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`A P P E A R A N C E S
` %
`
`
`
`
`
`)
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`TELEPHONICALLY FOR THE BOARD:
` ( '# % ((; $# ' &# 8
`JUDGE POLLOCK
` 9 #((#%"
`JUDGE GREEN
`+ 9
`JUDGE KAISER
` 9 "
`
`IL 60601
`
` 1
`
`FOR THE PETITIONER APOTEX:
`$# ' # # ,8
`STEVEN PARMELEE, ESQ.
` / ! ( . a-
`JAD MILLS, ESQ.
` 9 ! (( . a-
`MICHAEL ROSATO, ESQ.
` ! %' ( # #. a-
`Wilson Sonsini Goodrich & Rosati
`
`2 2
`
`
`b6 c 2
`
`701 Fifth Avenue
` $
`5 6 3 7
`Seattle, WA 98104
` . +
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`
`
`
`
`
`
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`
`TELEPHONICALLY FOR THE PETITIONER ARGENTUM:
`+ ( '# % ((; $# ' # !8
`TERESA REA, ESQ.
` . a-
`SHANNON LENTZ, ESQ.
` ' # ( 0. a-
`Crowell
`& Moring
`1 % c !
`
`1001 Pennsylvania Ave Northwest
` 2:3
` 3 62
`Washington, DC 20004
` 26
`
. % +
`
`
`
`
`
`TELEPHONICALLY FOR THE PETITIONER SUN:
` ( '# % ((; $# ' # 8
`SAMUEL PARK, ESQ.
` ! ( ". a-
`Winston & Strawn
`
` 2 c
`35 West Wacker Drive
` ) 2 b4
`3
`Chicago,
` %6
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`
`
`
`
`
`TELEPHONICALLY FOR THE PETITIONER SUN:
` ( '# % ((; $# ' # 8
`SAMUEL PARK, ESQ.
` ! ( ". a-
`Winston & Strawn
`
` 2 c
`35 West Wacker Drive
` ) 2 b4
`3
`Chicago,
` %6
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`TSG Reporting — Worldwide — 877—702—9580
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`+
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`TSG Reporting — Worldwide — 877—702—9580
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)
`
`A P P E A R A N C E S
`(CONTINUED)
` % d%# e
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`TELEPHONICALLY FOR THE PETITIONER TEVA:
` ( '# % ((; $# ' # / 8
`
`)
`
`GREGORY SPRINGSTED, ESQ.
` #; . a-
`Kirkland & Ellis
`+ "
`4 c
`2
`300 North LaSalle
` ) 6 (
`Chicago,
`IL 60654
` %6
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`A P P E A R A N C E S
`(CONTINUED)
` % d%# e
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`TELEPHONICALLY FOR THE PETITIONER TEVA:
` ( '# % ((; $# ' # / 8
`
`)
`
`GREGORY SPRINGSTED, ESQ.
` #; . a-
`Kirkland & Ellis
`+ "
`4 c
`2
`300 North LaSalle
` ) 6 (
`Chicago,
`IL 60654
` %6
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`
`TELEPHONICALLY FOR THE PATENT OWNER:
` ( '# % ((; $# ' # 8
`ROBERT TRENCHARD, ESQ.
` #& %' . a-
`JANE LOVE, ESQ.
` 9 (#/ . a-
`Gibson Dunn & Crutcher
`
`f2 7 c %7 b6
`200 Park Avenue
` 4 3 7
` ;4. ; 11
`
`New York, NY 10166
`
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`TSG Reporting — Worldwide — 877—702—9580
`
`
`
`1
`
`TELEPHONICALLY FOR THE PATENT OWNER:
` ( '# % ((; $# ' # 8
`ROBERT TRENCHARD, ESQ.
` #& %' . a-
`JANE LOVE, ESQ.
` 9 (#/ . a-
`Gibson Dunn & Crutcher
`
`f2 7 c %7 b6
`200 Park Avenue
` 4 3 7
` ;4. ; 11
`
`New York, NY 10166
`
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`TSG Reporting — Worldwide — 877—702—9580
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`
`CALL WITH BOARD
` % (( ' &#
`SEATTLE, WASHINGTON;
`JANUARY 10, 2018
` ( . ' # h 9 ; .
`8:00 a.m.
`) 8 -i-
`—oOo—
`+
`
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+
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` 1
`
`JUDGE POLLOCK: This call is in relation to
` 9 #((#%"8 6
`2 b
`2
`
`
`IPR2017—OO854. This is Judge Pollock.
`I have with me
` +- 6
`2
`2 97
`
` 1
`
`JUDGE POLLOCK: This call is in relation to
` 9 #((#%"8 6
`2 b
`2
`
`
`IPR2017—OO854. This is Judge Pollock.
`I have with me
` +- 6
`2
`2 97
b4- 63
` 6 i
`Judges Green and Kaiser.
` 97
` 6 i
`Judges Green and Kaiser.
` 97
2 "
`2-
`I would like to start with a roll call.
`Go
` 7
`4 2
` 6 b-
`ahead for petitioner.
` 6 5
`
` -
`MR. PARMELEE: Good morning, your Honors.
` !- ! ( 8 i
`
`2-
`I would like to start with a roll call.
`Go
` 7
`4 2
` 6 b-
`ahead for petitioner.
` 6 5
`
` -
`MR. PARMELEE: Good morning, your Honors.
` !- ! ( 8 i
`
. :7 ' 2-
`This is Steve Parmelee and Jad Mills for petitioner
` 6
`2
`2 3 i 9 !
`2 5
`
`
`Apotex.
`) j-
`
`
`
`MS. REA: Good morning. This is Teri Rea
`+ ! - 8 i
`
`This is Steve Parmelee and Jad Mills for petitioner
` 6
`2
`2 3 i 9 !
`2 5
`
`
`Apotex.
`) j-
`
`
`
`MS. REA: Good morning. This is Teri Rea
`+ ! - 8 i
`
- 6
`2
`2
`
`and Shannon Lentz on behalf of petitioner Argentum.
` 6 ( k f65 5
`
`
`2
`2
`
`and Shannon Lentz on behalf of petitioner Argentum.
` 6 ( k f65 5
`
`
7i-
`MR. PARK: Good morning. This is Sam Park
`1 !- "8 i
`
`MR. PARK: Good morning. This is Sam Park
`1 !- "8 i
`
- 6
`2
`2 i 4
`on behalf of petitioner Sun Pharmaceutical.
` f65 5
`
` 7 6ib7
`b-
`MR. SPRINGSTED: Good morning. This is
` !- 8 i
`
`2
`2 i 4
`on behalf of petitioner Sun Pharmaceutical.
` f65 5
`
` 7 6ib7
`b-
`MR. SPRINGSTED: Good morning. This is
` !- 8 i
`
- 6
`2
`2
`Gregory Springsted on behalf of petitioners Actavis and
`
`2
`2
`Gregory Springsted on behalf of petitioners Actavis and
`
:
`
`
2 f65 5
`
` 2 b 3
`2
`Teva.
` 3-
`
`JUDGE POLLOCK: Anyone else? Very good.
` 9 #((#%"8 : 2l /:
`
` 2 b 3
`2
`Teva.
` 3-
`
`JUDGE POLLOCK: Anyone else? Very good.
` 9 #((#%"8 : 2l /:
-
`Is there a court reporter on the line?
` 2 6 b7 6
` l
`MR. PARMELEE: Yes, your Honor, we do have a
`) !- ! ( 8 ;2. :7 ' . 63
`court reporter on the line.
`+ b7 6
` -
`JUDGE POLLOCK: And who engaged the court
` 9 #((#%"8 6
`Is there a court reporter on the line?
` 2 6 b7 6
` l
`MR. PARMELEE: Yes, your Honor, we do have a
`) !- ! ( 8 ;2. :7 ' . 63
`court reporter on the line.
`+ b7 6
` -
`JUDGE POLLOCK: And who engaged the court
` 9 #((#%"8 6
6 b7
`
`TSG Reporting — Worldwide — 877—702—9580
`
`
`
`TSG Reporting — Worldwide — 877—702—9580
`
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`
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`
`
`CALL WITH BOARD
` % (( ' &#
`reporter?
` l
`
`
`
`
`
`MR. PARMELEE: Petitioner Apotex.
`) !- ! ( 8
`
` j-
`JUDGE POLLOCK: Very good.
`If Apotex would
`+ 9 #((#%"8 /:
- 5 j 7
`submit a copy of the transcript as an exhibit when it's
` 27fi
` b: 5 6 2b
` 2 j6
`f
` 6
` m2
`available,
`that would be fine.
`1 3
`f. 6 7 f 5
` -
`MR. PARMELEE: Certainly we will.
` !- ! ( 8 %
` :
`-
`JUDGE POLLOCK: Petitioners requested this
` 9 #((#%"8
`
` 2 n72 6
`2
`call regarding the routine or additional discovery of
` b
`submit a copy of the transcript as an exhibit when it's
` 27fi
` b: 5 6 2b
` 2 j6
`f
` 6
` m2
`available,
`that would be fine.
`1 3
`f. 6 7 f 5
` -
`MR. PARMELEE: Certainly we will.
` !- ! ( 8 %
` :
`-
`JUDGE POLLOCK: Petitioners requested this
` 9 #((#%"8
`
` 2 n72 6
`2
`call regarding the routine or additional discovery of
` b
`
6 7
`
`
`
`2b3: 5
`FDA minutes of the February 2, 2005, meeting between the
` $ i
` 7 2 5 6 $f7: . . i
`
`
`
`
`2b3: 5
`FDA minutes of the February 2, 2005, meeting between the
` $ i
` 7 2 5 6 $f7: . . i
`
f 6
`FDA and Novartis, which is referenced in Exhibit 2066
` $ 3
`2. 6
`b6
`2 5 b
` j6
`f
` 11
`and at paragraph 55 of Dr. Lublin's second deposition
`
`FDA and Novartis, which is referenced in Exhibit 2066
` $ 3
`2. 6
`b6
`2 5 b
` j6
`f
` 11
`and at paragraph 55 of Dr. Lublin's second deposition
`
6 5 - (7f
` m2 2b 2
`
`
`which quotes Exhibit 2066;
`two, a briefing book for the
`) 6
`b6 n7 2 j6
`f
` 11h . f
`5
`
` m2 2b 2
`
`
`which quotes Exhibit 2066;
`two, a briefing book for the
`) 6
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`f
` 11h . f
`5
`
f4 5 6
`March 26th, 2007, end of phase two meeting, which is
`+ !b6 1 6. . 5 62 i
`
`March 26th, 2007, end of phase two meeting, which is
`+ !b6 1 6. . 5 62 i
`
. 6
`b6
`2
`referenced in Exhibit 2064, which itself is referenced
` 5 b
` j6
`f
` 1+. 6
`b6
` 25
`2 5 b
`via paragraph 46 of Dr. Lublin's second declaration; and
`1 3
`
`b6
`2
`referenced in Exhibit 2064, which itself is referenced
` 5 b
` j6
`f
` 1+. 6
`b6
` 25
`2 5 b
`via paragraph 46 of Dr. Lublin's second declaration; and
`1 3
`
6 +1 5 - (7f
` m2 2b b
` h
`an unredacted copy of 2063, which is cited at paragraphs
` 7 b b: 5 1). 6
`b6
`2 b
`
` m2 2b b
` h
`an unredacted copy of 2063, which is cited at paragraphs
` 7 b b: 5 1). 6
`b6
`2 b
`
62
`52 and 56 of Dr. Lublin's second declaration.
` 1 5 - (7f
` m2 2b b
` -
`Petitioner, would you like to begin?
`
`
` . 7 :7
`4 f
`52 and 56 of Dr. Lublin's second declaration.
` 1 5 - (7f
` m2 2b b
` -
`Petitioner, would you like to begin?
`
`
` . 7 :7
`4 f
` l
`MR. PARMELEE: Yes, your Honor.
`I just want
` !- ! ( 8 ;2. :7 ' - o72
`to confirm that counsel for patent owner is on the line.
` b 5
`i 6 b7 2 5
`2 6
` -
`I didn't hear them introduce themselves.
`
` m 6 6i
` 7b 6i232-
`JUDGE POLLOCK: Oh,
`I'm sorry. My mistake.
`) 9 #((#%"8 #6. mi 2:- !: i
`2 4-
`Is counsel for patent owner there?
`+ 2 b7 2 5 6l
`MR. TRENCHARD: We are, your Honor. This is
` !- %' 8 . :7 ' - 6
`2
`2
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`TSG Reporting — Worldwide — 877—702—9580
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`CALL WITH BOARD
` % (( ' &#
`Bob Trenchard and Jane Love from Gibson Dunn for the
` &f b6 9 (3 5i
`f2 7 5 6
`patent owner.
`) -
`JUDGE POLLOCK: My apologies. Well, good
`+ 9 #((#%"8 !:
`2- .
`morning.
` i
`
-
`
`
`
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1
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`MR. TRENCHARD: Good morning, your Honor.
`1 !- %' 8 i
`
`
`MR. TRENCHARD: Good morning, your Honor.
`1 !- %' 8 i
`
. :7 ' -
`JUDGE POLLOCK: Petitioner.
` 9 #((#%"8
`
` -
`MR. PARMELEE:
`Sure. Yeah,
`thank you, your
` !- ! ( 8 7- ;6. 6 4 :7. :7
`
` ' -
`
`was filed on November 13th, 2017.
`
`Regarding the —— you've gone through the
`
`JUDGE POLLOCK: Petitioner.
` 9 #((#%"8
`
` -
`MR. PARMELEE:
`Sure. Yeah,
`thank you, your
` !- ! ( 8 7- ;6. 6 4 :7. :7
`
` ' -
`
`was filed on November 13th, 2017.
`
`Regarding the —— you've gone through the
`
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6
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67
6 6
`three documents that we identified. We think it's a
` 6 b7i 2 6
`
`5
`- 6
` 4
` m2
`pretty straightforward matter on these three,
`so let me
` : 2
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`three documents that we identified. We think it's a
` 6 b7i 2 6
`
`5
`- 6
` 4
` m2
`pretty straightforward matter on these three,
`so let me
` : 2
`
6 5 i 62 6. 2 i
`touch on each of them what they are, and you've already
`) 7b6 b6 5 6i 6 6: . :7m3 :
`identified where they're referred to in the patent owner
`+
`
`5
` 6 6:m 5
` 6
`expert declaration. We also have cites where patent
` j b
` - 2 63 b
` 2 6
`owner relies on them in the patent owner response that
`1
`2 6i
` 6 2 2 6
`|_\ \l
` 2 5
` 3if ) 6. -
`|_\ 00
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`TSG Reporting — Worldwide — 877—702—9580
`
`
`touch on each of them what they are, and you've already
`) 7b6 b6 5 6i 6 6: . :7m3 :
`identified where they're referred to in the patent owner
`+
`
`5
` 6 6:m 5
` 6
`expert declaration. We also have cites where patent
` j b
` - 2 63 b
` 2 6
`owner relies on them in the patent owner response that
`1
`2 6i
` 6 2 2 6
`|_\ \l
` 2 5
` 3if ) 6. -
`|_\ 00
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`TSG Reporting — Worldwide — 877—702—9580
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`CALL WITH BOARD
` % (( ' &#
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`JUDGE POLLOCK: Does the —— the expert
` 9 #((#%"8 2 6 6 j
`report is citing another document, 2066, which quotes an
`1
`2 b
`
`
6 b7i . 11. 6
`b6 n7 2
`excerpt of that.
`So Dr. Lublin I don't see had access
` jb 5 6 - - (7f
` m 2 6 bb22
`to the entire minutes;
`is that correct?
` 6
` i
` 7 2h
`2 6 bb l
`MR. PARMELEE: Well,
`they're citing to in
` !- ! ( 8 . 6:m b
`
`
`b6 n7 2
`excerpt of that.
`So Dr. Lublin I don't see had access
` jb 5 6 - - (7f
` m 2 6 bb22
`to the entire minutes;
`is that correct?
` 6
` i
` 7 2h
`2 6 bb l
`MR. PARMELEE: Well,
`they're citing to in
` !- ! ( 8 . 6:m b
`
`
`
`20 —— they're actually citing to the FDA, quoting from
` 6:m b 7: b
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6 $ . n7
`
`
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`the FDA minutes that are quoted in the exhibit that they
` 6 $ i
` 7 2 6 n7
` 6 j6
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` 6 6:
`do provide.
`So basically they're trying to immunize
` 3
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`
`the FDA minutes that are quoted in the exhibit that they
` 6 $ i
` 7 2 6 n7
` 6 j6
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` 6 6:
`do provide.
`So basically they're trying to immunize
` 3
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`from production the underlying FDA minutes by having
`) 5i 7b
` 6 7 :
`
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` 7 2 f: 63
`
` 7 2 f: 63
`
`Dr. Lublin provide us a snippet from that document and
`+ - (7f
` 3
` 72 2
` 5i 6 b7i
`not addressing the entirety of the FDA minutes. And
` 22
`
6
` : 5 6 $ i
` 7 2-
`certainly it's relied on in the patent owner response as
`1 b
` :
` m2
`
` 6 2 2 2
`well.
` -
`
`
`
`JUDGE POLLOCK: All right. Please continue.
` 9 #((#%"8
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` : 5 6 $ i
` 7 2-
`certainly it's relied on in the patent owner response as
`1 b
` :
` m2
`
` 6 2 2 2
`well.
` -
`
`
`
`JUDGE POLLOCK: All right. Please continue.
` 9 #((#%"8
`
6 - 2 b
` 7-
`MR. PARMELEE:
`Sure.
`I don't know if you
` !- ! ( 8 7- m 4
`5 :7
`wanted me to discuss where they're also relying on
` i
`2b722 6 6:m 2 :
`
` 7-
`MR. PARMELEE:
`Sure.
`I don't know if you
` !- ! ( 8 7- m 4
`5 :7
`wanted me to discuss where they're also relying on
` i
`2b722 6 6:m 2 :
`
`these,
`this material in the patent owner response, but
` 62. 6
`2 i
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` 6 2 2. f7
`that's at pages 26 to 27 citing the Lublin declaration
` 6 m2
2 1 b
`
`
`
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6 (7f
` b
`
`discussing these exhibits.
`)
`2b722
`
` b
`
`discussing these exhibits.
`)
`2b722
`
62 j6
`f
` 2-
`JUDGE POLLOCK: Okay.
`+ 9 #((#%"8 #4:-
`MR. PARMELEE:
`The second document that we
` !- ! ( 8 6 2b b7i 6
`
`TSG Reporting — Worldwide — 877—702—9580
`
`
`f
` 2-
`JUDGE POLLOCK: Okay.
`+ 9 #((#%"8 #4:-
`MR. PARMELEE:
`The second document that we
` !- ! ( 8 6 2b b7i 6
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`TSG Reporting — Worldwide — 877—702—9580
`
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`CALL WI TH BOARD
` % (( ' &#
`believe should have been produced as routine discovery
` f
`3 267 63 f 7b 2 7
`
`2b3:
`is this briefing book for the March 22nd, 2007, meeting
`)
`2 6
`2 f
`5
`
f4 5 6 !b6 . . i
`
`
`with the FDA.
`It's a document that Novartis apparently
`+
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`prepared for a meeting with the FDA and it's described
` 5 i
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` 6 6 $
` m2 2b
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`in Exhibit 2064 at page 1 which quotes from the briefing
`1
` j6
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` 1+
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`5
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`book with big block quotes.
` f4
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`discussion carries over to paragraph 47 in the Lublin
`+
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`2 3
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` 6
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`discussion carries over to paragraph 47 in the Lublin
`+
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`2 3
6 +
` 6 (7f
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`declaration as well. And in the patent owner response,
` b
` 2 -
` 6 2 2.
`patent owner relies on this discussion by Dr. Lublin in
`1
`2 6
`2
`2b722
` f: - (7f
`
`
`the first paragraph on page 26, which cites these
` 6 5
`2
` 6 (7f
`
`declaration as well. And in the patent owner response,
` b
` 2 -
` 6 2 2.
`patent owner relies on this discussion by Dr. Lublin in
`1
`2 6
`2
`2b722
` f: - (7f
`
`
`the first paragraph on page 26, which cites these
` 6 5
`2
6
1. 6
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` 2 62
`portions of the Lublin declaration.
`
` 2 5 6 (7f
` b
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`Therefore, because it is cited and relied
` 65. fb72
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`2 b
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`on, we believe that document,
`the briefing book, should
` . f
`3 6 b7i . 6 f
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`portions of the Lublin declaration.
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`Therefore, because it is cited and relied
` 65. fb72
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`2 b
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`on, we believe that document,
`the briefing book, should
` . f
`3 6 b7i . 6 f
`5
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f4. 267
`have been produced to us as a matter of routine
` 63 f 7b 72 2 i 5 7
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`discovery.
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`2b3:-
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`The third document that we've asked for as a
`) 6 6
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`matter of routine discovery is the heavily redacted copy
`+ i 5 7
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`of 2063 which is a partial e—mail chain involving
` 5 1) 6
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`have been produced to us as a matter of routine
` 63 f 7b 72 2 i 5 7
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`discovery.
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`2b3:-
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`The third document that we've asked for as a
`) 6 6
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`matter of routine discovery is the heavily redacted copy
`+ i 5 7
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`2b3:
`2 6 63
`: b b:
`of 2063 which is a partial e—mail chain involving
` 5 1) 6
`b6
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`TSG Reporting — Worldwide — 877—702—9580
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`CALL WITH BOARD
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`— I don't know
` m 4
`that we need to get into where this document is referred
`+ 6
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`to in Dr. Lublin's declaration.
`The patent owner itself
`
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`relies on it and quotes directly from it at the bottom
`1
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`of page 26.
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`We think that there is a protective order in
` 6
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`2 b
`3
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`this case. Certainly Exhibit 2063 is stamped as
` 6
`2 b2- %
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`f
` 1)
`2 2 i 2
`protective order material, yet the document is heavily
` b
`3 i
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`2 63
`:
`redacted and we think we should be provided with an
` b 6
` 4 267 f 3
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` 6
`unredacted copy of the document.
` 7 b b: 5 6 b7i -
`(Telephonic interruption.)
`) d 6
`b
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`MR. PARMELEE:
`So I guess on these three
`+ !- ! ( 8
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`We think that there is a protective order in
` 6
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`2 b
`3
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`this case. Certainly Exhibit 2063 is stamped as
` 6
`2 b2- %
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`f
` 1)
`2 2 i 2
`protective order material, yet the document is heavily
` b
`3 i
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`2 63
`:
`redacted and we think we should be provided with an
` b 6
` 4 267 f 3
`
` 6
`unredacted copy of the document.
` 7 b b: 5 6 b7i -
`(Telephonic interruption.)
`) d 6
`b
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`MR. PARMELEE:
`So I guess on these three
`+ !- ! ( 8
722 62 6
`documents we think it's a pretty straightforward case of
` b7i 2 6
` 4
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`documents we think it's a pretty straightforward case of
` b7i 2 6
` 4
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6 5 b2 5
`documents that should have been produced as routine
`1 b7i 2 6 267 63 f 7b 2 7
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`discovery under rule 42.51(b)(l). They're documents
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`that are referred to and relied on in the patent owner
` 6 5
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`response and in at least one declaration.
` 2 2
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`We don't think that the patent owner should
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`be able to withhold them or shield these documents
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` 62 b7i 2
`simply because they've chosen not to assign an exhibit
` 2
`i: fb72 6:m3 b62 22
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`documents that should have been produced as routine
`1 b7i 2 6 267 63 f 7b 2 7
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`discovery under rule 42.51(b)(l). They're documents
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`2b3: 7 7 +-dfede- 6:m b7i 2
`that are referred to and relied on in the patent owner
` 6 5
`
` 6
`response and in at least one declaration.
` 2 2
` 2 b
` -
`We don't think that the patent owner should
` m 6
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`be able to withhold them or shield these documents
` f f
` 66 6i 26
` 62 b7i 2
`simply because they've chosen not to assign an exhibit
` 2
`i: fb72 6:m3 b62 22
`
j6
`f
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`number to them. That's not what rule 42.51 says.
`) 7if 6i- 6 m2 6 7 +- 2:2-
`Basically it amounts to a trial by snippet rather than
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`allowing the parties to see the documents that they're
`
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`f
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`number to them. That's not what rule 42.51 says.
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`Basically it amounts to a trial by snippet rather than
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`allowing the parties to see the documents that they're
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`TSG Reporting — Worldwide — 877—702—9580
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`TSG Reporting — Worldwide — 877—702—9580
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`CALL WI TH BOARD
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`relying on.
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`So we ask for these materials —— sorry. We
`) 24 5 62 i
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`have asked for these materials from the patent owner in
`+ 63 24 5 62 i
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`advance of the depositions that were held in December.
` 3 b 5 6 2
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`They refused and they continue to refuse. We've
`1 6: 572 6: b
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`actually been prejudiced by our inability to have these
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`documents prior to those depositions, and so we ask that
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`the board now order them to be produced to us without
` 6 f 6i f 7b 72
` 67
`any further delay.
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`JUDGE POLLOCK: All right. Patent owner, on
` 9 #((#%"8
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6 - .
`what basis do you oppose this requested discovery? Also
` 6 f2
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`2 n72
`2b3:l 2
`given that Dr. Lublin expressly relies on Exhibit 2063,
`)
`what basis do you oppose this requested discovery? Also
` 6 f2
`2 :7 2 6
`2 n72
`2b3:l 2
`given that Dr. Lublin expressly relies on Exhibit 2063,
`)
`3 6 - (7f
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`2 j6
`f
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`perhaps you can explain the reasons for the redaction.
`+ 62 :7 b j
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`MR. TRENCHARD:
`Sure, your Honor.
`I'm happy
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`|_\ ON
`1 2 6-
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`to start there.
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`CALL WITH BOARD
`|_\
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`2 I I I I I I I I I I I I I I I I I I I I I I
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`The parts that's redacted —— and we have
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`TSG Reporting — Worldwide — 877—702—9580
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`CALL WI TH BOARD
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`given the petitioners a declaration from our in—house
`
`3 6
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` 2 b
` 5i 7
` 672
`counsel on this issue.
`The part that's redacted is ——
`) b7 2 6
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`2
`is not part of the e—mail chain between Mount Sinai and
`+
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`Novartis, which is the document that Dr. Lublin relies
` 3
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`on —— documents,
`those are the documents he relies on,
`1 b7i 2. 62 6 b7i 2 6
`2 .
`but rather additional internal e—mails within Novartis
` f7 6
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`related to or connected to the back—and—forth with Mount
` b b 6 fb4 5 6
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`Sinai. But since Dr. Lublin was only talking about the
`
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f7 6
`back—and—forth between Mount Sinai and Novartis,
`that
` fb4 5 6 f !7
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` 3
`2. 6
`seemed or those seemed the relevant documents and those
` 2i 62 2i 6 3 b7i 2 62
`are the ones that we produced.
` 6 2 6 7b-
`It so happened that we found them in our
`) 2 6 6 57 6i
` 7
`e—mail system just by happenstance attached to later
`+ i
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`e—mails that have no bearing on Dr. Lublin's analysis,
` i
`2 6 63 f
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`back—and—forth between Mount Sinai and Novartis,
`that
` fb4 5 6 f !7
`
` 3
`2. 6
`seemed or those seemed the relevant documents and those
` 2i 62 2i 6 3 b7i 2 62
`are the ones that we produced.
` 6 2 6 7b-
`It so happened that we found them in our
`) 2 6 6 57 6i
` 7
`e—mail system just by happenstance attached to later
`+ i
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`e—mails that have no bearing on Dr. Lublin's analysis,
` i
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- (7f
` m2 :2
`2.
`and he has never seen them, and they have no connection
`1 6 62 3 2 6i. 6: 63 b b
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`to his opinions in the case.
`They relate to, as I said,
` 6
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`additional discussions amongst internal Novartis folks
`
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`2b722
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`2.
`and he has never seen them, and they have no connection
`1 6 62 3 2 6i. 6: 63 b b
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`to his opinions in the case.
`They relate to, as I said,
` 6
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`additional discussions amongst internal Novartis folks
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`2b722
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2
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`that have no bearing on the purpose for which this is
` 6 63 f
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`that have no bearing on the purpose for which this is
` 6 63 f
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`2
`introduced.
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`So that's why that stuff was —— another way
` 6 m2 6: 6 2 755 2 6 :
`to look at this would be if we happened to pick up a
` 4 6
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`different version of this e—mail chain that was earlier
`)
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`in the back—and—forth, it would have omitted all of the
`+
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` 7 63 i
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`internal Novartis chatter and have included only what
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`TSG Reporting — Worldwide — 877—702—9580
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`introduced.
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`So that's why that stuff was —— another way
` 6 m2 6: 6 2 755 2 6 :
`to look at this would be if we happened to pick up a
` 4 6
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`different version of this e—mail chain that was earlier
`)
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`2 i
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`in the back—and—forth, it would have omitted all of the
`+
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` 7 63 i
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`internal Novartis chatter and have included only what
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`TSG Reporting — Worldwide — 877—702—9580
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`CALL WI TH BOARD
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`Dr. Lublin discussed in his declaration and the
` - (7f
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`2b722
` 6
`2 b
` 6
`unredacted portion.
`) 7 b
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`And with respect to the other two documents,
`+
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`the FDA minutes and the briefing book, as your Honor
` 6 $ i
` 7 2 6 f
`5
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`CALL WI TH BOARD
` % (( ' &#
`Dr. Lublin discussed in his declaration and the
` - (7f
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`2b722
` 6
`2 b
` 6
`unredacted portion.
`) 7 b
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`And with respect to the other two documents,
`+
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`the FDA minutes and the briefing book, as your Honor
` 6 $ i
` 7 2 6 f
`5
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f4. 2 :7 '
`alluded to in the questioning of Mr. Parmelee and as is
`1 7
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`alluded to in the questioning of Mr. Parmelee and as is
`1 7
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5 !- i 2
`2
`laid out
`in the e—mail correspondence we had with
`
` 7
` 6 i
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`opposing counsel on this issue, we have provided full
` 2
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`2
`laid out
`in the e—mail correspondence we had with
`
` 7
` 6 i
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` 6
`opposing counsel on this issue, we have provided full
` 2
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b7 2 6
`2
`227. 63 3
` 57
`copies of all of the documents that Dr. Lublin actually
` b
`2 5 5 6 b7i 2 6 - (7f
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`saw and relied on.
`He has not seen and relied on —— not
` 2
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`even seen at all the documents that the petitioners are
` 3 2 6 b7i 2 6 6
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` 2
`seeking.
`So they —— those documents form no part of the
` 24
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`2
`227. 63 3
` 57
`copies of all of the documents that Dr. Lublin actually
` b
`2 5 5 6 b7i 2 6 - (7f
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`saw and relied on.
`He has not seen and relied on —— not
` 2
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`even seen at all the documents that the petitioners are
` 3 2 6 b7i 2 6 6
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` 2
`seeking.
`So they —— those documents form no part of the
` 24
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62 b7i 2 5i 5 6
`basis of Novartis's patent owner response here and
`) f2
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`2m2 2 2 6
`opposition. And this really is,
`in our view, an
`+ 2
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`2 :
`2.
` 7 3
`.
`inappropriate use of either, frankly,
`the required or
`
`
` 72 5
` 6. 5 4:. 6 n7
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`additional discovery protocols in the rules.
`1
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`2b3: b2
` 6 72-
`It always happens that documents are used
` :2 6 2 6 b7i 2 72
`that refer or often quote other documents.
`Sometimes
` 6 5 5 n7 6 b7i 2- i
`i2
`those quotes or referrals matter; sometimes they don't.
` 62 n7 2 52 i h 2i
`i2 6: m -
`But the rules are pretty clear that you only have to
` &7 6 72 : b 6 :7 : 63
`provide as required discovery the exhibits that are used
` 3
` 2 n7
`
`2b3: 6 j6
`f
` 2 6 72
`to advance your position. And I don't think it's
` 3 b :7 2
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` 4
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`disputed that we've done that.
`)
`27 6 m3 6 -
`Those exhibits do quote from other
`+ 62 j6
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`documents. That is —— that is for sure.
`The quotes
` b7i 2- 6
`2 6
`2 5 27- 6 n7 2
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`TSG Reporting — Worldwide — 877—702—9580
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`basis of Novartis's patent owner response here and
`) f2
`2 5 3
`2m2 2 2 6
`opposition. And this really is,
`in our view, an
`+ 2
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` - 6
`2 :
`2.
` 7 3
`.
`inappropriate use of either, frankly,
`the required or
`
`
` 72 5
` 6. 5 4:. 6 n7
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`additional discovery protocols in the rules.
`1
`
`
`2b3: b2
` 6 72-
`It always happens that documents are used
` :2 6 2 6 b7i 2 72
`that refer or often quote other documents.
`Sometimes
` 6 5 5 n7 6 b7i 2- i
`i2
`those quotes or referrals matter; sometimes they don't.
` 62 n7 2 52 i h 2i
`i2 6: m -
`But the rules are pretty clear that you only have to
` &7 6 72 : b 6 :7 : 63
`provide as required discovery the exhibits that are used
` 3
` 2 n7
`
`2b3: 6 j6
`f
` 2 6 72
`to advance your position. And I don't think it's
` 3 b :7 2
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` 4
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`disputed that we've done that.
`)
`27 6 m3 6 -
`Those exhibits do quote from other
`+ 62 j6
`f
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`documents. That is —— that is for sure.
`The quotes
` b7i 2- 6
`2 6
`2 5 27- 6 n7 2
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`And that's the purpose for which it is used
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`in the brief. That's the purpose for which it is used
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`And that's the purpose for which it is used
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`in the brief. That's the purpose for which it is used
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`from the other documents frankly are —— are not being
` 5i 6 6 b7i 2 5 4: f
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`used in the way that I think Mr. Parmelee is describing.
`) 72
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`Just to briefly touch on each of them.
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`4 I I I I I I I I I I I I I I I I I I I 2
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`Just to briefly touch on each of them.
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`4 I I I I I I I I I I I I I I I I I I I 2
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`CALL WI TH BOARD
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`in Dr. Lublin's declaration. You don't need the
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`underlying minutes to understand that point. What you
`) 7 :
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`need is the letter that we've provided from Mr. Watson
`+
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`to —— to Mount Sinai.
` !7
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`need is the letter that we've provided from Mr. Watson
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`to —— to Mount Sinai.
` !7
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`Dr. Lublin was capable of describing
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`all of that in his deposition if he had been asked based
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`N N
`on the documents that have been provided. And the
` 6 b7i 2 6 63 f 3
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`briefing book itself is not something that he relied on,
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`it's simply something quoted in a document that he
`+
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`it's simply something quoted in a document that he
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`relied on.
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`relied on.
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`CALL WI TH BOARD
` % (( ' &#
`I'm happy to talk about the additional
` mi 6: 4 f7 6
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`discovery perspective if your Honor would like, but
`)
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`4. f7
`since Mr. Parmelee limited his comments to required
`+ 2
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`discovery,
`I'm also happy to stop here right now and, if
`
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`CALL WI TH BOARD
` % (( ' &#
`I'm happy to talk about the additional
` mi 6: 4 f7 6
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`
`discovery perspective if your Honor would like, but
`)
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`5 :7 ' 7
`4. f7
`since Mr. Parmelee limited his comments to required
`+ 2
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`discovery,
`I'm also happy to stop here right now and, if
`
`2b3:. mi 2 6: 2 6
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6 .
`5
`your Honors have any questions, happy to talk about
`1 :7 ' 2 63 : n72
` 2. 6: 4 f7
`that.
` 6 -
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`JUDGE POLLOCK:
`I think it would be best if
` 9 #((#%"8 6
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` 7 f f2
`5
`you would talk about additional discovery as well,
` :7 7 4 f7
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`
`2b3: 2 .
`please.
` 2-
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`MR. TRENCHARD: Okay.
`I'm happy to talk
` !- %' 8 #4:- mi 6: 4
`about that.
` f7 6 -
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`We do not think there is any basis for
`) 6
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`allowing a motion for additional discovery with respect
`+
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`your Honors have any questions, happy to talk about
`1 :7 ' 2 63 : n72
` 2. 6: 4 f7
`that.
` 6 -
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`JUDGE POLLOCK:
`I think it would be best if
` 9 #((#%"8 6
` 4
` 7 f f2
`5
`you would talk about additional discovery as well,
` :7 7 4 f7
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`2b3: 2 .
`please.
` 2-
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`MR. TRENCHARD: Okay.
`I'm happy to talk
` !- %' 8 #4:- mi 6: 4
`about that.
` f7 6 -
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`
`
`We do not think there is any basis for
`) 6
` 4 6
`2 : f2
`2 5
`allowing a motion for additional discovery with respect
`+
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i
` 5
`
`
`2b3:
` 6 2b
`to any of the documents the petitioners have requested
` : 5 6 b7i 2 6
`
` 2 63 n72
`and there are a few reasons for that.
`1 6 5 2 2 5 6 -
`The most
`important reason is, under the
` 6 i2
`i 2
`2. 7 6
`Garmin factors,
`the factor number one and the factor on
` i
` 5b 2. 6 5b 7if 6 5b
`which requests like this typically founder is the
` 6
`b6 n72 2
`4 6
`2 :
`b: 57
`2 6
`requirements that there be some evidence or reasoning to
` n7
`i 2 6 6 f 2i 3
` b 2
`
` 5
`
`
`2b3:
` 6 2b
`to any of the documents the petitioners have requested
` : 5 6 b7i 2 6
`
` 2 63 n72
`and there are a few reasons for that.
`1 6 5 2 2 5 6 -
`The most
`important reason is, under the
` 6 i2
`i 2
`2. 7 6
`Garmin factors,
`the factor number one and the factor on
` i
` 5b 2. 6 5b 7if 6 5b
`which requests like this typically founder is the
` 6
`b6 n72 2
`4 6
`2 :
`b: 57
`2 6
`requirements that there be some evidence or reasoning to
` n7
`i 2 6 6 f 2i 3
` b 2
`
`suggest that the requested additional information will
` 27
2 6 6 n72
`
`
` 5i
`
`
`be favorable to the requestor's position. We —— as your
` f 53f 6 n72 m2 2
`
` - 2 :7
`Honors probably saw in the e—mail correspondence we
`) ' 2 ff: 2
` 6 i
` b2 b
`submitted before this call, we have repeatedly asked the
`+ 27fi
` f5 6
`2 b. 63 : 24 6
`petitioner for such reasoning or evidence, and so far as
`
`
` 5 27b6 2
`
`
`
` 5i
`
`
`be favorable to the requestor's position. We —— as your
` f 53f 6 n72 m2 2
`
` - 2 :7
`Honors probably saw in the e—mail correspondence we
`) ' 2 ff: 2
` 6 i
` b2 b
`submitted before this call, we have repeatedly asked the
`+ 27fi
` f5 6
`2 b. 63 : 24 6
`petitioner for such reasoning or evidence, and so far as
`
`
` 5 27b6 2
`
3
` b. 2 5 2
`
`TSG Reporting — Worldwide — 877—702—9580
`
`
` b. 2 5 2
`
`TSG Reporting — Worldwide — 877—702—9580
`
`
`
`
`
`
`Page
`
`
`CALL WITH BOARD
` % (( ' &#
`we can tell, we are aware of none.
`On the contrary,
`to
` b . 5 - # 6 b :.
`the extent that these additional documents, especially
`) 6 j 6 62
`
` b7i 2. 2b
`:
`the briefing book and the FDA minutes are discussed
`+ 6 f
`5
`
f4 6 $ i
` 7 2
`2b722
`(inaudible) of the evidence,
`they —— the evidence
` d
` 7
`fe 5 6 3
` b. 6: 6 3
` b
`suggests that they help Novartis's position and not the
`1 27
` 7 2
`2b722
`(inaudible) of the evidence,
`they —— the evidence
` d
` 7
`fe 5 6 3
` b. 6: 6 3
` b
`suggests that they help Novartis's position and not the
`1 27
2 2 6 6: 6 3
`2m2 2
`
` 6
`petitioner's position.
`So we think that you can't even
`
`
` m2 2
`
` - 6
` 4 6 :7 b m 3
`get past Garmin factor number one.
`
`2m2 2
`
` 6
`petitioner's position.
`So we think that you can't even
`
`
` m2 2
`
` - 6
` 4 6 :7 b m 3
`get past Garmin factor number one.
`
2 i
` 5b 7if -
`In our back—and—forth with counsel,
`they
` 7 fb4 5 6
` 6 b7 2. 6:
`said quite candidly that what they really wanted was the
` 2
` n7
` b
`: 6 6 6: : 2 6
`documents in order to evaluate Novartis's position
` b7i 2
` 37 3
`2m2 2
`
`
`rather than to advocate for some position of theirs.
` 6 6 3b 5 2i 2
`
` 5 6
`2-
`That's the type of fishing expedition that the rules are
`) 6 m2 6 : 5 5
`26
`
` 5b 7if -
`In our back—and—forth with counsel,
`they
` 7 fb4 5 6
` 6 b7 2. 6:
`said quite candidly that what they really wanted was the
` 2
` n7
` b
`: 6 6 6: : 2 6
`documents in order to evaluate Novartis's position
` b7i 2
` 37 3
`2m2 2
`
`
`rather than to advocate for some position of theirs.
` 6 6 3b 5 2i 2
`
` 5 6
`2-
`That's the type of fishing expedition that the rules are
`) 6 m2 6 : 5 5
`26
`
j
`
` 6 6 72
`designed to prevent.
`+ 2
`
`
` 6 6 72
`designed to prevent.
`+ 2
`
3 -
`In addition,
`the other factors we think of
`
`
` . 6 6 5b 2 6
` 4 5
`Garmin are either not particularly relevant or weigh in
`1 i
`
` 6
`b7: 3
`
`In addition,
`the other factors we think of
`
`
` . 6 6 5b 2 6
` 4 5
`Garmin are either not particularly relevant or weigh in
`1 i
`
` 6
`b7: 3
`
6
`
`our favor including the timing of where we are. We
` 7 53
` b7
`
`
`our favor including the timing of where we are. We
` 7 53
` b7
`
6
`i
`
`i
`
5 6 -
`didn't get a request for these documents until more than
`
` m
`didn't get a request for these documents until more than
`
` m
n72 5 62 b7i 2 7
` i 6
`three weeks had passed after we filed our patent owner's
` 6 42 6 22 5 5
` 7 m2
`responsibilities. Here we are and I think there's only
` 2 2
`f
`
`
`2- ' 6
` 4 6m2 :
`about that amount of time, maybe a little bit more
` f7 6 i7 5
`i. i:f
` f
` i
`before the reply briefs are due. Briefing at resolving
` f5 6 : f
`52 7- &
`5
`
` i 6
`three weeks had passed after we filed our patent owner's
` 6 42 6 22 5 5
` 7 m2
`responsibilities. Here we are and I think there's only
` 2 2
`f
`
`
`2- ' 6
` 4 6m2 :
`about that amount of time, maybe a little bit more
` f7 6 i7 5
`i. i:f
` f
` i
`before the reply briefs are due. Briefing at resolving
` f5 6 : f
`52 7- &
`5
`
23
`
`
`producing these documents in that time seems impractical
`) 7b
`
62 b7i 2
` 6
`i 2i2
`ib
`b
`to us.
`+ 72-
`
`
`
`And lastly and quite importantly, especially
` 2 : n7
`
`i :. 2b
`:
`
`TSG Reporting — Worldwide — 877—702—9580
`
`
` 6
`i 2i2
`ib
`b
`to us.
`+ 72-
`
`
`
`And lastly and quite importantly, especially
` 2 : n7
`
`i :. 2b
`:
`
`TSG Reporting — Worldwide — 877—702—9580
`
`
`
`
`
`
`
`
`CALL WITH BOARD
` % (( ' &#
`with respect to the briefing book and one of the other
`
` 6 2b 6 f
`5
`
f4 5 6 6
`documents that have been mentioned at one point in
`) b7i 2 6 63 f i
`
`
`
`e—mail correspondence we haven't discussed yet,
`there is
`+ i
` b2 b 63 m
`2b722 : . 6
`2
`a nontrivial effort involved in identifying and
`
`3
` 55
` 33
`
`
`5:
`
`documents that have been mentioned at one point in
`) b7i 2 6 63 f i
`
`
`
`e—mail correspondence we haven't discussed yet,
`there is
`+ i
` b2 b 63 m
`2b722 : . 6
`2
`a nontrivial effort involved in identifying and
`
`3
` 55
` 33
`
`
`5:
`
`producing the documents.
`The briefing book in
`1 7b
`
6 b7i 2- 6 f
`5
`
`5
`
f4
`
`particular,
`so your Honor understands how this works,
`
`b7. 2 :7 ' 7 2 2 6 6
`2 42.
`these are living documents with inside of Novartis that
` 62
`3
`
`
`particular,
`so your Honor understands how this works,
`
`b7. 2 :7 ' 7 2 2 6 6
`2 42.
`these are living documents with inside of Novartis that
` 62
`3
`
b7i 2
` 6
` 2
` 5 3
`2 6
`they update. Lots of people have input into them, but
` 6: 7 - ( 2 5 63
` 7
` 6i. f7
`they're not formal FDA submissions.
`So they're not like
` 6:m 5i $ 27fi
`22
` 2- 6:m
`4
`a new drug application or the formal submission that's
` 7
` 6
` 2
` 5 3
`2 6
`they update. Lots of people have input into them, but
` 6: 7 - ( 2 5 63
` 7
` 6i. f7
`they're not formal FDA submissions.
`So they're not like
` 6:m 5i $ 27fi
`22
` 2- 6:m
`4
`a new drug application or the formal submission that's
` 7
`b
` 6 5i 27fi
`22
` 6 m2
`in this exhibit that describes the futility protocol
`
` 6
`2 j6
`f
` 6 2b
`f2 6 57
`
` : b
`here.
`) 6-
`
`
`
`These are informal documents that are shared
`+ 62
` 5i b7i 2 6 26
`with FDA before our meeting. But what that means is
`
` 6 $ f5 7 i
`
- &7 6 6 i 2
`2
`that identifying and reviewing and producing these
`1 6
`
`5:
`
`2
`that identifying and reviewing and producing these
`1 6
`
`5:
`
3
`
`
`
`
7b
`
`
62
`documents within Novartis, especially here we are more
` b7i 2
` 6
` 3
`2. 2b
`: 6 i
`than ten years later,
`is a significant undertaking.
` 6 :2 .
`2 2
`
`documents within Novartis, especially here we are more
` b7i 2
` 6
` 3
`2. 2b
`: 6 i
`than ten years later,
`is a significant undertaking.
` 6 :2 .
`2 2
`
`5
`b 7 4
`
-
`And —— and so the burden we think as well weighs
` 2 6 f7 6
` 4 2
`
`And —— and so the burden we think as well weighs
` 2 6 f7 6
` 4 2
`
62
`against, at least with respect to that document,
`the
`
`against, at least with respect to that document,
`the
`
` 2 . 2
` 6 2b 6 b7i . 6
`petitioner's request.
`
`
` m2 n72 -
`I think that's all I had to say about the
`
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