1
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`CIVIL NO 11 5048 and 122928
`
`WARNER CHILCOTT CO LLC
`
`Plaintiff
`
`TRANSCRIPT OF PROCEEDINGS
`
`TRIAL
`
`vs
`
`LUPIN LTD and LUPIN
`PHARMACEUTICALS INC
`
`Defendants
`WARNER CHILCOTT CO LLC
`Plaintiff
`
`vs
`WATSON LABORATORIES INC
`
`Defendant
`
`Trenton New Jersey
`October 7 2013
`
`B E F O R E
`
`THE HONORABLE
`UNITED STATES DISTRICT COURT JUDGE
`
`JOEL A PISANO
`
`to Section 753 Title 28 United States
`Pursuant
`Code the following transcript
`is certified to be
`an accurate record as taken stenographically in the
`above entitled proceedings
`
`SJoanne M Caruso CSR CRR
`Official Court Reporter
`9083342472
`
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`JOANNE M CARUSO CSR CRR OFFICIAL COURT REPORTER
`A4745
`
`TRENTON NJ
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2003, Pg. 1
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`CIVIL NO 11 5048 and 122928
`
`WARNER CHILCOTT CO LLC
`
`Plaintiff
`
`TRANSCRIPT OF PROCEEDINGS
`
`TRIAL
`
`vs
`
`LUPIN LTD and LUPIN
`PHARMACEUTICALS INC
`
`Defendants
`WARNER CHILCOTT CO LLC
`Plaintiff
`
`vs
`WATSON LABORATORIES INC
`
`Defendant
`
`Trenton New Jersey
`October 7 2013
`
`B E F O R E
`
`THE HONORABLE
`UNITED STATES DISTRICT COURT JUDGE
`
`JOEL A PISANO
`
`to Section 753 Title 28 United States
`Pursuant
`Code the following transcript
`is certified to be
`an accurate record as taken stenographically in the
`above entitled proceedings
`
`SJoanne M Caruso CSR CRR
`Official Court Reporter
`9083342472
`
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`JOANNE M CARUSO CSR CRR OFFICIAL COURT REPORTER
`A4745
`
`TRENTON NJ
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2003, Pg. 1
`
`
`
`APPEARANCES
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`2
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`MC CARTER
`
`BY CYNTHIA S BETZ ESQ
`For Plaintiff
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`ENGLISH
`
`COVINGTON
`
`BURLING LLP
`
`BY GEORGE F PAPPAS ESQ
`JEFFREY B ELIKAN ESQ
`BENJAMIN C BLOCK ESQ
`ERIC R SONNENSCHEIN ESQ
`MICHAEL N KENNEDY ESQ
`
`For the Plaintiff
`
`FITZPATRICK CELLA HARPER
`BY DOMINICK A CONDE ESQ
`JEREMY COBB ESQ
`JASON A LEONARD ESQ
`MARY ALICE HIATT ESQ
`For Plaintiff
`
`SCINTO
`
`MAYER
`
`LEYDIG VOIT
`BY ROBERT F GREEN ESQ
`CARYN C BORG BREEN ESQ
`JAMAICA P SZELIGA ESQ
`MARC R WEZOWSKI ESQ
`NIMITA L PAREKH ESQ
`JESSICA TYRUS ESQ
`For Defendant Lupin
`
`FOX ROTHSCHILD
`
`BY KAREN A CONFOY ESQ
`CHRISTOPHER KINKADE ESQ
`HEATHER KUMO ESQ
`For Defendant Lupin
`
`LERNER DAVID LITTENBERG KRUMHOLZ
`
`BY PAUL H KOCHANSKI ESQ
`For Defendant Amneal Pharmaceutical of New York
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`MENTLIK
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`JOANNE M CARUSO CSR CRR OFFICIAL COURT REPORTER TRENTON NJ
`A4746
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2003, Pg. 2
`
`
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`3
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`WITNESS
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`DIRECT
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`CROSS
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`REDIRECT
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`RECROSS
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`KURT T BARNHART
`By Ms BorgBreen
`By Mr Elikan
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`JOANNE M CARUSO CSR CRR OFFICIAL COURT REPORTER TRENTON NJ
`A4747
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2003, Pg. 3
`
`
`
`4
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`October 7 2013
`THE COURT Good morning
`
`THE CLERK All rise
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`THE COURT Welcome everybody
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`Now there are a lot of people here Let’s see I
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`made my own list We’re going to be trying a case about
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`validity Is that correct
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`MR PAPPAS Good morning George Pappas
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`That
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`is correct
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`THE COURT As a result as I understand it having
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`read the trial briefs the defendants bear
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`the burden of
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`proof
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`MR PAPPAS That
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`is correct your Honor
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`THE COURT
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`So why don’t we have them go first and
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`introduce themselves and we’ll get moving
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`MR PAPPAS Very well
`MR GREEN Robert Green on behalf of the Lupin
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`defendants
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`THE COURT Mr Green
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`MR KOCHANSKI
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`Paul Kochanski Lerner David on
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`behalf of the ANDA holder Amneal Pharmaceuticals of New York
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`City
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`THE COURT
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`I have your substitution of attorney Mr
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`Kochanski
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`I’ve signed it Where is Mr Kennedy
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`MR KOCHANSKI Mr Kennedy is not here today just
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`JOANNE M CARUSO CSR CRR OFFICIAL COURT REPORTER TRENTON NJ
`A4748
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2003, Pg. 4
`
`
`
`I’m here today
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`THE COURT
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`I haven’t seen him for awhile I’ve
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`signed your order welcome
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`You and Mr Kennedy will be representing Amneal
`MR KOCHANSKI Yes
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`MS CONFOY Karen Confoy for the defendants as well
`THE COURT Now who is Mr Kinkade Is he with you
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`MS CONFOY Your Honor he is not here today
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`neither is Heather Kumo but
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`they may be here
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`THE COURT Filling from timetotime as local
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`counsel okay
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`Mr Green who do you have with
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`Miss Szeliga is here I see you
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`Who is Miss BorgBreen
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`MS BORG BREEN Caryn BorgBreen
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`THE COURT Mr Wezowski
`MR WEZOWSKI
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`Good morning
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`THE COURT Miss Tyrus
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`MS TYRUS
`
`Good morning
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`THE COURT Miss Parekh
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`MS PAREKH Good morning
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`THE COURT You’re all from the same firm
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`MR GREEN That
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`is correct your Honor
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`THE COURT Great
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`Now we have Warner Chilcott Miss Betz is here
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`JOANNE M CARUSO CSR CRR OFFICIAL COURT REPORTER TRENTON NJ
`A4749
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2003, Pg. 5
`
`
`
`6
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`MS BETZ
`
`Good morning
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`Cynthia Betz from McCarter English
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`THE COURT Mr Pappas good morning
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`Mr Block
`MR BLOCK Good morning your Honor
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`THE COURT
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`I just wrote them down in the order I
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`have them here
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`Mr Elikan
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`MR ELIKAN Mr Elikan your Honor
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`THE COURT Nice to see you
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`Mr Sonnenschein
`MR SONNENSCHEIN Good morning your Honor
`THE COURT Mr Kennedy
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`MR KENNEDY
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`Good morning your Honor
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`THE COURT Where is Mr Conde
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`MR CONDE Good morning
`THE COURT Mr Cobb
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`MR COBB Good morning your Honor
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`THE COURT Who is everybody else
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`MR CONDE Mr Jason Leonard and Miss Mary Alice
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`Hiatt
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`THE COURT We’ll try to make your stay efficient and
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`as pleasant as possible
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`Defendants bear
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`the burden of proof on this so it
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`seems they ought to go first Does anybody object
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`to that
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`JOANNE M CARUSO CSR CRR OFFICIAL COURT REPORTER TRENTON NJ
`A4750
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2003, Pg. 6
`
`
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`7
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`MR PAPPAS No objection we agree
`MR GREEN Fine with us
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`THE COURT
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`I’ve read your trial briefs I have the
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`patent I have the complaints and the pleadings
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`Why don’t you tell me how the case is going to be
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`tried how long you think it will take what you expect
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`to
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`happen and then we’ll get into it
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`MR GREEN On behalf of defendants we have three
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`live witnesses
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`We would expect
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`those to be completed by
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`first part of Wednesday and we have deposition designations
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`for two witnesses
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`If your Honor desires to have those
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`played we presently believe that that would be probably no
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`more than an hour and a half of total time
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`We’ve had a conversation with plaintiff’s counsel
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`here and we believe that it’s quite likely that with the
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`exception of one of plaintiff’s witnesses we can probably be
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`done by Thursday
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`THE COURT With the entire case
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`MR GREEN With one exception of Dr Darney who is
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`going to testify on behalf of plaintiffs As I understand it
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`he’s not available until Monday
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`It’s possible if things
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`move along with the speed we are currently predicting we
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`would have Monday through Thursday Friday a down day and
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`resuming with the last day of trial
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`THE COURT
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`How about Mr Kochanski what about you
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`JOANNE M CARUSO CSR CRR OFFICIAL COURT REPORTER TRENTON NJ
`A4751
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2003, Pg. 7
`
`
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`8
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`do you have a presentation
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`MR KOCHANSKI We’re following Lupin so we we’re
`not going to add anything to it
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`THE COURT Mr Pappas
`MR PAPPAS I agree with Mr Green’s statement
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`The
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`schedule we wouldn’t necessarily know this but
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`in the early
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`trial preparation we agreed their witnesses would go this
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`week and ours would go next week
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`We do have two live witnesses ready to put on when
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`the defendants close their case Our best estimate is that
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`will go through Thursday afternoon so Friday may be an open
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`day simply because initially when the trial schedule was set
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`and the estimate of witnesses Watson was a defendant and they
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`had a case we will be prepared to start
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`last time I
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`checked Monday is a federal holiday
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`THE COURT
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`So it is The most important one I might
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`add Columbus Day
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`MR PAPPAS Yes So we have assumed although the
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`state of affairs in Washington such as they are now I’m not
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`really sure what’s going on but we’ve assumed at least for
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`planning purposes unless you tell us that Monday will be a
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`holiday we’ll be begin with Dr Darney on Tuesday he’ll be
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`quite extensive and Dr Kagan after that and maybe some
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`deposition testimony we’re not sure
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`In any event we certainly will be able to finish
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`JOANNE M CARUSO CSR CRR OFFICIAL COURT REPORTER TRENTON NJ
`A4752
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`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2003, Pg. 8
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`
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`before Friday of next week which was the time set aside
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`That’s basically the schedule your Honor
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`THE COURT
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`We have three live witnesses and some
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`depositions from Lupin
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`MR GREEN Yes
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`THE COURT
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`And two live witnesses and perhaps
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`MR PAPPAS Four We have two this week that will
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`be ready to put on Once we recognized that the schedule may
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`speed up we got
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`the witnesses
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`we were able to get two of
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`the witnesses from week two into week one We’ll move it as
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`fast as we can
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`THE COURT Whatever you need by way of scheduling
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`you’ll have no lack of cooperation from us I don’t have
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`anything else scheduled for the courtroom unless something
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`comes in so however
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`the testimony goes whatever
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`is most
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`convenient
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`for you folks let us know and we’ll be happy to
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`accommodate you
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`In terms of having an open day on Friday I think all
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`of us can benefit
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`from that we all have other things to do
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`and otherwise you tend to ruin my reputation besides It’s
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`okay with me if Friday is dedicated to other things Maybe
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`you folks can get home for the weekend We have Monday off
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`so
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`MR GREEN We would enjoy that I think if possible
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`MR PAPPAS Your Honor I think Mr Green and the
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`JOANNE M CARUSO CSR CRR OFFICIAL COURT REPORTER TRENTON NJ
`A4753
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2003, Pg. 9
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`
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`10
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`parties had agreed that we can do brief openings limited to
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`45 minutes so I think Mr Green will open I’ll open and then
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`I believe you’re going to call Dr Barnhart
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`Is that correct
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`MR GREEN That’s fine
`MR PAPPAS He’s in the courtroom so we’re ready to
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`go
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`THE COURT
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`I participated in a panel discussion on
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`Thursday afternoon in Chicago as a matter of fact One of the
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`questions that was put to us is how should parties best
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`present deposition testimony do we want
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`the transcript
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`just
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`handed up or do we want it made or read into the record et
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`cetera I think every judge on the panel agreed that the most
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`effective way to present is to actually play it or read it
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`somehow that the simple mailing it in technique doesn’t get
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`the kind of attention that it should get because it’s part of
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`the testimony in the case so I think you’re right about
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`the
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`way you want to go forward
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`MR PAPPAS Very well your Honor
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`THE COURT Okay
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`MR GREEN If I may pass up copies of the
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`demonstratives we’ll be using in the opening
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`Good morning your Honor Robert Green on behalf of
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`the Lupin defendants
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`We’d like to begin by giving you a little background
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`on the witnesses that you will hear this morning that will be
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`JOANNE M CARUSO CSR CRR OFFICIAL COURT REPORTER TRENTON NJ
`A4754
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2003, Pg. 10
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`
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`11
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`virtually of top level background because during each of their
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`depositions during each of their periods of testimony of
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`course they will be giving you detailed information regarding
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`the backgrounds
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`If I can start first with Dr Kurt Barnhart Dr
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`Barnhart is presently the vice chair clinical research for
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`the Department of Obstetrics and Gynecology
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`I need to get
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`this correct That’s at
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`the University of Pennsylvania The
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`last time I introduced Dr Barnhart to Judge Chesler I said
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`he was from Penn State and I still have not quite lived that
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`down with Dr Barnhart
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`It’s the University of Pennsylvania
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`not Penn State
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`His testimony here today is going to be directed
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`toward giving the Court background information with respect
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`to
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`combination oral contraceptives which is a sub matter of the
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`present
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`litigation and he will address the prima facie case of
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`obviousness that the defendants plan to present
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`His testimony will also encompass rebuttal
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`testimony
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`for witnesses that your Honor will obviously not have heard
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`at that time It winds up being we have Dr Barnhart here we
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`have an agreement with plaintiffs we will simply address that
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`so to the extent Dr Barnhart’s testimony is a bit extended
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`it’s an attempt to also address the testimony that we expect
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`your Honor
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`to hear
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`from Dr Darney potentially Dr Kagan and
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`Dr Thisted and that will come after the initial presentation
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`JOANNE M CARUSO CSR CRR OFFICIAL COURT REPORTER TRENTON NJ
`A4755
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2003, Pg. 11
`
`
`
`Barnhart
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`Direct
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`50
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`THE COURT Miss Breen is that what you like to be
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`MS BORG BREEN Caryn BorgBreen It’s a hyphenated
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`called
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`name
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`THE COURT Yes I know that I didn’t know if you
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`wanted both
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`MS BORG BREEN
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`It’s actually my husband’s last
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`name
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`THE COURT
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`How are you
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`MS BORG BREEN
`I’m doing pretty well your Honor
`At this time Lupin would call its first witness Dr Kurt T
`Barnhart
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`THE COURT Dr Barnhart
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`MS BORG BREEN
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`He is a board certified obstetrician
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`and gynecologist who will be presenting testimony on behalf of
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`Lupin supporting prior art
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`Permission to approach
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`THE COURT Sure
`B A R N H A R T sworn
`THE COURT Good morning sir
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`K U R T
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`THE WITNESS
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`Good morning
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`Can I clarify two important things before we start
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`THE COURT Wait until Miss BorgBreen gets back
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`What have you given here
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`MS BORG BREEN
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`We have two binders of exhibits and
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`JOANNE M CARUSO CSR CRR OFFICIAL COURT REPORTER TRENTON NJ
`A4794
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2003, Pg. 12
`
`
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`Barnhart
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`Direct
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`51
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`a copy of the presentation I just handed up
`DIRECT EXAMINATION BY MS BORG BREEN
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`Q
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`May it please the Court good morning Dr Barnhart
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`Could you please introduce yourself to the Court
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`A
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`Sure Good morning
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`My name is Kurt Barnhart
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`I’m a professor of
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`obstetrics and gynecology and epidemiology learning how to
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`use a microphone at the University of Pennsylvania in
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`Philadelphia
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`MS BORG BREEN
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`Can you please bring up DTX108A
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`Q Dr Barnhart if you could just identify this document
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`A
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`for the Court
`So this is a copy of my curriculum vitae dated 813
`MS BORG BREEN
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`At this time we’d like to move
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`DTX108A into evidence
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`THE COURT
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`However you want to do this easiest is
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`the best way In terms of what you’re introducing into
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`evidence if there’s an agreement on what it is just tell me
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`there’s an agreement
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`this is admitted and it’s in evidence
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`In other words you don’t necessarily have to go through the
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`drill with every document
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`MS BORG BREEN Okay Would you prefer we just move
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`them into evidence
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`THE COURT Are they all accepted
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`Are all of these
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`exhibits in by consent
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`JOANNE M CARUSO CSR CRR OFFICIAL COURT REPORTER TRENTON NJ
`A4795
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2003, Pg. 13
`
`
`
`Barnhart
`
`Direct
`
`52
`
`MR ELIKAN It’s a very thick two binders I can’t
`
`imagine there’s going to be a problem
`
`THE COURT Why don’t we just
`
`I’ll tell you what
`
`disregard everything I just said
`
`There is no objection this is in evidence
`
`MS BORG BREEN
`Now Dr Barnhart could you please briefly summarize for
`
`Thank you your Honor
`
`Q
`
`the Court your educational background
`
`A
`
`Certainly I’m currently now at the University of
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`Pennsylvania in Philadelphia but my journey there was
`
`11
`
`including my undergraduate training at Tufts University in
`
`12
`
`Boston I went to medical school at Mt Sinai School of
`
`13
`
`Medicine in Manhattan
`
`14
`
`15
`
`I moved to Philadelphia to do my clinical training and
`
`obtained a masters of science degree also University of
`
`16
`
`Pennsylvania That’s what
`
`the MSE stands for clinical
`
`17
`
`epidemiology and biostatistics
`
`18
`
`19
`
`Q
`
`A
`
`And what
`
`is clinical epidemiology and biostatistics
`
`Epidemiology is the study of health trends or health
`
`20
`
`statistics Clinical epidemiology is bringing that to how it
`
`21
`
`might interact with a specific patient and biostatistics is
`
`22
`
`expertise in statistics but mostly relevant to biology or
`
`23
`
`clinical trials or clinical research
`
`24
`
`25
`
`Q
`
`A
`
`And are you board
`
`are you board certified
`
`Yes I am I’m board certified in both obstetrics and
`
`JOANNE M CARUSO CSR CRR OFFICIAL COURT REPORTER TRENTON NJ
`A4796
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2003, Pg. 14
`
`
`
`Barnhart
`
`Direct
`
`53
`
`gynecology as well as the subspecialty reproductive
`
`endocrinology and infertility which basically deals with
`
`human reproduction and the hormones that are involved in
`
`reproduction both aiding a woman to help get pregnant and
`
`aiding a women to help prevent pregnancy
`
`Q
`
`A
`
`Are you a practicing clinician
`
`I am I am part of a faculty practice called Penn
`
`Fertiity Care at
`
`the University of Pennsylvania
`
`Q
`
`A
`
`What
`
`is the focus of your clinical practice
`
`My clinical practice makes it easier focuses on
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`gynecology as opposed to obstetrics My focus is on treating
`
`12
`
`women for their reproductive needs including helping them get
`
`13
`
`pregnant helping them avoid pregnancy dealing with other
`
`14
`
`gynecologic problems menopause fibroids things like that
`
`15
`
`Q
`
`What percentage of your clinical practice focuses
`
`16
`
`on family planning
`
`17
`
`A
`
`Probably about 25 percent of my practice would be dealing
`
`18
`
`with family planning directly However the hormones are used
`
`19
`
`in oral contraceptives and used commonly for other disorders
`
`20
`
`as well and also interacts with my expertise in fertility in
`
`21
`
`general
`
`22
`
`23
`
`24
`
`25
`
`Q
`
`A
`
`Q
`
`A
`
`Do you prescribe oral contraceptives to patients
`
`Yes I do
`
`Do you conduct clinical research
`
`I do Approximately at least half of my job is to
`
`JOANNE M CARUSO CSR CRR OFFICIAL COURT REPORTER TRENTON NJ
`A4797
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2003, Pg. 15
`
`
`
`Barnhart
`
`Direct
`
`54
`
`oversee or conduct clinical research in the field of
`
`contraception early pregnancy and fertility treatment And
`
`that work has been funded over
`
`the last 15 to 20 years by the
`
`National
`
`Institute of Health as well as by some
`
`pharmaceutical companies and also includes both a lot of my
`
`own ideas
`
`Q
`
`Have you had any involvement
`
`in oral contraceptive
`
`clinical trials
`
`A
`
`Yeah I’ve had a long history of working with
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`contraception in general using the same hormones in nonoral
`
`11
`
`routes as well as in developing
`
`in studying oral
`
`12
`
`13
`
`14
`
`15
`
`16
`
`contraception as well
`
`Q
`
`A
`
`Q
`
`A
`
`Do you have any publications related to your research
`
`I do
`
`Approximately how many
`
`I think the amount of peerreviewed publications is in
`
`17
`
`the order of 160 or 170 and probably a third or so of that is
`
`18
`
`directly related to family planning and contraception
`
`19
`
`20
`
`Q
`
`A
`
`Do you hold any editorial positions
`
`I do I am the associate editor for the journal called
`
`21
`
`Fertility and Sterility which focuses on actually my
`
`22
`
`specialty which is both helping women get pregnant and
`
`23
`
`prevent pregnancy
`
`I held that position for a year and I’m
`
`24
`
`also the former associate editor of a journal called
`
`25
`
`Pharmacoepidemiology and Drug Safety
`
`JOANNE M CARUSO CSR CRR OFFICIAL COURT REPORTER TRENTON NJ
`A4798
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2003, Pg. 16
`
`
`
`Barnhart
`
`Direct
`
`55
`
`Q Dr Barnhart do you consider yourself to be an expert
`
`in
`
`obstetrics and gynecology and clinical epidemiology and
`
`biostatistics
`
`A
`
`Yes I do
`MS BORG BREEN
`
`At this time your Honor we would
`
`like to offer Dr Barnhart as an expert
`
`in the field of
`
`obstetrics and gynecology and clinical epidemiology and
`
`biostatistics
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`THE COURT Any objection
`
`MR ELIKAN No objection your Honor
`
`THE COURT
`
`Do you have any questions
`
`MR ELIKAN No
`THE COURT Your name is
`
`MR ELIKAN Mr Elikan
`
`THE COURT
`
`You are
`
`MR BLOCK Mr Block sorry
`Please bring up JTX1
`Dr Barnhart do you recognize JTX1
`I do This is the cover page for my understanding
`
`is the
`
`17
`
`Q
`
`18
`
`19
`
`A
`
`20
`
`patent
`
`that we’re discussing here in this litigation
`
`Q
`
`A
`
`21
`
`22
`
`23
`
`This is the 984 patent
`
`It is
`MS BORG BREEN
`
`At this time we move JTX1 into
`
`24
`
`evidence
`
`25
`
`THE COURT 107
`
`JOANNE M CARUSO CSR CRR OFFICIAL COURT REPORTER TRENTON NJ
`A4799
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2003, Pg. 17
`
`
`
`Barnhart
`
`Direct
`
`56
`
`JTX1
`MS BORG BREEN
`You need to keep your voice up I’m
`having trouble hearing you Mr Elikan is having trouble
`
`THE COURT
`
`MR ELIKAN No objection
`MS BORG BREEN
`
`I will certainly do my best to speak
`
`louder
`
`Q Dr Barnhart have you formed any opinions regarding the
`
`984 patent
`
`A
`
`Q
`
`A
`
`Yes I have
`
`And what
`
`is your opinion
`
`My opinion is based on the prior art available to the
`
`person of ordinary skill that this patent would have been
`
`obvious the claims in this patent
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`Q
`
`Have you formed an opinion regarding who the person of
`
`15
`
`ordinary skill in the art is that’s relevant
`
`to the 984
`
`16
`
`17
`
`18
`
`19
`
`patent
`
`Yes I have
`
`And do you have a demonstrative you prepared to summarize
`
`A
`
`Q
`
`this
`
`20
`
`A
`
`Yes
`
`21
`
`So my definition of a person of ordinary skill was a
`
`22
`
`physician who understood women’s health or specialty training
`
`23
`
`in gynecology had some experience in understanding
`
`the
`
`24
`
`development
`
`and research in oral contraception and of course
`
`25
`
`also had experience in administrating or evaluating those
`
`JOANNE M CARUSO CSR CRR OFFICIAL COURT REPORTER TRENTON NJ
`A4800
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2003, Pg. 18
`
`
`
`Barnhart
`
`Direct
`
`78
`
`opening argument which is correct That’s the endogenous
`
`estrogen the woman makes The higher the follicle gets the
`
`more estrogen the woman is making in her own body and
`
`competing with the estrogen in the pill When it’s suppressed
`
`again you’ve got a rise and then a fall You’ve got a
`
`fluctuation
`
`So if you can limit the fluctuation because you’re
`
`limiting the follicle growth not only are you making the pill
`
`more effective you’re making bleeding control better and
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`you’re also eliminating side effects that are associated with
`
`11
`
`this estrogen fluctuation So the goal might have been to
`
`12
`
`make a safer pill but it clearly is well understood by people
`
`13
`
`in the art that you’re not only fixing efficacy you’re
`
`14
`
`improving cycle control and you’re improving and lessening
`
`15
`
`16
`
`side effects
`
`Q Dr Barnhart can you identify some exhibits some trial
`
`17
`
`exhibits that support what you have been saying about this
`
`18
`
`244 regimen
`
`19
`
`A
`
`Yeah So this isn’t just my opinion and this is not
`
`20
`
`something that’s novel or not taught This is very well
`
`21
`
`understood
`
`22
`
`23
`
`24
`
`I put a number of references on the slide to give you
`
`that information For example under the day seven graph
`
`there’s a DTX 477 and DTX507 which are articles in the
`
`25
`
`literature in the late 90s that describe the problem with the
`
`JOANNE M CARUSO CSR CRR OFFICIAL COURT REPORTER TRENTON NJ
`A4822
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2003, Pg. 19
`
`
`
`Barnhart
`
`Direct
`
`79
`
`217 pill regimen It’s known ten years before this that the
`217 might not be optimum
`
`Then there was a lot of work supported in these other
`
`literatures under the four day pillfree interval
`
`I can read
`
`them DTX 433 445 481 484 505 520 530 and 531 as well as
`
`JTX 10 which are again examples and not an exhaustive list
`
`of a discussion of what
`
`the benefits would be to improve the
`
`oral contraception by making a shorter hormonefree interval
`
`Some of these papers like the ones I bolded have
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`actual data to show that this is a benefit
`
`to the pill Some
`
`11
`
`of them are widelypublicized review articles saying a menu a
`
`12
`
`road map saying there are four ways we can improve this
`
`13
`
`pillfree interval
`
`We can shorten it I’ll get to in a
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`second we can add estrogen to it
`
`This is exceedingly obvious and well discussed in the
`
`physiology biology medical literature about
`
`the oral
`
`contraceptive pill and again all
`
`again I can quote each
`
`data but all in the 80s and 90s well before the
`
`patentinsuit This is not new information
`
`MS BORG BREEN
`
`At this time your Honor we move
`
`DTX477 507 433 445 481 484 505 520 530 and 531 as
`
`well as JTX10 into evidence
`
`MR ELIKAN No objection your Honor
`
`THE COURT Okay
`
`Q Dr Barnhart we discussed at the beginning of your
`
`JOANNE M CARUSO CSR CRR OFFICIAL COURT REPORTER TRENTON NJ
`A4823
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2003, Pg. 20
`
`
`
`Barnhart
`
`Direct
`
`146
`
`A
`
`They noted in their review that the Pearl Index was the
`
`highest or the worse or highest pregnancy
`
`rate unintended
`
`pregnancy
`
`rate for Lo Loestrin than they had seen before or
`
`that they had approved I should say I don’t know what
`
`they’ve seen
`
`Q
`
`Can we have page two of this document
`
`Is this the portion of the document where the FDA
`
`talks about Lo Loestrin having the highest Pearl Index of any
`
`oral contraceptive previously approved
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`A
`
`That’s correct
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`MS BORG BREEN
`for Dr Barnhart at this time
`
`Your Honor we have nothing further
`
`THE COURT Okay
`
`Let’s take a short break
`
`THE CLERK All rise
`
`Recess
`
`K U R T
`
`B A R N H A R T previously sworn resumes
`
`the stand
`
`THE CLERK All rise
`
`THE COURT
`
`Have a seat
`
`CROSS EXAMINATION BY MR ELIKAN
`Q Dr Barnhart I handed up binders containing exhibits
`
`that will potentially be used in the cross examination
`
`Now Dr Barnhart this isn’t the first time that you
`
`have testified in a patent case correct
`
`JOANNE M CARUSO CSR CRR OFFICIAL COURT REPORTER TRENTON NJ
`A4890
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2003, Pg. 21
`
`
`
`Barnhart
`
`Cross
`
`147
`
`A
`
`Q
`
`That’s correct
`
`So you’re testifying in this case on behalf of Lupin that
`
`the patentinsuit is obvious right
`
`A
`
`Q
`
`Correct
`
`This is in fact the third time in two years that you
`
`you have opined on behalf of Lupin in a trial that an oral
`
`contraceptive patent was obvious right
`
`A
`
`I think
`
`the first time I was retained was Watson but
`
`I ended up with Lupin you’re correct but yes so I have been
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`involved in three trials
`
`11
`
`Q
`
`In one of those trials the one you alluded to at trial
`
`12
`
`you testified on behalf of Lupin that a patent covering the
`
`13
`
`oral contraceptive Ortho Cyclen would have been obvious at
`
`the
`
`14
`
`15
`
`16
`
`time of the invention right
`
`A
`
`Q
`
`That’s correct
`
`And you also testified for Lupin that a patent held by
`
`17
`
`Teva covering the Seasonique regimen would have been obvious
`
`18
`
`19
`
`20
`
`at the time of invention correct
`
`A
`
`Q
`
`I think the Court agreed
`
`So you did testify in that case that the patent was
`
`21
`
`obvious
`
`22
`
`23
`
`24
`
`A
`
`Q
`
`Yes
`
`And those three matters are the entirety of the patent
`
`cases in which you’ve testified at trial right
`
`25
`
`A
`
`That’s correct
`
`JOANNE M CARUSO CSR CRR OFFICIAL COURT REPORTER TRENTON NJ
`A4891
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2003, Pg. 22
`
`
`
`Barnhart
`
`Cross
`
`148
`
`Q
`
`So while you’ve testified time after time after time that
`
`patents covering oral contraceptive regimens would have been
`
`obvious you’ve never testified that any patent covering oral
`
`contraceptive regimen was not obvious right
`
`A
`
`The only three times I testified
`
`I looked at other
`
`patents
`
`The only three times I testified were I concluded
`
`they were obvious yes
`
`Q
`
`And so you never testified that a patent was not obvious
`
`covering oral contraceptive
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`A
`
`I’ve not testified in court to that affect no
`
`11
`
`Q Dr Barnhart can you keep your voice up as much as
`
`12
`
`possible
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`A
`
`Q
`
`A
`
`Q
`
`I’ll do my best
`
`Thank you so much
`
`Let’s talk about breakthrough bleeding shall we
`
`Sure
`
`Okay
`
`You’re aware of literature generally saying that as
`
`estrogen doses decline bleeding problems increase right
`
`20
`
`A
`
`As a general point I don’t disagree with that but
`
`21
`
`22
`
`23
`
`obviously we need to know what we’re talking about 21day
`pills or 24day pills because most of that literature is
`
`referring to 21
`
`24
`
`Q
`
`You understand you’re on crossexamination now and you’re
`
`25
`
`going to be answering my questions
`
`JOANNE M CARUSO CSR CRR OFFICIAL COURT REPORTER TRENTON NJ
`A4892
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2003, Pg. 23
`
`
`
`Barnhart
`
`Cross
`
`149
`
`A
`
`Q
`
`Did I not answer your question
`
`I just want to make sure your answer
`
`is you are aware of
`
`literature saying generally that as estrogen doses decline
`
`bleeding problems increase right
`
`A
`
`Again as a general proposition yes but it’s more
`
`complex than that
`
`Q
`
`And you’ve in fact written that low dose estrogen
`
`combination oral contraceptives have higher
`
`rates of bleeding
`
`pattern disturbances right
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`A
`
`Since you’re referring to my record yes I was referring
`
`11
`
`to 21 day seven pills when you low dose the estrogen you can
`
`12
`
`increase the
`
`might increase the bleeding
`
`13
`
`Q
`
`Can we have PTX 351
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`This is your article is it not Dr Barnhart
`
`Yes
`
`The Chapter 8 Contraception you’re one of
`
`the authors
`
`A
`
`Q
`
`right
`
`A
`
`Q
`
`Yes
`
`Can we turn to page 16 of 32
`
`If you can highlight
`
`the bottom of the first paragraph
`
`of page 16
`
`You see in this paragraph that you wrote so while
`
`COCs containing 20 microgram EE may be theoretically safer
`
`24
`
`this has not been proven and low dose estrogen COCs have
`
`25
`
`higher rates of bleeding pattern disruptions Is that right
`
`JOANNE M CARUSO CSR CRR OFFICIAL COURT REPORTER TRENTON NJ
`A4893
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2003, Pg. 24
`
`
`
`Barnhart
`
`Cross
`
`150
`
`A
`
`Q
`
`A
`
`Q
`
`Right That’s what I just said
`
`Did I read that correctly sir
`
`Yes
`
`At least in that sentence you didn’t qualify it and say
`
`20 microgram EE products or low dose estrogen COCs have in
`
`general higher rates of bleeding except for 24 4 regimens
`
`A
`
`I didn’t need to because three sentences above it I refer
`
`to the Cochran review which I know and if anyone looked at
`
`it reviewed evidence which was basically was confined to
`21day contraceptive
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`Q
`
`I’m just asking you about
`
`that sentence right now and you
`
`12
`
`13
`
`agree you didn’t put a qualification in it
`You restrict me to that single sentence no there is no
`
`A
`
`14
`
`qualification in that single sentence
`
`15
`
`Q
`
`Okay
`
`16
`
`17
`
`The sentence immediately above you wrote compared to
`
`the higher estrogen pills several COCs containing 20
`
`18
`
`microgram EE resulted in higher rates of early clinical trial
`
`19
`
`discontinuation overall and due to adverse events such as
`
`20
`
`irregular bleeding as well as increased rates of bleeding
`
`21
`
`disturbances both amenorrhea or infrequent bleeding and
`
`22
`
`23
`
`24
`
`25
`
`irregular prolonged frequent bleeding or breakthrough
`
`bleeding or spotting right
`
`A
`
`Q
`
`That’s what that sentence says
`
`Your words Dr Barnhart
`
`JOANNE M CARUSO CSR CRR OFFICIAL COURT REPORTER TRENTON NJ
`A4894
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2003, Pg. 25
`
`
`
`Barnhart
`
`Cross
`
`151
`
`A
`
`Yeah I actually want to go back to the sentence you
`
`said I didn’t qualify
`
`THE COURT Hold it hold it
`
`Dr Barnhart I’m going to ask you to simply listen
`to the question and answer it If you start volunteering and
`
`qualifying things this will be a long arduous process
`
`THE WITNESS Fair enough
`
`Q
`
`In effect you would agree with the statement that there
`
`is evidence that a 20 microgram EE there is an increase in
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`incidents of menstrual irregularities compared to higher
`
`11
`
`estrogen dose pills right
`
`12
`
`A
`
`That statement is true and referenced appropriately to
`
`13
`
`say where I’m getting that information correct
`
`14
`
`Q
`
`And you in fact agree the lower you go in estrogen
`
`15
`
`16
`
`dose the more problems you might have with cycle control
`
`right
`
`17
`
`A
`
`I listened to your question You said the lower the
`
`18
`
`dose the more problems you might have yes that’s true You
`
`19
`
`might have more problems
`
`20
`
`Q
`
`You would agree with me as well that women sometimes
`
`21
`
`complain about unscheduled vaginal bleeding while on an oral
`
`22
`
`contraceptives
`
`23
`
`24
`
`25
`
`A
`
`Q
`
`A
`
`Yes
`
`You’ve in fact seen that in your own practice
`
`Yes
`
`JOANNE M CARUSO CSR CRR OFFICIAL COURT REPORTER TRENTON NJ
`A4895
`
`Mylan v. Warner Chilcott IPR2015-00682
`WC Ex. 2003, Pg. 26
`
`
`
`Barnhart
`
`Cross
`
`152
`
`Q
`
`You would agree that there are many reasons why women
`
`find unscheduled bleeding disturbing right
`
`A
`
`Q
`
`Yes
`
`Unscheduled bleeding can be uncomfortable in an emotional
`
`sense right
`
`A
`
`I suppose
`
`Q Well in fact it is right You know that
`
`A
`
`Q
`
`I don’t know what you mean by uncomfortable emotionally
`
`Can we have the OTC trial transcript page 396 line six
`
`through 11
`
`Sir I’m showing you your trial testimony from the
`
`Ortho TriCyclen Lo case
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