CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
`
`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 GUY F. WEBSTER, M.D.
`
` Friday, May 9, 2014
`
` New York, New York
`
`Reported by:
`
`Robin LaFemina
`
`Ref. No.: 11688
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`
`
`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 GUY F. WEBSTER, M.D.
`
` Friday, May 9, 2014
`
` New York, New York
`
`Reported by:
`
`Robin LaFemina
`
`Ref. No.: 11688
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`
`
`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
`
`Page 2
`
` May 9, 2014
`
` 9:06 a.m.
`
` Videotaped Deposition of GUY F.
`
`WEBSTER, M.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
`
`
`
`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: PAUL AINSWORTH, ESQ.
`
` painsworth@skgf.com
`
` 202.772.8783
`
` -and-
`
` R. WILSON "TREY" POWERS III, Ph.D.
`
` tpowers@skgf.com
`
` 202.772.8876
`
` PAUL HASTINGS LLP
`
` Attorneys for Patent Owner
`
` 191 North Wacker Drive
`
` Thirteenth Floor
`
` Chicago, Illinois 60606
`
` BY: GREGORY A. MORRIS, PH.D., ESQ.
`
` 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
`
`
`
`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
`
`Page 4
`
`APPEARANCES (Continued):
`
` PAUL HASTINGS LLP
`
` Attorneys for Patent Owner
`
` 75 East 55th Street
`
` New York, New York 10022
`
` BY: EVAN D. DIAMOND, ESQ.
`
` evandiamond@paulhastings.com
`
` -and-
`
` JENNIFER NGUYEN, ESQ. (p.m. session)
`
` jennifernguyen@paulhastings.com
`
` 212.318.6000
`
`ALSO PRESENT:
`
` ALINSON GONZALEZ, 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
`
`
`
`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 media
`
` number 1 of the video deposition of Dr.
`
` Guy Webster in the matter of Amneal
`
` Pharmaceuticals, LLC versus Supernus
`
` Pharmaceuticals, Inc., Case No. IPR
`
` 2013-00358, IPR 2013-00371 and IPR
`
` 20130-0372 on May 9, 2014 at
`
` approximately 9:06 a.m.
`
` My name is Alinson Gonzalez and
`
` I am the legal video specialist.
`
` The court reporter today is
`
` Ms. Robin LaFemina.
`
` Will counsel please introduce
`
` themselves beginning with the party
`
` noticing this proceeding.
`
` MR. AINSWORTH: Paul Ainsworth
`
` with Sterne Kessler Goldstein & Fox on
`
` behalf of Amneal.
`
` MR. POWERS: Trey Powers on
`
` behalf of -- sorry -- with Sterne
`
` Kessler Goldstein & Fox on behalf of
`
` Amneal.
`
` MR. DIAMOND: Evan Diamond from
`
` Paul Hastings on behalf of Supernus and
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`
`
`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
`
` the witness.
`
` MR. MORRIS: Gregory Morris from
`
` Paul Hastings on behalf of Supernus and
`
` the witness.
`
` THE VIDEOGRAPHER: Will the
`
` court reporter please swear in the
`
` witness.
`
`G U Y F. W E B S T E R,
`
` called as a Witness, having been first
`
` 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. AINSWORTH:
`
` Q. Good morning, Dr. Webster.
`
` A. Good morning.
`
` Q. Could you please state your full
`
`name for the record?
`
` A. Guy F. Webster.
`
` Q. And, Dr. Webster, you have had
`
`your deposition taken before; is that correct?
`
` A. Yes.
`
` Q. On how many occasions?
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`
`
`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
`
` Webster - Confidential
`
` A. Three, four.
`
` Q. So you're generally familiar
`
`with the procedure for a deposition?
`
` A. Yes.
`
` Q. You understand that you're here
`
`today to testify under oath?
`
` A. Yes.
`
` Q. And if any of my questions to
`
`you today are unclear, will you let me know?
`
` A. Yes.
`
` Q. And if you answer my question,
`
`can I assume you understood it?
`
` A. You can assume I understood what
`
`I thought you asked.
`
` Q. Dr. Webster, you are a
`
`practicing dermatologist; is that correct?
`
` A. Yes.
`
` Q. In your current practice,
`
`approximately how many patients do you treat
`
`for rosacea?
`
` A. Hundreds.
`
` Q. Hundreds?
`
` A. (Witness nods head.)
`
` Q. 500?
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`
`
`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
`
` Webster - Confidential
`
` A. Probably not.
`
` Q. Less than 500?
`
` A. Yeah.
`
` Q. Less than 300?
`
` A. These aren't things that I count
`
`and they come in at irregular intervals, but
`
`I see rosacea patients most days.
`
` Q. Okay.
`
` What oral treatments do you
`
`prescribe for rosacea?
`
` A. I prescribe Oracea mainly.
`
` Q. Any other oral treatments that
`
`you prescribe for rosacea?
`
` A. Doxycycline when I can't get an
`
`Oracea. Oracea is the better drug by far,
`
`it's got low side effects, it's
`
`subantimicrobial, it is a single day --
`
`single day administrated -- administered
`
`drug, so it's better than the generic doxy,
`
`but you can't always get generic doxy for
`
`patients -- you can't always get Oracea for
`
`patients, so you have to do generic doxy.
`
` Q. And both Oracea and -- Oracea is
`
`also a doxycycline product; correct?
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`
`
`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
`
` Webster - Confidential
`
` A. Yes.
`
` Q. And when you prescribe generic
`
`doxycycline, at what dosage strength do you
`
`prescribe it?
`
` A. Typically 50, sometimes a
`
`hundred.
`
` Q. When you are treating a flare-up
`
`of rosacea, do you prescribe higher doses of
`
`doxycycline?
`
` A. What --
`
` MR. DIAMOND: Objection to form.
`
` A. What do you mean by flare-up?
`
` Q. Is flare-up a term that you ever
`
`use with respect to symptoms of rosacea?
`
` A. Perhaps, but I don't know what
`
`you mean by it. A flare-up could be that
`
`you're well maintained on drug and all of a
`
`sudden you explode or it could be that
`
`you're on no drug and you explode and you
`
`would treat those differently.
`
` Q. So -- and when you explode, you
`
`mean they present symptoms of lesions; is
`
`that correct?
`
` MR. DIAMOND: Objection to form.
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`
`
`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
`
` Webster - Confidential
`
` A. It could be that or it could be
`
`severe blushing and flushing. It could be a
`
`worsening of eye disease, which is also a
`
`feature of rosacea.
`
` Q. When someone is presently not on
`
`any treatment for rosacea and they are
`
`experiencing lesions, do you prescribe --
`
`what dose of doxycycline do you prescribe?
`
` A. I prescribe Oracea.
`
` Q. Approximately between your
`
`patients that you're prescribing Oracea and
`
`doxycycline to, what percentage are you
`
`prescribing generic doxycycline?
`
` A. I've never looked at it, I don't
`
`know. It would depend on what their
`
`insurance covers mainly.
`
` Q. Do you ever initiate therapy
`
`with doxycycline at higher levels and then
`
`taper down when you're treating rosacea?
`
` A. I did that more in the old days
`
`before Oracea. As Oracea has come out,
`
`we've appreciated that it is as good for
`
`most patients as higher levels of doxycycline.
`
`So I have a lot in the past. I don't know
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`
`
`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
`
` Webster - Confidential
`
`if I have lately. I may have.
`
` Q. So on occasions you may have
`
`prescribed higher doses of doxycycline?
`
` MR. DIAMOND: Objection to form.
`
` A. I may have.
`
` Q. Do you also prescribe topical
`
`treatments for treating rosacea?
`
` A. I do.
`
` Q. What topical treatments do you
`
`prescribe?
`
` A. Mainly metronidazole. There are
`
`patients who also have secondary problems
`
`with irritation or secondary problems with a
`
`second disease like atopic dermatitis,
`
`eczema, or seborrheic dermatitis, and in
`
`those patients they get drugs to treat those
`
`second problems as well.
`
` Q. When you're prescribing topical
`
`treatment, are you also prescribing it in
`
`conjunction with an oral treatment?
`
` A. I tend not to.
`
` Q. In what situations do you not
`
`prescribe a doxycycline product and only
`
`prescribe a topical product?
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`
`
`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
`
` Webster - Confidential
`
` A. The more severe patients will
`
`get the doxycycline product. Patients with
`
`milder disease or patients who say I don't
`
`want to take a pill of which there is some
`
`will get the cream.
`
` Q. When you are placing a patient
`
`on Oracea, do you ever provide them with
`
`free samples when you are starting them off?
`
` MR. DIAMOND: Objection to form.
`
` Outside the scope.
`
` A. You've hit on a hot button of
`
`mine. I think free samples are a waste of
`
`everybody's money. You can't judge on one
`
`or two pills basis whether or not a drug is
`
`going to work. I don't know what benefit
`
`they prescribe, so no, I don't.
`
` Q. You don't ever give out samples?
`
` A. Almost never.
`
` Q. Are you aware of any studies
`
`evaluating the use of samples among
`
`dermatologists treating acne and rosacea?
`
` MR. DIAMOND: Objection to form.
`
` Outside the scope.
`
` A. I am not aware of any of those
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`
`
`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
`
` Webster - Confidential
`
`studies.
`
` Q. Are you aware that other
`
`dermatologists will prescribe samples to
`
`patients when they're prescribing Oracea?
`
` MR. DIAMOND: Objection.
`
` Outside the scope.
`
` A. I am aware that samples are
`
`provided, I am aware that the drug companies
`
`think they're useful to their marketing.
`
`There must be people who use them.
`
` Q. Doctor, I am handing you what
`
`has been previously marked as Amneal 1001,
`
`1007 and 1009.
`
` MR. DIAMOND: I just have 406.
`
` MR. POWERS: One second.
`
` MR. DIAMOND: Okay.
`
` Q. Doctor, do you recognize --
`
` MR. DIAMOND: Could you hold on
`
` just a second, Paul? I haven't been
`
` handed all of the exhibits. Thank you.
`
` MR. AINSWORTH: Well, I'm sure
`
` you've seen them before.
`
` Q. Doctor --
`
` MR. DIAMOND: Can you hold on
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`
`
`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
`
` Webster - Confidential
`
` until I get all the exhibits? I would
`
` really appreciate it.
`
` Q. Doctor, have you -- are you
`
`familiar with the three exhibits in front of
`
`you?
`
` A. I have seen them.
`
` Q. And have you -- let's just focus
`
`on the one marked as Amneal 1001, which is
`
`the '740 patent.
`
` A. Here it is.
`
` Q. Have you read the '740 patent
`
`before?
`
` A. I've looked over it.
`
` Q. You've looked over it?
`
` A. Yes.
`
` Q. Have you read it carefully?
`
` A. No.
`
` Q. Have you reviewed the claims of
`
`the '740 patent, Doctor?
`
` A. I've relied on the report of Dr.
`
`Rudnic to determine whether or not Oracea is
`
`covered under the claims of these patents.
`
` Q. That wasn't my question, Doctor.
`
`My question was have you reviewed the claims
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`
`
`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
`
` Webster - Confidential
`
`of the '740 patent?
`
` A. I've reviewed Dr. Rudnic's
`
`analysis of the claims and that these drugs
`
`or this drug is covered under those patents.
`
` Q. Doctor, again, that wasn't my
`
`question. Have you reviewed personally the
`
`claims of the '740 patent?
`
` A. Not farther than Dr. Rudnic's
`
`analysis.
`
` Q. So the answer is no?
`
` MR. DIAMOND: Objection to form.
`
` A. I've not reviewed the patents
`
`other than looking at Dr. Rudnic's analysis
`
`with regard to the claims.
`
` Q. As with the '740 patent, would
`
`the same answer be true for the '405 and the
`
`'406 patent?
`
` A. The same answer would be true
`
`that I relied on Dr. Rudnic.
`
` Q. Now, Doctor, what is your
`
`understanding of the invention of the '740
`
`patent?
`
` MR. DIAMOND: Objection to form.
`
` Outside the scope.
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`
`
`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
`
` Webster - Confidential
`
` MR. AINSWORTH: Counsel, your
`
` objections are beyond what is permitted
`
` under the PTAB rules and if they
`
` continue, we're going to have an issue.
`
` Please keep them to the objections
`
` consistent with the PTAB rules.
`
` MR. DIAMOND: I believe
`
` objection to form and outside the scope
`
` are objections that are not only
`
` consistent with the PTAB rules, but
`
` objections made by your co-counsel in
`
` several of our depositions, so I
`
` disagree.
`
` MR. AINSWORTH: If it continues,
`
` counsel, we will take it to the PTAB.
`
` MR. DIAMOND: I disagree.
`
` Q. Doctor, what is your
`
`understanding of the invention of the '740
`
`patent?
`
` MR. DIAMOND: Objection to form.
`
` A. My understanding of the
`
`invention is that the '740 patent describes
`
`the drug that was produced, Oracea, in the
`
`30:10 composition that gave it the
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`
`
`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
`
` Webster - Confidential
`
`characteristics that have been so successful,
`
`that made it single dosage delayed release
`
`resulted in low side effects, resulted in
`
`subantimicrobial levels, all of which are
`
`desirable and long awaited.
`
` Q. What is your understanding of
`
`the invention of the '405 patent?
`
` MR. DIAMOND: Objection to the
`
` extent it calls for legal conclusion.
`
` Outside the scope.
`
` A. Well, as Dr. Rudnic said, the
`
`'405 patent describes the drug that we have
`
`named Oracea.
`
` Q. Do you have any understanding of
`
`the differences between the '740 patent and
`
`the '405 patent?
`
` A. I --
`
` MR. DIAMOND: Objection.
`
` Outside the scope.
`
` A. I completely relied on Dr.
`
`Rudnic for any patent claims discussion.
`
` Q. So you do not have an
`
`understanding of the differences between the
`
`'405 patent and the '740 patent?
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`
`
`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
`
` Webster - Confidential
`
` A. I did not consider them for my
`
`declaration.
`
` Q. And the same question with
`
`respect to the '406 patent. Do you have any
`
`understanding of the differences as to what
`
`is claimed in the '406 patent and what is
`
`claimed in the '740 patent?
`
` A. As far as writing my
`
`declaration, I just relied on Dr. Rudnic's
`
`testimony that they covered and described
`
`the drug that we're talking about.
`
` Q. And did you consider any
`
`differences between the '740 patent and the
`
`'406 patent in preparing your opinions in
`
`this case?
`
` A. In preparing my declaration, I
`
`relied on Dr. Rudnic's assertions that the
`
`drug was covered by those patents.
`
` Q. Again, Doctor, that wasn't my
`
`question.
`
` My question was: Did you
`
`consider any differences between the '740
`
`patent and the '406 patent in preparing your
`
`opinions in this case?
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`
`
`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
`
` Webster - Confidential
`
` MR. DIAMOND: Objection to form.
`
` A. I strictly relied on Dr.
`
`Rudnic's acceptance and went no further in
`
`analysis of the claims.
`
` Q. Doctor, we're going to be here a
`
`long time if you don't answer my questions.
`
`My question was did you consider any
`
`differences between the claims of the '740
`
`patent and the '406 patent in preparing your
`
`opinions today?
`
` MR. DIAMOND: Objection to form.
`
` Argumentative.
`
` A. I relied on Dr. Rudnic's
`
`consideration of whatever differences there
`
`might be, accepted his conclusion and then
`
`focused on my declaration.
`
` Q. So with respect to your opinion,
`
`Doctor, are you aware of any differences
`
`between the '740 patent and the '406 patent
`
`that's relevant to your opinions?
`
` A. I didn't consider them that way.
`
`I relied on Dr. Rudnic. I'm not aware of
`
`differences relevant to my opinion.
`
` Q. And is the same true for your
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`
`
`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
`
` Webster - Confidential
`
`opinions with respect to the '405 patent?
`
` A. The same is true.
`
` Q. Doctor, I'm handing you what has
`
`been previously marked as Supernus Pharms.
`
`Exhibit 2018 in the IPR 2013-00368 case,
`
`2018 in the 2013-0031 case and 2018 in the
`
`2013-00372 case.
`
` Doctor, do you recognize these
`
`three exhibits?
`
` A. Yes, I do.
`
` Q. What are these three exhibits?
`
` A. These are my declarations.
`
` Q. And these are your declarations
`
`for the '740 patent, the '405 patent and the
`
`'406 patent; correct?
`
` A. Correct.
`
` Q. Are you aware of any material
`
`differences between your three declarations,
`
`Doctor?
`
` A. The three declarations say
`
`substantially the same thing. There may be
`
`subtle differences, but I'm not aware of
`
`them.
`
` Q. For simplicity purposes, can we
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`
`
`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
`
` Webster - Confidential
`
`focus on the declaration related to the '740
`
`patent?
`
` MR. DIAMOND: Objection to form.
`
` Q. Is that fair?
`
` A. What was the question?
`
` Q. For simplicity purposes, can we
`
`focus on your declaration related to the
`
`'740 patent?
`
` MR. DIAMOND: Objection to form.
`
` Q. And if you think of any
`
`differences that may occur in your other
`
`directions, would you let me know?
`
` A. (Witness nods head.)
`
` Q. And you understand, Doctor --
`
`did you prepare that declaration?
`
` A. With the assistance of counsel,
`
`yes.
`
` Q. Did you review that declaration
`
`carefully?
`
` A. Very.
`
` Q. And did you understand that this
`
`is a declaration made under penalty of
`
`perjury?
`
` A. Yes.
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`
`
`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
`
` Webster - Confidential
`
` Q. Turning to paragraph 16 of your
`
`declarations on page 9, paragraph 16 is
`
`summarizing some of your opinions with
`
`respect to the '740 patent; is that correct?
`
` A. That is correct.
`
` Q. In the first sentence, you
`
`state: In my opinion, the community of
`
`patients affected by rosacea and the doctors
`
`who treated those patients had a long-felt
`
`need that -- I'm sorry --long-felt, but
`
`unmet need for a rosacea treatment that
`
`could be orally administered once-daily with
`
`minimal side-effects over prolonged periods
`
`of time.
`
` Do you see that?
`
` A. I do.
`
` Q. When you are referring to
`
`prolonged periods of time, what periods of
`
`time were you referring to?
`
` A. A rosacea patient could need
`
`treatment for years.
`
` Q. Are you familiar with the
`
`prescribing information for rosacea, Doctor?
`
` MR. DIAMOND: Objection to form.
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`
`
`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 - PURSUANT TO PROTECTIVE ORDER
`
`Page 23
`
` Webster - Confidential
`
` A. Which prescribing information?
`
` Q. The label.
`
` A. On?
`
` Q. On Oracea.
`
` A. Generally.
`
` Q. Do you know what the FDA has
`
`approved in terms of the period of time that
`
`the efficacy has been shown for treating
`
`rosacea with Oracea?
`
` A. I would be happy to look at the
`
`label if you have it.
`
` Q. I'm just asking you, do you know?
`
` A. I do not know. I would suspect
`
`it's a year or under.
`
` (Amneal Exhibit 1035, package
`
` insert for Oracea, marked for
`
` identification, as of this date.)
`
` Q. Doctor, I'm handing you what has
`
`been marked as Amneal 1035.
`
` A. Could it be any smaller?
`
` Q. Do you recognize what is marked
`
`as Amneal 1035?
`
` A. This is the package insert for
`
`Oracea.
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`
`
`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
`
` Webster - Confidential
`
` Q. Sometimes referred to as the
`
`label?
`
` A. Yes.
`
` Q. And if you go down to
`
`indications and usage, it's on the left-hand
`
`column toward the bottom.
`
` A. Yes.
`
` Q. Do you see it states: Efficacy
`
`of Oracea beyond 16 weeks and safety beyond
`
`nine months have not been established?
`
` A. I see that.
`
` Q. Do you disagree with the
`
`statement that the efficacy of Oracea beyond
`
`16 weeks and safety beyond nine months has
`
`not been established?
`
` MR. DIAMOND: Objection to form.
`
` A. I neither agree nor disagree
`
`with it in the practical sense. The FDA
`
`evaluates the data that they are presented.
`
`Sometimes they look for longer data when
`
`they think a drug may be dangerous when used
`
`chronically. They apparently didn't ask for
`
`that in the case of Oracea or there would
`
`have been longer data presented. They
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`
`
`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
`
` Webster - Confidential
`
`believed it to be safe within these time
`
`periods and presumed longer. FDA is very,
`
`very cautious about approving dangerous
`
`drugs for diseases that are less than life
`
`threatening and safety is really paramount
`
`in their view, maybe even more so than
`
`efficacy for certain things.
`
` Q. But with respect to Oracea, FDA
`
`has only found Oracea to be effective or is
`
`not -- I'm sorry -- has found that the
`
`efficacy of Oracea has not been established
`
`beyond 16 weeks; correct?
`
` MR. DIAMOND: Objection to form.
`
` A. I think a better way to make the
`
`statement would be to say that the FDA has
`
`asked for data up to 16 weeks and failed to
`
`see the need for further data regarding
`
`longer administration because they know full
`
`well that it will be given longer and
`
`they're very familiar with doxycycline.
`
` Q. Doctor, but the approved
`
`labeling for Oracea states that the efficacy
`
`has not been established beyond 16 weeks;
`
`correct?
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`
`
`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
`
` Webster - Confidential
`
` MR. DIAMOND: Objection to form.
`
` A. I can read the statement here,
`
`as you have, but that doesn't put it in the
`
`proper perspective.
`
` Q. Doctor, the FDA approved
`
`labeling states that Oracea has not been
`
`found to be efficacious beyond 16 weeks;
`
`correct?
`
` MR. DIAMOND: Objection to the
`
` form.
`
` A. The FDA approved labeling says
`
`that they have no data greater than 16 weeks
`
`and implicit in that is that they haven't
`
`asked for it and they haven't asked for it
`
`because they had no concern.
`
` Q. Have you seen any well-controlled
`
`clinical studies that show efficacy beyond
`
`16 weeks for Oracea?
`
` A. I don't know.
`
` Q. And you didn't cite any such
`
`studies in your declaration; correct?
`
` A. Let me look at my declaration.
`
` I would have to look at the
`
`Berman and Bikowski and Del Rosso articles
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`
`
`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
`
` Webster - Confidential
`
`to make sure that they didn't mention the
`
`length of therapy. I didn't address it in
`
`my declaration.
`
` Q. Turning back to your
`
`declaration, paragraph 16, Doctor, in the
`
`next sentence of paragraph 16, you state:
`
`Oracea - an embodiment of the '740 patent
`
`consisting of a 30 mg. immediate release and
`
`a 10 mg. delayed release dose of doxycycline
`
`(30 mg. IR, 10 mg. DR) for once-daily
`
`administration - fulfilled that need by
`
`providing a once-daily treatment for rosacea
`
`that is effective and remains below blood
`
`levels linked to the side effects of
`
`traditional antibiotic doxycycline dosages.
`
` Do you see that?
`
` A. I do see that.
`
` Q. When you refer to the side
`
`effects of traditional antibiotic
`
`doxycycline dosages, what side effects were
`
`you referring to?
`
` A. The side effects of -- first the
`
`concern about inducing antibiotic
`
`resistance, which is a real concern, and
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`
`
`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
`
` Webster - Confidential
`
`second -- and yeast infections and all the
`
`consequences of altering the microbial
`
`floor, GI upset in its various floors which
`
`oral doxycycline in higher doses is
`
`notorious for and which Oracea is
`
`essentially free of problems, sunburning
`
`which is a big deal with higher dosages.
`
` Q. So I have antibiotic resistance,
`
`yeast infections, GI upset and sunburning.
`
`Are those --
`
` A. And dizziness sometimes as well.
`
` Q. Dizziness?
`
` A. And there's another longer list,
`
`but those are the relevant ones that you see
`
`in practice, and you don't see them with
`
`Oracea.
`
` Q. So, Doctor, when you said -- I
`
`just want to make sure -- besides antibiotic
`
`resistance, yeast resistance, GI upsets,
`
`sunburning and dizziness, are there any
`
`other side effects of traditional antibiotic
`
`doxycycline dosages that come to mind?
`
` A. There is the endless list which
`
`is on every drug that contains every
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`
`
`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
`
` Webster - Confidential
`
`horrible possible side effect, but those are
`
`the common ones that are really at play in
`
`every day practice.
`
` Q. Now, Doctor, in your statement
`
`here, you indicate that there are blood
`
`levels linked to the side effects of these
`
`traditional antibiotic doxycycline dosages;
`
`correct?
`
` A. That's what I say in my
`
`declaration.
`
` Q. What blood level is linked with
`
`the side effect of trading antibiotic
`
`resistant bugs?
`
` A. Blood levels in the antibiotic
`
`range.
`
` Q. So what blood levels are those?
`
` A. I don't know the blood levels
`
`offhand. I know they result from dosing at
`
`100 or 50 or 200 a day of doxycycline.
`
` Q. And what blood levels are linked
`
`to the side effect of yeast infections?
`
` A. Blood levels that result in
`
`antibiotic activity which Oracea doesn't
`
`reach.
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`
`
`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
`
` Webster - Confidential
`
` Q. What blood levels are linked to
`
`side effects of a GI upset?
`
` A. That's a somewhat idiosyncratic
`
`reaction. It also depends on how much water
`
`you drink it with and what position you stay
`
`in. There are patients who get it at modest
`
`doses like even 50 a day and patients who do
`
`fine at higher doses, so there's not exactly
`
`a dose correlation. Clearly, the more you
`
`take, the higher the risk.
`
` Q. You say clearly the more dosage
`
`you take, there's a higher risk of
`
`gastrointestinal upset?
`
` A. Yes. That's what you see in
`
`practice.
`
` Q. And do you see GI upset with
`
`Oracea?
`
` A. I've not ever.
`
` Q. Really?
`
` A. Really. Not once.
`
` Q. We'll come back to that.
`
` Sunburning, what blood levels
`
`are linked to the side effect of sunburning
`
`with doxycycline?
`
`TransPerfect Legal Solutions
`212.400.8845 - Depo@TransPerfect.com
`
`
`
`CONFIDENTIAL - PURSUANT TO PROTECTIVE ORDER
`
`Page 31
`
`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
`
` Webster - Confidential
`
` A. Same answer as GI upset. Not a
`
`direct correla
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
