William C. Biggs, MD
`
`San Diego, CA
`
`10/15/2019
`Page
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC., )
`and PFIZER INC., )
` )
` Petitioners )
` )
` vs. )
` )
`SANOFI-AVENTIS DEUTSCHLAND GMBH, )
` )
` Patent Owner. )
`__________________________________)
`
` VIDEOTAPED DEPOSITION OF
`
` WILLIAM C. BIGGS, MD
`
` October 15, 2019
`
` 9:20 a.m.
`
` US Grant Hotel
`
` 326 Broadway
`
` San Diego, California
`
` Lorie Rhyne, CSR No. 12905
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`1-800-FOR-DEPO
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`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2317.001
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`San Diego, CA
`
`10/15/2019
`Page
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC., )
`and PFIZER INC., )
` )
` Petitioners )
` )
` vs. )
` )
`SANOFI-AVENTIS DEUTSCHLAND GMBH, )
` )
` Patent Owner. )
`__________________________________)
`
` VIDEOTAPED DEPOSITION OF
`
` WILLIAM C. BIGGS, MD
`
` October 15, 2019
`
` 9:20 a.m.
`
` US Grant Hotel
`
` 326 Broadway
`
` San Diego, California
`
` Lorie Rhyne, CSR No. 12905
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`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2317.001
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`William C. Biggs, MD
`
`San Diego, CA
`
`10/15/2019
`Page 2
`
` APPEARANCES OF COUNSEL
`
` On Behalf of Petitioners:
`
` WENDY LYNN DEVINE, ESQ.
`
` Wilson Sonsini Goodrich & Rosati
`
` One Market Plaza
`
` Spear Tower, Suite 3300
`
` San Francisco, California 94105-1126
`
` (415) 947-2027
`
` wdevine@wsgr.com
`
` JAMES P.H. STEPHENS, ESQ.
`
` Wilson Sonsini Goodrich & Rosati
`
` 12235 El Camino Real
`
` San Diego, California 92130-3002
`
` (858) 350-2279
`
` jstephens@wsgr.com
`
` On Behalf of Patent Owner:
`
` ANDREW PETER GESIOR, ESQ.
`
` Weil, Gotshal & Manges LLP
`
` 767 Fifth Avenue
`
` New York, New York 10153-0119
`
` (212) 310-8244
`
` andrew.gesior@weil.com
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`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2317.002
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`William C. Biggs, MD
`
`San Diego, CA
`
`10/15/2019
`Page 3
`
` APPEARANCES OF COUNSEL (Continued)
`
` On Behalf of Patent Owner:
`
` ROBERT T. VLASIS, III, ESQ. (via telephone)
`
` Weil, Gotshal & Manges LLP
`
` 2001 M Street NW, Suite 600
`
` Washington, D.C. 20036
`
` (202) 682-7024
`
` robert.vlasis@weil.com
`
` KATELYN O'REILLY, ESQ. (via telephone)
`
` Walsh Pizzi O'Reilly Falanga LLP
`
` Three Gateway Center
`
` 100 Mulberry Street, 15th Floor
`
` Newark, New Jersey 07102
`
` (973) 757-1023
`
` koreilly@walsh.law
`
` Videographer: ISAAC ORIHUELA
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`1-800-FOR-DEPO
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`www.AldersonReporting.com
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`Alderson Court Reporting
`
`Sanofi Exhibit 2317.003
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`William C. Biggs, MD
`
`San Diego, CA
`
`10/15/2019
`Page 4
`
` INDEX OF EXAMINATION
`
`WITNESS: WILLIAM C. BIGGS, MD
`
`EXAMINATION PAGE
`
`By Mr. Gesior 6
`
` INDEX TO EXHIBITS
`
` (Previously marked)
`
`EXHIBIT DESCRIPTION PAGE
`
`Exhibit 1047............................ 76
`
` Article, "Assessment by Patient with
`
` Diabetes Mellitus of Two Insulin Pen
`
` Delivery Systems Versus a Vial and Syringe"
`
`Exhibit 1049............................ 7
`
` Declaration of Dr. William C. Biggs
`
` in Support of Mylan-Pfizer Reply
`
`Exhibit 1060............................ 27
`
` Declaration of DeForest McDuff, Ph.D.
`
`Exhibit 1067............................ 73
`
` Article, "Insulin Pen - The 'iPod' for Insulin
`
` Delivery (Why Pen Wins over Syringe)"
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`1-800-FOR-DEPO
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`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2317.004
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`William C. Biggs, MD
`
`San Diego, CA
`
`10/15/2019
`Page 5
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` DEPOSITION OF WILLIAM C. BIGGS, MD
`
` OCTOBER 15, 2019
`
` THE VIDEOGRAPHER: We are now on the record
`
` in the matter of Mylan Pharmaceuticals versus
`
` Sanofi-Aventis Deutschland GMBH. Today's date is
`
` October 15th, 2019. The time on the record is
`
` 9:20 a.m. This is the video-recorded deposition of
`
` William Biggs, taken at the US Grant Hotel in
`
` San Diego, California.
`
` I'm the camera operator. My name is
`
` Isaac Orihuela, in association with Alderson Reporting.
`
` The court reporter is Lorie Rhyne, also in association
`
` with Alderson Reporting.
`
` Will all attorneys please identify
`
` themselves and the parties they represent, beginning
`
` with the party noticing the proceeding?
`
` MR. GESIOR: Andrew Gesior of Weil,
`
` Gotshal & Manges on behalf of Sanofi. And joining by
`
` phone, and also representing Sanofi, are Robert Vlasis
`
` of Weil and Katelyn O'Reilly of Walsh Pizzi O'Reilly
`
` Falanga.
`
` MS. DEVINE: Wendy Devine from Wilson
`
` Sonsini Goodrich & Rosati on behalf of Mylan. And with
`
` me is my colleague James Stephens of the same firm.
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2317.005
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`William C. Biggs, MD
`
`San Diego, CA
`
`10/15/2019
`Page 6
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` THE VIDEOGRAPHER: Will the reporter please
`
` swear in the witness?
`
` WILLIAM C. BIGGS, MD,
`
` having been first duly sworn, testified as follows:
`
` EXAMINATION
`
` BY MR. GESIOR:
`
` Q. Good morning.
`
` A. Good morning.
`
` Q. Can you please state your name and address
`
` for the record?
`
` A. William Curtis Biggs. My address is 1215
`
` South Coulter Street, Suite 400, Amarillo, Texas.
`
` Q. My name is Andrew Gesior, and I represent
`
` Sanofi, and I'll be asking you just a few questions
`
` today.
`
` How many times have you been deposed as an
`
` expert before?
`
` A. Three or four times.
`
` Q. Okay. I'm just going to go over a couple of
`
` preliminaries so we can have some ground rules. When I
`
` ask a question, if you answer, I'll assume that you
`
` understood the question. If you need me to clarify
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2317.006
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`William C. Biggs, MD
`
`San Diego, CA
`
`10/15/2019
`Page 7
`
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` anything, just please let me know, and I'll do so.
`
` Anytime you want a break, just let me know, and we can
`
` take a break. I only ask that you finish answering any
`
` question that I've asked first.
`
` Does that all make sense to you?
`
` A. Yes.
`
` Q. Is there any reason you're not able to give
`
` truthful testimony today?
`
` A. No.
`
` Q. Is it correct that you were retained by
`
` Mylan with respect to six IPR proceedings involving
`
` Sanofi's device patents?
`
` MS. DEVINE: Objection; scope.
`
` THE WITNESS: I don't know if there were six
`
` there, actually. I'm aware of -- I don't know how they
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` were organized. There's one.
`
` MS. DEVINE: Thank you.
`
` THE WITNESS: Okay. So we're counting all
`
` of these? Okay. I was just thinking of that as one.
`
` BY MR. GESIOR:
`
` Q. Yeah. So I just handed you Exhibit 1049
`
` from IPR208 -- -18-1 -- sorry -- -01670. Do you
`
` recognize this document?
`
` A. Yes.
`
` Q. And this is the declaration you submitted on
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2317.007
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`William C. Biggs, MD
`
`San Diego, CA
`
`10/15/2019
`Page 8
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` behalf of Mylan in these IPRs; correct?
`
` A. Yes.
`
` Q. And the declaration was submitted in the six
`
` IPRs listed on the cover page of the document; correct?
`
` MS. DEVINE: Objection; scope.
`
` THE WITNESS: There's six cases listed, yes.
`
` BY MR. GESIOR:
`
` Q. And did you submit a declaration in any
`
` cases besides those six listed?
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` MS. DEVINE: Objection; scope.
`
` THE WITNESS: No. I had something last
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` year. I'm not sure what the legal terminology was of
`
` it. But I think Mr. Vlasis was involved in that
`
` deposition for that IPR.
`
` BY MR. GESIOR:
`
` Q. Got it. This year did you submit a
`
` declaration in any IPRs on behalf of Mylan, aside from
`
` these six?
`
` A. This one, yes.
`
` Q. Is your declaration substantively identical
`
` across the six IPR proceedings?
`
` A. I believe that was my intention, yes.
`
` Q. You intended to submit the same
`
` declaration --
`
` A. Yeah.
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2317.008
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`William C. Biggs, MD
`
`San Diego, CA
`
`10/15/2019
`Page 9
`
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` Q. -- in all six; correct?
`
` A. Yeah.
`
` Q. Did you write this declaration?
`
` A. I -- this is -- this is my -- these are my
`
` thoughts and words, and it was with the assistance of
`
` the counsel that this was -- was created.
`
` Q. Who wrote the first draft of the
`
` declaration?
`
` MS. DEVINE: Objection; privileged.
`
` You're looking for drafts?
`
` MR. GESIOR: I'm just wondering who wrote
`
` the first draft.
`
` THE WITNESS: I would say I did on this. I
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` mean, this is -- it wasn't -- you know, before there
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` was a -- a draft, I mean, I discussed with -- what all
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` of my thoughts were about this issue.
`
` BY MR. GESIOR:
`
` Q. Did you have anyone other than counsel help
`
` you prepare this declaration?
`
` A. No.
`
` Q. And I understand you have some corrections
`
` you brought today to this declaration; is that correct?
`
` A. Yes. On page 13, paragraph 38, the second
`
` sentence, In my practice at any given point in time,
`
` about 60 percent of my diabetic patients are not using
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2317.009
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`William C. Biggs, MD
`
`San Diego, CA
`
`10/15/2019
`Page 10
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` insulin pens.
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` So we need to add the word "pens" to that
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` sentence. That's the only correction.
`
` Q. Okay. Just so I'm clear, in paragraph 38 at
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` the end of the first sentence -- the second
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` sentence -- at the end of the second sentence, we're
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` adding the word "pens" so that it reads "about
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` 60 percent of my diabetic patients are not using
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` insulin pens." Correct?
`
` A. Yes.
`
` Q. Did you notice any other mistakes in this
`
` declaration since you signed it?
`
` A. No.
`
` Q. Do you know who DeForest McDuff is?
`
` A. No.
`
` Q. You've never met him or spoken to him?
`
` A. I don't know who he is.
`
` Q. And I take it you haven't reviewed his
`
` declarations submitted in this case, then?
`
` A. No.
`
` Q. Do you know who Karl Leinsing is?
`
` A. No.
`
` Q. You've never met or spoke to him?
`
` A. Not that I know of, no.
`
` Q. And you haven't reviewed his declaration
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2317.010
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`William C. Biggs, MD
`
`San Diego, CA
`
`10/15/2019
`Page 11
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` submitted in this case?
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` A. No.
`
` Q. How many hours did you spend preparing your
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` declaration?
`
` A. You know, I -- it's been kind of mixed in
`
` with this other federal court case, so I don't know if
`
` I've necessarily counted for them individually. Are
`
` you asking individually or --
`
` Q. Let's go ahead and take it as a total amount
`
` of time between the two cases preparing the
`
` declaration: in the IPR and the expert report and the
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` district court.
`
` A. You know, I would estimate, you know,
`
` somewhere 75 hours' time; quite a bit of time.
`
` Q. And did you personally review all of the
`
` materials you've cited in your declaration?
`
` A. Yes.
`
` Q. And you did that review during those 75
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` hours; correct?
`
` A. Yes.
`
` Q. How did you prepare for this deposition?
`
` A. I reviewed my statement and the patents and
`
` Dr. Goland's statement.
`
` Q. How much time did you spend in that
`
` preparation?
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2317.011
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`William C. Biggs, MD
`
`San Diego, CA
`
`10/15/2019
`Page 12
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` A. Probably six hours.
`
` Q. And did you meet with counsel at all to
`
` prepare for this deposition?
`
` A. Yes.
`
` Q. And is -- was that time included -- did you
`
` also meet for six hours, or was there more time that
`
` you met with counsel?
`
` A. Met with counsel for maybe three hours.
`
` Q. And when -- when did you do that?
`
` A. Yesterday.
`
` Q. So in preparing for this deposition, you
`
` reviewed the materials for about six hours and met with
`
` counsel yesterday for about three hours; correct?
`
` A. Um-hum.
`
` Q. And how much have you billed to date on this
`
` declaration you submitted in the IPR proceeding?
`
` A. Again, it's mixed, you know. I think -- you
`
` know, so far, I think I've billed about, you know, not
`
` quite 50 hours of that time.
`
` Q. Okay. And I assume you will be billing for
`
` the additional 25 hours?
`
` A. Yes, um-hum.
`
` Q. And what's your hourly rate?
`
` A. $600.
`
` Q. Okay. If you could turn to paragraph 34 of
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2317.012
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`William C. Biggs, MD
`
`San Diego, CA
`
`10/15/2019
`Page 13
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` your declaration. Do you see in paragraph 34, you
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` state, Indeed, the claims do not mention insulin,
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` diabetes or lower injection force or thumb extension?
`
` A. Yes.
`
` Q. You're a medical doctor; correct?
`
` A. Yes.
`
` Q. So are you an expert in designing mechanical
`
` delivery devices?
`
` A. No. I -- I would say I'm an expert in -- in
`
` how -- how they are actually used by patients and, you
`
` know, people that use them.
`
` Q. But you're not an expert in the design of
`
` the pen before it gets used by patients; correct?
`
` A. No. I'm not claiming to be. No.
`
` Q. And do you know whether the challenged
`
` claims in this proceeding enable injection force and
`
` other feature -- and the other features you mentioned?
`
` A. Can I see the claims that you're referring
`
` to?
`
` Q. Yeah. Well, just before we do that, have
`
` you done an analysis, as part of this declaration, of
`
` the claims in the patent?
`
` A. I've read the claims.
`
` Q. And have you done an analysis as to whether
`
` they enable lower injection force or other features?
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2317.013
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`William C. Biggs, MD
`
`San Diego, CA
`
`10/15/2019
`Page 14
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` A. I didn't see any mention of anything about
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` injection force or thumb extension in the claims.
`
` Q. So you didn't see it explicitly mentioned,
`
` but you're not an expert to understand whether the
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` mechanical features claimed in those claims would allow
`
` for lower injection force; correct?
`
` MS. DEVINE: Object to form.
`
` THE WITNESS: Well, you know, I think I'm
`
` here to say that, you know, the -- we didn't see any
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` substantial reduction in injection force, and there
`
` wasn't in the claims.
`
` BY MR. GESIOR:
`
` Q. Got it. But that wasn't in the claims.
`
` Are -- are you -- did you -- strike that.
`
` Did you investigate whether the mechanical
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` device claimed in those claims could create a pen with
`
` a lower injection force or the other features you
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` discuss in your declaration?
`
` MS. DEVINE: Objection; form.
`
` THE WITNESS: Well, I would say my
`
` investigation would be that I actually use these
`
` devices every day, and there's no substantial
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` difference in the injection force or the thumb
`
` extension.
`
` BY MR. GESIOR:
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2317.014
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`William C. Biggs, MD
`
`San Diego, CA
`
`10/15/2019
`Page 15
`
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` Q. So you're --
`
` A. So I don't --
`
` Q. Sorry.
`
` A. So I'm -- you know, it -- I'm not seeing it
`
` in the real world, and I didn't -- I'm not seeing it in
`
` the claims.
`
` Q. So your opinions are based mostly on the
`
` experience you have with the pens themselves and not
`
` the claim language; correct?
`
` MS. DEVINE: Objection to form.
`
` THE WITNESS: Well, I don't see any claim
`
` language that mentions diabetes, insulin or lower
`
` injection force. I have not seen anything to back up
`
` those claims when I use the devices --
`
` BY MR. GESIOR:
`
` Q. But --
`
` A. -- I mean, the -- those -- you know,
`
` the -- the contention that they lower injection force
`
` and thumb extension. That's not what I'm seeing.
`
` Q. You're not seeing that in the devices you've
`
` used?
`
` A. Correct.
`
` Q. But even though the words "injection force"
`
` don't appear in the patent claims, you don't know
`
` whether those limitations described in the claims
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2317.015
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`William C. Biggs, MD
`
`San Diego, CA
`
`10/15/2019
`Page 16
`
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` nevertheless enable a pen with lower injection force;
`
` correct?
`
` MS. DEVINE: Objection; form.
`
` THE WITNESS: No. All I can tell you is I'm
`
` not seeing it, you know. If it's -- if somebody
`
` believes it's there, I guess they're entitled to their
`
` opinion. But I'm not seeing any substantial difference
`
` in injection force, thumb extension. And it's not in
`
` the claims. None of those words are in the claims.
`
` BY MR. GESIOR:
`
` Q. So your opinion is just saying that those
`
` specific words aren't anywhere in the claims, in your
`
` view?
`
` MS. DEVINE: Objection; form.
`
` THE WITNESS: No. I've told you already
`
` that I'm not seeing any -- any relevant reduction in
`
` injection force, thumb extension, and the claims don't
`
` say anything about diabetes or insulin.
`
` BY MR. GESIOR:
`
` Q. As part of your practice, do you typically
`
` read patent claims? Are you -- strike that.
`
` In your practice, do you typically read
`
` patent claims?
`
` MS. DEVINE: Objection; form.
`
` THE WITNESS: I have read practice claims.
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2317.016
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`William C. Biggs, MD
`
`San Diego, CA
`
`10/15/2019
`Page 17
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` I have a couple patents.
`
` BY MR. GESIOR:
`
` Q. Do you regularly interpret patent claims?
`
` A. No. I'm not a lawyer. No.
`
` Q. So your expertise isn't in interpreting
`
` patent claims; correct?
`
` MS. DEVINE: Objection; form.
`
` THE WITNESS: Well, I can -- I can read the
`
` claims. I know that there's -- none of those words are
`
` in the claims.
`
` BY MR. GESIOR:
`
` Q. So let's move on to your practice.
`
` You're a medical doctor; correct?
`
` A. Yes.
`
` Q. And in your practice, you treat many
`
` patients with diabetes?
`
` A. Yes.
`
` Q. How many patients do you treat with diabetes
`
` right now, approximately?
`
` A. I work with a couple of nurse practitioners.
`
` We kind of comanage these patients. So, you know,
`
` I'm -- you know, estimating about 1,200.
`
` Q. And generally, what kind of patients do you
`
` see that have diabetes? Is there any commonalities
`
` between them?
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2317.017
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`William C. Biggs, MD
`
`San Diego, CA
`
`10/15/2019
`Page 18
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` A. Every patient's unique, so I -- I mean,
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` maybe you could, you know, elaborate on, you know, how
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` you want to categorize them.
`
` Q. Do your patients with diabetes tend to have
`
` other health problems as well that they share in
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` common?
`
` A. Some of them do.
`
` Q. What kind of problems would those be?
`
` A. Well, I mean, just about any problem a
`
` person can get, a person with diabetes can get that,
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` too.
`
` Are you -- are you asking for complications
`
` of diabetes, or what are you --
`
` Q. Yeah. Let me ask a couple different things.
`
` Do -- do you have patients with diabetes
`
` that suffer from dexterity issues, for example?
`
` A. I do.
`
` Q. How many of your diabetes patients would you
`
` say suffer from dexterity issues?
`
` A. A small number. Are you looking for a
`
` percentage or something like that or...
`
` Q. Just a rough estimation.
`
` A. I guess, you know, we'd have to put
`
` a -- a -- you know, just how severe of a dexterity
`
` issue are we talking about? I mean, some people have
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2317.018
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`William C. Biggs, MD
`
`San Diego, CA
`
`10/15/2019
`Page 19
`
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` minor issues. People that have major problems with
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` dexterity, less than 1 percent.
`
` Q. So you mentioned that these kind of issues
`
` can range from minor issues to major issues.
`
` What do the dexterity issues look like in
`
` your patients? How do they manifest?
`
` MS. DEVINE: Objection; form.
`
` THE WITNESS: Well, there's different kind
`
` of reasons for having dexterity issues. I mean, that's
`
` kind of a nonspecific term. Some people have
`
` neuropathy in their hands, so that they don't have
`
` normal sensation in their fingers. And so the muscles
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` work fine, the tendons work fine; it's just that they
`
` don't have normal feeling.
`
` Other people do have limitations due to the
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` tendons in their hands becoming stiffer. Some people
`
` have arthritis related to aging or rheumatoid
`
` arthritis. Some people have muscle atrophy due to
`
` neuropathy or other neuromuscular diseases.
`
` So there's lots of different manifestations
`
` that a person could have.
`
` BY MR. GESIOR:
`
` Q. And you, in your treatment -- strike that.
`
` You, in your practice, treat patients with
`
` diabetes who also have this range of dexterity issues
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2317.019
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`William C. Biggs, MD
`
`San Diego, CA
`
`10/15/2019
`Page 20
`
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` that you just -- just described; correct?
`
` A. I do.
`
` Q. What kind of problems do these issues create
`
` in patients' everyday lives?
`
` MS. DEVINE: Objection; form.
`
` THE WITNESS: You know, not -- I think that
`
` people that have, like, arthritic diseases might have
`
` trouble opening, you know, pickle jars or, you know,
`
` they definitely have, you know, limitations as far as
`
` the strength of their hands. You know, I mean, again,
`
` it depends on exactly which problem we're talking about
`
` here.
`
` BY MR. GESIOR:
`
` Q. So these problems can create different
`
` issues, depending on the patient, in their everyday
`
` lives from minor to pretty substantial hindrances to
`
` their daily activities; correct?
`
` MS. DEVINE: Objection; form and scope.
`
` THE WITNESS: There's a wide range, you
`
` know, so I would say the more common things are the
`
` more minor things.
`
` BY MR. GESIOR:
`
` Q. So, for example, do you have patients who
`
` have trouble opening pill bottles?
`
` MS. DEVINE: Objection; form and scope.
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2317.020
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`William C. Biggs, MD
`
`San Diego, CA
`
`10/15/2019
`Page 21
`
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` THE WITNESS: You know, I haven't had any
`
` complaints about people opening pill bottles. I think
`
` that, you know, very often they can be palmed. If I do
`
` have somebody that has problems with pill bottles, we
`
` have good alternatives for them. There are pill packs.
`
` So, yeah, I mean, there are -- you know,
`
` again, we -- I think we've got everybody accommodated,
`
` and that's -- that specific problem tends to be
`
` something that is handled by the pharmacist when they
`
` dispense the product, that it's dispensed in a way that
`
` the patient can use.
`
` BY MR. GESIOR:
`
` Q. So you would adjust the treatment regimen,
`
` if needed, for a patient who had issues with, say,
`
` their ongoing treatment regimen --
`
` (Reporter clarification.)
`
` BY MR. GESIOR:
`
` Q. -- their ongoing treatment regimen, for
`
` example, being unable to open a pill bottle?
`
` MS. DEVINE: Objection; form and scope.
`
` THE WITNESS: You know, there's -- again,
`
` there's numerous alternatives, so, I mean, usually it
`
` doesn't rise to -- to, you know, my level. That's
`
` usually handled by the patient themselves or -- or the
`
` pharmacist. It's not necessarily something that I need
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2317.021
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`William C. Biggs, MD
`
`San Diego, CA
`
`10/15/2019
`Page 22
`
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` to -- to be ordering specifically.
`
` BY MR. GESIOR:
`
` Q. Are there any other health issues that
`
` people with diabetes are more -- more likely to have?
`
` MS. DEVINE: Objection; form and scope.
`
` THE WITNESS: So are you asking for what
`
` complications of diabetes a person with diabetes can
`
` get?
`
` BY MR. GESIOR:
`
` Q. Sure.
`
` A. They can have diabetic retinopathy that
`
` affects the eyes and vision if untreated, diabetic
`
` neuropathy affecting the sensation in their feet and
`
` hands, as well as the muscle strength diffusely. They
`
` can have kidney disease, or diabetic nephropathy. They
`
` can have increased risk of cardiovascular disease,
`
` including heart attack, stroke, peripheral vascular
`
` disease.
`
` So diabetes is a serious illness. And many
`
` of those complications are avoidable with good care.
`
` Q. So you just previously clarified my question
`
` to ask if I was asking about complications of diabetes.
`
` Are there other health problems that usually
`
` accompany diabetes that patients are suffering from
`
` that aren't necessarily complications of the disease
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2317.022
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`William C. Biggs, MD
`
`San Diego, CA
`
`10/15/2019
`Page 23
`
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` itself?
`
` MS. DEVINE: Objection; form and scope.
`
` THE WITNESS: Well, for type 1 diabetes,
`
` this is an autoimmune form of diabetes, and the
`
` immunity can sometimes cause associated endocrine
`
` issues such as adrenal insufficiency, pernicious
`
` anemia, Hashimoto's thyroiditis with hypothyroidism,
`
` Graves' disease --
`
` (Reporter clarification.)
`
` THE WITNESS: -- Hashimoto's thyroiditis or
`
` Graves' disease.
`
` I don't know if I said vitiligo,
`
` hypoparathyroidism, premature gonadal failure, among
`
` other things.
`
` Type 2 diabetes is associated with
`
` hyperlipidemia and hypertension, which can cause
`
` premature cardiovascular disease.
`
` BY MR. GESIOR:
`
` Q. And can any of these health problems
`
` affect -- strike that.
`
` Can any of these health problems you just
`
` discussed, both the complications and the -- the term
`
` might be "co-morbidities" -- do any of -- strike that.
`
` Is the term co- -- "co-morbidities" for the
`
` diseases you discussed that diabetes -- diabetic
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2317.023
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`William C. Biggs, MD
`
`San Diego, CA
`
`10/15/2019
`Page 24
`
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` patients are more likely to have?
`
` A. I would say they're associated --
`
` Q. Associated.
`
` A. -- illnesses.
`
` Q. Thank you. So for all the health problems
`
` you discussed, both the complications and the
`
` associated illnesses, do any of these health problems
`
` make administering diabetes treatments more difficult?
`
` A. I'm not having trouble getting people their
`
` treatments with or without any of those problems.
`
` Q. And you're speaking of your patients today?
`
` A. I don't remember having -- I don't think
`
` I've had any problems delivering their medications -- I
`
` mean, there's -- we've always had something we can do.
`
` So that's -- I've never had any limitations on
`
` providing medications to a person.
`
` Q. And that was also true in 2006 or 2007?
`
` A. Correct.
`
` Q. And you mentioned that there was always
`
` something we can do in order to make sure the patient
`
` receives their medication. Does that mean that there
`
` were room for improvement in the treatments, but there
`
` was some workaround that you could use at the time as
`
` an alternative?
`
` MS. DEVINE: Objection; form and scope.
`
`1-800-FOR-DEPO
`
`www.AldersonReporting.com
`
`Alderson Court Reporting
`
`Sanofi Exhibit 2317.024
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`William C. Biggs, MD
`
`San Diego, CA
`
`10/15/2019
`Page 25
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` THE WITNESS: You know, the -- the disease
`
` has not been cured or prevented, and so until that day
`
` has come, there will be room for improvement.
`
` BY MR. GESIOR:
`
` Q. And so there's also room for improvement in
`
` delivering the medication that is available at any
`
` given point?
`
` MS. DEVINE: Objection; form and scope.
`
` THE WITNESS: You know, I'm not -- I don't
`
` think that any of us are unhappy with, you know, how
`
` the medicine's delivered today.
`
` BY MR. GESIOR:
`
` Q. Do you agree, as a general matter, that
`
` patients with diabetes that have deterioration of fine
`
` motor skills or these dexterity issues or limited joint
`
` mobility that you discussed, that that can have an
`
` impact on hand-eye coordination, balance, dexterity,
`
` tracking and other skills?
`
` MS. DEVINE: Objection; form.
`
` THE WITNESS: Do you want to say that
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