`
`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
`
` __________________________
`
` CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
`
`VIDEOTAPED DEPOSITION OF HENRY GEORGE GRABOWSKI, Ph.D.
`
` Tuesday, May 13, 2014
`
` New York, New York
`
`Reported by:
`
`Robin LaFemina
`
`Ref. No.: 11689
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`1
`
`
`
`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
`
`Page 2
`
` May 13, 2014
`
` 9:06 a.m.
`
` Videotaped Deposition of HENRY GEORGE
`
`GRABOWSKI, Ph.D., held at the offices of
`
`Paul Hastings, 75 East 55th Street, New
`
`York, New York, pursuant to Notice, before
`
`Robin LaFemina, a Registered Professional
`
`Reporter, Certified LiveNote Reporter and
`
`Notary Public within and for the State of
`
`New York.
`
`1 2
`
`3
`
`4 5 6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`2
`
`
`
`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
`
`Page 3
`
`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: DENNIES VARUGHESE, PHARM.D., ESQ.
`
` dvarughe@skgf.com
`
` 202.772.8805
`
` -and-
`
` DAVID HOLMAN, PH.D., ESQ.
`
` dholman@skgf.com
`
` PAUL HASTINGS LLP
`
` Attorneys for Patent Owner and Witness
`
` 191 North Wacker Drive
`
` Thirteenth Floor
`
` Chicago, Illinois 60606
`
` BY: GREGORY A. MORRIS, PH.D., ESQUIRE
`
` gregorymorris@paulhastings.com
`
` 312.499.6064
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`3
`
`
`
`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
`
`Page 4
`
`APPEARANCES (Continued):
`
` PAUL HASTINGS LLP
`
` Attorneys for Patent Ownerand Witness
`
` 75 East 55th Street
`
` New York, New York 10022
`
` BY: VANESSA Y. YEN, ESQUIRE
`
` vanessayen@paulhastings.com
`
` -and-
`
` EVAN DIAMOND, ESQ. (11:48-2:24)
`
` evandiamond@paulhastings.com
`
` 212.318.6000
`
` FOLEY & LARDNER LLP
`
` Attorneys for Patent Ownerand Witness
`
` Washington Harbour
`
` 3000 K Street, N.W.
`
` Suite 600
`
` Washington, DC 20007-5109
`
` BY: ANDREW S. BALUCH, ESQUIRE
`
` abaluch@foley.com
`
` 202.672.5520
`
` ALSO PRESENT:
`
` RODOLFO DURAN, Videographer
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`4
`
`
`
`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
`
`Page 5
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Confidential
`
` THE VIDEOGRAPHER: This is tape
`
` number 1 of the videotaped deposition
`
` of Dr. Henry Grabowski in the matter
`
` Amneal Pharmaceuticals, LLC and
`
` Supernus Pharmaceuticals, LLC. This
`
` deposition is being held at the offices
`
` of Paul Hastings, 75 East 55th Street,
`
` New York, New York on May 13, 2014 at
`
` approximately 9:06 a.m.
`
` My name is Rodolfo Duran, I am
`
` the legal video specialist. The court
`
` reporter today is Ms. Robin LaFemina.
`
` We are both in association with
`
` TransPerfect Legal Solutions.
`
` Will counsel please introduce
`
` themselves.
`
` MR. VARUGHESE: Dennies
`
` Varughese from the Law Firm of Sterne
`
` Kessler Goldstein & Fox on behalf of
`
` petitioner Amneal Pharmaceuticals, LLC.
`
` With me today is Mr. David Holman, also
`
` on behalf of Sterne Kessler Goldstein &
`
` Fox and also on behalf of Amneal.
`
` MS. YEN: Vanessa Yen from Paul
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`5
`
`
`
`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
`
`Page 6
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Confidential
`
` Hastings on behalf of Supernus and the
`
` witness.
`
` MR. MORRIS: Greg Morris from
`
` Paul Hastings on behalf of Supernus and
`
` the witness.
`
` MS. BALUCH: Andrew Baluch from
`
` the Law Firm of Foley & Lardner, LLP on
`
` behalf of Supernus and the witness.
`
` MR. VARUGHESE: Good morning,
`
` Dr. Grabowski.
`
` THE VIDEOGRAPHER: Will the
`
` court reporter please swear in the
`
` witness.
`
`H E N R Y G E O R G E G R A B O W S K I,
`
` called as a Witness, having been duly
`
` sworn by Robin LaFemina, a Notary
`
` Public within and for the State of New
`
` York, was examined and testified as
`
` follows:
`
`EXAMINATION BY
`
`MR. VARUGHESE:
`
` Q. Good morning, Dr. Grabowski.
`
` A. Good morning.
`
` Q. How are you doing?
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`6
`
`
`
`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
`
`Page 7
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Grabowski - Confidential
`
` A. Okay.
`
` Q. Can you state your full name for
`
`the record, please?
`
` A. Henry George Grabowski.
`
` Q. And your professional address?
`
` A. Department of Economics, Duke
`
`University, Durham, North Carolina 20078.
`
` Q. You understand that you're here
`
`testifying as part of an inter partes review?
`
` A. Yes.
`
` Q. Do you know what that is?
`
` A. I have some idea.
`
` Q. What's your idea?
`
` A. That one can petition the Patent
`
`Office, the US Patent Office to have a
`
`review of issued patents.
`
` Q. Have you been part of any other
`
`inter partes reviews?
`
` A. Yes.
`
` Q. Which one?
`
` A. There was one in a case that I
`
`was recently in, I would have to give some
`
`thought to be sure that I give you the right
`
`case.
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`7
`
`
`
`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
`
`Page 8
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Grabowski - Confidential
`
` Q. Did you testify in that case?
`
` A. No. The case was settled.
`
` Q. Okay.
`
` How long ago was that?
`
` A. Toward the end of last year, I
`
`think.
`
` Q. Was that a pharmaceutical case?
`
` A. Yes.
`
` Q. Is that the only other inter
`
`partes review that you've been involved in?
`
` A. Yes.
`
` Q. Who retained you for this
`
`particular matter?
`
` A. I was retained by Paul Hastings
`
`on behalf of the client.
`
` Q. Okay.
`
` And are you being compensated
`
`for your time on this matter?
`
` A. Yes.
`
` Q. And who is compensating you?
`
` A. I assume that Galderma
`
`ultimately compensates me, but I get my
`
`checks through Paul Hastings.
`
` Q. Do you have an engagement with
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`8
`
`
`
`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
`
`Page 9
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Grabowski - Confidential
`
`Galderma?
`
` A. No. Not directly.
`
` Q. And do you have an engagement
`
`with Supernus?
`
` A. No.
`
` Q. You testified in a related
`
`litigation last year, do you recall?
`
` A. Yes.
`
` Q. I think -- I believe it was you
`
`and I in the deposition room at that time,
`
`too.
`
` A. Yes.
`
` Q. And you were appearing at that
`
`deposition on behalf of Galderma; right?
`
` A. Yes.
`
` Q. Is that engagement still ongoing?
`
` A. To the best of my knowledge, it
`
`is.
`
` Q. And just so we're clear, today's
`
`proceeding you may hear referred to as a
`
`deposition both by me, possibly by others in
`
`this room, but you understand it is actually
`
`a cross-examination of your inter partes
`
`review.
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`9
`
`
`
`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
`
`Page 10
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Grabowski - Confidential
`
` Do you understand that?
`
` A. I don't understand that, but
`
`I'll take your representation.
`
` Q. Okay.
`
` Can you tell me, sir, I know
`
`obviously you're very experienced in this
`
`arena, how many times have you been deposed
`
`before?
`
` A. At least maybe 25 times.
`
` Q. Were those all patent cases?
`
` A. No.
`
` Q. Approximately how many of those
`
`were patent cases?
`
` A. Maybe three quarters.
`
` Q. Three quarters, did you say?
`
` A. Yes.
`
` Q. So given that you've testified
`
`in nearly 25 depositions, and I'll go
`
`through the ground rules pretty briefly just
`
`so that we're all on the same page, do you
`
`understand that you're under oath?
`
` A. Yes.
`
` Q. Do you understand that you are
`
`to testify truthfully and accurately to the
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`10
`
`
`
`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
`
`Page 11
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Grabowski - Confidential
`
`best of your ability?
`
` A. Yes.
`
` Q. I'm going to ask you questions.
`
` Are you aware of any ailments or
`
`any medications that you're taking today
`
`that would preclude you from testifying
`
`truthfully and accurately to my questions?
`
` A. No.
`
` Q. Dr. Grabowski, I'm not here to
`
`play any word games with you. I'm going to
`
`try to ask my questions in plain English,
`
`I'm going to assume that you understand the
`
`plain and ordinary meaning of those words.
`
`Obviously if you don't understand them, will
`
`you let me know?
`
` A. Yes.
`
` Q. And if you need a break, please
`
`let me know, you can have a break whenever
`
`you need one, but if there is a question
`
`pending, I'm going to ask that you try to
`
`answer that question before we take a break
`
`unless there's some sort of emergency.
`
` Is that okay with you?
`
` A. Yes. That's fine.
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`11
`
`
`
`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
`
`Page 12
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Grabowski - Confidential
`
` Q. Dr. Grabowski, I'm about to hand
`
`you what's been marked as Supernus Exhibit
`
`2017 in Amneal Pharms. versus Supernus
`
`Pharms. IPR2013-00368. I'm also going to
`
`hand you what's been marked as Supernus
`
`Exhibit 2017 in Amneal Pharms. versus
`
`Supernus Pharms. IPR 27-00372. And finally
`
`I'm going to hand you what's been marked as
`
`Supernus Pharms. Exhibit 2017 in Amneal
`
`Pharms. versus Supernus Pharms. IPR27-00371.
`
` Please take a moment to orient
`
`yourselves to those documents, please.
`
` (Witness reviewing document.)
`
` A. Yes.
`
` Q. Okay?
`
` Dr. Grabowski, have you seen
`
`these documents before?
`
` A. Yes, I have.
`
` Q. Can you identify them, please?
`
` A. Yes. These are my declarations
`
`in this matter involving the patent, the
`
`'740 patent, the '405 patent and the '406
`
`patent.
`
` Q. And those are three
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`12
`
`
`
`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
`
`Page 13
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Grabowski - Confidential
`
`declarations, one for each of the three
`
`different inter partes reviews, for the '740
`
`patent, the '405 patent and the '406 patent;
`
`is that correct?
`
` A. Yes.
`
` Q. And just so the record is clear,
`
`by the '740 patent, we are referring to US
`
`Patent No. 8,206,740.
`
` Do you understand that?
`
` A. Yes.
`
` Q. And then when we see '405
`
`patent, we are referring to US Patent
`
`8,394,405?
`
` A. Yes.
`
` Q. And when we say the '406 patent,
`
`we are talking about US Patent No. 8,394,406?
`
` A. Yes.
`
` Q. Okay.
`
` How are these declarations
`
`different from one another?
`
` A. They refer to different patents.
`
` Q. Okay.
`
` Any other differences?
`
` A. The patents don't all expire on
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`13
`
`
`
`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
`
`Page 14
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Grabowski - Confidential
`
`the same date, so that affected one of my
`
`calculations on projecting operating profits
`
`under a particular scenario. That's one
`
`difference.
`
` Q. Okay.
`
` So if you could turn to page 3
`
`of your declaration for the '740 patent, and
`
`specifically paragraph 9, can you read the
`
`last sentence of paragraph 9 for the record,
`
`sir?
`
` A. My report focuses on the
`
`commercial success of Oracea, which is a
`
`commercial embodiment of the '740 patent.
`
` Q. Okay.
`
` And you've put forth your
`
`opinion with respect to that issue in these
`
`declarations; is that correct?
`
` A. Yes.
`
` Q. And what is your conclusion?
`
` A. I don't understand the question.
`
`The conclusion of what are all my opinions?
`
` Q. No. On the question of
`
`commercial success.
`
` A. Oh. That Oracea is a commercial
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`14
`
`
`
`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
`
`Page 15
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Grabowski - Confidential
`
`success.
`
` Q. And that renders the '740 patent
`
`nonobvious; is that your opinion?
`
` A. Well, there's a two step
`
`procedure that there is my analysis of
`
`commercial success, which covers sales,
`
`prescriptions, comparisons with other
`
`products used for rosacea, the profitability
`
`of the product are all metrics that I use in
`
`determining commercial success and then the
`
`second step is to see whether that
`
`commercial success has a nexus or link to
`
`the patented invention, and that analysis is
`
`described in Section 4 beginning on page 23,
`
`the section entitled The Commercial Success
`
`of Oracea Is Due to the Unique Benefits and
`
`Advantages.
`
` Q. Okay. Thanks.
`
` So that analysis that you
`
`conducted, is there any difference in that
`
`analysis between the three patents, or I
`
`should say -- strike that. Is there a
`
`difference in the analysis that you put
`
`forth in those three separate declarations?
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`15
`
`
`
`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
`
`Page 16
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Grabowski - Confidential
`
` A. There's a comparable analysis in
`
`each case. One difference is in the
`
`operating profits section, as I mentioned.
`
`Other than that, I would have to go through
`
`the report to see if there's any other
`
`differences, but basically the analysis is
`
`similar.
`
` Q. Okay.
`
` And just so we're clear, today
`
`I'm going to have you refer to the
`
`declaration of the '740 patent. Okay? Is
`
`that all right?
`
` A. Yes.
`
` Q. So the record is clear, when I
`
`refer you to a paragraph, we'll be referring
`
`to the declaration of the '740 patent.
`
` A. That's fine.
`
` Q. Dr. Grabowski, I'm going to hand
`
`you what's been marked as Amneal Exhibit
`
`1001 in Amneal Pharms. versus Supernus
`
`Pharms. IPR 2013-00368. I'm also going to
`
`hand you what's been marked as Amneal
`
`Exhibit 1007 in IPR 2013-00371. And finally
`
`I'm going to hand you what's been marked as
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`16
`
`
`
`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
`
`Page 17
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Grabowski - Confidential
`
`Amneal Exhibit 1009 in IPR 2013-00372.
`
` Please take a moment to orient
`
`yourselves to those documents, sir.
`
` (Witness reviewing documents.)
`
` A. Okay.
`
` Q. Okay?
`
` Do you recognize those documents,
`
`sir?
`
` A. Yes.
`
` Q. Can you identify them?
`
` A. These are the patents that were
`
`issued by the Patent Office to inventors
`
`Chang, et al., the assignee is Supernus and
`
`the patents are the ones at issue here.
`
` Q. Okay. And just to be clear,
`
`Amneal 1001 is the '740 patent; correct?
`
` A. Yes.
`
` Q. And Amneal Exhibit 1007 is the
`
`'405 patent?
`
` A. Yes.
`
` Q. And Amneal Exhibit 1009 is the
`
`'406 patent?
`
` A. Right.
`
` Q. Okay.
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`17
`
`
`
`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
`
`Page 18
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Grabowski - Confidential
`
` Have you seen these patents
`
`before?
`
` A. Yes.
`
` Q. Have you reviewed them?
`
` A. I have reviewed them; yes.
`
` Q. In their entirety?
`
` A. I believe at some point I looked
`
`at them in their entirety. It may have been
`
`several months ago.
`
` Q. Did you review them in
`
`connection with preparing your declarations
`
`in these IPRs?
`
` A. Yes.
`
` Q. Did you review the claims?
`
` A. Yes.
`
` Q. Can you tell me how these
`
`patents are different from one another?
`
` A. What I reviewed is just to
`
`refresh my memory about the -- that each of
`
`the patents -- well, basically let me say,
`
`first of all, that I rely on Dr. Rudnic for
`
`that the product Oracea is covered by the
`
`claims of the patent and that Oracea is a
`
`commercial embodiment of the claims and I
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`18
`
`
`
`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
`
`Page 19
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Grabowski - Confidential
`
`just went back and reviewed that that was
`
`the case based on my layman's understanding
`
`of that.
`
` Q. So in your declarations, you've
`
`opined on whether or not Oracea is a
`
`commercial success and whether that success
`
`renders the claims of the '740, '405 and
`
`'406 patents nonobvious; is that correct?
`
` A. Well, that it's a commercial
`
`success and there's a nexus to the patent
`
`and I understand that that's a secondary
`
`condition of nonobviousness. I think it's
`
`for the Patent Office to determine how my
`
`analysis is to be utilized.
`
` Q. Fair enough.
`
` You just said you undertook to
`
`determine whether there's a nexus between
`
`the commercial success and the patent; is
`
`that correct?
`
` A. Yes.
`
` Q. When you say the patent, what
`
`are you talking about? Are you talking
`
`about the claims, are you talking about the
`
`specification of the patent? A nexus to
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`19
`
`
`
`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
`
`Page 20
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Grabowski - Confidential
`
`what?
`
` MS. YEN: Objection to form.
`
` A. Well, it's stated in here that
`
`I'm talking about that the claimed
`
`inventions, there's a nexus to the claimed
`
`invention and I rely on Dr. Rudnic who is a
`
`scientist who has examined the issue and
`
`indicates there is a -- the Oracea, the
`
`product that I'm analyzing the commercial
`
`success of, is covered by the claims and
`
`it's an embodiment of the claims, of each of
`
`these patents.
`
` Q. So did you try to analyze
`
`whether there's a nexus to the claims of the
`
`patents?
`
` A. Not beyond assuring myself that
`
`what is in Dr. Rudnic's report corresponds
`
`to his analysis of the patent, but that's
`
`the extent that I, you know, I rely on his
`
`opinions.
`
` Q. Okay.
`
` Let's say if I were to ask you
`
`are there any features of the claims of the
`
`'405 patent that for purposes of your
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`20
`
`
`
`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
`
`Page 21
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Grabowski - Confidential
`
`opinion are different from the features of
`
`the '740 patent, you know, is there any
`
`special nexus with respect to the '405
`
`patent that wouldn't exist with respect to
`
`the '740 patent?
`
` MS. YEN: Objection. Form.
`
` A. I'm not sure what you're asking
`
`me. You know, all I -- as I said, I'm --
`
`this is -- Dr. Rudnic has these opinions and
`
`I haven't tried to look at what's different
`
`about these patents. I've just tried to use
`
`my layman's understanding to say that yes,
`
`each of the -- each patent's claims cover
`
`the product Oracea.
`
` Q. All the claims of each patent?
`
` MS. YEN: Objection. Form.
`
` A. I haven't looked at all the
`
`claims of the patent. Some of them involve
`
`technical chemical issues. I've read
`
`through them, but I haven't attempted to
`
`pars out whether all the claims that Dr. --
`
`that's an area for Dr. Rudnic.
`
` Q. But Dr. Rudnic didn't opine on
`
`nexus, so you don't know if there's a nexus
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`21
`
`
`
`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
`
`Page 22
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Grabowski - Confidential
`
`to all the claims of each of the patents?
`
` A. It's a question for Dr. Rudnic.
`
`Dr. Rudnic, his opinion is that the
`
`commercially approved product Oracea is
`
`covered by the claims and is an embodiment
`
`of the claims and that is sufficient for me
`
`to do my analysis along with other input of
`
`nexus. It's one of the components of my
`
`nexus analysis.
`
` Q. Okay.
`
` So as part of your nexus
`
`analysis, do you know which claims there's a
`
`nexus to?
`
` A. If we look at the '740 patent
`
`that we started with, claim number 1 is an
`
`oral pharmaceutical composition of
`
`doxycycline, which at a once-daily dosage
`
`will give steady state blood levels of
`
`doxycycline at a minimum of 1.0 micrograms
`
`per milliliter and a maximum of 1.0
`
`micrograms per milliliter, the composition
`
`consisting of an immediate release (IR)
`
`portion comprising 30 mg. doxycycline, a
`
`delayed release portion comprising 10 mg.
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`22
`
`
`
`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
`
`Page 23
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Grabowski - Confidential
`
`doxycycline and optionally one or more
`
`pharmaceutically acceptable excipients, so
`
`my understanding from Dr. Rudnic is that
`
`this product Oracea is covered by claim 1
`
`and then and then claim 19, a method for
`
`treating rosacea in a mammal in need there
`
`of comprising, administering an oral
`
`pharmaceutical composition of doxycycline
`
`comprising -- which at a once-daily dosage
`
`will give steady state blood levels of
`
`doxycycline of a minimum, and then there's a
`
`range -- same range. The composition
`
`consisting of an immediate release IR
`
`portion comprising 30 mg. doxycycline, a
`
`delayed release portion comprising 10 mg.
`
`doxycycline and optionally one or more
`
`pharmaceutically acceptable expedients.
`
` Q. Okay. So I see that you just
`
`read into the record claim 1 and claim 19.
`
`Let's look at some of the other claims.
`
`Let's look at claim 7.
`
` Do you see that, sir?
`
` A. Yes.
`
` Q. Okay. Can you read that into
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`23
`
`
`
`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
`
`Page 24
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Grabowski - Confidential
`
`the record?
`
` A. The composition of claim 1 which
`
`is in a dosage form of a combination of
`
`pellets.
`
` Q. Did you analyze or as part of
`
`your analysis, did you determine whether
`
`there was any nexus between the sales of
`
`Oracea and to this feature of being a dosage
`
`form of a combination of pellets?
`
` MS. YEN: Objection to form.
`
` A. I did not do that analysis.
`
` Q. Okay. Let's look at claim 8.
`
`Can you read that, sir?
`
` A. The composition according to
`
`claim 1 where the DR portion comprises at
`
`least one enteric polymer.
`
` Q. And as part of your analysis,
`
`did you understand to determine whether
`
`there was a nexus between the sales of
`
`Oracea and to the feature wherein the DR
`
`comprises at least one enteric polymer?
`
` A. No, I did not. Dr. Rudnic did
`
`an analysis of patent claims and construction
`
`and I rely on him.
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`24
`
`
`
`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
`
`Page 25
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Grabowski - Confidential
`
` Q. Okay, but do you know if he
`
`undertook to determine whether there was a
`
`nexus?
`
` MS. YEN: Objection.
`
` A. I'm not sure what you're asking
`
`me. He looked at the claims of the patent
`
`and he analyzed whether Oracea was a
`
`commercial embodiment of the claims and
`
`whether it was covered by the claims.
`
` Q. Okay. So my question was, and
`
`I'll read it back to you, as part of your
`
`analysis, did you undertake to determine
`
`whether there was a nexus between the sales
`
`of Oracea and to the feature where in the DR
`
`portion comprises at least one enteric
`
`polymer?
`
` MS. YEN: Objection to form.
`
` MR. VARUGHESE: My question was
`
` about nexus.
`
` A. Where the --
`
` MS. YEN: Objection.
`
` A. I think I may have misunderstood
`
`your question. You're asking me whether I
`
`did that analysis.
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`25
`
`
`
`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
`
`Page 26
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Grabowski - Confidential
`
` Q. Yes.
`
` A. I think that's within the scope
`
`of Dr. Rudnic.
`
` Q. So you are relying on Dr. Rudnic
`
`to determine whether there was a nexus?
`
` MS. YEN: Objection to form.
`
` A. I rely on his opinions as part
`
`of my nexus opinion.
`
` Q. Okay. So getting back to claim
`
`8, there's a feature recited there. It
`
`says: Wherein the DR portion comprises at
`
`least one enteric polymer, and my question
`
`to you was: Did you evaluate whether a
`
`nexus exists between the sales of Oracea to
`
`that feature?
`
` MS. YEN: Objection to form.
`
` A. No, I did not.
`
` Q. Do you see claim 9, sir?
`
` A. Yes.
`
` Q. It's a rather lengthy claim and
`
`I'll do us all a favor and not read that
`
`into the record, but you will see in claim 9
`
`there is a number of excipients mentioned
`
`there.
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`26
`
`
`
`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
`
`Page 27
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Grabowski - Confidential
`
` Do you see that?
`
` A. Yes.
`
` Q. Did you undertake to determine
`
`whether sales of Oracea, whether there was a
`
`nexus between those sales to these features
`
`recited in claim 9?
`
` MS. YEN: Objection to form.
`
` A. No. That wasn't the scope of my
`
`assignment.
`
` Q. Please look at claim 10. Can
`
`you read that into the record, sir?
`
` A. The composition according to
`
`claim 1, wherein the DR formulation is in
`
`the form of granules, pellets or tablet.
`
` Q. Okay.
`
` Did you do any analysis to
`
`determine whether there was a nexus between
`
`the sales of Oracea to the features recited
`
`in claim 10?
`
` MS. YEN: Objection to form.
`
` A. No, I did not do an analysis of
`
`whether -- of that issue. That's in Dr.
`
`Rudnic's area.
`
` Q. I'd like to draw your attention
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`27
`
`
`
`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
`
`Page 28
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Grabowski - Confidential
`
`to claim 12.
`
` Can you please read that, sir?
`
` A. The composition of claim 11,
`
`wherein the one or more pharmaceutically
`
`acceptable excipients is a binder, a
`
`disintegration agent, a filling agent, a
`
`surfactant, a solubilizer, a stabilizer, and
`
`combinations thereof.
`
` Q. Did you undertake to determine
`
`whether there was a nexus between the sales
`
`of Oracea to the features recited there in
`
`claim 12?
`
` A. No --
`
` MS. YEN: Objection to form.
`
` A. No, that's in Dr. Rudnic's area.
`
` Q. So, Dr. Grabowski, I guess my
`
`question to you is if in your nexus analysis
`
`in determining whether a nexus existed
`
`between the sales of Oracea to the claims of
`
`these three patents, did you evaluate nexus
`
`on a claim by claim basis?
`
` MS. YEN: Objection to form.
`
` A. No. As I indicated in my report
`
`in footnote 10, as explained in the expert
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`28
`
`
`
`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
`
`Page 29
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Grabowski - Confidential
`
`declaration of Dr. Rudnic, Oracea is covered
`
`at least claims 1, 2, 5 to 13 and 19 to 22
`
`of the Chang '740 patent.
`
` Q. I guess my question to you is:
`
`The features recited in those claims, did
`
`you undertake to evaluate whether there was
`
`a nexus to the specific features recited in
`
`those claims?
`
` MS. YEN: Objection to form.
`
` A. I've relied on Dr. Rudnic that
`
`Oracea is covered by those specific claims
`
`and is a commercial embodiment of the patent
`
`mentioned and that was in part of my
`
`analysis of nexus.
`
` Q. But I am asking a little
`
`different question. I'm asking whether you
`
`considered those specific features in
`
`determining whether there was a nexus. I
`
`understand that you relied on Dr. Rudnic for
`
`the notion that commercial -- that Oracea is
`
`a commercial embodiment of the claims. I'm
`
`asking you: Did you look at those specific
`
`features in your nexus analysis?
`
` MS. YEN: Objection to form.
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`29
`
`
`
`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
`
`Page 30
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Grabowski - Confidential
`
` A. I looked at them, but then I
`
`rely on Dr. Rudnic that it's covered and
`
`then I do my analysis -- my economic analysis.
`
` Q. So you didn't look at the
`
`specific features of the claims?
`
` MS. YEN: Objection to form.
`
` A. I think I just said I looked at
`
`them, but I'm not a patent expert. I rely
`
`on a scientist, an expert who is in this
`
`area and has done an analysis for the Patent
`
`Office in this matter, and I rely on his
`
`opinions, and then I do my economic analysis.
`
` Q. So you rely on Dr. Rudnic on
`
`whether or not there's a nexus between the
`
`sales of Oracea and these specific features?
`
` MS. YEN: Objection to form.
`
` A. It's one input that I rely on,
`
`that this is a commercial embodiment, and
`
`then I do other economic analysis and I also
`
`rely on Dr. Webster who is a medical expert
`
`in terms of what the important features ar