US Patent and Trademark Office
`_________________________________________
`
`Coalition for Affordable Drugs VI
`v.
`Celgene
`
`_________________________________________
`
`Video Deposition of:
`Dr. Jeffrey Fudin, Volume 1
`January 7, 2016
`
`Page 1 of 201
`
`Case IPR2015-01103
`
`CELGENE EXHIBIT 2061
`
`

`
`US Patent and Trademark Office
`CFAD v. Celgene
`
`Page 1
`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`-----------------------------------------------------
`COALITION FOR AFFORDABLE DRUGS VI, LLC,
`
`FINAL - January 7, 2016
`Dr. Jeffrey Fudin, Volume 1
`
`Page 3
`
` I N D E X
`
`WITNESS: JEFFREY FUDIN, VOLUME 1
`
`Examination by Mr. Chalson........................ 5
`
`Reporter's Certificate............................ 395
`
`Exhibit Index..................................... 396
`
` Petitioner,
`
`v.
`
`CELGENE,
`
` Patent Owner.
`
`Case No.: IPR2015-01092; IPR2015-01096;
`IPR2015-01102; IPR2015-01103
`-----------------------------------------------------
`
`VIDEO DEPOSITION OF
`Dr. Jeffrey Fudin, Volume 1
`January 7, 2016
`Dallas, Texas
`Lead: Andrew Chalson, Esquire
`Firm: Quinn Emanuel
`
`FINAL COPY
`JANE ROSE REPORTING 1-800-825-3341
`
`APPEARANCES
`
`FOR THE PETITIONER
` Sarah Spires, Esquire
` Parvathi Kota, Ph.D.
` Sadaf Abdullah, Esquire
` SKIERMONT DERBY LLP
` 2200 Ross Avenue, Suite 4800W
` Dallas, Texas 75201
` Telephone: 214.978.6613
`
`FOR THE PATENT OWNER
` Andrew Chalson, Esquire.
` Frank Calvosa, Esquire
` Quinn Emanuel Urquhart & Sullivan, LLP
` 51 Madison Avenue, 22nd Floor
` New York, New York 10010
` Telephone: 212.849.7000
`
` Gasber LaRosa, Esquire
` JONES DAY
` 222 East 41st Street
` New York, New York 10017
` Telephone: 212.326.3939
`
`JANE ROSE REPORTING
` Laurie Carlisle, CSR, CRR, RMR
` Joshua Nation, Videographer
`
`Page 2
`
`Page 4
` THE VIDEOGRAPHER: Good morning. This
`begins Videotape No. 1 in the deposition of
`Dr. Jeffrey Fudin in the matter of Coalition for
`Affordable Drugs VI versus Celgene. Today is
`January 7, 2016 and the time is 9:09 a.m. This
`deposition is taking place at the offices of
`Skiermont Derby, LLP. It was made at the request of
`Quinn Emanuel, New York.
` I'm Joshua Nation, the videographer.
`The court reporter is Laurie Carlisle with Jane Rose
`Reporting, New York, New York. Counsel, please
`identify yourselves and state whom you represent and
`please speak slowly for the court reporter.
` MS. SPIRES: Sarah Spires on behalf of
`Coalition for Affordable Drugs, and with me today is
`Parvathi Kota and Sadaf Abdullah. All three of us
`from the law firm of Skiermont Derby.
` MR. CHALSON: Andrew Chalson from
`Quinn Emanuel Urquhart & Sullivan in New York on
`behalf of Celgene Corporation. With me is Frank
`Calvosa, also from Quinn Emanuel, and Gasper LaRosa
`from Jones Day.
`
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`JANE ROSE REPORTING
`1-800-825-3341
`
`National Court-Reporting Coverage
`janerose@janerosereporting.com
`
`Page 2 of 201
`
`

`
`US Patent and Trademark Office
`CFAD v. Celgene
`
`FINAL - January 7, 2016
`Dr. Jeffrey Fudin, Volume 1
`
`Page 5
`
`Page 7
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` JEFFREY FUDIN,
`having been first duly sworn, testified as follows:
` EXAMINATION
`BY MR. CHALSON:
` Q. Good morning, sir.
` A. Good morning.
` Q. Can you please state your full name and
`home address for the record?
` A. Dr. Jeffrey Fudin, F-U-D-I-N. Home address
`is 34 Wakefield Court, Del Mar, New York 12054.
` Q. You understand you're under oath today,
`sir?
` A. I do.
` Q. Is there any reason you can't testify
`truthfully and accurately today?
` A. No.
` Q. Are you represented by counsel today, sir?
` A. Yes.
` Q. Who are you represented by?
` A. Represented by Skiermont and colleagues.
` MR. CHALSON: Do you agree with that?
` MS. SPIRES: Yes.
` MR. CHALSON: You didn't say when you
`announced yourself, so just making sure.
` Q. (By Mr. Chalson) Sir, have you been deposed
`
`Page 6
`
`before?
` A. Yes.
` Q. About how many times?
` A. Maybe five.
` Q. Can you just generally describe the context
`of those depositions, please?
` A. They were mostly cases either for or
`against various clinicians, either a pharmacist
`and/or physicians. Some of them were for the
`clinician; some of them were for the patient. There
`was one deposition in Toronto which was also a patent
`case.
` Q. Was the patent case involving a drug
`product?
` A. Yes, it was.
` Q. What product?
` A. OxyContin.
` Q. Did you represent -- or did you work with
`the brands or the generics?
` A. Generic.
` Q. Do you know specifically which generic?
` A. The company?
` Q. Yes.
` A. It was -- I believe it was Teva.
` Q. Do you recall generally what opinions you
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`offered in that case?
` A. Yes. In that particular case my opinions
`had to do with some part of a generic equivalent for
`an extended-release oxycodone.
` Q. Do you know if it related to the issue of
`infringement?
` A. Yes, it did.
` Q. Did it also relate to issues regarding
`validity of the patents in suit?
` A. I don't remember.
` Q. Did you testify at trial in that case?
` A. Well, no. In Canada it was a bit
`different, so the deposition was kind of like a
`trial.
` Q. That was the only testimony you gave in the
`case, the deposition?
` A. Yes.
` Q. Have you ever been deposed in connection
`with an IPR before?
` A. No.
` Q. Just generally cover some ground rules so
`we're on the same page. We're going to have a series
`of questions and answers. We need you to respond
`orally so the court reporter can take down your
`answer. Try not to speak over each other. You
`
`Page 8
`
`understand?
` A. Yes.
` Q. We can take a break anytime you'd like.
`I just ask that you don't take a break when a
`question is pending. Okay?
` A. Okay.
` Q. If I ask you a question and you answer, I'm
`going to assume you understood the question. Is that
`fair?
` A. Yes.
` Q. If you need clarification, please ask.
` A. Okay.
` Q. Do you have any patents in your name?
` A. Yes, I do.
` Q. Can you describe, please?
` A. I have a -- well, a patent pending. I
`don't have an actual patent. It's with regard to a
`product called Urintel.
` Q. What is Urintel?
` A. Urintel is a software application that
`helps clinicians to interpret urine drug screens.
` Q. Are you the sole inventor of that
`application?
` A. No.
` Q. How many others?
`
`JANE ROSE REPORTING
`1-800-825-3341
`
`National Court-Reporting Coverage
`janerose@janerosereporting.com
`
`Page 3 of 201
`
`

`
`US Patent and Trademark Office
`CFAD v. Celgene
`
`FINAL - January 7, 2016
`Dr. Jeffrey Fudin, Volume 1
`
`Page 9
`
`Page 11
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` A. There's two others.
` Q. Do you work with those individuals in a
`context outside of that patent or just in connection
`with the patent?
` A. Just in -- well, they're friends of mine.
`But in connection with the patent, yes.
` Q. Do you know where in the process that
`application is at this point?
` A. It's -- we secured patent pending, and I'm
`probably not going to have it patented.
` Q. Why do you say that?
` A. Because that's what my counsel advised me,
`not to patent it.
` Q. Okay. So you mean you're probably not
`going to continue with the prosecution?
` A. Correct.
` Q. Have you received any feedback from the
`Patent Office relating to that filing?
` A. Just the paperwork for a patent pending.
` Q. So they accepted the filing; and other than
`that, you haven't heard?
` A. Correct.
` Q. I think you mentioned before that you
`consider a clinician to be a pharmacist or a
`physician. Is that right?
`
`Page 10
`
` A. Yes.
` Q. Can you just generally describe what a
`clinician is, in your opinion?
` A. Clinician is a person that takes care of
`patients usually directly either in a clinic or in a
`patient setting. Somebody that has direct patient
`care.
` Q. Do you think all pharmacists are
`clinicians?
` A. Yes.
` Q. You understand that the deposition today
`concerns sworn declarations that you submitted in
`connection with four separate inter partes review at
`the Patent Office?
` A. I do.
` Q. And those four separate IPRs relate to
`two patents owned by Celgene, correct?
` A. Correct.
` Q. What did you do to prepare for the
`deposition today?
` A. How far back does the question go?
` Q. Whatever you consider to be preparation for
`this deposition, I'd like you to describe it for the
`record.
` A. Okay. I'll start with the most recent and
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`I'll go back, if that's okay.
` Q. Fair enough.
` A. Okay. So in the last day I sat with
`counsel. We discussed various documents, all of
`which I presume you have. Before that, I spent time
`also reviewing the documents, which required reading
`articles, searching for some articles, re-reading
`articles, looking at the various patents, at the --
`that are in question today, looking at some other
`patents. For example, the Cunningham patent. Before
`that, many telephone conversations, many writings in
`preparation for my -- what's it called, my -- my
`report. Okay. And then before that, communications.
`The first communication was from, I believe,
`Paul Skiermont, who contacted me by e-mail. And
`that's about it. I mean, mostly computer searches
`and reviewing documents.
` Q. All right. Let's unpack that a little bit.
`I think you first said you reviewed documents?
` A. Yes.
` Q. And you suggested that you thought I would
`have everything you reviewed. Why do you say that?
` A. Well, I don't know that.
` Q. Did you review anything that was not
`submitted to the Patent Office, either with your
`
`Page 12
`
`declaration or with the petitions that your
`declaration supports?
` A. Repeat that question.
` Q. Sure. I'm just trying to understand if, in
`preparing for your deposition, you reviewed any
`materials that were not submitted to the
`Patent Office, either with your declaration or with
`the petitions that were filed.
` A. Okay. I have no idea.
` Q. You didn't look to see whether or not it
`was part of the record as it exists today?
` A. No.
` Q. Do you recall specifically everything that
`you reviewed?
` A. Probably not.
` Q. You also said you met with attorneys.
`I think you said that was yesterday?
` A. Yes.
` Q. Did you meet with them all day?
` A. I met with them -- no. About half a day
`yesterday.
` Q. Does that include the attorneys who are
`here today?
` A. It does.
` Q. Were there any others present?
`
`JANE ROSE REPORTING
`1-800-825-3341
`
`National Court-Reporting Coverage
`janerose@janerosereporting.com
`
`Page 4 of 201
`
`

`
`US Patent and Trademark Office
`CFAD v. Celgene
`
`FINAL - January 7, 2016
`Dr. Jeffrey Fudin, Volume 1
`
`Page 13
`
`Page 15
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` A. No.
` Q. Did you talk to anyone else in preparation
`for the deposition today?
` A. No.
` Q. Have you ever spoken to anyone who's
`affiliated with CFAD, the Coalition for Affordable
`Drugs?
` A. No. Not that I know of.
` Q. Did you ever speak to Kyle Bass about these
`matters?
` A. I don't know who Kyle Bass is.
` Q. Fair enough. Have you ever spoken to Erich
`Spangenberg about these matters?
` A. Erich Spangenberg sent me an e-mail and,
`I think, initially asked me if I would be interested
`to speak with him about being an expert. I think I
`spoke to him once, and that's probably it.
` Q. Do you recall what he said in the e-mail
`that he sent to you?
` A. No, I don't. It's a long time ago.
` Q. Do you still have a copy of that e-mail?
` A. I don't know.
` MR. CHALSON: To the extent you do,
`Counsel, we'd request production of that e-mail.
` Q. (By Mr. Chalson) You said you reviewed the
`
`Page 14
`
`patents that are at issue in this proceeding?
` A. Yes.
` Q. These proceedings, I should say. Right?
` A. Yes.
` (Exhibit 1001-case 1092 and 1001-case 1093 marked)
` Q. Sir, I'm handing you copies of the '501 and
`the '720 patents that are the two patents at issue in
`these proceedings. And I'll just note for the record
`that the '501 patent is Exhibit 1001 in Case 1092,
`Exhibit 1003 in Case 1096, Exhibit 1003 in Case 1102,
`and Exhibit 1003 in Case 1103. And the '720 patent
`is Exhibit 1001 in all three of the cases -- 1096,
`1102 and 1103. Do you have those in front of you,
`sir?
` A. Yes, I do.
` Q. Your understanding is that these are the
`two patents that are owned by Celgene that are at
`issue in this proceeding?
` A. That's my understanding.
` Q. If you could just look at the '501 patent
`for a moment, please. The title of that patent is
`"Methods for Delivering a Drug to a Patient while
`Preventing the Exposure of a Fetus or Other
`Contraindicated Individual to the Drug," correct?
` A. Correct.
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` Q. And the title of the '720 patent is
`"Methods for Delivering a Drug to a Patient while
`Avoiding the Occurrence of an Adverse Side Effect
`Known or Suspected of Being Caused by the Drug,"
`correct?
` A. Correct.
` Q. You would agree with me, right, that both
`of these patents focus on avoiding adverse events
`associated with drug products?
` MS. SPIRES: Object to form.
` A. Yes.
` Q. (By Mr. Chalson) You'd agree in general
`that the patents aren't broadly focused on
`pharmaceutical prescriptions, right?
` A. I'm not really sure what the question is
`asking.
` Q. Sure. I just want to understand -- or
`I want to get your understanding of what is really
`the subject matter of the patents. And I'm asking,
`in your opinion, the patents don't focus broadly on
`pharmaceutical prescriptions. Generally, instead,
`they focus on mitigating and avoiding adverse events
`associated with potentially dangerous drugs, right?
` MS. SPIRES: Object to form.
` A. I'm not sure what you're asking, if you're
`
`Page 16
`asking me -- you said prescription drugs. I don't
`really know what you're getting at.
` Q. (By Mr. Chalson) Well, I think you agreed
`with me a moment ago that the patents focus on
`mitigating and avoiding adverse events associated
`with potentially dangerous drugs, right?
` A. That I agree with, yes.
` Q. And in general, the concept of
`pharmaceutical prescriptions is much broader than
`that. Right?
` MS. SPIRES: Object to form.
` A. I really don't know what you're asking me.
` Q. (By Mr. Chalson) Well, okay. So you know
`what a pharmaceutical prescription is, right?
` A. Yes.
` Q. And there are -- there are documents out
`there you could look up if you wanted to learn all
`about pharmaceutical prescriptions, right?
` A. Yes.
` Q. These particular patents have a narrower
`focus than the broad realm of pharmaceutical
`prescriptions, right? They focus on what we've been
`discussing, which is avoiding adverse events
`associated with potentially dangerous drugs, correct?
` A. Okay, yes.
`
`JANE ROSE REPORTING
`1-800-825-3341
`
`National Court-Reporting Coverage
`janerose@janerosereporting.com
`
`Page 5 of 201
`
`

`
`US Patent and Trademark Office
`CFAD v. Celgene
`
`FINAL - January 7, 2016
`Dr. Jeffrey Fudin, Volume 1
`
`Page 17
`
` MS. SPIRES: Object to form.
` Q. (By Mr. Chalson) Sorry. You said yes?
` A. Yes.
` Q. You would agree that all of the claims of
`the '501 patent are limited to teratogenic drugs,
`right?
` A. I don't know. I'd have to look at it.
` Q. Feel free to take a look at it.
` A. Okay. Yes.
` Q. So you -- just to make the record clear,
`you agree that all the claims of the '501 patent are
`limited to teratogenic drugs, correct?
` A. Yes.
` Q. And feel free to take a look if you'd like,
`but at least some of the claims of the '720 patent
`are also limited just to teratogenic drugs, right?
` A. '720 is not limited only to teratogenic
`drugs.
` Q. Some of the claims are limited just to
`teratogenic drugs, right?
` A. Some of the claims -- some of the claims
`are specific to teratogenic drugs, but I would not
`use the word "limited" because if you use the word
`"limited," then it wouldn't include others.
` Q. Sure. So that's actually exactly my
`
`Page 18
`
`question. Some of the claims -- and I'm
`intentionally using the word "limited" here. Some of
`the claims are limited just to teratogenic drugs,
`right -- not all the claims just some of the claims?
` A. Yes. Yes.
` Q. In your opinion, what is a teratogenic
`drug?
` A. A teratogenic drug is a drug that can harm
`a fetus or kill a fetus.
` Q. Would you agree that it's any agent that
`can cause a malformation in an embryo?
` A. Yes.
` Q. I mean, the word "teratogen" literally
`means monster-maker if you translate from the Latin,
`right?
` A. That is correct.
` Q. When you started your analysis of the
`obviousness issue in these cases, did you start with
`the claims and then try to figure out where in the
`cited references the claimed elements were discussed?
` A. I don't remember.
` Q. Did you research and obtain the references
`yourself?
` A. Some of them.
` Q. What about the rest?
`
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` A. Some of them I was asked to review, and
`some of them I pulled myself.
` Q. Do you recall what came first? Were you --
`did it start with counsel handing you some references
`or the other way around?
` A. I don't remember.
` Q. When you say some of them you were asked to
`review, you mean by counsel?
` A. Yes.
` Q. You would agree that, in general, all
`pharmaceutical prescriptions are regulated, right?
` A. Yes.
` Q. And that could be at the Federal level or
`the State level or even an institutional level,
`right?
` A. Correct.
` Q. When you were preparing for your
`deposition, did you review your declarations?
` A. Yes, I did.
` Q. How about the petitions that were filed by
`the Coalition? Did you review those?
` A. Yes.
` Q. Did you review Celgene's initial responses
`to the petitions?
` A. Celgene's initial responses?
`
`Page 20
` Q. They're technically called the Patent Owner
`Preliminary Response, if that helps.
` A. Can you just clarify what you mean by that,
`the initial responses? I saw what was filed.
`I didn't see what was -- if there was any preparation
`before it was filed.
` Q. Sure. So maybe I can ask you a different
`question. Did you review everything that's been
`filed with the Patent Office up to this point?
` A. Yes, I have.
` Q. So that includes responses submitted by
`Celgene, right?
` A. Yes.
` Q. And it would also include decisions that
`had been rendered up to this point by the
`Patent Office?
` A. Yes.
` Q. Did you look at all of the exhibits that
`were submitted by the petitioners, yourself and
`Celgene when you prepared for your deposition?
` A. Yes.
` Q. Aside from those documents, sitting here
`today, do you recall reviewing anything else in
`preparation for your deposition?
` A. No.
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`JANE ROSE REPORTING
`1-800-825-3341
`
`National Court-Reporting Coverage
`janerose@janerosereporting.com
`
`Page 6 of 201
`
`

`
`US Patent and Trademark Office
`CFAD v. Celgene
`
`Page 21
` Q. Just so we're clear, did you review all of
`the documents that were submitted to the
`Patent Office or just the documents that you cited in
`your declarations?
` A. I really don't know if I reviewed all of
`them.
` Q. Did you pull documents yourself to review
`for your deposition, or were they provided to you by
`counsel?
` A. Both.
` Q. Sitting here today, though, you don't
`recall one way or the other if you had looked at
`everything that you had cited?
` A. Oh, I looked at everything that I cited for
`sure.
` Q. You're just not sure if you looked at
`everything else?
` A. Correct.
` (Exhibit 1014 marked)
` Q. I'm handing you a copy of the CV that's
`attached to your declarations. This is Exhibit 1014
`in Case 1092; Exhibit 1022 in Case 1096; Exhibit 1028
`in the other two cases, 1102 and 1103.
` Is this a current copy of your CV,
`sir?
`
`Page 22
`
` A. It is not.
` Q. What's changed between this version of your
`CV and whatever you believe to be the current
`version?
` A. I think there's a couple of typos that I
`corrected. Several publications and several post --
`several, I don't know -- yeah, a few poster
`presentations as well.
` Q. Any typos that are substantive that would
`change the meaning of anything you see in here?
` A. No.
` Q. Are there any publications or presentations
`that you think are particularly relevant to the
`subject matter of these cases?
` A. No.
` Q. If I wanted a current copy of your CV,
`I could pull that off your website. Is that correct?
` A. Correct.
` Q. You update that regularly?
` A. Pretty much, yes.
` Q. You obtained a BS in pharmacy in 1981,
`correct?
` A. That's correct.
` Q. And a Pharm.D in 1988?
` A. 1998.
`
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`FINAL - January 7, 2016
`Dr. Jeffrey Fudin, Volume 1
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`Page 23
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` Q. 1998, I'm sorry. What did you do in
`between?
` A. Wow. Okay. So I graduated in 1981. After
`that, I worked briefly in a retail store called
`Ace Drug Company. I don't think that's on my CV. It
`was relatively -- it was a long time ago. Then I
`took a fellowship position at Upstate Medical Center
`in Syracuse, doing oncology and hematology. I was
`there for a few months and then --
` Q. Sorry, I don't mean to interrupt but I
`think there's a lot covered in these 17 years. So if
`you don't mind, I just want to ask you a question.
` A. Okay.
` Q. You did a fellowship in oncology and
`hematology?
` A. Yes.
` Q. Why those fields?
` A. I think that -- well, the fields interested
`me, and I really wanted to learn more about
`hematology and oncology.
` Q. At the time were there any particular
`cancer drugs that you dealt with particularly?
` A. There was a lot of them.
` Q. Was there anything specific, or was it just
`a broad array of HEM/ONC drugs?
`
`Page 24
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` A. A broad array of HEM/ONC, yes.
` Q. Sorry. Go ahead.
` A. Okay. So I did hematology and oncology.
`I worked in a clinic. After that, I worked in a
`pharmacy called Kress Pharmacy. I think it was
`K-R-E-S-S. In Syracuse. I stayed there for a short
`time in Syracuse, and then I took a job at a hospital
`in Newburgh, New York -- no, it wasn't Newburgh. It
`was Cornwall, New York. Cornwall Hospital. And I
`worked there as a staff pharmacist for I think seven
`or eight months. And after that, I took a job at the
`Stratton VA Hospital, and I've been there ever since.
` Q. I'm sorry, were you finished?
` A. Well, I'll go on as long as you want me to.
` Q. If you feel your answer is complete, you
`can stop. If not, just go ahead.
` A. Well, I think, you know, it may be
`important for this case to tell you a little bit
`about what I did when I was at the VA.
` Q. I think we're going to cover that.
` A. Okay. Sure.
` Q. Let's go through that, and then if you'd
`like to add anything, you can.
` So under your experience in your CV
`you list the VA position that you've held since --
`
`JANE ROSE REPORTING
`1-800-825-3341
`
`National Court-Reporting Coverage
`janerose@janerosereporting.com
`
`Page 7 of 201
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`

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`US Patent and Trademark Office
`CFAD v. Celgene
`
`FINAL - January 7, 2016
`Dr. Jeffrey Fudin, Volume 1
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`Page 25
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`Page 27
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`actually it looks like, according to this, since
`1982?
` A. Yes.
` Q. But you don't list a position here. Can
`you tell me what your position is?
` A. Now?
` Q. I suppose it changed throughout. Is that
`what's listed underneath in the CV? I'm on page 4.
` A. Okay. The CV got so long, I started to
`pare it down a little bit. So I mean this is all
`correct, but I dropped off a lot of the specific
`things that I did in the earlier years.
` Q. Fair enough. But in terms of what your
`actual position was at any given point in time, the
`bullet points under the first line of your
`experience, that's all correct?
` A. That is correct, yes.
` Q. So currently you're the director of a
`pharmacy pain residency at the Samuel Stratton
`Department of Veteran Affairs Medical Center?
` A. I am, yes.
` Q. You also have several -- I'll let you
`characterize what they are, but the letters after
`your title on the cover page of the CV are listed,
`and so we've already covered the Pharm.D and the BS.
`
`Page 26
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`What is the DAAPM?
` A. Diplomate of the American Academy of
`Pain Management.
` Q. And what is that?
` A. It's a certification status with that
`organization, which requires that you have a certain
`number of hours in pain management with direct
`patient care and that you pass an exam. And
`depending on your degree level would depend on where
`you fall as opposed -- you know, like diplomate
`versus -- I don't even know what the other terms are,
`but they have different terms for different education
`levels.
` Q. Okay. The next is FACCP?
` A. That stands for Fellow of the American
`academy -- I mean of the American College of Clinical
`Pharmacy. That is something that you need to be --
`you need to apply for. It's based on your years of
`experience, your contribution to the profession over
`many years. You have to have a Pharm.D for a certain
`number of years. At least you did. I don't know if
`that's changed. I don't think it has. And it goes
`to a board of people who review your application,
`review everything you've done. It's pretty intense
`actually, and so that's what that is.
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` And then FASHP is a Fellow of the
`American Society of Health Systems Pharmacists.
`That, I believe, is the largest pharmacy organization
`in the world. Originally they focused on hospital
`pharmacy, but several years ago they switched their
`name to health systems pharmacy, realizing that the
`role of pharmacists has broadened beyond hospital.
`And that's similar to FCCP. Also you have to apply,
`it goes to a board, they look at your lifetime
`achievements, so on and so forth.
` Q. You don't list a Ph.D., do you?
` A. I do not.
` Q. You haven't earned a Ph.D. in any subject?
` A. I have not.
` Q. And you don't list an MD. You're not a
`medical doctor, right?
` A. I am not.
` Q. Do you have any formal education in
`pharmaceutical risk management?
` A. Continuing education, ongoing education in
`risk management. The entire field is based around
`risk management.
` Q. Sure. I guess I'm asking about formal
`education in connection with any of the degrees that
`you have?
`
`Page 28
`
` A. No.
` Q. Before we start talking about some other
`things related to your experience, we talked a little
`while ago about the patents and what they relate to.
`We also talked about how all pharmaceuticals are
`regulated in one way or the other, right?
` A. Yes.
` Q. You would agree the patents again are more
`focused than just the general idea of regulating
`prescriptions, right?
` A. Yes.
` Q. So you agree that you're not a medical
`doctor, but you go by Dr. Fudin. Can you explain
`that, please?
` A. Well, I'm not really sure what you're
`asking. Can I explain what a Pharm.D is? Is that
`what you're asking me?
` Q. Is that the reason, because you've earned a
`Pharm.D?
` A. Yes, it's a doctor of pharmacy so they call
`me Dr. Fudin, just like a podiatrist or whatever.
` Q. Sure. Just asking to make a record here.
` A. Okay.
` Q. Is it your understanding that anyone who
`earns a Pharm.D is a doctor?
`
`JANE ROSE REPORTING
`1-800-825-3341
`
`National Court-Reporting Coverage
`janerose@janerosereporting.com
`
`Page 8 of 201
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`

`
`US Patent and Trademark Office
`CFAD v. Celgene
`
`FINAL - January 7, 2016
`Dr. Jeffrey Fudin, Volume 1
`
`Page 29
` A. Anybody that earns a Pharm.D can use the
`title "doctor."
` Q. Do they typically do that, in your
`experience?
` A. I think it depends on the person, really,
`and the environment that they're in.
` Q. You have a website that you run that has
`on it information relating to your professional and
`personal life. Do you agree with that?
` A. I agree.
` Q. And that website is PainDr.com, right?
` A. Right.
` Q. Do you consider yourself to be a pain
`doctor?
` A. I think it depends on what your definition
`of a pain doctor is.
` Q. Well, I guess that's why I'm asking. Have
`you ever had any patients who think that you're a
`medical doctor when you tell them you're a pain
`doctor?
` MS. SPIRES: Object to form.
` A. Well, I don't tell them that I'm a medical
`doctor. I don't tell them I'm a pain doctor. When I
`meet a patient for the first time, I introduce myself
`as Dr. Fudin, and I say I am a doctor of pharmacy.
`
`Page 30
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` Q. (By Mr. Chalson) Your website is
`PainDr.com, though, right?
` A. Yes.
` Q. You've never had a patient come up to you
`and be confused as to whether you are a medical
`doctor or not?
` MS. SPIRES: Object to form.
` A. I don't know; but if you want to know more
`about that, I actually wrote a blog that topic.
` Q. (By Mr. Chalson) I'm just curious if you
`have a recollection of a patient ever raising the
`issue with you. If not, that's fine.
` A. I think there's been discussions before.
`I can't -- I can't put my finger on it.
` Q. Okay. If we can go back to your CV,
`I think we were on page 4.
` A. Okay.
` Q. If you look at the bullets at the bottom
`where you start talking about your specific patient
`care activities?
` A. Yes.
` Q. The third bullet from the bottom begins by
`stating that you prescribe medications. Do you see
`that?
` A. I do.
`
`Page 31
` Q. Is it generally permitted for pharmacists
`to prescribe medications under Federal and State law?
` A. Yes.
` Q. All pharmacists?
` A. Well, I'm not sure. Can you be more
`specific?
` Q. Well, I guess that's what I'm trying to
`understand is really what your opinion is on this.
`If I have a BS in pharmacy, can I write a scrip right
`now for you on my pad and say, Here, go take this
`medicine. Go get this prescription filled?
` A. Generally not.
` Q. And if I have a Pharm.D, the same is true,
`right, I can't just -- I don't have a pad on which
`I can write the prescription that you can go fill as
`a patient?
` A. Okay. So it's a more complex answer. I'm
`happy to answer it if you give me the latitude to do
`that.
` First of all, there are very few
`pharmacists anymore that are writing prescriptions on
`pads. It's mostly electronic. That's No. 1.
` No. 2, I would say the majority of
`states, if not all states at this point, do allow
`pha