throbber
Page 1
`
` 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
`
`TSG Reporting - Worldwide 877-702-9580
`
`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
`
`Mylan Ex.1056
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`Page 2
`
` September 10, 2019
` 8:07 a.m.
`
` 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
`Jersey, and Delaware.
`
`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
`
`TSG Reporting - Worldwide 877-702-9580
`
`Mylan Ex.1056
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`Page 3
`
`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)
`
`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
`
`TSG Reporting - Worldwide 877-702-9580
`
`Mylan Ex.1056
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`Page 4
`
`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
`
` 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
`
`TSG Reporting - Worldwide 877-702-9580
`
`Mylan Ex.1056
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`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
`
` ROBIN S. GOLAND
`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
`
`TSG Reporting - Worldwide 877-702-9580
`
`Mylan Ex.1056
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`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
`
` ROBIN S. GOLAND
`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.
`
`TSG Reporting - Worldwide 877-702-9580
`
`Mylan Ex.1056
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`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
`
` ROBIN S. GOLAND
` 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.
`
`TSG Reporting - Worldwide 877-702-9580
`
`Mylan Ex.1056
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`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
`
` ROBIN S. GOLAND
` 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?
`
`TSG Reporting - Worldwide 877-702-9580
`
`Mylan Ex.1056
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`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
`
` ROBIN S. GOLAND
` 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.
`
`TSG Reporting - Worldwide 877-702-9580
`
`Mylan Ex.1056
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`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
`
` ROBIN S. GOLAND
` 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?
`
`TSG Reporting - Worldwide 877-702-9580
`
`Mylan Ex.1056
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`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
`
` ROBIN S. GOLAND
` 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.
`
`TSG Reporting - Worldwide 877-702-9580
`
`Mylan Ex.1056
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`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
`
` ROBIN S. GOLAND
` 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.
`
`TSG Reporting - Worldwide 877-702-9580
`
`Mylan Ex.1056
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`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
`
` ROBIN S. GOLAND
` 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.
`
`TSG Reporting - Worldwide 877-702-9580
`
`Mylan Ex.1056
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`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
`
` ROBIN S. GOLAND
` 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
`
`TSG Reporting - Worldwide 877-702-9580
`
`Mylan Ex.1056
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`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
`
` ROBIN S. GOLAND
`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
`
`TSG Reporting - Worldwide 877-702-9580
`
`Mylan Ex.1056
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`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
`
` ROBIN S. GOLAND
`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.
`
`TSG Reporting - Worldwide 877-702-9580
`
`Mylan Ex.1056
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`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
`
` ROBIN S. GOLAND
` 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
`
`TSG Reporting - Worldwide 877-702-9580
`
`Mylan Ex.1056
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`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
`
` ROBIN S. GOLAND
`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
`
`TSG Reporting - Worldwide 877-702-9580
`
`Mylan Ex.1056
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`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
`
` ROBIN S. GOLAND
`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.
`
`TSG Reporting - Worldwide 877-702-9580
`
`Mylan Ex.1056
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`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
`
` ROBIN S. GOLAND
` 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?
`
`TSG Reporting - Worldwide 877-702-9580
`
`Mylan Ex.1056
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`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
`
` ROBIN S. GOLAND
` 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?
`
`TSG Reporting - Worldwide 877-702-9580
`
`Mylan Ex.1056
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`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
`
` ROBIN S. GOLAND
` 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
`
`TSG Reporting - Worldwide 877-702-9580
`
`Mylan Ex.1056
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`Page 23
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` ROBIN S. GOLAND
`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
`
`TSG Reporting - Worldwide 877-702-9580
`
`Mylan Ex.1056
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`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
`
` ROBIN S. GOLAND
`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.
`
`TSG Reporting - Worldwide 877-702-9580
`
`Mylan Ex.1056
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`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
`
` ROBIN S. GOLAND
` 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
`
`TSG Reporting - Worldwide 877-702-9580
`
`Mylan Ex.1056
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`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
`
` ROBIN S. GOLAND
`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
`
`TSG Reporting - Worldwide 877-702-9580
`
`Mylan Ex.1056
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`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
`
` ROBIN S. GOLAND
`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
`
`TSG Reporting - Worldwide 877-702-9580
`
`Mylan Ex.1056
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`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
`
` ROBIN S. GOLAND
`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.
`
`TSG Reporting - Worldwide 877-702-9580
`
`Mylan Ex.1056
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`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
`
` ROBIN S. GOLAND
` 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
`
`TSG Reporting - Worldwide 877-702-9580
`
`Mylan Ex.1056
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`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
`
` ROBIN S. GOLAND
`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

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

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.

throbber

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.

Become a Member

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

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket