Scott Serels, M.D.
`August 22, 2016
`
`-----
`
`INDEX
`EXAMINATION BY
`WITNESS
`SCOTT SERELS, M.D. MS. DONOVAN
`MS. MATERASSI
`195
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`- - - - --
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`Page 3
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`PAGE
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`7 ---- EXHIBITS-- - - - - --
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`Page 1
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`AMERIGEN PHARMACEUTICALS LIMITED,
`Petitioner,
`-against-
`JANSSEN ONCOLOGY, INC.,
`Patent Owner.
`Case 1P52016 -00286
`
`x
`
`x
`
`787 Seventh Avenue
`New York, New York
`
`August 22, 2016
`9:23 a.m.
`
`DEPOSITION of SCOTT SERELS, M.D., taken
`before Sadie L. Herbert, a Registered
`Professional Reporter and Notary Public of the
`States of New York and New Jersey.
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`DESCRIPTION
`JANSSEN
`Exhibit 2028 Patent Owner's Notice of
`Deposition of Scott R.
`Serels, M.D.
`Exhibit2029 Curriculum Vitae
`Exhibit 2030 Jubelirer Article
`Exhibit 2031 O'Donnell Article with
`handwritten notations
`154
`
`FOR I.D.
`
`5
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`5
`137
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`___- PREVIOUSLY MARKED EXHIBITS-- -
`
`AMERIGEN
`Exhibit 1001 US Patent 8.822,438
`Exhibit 1002 Declaration of Scott R.
`Serels, M.D.
`10
`Exhibit 1003 O'Donnell Article
`Exhibit 1004 Gerber Article
`Exhibit 1005 US Patent 5,604,213
`Exhibit 1020 Harris Article
`Exhibit 1021 Oh Article
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`INC.
`THE MCS GROUP,
`1601 Market Street, 8th Floor
`Philadelphia, PA
`19103
`(215) 905 -8178
`
`Page 2
`
`APPEARANCES:
`
`MCNEELY, HARE & WAR LLP
`ON BEHALF OF PETITIONER
`12 Roszel Road, Suite C104
`Princeton, New Jersey 08540
`BY: GABRIELA MATERASSI, ESQ.
`Materassi@miplaw.com
`Phone 347.400.1154
`WILLIAM D. HARE, ESQ.
`Bill@miplaw.com
`
`SIDLEY AUSTIN LLP
`ON BEHALF OF PATENT OWNER
`787 Seventh Avenue
`New York, New York 10019
`BY: BINDU DONOVAN, ESQ.
`Bdonovan@sidley.com
`Phone 212.839.5696
`ALYSSA B. MONSEN, ESQ.
`Amonsen @sidley.com
`
`ALSO PRESENT:
`JENNIFER REDA, Johnson & Johnson
`TOM DEVINE, Videographer
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`PREVIOUSLY MARKED EXHIBITS
`DESCRIPTION
`FOR I.D.
`AMERIGEN
`Exhibit 1028 Jubelirer Abstract
`
`Page 4
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`(Confd) -
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`(EXHIBITS TO BE PRODUCED)
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`0 zEXHIBIT
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`THE MCS GROUP, INC..
`
`1
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`(Pages 1 to 4)
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`JANSSEN EXHIBIT 2020
`Wockhardt v. Janssen IPR2016-01582
`
`

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`Scott Serels, M.D.
`August 22, 2016
`
`Page 5
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`-
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`PROCEEDINGS
`(Janssen Exhibit 2028, Patent
`Owner's Notice of Deposition of
`Scott R. Serels, M.D., was
`marked for identification.)
`(Janssen Exhibit 2029,
`Curriculum Vitae, was marked
`for identification.)
`THE VIDEOGRAPHER: Good
`morning. We are now on the record.
`Today's date is August 22nd, 2016,
`and the time is approximately
`9:23 a.m.
`We are located at the offices
`of Sidley Austin LLP located at 787
`7th Avenue, New York, New York.
`We are taking the deposition of
`Dr. Scott Serels for an inter
`partes review proceeding in the
`matter of Amerigen Pharmaceuticals
`Limited V Janssen Oncology --
`Oncology, Incorporated before the
`U.S. Patent and Trademark Office
`before the Patent Trial and Appeal
`Board, case number IPR 2016 -00286.
`
`Page 6
`
`My name is Thomas Devine and I
`am the legal video specialist with
`Deitz Reporting. The court
`reporter is Sadie Herbert, also
`with Deitz Reporting.
`At this time, I would like to
`ask the attorneys present to please
`introduce themselves for the video
`record, please state your name, the
`firm with which you are affiliated
`and whom you represent, after which
`the court reporter will swear in
`the witness and we may proceed.
`MS. DONOVAN: Bindu Donovan
`with Sidley Austin representing
`patent owner, Janssen Oncology Inc.
`And with me is my colleague, Alyssa
`Monsen.
`MS. MATERASSI: Gabriela
`Materassi of McNeely, Hare & War
`LLP representing petitioner,
`Amerigen Pharmaceuticals Limited.
`With me is my colleague, William.
`Hare.
`MS. REDA: Jennifer Reda with
`
`Page 7
`
`Johnson & Johnson representing
`Janssen Oncology.
`
`SCOTT SERELS, M.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:
`MS. DONOVAN: Just before we
`start, I'd just like to state on
`the record, I've marked Dr. Hare --
`the notice of deposition that we
`served for Dr. Hare as Janssen
`Exhibit 2028.
`MR. HARE: Serels.
`MS. DONOVAN: Okay. Serels.
`THE WITNESS: Serels.
`MS. DONOVAN: I apologize. I'm
`not going to ask any questions, but
`I just wanted it on the record.
`MR. HARE: Sure.
`CROSS- EXAMINATION
`BY MS. DONOVAN:
`Q Dr. Serels, please could you state
`your full name for the record.
`A Scott Serels.
`
`Page 8
`Q And what is your home address?
`A 9 North Ridge Road in Westford,
`Connecticut.
`Q Okay. And have you had your
`deposition taken before today, sir?
`A Yes, not in this case, but other
`cases.
`Q Have you had it taken previously in
`a patent infringement proceeding?
`A Yes.
`Q Could you tell me which proceeding
`that was?
`I don't have the exact docket
`A
`number, but it was a case involving an
`overactive bladder medication, used to treat
`problems with urinary incontinence.
`Q And were you testifying as an
`expert witness in that case?
`I was.
`A
`Q And other than that case, have you
`testified in any other patent infringement
`proceeding?
`A No.
`Q And did -- in that patent
`infringement case that you mentioned, did
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`THE MCS GROUP, INC.
`
`(Pages 5 to 8)
`
`2
`
`

`

`Scott Serels, M.D.
`August 22, 2016
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`you also testify at trial?
`A
`I did.
`Q Do you remember the name of the
`medication?
`I believe it was tolterodine.
`A
`Q Okay. And other than this patent
`infringement case, can you just describe,
`have you been deposed in other matters?
`A Yes.
`Q How many times?
`A To give you a rough number,
`probably four or five times a year.
`Q And could you generally describe
`the nature of those matters?
`A Those matters are usually related
`to medical devices or medical malpractice.
`Q And have you also previously, other
`than this patent case, testified at trial?
`A No.
`Q Okay. So you're generally familiar
`with the deposition procedure. I'll just
`remind you, if you don't understand a
`question, please let me know and I will
`rephrase it for you. And if you don't ask
`me to rephrase a question, I'm going to
`
`Page 10
`
`assume that you understand the question,
`okay, sir?
`A Fine.
`Q All right. I'm going to show the
`witness what's been previously marked as
`Amerigen Exhibit 1002.
`(Amerigen Exhibit 1002,
`Declaration of Scott R Serels,
`M.D., having been previously
`marked, was introduced into the
`record.)
`Q Sir, do you recognize this
`document?
`A
`I do.
`Q This is your December 4th, 2015
`declaration in this matter; is that correct?
`A That's correct.
`Q When did you last review your
`declaration?
`A Yesterday.
`Q And when were you first approached
`to get involved in this matter?
`MS. MATERASSI: Objection to
`form.
`It was probably six to eight months
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`ago.
`Q And who approached you?
`A Bill Hare.
`Q Okay. And about how many in-person
`meetings did you have with your attorneys
`related to the preparation of your
`declaration?
`A
`In person, before today, none.
`Q Did you have teleconferences with
`them?
`A We had some phone conversations,
`yes.
`Q About how - how many times did you
`talk on the phone?
`A Once or twice.
`Q And did you write the declaration
`yourself?
`A
`I had the aid of some attorneys and
`others.
`Q About how much time in total did
`you spend in the preparation of your
`declaration?
`A
`I would say, five hours, maybe, six
`hours.
`Q And how much, in total, in expert
`
`Page 12
`
`fées have you billed?
`A
`I do not have the exact amount.
`I'd have to get that for you.
`Q Do you have an estimate?
`A Maybe $3,000.
`Q And I asked you about the total
`time you spent in preparation of your
`declaration, you said five, maybe six hours?
`A Correct.
`Q Does that include reviewing
`literature or -
`A Yes.
`Q -just -
`A Yes.
`Q So in total, the drafting of the
`declaration and review of literature, you
`spent about five to six hours?
`A Correct.
`I'm going to show the witness what
`Q
`has been previously marked as Janssen
`Exhibit 2029.
`MS. MATERASSI: So just a
`question, Counsel, are we marking
`these exhibits in numerical order,
`is this Exhibit 3 or are we
`
`THE MCS GROUP, INC.
`
`3
`
`(Pages 9 to 12)
`
`

`

`Scott Serels, M.D.
`August 22, 2016
`
`Page 13
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`following the original designation
`of the exhibit number ?..
`MS. DONOVAN: We are not
`marking what's previously been
`marked, we're following the
`Amerigen exhibit number. What I've
`given you right now is Dr. Serels'
`CV, this was not previously part of
`the record, so I've given it the
`next Janssen exhibit number.
`So we've -- the last paper that
`was filed was the pro hac
`submission for Isaac Olson, that
`was 2027, we've now started the
`notice of deposition as 2028 and
`Dr. Serels' CV is 2029.
`MS. MATERASSI: Okay. Thank
`you.
`BY MS. DONOVAN:
`Q Sir, do you recognize Janssen
`Exhibit2029?
`A
`I do.
`Q Okay. And that's your CV; correct?
`A Correct.
`Q And when did you last update your
`
`Page 14
`
`CV?
`I want to say, probably September
`A
`of last year.
`Q Do you consider it to be up to date
`and generally reflective of your
`professional background?
`A Yes.
`Q Now, your current position is
`director of daily operations at the Bladder
`Control Center of Norwalk; correct?
`A Correct.
`Q And there, you state on your CV,
`you're director of daily operations which
`involve urodynamics, female urology and
`neurourology; is that right?
`A Neurourology, correct.
`Q So you don't specialize in prostate
`cancer; right, sir?
`A Correct.
`Q Did you treat men who have been
`diagnosed with prostate cancer?
`A Yes.
`Q What percentage of your practice
`involves the treatment of men who have been
`diagnosed with prostate cancer?
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`A Probably about 20 percent.
`Q And what percentage of your
`practice involves the treatment of men with
`metastatic castration -resistant prostate
`cancer?
`A Probably somewhere between 5 to
`8 percent.
`Q Now, with regard to the prostate
`cancer patients that you treat, what
`percentage of your practice involves
`actually treating the cancer?
`MS. MATERASSI: Objection.
`I would say the 20 percent.
`A
`Q Have you administered ADT?
`A
`I have.
`. Q And what about second -line hormonal
`therapy?
`A
`I have.
`Q Your CV lists one publication dated
`1997 that concerns prostate cancer; is that
`correct?
`A Correct.
`Q So you haven't published an article
`concerning prostate cancer in about
`20 years; is that right?
`
`Page 16
`
`A Correct.
`Q And your CV also lists one
`presentation concerning prostate cancer
`dated 1996; is that right?
`A Correct.
`Q So you haven't made any
`presentations concerning prostate cancer in
`about 20 years; is that right?
`A Correct.
`Q So you're not an expert in the
`treatment of prostate cancer; is that
`correct?
`I'm a urologist who treats prostate
`A
`cancer.
`Q Do you consider yourself an expert
`in the treatment of prostate cancer?
`A No.
`Q Do you have any drug discovery
`experience, sir?
`A Drug discovery --
`Q Discovery.
`A Could you elaborate on the
`question.
`Q Have you been involved in the
`design of any clinical trials?
`
`4
`
`(Pages 13 to 16)
`
`THE NOS GROUP, INC.
`
`

`

`Scott Serels, M.D.
`August 22, 2016
`
`Page 17
`
`A Yes.
`Q Have you been involved in the
`design of any clinical trials relating to
`prostate cancer?
`A No.
`Q Have you been involved in any
`medicinal chemistry research relating to the
`discovery of drugs?
`A Explain, explain a little more
`clearly what you mean by that.
`Q Have you - have you been involved
`in any medicinal chemistry research?
`A So actually doing the chemistry?
`Q Yes.
`A All my research has been clinical
`recently.
`Q Wily don't - can you explain to me
`the type of clinical research that you do.
`A Yeah. Essentially, once a compound
`has been created and either it has FDA
`approval or it's going to get - or looking
`to get FDA approval, I'll be involved in the
`clinical trials to bring that medication or
`drug to market.
`Q And you just confirmed none of
`
`Page 18
`
`these clinical trials have concerned
`prostate cancer drugs?
`A Correct.
`Q Other than this clinical trial
`research, have you been involved in any
`other type of research relating to the
`discovery or development of a drug?
`A No.
`Q Can you describe for me, just
`generally, the clinical trials that you have
`been involved with, the type of medications?
`A They've all been related to
`urologic care regarding either prostate
`problems or prostatitic problems.
`Q Do you agree drug discovery is
`unpredictable?
`MS. MATERASSI: Objection to
`form.
`I'm not sure -- can you elaborate
`A
`on the question.
`Q That's my question.
`Do you agree drug discovery is
`unpredictable, sir, is that a correct
`statement?
`A Yes.
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`Page 19,
`Q Do you agree replacing one drug for
`another in a drug combination can have
`unpredictable results?
`A Depending on how far along you are,
`yes. you could be surprised by things.
`Q So replacing one drug for another
`in a drug combination can have unpredictable
`results; correct?
`I imagine it could, yes.
`A
`Q Okay. And you agree it's not
`possible to know in advance whether therapy
`will be safe and effective without
`conducting a clinical trial; correct?
`A Yes.
`Q And you have never developed any
`drug combinations for prostate cancer;
`correct?
`A Correct.
`Q AU right, sir, if you could look
`at your declaration, please.
`Could you please turn to
`Paragraph 8 of your declaration, sir. And
`in Paragraph 8, you provide an opinion
`concerning the person of ordinary skill in
`the art at the time of the filing of the
`
`Page 20
`
`'438 patent.
`A Mm -hmm.
`Q Correct?
`A Mm -hmm, correct.
`Q And there, you say that the person
`of ordinary skill in the art at the time of
`filing of this patent is, "A physician
`specializing in urology or oncology or holds
`a Ph.D. in pharmacology, biochemistry or a
`related discipline."
`Do you see that, sir?
`A Yes, I do.
`Q Do you agree, sir, that in actual
`practice, not all urologists treat prostate
`cancer?
`MS. MATERASSI: Objection.
`Form.
`I mean, I'm sure there are some
`A
`that don't, but urologists tend to treat a
`broad, a group of different conditions and
`usually prostate cancer is one of them.
`Q But you'd agree that there may be
`some urologists that don't treat prostate
`cancer; is that true?
`I'm sure there are some.
`A
`
`5
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`(Pages 17 to 20)
`
`THE MCS GROUP, INC.
`
`

`

`Scott Serels, M.D.
`August 22, 2016
`
`Page 21
`Q And is it also true that in actual
`practice, not all oncologists treat prostate
`cancer?
`A
`I would agree with that.
`Q So my question is: In your
`opinion, would a person of ordinary skill in
`the art, as you've defined it in
`Paragraph 8, need to have experience in the
`treatment of prostate cancer?
`A Yes.
`Q And how many years of experience
`would the person of ordinary skill in the
`art need to have in the treatment of
`prostate cancer?
`It depends on the volume of cases
`A
`they see. That's a tough question to
`answer. Could be an intensive year that
`would do that.
`Q So are you - I'm - I'd like you
`to clarify.
`A Mm -hmm.
`Q Are you saying it - it would be
`variable?
`A Yes.
`Q Can you please define for me and
`
`Page 22
`
`give me a range of how many years of
`experience the person of ordinary skill
`would need in treating prostate cancer to
`qualify as a person of ordinary skill.
`It - it just depends on the volume
`A
`of patients that they have. So someone of
`ordinary skill, if they did a fellowship in
`prostate cancer and every patient they saw
`for a year was a prostate cancer patient, a
`year would be enough to make them fairly
`well- experienced with it. Someone who sees
`less patients, it may take them a longer
`period of time. I don't think you can put
`an actual time limit on how long it takes to
`become an expert in it.
`Q So you're not able to define the
`amount of time that the person of ordinary
`skill, the amount of experience the person
`of ordinary skill would need in prostate
`cancer.
`I couldn't -
`A
`Is that right?
`Q
`I couldn't make that definition.
`A
`Is there a volume of patients that
`Q
`the physician would need to see before they
`
`Page 23
`are a person of ordinary skill in the art,
`under your definition?
`A You know, there, again, it's a hard
`thing to define, I think everybody learns at
`a different pace, so I couldn't give you an
`absolute number, nor do I think the American
`Urologic Association would do that or any of
`the oncologie associations.
`Q So you don't know; is that correct?
`I don't think there's a definition.
`A
`Q So you don't know what the
`definition, the amount of experience, in
`terms of years or patients that the person
`of ordinary skill in the art would need,
`under your definition, to qualify as a
`person of ordinary skill?
`MS. MATERASSI: Objection.
`Mischaracterizes the witness'
`testimdny.
`A Yes, I - I couldn't give you an
`absolute timeframe.
`Q So I just want to clear the record
`a little bit -
`A No, I just - I really.
`-- this question.
`Q
`
`Page 24
`
`One second.
`I don't have an answer to the
`A
`question.
`Q So I just would like to confirm
`that you are not able to define in the
`number of years, the amount of experience
`the person of ordinary skill would need to
`have in treating prostate cancer; is that
`correct?
`A If I can elaborate a tiny bit. You
`know, as a - it may be different in other
`fields, but as a urologist, you spend a
`certain amount of time training, usually
`it's six years training in urology, and once
`you get out, your -- you take your boards,
`and at that point, if you pass your boards
`and you have the adequate experience, you
`are considered to be someone who can treat
`people with prostate cancer. So I think
`you're an ordinary person skilled in the art
`of treating prostate cancer after your
`residency and after you've taken your boards
`and have become board -certified by the
`American Urologic Association.
`Q And what if for the next ten years
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`THE MCS GROUP, INC.
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`6 (Pages 21 to 24)
`
`

`

`Scott Serels, M.D.
`August 22, 2016
`
`Page 25
`you didn't treat any prostate. cancer
`patients, would you continue to be a person
`of ordinary skill in the art for the
`treatment of prostate cancer as you have
`defined it?
`A Yes.
`And to elaborate further, during
`those - that period of time, you are taking
`continuing medical education credits and you
`are getting recertified in the board of
`urology, so there, again, if the American
`Urologic Association is the governing body
`and they deem you a person of ordinary skill
`to treat prostate cancer, then I think I --
`I would most often go by that.
`Q So under your definition, to
`continue to qualify to be a person of
`ordinary skill in the art, the physician
`would need to be recertified -
`A Correct.
`Q - in urology?
`A That would be fair to say.
`Q You don't have a Ph.D. or
`additional experience in pharmacology,
`biochemistry or a related discipline; is
`
`Page 26
`
`that correct?
`A That's correct.
`Q And you don't have a Ph.D. or
`additional experience in pharmaceutical
`sciences; is that correct?
`A Correct.
`Q And in determining the level of
`skill for this person of ordinary skill,
`what timeframe did you apply?
`MS. MATERASSI: Objection.
`Vague.
`A You know, there again, I think
`it's a -- if you are a board- certified
`urologist, you're a person of ordinary
`skill.
`Q Let me rephrase that question.
`You said in Paragraph 8, in your
`opinion, given the disclosure of the '438
`patent, "I consider a person of ordinary
`skill in the art at the time of filing of
`this patent to be someone," and then you
`gave a definition.
`So my question is: What time
`period did you apply when you determined the
`person of ordinary skill in the art?
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`MS. MATERASSI: Objection.
`Vague.
`A Yeah, I -- I guess, in order to be
`able to answer your question, I'd have to
`say, if at that time you were
`board -certified, at the time of filing of
`the patent, then I think you'd be considered
`to fall into the category that you're
`looking for.
`Q And what is the time of filing of
`the patent that you're applying?
`A The exact date, I don't know, but I
`think it was somewhere around 2006, perhaps,
`2004, but I'm not -- I'm not completely
`sure.
`Q So at this time, you don't recall?
`I don't recall the time the patent
`A
`was file -- filed.
`Q Okay. Now, the timeframe that
`you've given, when you define the person of
`ordinary skill in the art, did you
`incorporate - strike that.
`When you conducted your analysis
`from the perspective of an ordinary -a
`person of ordinary skill in the art, did you
`
`Page 28
`incorporate your current understanding of
`the art into your analysis?
`A Yes.
`Q So how did you - and so your
`current understanding would be the
`understanding you have today; is that
`correct?
`A Sure, yes.
`Q So in performing your analysis and
`providing your opinions in your declaration,
`did you use the perspective of a person of
`ordinary skill in the art?
`A Yes.
`Q Are you aware that under the law, a
`person of ordinary skill in the art is
`someone who thinks along conventional lines
`and has ordinary creativity?
`MS. MATERASSI: Objection.
`Legal conclusion.
`I was not aware of that specific
`A
`definition, but that seems reasonable.
`Q So - how did you get your
`understanding of - of the standard for a
`person of ordinary skill in the art?
`I mean, I'm sure at one time I read
`A
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`THE MCS GROUP, INC.
`
`7
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`(Pages 25 to 28)
`
`

`

`Scott Serels, M.D.
`August 22, 2016
`
`Page 29
`
`a definition of it, but I think it's
`self -explanatory.
`Q But you didn't consider that the
`skilled person is a person who thinks along
`conventional lines and has ordinary
`creativity; is that correct?
`I think -- thinks along
`A
`conventional lines makes sense, the -- the
`creativity aspect is -- is something that I
`didn't -- wouldn't normally associate with
`ordinary skill, but I think it's a
`reasonable way to describe it.
`Q So when you did your analysis, how
`did you separate your current understanding
`from what the perspective would be of the
`skilled person who would be thinking along
`conventional lines and have ordinary
`creativity?
`MS. MATERASSI: Objection.
`Vague, legal conclusion.
`A Yeah, I think as a physician, you
`know, I was thinking in terms of your
`ordinary physician treating prostate cancer
`and they would have the knowledge of, in the
`normal circumstance, certain things and that
`
`Page 30
`
`was how I thought, an ordinary skilled
`physician to relate that to whatever study
`they're working on, whether it be prostate
`cancer or something otherwise.
`Q But you're someone with more than
`ordinary skill; is that correct?
`A Well, I think I'm a practicing
`physician who treats prostate cancer, so
`I -- I hold all of my colleagues in high
`regard.
`Q That's not my question, sir.
`My question is: Are you someone
`with ordinary skill in the art?
`A Yes, I am.
`Q And are you someone with more than
`ordinary skill in the aft?
`A No, I'm someone with ordinary skill
`in the art.
`Q Okay. Are you aware that under the
`laws, a person of ordinary skill in the art
`is presumed to be aware of all of the
`pertinent prior art?
`MS. MATERASSI: Objection.
`Legal conclusion.
`A Yes.
`
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`Page 31
`Q Now, you cited certain literature
`in your declaration; correct?
`A Correct.
`Q Who provided you with the
`references that are cited in your
`- declaration?
`It was a combination. Some I
`A
`found, some other people found at the law
`firm that I was working with. We pooled our
`resources.
`If you could turn to pages -
`Q
`Page 3.
`A Page 3.
`Q Of your declaration, sir.
`You see there's a listing of
`"Materials Considered "?
`A Yes.
`Q And you see it continues on to
`Page 5?
`A Yes.
`Q Just looking at it, are you able to
`tell me which - if there are references on
`here that you identified independent of your
`attorneys?
`A Let's see. The first -- the
`
`Page 32
`
`second, third, certainly. The patent ones I
`did not.
`Q And what are you referring to, if
`you could just use the exhibit number to -
`A Oh, I'm sorry. It was -- it was
`1003, 1004, 1018, 1019 that tangentially
`relates to 1026. I mean, there are others,
`but I think there may have been a
`combination of - of how we came about on
`those.
`Q And what do you mean by "a
`combination "?
`I think, you know, that it was
`A
`almost simultaneous, that - that I may have
`found them at a similar time that somebody
`else did, so it may have brought -- been
`brought up independently.
`Q So your attorneys told you about
`them and you were aware of them; is that
`what you're saying?
`A Correct, that is what I'm saying.
`Q But you didn't independently
`identify them independent of your attorneys,
`is that right?
`MS. MATERASSI: Objection.
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`THE MCS GROUP, INC.
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`
`

`

`Scott Serels, M.D.
`August 22, 2016
`
`Page 33
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`Page 35
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`A
`
`Mischaracterizes his testimony.
`I think it was -- Pm sorry.
`I think it's a mixture, like 1025,
`you know, something that, you know, we had
`talked about before, I didn't actually have
`the -- you know, the actual reference, but I
`knew it existed in that, and we had talked
`about finding it. So I -- I think it was we
`came up with some of these references in
`combination. It was one of those things
`where I remembered there was an article
`written by - on this topic by this, you
`know, person, published around this time,
`and they were able to -- to find that
`article.
`Q But the - did your attorneys send
`you the O'Donnell reference that's 1003?
`A
`I think that -- that's one we came
`up with together, you know, that we both had
`realized it existed and -
`Q So they sent it to you?
`MS. MATERASSI: Objection.
`A Well, I think they may have pulled
`the reference, yes.
`Q And did you bring it up yourself or
`
`.
`
`Page 34
`did it - who - who mentioned it first?
`I think - I mean, the process, in
`A
`our situation, a lot of times we would do
`literature searches and find different
`articles and I wouldn't always have access
`to the actual article. sometimes there was a
`cost associated with it, sometimes you have
`to join a certain journal to get that
`article, so they were better in facilitating
`that. So I think abstract -wise, finding the
`articles may have been a group effort. Did
`they actually produce the article and mail
`it to me, yes, I think you're going to find
`that to be true in the article you
`mentioned.
`Just focusing on the O'Donnell
`Q
`reference, prior to this matter, were you
`aware of that reference? .
`A Well, no, that was something that
`we found when we were researching. We knew
`that certain things occurred and we wanted
`to find out supportive evidence for those
`things to occur and that's how an article
`like that came about.
`Q So prior to this matter, you were
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`not aware of the O'Donnell reference; is
`that correct?
`A Correct.
`Q And prior to this matter, you were
`not aware of the Gerber reference; is that
`correct?
`I mean, I -- the Gerber reference
`A
`has been referenced in other papers and in
`textbooks, so I was aware of that article.
`Did I know the exact title and where it was,
`no.
`Q Prior to this matter, when is the
`last time you had read an article that
`mentioned the Gerber reference?
`A
`It could have been years.
`Q And prior to this matter, were you
`aware - well, strike that.
`Prior to this matter, were you
`aware of the Auchus reference, that's AMG
`1026?
`A Well, in that -- the short answer
`is, yes. The longer answer is that that was
`something that was based on some of the
`other things we had found previously. So
`that was referenced in some of the other
`
`Page 36
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`articles that we had looked at, so --
`Q That's not my question, sir.
`So my question is: Prior to this
`matter -
`A Yeah.
`Q - were you aware of the Auchus
`reference?
`A Yes, in the sense that I was aware
`of the articles that had described that
`reference. I had not pulled that reference,
`but I knew there was a reference.
`Q Prior to this matter, when is the
`last time you read an article that mentioned
`the Auchus reference?
`I would say, probably within the
`A
`last year or two.
`Q Why?
`A Well, for some of the medications
`that we use, there are certain FDA
`requirements for things to be used in
`conjunction, and this article is part of the
`supportive evidence as to why that may
`occur.
`Q And what medicines are you speaking
`about?
`
`'
`
`THE MCS GROUP, INC.
`
`(Pages 33 to 36)
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`9
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`

`

`Scott Serels, M.D.
`August 22,. 2016
`
`Page 37
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`A Well, there's -- abiraterone is
`used in conjunction with a corticosteroid
`and in the description of why that's an FDA
`requirement, this article is described.
`THE VIDEOGRAPHER: Counsel, I'm
`sorry to interrupt, but when you
`lean against it, the wire is
`pulled, it makes a clicking sound,
`50 sorry.
`MS. DONOVAN: No problem.
`Q All right. If you could look at
`your declaration, please, sir.
`A Sure.
`Q At Paragraph 11. You have a
`discussion of the o