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Page 1
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
`
` ---------------------------
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` ---------------------------
`
` AMNEAL PHARMACEUTICALS, LLC
`
` Petitioner
`
` vs.
`
` SUPERNUS PHARMACEUTICALS, LLC
`
` Patent Owner
`
` U.S. Patent Nos. 8,394,405,
`
` 8,394,406 and 8,206,740
`
` ---------------------------
`
` Cases IPR2013-00368, IPR2013-00371,
`
` and IPR2013-00372
`
` ---------------------------
`
` VIDEOTAPED DEPOSITION OF EDWARD MICHAEL RUDNIC, Ph.D.
`
` New York, New York
`
` Friday, April 25, 2014
`
` 9:33 a.m.
`
`Reported by:
`
`Jennifer Ocampo-Guzman, CRR, CLR
`
`JOB NO. 11686
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`1
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`

`

`Page 2
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`Page 4
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`APPEARANCES (Continued):
`
`ALSO ON BEHALF OF THE PATENT OWNER:
`
` FOLEY & LARDNER, LLP
` Attorneys for Patent Owner
` 3000 K Street, NW
` Washington, New York 20007
` BY: ANDREW S. BALUCH, ESQ.
` (202) 672-5520 abaluch@foley.com
`
`ALSO PRESENT:
` RODOLFO DURAN, Videographer
`
`Page 5
`
` Rudnic
` THE VIDEOGRAPHER: This is tape 1
` of the videotaped deposition of Edward
` Rudnic, Ph.D., in the matter Amneal
` Pharmaceuticals LLC versus Supernus
` Pharmaceuticals. This deposition is
` being held at Paul Hastings located at
` 75 East 55th Street, New York, New York
` on April 25, 2014, at approximately
` 9:33 a.m. My name is the Rodolfo Duran.
` I am the legal video specialist. The
` court reporter today is Ms. Jennifer
` Ocampo-Guzman and we're both in
` association with the TransPerfect Legal
` Solutions.
` Will counsel please introduce
` themselves.
` MR. SABHARWAL: Yes, Keeto
` Sabharwal from the law firm of Sterne
` Kessler Goldstein & Fox on behalf of
` petitioner Amneal Pharmaceuticals.
` DR. POWERS: Trey Powers on behalf
` of -- from the law firm of Sterne
` Kessler Goldstein & Fox on behalf of
` Amneal Pharmaceuticals.
`
`2 (Pages 2 to 5)
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` April 25, 2014
` 9:33 a.m.
`
` Videotaped Deposition of EDWARD MICHAEL
` RUDNIC, Ph.D., held at the offices of Paul
` Hastings, 75 East 55th Street, New
` York, New York, pursuant to notice,
` before Jennifer Ocampo-Guzman, a Notary
` Public of the State of New York.
`
`Page 3
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`A P P E A R A N C E S:
` STERNE KESSLER GOLDSTEIN FOX
` Attorneys for Petitioner
` 1100 New York Avenue, NW
` Washington, DC 20005
` BY: H. KEETO SABHARWAL, ESQ.
` 202-371-2600 keeto@skgf.com
` -and-
` BY: R. WILSON "TREY" POWERS III, Ph.D.
` tpowers@skgf.com
` -and-
` BY: DAVID HOLMAN, Ph.D.
` dholman@skgf.com
`
` PAUL HASTINGS LLP
` Attorneys for Patent Owner
` 191 N. Wacker Drive
` Chicago, Illinois 60606
` BY: GREGORY A. MORRIS, Ph.D.
` (312) 499-6064
` gregorymorris@paulhastings.com
` -and-
` BY: EVAN D. DIAMOND, ESQ.
` evandiamond@paulhastings.com
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` Rudnic
` DR. HOLMAN: David Holman from the
` law firm of the Sterne Kessler Goldstein
` & Fox on behalf after Amneal
` Pharmaceuticals.
` MR. MORRIS: Gregory Morris from
` Paul Hastings on behalf of Supernus.
` MR. DIAMOND: Evan Diamond from
` Paul Hastings on behalf of Supernus.
` MR. BALUCH: Andrew Baluch from the
` law firm of Foley & Lardner, on behalf
` of Supernus.
` THE VIDEOGRAPHER: Will the court
` reporter please swear in the witness.
`E D W A R D M I C H A E L R U D N I C, called as a
`witness, having been duly sworn, was examined
`and testified as follows:
`EXAMINATION BY
`MR. SABHARWAL:
` Q. Good morning, Dr. Rudnic.
` A. Good morning.
` Q. Nice to see you again.
` A. Nice to see you again too.
` Q. Could you state your full name for
`the record?
`
`Page 7
`
` Rudnic
` A. Edward Michael Rudnic.
` Q. Dr. Rudnic, I know you've been
`deposed before, because I deposed you in a
`litigation, but have you ever been deposed in
`an IPR proceeding before?
` A. No.
` Q. The rules are overlapping, but
`different, and I'm going to go through them,
`just since this is your first time. Okay?
` A. Thank you.
` Q. First of all, you understand that
`you are testifying under oath?
` A. I do.
` Q. And as part of your oath, you
`understand that you are going to be
`testifying fully and accurately to the best
`of your knowledge?
` A. I do.
` Q. Okay. Consistent with my prior
`admonition, Dr. Rudnic, I don't want to play
`word games with you. I expect you to
`understand the questions that I ask, but if
`you don't, will you let me know?
` A. Yes.
`
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` Q. Otherwise, I can assume that you
`understood the question and you are going to
`answer the question I asked you, right?
` A. Yes.
` Q. Good. I'm going to read you
`something so that you understand the
`difference between a litigation proceeding
`and an IPR proceeding, and then I'm just
`going to make sure that you understand it.
`Okay?
` A. Fine.
` Q. "Consistent with the policy
`expressed in Rule 1 of the Federal Rules of
`the Civil Procedure and corresponding section
`42.1(b), unnecessary objections," quote,
`"speaking objections and coaching the witness
`in proceedings before the board are strictly
`prohibited," period. "Cross-examination
`testimony should be a question and answer
`conversation between the examining lawyer and
`the witness. The defending lawyer must not
`act as an intermediary," comma, "interpreting
`questions," comma, "deciding which questions
`the witness should answer," comma, "and
`
`Page 9
`
` Rudnic
`helping the witness formulate the answers
`while testifying."
` Did you understand what I just read
`you?
` A. Yes.
` Q. Okay. Now, couple of other things,
`based upon our prior proceeding, I'm going to
`ask that you answer the question that I ask
`you only. Do you understand that?
` A. I'm going to give you the best
`answer that I can.
` Q. Okay.
` A. For the question you ask me.
` Q. I appreciate that, and I also would
`ask that you not take an unreasonable amount
`of time to answer the question. Do you
`understand that?
` MR. MORRIS: Objection, counsel.
` A. Are you saying that I took an
`unreasonable amount of time last time?
` Q. Yes, I am. You took 25 minutes to
`answer my first question.
` MR. MORRIS: Objection. Counsel, I
` don't think it's relevant here to talk
`
`3 (Pages 6 to 9)
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` about another matter in this deposition.
` MR. SABHARWAL: Is he doing what we
` told him not to do?
` DR. POWERS: Yes.
` MR. SABHARWAL: Mr. Morris, I'm
` going to ask you one time and one time
` only. You are not to engage in speaking
` objections.
` Q. I'm just going to ask you, if I ask
`you a question, I would like for you to take
`just a reasonable amount of time. Do you
`understand that?
` A. I do, but I disagree with your
`assertion that I was unreasonable last time.
` Q. That's fine.
` Dr. Rudnic, how long did you spend
`preparing for your deposition today?
` A. I couldn't give you an exact
`number, but I got here yesterday.
` Q. You got to Paul Hastings yesterday?
` A. Yeah.
` Q. Okay. And did you meet with your
`attorneys in preparation for your deposition?
` A. Yes.
`
`Page 11
`
` Rudnic
` Q. And which attorneys did you meet
`with?
` A. I met with Mr. Morris, Mr. Diamond,
`and they had another associate, Elina.
` Q. Did you meet with Mr. Flattmann?
` A. No.
` Q. Did you meet with Mr. Baluch? Is
`it Baluch?
` A. No, I met him about a half hour
`before we started.
` Q. And how long did you spend
`preparing for your deposition?
` A. Oh, I read some documents in the
`past week or so and I've --
` MR. MORRIS: I just want to caution
` the witness not to reveal any
` attorney/client privilege information in
` your answer.
` Q. Yes, sorry. Thank you. Don't tell
`me what you discussed. Just tell me how long
`you spent.
` A. A few days.
` Q. Okay.
` A. I mean over the course of the last
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` Rudnic
`few weeks, including the one day yesterday.
` Q. So let's just start with yesterday.
`How long did you spend with Mr. Morris and
`Mr. Diamond yesterday?
` A. Total time, I got here --
` Q. Approximately.
` A. -- I got here about 9:30, left
`about 5:00.
` Q. And did you review any documents
`yesterday in preparation for your deposition?
` A. Yes.
` Q. Which documents?
` MR. MORRIS: I object to that
` question on the basis of attorney/client
` privilege.
` MR. SABHARWAL: Are you instructing
` him not to answer?
` MR. MORRIS: I caution the witness
` not to reveal the substance of any
` attorney/client privilege information in
` your answer.
` Q. Just tell me the names of the
`documents you reviewed, and I'm talking about
`documents that, just to make this easy,
`
`Page 13
`
` Rudnic
`documents that you relied on and recited in
`your declaration?
` MR. MORRIS: Sorry, finish your
` question.
` MR. SABHARWAL: That's fine. I was
` done.
` MR. MORRIS: I think I'm going to
` instruct the witness not to answer that
` question. I think it's too broad and it
` could reveal the substance of
` attorney/client privilege.
` MR. SABHARWAL: I'm going to try
` the question again and please don't
` coach the witness.
` Q. What public documents, in other
`words, documents that you filed in this
`petition --
` MR. SABHARWAL: Strike the
` question.
` Q. What documents did you review that
`you recite in your declaration? Tell me
`that.
` A. I can't remember.
` Q. Okay. Did you review your
`
`4 (Pages 10 to 13)
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`declaration, yesterday?
` A. I think that's between me and my
`attorneys.
` Q. No, it's not. I'm asking you the
`question.
` MR. SABHARWAL: Are you going to
` instruct him not to answer?
` MR. MORRIS: No, I'm going to
` caution the witness not to reveal the
` substance of any attorney/client
` privilege information. You can answer
` yes or no.
` A. Can you repeat the question?
` Q. Sure. Did you review your
`declaration yesterday with your attorneys;
`yes or no?
` MR. MORRIS: Same instruction.
` Q. It's a simple question, yes or no,
`or I don't recall.
` A. I'm confused about the legal
`standard here. I'm not an attorney, but I
`believe that what we talked about yesterday
`is covered by attorney/client privilege.
` Q. Are you an attorney?
`
`Page 15
`
` Rudnic
` A. No.
` MR. MORRIS: Dr. Rudnic, I just
` want to instruct you, you can answer
` that question yes or no.
` Q. He's telling you you can answer the
`question. So please answer the question.
` A. Yes.
` Q. Okay. Thank you.
` Did you review the '740 patent?
` MR. MORRIS: Same thing, you can
` answer yes or no.
` A. Yes.
` Q. Did you review the Sheth patent?
` MR. MORRIS: Same thing.
` A. Yes.
` Q. Did you review the '932 patent
`application?
` MR. MORRIS: Same thing.
` A. No.
` Q. Did you review the decision by the
`PTAB to institute trial in this proceeding,
`yesterday?
` MR. MORRIS: Same instruction.
` A. Explain that.
`
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` Q. Sure. You understand that there
`was a written decision by the Patent Trial
`and Appeal Board that instituted the trial in
`this case, right?
` A. Right.
` Q. Did you review that yesterday?
` A. No.
` Q. Have you seen that before?
` A. No.
` Q. Did you review Amneal's petition
`when they filed the inter partes review?
` MR. MORRIS: Same instruction.
` A. Repeat that.
` Q. Sure. In order to institute this
`proceeding, Amneal filed what's called a
`petition for inter partes review. Did you
`review that?
` A. No.
` Q. Have you reviewed that at any time
`prior to today?
` A. No.
` Q. Did you review the patent owner
`response?
` A. Repeat that.
`
`Page 17
`
` Rudnic
` Q. Sure. So there was a response that
`was filed by Supernus in response to the
`petition that Amneal filed. Did you review
`that? Do you recall reviewing that?
` MR. MORRIS: Same instruction.
` A. No.
` Q. Do you recall reviewing that at any
`time prior to today?
` MR. MORRIS: Dr. Rudnic, one thing
` I wanted to say, I had some
` instructions, so I just want you to slow
` down a little bit so I can make my
` objection or caution the witness on the
` basis of privilege. Thank you.
` A. Repeat the question, please.
` Q. Sure.
` Were you aware that there was a
`response called a patent owner response that
`was filed by Supernus in this proceeding?
` A. No.
` Q. And you don't recall ever looking
`at that?
` A. No.
` Q. Let's see here.
`
`5 (Pages 14 to 17)
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` Rudnic
` Did you review any of the patent
`references that were cited in the '740
`patent?
` A. Any?
` Q. Yes.
` A. Yes.
` Q. Which ones?
` A. I can't remember.
` Q. Do you remember the subject matter?
`Again, don't tell me anything that you talked
`about with your attorneys.
` MR. MORRIS: You can answer yes or
` no to that question.
` A. No, I don't.
` Q. All right.
` MR. SABHARWAL: Is this a touch
` screen?
` (Discussion off the record.)
` Q. Okay. So just so that my
`understanding is clear, you don't recall ever
`reviewing the petition that Amneal filed in
`this proceeding, correct?
` A. That's correct.
` Q. And you don't recall ever reviewing
`
`Page 19
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` Rudnic
`the patent owner response, correct?
` A. That's correct.
` Q. And you don't recall ever reviewing
`the decision by the Patent Trial and Appeal
`Board that instituted the trial?
` A. That's correct.
` Q. Okay.
` Now, I'm going to hand you your
`declaration.
` (Discussion off the record.)
` Q. Dr. Rudnic, I am going to be
`handing you what has been previously marked
`an exhibit marked as 2016 for identification
`purposes.
` MR. SABHARWAL: Sorry, Greg.
` Q. Please take a moment to review it.
` MR. SABHARWAL: Let me hand it to
` him.
` MR. MORRIS: Sure.
` Q. Please take a moment to review and
`let me know when you are done.
` MR. SABHARWAL: Jennifer, you want
` one of these autograph copies? I really
` don't want to take this back.
`
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` MR. DIAMOND: Yes. I'll take
` whatever you have throughout the day.
` MR. SABHARWAL: Absolutely.
` A. Okay.
` Q. Do you recognize this document,
`sir?
` A. I do.
` Q. Can you identify it for me?
` A. It is the declaration I made.
` Q. Okay.
` A. Regarding the U.S. Patent
`8,206,740, and that's the declaration.
` Q. Okay. All right. Directing your
`attention to the last page of the document,
`that's going to be 119. Is that your
`signature, sir?
` A. It is.
` Q. Do you recall signing it on or
`about March 10th of this year?
` A. Yes.
` Q. Okay. Now, since you just looked
`at it yesterday, is there anything that you
`want to change in your declaration as you sit
`here today? Anything that comes to mind?
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`Page 21
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` Rudnic
` A. I would -- there's something I
`might have said better. I'm just trying to
`find it.
` Q. Okay. No problem.
` A. I will try to find it efficiently.
` Q. No problem.
` A. On page 26, which is a continuation
`of the footnote on page 25.
` Q. Yes, sir.
` A. I had meant to say, and it was in
`an earlier version of this and somehow the
`correction didn't get into this, but that the
`highlighted word "no active ingredient,"
`needs to read "no active ingredient with an
`absorption window." So that one correction
`is one that I would make.
` Q. Okay. So just for the record, the
`sentence should read in footnote 3 that
`starts on page 25 and continues on to page
`26, "Rather," comma, "the Cole et al.
`reference merely discusses a gamma" --
` A. Scintigraphy.
` Q. -- "scintigraphy imaging study
`conducted on enteric-coated capsules
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`containing no active ingredient with an
`absorption window," comma, "to evaluate
`capsule disintegration at various points in
`the GI tract."
` A. That is correct.
` Q. Thank you, sir.
` Other than that, are there any
`other revisions or corrections you would like
`to make?
` A. None that I'm aware of.
` Q. As you sit here today, you believe
`that everything that's stated in here is true
`and accurate to the best of your knowledge?
` A. To the best of my knowledge.
` Q. And everything in here is your
`opinion, correct?
` A. That's correct.
` Q. Okay. Thank you.
` Dr. Rudnic, I assume that you are
`getting compensated for your deposition time?
` A. I'm being reimbursed my time, yes.
` Q. And who is paying you?
` A. Supernus.
` Q. And approximately -- and again this
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`Page 23
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`is not -- I don't need an accurate answer
`here, to the best of your knowledge, about
`how many hours have you spent being
`reimbursed for this proceeding, and I'm
`talking about preparing your declaration,
`preparing for your deposition, et cetera?
` A. I couldn't give you an accurate
`number.
` Q. That's fine. But it's more than
`10 hours, right?
` A. Slightly more.
` Q. We will just leave it at that.
` A. Okay.
` Q. Have you been compensated by
`Galderma for this proceeding?
` A. No, I've never been compensated by
`Galderma for anything.
` Q. Okay. All right. And I'm sorry,
`sir, what is your hourly rate?
` A. $500 an hour.
` Q. And you are being compensated on an
`hourly rate?
` A. That's right.
` Q. You are not being compensated based
`
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`upon the outcome of the proceeding?
` A. No.
` Q. All right. Now, I would like to
`direct your attention to paragraph 28 of your
`declaration.
` All right. Now, you have in
`paragraph 28 a description of what you
`believe to be a person of ordinary skill in
`the field of the invention as of the
`2002-2003 time frame, correct?
` A. Yes.
` Q. Okay. Was it your understanding
`that the person of ordinary skill is an
`actual person or a hypothetical person?
` A. Both.
` MR. MORRIS: Objection, calls for a
` legal conclusion.
` A. Both. They're actual people that
`are people of ordinary skill in the art, and
`then there is a description of those actual
`people that are hypothetical. Which would
`you like to talk about?
` Q. Well, you said both. When you
`analyzed the --
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` Rudnic
` MR. SABHARWAL: Strike that.
` Q. When you put forth the opinions in
`your declaration, did you do it from the
`perspective of an actual person or a
`hypothetical person?
` A. A hypothetical person.
` Q. Not an actual person?
` A. No.
` Q. And did you understand that this
`hypothetical person of skill in the art is
`aware of all the pertinent art in the field?
` A. Well, my opinion is that "a person
`of ordinary skill in the field of the
`invention as of the 2002-2003 time frame had
`education, experience in drug delivery and
`formulation. In this field, education,
`experience levels may vary between persons of
`ordinary skill, with some persons holding a
`bachelor's degree with many years of
`experience and others holding higher degrees
`but having less work experience. Through
`education and/or experience, a person of
`ordinary skill would have knowledge and skill
`relating to the use, function and formulation
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`7 (Pages 22 to 25)
`
`7
`
`

`

`Page 26
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`Page 28
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`of pharmaceutical excipients; knowledge and
`training regarding the equipment, processes
`and techniques used to analyze and test
`formulations materials and an understanding
`of pharmacokinetic principles and how they
`relate to the drug development."
` That's my answer in terms of what
`their knowledge would be.
` Q. Dr. Rudnic, I asked you not to read
`from your declaration. I asked you whether
`or not you understand whether a hypothetical,
`this hypothetical person of ordinary skill in
`the art is aware of all pertinent art in the
`field?
` MR. MORRIS: Objection, to the
` extent it calls for a legal conclusion.
` A. I don't understand your question.
`I have an opinion as to what a person of
`ordinary skill in the art is. I just gave it
`to you. And I don't understand your
`question.
` Q. What part of it did you not
`understand?
` A. All of it.
`
`Page 27
`
` Rudnic
` Q. All right. Let's break it down.
` We just talked about a person of
`ordinary skill in the art, right?
` A. I just told you what my opinion of
`what a person of ordinary skill is, yes.
` Q. All right. Do you have an
`understanding as to whether or not this
`person of ordinary skill in the art has
`knowledge of the prior art?
` MR. MORRIS: Objection, to the
` extent it calls for a legal conclusion.
` A. It depends.
` Q. On what?
` A. What the prior art is.
` Q. So you're saying that they would
`know about some prior art but not all the
`prior art?
` MR. MORRIS: Same objection.
` A. There's a lot --
` MR. MORRIS: Dr. Rudnic, I'm sorry.
` I just want to -- you need to leave me a
` little space for my objection.
` MR. SABHARWAL: Just give him a
` second.
`
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` A. You would have to give me a lot
`more definition around "pertinent" and a lot
`more definition around "art" for me to agree
`with the premise of your question. So I
`don't understand -- when you say all -- "all"
`is a very encompassing word. "Pertinent,"
`pertinent is a matter of subjective opinion
`and "art" is not a firm set of documents.
` Q. Okay. You understand that there is
`prior art that relates to the invention in
`this case, right?
` MR. MORRIS: Objection, to the
` extent it calls for a legal conclusion.
` A. I'm not an attorney, so I'm just
`going to tell you, I have an opinion of what
`a person of ordinary skill in the art is. I
`don't know that I can parse it for you in
`legal terms, in terms of how much --
` Q. I'm not asking you to parse it.
`I'm asking you to a simple question. You
`talked about certain prior art in this
`declaration, did you not?
` A. There is --
` Q. Yes or no, did you not?
`
`Page 29
`
` Rudnic
` A. Some, yes.
` Q. Okay. And you understand that some
`of the references that you talked about here
`are considered prior art, right?
` A. Some of the references here are
`considered prior art.
` Q. Okay. So far we're making
`progress.
` Now, do you understand whether or
`not a person of ordinary skill in the art,
`that you are talking about, is aware of all
`of the relevant prior art; yes or no?
` MR. MORRIS: Objection, to the
` extent it calls for a legal conclusion.
` A. I don't know --
` Q. Just, if you don't know, just say
`you don't know.
` A. I don't know.
` Q. Let's go to paragraph 4 (sic).
` A. Paragraph 4.
` Q. Now you have in paragraph 40.
` A. Oh, 40? I thought you said 4.
` Q. 40, I'm sorry. My fault.
` A. So we're at paragraph 40.
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`8 (Pages 26 to 29)
`
`8
`
`

`

`Page 30
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`Page 32
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` Q. Yes, sir.
` It says, "Because of the
`difficulties and challenges in designing
`controlled release drugs," comma, "many
`specialty companies with particular expertise
`in controlled release formulations exist,"
`period. "In my opinion and experience,"
`comma, "these companies," dash, "which have
`particular expertise beyond those of ordinary
`skill in the art," dash, "suffer many
`failures and setbacks even when using their
`own technology," period.
` So this hypothetical person of
`ordinary skill in the art, how much
`experience do they have with controlled
`release formulations?
` A. Are we talking about the specific
`people with -- beyond those of the ordinary
`skill in the art?
` Q. No.
` A. Because we just read that and so
`now you're confusing me.
` Q. Yeah, I'm sorry. You're
`contrasting companies that have particular
`
`Page 31
`
` Rudnic
`experience beyond those of ordinary skill in
`the art, or you are making a differentiation
`between a person of ordinary skill in the art
`and companies which have particular expertise
`beyond that?
` A. That's correct.
` MR. MORRIS: Objection to form.
` Q. So my question is: How much
`experience does a person of ordinary skill in
`the art have in controlled release
`formulation?
` MR. MORRIS: Objection, form.
` A. It varies. I --
` Q. Go ahead.
` A. It varies.
` Q. It varies based on what?
` A. Experience, education, work
`experience. A variety of factors.
` Q. So you are saying that the -- that
`the experience level of a person of ordinary
`skill in the art would vary?
` A. Well, you asked me of a person, so
`I said it would vary, and you were asking a
`question about specific training or knowledge
`
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`that a specific person would have, and I
`said -- because we're talking about a
`hypothetical, right?
` Q. Absolutely.
` A. So that hypothetical person, you
`don't have one set, oh, they have to have
`this kind of a degree or they have to have
`this many years of experience, or they have
`to have this much knowledge of this field.
` So a person of ordinary skill has,
`I have seen people without a bachelor's
`degree but have 30 years of work experience.
`They would have -- they would be a person of
`ordinary skill. I'm not saying that 30 years
`is the minimum. I'm just saying I know
`particular people that would fit my
`definition of someone of ordinary skill that
`has a high school degree but has a lot of
`work experience in this area.
` I know people that have a
`bachelor's degree that have what I would call
`particular expertise beyond those of ordinary
`skill in the art because of their long
`history in, say, drug delivery or some
`
`Page 33
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` Rudnic
`specialized field, where their expertise
`might be applicable.
` Q. Okay.
` A. So when I say it varies, education,
`amount of time dealing within a particular
`field, all those things play a role.
` Q. Would a person of ordinary skill in
`the art be employed by any of these companies
`that you are talking about in paragraph 40?
` A. The companies that we're talking
`about, of having -- just so I'm --
` Q. Sure.
` A. -- clear. These companies which
`have particular expertise beyond those of
`ordinary skill in the art? Those are the
`companies that we're talking?
` Q. Yes, sir.
` A. Okay. So they would have a variety
`of people that they would employ. They would
`have some people that, for example, somebody
`in human resources or --
` Q. Hold on a second. I'm not asking
`that. I'm asking you a very simple question.
` Would these particular companies
`
`9 (Pages 30 to 33)
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`9
`
`

`

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`employ persons of ordinary skill in the art;
`yes or no?
` A. Yes.
` Q. Now, if they employ persons of
`ordinary skill in the art, how can they have
`expertise beyond the employees who are
`persons of ordinary skill in the art?
` A. They probably also employ people
`that have particular skill and expertise
`beyond those of ordinary skill in the art.
`So they would have both.
` Q. And how do you know that?
` A. Because I've been running research
`departments in those kinds of companies, and
`I've been the CEO of those kinds of
`companies.
` Q. Well -- so, you talked about, as an
`exemplary person of ordinary skill in the
`art, somebody that has 30 years work
`experience but no bachelor's degree, right?
` A. Yes, and I am using a particular
`person as an example.
` Q. So if that's a person of ordinary
`skill in the art and if they were employed at
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`Page 35
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` Rudnic
`one of these companies, what other expertise
`does this company have beyond somebody who
`has been in the field for 30 years?
` A. Well, there are some people that
`might have advanced degrees as well as
`significant work experience in a very
`specialized field. So someone who is
`interested in drug absorption, per se, might
`not know how to run a tablet press, which
`someone of ordinary skill might know,.
` Q. Okay.
` A. But they might know a lot more
`about the mechanisms of the drug absorption
`or elimination or pharmacokinetics or some
`specialized field.
` Q. Okay.
` A. Those people would have expertise
`beyond those of ordinary skill in the art.
` Q. What would a -- what type of
`experience -- I'm sorry if I'm asking the
`same question again. But let's take the
`person of ordinary skill in the art who is in
`fact employed by these companies that you are
`talking about.
`
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`

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