Case 1:17-cv-00181-IMK Document 64 Filed 01/10/18 Page 1 of 39 PageID #: 1451
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` 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`
`SANOFI-AVENTIS U.S.LLC, ET AL,
`
` Plaintiff,
`
` vs. CIVIL ACTION NUMBER: 1:17CV181
`
`MYLAN N.V. ET AL,
`
` Defendant.
`
`- - -
`
`Proceedings had in the Motion/Scheduling Conference of
`
`the above styled action on January 3, 2018, at 10:00 a.m.,
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`before The Honorable Irene M. Keeley, Senior Judge, at
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`Clarksburg, West Virginia.
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`APPEARANCES:
`
`FOR THE PLAINTIFF:
`
`FRANK E. SIMMERMAN, JR., ESQUIRE
`CHAD L. TAYLOR, ESQUIRE
`Simmerman Law Office PLLC
`254 E. Main Street
`Clarksburg, West Virginia 26301
`304-623-4900
`
`ELIZABETH WEISWASSER, ESQUIRE
`PRIYATA PATEL, ESQUIRE
`Weil, Gotshal & Manges LLP
`767 Fifth Avenue
`New York, New York 10153
`212-310-8022
`
`Proceedings recorded by stenomask, transcript produced by
`official court reporter.
`
`LINDA L. BACHMAN, CCR, CVR-M, OFFICIAL COURT REPORTER
`P.O. BOX 969, CLARKSBURG, WEST VIRGINIA 26302-0969
`304-282-0395
`
`Sanofi Exhibit 2024.001
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
` 1
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`
`SANOFI-AVENTIS U.S.LLC, ET AL,
`
` Plaintiff,
`
` vs. CIVIL ACTION NUMBER: 1:17CV181
`
`MYLAN N.V. ET AL,
`
` Defendant.
`
`- - -
`
`Proceedings had in the Motion/Scheduling Conference of
`
`the above styled action on January 3, 2018, at 10:00 a.m.,
`
`before The Honorable Irene M. Keeley, Senior Judge, at
`
`Clarksburg, West Virginia.
`
`APPEARANCES:
`
`FOR THE PLAINTIFF:
`
`FRANK E. SIMMERMAN, JR., ESQUIRE
`CHAD L. TAYLOR, ESQUIRE
`Simmerman Law Office PLLC
`254 E. Main Street
`Clarksburg, West Virginia 26301
`304-623-4900
`
`ELIZABETH WEISWASSER, ESQUIRE
`PRIYATA PATEL, ESQUIRE
`Weil, Gotshal & Manges LLP
`767 Fifth Avenue
`New York, New York 10153
`212-310-8022
`
`Proceedings recorded by stenomask, transcript produced by
`official court reporter.
`
`LINDA L. BACHMAN, CCR, CVR-M, OFFICIAL COURT REPORTER
`P.O. BOX 969, CLARKSBURG, WEST VIRGINIA 26302-0969
`304-282-0395
`
`Sanofi Exhibit 2024.001
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`Case 1:17-cv-00181-IMK Document 64 Filed 01/10/18 Page 2 of 39 PageID #: 1452
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` 2
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`APPEARANCES: (Continued)
`
`FOR THE PLAINTIFF:
`
`FOR THE DEFENDANT:
`
`ROBERT T. VLASIS, III, ESQUIRE
`Weil, Gotshal & Manges LLP
`1300 Eye Street NW - Suite 900
`Washington, DC 20005-3314
`202-682-7000
`
`JEFFREY A. KIMBLE, ESQUIRE
`E. RYAN KENNEDY, ESQUIRE
`Robinson & McElwee, PLLC
`P.O. Box 128
`Clarksburg, West Virginia 26302
`304-622-5022
`
`DOUGLAS H. CARSTEN, ESQUIRE
`ELHAM F. STEINER, ESQUIRE
`Wilson Sonsini Goodrich & Rosati
`12235 El Camino Real, Suite 200
`San Diego, California 92130
`858-350-2300
`
`LINDA L. BACHMAN, CCR, CVR-M, OFFICIAL COURT REPORTER
`P.O. BOX 969, CLARKSBURG, WEST VIRGINIA 26302-0969
`304-282-0395
`
`Sanofi Exhibit 2024.002
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`Case 1:17-cv-00181-IMK Document 64 Filed 01/10/18 Page 3 of 39 PageID #: 1453
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`I N D E X
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`WITNESS DIRECT CROSS REDIRECT RECROSS
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`(No Witnesses Called)
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`
`
`Sanofi Exhibit 2024.003
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`Case 1:17-cv-00181-IMK Document 64 Filed 01/10/18 Page 4 of 39 PageID #: 1454
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`P R O C E E D I N G S
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`(01-03-2018, 10:00 o'clock a.m.)
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`THE COURT: Good morning to all. Would the Clerk
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`please call the case?
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`THE CLERK: This is the case of Sanofi-Aventis U.S.
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`LLC, et al versus Mylan N.V. et al, Civil Action 1:17CV181.
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`Will counsel please note their appearance?
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`MR. SIMMERMAN: Good morning, Your Honor, may it
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`please the Court. Frank Simmerman and Chad Taylor on behalf
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`of Sanofi. If I may introduce respectively the Weil team.
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`To my right is Elizabeth Weiswasser, I want to say
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`Weiswasser but in any event--
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`THE COURT: We're in the States, not in Germany.
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`MR. SIMMERMAN: That's right.
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`THE COURT: Or Austria, as the case may be.
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`MR. SIMMERMAN: Seated behind me is Robert Vlasis,
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`Your Honor, and also Priyata Patel. They've all been
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`admitted pro hac and also with us today is Stephanie
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`Donahue, U.E. Ms. Donahue is the Senior Director of Patent
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`Litigation at Sanofi.
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`THE COURT: Well, good morning to all of you to
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`freezing West Virginia, but not too much different from
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`where you probably came from.
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`All right. Good morning to Mylan's counsel. Who's
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`leading?
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`Sanofi Exhibit 2024.004
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`Case 1:17-cv-00181-IMK Document 64 Filed 01/10/18 Page 5 of 39 PageID #: 1455
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`MR. KIMBLE: Good morning, Your Honor, Jeff Kimble
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`and Ryan Kennedy from Robinson McElwee Clarksburg here for
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`Mylan and also seated to my left, the far left is Elham
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`Steiner and to my direct left is Doug Carsten, both with the
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`Wilson Sonsini Goodrich & Rosati firm in San Diego,
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`California.
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`THE COURT: All right. Good morning to all of you
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`as well. The hearing this morning is scheduled for several
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`purposes but I think initially we'd better move directly to
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`the motion to stay. Is that how you all saw this this
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`morning, to handle the motion to stay first?
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`MS. WEISWASSER: Yes.
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`THE COURT: All right. I'll be happy to hear
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`counsel on that and I have read the briefs.
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`MS. WEISWASSER: Good morning, Your Honor.
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`THE COURT: You can move that microphone so you
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`don't have to lean over. Thank you.
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`MS. WEISWASSER: Thank you to my colleague Frank
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`Simmerman for introducing me this morning. As he said my
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`name is Elizabeth Weiswasser. I'm at Weil Gotshal & Manges
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`in New York City. It's a privilege to be before Your Honor
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`this morning on behalf of Sanofi.
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`We recognize that Your Honor has read the stay briefing.
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`As you know we filed, on behalf of Sanofi, our lead action
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`in New Jersey. The New Jersey case is assigned to Judge
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`Sanofi Exhibit 2024.005
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`Case 1:17-cv-00181-IMK Document 64 Filed 01/10/18 Page 6 of 39 PageID #: 1456
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`Chesler and Magistrate Judge Waldor. The case is moving
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`along actively on the merits. We had a scheduling
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`conference with Judge Waldor in the middle of December.
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`We have a schedule that we have provided to Your Honor
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`that takes the parties through the claim construction
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`proceedings.
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`We have exchanged our initial disclosures.
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`We have served merits discovery and Mylan will be
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`providing its contentions in two weeks and Sanofi will be
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`responding to those contentions in the beginning of March.
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`The case is moving well along on the merits.
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`THE COURT: There's been no ruling on the venue
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`motion?
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`MS. WEISWASSER: No, the merits proceeding is
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`moving along in parallel with the venue briefing.
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`As Your Honor--
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`THE COURT: Who has the venue motion?
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`MS. WEISWASSER: Judge Chesler and he will be
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`ruling on the venue motion. The only thing that remains is
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`Mylan will be filing its reply brief, I believe it is this
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`Friday and then--
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`THE COURT: The motion will be ripe at the end of
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`this week?
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`MS. WEISWASSER: It will be ripe at the end of this
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`week. Judge Chesler will either have an oral hearing or not
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`Sanofi Exhibit 2024.006
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`Case 1:17-cv-00181-IMK Document 64 Filed 01/10/18 Page 7 of 39 PageID #: 1457
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`on the venue motion. We do expect that there will be a
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`decision at some time in the near future.
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`I did want to let you know, and I believe this was in
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`our 26(f) report, it's probably about a month ago now, we
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`had proposed a stipulation to Mylan that in our view would
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`effectively eliminate the need for any venue dispute in New
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`Jersey. We had proposed that we would dismiss the three
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`Mylan entities that have not submitted the FDA application
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`and what that would leave is one Mylan entity that is a
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`foreign entity. It is not incorporated in the U.S. and in
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`our view, and I know that Mylan disputes this, but in our
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`view it's very clear under Heartland and Brunette and also
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`under Mylan's position they've taken in another case that
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`venue is appropriate in any--in any court against a foreign
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`entity, but we have proposed that stipulation to them that
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`would remove the two domestic entities and the other Mylan
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`entity as long as they would agree to be bound by any final
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`ruling and to provide discovery to us.
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`We sent that to them about a month ago and then after we
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`talked about that with Judge Waldor in New Jersey at the
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`scheduling conference and she seemed certainly very
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`interested in the streamlining that would provide and also
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`eliminate the need for any venue discovery, we had
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`re-proposed that to Mylan but we just haven't heard from
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`them.
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`Sanofi Exhibit 2024.007
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`Case 1:17-cv-00181-IMK Document 64 Filed 01/10/18 Page 8 of 39 PageID #: 1458
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`All of that said, Your Honor, everything is moving in
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`parallel. As I said the venue dispute will be fully briefed
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`as of Friday. We expect a decision in the relative near
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`term but most importantly everything is proceeding on the
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`merits and we have a scheduling order.
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`THE COURT: Your scheduling order does not include
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`a trial date however, correct?
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`MS. WEISWASSER: Yes, it does not, and that really
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`goes to Judge Chesler's practice. What he does is he will
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`typically, and that is the case here, provide a schedule
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`that takes the parties through the claim construction
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`proceedings and that's what we see here where claim
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`construction briefing will be complete by the end of the
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`summer. Sometimes he will hold an oral claim construction
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`hearing. Sometimes he will decide just to make a decision
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`on the papers. What he has done is he has set aside the
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`week of September 10th of this year for a Markman hearing if
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`he decides he would like to have one and also subject to the
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`Court's availability.
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`What's important about that date though, it's right now
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`the same tentative goal date that is in the related
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`litigation that Sanofi has pending against Merck--
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`THE COURT: In Delaware?
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`MS. WEISWASSER: No, in New Jersey.
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`THE COURT: Oh, in New Jersey. Okay. Oh, that's
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`Sanofi Exhibit 2024.008
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`Case 1:17-cv-00181-IMK Document 64 Filed 01/10/18 Page 9 of 39 PageID #: 1459
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`right. Yeah.
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`MS. WEISWASSER: Yeah. There are two different
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`cases against Merck right now. One is before Judge Andrews
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`in Delaware and that case is going to trial this May.
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`THE COURT: That's only on two of the patents?
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`MS. WEISWASSER: No. That is actually on eight
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`patents, the one in Delaware.
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`THE COURT: Okay.
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`MS. WEISWASSER: That--Your Honor, that case
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`involves a pen product and that's why there are both device
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`patents and formulation patents asserted in Delaware.
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`In New Jersey the Merck case is on a vial product and
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`that only involves two of the patents, the two formulation
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`patents. We are asserting the same two formulation patents
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`here and Mylan has vial and pen products.
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`Getting back to your question about a trial date. So
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`what Judge Chesler does, and what you'll see reflected on
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`the scheduling order, is he then cues the dates up through
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`the trial off of the issuance of the claim construction
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`ruling and that's more efficient because it allows for
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`expert discovery and disclosures based on the claim
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`construction rulings.
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`I think what's most important for Your Honor's purposes
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`is that Judge Chesler has--he has presided over, I think
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`it's about fifty Hatch-Waxman cases. He is cognizant of the
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`Sanofi Exhibit 2024.009
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`Case 1:17-cv-00181-IMK Document 64 Filed 01/10/18 Page 10 of 39 PageID #: 1460
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`unique posture of these cases, the importance of resolving
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`them well in advance of expiration of the thirty month stay.
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`And during the hearing that Judge Waldor had with the
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`parties in New Jersey in the middle of December she did
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`repeatedly recognize, and it's reflected on her order, that
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`the Court will be mindful of expiration of the stay. She
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`will have periodic check ins with the party and in fact
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`our first one is scheduled now for March 1st when she wants
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`to talk with the parties, make sure that everything is
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`moving along with the aim of having this case trial ready
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`sufficiently in advance of expiration of the thirty month
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`stay so that there won't be any issue as to whether Judge
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`Chesler will have resolved the merits issues well in advance
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`of the thirty month stay.
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`THE COURT: All right. If I look at the dates that
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`have been provided to me and your proposed dates in this
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`case, for example, a bench trial date in November or
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`December of 2019, the--the change in the statute takes place
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`in March of 2020?
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`MS. WEISWASSER: Yes, March 23rd.
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`THE COURT: It's a major point in Mylan's briefs
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`that I think is well taken--
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`MS. WEISWASSER: Uh-huh (yes).
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`THE COURT: --which you haven't addressed yet, and
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`I assume that it was addressed by Judge Chesler?
`
`Sanofi Exhibit 2024.010
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`Case 1:17-cv-00181-IMK Document 64 Filed 01/10/18 Page 11 of 39 PageID #: 1461
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`MS. WEISWASSER: What she--let me give you--
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`THE COURT: Judge Waldor, excuse me.
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`MS. WEISWASSER: Yeah. Judge Waldor. So first of
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`all, the trial date that Sanofi is proposing for New Jersey
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`is in October of 2019 and that's five months before
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`expiration of the thirty month stay and we would propose a
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`conditional trial date here maybe about a month after that
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`in November of 2019.
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`Let me explain the transition date. First of all, it is
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`our view that this is not the fire drill at all that Mylan
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`has identified it to be. What the transition date is, and
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`it's March 23rd of 2020, it is the date when the FDA will
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`start looking at insulin as a biologic and so it will no
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`longer be governed by the Hatch-Waxman Act.
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`So import--
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`THE COURT: My understanding was from reviewing the
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`regs and reading the briefs, and I don't mean to interject
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`but it is a main question I have, what--what I understood is
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`there will be--any case in process--any NDA case in process
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`will simply die on the vine.
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`MS. WEISWASSER: Right. And so--
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`THE COURT: It did sound like a bit of a fire drill
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`to me as a consequence.
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`MR. WEISWASSER: Let me explain to you why it is
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`not a fire drill. Okay. So, first of all there are two
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`Sanofi Exhibit 2024.011
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`Case 1:17-cv-00181-IMK Document 64 Filed 01/10/18 Page 12 of 39 PageID #: 1462
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`issues with obtaining final FDA approval in advance of the
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`transition date. One are the patent issues. That's what
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`this case is about. The other one are regulatory issues
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`that have nothing to do with anything here.
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`THE COURT: The FDA issues.
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`MS. WEISWASSER: With the FDA and that's Mylan's
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`back and forth with the FDA to make sure that they have
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`everything together such that the FDA is comfortable
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`approving it for regulatory reasons.
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`When the thirty month stay expires, there is no
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`longer--as a matter of law under the statute, there is no
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`longer any patent related barrier to approval. That stay
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`expires on March 18th of 2020.
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`Now what Mylan has said, and will tell you, is that it's
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`not doable for them to get this conversion in that two day
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`business day period, which they will say, or five day
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`period, but that--that is not the reality of how this is
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`going to play out. Okay.
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`First of all, we are proposing and we understand Judge
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`Chesler is committed to, not resolving this case on the very
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`last day that the stay expires. He's committed to, and his
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`practice has been, to get this case resolved in advance of
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`the thirty month stay and we're proposing October 2019 as
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`the trial date so that that is doable. Okay. So that's the
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`patent side of it.
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`Sanofi Exhibit 2024.012
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`Case 1:17-cv-00181-IMK Document 64 Filed 01/10/18 Page 13 of 39 PageID #: 1463
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`The regulatory side of it, that transition date is
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`twenty-seven months from now. It is really on Mylan to work
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`with the FDA, and our understanding is that the FDA wants to
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`do this, that it's its regular practice to work with ANDA or
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`505(b)(2) applicants to make sure that the regulatory issues
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`are addressed well in advance of expiration of the thirty
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`month stay. Mylan now has over two years to work with the
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`FDA to secure what we will call the tentative approval and
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`the way that works is that once the FDA concludes that all
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`of the regulatory requirements for obtaining approval, safe,
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`effective, et cetera, are met it will issue what's called a
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`tentative approval. All that remains than to secure the
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`final approval is resolution of the patent issues. They
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`have twenty-seven months between now and then to secure that
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`tentative approval. As a practical matter we're not saying
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`that the patent issues won't be resolved until two business
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`days before the--before the transition date. We're
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`proposing to get it resolved five months before.
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`What they're asking Your Honor to do now is to run
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`everything in parallel with the schedule that's already in
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`place and moving along in New Jersey and give them a trial
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`date a year from this April. Okay. That's fifteen months
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`from now.
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`First of all, this is an eighteen patent case. It's
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`complicated. I think it would be highly prejudicial to us
`
`Sanofi Exhibit 2024.013
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`Case 1:17-cv-00181-IMK Document 64 Filed 01/10/18 Page 14 of 39 PageID #: 1464
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`to even get this case ready for trial by a year from April,
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`but putting that aside, that is not necessary, that kind of
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`prejudice. There's no reason to try this case in fifteen
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`months. We propose to get it done and I think the New
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`Jersey court is committed to doing it, by October of next
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`year.
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`Now let me just say this. What we're proposing today is
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`not that you stay the case for all time. What we're
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`proposing is that for efficiency reasons we let Judge
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`Chesler and Judge Waldor continue to move this forward. We
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`stay the case. We can set a conditional trial date, until
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`we see what Judge Chesler does on venue. Okay. And we'll
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`report to you when there is a decision. We'll do periodic
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`status updates, whatever it is that would make you
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`comfortable, just to make sure that everything is proceeding
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`and what we would propose to do is let Judge Chesler decide
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`whether he has venue or not. If he concludes, as we believe
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`he will, but it's within his own purview to make the
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`decision, that venue is appropriate in New Jersey, at that
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`point we will continue it forward and we'll resolve the case
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`and he's perfectly experienced and capable of doing that.
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`If he concludes, however, that he does not have venue,
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`this is not a situation where that case is stagnant, that
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`nothing is getting done. What Your Honor can be comfortable
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`with, we would respectfully submit, is that merits
`
`Sanofi Exhibit 2024.014
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`Case 1:17-cv-00181-IMK Document 64 Filed 01/10/18 Page 15 of 39 PageID #: 1465
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`discovery, contentions, claim construction, it's moving
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`forward and so if Judge Chesler ultimately concludes he does
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`not have venue, we can take all the good work that's being
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`done in New Jersey and move it to this court and then
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`continue and move toward a trial date that we would propose
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`for October or November of 2019 and resolve this case
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`responsibly well in advance of the thirty month stay.
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`And in the meantime, during all of these months, Mylan
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`has its own job to do with the FDA to make sure that it gets
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`its tentative approval so that it can work responsibly with
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`the FDA, that when the patent issues are resolved, and
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`again, they will be before the thirty month stay expires,
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`they can then move to their final approval and this will all
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`be in advance of the transition date.
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`THE COURT: All right. Thank you very much.
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`MS. WEISWASSER: Sure.
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`THE COURT: Mylan's counsel.
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`MR. CARSTEN: Good morning, Your Honor. May it
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`please the Court. My name is Doug Carsten from Wilson
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`Sonsini in San Diego.
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`First, let me just thank the Court for moving the
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`scheduling conference up by three weeks in response to our
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`request to do so.
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`THE COURT: I thought you might have had buyer's
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`remorse when you saw the weather.
`
`Sanofi Exhibit 2024.015
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`Case 1:17-cv-00181-IMK Document 64 Filed 01/10/18 Page 16 of 39 PageID #: 1466
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`MR. CARSTEN: I may well have and I thought I had
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`some extra room in my carry-on to bring some sunny weather
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`from San Diego but it turns out I didn't.
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`Your Honor, you're absolutely right, when you say that
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`this is a bit of a fire drill. This is not your--
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`THE COURT: No, no, you all said it. She said it's
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`not. I said I thought it kind of looked like one but it's
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`up to you all to convince me that it is.
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`MR. CARSTEN: Fair enough. Well, let me do my best
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`to do that. This is not your typical Hatch-Waxman case
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`where we usually have the thirty month stay that everyone's
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`concerned about and Ms. Weiswasser talked a fair bit about
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`securing tentative approval and rest assured Mylan is doing
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`everything it can to secure that tentative approval but here
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`we have a bit of a sword of Damocles hanging over our head
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`that's beyond the thirty month stay and that is the March
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`23rd date.
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`On March 23rd, if we have tentative approval, according
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`to what the FDA has been telling us thus far, we have
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`nothing. It will be a--I think you said it dies on the
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`vine. Our application would, in theory, die on the vine if
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`the FDA maintains the position it's taken to date. A
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`tentative approval doesn't get us there. We would have to
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`have a final approval.
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`THE COURT: I was--I was wondering with regard to
`
`Sanofi Exhibit 2024.016
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`Case 1:17-cv-00181-IMK Document 64 Filed 01/10/18 Page 17 of 39 PageID #: 1467
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`those, I don't know that they're the final regs. Are those
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`draft regulations that are out for comment or are those in
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`fact the FDA's final regs on all of this?
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`MR. CARSTEN: I believe, Your Honor, that they are
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`the draft guidances and we have--
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`THE COURT: Well they called it guidance so I
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`wasn't sure from the administrative law side of this whether
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`they are subject to comment, are they subject to further
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`drafting or editing or is this the guidance that you all
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`should rely on because it is not going to change?
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`MR. CARSTEN: That's a great question, Your Honor,
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`and I don't know that I have the final answer on that. I
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`certainly know that Mylan is behaving as if this is thus far
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`the last word.
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`There was an opportunity for comment and I believe that
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`in Sanofi-Aventis' reply brief at Exhibit 1 they provided
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`the Mylan letter as Exhibit 1 to the reply brief that we had
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`provided to the FDA in which we told the FDA that this kind
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`of draconian drop dead date or what we call the transition
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`date, would be devastating to our ongoing development
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`efforts. I think we said that in--sometime in 2016, so
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`we've been fighting that fight as well.
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`But here we sit with an application that we've prepared
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`and submitted to the FDA as timely as we could and now we're
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`looking at a date that's--with a potential transition date,
`
`Sanofi Exhibit 2024.017
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`Case 1:17-cv-00181-IMK Document 64 Filed 01/10/18 Page 18 of 39 PageID #: 1468
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`you know, five days or really two business days after the
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`expiration of the thirty month stay.
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`Now, Your Honor, I understand that Ms. Weiswasser has
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`said, well look, Mylan, you can do all you can to sort of
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`work the system in the twenty odd months you've got between
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`now and then and sure we're doing that.
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`But the FDA, God bless their souls, they're a big
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`organization and to expect that the FDA is going to turn on
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`a dime and convert a tentative approval to a final approval
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`within two business days or even more generously under their
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`schedule or proposal, assuming that we get a decision from
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`Judge Chesler some time a month or so before then, that in
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`that month the FDA's going to do that, I don't want to put
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`my chips in--on that table the way it is.
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`THE COURT: Well in the letter it talks about a
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`regulatory dead zone as opposed to the fire drill and you
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`all are suggesting in this letter to the FDA that that
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`could--that is a dead zone that could last anywhere from two
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`to four years and it's--there's a footnote. If the
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`regulatory dead zone extends four years prior to March 23rd,
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`2020, it would've started on March 23rd, 2016, approximately
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`a week after FDA issued the draft guidance.
`
`So I was trying to kind of fit the puzzle together to
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`see whether candidly you have any hope at all of meeting
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`these deadlines.
`
`Sanofi Exhibit 2024.018
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`Case 1:17-cv-00181-IMK Document 64 Filed 01/10/18 Page 19 of 39 PageID #: 1469
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`MR. CARSTEN: I think we do, Your Honor, and
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`certainly one way to do it is, as Ms. Weiswasser suggested,
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`was to go ahead and do all we can on the regulatory side to
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`get to a period of tentative approval and then resolve the
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`patent issues as rapidly as we can. Because remember now,
`
`Your Honor, the thirty month stay, it's up to thirty months
`
`so it's up to thirty months or until we have a judgment on
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`the merits.
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`At that point then, Your Honor, we're not looking at a
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`two business day or a month of time to try to convert that
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`tentative approval to a final. We have four months or six
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`months and, Your Honor, that's why I think it's so critical
`
`here that we come out today with a trial date that is akin
`
`to what this Court typically does in Hatch-Waxman cases or
`
`patent cases, which according to the information that we've
`
`looked at, looks like it's on the order of nineteen months
`
`from--from time of filing. I think that we can all operate
`
`under a schedule that is designed to get us there.
`
`It seemed to me that Sanofi was being fairly reasonable
`
`frankly in saying that the discovery that applies in one
`
`case applies in the other and I agree wholeheartedly with
`
`that.
`
`I would submit, Your Honor, that we proceed with setting
`
`a trial schedule here and setting dates and then proceeding
`
`under that schedule and we see what the District Court in
`
`Sanofi Exhibit 2024.019
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`Case 1:17-cv-00181-IMK Document 64 Filed 01/10/18 Page 20 of 39 PageID #: 1470
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`New Jersey with Judge Chesler does.
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`THE COURT: Well if we have a concept of judicial
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`efficiency and economy in mind, let me start with the
`
`argument that Sanofi opened with on the stipulation that it
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`was offered to Mylan and that there's been no response
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`because candidly, in our review of the briefs in New Jersey,
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`it looks like, you know, the big argument, not that it was
`
`raised here and it need not be, but it really depends on a
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`different venue statute then the patent venue statute,
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`right?
`
`MR. CARSTEN: Well--
`
`THE COURT: I'm just saying that you've got what,
`
`four Mylan entities in the New Jersey case?
`
`MR. CARSTEN: There are four Mylan entities that
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`Sanofi has sued in New Jersey and here, Your Honor. Yes,
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`that's correct.
`
`THE COURT: Right. And the applicant for the ANDA
`
`or the A-N-D-A, is the foreign entity?
`
`MR. CARSTEN: It is. Mylan GMBH, Your Honor.
`
`THE COURT: GMBH. And so if--if we're waiting to
`
`hear from Judge Chesler on that issue, which does sound like
`
`a very interesting issue and I would assume knowing Judge
`
`Chesler's reputation, he'll get to that pretty quickly once
`
`it's fully briefed, are we wasting our time here today to go
`
`ahead and start scheduling here before we know whether in
`
`Sanofi Exhibit 2024.020
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`Case 1:17-cv-00181-IMK Document 64 Filed 01/10/18 Page 21 of 39 PageID #: 1471
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`fact anything will show up here?
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`MR. CARSTEN: I don't believe so, Your Honor, at
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`all. I think the--the schedule--I actually think the
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`scheduling order in New Jersey demonstrates exactly what
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`we've been talking about and why we think it's critical that
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`we do secure a trial date with Your Honor.
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`THE COURT: Well, are you all the ones briefing the
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`issue in New Jersey?
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`MR. CARSTEN: Yes, Your Honor.
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`THE COURT: Okay. So what is your expectation? Do
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`you think Judge Chesler is going to have oral argument on
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`the question? I mean it's not a--it's not a foursquare TC
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`Heartland question.
`
`MR. CARSTEN: It is not, Your Honor. In fact
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`there's sort of a pregnant piece of dicta in TC Heartland
`
`which says that it is not addressing the question of venue
`
`in patent cases over foreign defendants because of the--in
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`part, having noted that the Brunette case was decided under
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`a different statute. The statutory language had changed so
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`I think it is an interesting issue and I don't believe that
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`TC Heartland--I think TC Heartland certainly opened the door
`
`to a change in the patent venue for domestic and I think
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`that it foretold that there may well be a change coming
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`on--on international and non-U.S. resident entities as well.
`
`So that is an interesting issue.
`
`Sanofi Exhibit 2024.021
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`Case 1:17-cv-00181-IMK Document 64 Filed 01/10/18 Page 22 of 39 PageID #: 1472
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`I would assume that Judge Chesler would hear oral
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`argument. I know that Sanofi has requested discovery on
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`this and in fact had told us that they were going to--that
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`they were not going to file their opposition brief to our
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`motion until they had discovery, then went ahead and filed
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`their opposition, perhaps because of the motion to stay and
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`so forth here, but they have reiterated--and before Judge
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`Waldor their interest in taking venue discovery on these
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`entities. They did put forth the stipulation but the
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`stipulation would be you're in discovery, you're--you're
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`actually--the entity GMBH would be in New Jersey, subject to
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`the New Jersey thirty plus months standard time to trial
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`that we're seeing and that just doesn't work in this case.
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`THE COURT: I was a little interested in that
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`statistic. Is that solely patent cases or is that all civil
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`litigation?
`
`MR. CARSTEN: That's the--we provided Your Honor
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`the citation to that. I believe it's all patent cases and I
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`know that Judge Chesler is a very savvy judge when it comes
`
`to Hatch-Waxman cases. He hears them regularly, as do you,
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`Your Honor. You've got your--more than your fair share of
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`Hatch-Waxman cases as well. But I would submit that neither
`
`you, Your Honor, nor Judge Chesler has ever had a case where
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`this particular transition date BPCIA issue has been raised
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`and so to say that just because Judge Chesler is familiar
`
`Sanofi Exhibit 2024.022
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`Case 1:17-cv-00181-IMK Document 64 Filed 01/10/18 Page 23 of 39 PageID #: 1473
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`with--with trying or moving along Hatch-Waxman cases makes
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`him the perfect candidate for this case, I don't--I don't
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`think that necessarily follows, Your Honor.
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`I actually think, and I would submit, with respect, that
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`Your Honor, who has in the past when plaintiffs have come to
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`you saying we need a stay and Mylan, for one reason or
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`another, often times we agree. Okay, it's fine to stay it
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`if we can get a conditional trial date et ce
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