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`P A R P H A R M A C E U T I C A L , )
`
`I N C . , W O C K H A R D T B I O A G )
`
`a n d A M N E A L )
`
`P H A R M A C E U T I C A L S L L C , ) N o .
`
` P e t i t i o n e r s , ) I P R 2 0 1 5 - 0 0 5 4 8
`
` v s . )
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`J A Z Z P H A R M A C E U T I C A L S , )
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`I N C . , )
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` P a t e n t O w n e r . )
`
`_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ )
`
` C O N T I N U E D D E P O S I T I O N U N D E R O R A L E X A M I N A T I O N
`
` O F
`
` B R Y A N B E R G E R O N , M D , F A C M I
`
` J a n u a r y 2 2 , 2 0 1 6
`
` N e w Y o r k , N e w Y o r k
`
` R E P O R T E D B Y : D A N A N . S R E B R E N I C K , C R R C L R
`
`GregoryEdwards, LLC | Worldwide Court Reporting
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`
`JAZZ EXHIBIT 2012
`Amneal Pharms. et al. (Petitioners) v. Jazz Pharms., Inc. (Patent Owner)
`Case IPR2015-01903
`
`
`
`Bryan Bergeron, MD, FACMI - Volume II - January 22, 2016
`
`Page 248
`
`2 (Pages 248 to 251)
`
`Page 250
`
`1 A P P E A R A N C E S (continued)
`
`2 3
`
` JONES DAY
`4 BY: JOHN V. BIERNACKI, ESQ.
`5 North Point
`6 901 Lakeside Avenue
`7 Cleveland, Ohio 44114-1190
`8 216.586.7747
`9 jvbiernacki@jonesday.com
`10 Counsel for the Patent Owner,
`11 Jazz Pharmaceuticals
`12
`13
`14 QUINN EMANUEL URQUHART &
`15 SULLIVAN LLP
`16 BY: FRANK CALVOSA, ESQ.
`17 EVANGELINE SHIH, ESQ.
`18 51 Madison Avenue, 52nd Floor
`19 New York, New York 10010
`20 212.849.7569
`21 Evangelineshih@quinnemanuel.com
`22 frankcalvosa@quinnemanuel.com
`23 Counsel for the Patent Owner,
`24 Jazz Pharmaceuticals, Inc.
`25
`
` Continued Transcript of the
` deposition of BRYAN BERGERON, MD,
` FACMI, called for Oral Examination in
` the above-captioned matter, said
` deposition taken pursuant to United
` States Patent and Trademark Office
` rules and regulations, by and before
` DANA N. SREBRENICK, a
` Federally-Approved Certified Realtime
` Reporter, a New Jersey Certified Court
` Reporter, a Certified Livenote
` Reporter, and a Notary Public for the
` State of New York, at the offices of
` QUINN EMANUEL URQUHART & SULLIVAN LLP,
` 51 Madison Avenue, New York, New York
` 10010, commencing at 9:30 a.m.
`
` - - -
`
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`Page 249
`
`Page 251
`
` - - -
` BRYAN BERGERON, MD, FACMI,
` 27 Stearns Road, Brookline,
` Massachusetts 02406, after having been
` duly sworn, was examined and testified
` as follows:
` - - -
` CONTINUED EXAMINATION BY MR. BERMAN:
` - - -
`
` Q. Q. Good morning, Dr. Bergeron.
`
` Q. Q.
`
` A. A. Good morning.
`
` A. A.
`
` Q. Q. Let's pick up where we left off
`
` Q. Q.
` yesterday in your report, Exhibit 2047 for
` the '059 IPR. Let's go to page 20 at
` paragraph 46. Are you there?
`
` A. A. I'm there, yes, yes.
`
` A. A.
`
` Q. Q. The first sentence says, "Based
`
` Q. Q.
` on the ACA disclosures, it is my opinion
` that a POSA would have understood that
` generating data for any possible
` investigations and prosecutions is not the
` same as generating periodic reports." Do
` you see that?
`
` A. A. I do.
`
` A. A.
`
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`1 A P P E A R A N C E S
`
`23
`
` ARENT FOX
`4 BY: RICHARD J. BERMAN, ESQ.
`5 1717 K Street, NW
`6 Washington, DC 20036-5342
`7 202.857.6000
`8 Richard.berman@arentfox.com
`9 Counsel for the Petitioner,
`10 Par Pharmaceutical
`11
`12 MADDOX EDWARDS, PLLC
`13 BY: MATTHEW C. RUEDY, ESQ.
`14 1900 K Street NW - Suite 725
`15 Washington, DC 20006
`16 202.830.0779
`17 mruedy@meiplaw.com
`18 Counsel for the Petitioner,
`19 Amneal Pharmacuetical
`20
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`24
`25
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`GregoryEdwards, LLC | Worldwide Court Reporting
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`Page 2 of 30
`
`
`
`Bryan Bergeron, MD, FACMI - Volume II - January 22, 2016
`
`Page 252
`
` BRYAN BERGERON, M.D.
`
` Q. Q. And that's because the
`
` Q. Q.
` information provided in such a manner is
` done so upon request; is that right?
`
` A. A. That's right.
`
` A. A.
`
` Q. Q. Going on to -- towards the end
`
` Q. Q.
` of that paragraph, the last sentence, "It
` is my opinion that the ACA materials only
` disclose generating retrospective ad hoc
` reports to aid in diversion investigations
` once those investigations have already
` been initiated. The ACA materials were
` not disclosed, taught or suggested the
` claimed prospective periodic reports that
` will aid the central pharmacy in
` evaluating potential diversion patterns."
` Do you see that?
`
` A. A. I do, yes.
`
` A. A.
`
` Q. Q. Let's take that second sentence
`
` Q. Q.
` first. When you say "the claimed
` prospective periodic reports," what do you
` mean?
`
` A. A. I think I'm referring to the
`
` A. A.
` claimed reports in the patent, in other
` words, the claims.
`
`Page 253
`
` BRYAN BERGERON, M.D.
` Q. Q. Does the word "prospective"
`
`
` Q. Q.
` appear in the claims?
`
` A. A. I don't recall. I can check. I
`
` A. A.
` assume you probably checked.
`
` Q. Q. I submit to you it does not. It
`
` Q. Q.
` does not appear in the claim.
`
` A. A. I'll accept that.
`
` A. A.
`
` Q. Q. Since it does not appear in the
`
` Q. Q.
` claims, what's your basis that the claims
` are limited to prospective periodic
` reports?
`
` A. A. I'm not saying it's limited,
`
` A. A.
` first of all. And I'm talking about
` periodic reports, and so by nature,
` reports -- a periodic report I talked
` about earlier is something that occurs --
` the exact wording here -- at regular
` frequencies or intervals as opposed to
` intermittently or upon request.
` So, for example, a weekly report
` would be weekly. So it's a preset
` frequency. So if I expect a weekly
` report, I would see it next week, the
` following week, the week after that, the
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`3 (Pages 252 to 255)
`
`Page 254
`
` BRYAN BERGERON, M.D.
` week after that.
`
` Q. Q. And so do you --
`
` Q. Q.
`
` A. A. So that's going into the future.
`
` A. A.
`
` Q. Q. So when you use the term
`
` Q. Q.
` "prospective," you're just meaning
` sometime in the future?
` MR. CALVOSA: Objection.
` Mischaracterizes.
`
` A. A. I mean that's part of a periodic
`
` A. A.
` report. So a -- a periodic report is what
` is claimed here. So, for example, a
` weekly report is a report given every
` week, not every -- not once a week and it
` skips three weeks, another week and two
` weeks and another week. But it's weekly,
` so it's prospective.
` I can expect that at a set
` interval, at regular frequencies or
` intervals, as opposed to intermittently or
` upon request. So that regular frequency
` in that case would be a week, so that's
` looking -- I can expect a weekly report
` six months from now in the system.
` If I'm established -- if I have
`
`Page 255
`
` BRYAN BERGERON, M.D.
` a weekly report, I can look ahead a month
` and know there will be a weekly report
` there on the week. That's the meaning in
` the context of "prospective."
` BY MR. BERMAN:
`
` Q. Q. When you're using the term
`
` Q. Q.
` "prospective," you mean prospective in
` time?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. Okay. And in your opinion the
`
` Q. Q.
` claimed prospective reports aid the
` central pharmacy in evaluating potential
` diversion patterns, correct?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. So what are some examples of
`
` Q. Q.
` prospective reports, according to the
` patent?
`
` A. A. So if you look at figure 13-A in
`
` A. A.
` the patent, these reports, for example, on
` the figure 13-A, the first report, the
` first activity report, RX by zip, new and
` total, so the first entry has associated
` with it weekly, monthly, and quarterly
` reports. And the title of that column in
`
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`Page 3 of 30
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`
`
`Bryan Bergeron, MD, FACMI - Volume II - January 22, 2016
`
`Page 256
`
` BRYAN BERGERON, M.D.
` the right is "The Report Frequency," so I
` would expect that -- the RX by zip, new
` and total weekly, monthly and quarterly
` reports.
`
` Q. Q. Is a report tracking
`
` Q. Q.
` prescriptions by physician a prospective
` report in your opinion?
`
` A. A. Can you point to a specific
`
` A. A.
` spot? Are you pointing to the second
` entry, what are you asking me?
`
` Q. Q. I'm not pointing to the second
`
` Q. Q.
` entry. I'm just asking if that would be a
` prospective report in your opinion?
`
` A. A. It would depend.
`
` A. A.
`
` Q. Q. On what?
`
` Q. Q.
`
` A. A. Is it a weekly report?
`
` A. A.
`
` Q. Q. I'm asking whether a report
`
` Q. Q.
` tracking prescriptions by physician would
` be a prospective report in your opinion?
` MR. CALVOSA: Objection to form.
`
` A. A. I would need to know more. I
`
` A. A.
` don't have enough information. It
` depends, so I cannot make a decision based
` on what you've told me.
`
`Page 257
`
` BRYAN BERGERON, M.D.
` BY MR. BERMAN:
`
` Q. Q. So let's look at some of these
`
` Q. Q.
` other reports on 13-A. One area of
` reports listed here is call center. Do
` you see that?
`
` A. A. Call center, yes, middle of the
`
` A. A.
` 13-A.
`
` Q. Q. Yeah. And you see that there is
`
` Q. Q.
` several entries there under the call
` center, number of calls received, number
` of calls initiated, number of calls
` answered in 30 seconds, et cetera,
` percentage of calls answered in 30
` seconds, number of abandoned calls,
` percentage of abandoned calls and average
` call length. Do you see all of those?
`
` A. A. I see those, yes.
`
` A. A.
`
` Q. Q. And each of those is associated
`
` Q. Q.
` in figure 13-A with a monthly report,
` correct?
`
` A. A. I see that, yes.
`
` A. A.
`
` Q. Q. So would that be a prospective
`
` Q. Q.
` report in your opinion?
` MR. CALVOSA: Objection. Form.
`
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`4 (Pages 256 to 259)
`
`Page 258
`
` BRYAN BERGERON, M.D.
`
` A. A. Well, I mean, I understand 13-A
`
` A. A.
` to illustrate reports at a -- I'm sorry --
` periodic reports, and a period of these
` reports would be monthly.
` BY MR. BERMAN:
`
` Q. Q. So is that prospective in your
`
` Q. Q.
` opinion?
`
` A. A. The reporting is prospective.
`
` A. A.
`
` Q. Q. Okay. And do the call center
`
` Q. Q.
` reports aid the central pharmacy in
` evaluating potential diversion patterns in
` your opinion?
`
` A. A. It depends.
`
` A. A.
`
` Q. Q. It depends on what?
`
` Q. Q.
`
` A. A. It depends on the situation. I
`
` A. A.
` haven't -- I haven't studied or opined on
` the specific entries in this table and how
` they apply to potential use by
` third-parties.
`
` Q. Q. So you don't have an opinion as
`
` Q. Q.
` to whether all the activity reports in
` figure 13-A aid the central pharmacy in
` evaluating potential diversion patterns?
` MR. CALVOSA: Objection.
`
`Page 259
`
` BRYAN BERGERON, M.D.
` Mischaracterizes.
`
` A. A. What I said is I haven't studied
`
` A. A.
` each individual entry in terms of its
` potential for that use. It's not
` excluding some of this for that use.
` BY MR. BERMAN:
`
` Q. Q. So not all of the activity
`
` Q. Q.
` reports on 13-A would aid the central
` pharmacy in evaluating potential diversion
` patterns?
`
` A. A. Again, I haven't performed that
`
` A. A.
` analysis.
`
` Q. Q. You have no opinion on that?
`
` Q. Q.
` MR. CALVOSA: Objection.
` Mischaracterizes.
`
` A. A. Well, my opinion is that I
`
` A. A.
` haven't done that analysis. My opinion on
` this use -- I offer this 13-A in response
` to your question about the nature of these
` periodic reports, prospective periodic
` reports.
` That's -- that's how I'm
` offering this. I have not done an
` analysis of each entry in this report for
`
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`Page 4 of 30
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`
`
`Bryan Bergeron, MD, FACMI - Volume II - January 22, 2016
`
`Page 260
`
` BRYAN BERGERON, M.D.
` a particular use.
` BY MR. BERMAN:
`
` Q. Q. Turning to the sentence on
`
` Q. Q.
` retrospective reports, what do you mean by
` "retrospective reports" in your opinion on
` paragraph 46?
`
` A. A. I'm sorry, can you point me to
`
` A. A.
` which page?
`
` Q. Q. Sure. It's on page 21, last
`
` Q. Q.
` sentence -- I'm sorry, second to last
` sentence. "It is my opinion that the ACA
` materials only disclose generating
` retrospective ad hoc reports." Do you see
` that?
`
` A. A. I do.
`
` A. A.
`
` Q. Q. Okay. What do you mean by
`
` Q. Q.
` "retrospective reports" in that instance?
`
` A. A. Well, first of all, the ad hoc
`
` A. A.
` reports are generated or event-driven, so
` they are -- there's a need for a report
` and then the report is created; and so in
` contrast to the prospective reporting,
` which occurs every week or every month,
` whatever the periodicity is.
`
`Page 261
`
` BRYAN BERGERON, M.D.
` That because the report is ad
` hoc, and generated as needed, it
` necessarily includes information or data
` from things that occurred up to that
` current -- up to that point in time and
` it's retrospective.
`
` Q. Q. Going back to figure 13-A just
`
` Q. Q.
` so I can clarify what you mean there. In
` the reports, for example, the call center
` reports that are reported monthly, doesn't
` that include data information or data from
` things that occurred up to that point in
` time?
`
` A. A. At what point in time?
`
` A. A.
`
` Q. Q. At the point in time the report
`
` Q. Q.
` is generated.
`
` A. A. I would expect so, yes.
`
` A. A.
`
` Q. Q. So you said -- in
`
` Q. Q.
` differentiating between ad hoc and
` prospective reporting, you said that the
` report, when the report is ad hoc, it
` necessarily includes information or data
` from things that occurred up to that
` current point in time, and you labeled
`
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`5 (Pages 260 to 263)
`
`Page 262
`
` BRYAN BERGERON, M.D.
` that being retrospective.
` So I'm trying to understand
` what's the difference between the data
` that's in a retrospective report in your
` opinion and a data that's in a prospective
` report?
`
` A. A. I think you're mixing up two
`
` A. A.
` concepts that we've been talking about, at
` least I've been talking about. Right now
` you're talking about the data and we were
` talking -- I understood we were talking
` about -- this conversation about -- we
` first start off with prospective periodic
` reports, and that's the frequency of the
` reports, so I can look forward -- if it's
` a weekly report, to a report being
` provided next week.
` I'm not talking about data in
` the report. I'm talking about the report
` itself being provided. If it's a weekly
` report, every week.
` So an ad hoc report occurs at
` one point in time. There's no suggestion
` in my mind that it's going to occur again.
`
`Page 263
`
` BRYAN BERGERON, M.D.
` It can never occur again ever. So it
` cannot be prospective. It's ad hoc. So
` it -- by necessity, that report -- I'm not
` talking about the data in the report, the
` data in the report has to occur -- it
` can't have future data in it. It has to
` have the data up to that point in time.
` Or if it's a periodic report,
` say a weekly report or a monthly, I would
` expect next month to have another report
` and the next month to have another report
` and the next month to have another report,
` so the reporting is prospective.
` At each one of those report
` dates, it would then contain data of
` course that previously occurred, because
` you can't have reports on -- maybe someone
` could -- I wouldn't expect data to be from
` the future in any of the reports.
` So that's what I'm
` differentiating in the report itself. I'm
` not looking at -- analyzing the data in
` the report, characterizing the data in the
` report as by necessity being prior to the
`
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`Bryan Bergeron, MD, FACMI - Volume II - January 22, 2016
`
`Page 264
`
` BRYAN BERGERON, M.D.
` report in all cases.
`
` Q. Q. So theoretically,
`
` Q. Q.
` hypothetically, a -- an ad hoc report that
` happened to be generated at the same time
` as a monthly report would contain the same
` data, correct?
` MR. CALVOSA: Objection.
`
` A. A. It would depend on the report.
`
` A. A.
` BY MR. BERMAN:
`
` Q. Q. If it was reporting the same
`
` Q. Q.
` items?
` MR. CALVOSA: Objection.
`
` A. A. It would depend.
`
` A. A.
`
` Q. Q. It would depend on what?
`
` Q. Q.
`
` A. A. You have to characterize the
`
` A. A.
` report -- it depends on the report. I
` don't know -- I don't know whether it's a
` monthly report on -- I mean --
`
` Q. Q. Okay.
`
` Q. Q.
`
` A. A. It would depend on lots of
`
` A. A.
` things.
`
` Q. Q. Let's take an example. Looking
`
` Q. Q.
` at figure 13-A, the first line that we
` were talking about in sales that you were
`
`Page 265
`
` BRYAN BERGERON, M.D.
` talking about, excuse me, "RX by zip, new
` and total, which is generated according to
` 13-A, weekly, monthly or quarterly." If
` by happenstance a report was generated ad
` hoc that included this information at the
` same time that the weekly, monthly or
` quarterly report was generated, that would
` contain the same data, right?
`
` A. A. Assuming all else being equal.
`
` A. A.
`
` Q. Q. Yes.
`
` Q. Q.
`
` A. A. Assuming everything else is the
`
` A. A.
` same, then okay.
`
` Q. Q. That's correct, right?
`
` Q. Q.
`
` A. A. Assuming everything else is the
`
` A. A.
` same, yes.
`
` Q. Q. Back to your opinion -- I'm
`
` Q. Q.
` sorry, your declaration on paragraph 46,
` that second to last sentence that we've
` been talking about, it's your opinion that
` the ACA materials only disclose generating
` reports to aid in diversion investigations
` once those investigations have been
` initiated, correct?
`
` A. A. It's my opinion that the ACA
`
` A. A.
`
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`
`6 (Pages 264 to 267)
`
`Page 266
`
` BRYAN BERGERON, M.D.
` materials only disclose generating
` retrospective ad hoc reports to aid in
` diversion investigations once those
` investigations have already been
` initiated.
`
` Q. Q. What do you mean by that?
`
` Q. Q.
`
` A. A. What part is not -- which part
`
` A. A.
` are you asking about?
`
` Q. Q. The -- that the reports aid in
`
` Q. Q.
` diversion investigations once those
` investigations have already been
` initiated, what do you mean?
`
` A. A. I'm maybe missing that, but if
`
` A. A.
` there's an investigation, the -- this is
` an ad hoc report. There was an
` investigation and the report is in -- can
` be, I assume, subpoenaed or however it's
` required -- requested by the agency and
` that information is provided.
` So it would have by necessity
` have been initiated, already been
` initiated.
`
` Q. Q. Can we go back to Exhibit 1003,
`
` Q. Q.
` that's the transcript. Go back to 16,
`
`Page 267
`
` BRYAN BERGERON, M.D.
` lines 4 through 10. And it says here,
` "All patients and physicians will be
` entered into a registry and there will be
` close surveillance instituted to ensure
` that untoward events are minimized, for
` example, to ensure that patients don't go
` from doctor to doctor trying to get
` refills of prescriptions that are
` inappropriate." Do you see that?
` MR. CALVOSA: This is actually
` outside the scope.
` BY MR. BERMAN:
`
` Q. Q. Do you see that?
`
` Q. Q.
` THE WITNESS: Did you say
` something?
`
` Q. Q. He objected, but you can answer.
`
` Q. Q.
`
` A. A. I see this, yes.
`
` A. A.
`
` Q. Q. So this paragraph describes
`
` Q. Q.
` entering patients and physicians into a
` registry, correct?
` MR. CALVOSA: Objection.
` Outside the scope.
`
` A. A. I haven't been asked to opine on
`
` A. A.
` this before.
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Page 6 of 30
`
`
`
`Bryan Bergeron, MD, FACMI - Volume II - January 22, 2016
`
`Page 268
`
` BRYAN BERGERON, M.D.
` BY MR. BERMAN:
`
` Q. Q. But it says that the patients
`
` Q. Q.
` and physicians will be entered into a
` registry, correct?
` MR. CALVOSA: Objection.
`
` A. A. I see those words.
`
` A. A.
`
` Q. Q. And it also says that there will
`
` Q. Q.
` be close surveillance instituted. Do you
` see that?
`
` A. A. I see that.
`
` A. A.
`
` Q. Q. So in order to have close
`
` Q. Q.
` surveillance of patients and physicians
` entered into a registry, do you need to
` monitor the data?
` MR. CALVOSA: Objection.
` Outside the scope.
`
` A. A. Again, I haven't been asked to
`
` A. A.
` opine on this 4 through 10.
`
` Q. Q. I understand that.
`
` Q. Q.
`
` A. A. And I have no opinion at this
`
` A. A.
` point.
`
` Q. Q. You have no opinion?
`
` Q. Q.
`
` A. A. No.
`
` A. A.
`
` Q. Q. You can't give an opinion as to
`
` Q. Q.
`
`Page 269
`
` BRYAN BERGERON, M.D.
` whether this describes close surveillance
` of physicians and patients entered into a
` registry?
` MR. CALVOSA: Same objection.
`
` A. A. I cannot.
`
` A. A.
` BY MR. BERMAN:
`
` Q. Q. Let's go to page 184, line 24
`
` Q. Q.
` through 185, line 7, a section that we
` talked about at quite some length
` yesterday. Are you there?
`
` A. A. So the numbers are 24 through 4?
`
` A. A.
`
` Q. Q. 24 through 7.
`
` Q. Q.
`
` A. A. Sorry, 24 through 7.
`
` A. A.
`
` Q. Q. Yeah. And you've cited this in
`
` Q. Q.
` your report, right?
`
` A. A. I have. I forget the context.
`
` A. A.
`
` Q. Q. So this paragraph states that
`
` Q. Q.
` the central data repository can identify
` identification of -- I'm sorry -- excuse
` me. Strike that.
` This paragraph says that the
` central data repository can identify a
` number of unusual types of behavior,
` correct?
`
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`7 (Pages 268 to 271)
`
`Page 270
`
` BRYAN BERGERON, M.D.
`
` A. A. Allows for identification of a
`
` A. A.
` number of unusual types of behavior.
` That's the same thing, yes.
`
` Q. Q. And those include duplicate
`
` Q. Q.
` prescriptions, right?
`
` A. A. That's what it says, yes.
`
` A. A.
`
` Q. Q. And attempts to overprescribe?
`
` Q. Q.
`
` A. A. I see that.
`
` A. A.
`
` Q. Q. And attempts at overuse by
`
` Q. Q.
` patients?
`
` A. A. Yes, I see that.
`
` A. A.
`
` Q. Q. Okay. In order to identify any
`
` Q. Q.
` of these unusual types of behaviors, you
` have to look at the data, correct?
`
` A. A. That would seem reasonable.
`
` A. A.
`
` Q. Q. Okay. And is there anything in
`
` Q. Q.
` this section that says that you have to
` look at the data only after an
` investigation has been initiated?
`
` A. A. Nothing.
`
` A. A.
`
` Q. Q. And on the contrary, it says in
`
` Q. Q.
` the next sentence on 185, line 4 through
` 7, the benefit here is that that
` information is available prior to filling
`
`Page 271
`
` BRYAN BERGERON, M.D.
` the prescription so appropriate pharmacist
` intervention can occur. Do you see that?
`
` A. A. I do.
`
` A. A.
`
` Q. Q. So this paragraph discloses
`
` Q. Q.
` identifying these behaviors prior to
` filling the prescription, correct?
`
`