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` KURT BARNHART, M.D.
` IN THE UNITED STATES DISTRICT COURT
` FOR THE DISTRICT OF NEW JERSEY
`
`WARNER CHILCOTT COMPANY, LLC, )
` Plaintiff, )Case No.
` vs. )3-11-cv-05048-JAP-TJB
`LUPIN, LTD. and LUPIN )
`PHARMACEUTICALS, INC., )
` Defendants. )
`
`
`
` DEPOSITION OF KURT BARNHART, M.D.
` Chicago, Illinois
` July 30, 2013
`
`JOB 64156
`REPORTED BY: Tina Alfaro, RPR, CRR, RMR, CLR
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`TSG Reporting - Worldwide 877-702-9580
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`Mylan v. Warner Chilcott IPR2015-00682
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` KURT BARNHART, M.D.
` IN THE UNITED STATES DISTRICT COURT
` FOR THE DISTRICT OF NEW JERSEY
`
`WARNER CHILCOTT COMPANY, LLC, )
` Plaintiff, )Case No.
` vs. )3-11-cv-05048-JAP-TJB
`LUPIN, LTD. and LUPIN )
`PHARMACEUTICALS, INC., )
` Defendants. )
`
`
`
` DEPOSITION OF KURT BARNHART, M.D.
` Chicago, Illinois
` July 30, 2013
`
`JOB 64156
`REPORTED BY: Tina Alfaro, RPR, CRR, RMR, CLR
`
`TSG Reporting - Worldwide 877-702-9580
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` KURT BARNHART, M.D.
`
`Page 2
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` July 30, 2013
` 8:12 a.m.
`
` The videotaped deposition of KURT BARNHART,
`M.D., held at the offices of Leydig, Voit & Mayer,
`Two Prudential Plaza, 180 North Stetson Avenue, Suite 4900,
`Chicago, Illinois, pursuant to agreement before Tina M. Alfaro,
`a Registered Professional Reporter of the State of Illinois.
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` KURT BARNHART, M.D.
`A P P E A R A N C E S:
` COVINGTON & BURLING
` BY: JEFFREY ELIKAN, ESQ.
` ERIC SONNENSCHEIN, ESQ.
` 1201 Pennsylvania Avenue, NW
` Washington, DC 20004
`
` and
`
` FITZPATRICK, CELLA, HARPER & SCINTO
` BY: JASON LEONARD, ESQ.
` 1290 Avenue of the Americas
` New York, New York 10104
`
` On behalf of the Plaintiff;
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` KURT BARNHART, M.D.
`A P P E A R A N C E S: (Cont'd)
` LEYDIG, VOIT & MAYER
` BY: MARC WEZOWSKI, ESQ.
` ROBERT GREEN, ESQ.
` Two Prudential Plaza
` 180 North Stetson Avenue, Suite 4900
` Chicago, Illinois 60601
`
` On behalf of the Defendants Lupin Ltd
` and Lupin Pharmaceuticals;
`
`ALSO PRESENT: Jeremy Mangan (videographer)
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` KURT BARNHART, M.D.
` I N D E X
` EXAMINATION
`WITNESS PAGE
`KURT BARNHART, M.D.,
` By Mr. Elikan 8
` EXHIBITS
`BARNHART EXHIBITS PAGE
`Exhibit 1 8
` Exhibit B to opening expert report
`Exhibit 2 31
` Opening expert report
`Exhibit 3 32
` Reply expert report
`Exhibit 4 34
` European Patent Application 0253607
`Exhibit 5 40
` '940 Patent
`Exhibit 6 49
` '394 Patent
`Exhibit 7 87
` '251 Patent
`Exhibit 8 133
` Exhibit 4 from responsive report of Dr.
` Darney
`Exhibit 9 161
` Killick article
`Exhibit 10 233
` Diagram
`Exhibit 11 243
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` KURT BARNHART, M.D.
` EXHIBITS
` (Cont'd)
`
`BARNHART EXHIBITS PAGE
`
`Exhibit 12 301
` (Not described)
`Exhibit 13 307
` Article entitled "Clinical Comparison of
` Triphasic Norgestimate/35 Micrograms
` Ethinyl Estradiol and Monophasic
` Norethindrone Acetate/20 Micrograms
` Ethinyl Estradiol Cycle Control, Lipid
` Effects, and User Satisfaction"
`Exhibit 14 310
` Patent in Seasonique litigation
`
`Exhibit 15 311
` '490 Patent
`Exhibit 16 330
` Preston reference
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` KURT BARNHART, M.D.
` THE VIDEOGRAPHER: We are now on the record.
`This marks the beginning of videotape No. 1 in the
`deposition of Dr. Kurt Barnhart in the matter of
`Warner Chilcott Company, LLC, versus Lupin and Lupin
`Pharmaceuticals in the U.S. District Court for the
`District of New Jersey, Case No. 311-CV-05048.
` This deposition is being held at 180 North
`Stetson Street, Chicago, Illinois on July 30, 2013,
`and the time is now 8:12 a.m.
` Will attorneys please identify
`themselves.
` MR. ELIKAN: Jeffrey Elikan of Covington &
`Burling representing Warner Chilcott LLC. With me
`today are Eric Sonnenschein also of Covington &
`Burling. And, Jason, you can introduce yourself.
` MR. LEONARD: Sure. Jason Leonard from
`Fitzpatrick, Cello, Harper & Scinto on behalf of
`Warner Chilcott.
` MR. WEZOWSKI: And I am Marc Wezowski from
`Leydig Voit & Mayer on behalf of Lupin Ltd. and
`Lupin Pharmaceuticals, Inc. and with me is Bob
`Green, also for Lupin also from Leydig.
` THE VIDEOGRAPHER: Will the court reporter
`please swear in the witness.
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` KURT BARNHART, M.D.
` (Witness sworn.)
`WHEREUPON:
` KURT BARNHART, M.D.,
`called as a witness herein, having been first duly
`sworn, was examined and testified as follows:
` EXAMINATION
`BY MR. ELIKAN:
` Q. Good morning, Dr. Barnhart. You've been
`deposed before, correct?
` A. Yes.
` Q. In fact, I've taken your deposition before?
` A. I've had the privilege.
` Q. And how many other times have you been
`deposed within the last year?
` A. Within the last year, I think I've been
`deposed twice.
` (Barnhart Exhibit 1 was marked
` as requested.)
`BY MR. ELIKAN:
` Q. I've had marked as Exhibit 1 Exhibit B to
`your opening expert report. Am I correct that this
`is indeed Exhibit B to your opening expert report?
` A. Yes.
` Q. And this lists the deposition and trial
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` KURT BARNHART, M.D.
`testimony that you've given over the last four
`years?
` A. With the exception of the last two I
`just -- you just asked me about.
` Q. What are those last two?
` A. They were two recent depositions in medical
`liability cases.
` Q. And when were you deposed in those two
`cases?
` A. One was about a month ago, and one was
`about ten days ago.
` Q. Can you tell me about the one that was
`about a month ago. What was the subject matter of
`the litigation?
` A. It was about -- it was medical malpractice
`regarding treatment of a potential tubal
`pregnancy.
` Q. What was the opinion that you offered in
`that -- or are offering in that case?
`
`
` MR. WEZOWSKI: I would caution you not to
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` KURT BARNHART, M.D.
`approached and what was the general matter. So why
`don't we -- if you think I'm getting into it, please
`interject, but I'm going to stay away from that as
`much as possible.
`BY MR. ELIKAN:
` Q. Dr. Barnhart, are there other projects that
`you've been approached by Lupin to consult with?
` A. I don't believe so.
` Q. Have you been approached about serving as
`an expert in patent litigation involving Natazia?
` A. I don't believe so.
` Q. By Lupin or anyone else?
` A. I don't think so.
` Q. Have you been retained as an expert in any
`patent litigation other than the matters in which
`you've been retained by Lupin?
` A. No.
` (Barnhart Exhibit 2 was marked
` as requested.)
`BY MR. ELIKAN:
` Q. Doctor, I'm handing you now what's been
`marked as Exhibit 2. Sir, I'd like you to identify
`Barnhart Exhibit 2 for the record.
` A. This is a copy of my opening report for
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` KURT BARNHART, M.D.
`this case.
` Q. Is that your signature on page 49 of the
`report?
` A. Yes, it is.
` (Barnhart Exhibit 3 was marked
` as requested.)
`BY MR. ELIKAN:
` Q. I'm handing you Barnhart 3. I'm going to
`ask that you identify that as well for the record.
` A. This is a reply expert report with my name.
` Q. And does your signature appear on page 56
`of your reply expert report?
` A. It does.
` Q. Can you turn now to your reply expert
`report, Exhibit 3, at paragraph 85.
` A. Direct me again, please.
` Q. Paragraph 85, reply expert report. It's
`page 46 if that's helpful.
` A. I have it.
` Q. All right. Can you read that to yourself,
`and I'm going to ask you a couple questions about
`it?
` (Witness viewing document.)
`BY THE WITNESS:
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` KURT BARNHART, M.D.
` Q. Would a person of ordinary skill in the art
`choosing to make an oral contraceptive that's
`modified from this '940 Patent choose to make an
`oral contraceptive containing gestodene?
` A. They may choose to.
` Q. Okay. Let's turn now to -- I don't think
`I've marked it. Okay. We're moving on to the next
`exhibit.
` Doctor, you've offered opinions in this
`case in both your expert -- opening expert and reply
`expert report on the '394 Patent, correct?
` A. The '394 Patent?
` Q. The Hodgen patent.
` A. Yes.
` Q. Now, is studying cycle control in monkeys a
`standard way of measuring cycle control?
` A. No.
` MR. WEZOWSKI: Objection, form.
`BY THE WITNESS:
` A. No.
` Q. Have you seen cycle control studied in
`monkeys in other studies?
` A. Yes.
` Q. Which studies?
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` KURT BARNHART, M.D.
` A. I know monkeys have been used as a model to
`study in hormone replacement therapy in cycle
`control and maybe in some other oral contraceptive
`preparations.
` Q. Let's confine the question to oral
`contraceptives. Are you aware of any studies that
`used monkeys to study cycle control in oral
`contraceptives?
` A. I can't list any now, but I'm not going to
`say that there aren't any.
` Q. You're not aware of any sitting here today?
` A. Correct.
` Q. Would a POSA in 2005 have believed that
`studying cycle control in monkeys was a standard way
`of measuring cycle control in an oral contraceptive?
` MR. WEZOWSKI: Objection, form.
`BY THE WITNESS:
` A. I don't think they would have considered it
`a standard, no.
` Q. Would a POSA in 2005 have believed that it
`was a reliable way of studying cycle control with an
`oral contraceptive?
` A. When I hear "reliable," I always think
`reliable compared to what. I mean, it has some
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` KURT BARNHART, M.D.
`reliability in that you can study bleeding, but it's
`not a person and therefore the findings may not be
`completely generalizable to what happens in women.
` Q. What are the differences between humans and
`monkeys that make it difficult to generalize
`findings in monkeys to humans?
` A. There are a lot of differences between
`women and monkeys.
` Q. Expound, sir.
` A. Well, women are not monkeys. So there may
`be differences in the physiology, the doses of the
`pills might have to be changed slightly, the
`menstrual patterns might be slightly different.
` Q. Okay. Do you have Barnhart 6 still in
`front of you, the '394 Hodgen patent?
` COURT REPORTER: Did you give it to him?
` MR. ELIKAN: I'm told that I did. Here it is,
`Dr. Barnhart, right on the top of the pile.
`BY THE WITNESS:
` A. Okay.
` Q. Is that the '394 Patent that I mentioned
`earlier that you've given opinions on in this
`case?
` A. '394 Hodgen, yes.
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` Q. In contraceptive studies with humans, is
`cycle control usually measured by women filling out
`diaries to record instances of bleeding or spotting?
` A. That is common, yes.
` Q. That's the pervasive method used, correct?
` A. Sometimes they fill out diaries. Sometimes
`they do it by recollection. Sometimes they're asked
`by an investigator.
` Q. What is the most reliable of those three
`methods?
` A. I don't think I know.
` Q. Are either of those three methods ones that
`were used by the investigators in the monkey study
`that's discussed in this patent?
` A. I don't think so.
` Q. Now, women can voluntarily discontinue
`their participation in a study, right?
` A. Yes.
` Q. And that would include an oral
`contraceptive study?
` A. Of course.
` Q. Can monkeys do that?
` A. I don't believe they can.
` Q. Do you know what the rate was of breast
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`tenderness that was recorded for the monkeys in
`either of the two arms that were studied by
`Dr. Hodgen in this patent?
` A. I don't think it's written in the patent,
`and I assume there's some facetiousness in your
`question that I don't think the monkeys reported it.
` Q. What about nausea, any instances of nausea
`in either arm of the study?
` A. I don't think the monkeys reported on
`nausea either.
` Q. What was the lipid profile of the two
`groups in the study?
` A. I don't recall that they measured it.
` Q. Do you know what the average size was of
`the monkey follicles in the study at any point?
` A. I don't think so.
` Q. Did it vary between the two arms of the
`study?
` A. I don't believe they looked at it.
` Q. Do we know if the monkeys were all of the
`same age?
` A. I would have to look to see. I don't
`recall if they were the exact same age or not.
` Q. Do you know whether the monkeys being of
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`different ages could have affected how much each
`monkey bled during the course of the study?
` A. I don't -- other than it says that they are
`ten adult monkeys and I assume that they were having
`menstrual cycles, I don't know that the age of an
`adult monkey affects their bleeding.
` Q. Does the age of an adult woman affect
`whether or not she's going to bleed?
` A. Assuming she's post-pubertal --
`post-puberty -- well, yes. In a certain degree,
`yes. There are times in a woman's life when the
`cycles are more irregular than others.
` Q. And in a study with five subjects per arm,
`is it possible that one group but not the other
`could be particularly susceptible to bleed?
` A. It's possible.
` Q. And is it possible that the five subjects
`in either arm wouldn't be representative of the
`population as a whole?
` A. That's also possible.
` Q. Was this a blinded study?
` A. I don't recall.
` Q. I didn't see anything in here about
`blinding.
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` A. I agree with you. I don't remember seeing
`it.
` Q. Do you agree that blinding in a study
`reduces bias because it increases the likelihood
`that the data are collected and reported in the same
`manner for all participants?
` A. Yes.
` Q. Would a POSA in 2005 have agreed with that?
` A. Yes.
` Q. Do you see in column 3, lines 35 through 36
`a statement that the invention "Relates to a method
`of female contraception which is characterized by a
`reduced incidence of break-through bleeding"?
` A. I see that.
` Q. Other than the monkey data that's provided
`in the patent, is there other data in this patent
`supporting that assertion?
` A. No.
` Q. Is use of monkeys a standard way of
`measuring contraceptive efficacy of a combination
`oral contraceptive in human females?
` MR. WEZOWSKI: Objection, form.
`BY THE WITNESS:
` A. No.
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` KURT BARNHART, M.D.
` Q. Would the person of ordinary skill in the
`art have agreed with that opinion in 2005?
` A. Yes.
` Q. Do you believe that -- would the FDA allow
`a company to gain FDA approval based on monkey
`subjects for an oral contraceptive?
` A. Solely, no.
` Q. How many cycles does the FDA generally
`require for proof of efficacy of a combination oral
`contraceptive?
` A. I think the standard has changed, but I
`believe it's in the order of either 10,000 or
`20,000.
` Q. Can you look at column 5, 47 through 52.
`Do you have that, sir?
` A. Yes.
` Q. And do you see that Dr. Hodgen extrapolates
`from the doses given to the monkeys based on
`assuming an average weight for a woman of
`50 kilograms?
` A. I see that.
` Q. Is that the average weight of an average
`woman?
` A. I don't know.
`
`TSG Reporting - Worldwide 877-702-9580
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`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2022, Pg. 19
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` KURT BARNHART, M.D.
` Q. Do you believe that to have been the
`average weight of a woman in 2005?
` A. I don't know. I guess it would depend on
`which population and lots of other things, but...
` Q. Is that about 110 pounds?
` A. That's about right, a hundred and -- in
`that range, yes.
` Q. You have some larger women in your
`practice?
` A. I certainly do.
` Q. What is your estimate of the average weight
`of women in your practice?
` A. I don't think I've ever tried to quantitate
`it. There are certainly women that are 110 pounds,
`and there are certainly a lot of women that are
`heavier than that.
` Q. Do you figure that it's higher than an
`average weight of 110 pounds?
` A. Yes, I do.
` Q. Do you see in the paragraph above
`Dr. Hodgen says that "The dose of ethinyl estradiol
`was 1.2 micrograms per day, while the dose of
`norethindrone acetate was .06 micrograms per day"?
` A. I see that.
`
`TSG Reporting - Worldwide 877-702-9580
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`
` KURT BARNHART, M.D.
` Q. Do you see that the way he extrapolated to
`find a comparable dose in human females in the next
`paragraph was multiply those figures by 10?
` A. I don't see the derivative of 10.
` Q. You see that the monkeys are said to weigh
`about 5 kilograms, right?
` A. Yes. Okay. I see what you're saying.
` Q. Okay. I'm not sure the record is clear.
`Do you see that the way he extrapolated to find
`comparable doses of ethinyl estradiol and
`norethindrone for human females was to multiply the
`doses administered to the monkeys by 10?
` A. I don't see the multiples of 10, but I see
`the 5 kilogram -- with the monkey's body weight
`about 5 kilograms and a woman's at 50 kilograms.
` Q. That's a 10 to 1 ratio, correct?
` A. That's correct.
` Q. And multiplying 1.2 micrograms per day
`times 10 yields 12 micrograms of ethinyl estradiol,
`right?
` A. Correct.
` Q. And that's the amount recorded as being the
`comparable amount for human females, correct?
` A. That's correct.
`
`TSG Reporting - Worldwide 877-702-9580
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`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2022, Pg. 21
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`
` KURT BARNHART, M.D.
` Q. And similarly, the amount of norethindrone
`acetate, the 6 micrograms per day, was multiplied by
`10 to yield .6 micrograms of norethindrone acetate
`for a woman, right?
` A. Correct.
` Q. So they're both multiplied by 10 to convert
`the monkey doses to comparable human doses, right?
` A. Yes.
` Q. And that's based on the difference between
`the monkey and human weight that Dr. Hodgen
`specifies?
` A. Yes.
` Q. 5 kilograms for the monkey and 50 for the
`woman, right?
` A. Yes.
` Q. You mentioned earlier a governmental agency
`called preventative something or other. Do you
`remember that?
` A. Yes.
` Q. What was the name of that?
` A. I didn't look it up. I think it's the
`United States preventative health task force or
`something close to that.
` Q. Is that part of Health and Human
`
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`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2022, Pg. 22
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`Page 301
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` KURT BARNHART, M.D.
`Services?
` A. I think it is.
` Q. Have you heard of the Center for Disease
`Control?
` A. Yes.
` Q. What is that?
` A. Governmental agency that looks at
`epidemiological issues of human health and disease.
` Q. Would the Center for Disease Control be a
`reliable source of information on average weights
`and heights of males and females?
` A. Yes.
` MR. ELIKAN: Can you mark this as 12.
` (Barnhart Exhibit 12 was marked
` as requested.)
`BY MR. ELIKAN:
` Q. Do you see in the second paragraph after
`the heading "Average weight/height on the rise" a
`sentence ending with "For women average weight was
`163 pounds"?
` A. No, I don't see it. I'm sure it's here. I
`just don't see it.
` Q. Okay. Let's start at the top. Do you see
`the third paragraph which says "On average both men
`
`TSG Reporting - Worldwide 877-702-9580
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`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2022, Pg. 23
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`
` KURT BARNHART, M.D.
`and women gain more than 24 pounds between the early
`1960s and 2002 says the CDC in the report in body
`weight height and body mass index, United States,
`1960, 2010"?
` A. I see that.
` Q. And do you see the date of this article is
`October 27, 2004?
` A. Yes.
` Q. And do you understand that this is
`reporting on a CDC publication?
` A. I understand that.
` Q. Now, if we skip down three paragraphs or
`four paragraphs, do you see a paragraph beginning
`"In people older than 20"?
` A. I see that.
` Q. And then the last sentence in that
`paragraph reads "By 2002 average weight for women
`was almost 191 pounds, for women average weight was
`163 pounds."
` A. You said women twice, but I see men were
`191 and women 163.
` Q. Let's try that again. Do you see the
`sentence says "By 2002 average weight for men was
`almost 191 pounds, for women average weight was
`
`TSG Reporting - Worldwide 877-702-9580
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`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2022, Pg. 24
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`
` KURT BARNHART, M.D.
`163 pounds"?
` A. Yes.
` Q. Do you have any reason to doubt the
`accuracy of the CDC's figures here?
` A. No.
` Q. Am I correct that that's approximately a
`50 percent increase in average weight as compared to
`the 50 kilogram figure that Dr. Hodgen used?
` A. Yes.
` Q. And does this reflect, among other things,
`the obesity epidemic in the United States?
` A. Yes.
` Q. Are you aware of any parallel obesity
`epidemic among Cynomolgus monkeys during the same
`time frame?
` A. Probably only ones that were in
`captivity.
` Q. Are you aware of any reports on obesity
`epidemics among Cynomolgus monkeys in captivity?
` A. No. I was trying to be funny.
` Q. If we were to instead use the 163 pounds
`for the average weight of a woman, the ratio of the
`weight of the woman to the monkey would be in the
`order of 15 to 1, correct?
`
`TSG Reporting - Worldwide 877-702-9580
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`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2022, Pg. 25
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` KURT BARNHART, M.D.
` A. Correct.
` Q. And if we multiplied the 1.2 micrograms of
`ethinyl estradiol by 15, we would end up with
`18 micrograms of ethinyl estradiol, right?
` A. Yes.
` Q. And if we multiplied the 60 micrograms of
`norethindrone by 15, we end up with 900 micrograms
`of norethindrone, right?
` A. Correct.
` Q. The 18 is much like 20 micrograms of
`ethinyl estradiol, right?
` A. Yes.
` Q. No reason to think, as you've told me
`before, that 2 micrograms will make any
`physiological difference, right?
` A. Agreed.
` Q. Is there any reason to believe that
`900 micrograms of norethindrone acetate would behave
`differently than 1,000 micrograms of norethindrone
`acetate physiologically?
` A. I don't think there would be a dramatic
`difference.
` Q. Now, would a person of ordinary skill in
`the art in April 2005 believe that coupling one
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`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2022, Pg. 26
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` KURT BARNHART, M.D.
`microgram of ethinyl estradiol with 250 micrograms
`of norethindrone acetate in a 24/4 regimen, 24 days
`of combined pill administration, 4 days of placebo,
`to be contraceptively effective?
` A. I got the --
` MR. WEZOWSKI: Objection, incomplete
`hypothetical.
`BY THE WITNESS:
` A. I got the 24/4. You need to tell me the
`doses again.
` Q. 1 microgram ethinyl estradiol.
` A. Okay.
` Q. Coupled with 250 micrograms of
`norethindrone acetate.
` MR. WEZOWSKI: Same objections.
`BY THE WITNESS:
` A. No, I don't think that that would be
`contraceptively efficacious.
` Q. Would a person of ordinary skill in the art
`in 2005 have believed that that regimen would be
`contraceptively effective?
` MR. WEZOWSKI: Same objections.
`BY THE WITNESS:
` A. No.
`
`TSG Reporting - Worldwide 877-702-9580
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` KURT BARNHART, M.D.
` Q. Why not?
` A. Very low dose of estrogen and that may not
`be synergizing with the progestin dose, and the
`progestin dose is also lower than that of a
`commercial contraceptive that is using progestin
`only.
` Q. Now, would you agree with me that
`1 microgram of ethinyl estradiol and 250 micrograms
`of norethindrone acetate delivered as a 24/4
`regimen, 24 days combined, 4 days of placebo, would
`fall within the scope of this Hodgen '394 Patent?
` A. Yes, I would.
` Q. So is it fair to say that the person of
`ordinary skill in the art in 2005 would have
`understood that not all regimens encompassed by the
`'394 Patent would be contraceptively effective?
` A. Yes.
` Q. Whose Patricia Sulak?
` A. She is a physician who has published in the
`field of hormonal contraception.
` Q. Do you know her?
` A. I have met her on occasion.
` Q. Is she somebody well regarded in your
`field?
`
`TSG Reporting - Worldwide 877-702-9580
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2022, Pg. 28
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