
`obvious; correct?
` A It can be. It depends on the
`circumstances.
` Q But you would agree that it can be
`relevant to a determination of whether a
`patent is nonobvious; correct?
` A Yes, it can be. It depends on the
`circumstances.
` Q And commercial success constitutes
`independent evidence of nonobviousness that
`must be considered when presented to an
`examiner or a court; correct?
` A That strikes me as a legal
`conclusion. I don't, sitting here, have an
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`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
`
`25
`
`mean that a drug ceased to be commercially
`successful; correct?
` A Not necessarily, no.
` Q A decrease in patient share does
`not mean that a drug ceased to be
`commercially successful; is that correct?
` A Not necessarily or by itself, no.
` Declines in sales or market share
`or patient share would tend to make a
`product less successful, all else being
`equal.
` Q A product can be commercially
`successful even if there are other competing
`products on the market that are also
`commercially successful; correct?
` A That's possible, yes.
` Q So there can be more than one
`commercially successful product in a given
`market; is that correct?
` A That's possible, yes. It depends
`on the market.
` Q In Paragraph 16 of Amerigen
`Exhibit 1017, you state that "The Patent
`Owner must show that the commercial success
`is attributable to the novel parts of a
`
`THE MCS GROUP, INC.
`
`6 (Pages 21 to 24)
`
`

`
`DeForest McDuff, Ph.D.
`September 1, 2016
`
`Page 25
`
`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
`
`25
`
`patent claim and not on factors that are
`unrelated or were already known"; is that
`correct?
` A I believe you read that more or
`less correctly.
` Q Was there anything incorrect about
`the way I read it?
` A No, I just didn't quite follow all
`of your words, so I can't confirm that's
`exactly what was written here.
` Q Okay. Let's just try it again.
` At the bottom of Page 13, the last
`sentence there begins, "In other words..."
` Do you see that?
` A Yes.
` Q Okay. So in other -- the
`Paragraph 16 -- in Paragraph 16, you state,
`"In other words, the Patent Owner must show
`that the commercial success is attributable
`to the novel parts of a patent claim and not
`on factors that are unrelated or were
`already known"; is that correct?
` A Yes.
` Q The existence of marketing or
`promotional expenses does not preclude a
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`correct?
` A Yes.
` Q And that's an accurate statement?
` A Yes.
` Q Skipping down to the next sentence
`that begins "Accordingly..."
` In Paragraph 17, you state that
`"Analysis of commercial success frequently
`includes evaluation of sales, profits,
`market shares, prices and other metrics to
`draw inferences on economic incentives for
`development"; correct?
` A Yes, I see that.
` Q Which of those factors did you
`apply when evaluating whether Zytiga has
`achieved commercial success?
` A In my evaluation here, I evaluated,
`to some degree, sales, market shares and
`prices. I did not evaluate profits as I'm
`not aware of that information being provided
`by the Patent Owner.
` Q Okay. Were there any other metrics
`that you considered?
` A Well, there is other information
`that I evaluated, and that's described
`
`Page 28
`
`Page 26
`
`finding that there is a nexus between
`commercial success and the claimed
`invention; correct?
` A Not necessarily, not by its
`existence. It is one factor that can affect
`a finding of commercial success.
` Q Commercial success does not have to
`be entirely attributable to the claimed
`invention for there to be nexus; correct?
` A That strikes me as a legal
`conclusion. I wouldn't necessarily provide
`an opinion on that, not from a legal
`perspective.
` Q In your analysis, did you assume
`that commercial success has to be entirely
`attributable to the claimed invention for
`there to be nexus?
` A No.
` Q Let's turn to Paragraph 17 of your
`declaration.
` In Paragraph 17 of your
`declaration, you state that "A finding of
`commercial success can, in some
`circumstances, support the notion that a
`patent was" nonobvi- -- "was not obvious";
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`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
`
`25
`
`throughout my declaration. Whether one
`thinks of that as a metric or not, I'm not
`sure. But the declaration speaks for
`itself, to some degree, in terms of the
`items I evaluated.
` Q Zytiga was the first orally
`administered secondary hormonal therapy drug
`approved for the treatment of prostate
`cancer; correct?
` A I'm not sure sitting here. I can't
`confirm that one way or the other.
` Q In 2015, Zytiga achieved over
`$1 billion in net sales in the United
`States; correct?
` A I'm not sure whether that's correct
`or not, sitting here.
` MR. OLSON: Can we mark this as
` Janssen 2033.
` (Janssen Exhibit 2033, Press
` Release, 1/26/16, was marked
` for identification.)
` Q You've been handed what's been
`marked as Janssen Exhibit Number 2033.
` Have you seen this document before?
` A (Document review.)
`
`THE MCS GROUP, INC.
`
`7 (Pages 25 to 28)
`
`

`
`DeForest McDuff, Ph.D.
`September 1, 2016
`
`Page 29
`
`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
`
`25
`
` No, I don't believe so.
` Q Janssen Exhibit Number 2033 is a
`January 26th, 2016 Johnson & Johnson report
`of the 2015 fourth quarter results; correct?
` A It appears to be.
` Q Do you have any reason to doubt
`that the document is what it says it is?
` A It appears to be a press release
`relating to 2014[sic] fourth quarter
`results. I don't have any reason to
`question that.
` Q I think you said "2014 fourth
`quarter results," it's 2015; correct?
` A Yes. If I said 2014, I must have
`misspoke.
` Q Okay. If you can turn to the third
`to the last page in Janssen Exhibit 2033.
`See, if you go back just a couple pages,
`there's a bunch of tables here at the end.
`The third to the last page, if you look at
`the bottom of that page, there's an entry
`for Zytiga.
` A I'm there.
` Q And if you follow across in the US
`entry for Zytiga, looking at the 12-month
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`correct?
` A It is, yes.
` Q So Zytiga is a blockbuster drug;
`correct?
` A By that definition, I would
`understand it to be, yes.
` Q Net sales of Zytiga in the United
`States have increased each year since
`launch; is that correct?
` A Well, I don't think that's true. I
`was just looking at this press release that
`you handed me as Exhibit 2033, and I see a
`decline in Zytiga sales worldwide of around
`$6 million. The international decline was
`approximately 8.3 percent, at least
`according to this document.
` Q My question was specifically about
`the United States, though, not the worldwide
`sales.
` The net sales of Zytiga in the
`United States have increased each year since
`launch; correct?
` A They may have. I don't have all
`the data in front of me to confirm that for
`you.
`
`Page 32
`
`Page 30
`
`period for 2015, the reported value there is
`1,070,000,000; correct?
` A I see that, yes.
` Q And that's reported sales; correct?
` A Yes.
` Q So in 2015, would you agree that
`Zytiga achieved over $1 billion in net sales
`in the United States?
` A It appears, yes, that's what this
`document shows.
` Q Do you agree that a drug that has
`$1 billion in sales is a commercial success?
` A It can be. It would not
`necessarily be or not always be.
` Q So is it your opinion that a drug
`with over a billion dollars in annual sales
`is not commercially successful?
` A It would depend on the
`circumstances. That wouldn't be the only
`factor I would look at and wouldn't
`necessarily conclude one way or the other
`based on that factor alone.
` Q A drug that has achieved at least a
`billion dollars in net sales in a year is
`commonly referred to as a blockbuster drug;
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`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
`
`25
`
` Q Okay. Well, if we look at the
`sales in Attachment B-3, starting in 2012.
` In 2012, Zytiga sales were
`$470.4 million; correct?
` I'm looking at Attachment B-3 of
`your report.
` A I understand. I just wanted to
`look up one item first.
` Q Sure.
` A (Document review.)
` Yes, 470.4.
` Q Okay. And in 2013, there was an
`increase to $793.1 million; correct?
` A Yes, that's correct. These are
`gross sales reported by IMS Health and would
`not include discounts for rebates and would
`not be the net sales earned by the company.
` Q Okay.
` MR. OLSON: Can we mark this as
` 2034.
` MR. HARE: Thank you.
` (Janssen Exhibit 2034, Press
` Release, 1/21/14, was marked
` for identification.)
` Q So you have been handed what's been
`
`THE MCS GROUP, INC.
`
`8 (Pages 29 to 32)
`
`

`
`DeForest McDuff, Ph.D.
`September 1, 2016
`
`Page 33
`
`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
`
`25
`
`marked as Janssen Exhibit 2034. It's a
`January 21st, 2014 Johnson & Johnson 2013
`report on fourth quarter and full year
`results; correct?
` A It appears to be. It appears to be
`a press release relating to that.
` Q If you turn to the second to last
`page of Janssen Exhibit 2034. You see about
`halfway down the page there's an entry in
`the table for Zytiga; correct?
` A Yes, I see that.
` Q Looking at the US sales for Zytiga
`in 2013, the reported sales were
`$750 million; correct?
` A Yes, I see that.
` Q And in 2012, the reported sales
`were $463 million in the US; correct?
` A Yes.
` Q And so there was an increase from
`2012 to 2013; correct?
` A Yes, that's how I read this.
` MR. OLSON: Will you mark this
` as 2035.
` (Janssen Exhibit 2035, Press
` Release, 1/20/15, was marked
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`1,070,000,000; correct?
` A Yes.
` Q Which is an increase over the
`$971 million reported for 2014; correct?
` A Yes, it appears the rate of
`increase is declining, but it is an
`increase, yes.
` Q So you would agree that sales of
`Zytiga in the United States have increased
`in each year since launch of Zytiga;
`correct?
` A Well, I was looking for sales in
`2011, and I didn't see those. I don't
`recall if there were any. Although, I did
`notice in my report that Zytiga appears to
`have gotten FDA approval in 2011, so I would
`have to look. And I don't have sales,
`sitting here, of 2016. But for the years
`that we've discussed, that's true.
` Q Okay. So for the years 2012 to
`2015, sales of Zytiga in the United States
`have increased each year; is that correct?
` A Yes, that's my under