`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`----------------------------------------x
`MYLAN PHARMACEUTICALS, INC.,
` Petitioner,
` v.
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
` Patent Owner.
`----------------------------------------x
` Case IPR2018-01670
` Case IPR2018-01675
` Case IPR2018-01676
` Case IPR2018-01678
` Case IPR2018-01679
` Case IPR2018-01680
` Case IPR2018-01682
` Case IPR2018-01684
` Case IPR2019-00122
` Patent No. 8,603,044
` Patent No. 8,679,069
` Patent No. 8,992,486
` Patent No. 9,526,844
` Patent No. 9,604,008
`
` DEPOSITION OF ROBIN S. GOLAND
` New York, New York
` Tuesday, September 10, 2019
`
`Reported by:
`Amy A. Rivera, CSR, RPR, CLR
`JOB NO. 167682
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` September 10, 2019
` 8:07 a.m.
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` Deposition of ROBIN S. GOLAND held at
`the office of WILSON, SONSINI, GOODRICH & ROSATI,
`P.C., 1301 Avenue of the Americas, 40th Floor, New
`York, New York, pursuant to Notice, before Amy A.
`Rivera, Certified Shorthand Reporter, Registered
`Professional Reporter, Certified LiveNote Reporter,
`and a Notary Public of the States of New York, New
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`A P P E A R A N C E S:
`WEIL, GOTSHAL & MANGES
`Attorneys for Patent Owner
` 767 Fifth Avenue
` New York, New York 10153
`BY: ANNA DWYER, ESQ.
` ROBERT VLASIS, ESQ.
`
`WILSON SONSINI GOODRICH & ROSATI
`Attorneys for the Petitioner
` 12235 El Camino Real
` San Diego, California 92130
`BY: ELHAM STEINER, ESQ.
`
`WINSTON & STRAWN
`Attorneys for Pfizer
` 1700 K Street, N.W.
` Washington, D.C. 20006
`BY: JOVIAL WONG, ESQ. (Telephonically)
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` ROBIN S. GOLAND
`R O B I N S. G O L A N D, having been duly
`sworn, testified as follows:
`EXAMINATION
` BY MS. STEINER:
` Q. Good morning, Dr. Goland.
` A. Good morning.
` Q. I just introduced myself a few minutes
`ago. My name is Elli Steiner, and I'm going to be
`asking you a few questions about your work in
`connection with the IPR proceedings.
` A. Okay.
` Q. Have you been deposed before?
` A. Yes.
` Q. Approximately how many times?
` A. Twice.
` Q. And do you recall when those
`depositions took place?
` A. The first was many years ago, and the
`second was as part of the Merck proceedings.
` Q. And you testified on behalf of Sanofi
`in the Merck proceedings?
` A. Yes.
` Q. And the case that was many years ago,
`was that -- did that case involve a patent
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`litigation?
` A. No.
` Q. And have you ever testified at trial?
` A. Yes.
` Q. How many times?
` A. Once.
` Q. Was that at the Merck trial?
` A. Yes.
` Q. So just so you understand, you're
`going to be providing testimony here today, and
`the court reporter is going to be taking down your
`testimony, and your testimony is going to be under
`oath.
` A. I understand.
` Q. Now, is there any reason that you
`can't provide complete and accurate testimony here
`today?
` A. No.
` Q. I'm going to do my best to make sure
`that my questions are clear today. If for some
`reason you don't understand my question or require
`clarification, please go ahead and let me know,
`and I will attempt to reframe the question for
`you. To the extent you answer my questions, we're
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`going to assume that you understood them.
` Is that fair?
` A. Okay.
` Q. Okay. And just to be clear, she is
`taking down a record of today, so no nodding or
`shaking your head. If you could just provide a
`verbal answer, that would be great.
` A. Okay.
` Q. And I don't expect it to be a very
`long deposition today, but if at any point in time
`you need to take a break, just let me know, if you
`would.
` A. Okay.
` Q. Dr. Goland, are you being compensated
`for your time here today?
` A. Yes, I am.
` Q. And how much is your compensation?
` A. $750 an hour.
` Q. Is that your standard rate for expert
`services?
` A. Yes, it is.
` Q. And who is providing your compensation
`in this matter?
` A. The law firm.
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` Q. That law firm is Weil?
` A. Yes.
` Q. Were you retained by Weil in this
`case?
` A. Yes, I was.
` Q. Do you know who at Weil contacted you?
` Robert?
` A. Robert and Anna.
` Q. Got it. Okay.
` Dr. Goland, do you have a current
`affiliation with Sanofi other than the IPR
`proceedings for which you're being deposed today?
` A. No, I do not.
` Q. Have you ever had an affiliation with
`Sanofi in the past?
` A. No.
` Q. You've never served as an investigator
`for any clinical trials that Sanofi was
`sponsoring?
` A. Well, I have served as a clinical
`investigator. I am a clinical investigator on an
`NIH trial called the "GRADE Trial" for Sanofi as
`providing Lantus as part of the four medications
`that we were evaluating in that trial.
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` Q. And that's the only instance where --
` A. Yes, that I recall.
` Q. Okay. Have you authored any articles
`that were sponsored by Sanofi?
` A. I don't believe so.
` Q. I'm going to hand you a copy of
`Exhibit 2111.
` (Exhibit 2111, declaration, was marked
` for identification at this time.)
` BY MS. STEINER:
` Q. Do you recognize this document,
`Dr. Goland?
` A. Yes, I do.
` Q. What is it?
` A. It's my declaration.
` Q. And you submitted the same declaration
`in each of the IPRs relating to the patents that
`we're going to be discussing today. Is that
`correct?
` A. I submitted one declaration.
` Q. One declaration. Okay.
` You'll see on the cover page of your
`declaration that there is a case number and a U.S.
`patent number?
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` It's about a little under -- over --
` A. Yes, I do.
` Q. Okay. Do you understand that there's
`more than one patent at issue in these IPRs?
` A. I don't really know anything about the
`patents. That's outside of my area of expertise.
` Q. Okay. If you could take a look at
`Exhibit 2111, your signature is on page 15 of this
`exhibit, correct?
` A. Yes, that is correct.
` Q. Did you review your declaration before
`signing it, Dr. Goland?
` A. Yes, I did.
` Q. And did you have sufficient time to
`review the declaration before finalizing and
`signing it?
` A. Yes, I did.
` Q. Who wrote this declaration?
` A. I did.
` Q. In its entirety?
` A. Yes.
` Q. Counsel didn't help you with the
`drafting of the declaration in any way?
` A. There were multiple drafts.
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` Q. So it was a joint effort between you
`and counsel?
` A. Yes.
` Q. Who wrote the first draft?
` A. I did.
` Q. And when you signed your declaration
`on June 24, 2019, were there any outstanding
`issues that you wanted to investigate further
`within the scope of your declaration?
` MS. DWYER: Objection.
` I'll just counsel you not to divulge
` any privileged information.
` A. Not that I recall.
` Q. Okay. And so when you signed this
`declaration, you thought -- the entirety of your
`opinions with respect to these IPR proceedings
`were set forth in your declaration?
` A. Yes.
` Q. Did you review your -- let me back up.
` You submitted an expert report in the
`Merck litigation. Is that true?
` A. Yes.
` Q. And did you review that expert report
`when you were drafting this declaration?
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` A. Yes.
` Q. Were your opinions in this -- the
`opinions that are set forth in this declaration
`similar or the same as the -- your opinions set
`forth in your expert report in the Merck
`litigation?
` A. They were similar.
` Q. Is there anything in your declaration
`that you'd like to modify or correct?
` A. No.
` Q. Are you aware that your declaration
`must contain all facts and data that you
`considered to form your opinions?
` A. Yes.
` Q. And does your declaration, in fact,
`include all facts and data that you considered?
` A. Yes.
` Q. Did you speak to anyone about the
`opinions that are set forth in your declaration?
` MS. DWYER: Again, I'll object.
` And just counsel you not to divulge
` any privileged information.
` THE WITNESS: Okay.
` A. Yes.
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` Q. Who did you speak with?
` A. I had a telephone conversation with
`Dr. Grabowski.
` Q. And who is Dr. Grabowski?
` A. He's an economist.
` Q. And Dr. Grabowski is providing -- has
`provided -- submitted a declaration in the IPR
`proceedings as well, correct?
` A. Yes.
` Q. And what did you discuss with
`Dr. Grabowski?
` A. We discussed the features of the
`SoloSTAR pen and the use of the pen and insulin in
`the treatment of type 1 and type 2 diabetes.
` Q. And just to confirm, that was
`Dr. Grabowski, the economist, that you spoke with
`about this?
` A. Yes.
` Q. And what did Dr. Grabowski tell you
`about the features of the pen?
` A. That it's easy to use and has a low
`injection force.
` Q. Has -- is Dr. Grabowski an engineer?
` A. No.
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` Q. Does he have personal experience with
`using the SoloSTAR pen?
` A. I don't know.
` Q. He didn't tell you the basis of his
`opinion about the features of the pen?
` A. No.
` MS. DWYER: Objection. Form.
` Q. And what did he tell you about the low
`injection force?
` MS. DWYER: Objection. Form.
` A. That it was a feature of the SoloSTAR
`pen.
` Q. Did he mention anything about the
`patents that are asserted in this IPR -- or at
`issue in this IPR?
` A. Not really.
` Q. Did you speak with anyone else other
`than Dr. Grabowski and counsel?
` A. Oh, no.
` Q. And when -- when did this conversation
`take place?
` A. On June 20th.
` Q. Was it a telephone conversation?
` A. Yes.
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` Q. Have you ever met Dr. Grabowski?
` A. Yes.
` Q. Is that in connection with the Merck
`litigation?
` A. Yes.
` Q. So other than counsel and
`Dr. Grabowski, you have not discussed the opinions
`set forth in your declaration with anyone else?
` A. That is correct.
` Q. Now, since you signed your declaration
`on June 24, 2019, have you had a chance -- have
`you had an opportunity to review it?
` A. Yes, I have.
` Q. Was that in connection with preparing
`for this deposition today?
` A. Yes.
` Q. And did you see anything -- while you
`were reviewing it, did you see anything in your
`declaration that you wanted to change?
` A. No.
` Q. Now, prior to your involvement in the
`Merck litigation and these IPR proceedings, did
`you have experience with providing opinions with
`respect to pen devices used to deliver diabetes
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`medication?
` MS. DWYER: Objection. Form.
` A. I don't understand the question.
` Q. Sure.
` So the Merck litigation involved the
`same -- or some of the patents that are at issue
`in these IPR proceedings, correct, as far as you
`know?
` A. Yes.
` Q. Okay. And both the Merck litigation
`and this litigation, the device that is -- one of
`the devices at issue or that is involved in the
`proceedings is the Lantus SoloSTAR, correct?
` A. Yes.
` MS. DWYER: Objection, form.
` Q. Now, prior to your involvement in that
`Merck litigation and in these IPR proceedings, did
`you provide opinions with respect to pen delivery
`systems or injection devices for diabetes
`medication?
` MS. DWYER: Objection. Form.
` A. In legal proceedings or to patients?
` Q. Let's start with legal.
` A. I have not participated in other legal
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`proceedings.
` Q. Okay. And with respect to patients,
`are you referring to just training or discussions
`with your patients about the product that they
`would be using?
` MS. DWYER: Objection. Form.
` A. I have a longer than 30-year career
`taking care of and running the diabetes center
`that cares for more than 14,000 patients, so I
`have extensive experience with all insulin
`products and insulin pen devices.
` So I have given a lot of advice about
`insulin devices in that context.
` Q. Okay. And your opinions with respect
`to insulin products, and specifically insulin pen
`devices, has that been from the point of view of a
`user about the user interface or has it been about
`the inner workings of the pen?
` MS. DWYER: Objection. Form.
` A. It's been from the point of view of a
`clinician who advises patients.
` I'm not a mechanical engineer. I
`don't have that expertise.
` Q. Okay. Thank you.
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` Now, you were -- you mentioned that
`you have 30 years or over 30 years of experience
`as a clinician in the diabetes field.
` Are you relying on that expertise to
`offer your opinions that are set forth in your
`declaration?
` A. I'm relying on my many decades of
`clinical experience and public literature, many
`decades of attending diabetes meetings -- the last
`was in San Diego -- and discussions with
`colleagues, all of those.
` Q. And your field is endocrinology. Is
`that correct?
` A. Yes.
` Q. And so all of those things that you
`listed, your clinical experience, public
`literature, diabetes meetings and discussions with
`colleagues, are those all in the field of
`endocrinology?
` A. Broadly speaking.
` Diabetes is a very broad topic, so
`surgeons, cardiologists, nephrologists, primary
`care doctors weigh in about diabetes. The FDA
`weighs in about diabetes. It's not just
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`endocrinologists.
` Q. Understood.
` And I think you mentioned earlier
`you're not an engineer, correct?
` A. Correct.
` Q. And you've never designed an injector
`pen, correct?
` A. That is correct.
` Q. And do you have any legal expertise,
`other than what you may have picked up in the
`Merck litigation and these proceedings?
` A. No, I do not.
` Q. Now, we briefly discussed the patents
`at issue in these proceedings earlier.
` Do you understand that there are four
`patents that are at issue in these IPR
`proceedings?
` A. No, I don't know anything about the
`patents at issue.
` Q. Okay. So if I were to tell you what
`the numbers of those patents were, that would be
`meaningless to you?
` A. That is correct.
` Q. If I refer -- so I'll represent to you
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`that there are four patents at issue in these IPR
`proceedings. I won't bore you with the numbers,
`but if I refer to them collectively as the "device
`patents," will you know what I'm referring to?
` A. I will assume that means the patents
`that refer to the device.
` Q. Okay. And specifically, the four
`device patents that are at issue in these
`proceedings?
` A. But I don't know what those are. I
`mean, I understand the words in English.
` Q. Would you like me to tell you what
`those patent numbers are? Would that be helpful
`to you, or can we just refer to them as the
`"device patents"?
` A. It seems fine.
` Q. Okay. So is it fair to say that you
`did not review the device patents prior to forming
`your opinions in this case?
` A. Yes.
` Q. Is it your -- do you have an
`understanding as to whether the device patents
`cover the current Lantus SoloSTAR product?
` A. I do not.
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` Q. And so is it fair to say that you
`don't have an understanding as to whether the
`device patents cover the Lantus vial product?
` A. I do not.
` Q. Did you review any patents in
`connection with your work in the Merck litigation?
` A. No, I did not.
` Q. Okay. Now, Dr. Goland, it's your
`opinion that Lantus SoloSTAR met a long-felt but
`unmet need. Is that correct?
` A. Yes.
` Q. What is a long-felt, unmet need?
` A. It's a need that diabetes patients had
`for a peakless, long-lasting insulin that could be
`injected with a device that was easy to use, easy
`to push, that would improve the adherence with a
`really important drug for their ultimate health.
` Q. And do you have an understanding as to
`whether the device patents that are at issue in
`this proceeding and that you're opining on have
`anything to do with long-lasting insulin?
` MS. DWYER: Objection. Form.
` A. No.
` Q. You don't know one way or the other?
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` How long does a need -- sorry. Strike
`that. Let me start over.
` How long does a need need to be -- how
`long does a need need to be unmet before you
`consider it long-felt?
` That's a mouthful.
` A. Well, I've been in practice more than
`30 years, and the need was there at least that
`long. So more than that, and that certainly
`describes the need for peakless, long-lasting
`insulin in an easy-to-use, easy-to-push device.
` I think that's obviously a subjective
`question, but in my case, that certainly satisfies
`my definition of long-felt, unmet need.
` Q. And when you refer -- you mentioned
`that you've been in practice for more than 30
`years, and the need was there at least that long.
` You're referring to the need for a
`peakless, long-lasting insulin that is supplied in
`an easy-to-use device?
` A. Yes. Sorry.
` Q. Were there any pen devices that were
`used in connection with the treatment of diabetes
`30 years ago?
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` A. No.
` Q. Do you recall when the -- when the
`first pen was used in connection with diabetes
`treatment?
` MS. DWYER: Objection. Form.
` A. Early pens were the OptiClik and the
`FlexPen. They came out before SoloSTAR.
` Q. Do you recall around what time frame
`that was?
` A. Not precisely.
` Q. Speaking of time frames, what time
`frame did you use for your assessment about this
`long-felt, unmet need?
` MS. DWYER: Objection. Form.
` A. Well, historically from the time
`insulin was discovered, which was 90 years ago,
`and from my own clinical practice, which is when I
`started to practice endocrinology, which was 1987.
` Q. So are you familiar with the, I guess,
`legal idea of a long-felt need in patent cases?
` A. I understand it is a legal term.
` Q. And with respect to the time frame
`that you're supposed to consider in assessing
`whether or not there is a long-felt but unmet
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`need, do you know what time frame that is supposed
`to be?
` A. I don't.
` Q. And so is it fair to say that in
`connection with forming the opinions that are set
`forth in your declaration, you didn't apply any
`specific time frame?
` MS. DWYER: Objection. Form.
` A. I applied the time frame from the
`discovery of insulin in 1922.
` Q. So in 1922, there was a long-felt need
`for peakless, long-lasting insulin that could be
`delivered in an easy-to-use device?
` MS. DWYER: Objection. Form.
` A. From the time that doctors started
`treating patients with insulin, this was a big
`advance, because before then, people with type 1
`diabetes died.
` But the next big advance arguably was
`a vast improvement in insulin and the way it was
`delivered.
` Q. Now, going back to your declaration,
`Dr. Goland, is it your opinion that the claimed
`invention of the device patents fulfilled a
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`long-felt need for a long-lasting insulin or
`insulin glargine drug in an easy-to-use disposable
`pen?
` A. Yes.
` Q. So I just want to break that down a
`little bit.
` Was the long-felt but unmet need for
`long-lasting insulin?
` A. It was for both the long-lasting
`insulin and the way it's administered.
` Q. So if you look at page 1 of your
`declaration, in the second paragraph, the last
`sentence -- or second part of that last sentence,
`so your -- I just want to make sure that I'm
`characterizing your opinion fairly.
` So your opinion is that the long-felt
`but unmet need was for a long-lasting insulin or
`insulin glargine drug in an easy-to-use disposable
`pen as a package?
` A. Yes.
` Q. Do you know what patent -- what
`patented features of the Lantus SoloSTAR satisfied
`the long-felt need?
` A. No.
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` Q. Did you speak with Dr. Grabowski about
`what patented features of Lantus SoloSTAR
`satisfied the long-felt need?
` A. No.
` Q. So if I asked you to quantify how much
`of the need was for the medication of insulin --
`sorry -- long-lasting insulin or insulin glargine
`versus the method of delivery, would you be able
`to do that?
` A. No.
` Q. So in your mind, you can't separate
`the two?
` MS. DWYER: Objection. Form.
` A. As a clinical doctor, I prescribe them
`together, and so the features of the insulin and
`the pen, I explain them together.
` Q. And so to your mind, those features of
`the insulin and the pen, one isn't more important
`to the patient or to you as a clinician than the
`other?
` MS. DWYER: Objection. Form.
` A. They're both important.
` Q. Equally important?
` A. It's the combination of the two that
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`are important.
` Q. And the combination -- so I understand
`that your opinion is that it is a package of those
`two or a combination of those two.
` My question is more to attempting to
`quantify. So there's no way for you in your mind
`to quantify, you know, 50 percent of it is due to
`the medication, 50 percent is due to the device?
` MS. DWYER: Objection. Form.
` A. I would say it's a great synergy.
` Q. A great synergy of what?
` A. Of the medication and the device
`together.
` Q. Can insulin glargine be used with a
`different pen?
` A. No.
` Q. Because Sanofi doesn't offer it in a
`different pen?
` A. Correct.
` Q. Are you aware that Eli Lilly has a
`product that contains insulin glargine?
` MS. DWYER: Objection. Form.
` A. No.
` Q. And going back to my last question, so
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`insulin glargine can be delivered via a syringe or
`a pen. Is that correct?
` A. Yes.
` Q. Pesky thing about the record.
` A. Yes. Sorry.
` Q. All right. If you could turn to
`paragraph 19 of your declaration.
` A. Paragraph 19.
` MS. DWYER: On page 6.
` Q. Okay. Have you had a chance to review
`paragraph 19?
` A. Starting with "Patient preference"?
` Q. Correct.
` A. Yes.
` Q. You say that finding the right
`treatment for any given patient could take weeks
`or months or even longer, correct?
` MS. DWYER: Objection. Form.
` A. Yes.
` Q. How do you determine what the right
`treatment is for a patient?
` A. In the case of insulin, you start with
`a dose, the patient checks the blood sugar,
`reports back, and you change the dose or you teach
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`the patient to change the dose.
` Q. And so you're referring specifically
`to insulin, right?
` So at this point, you've already
`decided that the patient requires insulin of some
`sort?
` A. Yes, that's correct.
` Q. And how do you determine between the
`various insulin options that are available which
`one is the right treatment?
` A. Well, in a broad category, there is
`long-acting, intermediate-acting, short-acting,
`and depending on the patient's diagnosis and blood
`sugar pattern, you match the insulin to the blood
`sugar pattern.
` And if they have type 1, type 2,
`stearate-induced diabetes, cystic fibrosis-related
`diabetes, then there is the appropriate insulin
`regimen.
` Changing at that point, after the
`patient is stabilized, to a different insulin
`could destabilize that patient's regimen, and
`virtually no doctor would think that is a good
`idea.
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` Patients are not in favor of it
`either.
` Q. And in your patients -- you mentioned
`intermediate-acting, long-acting, and short-acting
`insulin.
` What is the breakdown in your patients
`that you prescribe between those three types of
`insulin?
` A. If you turn to -- I characterize this
`in paragraph 18. This is an estimate.
` So all of my type 1 patients use
`rapid-acting insulin; 5 percent use
`intermediate-acting insulin, and 40 percent use
`long-acting insulin or insulin analog.
` That's because many -- increasing
`numbers of people with type 1 are on the pump, and
`that's only very rapid-acting insulin.
` Thirty percent of the type 2 patients
`use long-acting insulin or insulin analog, and 5
`percent use rapid-acting.
` Q. And what about the remainder of your
`type 2 patients, what do they use?
` A. There are huge numbers of oral classes
`of medication and now injectable classes of
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`medication in addition to insulin that can be used
`in patients with type 2 diabetes, and so
`they're -- many of them are on three or four
`medications -- classes of medication in addition
`to insulin.
` Q. One of those medications is metformin,
`correct?
` A. Correct.
` Q. Now -- so let's take a step back to
`you've determined what the right treatment is for
`a particular patient, and you've decided that
`you're going to prescribe a long-acting patient --
`long-acting insulin, because that's the
`appropriate medication.
` Do you train that patient on how to
`inject when you prescribe insulin for that first
`time?
` MS. DWYER: Objection. Form.
` A. Patients who are first started on
`insulin all need to be trained. It's a huge
`barrier to starting people on insulin, and
`practices around the country and around the world
`have different resources f