2/4/2016
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`Amneal Pharmaceuticals, LLC, et al. v. Jazz Pharmaceuticals, Inc.
`
`Dr. Joseph DiPiro
`
`Page 283
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` _________________
`
` BEFORE THE PATIENT TRIAL AND APPEAL BOARD
` _________________
`AMNEAL PHARMACEUTICALS LLC, PAR PHARMACEUTICALS, INC. and
` WOCKHARDT BIO AG,
`
` Petitioners,
`
` v.
`
` JAZZ PHARMACEUTICALS, INC.,
`
` Patent Owner
` ____________________
` Case IPR2015-00554
` Patent 7,668,730
` ____________________
`
` Continued oral deposition of DR. JOSEPH DIPIRO, taken
`at the offices of Quinn Emanuel Urquhart & Sullivan, LLP,
`51 Madison Avenue, 22nd Floor, New York, New York 10010, on
`Thursday, February 4, 2016, at 9:30 a.m., before Anthony
`Armstrong, a Realtime Systems Administrator, Certified
`Realtime Reporter, Certified Court Reporter and Notary
`Public of the State of New York.
`---------------------------------------------------
` DIGITAL EVIDENCE GROUP
` 1730 M Street NW, Suite 812
` Washington, DC 20036
` (202) 232-0646
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2016
`
`202-232-0646
`
`RCT2162
`KRT!qh!W/U/!Rcvgpv!Pq/!9-842-;74
`Rcig!2!qh!49
`
`

`
`2/4/2016
`
`Amneal Pharmaceuticals, LLC, et al. v. Jazz Pharmaceuticals, Inc.
`
`Dr. Joseph DiPiro
`
`A P P E A R A N C E S:
`
`MADDOX EDWARDS, PLLC
`1900 K Street NW, Suite 725
`Washington, DC 20006
`BY: MATTHEW C. RUEDY, ESQ.,
`(202)830-0779
`mruedy@meiplaw.com
`Attorneys for Amneal Pharmaceuticals
`
`ARENT FOX, LLP
`1717 K Street, NW
`Washington, DC 20038
`BY: RICHARD J. BERMAN, ESQ.,
`(202)857-6000
`richard.berman@arentfox.com
`Attorneys for Par Pharmaceuticals
`
`QUINN EMANUEL URQUHART & SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, New York 10010
`BY: ERIC STOPS, ESQ.,
`(212)849-7561
`ericstops@quinnemanuel.com
`BY: EVANGELINE SHIH, ESQ.,
`(212)849-7000
`evangelineshih@quinnemanuel.com
`Attorneys for Jazz Pharmaceuticals
`
`Page 284
`
` INDEX
`
`WITNESS PAGE
`DR. JOSEPH DIPIRO
` By Mr. Berman 286, 424
` By Mr. Stops 417
`
` E X H I B I T S
`
`NUMBER DESCRIPTION PAGE
`
`DiPiro Exhibit 1052 Patent Owner Response 287
`
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`J O S E P H D I P I R O, Pharma.D., a witness, having
` been previously sworn, testifies as
` follows:
`CROSS-EXAMINATION (Cont'd)
`BY MR. BERMAN:
` Q. Good morning, Dr. DiPiro. Let's pick
` up where we left off in your report, Exhibit 2046
` on the '059 patent. And I'll refer you to
` paragraph 55 of your report. That's page 21.
` Are you there?
` A. Yes.
` Q. Okay. You say in the first sentence,
` "It is my opinion that only those with skill
` exceeding that of a POSA would have a need or
` motivation to thoroughly read the federal
` register." Do you see that?
` A. Yes.
` Q. What do you mean by skill exceeding
` that of a POSA?
` A. I don't define that in my statement.
` So we have talked before about the definition of
` a POSA that we're using, so this is referring to
`Page 286
`
` any and all other skill outside that I would
` expect of a POSA.
` Q. So can you give me an example of what
` that means?
` A. I don't know where to start. That
` would -- could be any skill.
` Q. So you said only those with skill
` exceeding that of a POSA would have a need or
` motivation to thoroughly read the federal
` register, right?
` A. It is my opinion that only those with
` skills exceeding that of a POSA would have a need
` or motivation to thoroughly read the federal
` register, yes.
` Q. So when you say exceeding that of a
` POSA in this context, can you explain what you
` mean by that?
` A. No. I haven't considered that or
` defined that.
` (Whereupon, DiPiro Exhibit No.
` 1052 was marked for identification.)
` ************
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`

`
`2/4/2016
`
`Amneal Pharmaceuticals, LLC, et al. v. Jazz Pharmaceuticals, Inc.
`
`Dr. Joseph DiPiro
`
`1
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`BY MR. BERMAN:
` Q. Showing you what's been marked as
` Exhibit 1052. This is paper entitled Patent
` Owner Response. Do you see that?
` A. Yes.
` Q. I'll submit to you this was filed by
` Jazz Pharmaceuticals in the '059 patent IPR.
` Let's go to page 18. And the first
` full paragraph there it says, "In Dr. DiPiro's
` opinion, only those whose skill exceeds that of a
` POSA such as a researcher focused on drug
` distribution, safety and abuse prevention or
` regulatory affairs would have had a reason to look
` to the federal register and to advisory committee
` meetings." Do you see that?
` A. Yes.
` Q. So is it your opinion that a skill
` exceeding that of a POSA includes a researcher
` focused on drug distribution, safety and abuse
` prevention or regulatory affairs?
` A. Before I can answer that, I need to
` be oriented to the document that we're speaking
`Page 288
`
` about here.
` Q. Do you have a particular question
` regarding that document that I can potentially
` clarify?
` A. Well, at the moment I may recall, but
` I'm not recalling that I have seen this before.
` What this is to both, '059, '059 --
` MR. STOPS: You want to tell him what
` it is?
`BY MR. BERMAN:
` Q. I'll submit to you what this is --
` I'll just generally explain is that after your
` report was filed, your declaration, or
` concurrently with your declaration being filed,
` Jazz also filed this document, Exhibit 1052, in
` the patent office explaining to the patent office
` their response to the petitions that were filed
` in the IPR proceedings. Okay?
` A. I see.
` Q. Does that clarify what this document
` is?
` A. Yes. So this is -- I may have
`Page 289
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` another question or so. I see that it doesn't
` have my signature, so it is not my statement.
` But I understand then from your explanation, and
` I haven't seen this document before, that this is
` a document -- I'm assuming this is a document
` prepared by Jazz counsel in response to the
` petitioner's --
` Q. Correct, yes. So this was prepared
` by Jazz's attorneys, and so they are stating in
` this response certain statements. So one of the
` statement is the one that I directed you to.
` A. That should refer back to something
` in my declaration?
` Q. Correct. So, for example -- well,
` let's look at the sentence that I had just read.
` That refers to your report at paragraph 55, which
` is the section we have just been discussing in
` your report. Does that orient you as to the
` topic?
` A. I think so. I may have another
` question later. So then does this refer back to
` the paragraph in my statement?
`
`Page 290
`
` Q. Yes. You see how it refers to
` Exhibit 2046, paragraph 55?
` A. I see.
` Q. So when you're ready, I'll repeat the
` question or rephrase.
` A. Sure. It will take me a minute or
` two to make sure I'm oriented.
` (Perusing.)
` I'm ready. Thank you.
` Q. On page 18 of 1052, Jazz's attorneys
` say, "In Dr. DiPiro's opinion, only those whose
` skill exceeds that of a POSA such as a researcher
` focused on drug distribution safety and abuse
` prevention or regulatory affairs would have had a
` reason to look to the federal register and to
` advisory committee meetings." Do you see that?
` A. Yes.
` Q. And that cites your exhibit -- your
` declaration at paragraph 55. Do you see that?
` A. I do.
` Q. And so what you said in paragraph 55
` is that it is your opinion that only those with
`Page 291
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`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2016
`
`RCT2162
`KRT!qh!W/U/!Rcvgpv!Pq/!9-842-;74
`Rcig!4!qh!49
`
`

`
`2/4/2016
`
`Amneal Pharmaceuticals, LLC, et al. v. Jazz Pharmaceuticals, Inc.
`
`Dr. Joseph DiPiro
`
`1
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` skill exceeding that of a POSA would have a need
` or motivation to thoroughly read the federal
` register. Do you see that?
` A. Yes.
` Q. Well, you see that the attorneys did
` not quote your statement on paragraph 55,
` correct? They didn't use quotation marks?
` A. I'm not agreeing other than I don't
` see the exact text from my declaration statement
` 55 in this portion of the document. I have not
` had an opportunity to review other parts of this
` document.
` Q. Right. So they are paraphrasing your
` paragraph 55 in the statement on page 18 of
` Exhibit 1052, correct?
` MR. STOPS: Objection, foundation.
` A. I'm not seeing it that way. There's
` additional information that isn't in paragraph
` 55.
`BY MR. BERMAN:
` Q. Okay. So let's talk about that
` additional information.
`
`Page 292
`
` Is it your opinion that a researcher
` focused on drug distribution, safety and abuse
` prevention or regulatory affairs is someone whose
` skill exceeds that of a POSA?
` A. I posed those as examples of someone
` whose skill exceeds that of a POSA.
` Q. So that's a yes?
` A. I posed those as examples of someone
` whose -- exactly that. Their skill exceeds of a
` POSA.
` Q. So there could be other skills that
` exceed that of a POSA?
` A. And I have not considered what those
` skills would be. It's not part of my testimony,
` not anything I'm offering. I'm not offering an
` opinion about the skills exceeding a POSA other
` than these examples.
` Q. So is it your opinion that a person
` of ordinary skill in the art would not be focused
` on drug distribution, safety and abuse prevention
` or regulatory affairs?
` MR. STOPS: Objection, form.
`Page 293
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` A. Well, I have to go back to the
` definition that we're using. We have defined it,
` we have talked about that, we have gone over it.
` And we're using and accepting the definition that
` Dr. Valuck has posed, and I have not defined POSA
` any further than that and Dr. Valuck has gone
` with it.
` Q. Let's look at page 23 of your
` opinion -- I mean declaration, excuse me, at
` paragraph 58.
` A. We're still on Exhibit 2046?
` Q. Yes. And I want to -- it's the top
` of page 23. And the last sentence says, "In my
` opinion, the reasons a Pharmacist POSA would have
` looked to the federal register are extremely
` limited. For example, to look for information
` regarding requests for proposals to undertake
` contract work for various federal agencies." Do
` you see that?
` A. Yes.
` Q. What's the basis for your opinion?
` MR. STOPS: Objection. The question
`Page 294
`
` was asked yesterday.
` A. So the full statement here in
` paragraph 58, in the off chance that a Pharmacist
` POSA would have been motivated to look to the
` federal register, it is my opinion that the POSA
` still would not look to find meeting
` announcements regarding the history of an
` approved drug's distribution system. So instead,
` in my opinion the reasons a Pharmacist POSA would
` have looked to the federal register are extremely
` limited, for example, to look for information
` regarding requests for proposals to undertake
` contract work for various federal agencies.
` So what is the basis of that opinion
` in --
` Q. In 58, yes.
` A. So it goes to my experience, as I
` indicated yesterday, of 38 years that the only
` time I can recall someone, Pharmacist POSA,
` including myself, looking at the federal register
` would have been before 1981. And in that
` specific instance, I was working in a pharmacy
`Page 295
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`
`Digital Evidence Group C'rt 2016
`
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`
`

`
`2/4/2016
`
`Amneal Pharmaceuticals, LLC, et al. v. Jazz Pharmaceuticals, Inc.
`
`Dr. Joseph DiPiro
`
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` system that was doing contracts for federal
` agencies and would look specifically to federal
` documents, one of which is the federal register.
` I have a vague recollection of all of the
` materials because it was so long ago, Commerce
` Business Daily, to become alerted to contracts
` for research projects.
` Q. Besides your own experience, did you
` do any other research regarding the statement you
` made in paragraph 58?
` A. No.
` Q. What other reasons besides the ones
` you listed -- are there other reasons a
` pharmacist would look to the federal register?
` A. Could I add to my response to the
` last question?
` In that instance, I was involved in
` activity -- it was a mix of activity, some of
` which was within the realm of a POSA. The purpose
` for looking at the federal register was my
` research activity which was outside of that scope.
` This was something that was just not common or
`Page 296
`
` typical for a POSA. So these were concurrent but
` not within my function as a POSA at that time.
` Q. Okay. Thank you.
` So are there any other reasons a
` Pharmacist POSA would look to the federal register
` besides the ones you listed?
` A. Not that I'm aware of. That's a no.
` Q. Let's go back to Exhibit 105, to page
` 18 again. And there's say statement above the
` one we were focused on the last time. It says,
` "In Dr. DiPiro's opinion, the only reason a
` Pharmacist POSA would look to the federal
` register would be for information regarding
` requests for proposals to undertake contract work
` for federal agencies." Do you see that?
` A. Not yet, no.
` Q. It's the third line from the top.
` A. Where it begins instead?
` Q. Yes.
` A. I do see that now.
` Q. Do you see that?
` A. Yes.
`
`Page 297
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` Q. Do you agree with that statement?
` A. Yes.
` Q. So if we can go back to your report
` at page 21, paragraph 56. And yesterday we were
` discussing the interest level of a Pharmacist
` POSA in drug distribution, safety and abuse or
` regulatory affairs. Do you recall that?
` A. I do.
` Q. And you said that a Pharmacist POSA,
` depending on the requirements of their job, may
` be interested in learning about these areas as it
` applies to their job and keeping up with the
` field. Do you recall that?
` MR. STOPS: Objection.
` Mischaracterizes. Form.
` A. Are you suggesting that's my exact
` words?
` Q. I'm just paraphrasing what you said
` to orient you to my next question.
` A. Well, I'd like to go back to my exact
` words from yesterday then.
` Q. Sure. But you recall the substance
`Page 298
`
` of what I'm talking about, right?
` A. I recall the question. But again, as
` to recharacterizing my words, I would go back to
` the way that I answered that yesterday.
` Q. I understand. That's fine. I don't
` mean to at all alter your testimony in that
` regard. But I wanted to orient you to that group
` of POSAs, the ones that may be interested in
` learning about drug distribution, safety and
` abuse or regulatory affairs. Okay?
` MR. STOPS: Objection, foundation.
` A. Not necessarily. And I don't know
` where you are headed. But I haven't defined that
` group of POSAs -- I'm using Valuck's definition
` of a POSA. That's the limit of my consideration.
` Q. Okay. So yesterday we were
` discussing the interest level of a Pharmacist
` POSA in drug distribution, safety abuse or
` regulatory affairs. You recall that, correct?
` A. The general discussion. Again, not
` the exact words.
` Q. Right. And generally, it was your
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`
`2/4/2016
`
`Amneal Pharmaceuticals, LLC, et al. v. Jazz Pharmaceuticals, Inc.
`
`Dr. Joseph DiPiro
`
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` testimony that some Pharmacist POSA, depending on
` their job, may have an interest in these areas,
` correct?
` MR. STOPS: Objection,
` mischaracterizes.
` A. I would refer back again to my
` specific words. I wouldn't want to alter those.
` So I don't know if that's possible.
` MR. BERMAN: Let's go off the record.
` (There was a recess.)
` **********
` (The record was read.)
`BY MR. RUEDY:
` Q. So those people that you described in
` your testimony yesterday, those that may be
` interested in learning about these areas as it
` applies to their job and keeping up with the
` field, those are the POSAs I would like to
` question you about, okay?
` MR. STOPS: Objection, foundation.
` A. I may have further questions about --
` if we're talking about a subset of POSA.
`Page 300
`
` Q. Yes.
` A. And by this, my intention was that a
` POSA or each POSA has a particular job of which
` there are many varieties within the definition of
` POSA that would determine their interests.
` Q. I understand. So I'd like to focus
` on that subset of POSAs who, depending on the
` requirement of their job, may be interested in
` learning about drug distribution, safety, abuse
` and regulatory affairs, okay?
` MR. STOPS: Objection. Foundation.
` Form.
` A. Yeah. Not sure if it's okay if
` you're asking -- yes. I'm not saying it's okay,
` because we could be beyond or outside the scope
` of what is in my testimony and the definition. I
` have not considered subsets of POSAs. I have not
` further defined that. You know, here are some
` examples, but I have not considered that beyond
` the testimony.
` Q. Let me ask you a couple of questions.
` We'll see where it goes.
`
`Page 301
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` So you acknowledge -- you acknowledged
` yesterday that there may be a group of POSAs that
` are interested in learning about drug
` distribution, safety and abuse of regulatory
` affairs, right?
` MR. STOPS: Objection.
` Mischaracterizes the testimony.
` A. I would say no.
` Q. There are not -- no POSAs would be
` interested in learning about drug distribution,
` safety and abuse or regulatory affairs?
` MR. STOPS: Objection,
` mischaracterizes.
` A. No. I'm disagreeing with your
` wording. So going back, I would go back -- your
` words were different than my statement.
` Q. I'm asking now do you have an opinion
` that there are a subset of POSAs that would be
` interested in learning about drug distribution,
` safety and abuse or regulatory affairs?
` A. No, I have not rendered an opinion on
` that.
`
`Page 302
`
` Q. So you don't have an opinion as to
` whether --
` A. I have not rendered an opinion on
` that.
` Q. But do you have an opinion as to
` whether there are POSAs that would be interested
` in learning about drug distribution, safety and
` abuse or regulatory affairs?
` A. I do not.
` Q. So then do you have an opinion as to
` whether POSAs interested in learning about drug
` distribution, safety and abuse or regulatory
` affairs would have consulted the federal
` register?
` MR. STOPS: Objection, foundation.
` A. I have not constructed or considered
` and do not have an opinion on that question.
` Q. I'm showing you what's been marked as
` Exhibit 2059. This is entitled Supplemental
` Declaration of Joseph Dr. DiPiro. Do you see
` that?
` A. I do.
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2016
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`
`2/4/2016
`
`Amneal Pharmaceuticals, LLC, et al. v. Jazz Pharmaceuticals, Inc.
`
`Dr. Joseph DiPiro
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` Q. And that's your signature on page
` two?
` A. It is.
` Q. So you have reviewed this document
` before?
` A. Yes.
` Q. Let's go to paragraph 2. It says, "I
` have reviewed the deposition testimony of Dr.
` Glenn A. Van Buskirk submitted as Exhibit 2054 in
` this IPR." Do you see that?
` A. Yes.
` Q. Who is Dr. Glenn A. Van Buskirk?
` A. You have Exhibit 2054 that you're
` referring?
` Q. We do. I'm just wondering if you
` know who he is?
` A. I just want to see the exhibit.
` Q. Without the exhibit can you answer my
` question?
` A. You have referred to paragraph 2 that
` speaks to the exhibit, so I would like to see the
` exhibit.
`
`Page 304
`
` Q. But do you know Dr. Glenn A. Van
` Buskirk?
` A. I do not.
` Q. Have you ever heard of him before
` this case?
` A. Again, I would like to see the
` exhibit you have referred to.
` Q. But have you ever heard of him before
` this case?
` MR. STOPS: Objection, badgering.
` A. I'll wait until I see the exhibit.
` Q. Showing you what's been marked as
` Exhibit 2054. Have you seen this document
` before?
` A. Yes.
` Q. Do you know who Dr. Glenn A. Van
` Buskirk is?
` A. Please repeat the question.
` Q. Yes. Do you know who Dr. Glenn A.
` Van Buskirk is?
` A. Only from this document.
` Q. Prior to Exhibit 2054, have you ever
`Page 305
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` heard of him?
` A. No.
` Q. Do you know if he is respected in the
` pharmacist community?
` A. I have no opinion about that.
` Q. Do you have an opinion as to whether
` Dr. Van Buskirk is a POSA?
` A. I have no opinion about that.
` Q. Did you review any additional
` portions of Dr. Van Buskirk's testimony besides
` Exhibit 2054?
` A. No.
` Q. If we can go to Exhibit 2054. Go to
` the second page of the exhibit. It says, "Glenn
` A. Van Buskirk, Ph.D., Non-clinical Drug
` Development Consulting Services LLC."
` Do you see that?
` A. Yes.
` Q. Have you ever heard of that company?
` A. No.
` Q. Do you have any idea what they do?
` A. Yes.
`
`Page 306
`
` Q. What do they do?
` A. Non-clinical drug development.
` Q. And you know that from the title of
` the company?
` A. Yes.
` Q. Do you know that from any other
` source?
` A. No.
` Q. Do you know what kind of non-clinical
` drug development?
` MR. STOPS: Objection. Outside the
` scope.
` A. I said not part of my opinion, not
` part of my research or part of my statement. So
` I don't have an opinion.
` Q. If you can go to page four of the
` exhibit, please. And this portion of Dr. Van
` Buskirk's deposition testimony indicates that he
` has a bachelor of science degree in pharmacy,
` correct?
` A. I'm seeing here, beginning line 10,
` "Something I forgot to get in your educational
`Page 307
`Pages 304 to 307
`202-232-0646
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2016
`
`RCT2162
`KRT!qh!W/U/!Rcvgpv!Pq/!9-842-;74
`Rcig!8!qh!49
`
`

`
`2/4/2016
`
`Amneal Pharmaceuticals, LLC, et al. v. Jazz Pharmaceuticals, Inc.
`
`Dr. Joseph DiPiro
`
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` background.
` You have a bachelor of science in
` pharmacy?
` Correct.
` Answer: I do."
` Q. Okay. And it also indicates that he
` has a master's and Ph.D. in pharmaceutical
` science, correct?
` A. I'm reading in the document that
` says, line 14, "Question: And a master's in
` pharmaceutical science."
` Line 16, "Answer: Correct."
` Q. And he is a licensed pharmacist,
` correct?
` A. I'm reading on line 20, "Question:
` And you -- you are also a licensed pharmacist."
` Line 22, "Answer: Yes, I am."
` Q. Does Dr. Van Buskirk's deposition
` testimony indicate that he has three to five
` years of relevant work experience as a
` pharmacist?
` A. I have no opinion or knowledge about
`Page 308
`
` that.
` Q. I'm asking whether this exhibit,
` 2054, indicates anywhere that Dr. Van Buskirk has
` three to five years of relevant work experience
` as a pharmacist?
` A. Again, I have no opinion about that.
` Q. So he would not qualify as a
` Pharmacist POSA, correct?
` MR. STOPS: Objection.
` Mischaracterizes the testimony.
` A. I didn't say that.
` Q. Do you have an opinion as to whether
` he would qualify as a Pharmacist POSA?
` A. I do not.
` Q. If you can go to page five of
` Exhibit 2054. It says there, "Question: Do
` individuals with degrees in pharmacy generally
` monitor the federal register for notices on
` unapproved drugs?
` Answer: Not unless they're in
` regulatory affairs."
` Do you see that?
`
`Page 309
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` A. Yes.
` Q. So Dr. Van Buskirk testified that
` individuals in regulatory affairs may monitor the
` federal register for notices on unapproved drugs,
` correct?
` MR. STOPS: Objection, vague.
` A. No. I would characterize it in the
` exact words that are here in the document.
` "Question: Do individuals with degrees in
` pharmacy generally monitor the federal register
` for notices on a proved drugs?
` Answer: Not unless they're in
` regulatory affairs."
` Q. Okay. So what does that mean to you?
` A. Exactly as stated there, so I don't
` take it for anymore or any less than what he is
` saying. "Not unless they are in regulatory
` affairs," continuing on with that paragraph in
` the exact words that he is using.
` Q. Let's go back to your Exhibit 2059,
` your second declaration, paragraph 3. It says
` there, "Dr. Van Buskirk's testimony is consistent
`Page 310
`
` with my opinion that a POSA would not be scanning
` the federal register regularly for notices of
` advisory committee meetings."
` Do you see that?
` A. I do.
` Q. Which portion of his testimony are
` you referring to?
` A. All of it. It is not redacted.
` Q. There aren't specific portions of his
` testimony that support your opinion?
` A. I'm citing the entire document.
` Exhibit 2054 is what I have reviewed to determine
` that his testimony is consistent with my opinion
` that a POSA would not be scanning the federal
` register regularly for notices of advisory
` committee meetings, and that only those with
` skill exceeding that of a POSA would have a need
` or motivation to thoroughly read the federal
` register specifically to find meeting
` announcements, and even more specifically, to
` search for announcements that contain information
` concerning the distribution, safety and abuse of
`Page 311
`Pages 308 to 311
`202-232-0646
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2016
`
`RCT2162
`KRT!qh!W/U/!Rcvgpv!Pq/!9-842-;74
`Rcig!9!qh!49
`
`

`
`2/4/2016
`
`Amneal Pharmaceuticals, LLC, et al. v. Jazz Pharmaceuticals, Inc.
`
`Dr. Joseph DiPiro
`
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` drugs that have not been approved.
` Q. How is Dr. Van Buskirk's testimony
` consistent with your opinion?
` A. In that a POSA would not be scanning
` the federal register regularly for notices of
` advisory committee meetings.
` Q. Is that what he said?
` A. I'm seeing in his document to the
` question do individuals with degrees in pharmacy
` generally monitor the federal register for
` notices of unapproved drugs. The answer: Not
` unless they're in regulatory affairs.
` Q. And that statement in your opinion is
` consistent with your opinion?
` A. His testimony, his document is
` consistent because I have referred to the entire
` document 2054 is consistent with my opinion.
` Q. Sir, you refer to the second part of
` your sentence there in paragraph three, only
` those with skill exceeding that of a POSA
` sentence. Do you see that?
` A. Paragraph three --
`
`Page 312
`
` Q. You say only those with skill on the
` fourth -- I'm sorry, third line.
` A. Yes. I'm reading that as one --
` paragraph three as one sentence.
` Q. Right. I'm just taking it from the
` and portion. So you say, "Only those with skill
` exceeding that of a POSA would have a need or
` motivation to thoroughly read the federal
` register." And it goes on from there. Do you
` see that?
` A. I do.
` Q. Okay. So does an individual with a
` degree in pharmacy who works in regulator