Free Transcript - District Court of Delaware - Delaware

Case 1:08-cv-00022-GMS-LPS

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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 BEFORE:

IN THE UNITED STATES DISTRICT COURT IN AND FOR THE DISTRICT OF DELAWARE FOREST LABORATORIES, INC., FOREST LABORATORIES HOLDINGS, LTD. MERZ PHARMA GMBH & CO. KGAA, and MERZ PHARMACEUTICALS GMBH, : CIVIL ACTION : : : : Plaintiffs, : v. : : COBALT LABORATORIES, INC., LUPIN : PHARMACEUTICALS, INC., LUPIN LTD., : ORCHID PHARMACEUTICALS, INC., ORCHID : CHEMICALS AND PHARMACEUTICALS LTD. : (D/B/A ORCHID HEALTHCARE), TEVA : PHARMACEUTICALS USA, INC., UPSHER: SMITH LABORATORIES, INC., WOCKHARDT : USA, INC., AND WOCKHARDT LIMITED, : : NO. 08-21 (GMS/LPS) Defendants. ------------------------------------FOREST LABORATORIES, INC., FOREST : LABORATORIES HOLDINGS, LTD. MERZ : PHARMA GMBH & CO. KGAA, and : MERZ PHARMACEUTICALS GMBH, : : Plaintiffs, : and v. : : PLIVA D.D., PLIVA-HRVATSKA D.O.O., : BARR LABORATORIES, INC., and : BARR PHARMACEUTICALS, INC., : : NO. 08-22 (GMS/LPS) Defendants. - - Wilmington, Delaware Tuesday, May 20, 2008 at 10:04 a.m. TELEPHONE CONFERENCE - - HONORABLE LEONARD P. STARK, Magistrate Judge - - (Caption and Appearances continued on Page 2)

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FOREST LABORATORIES, INC., FOREST LABORATORIES HOLDINGS, LTD. MERZ PHARMA GMBH & CO. KGAA, and MERZ PHARMACEUTICALS GMBH,

: CIVIL ACTION NO. : : : : Plaintiffs, : v. : : DR. REDDY'S LABORATORIES, INC., DR. : REDDY'S LABORATORIES LIMITED, GENPHARM : INC., GENPHARM, L.P., INTERPHARM : HOLDINGS, INC., INTERPHARM, INC., : MYLAN PHARMACEUTICALS INC., RANBAXY : INC., RANBAXY LABORATORIES LIMITED, : KENDLE INTERNATIONAL INC., SUN INDIA : PHARMACEUTICAL INDUSTRIES LIMITED : (A/K/A SUN PHARMACEUTICAL INDUSTRIES : LIMITED), SYNTHON HOLDING B.V., : SYNTHON B.V., SYNTHON LABORATORIES, INC.,: and SYNTHON PHARMACEUTICALS, INC., : NO. 08-52 (GMS/LPS) : Defendants. : - - -

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APPEARANCES: MORRIS, NICHOLS & TUNNELL, LLP BY: JACK B. BLUMENFELD, ESQ. and

16 17 18 19 20 21 22 23 24 25 KIRKLAND & ELLIS, LLP BY: GERALD J. FLATTMANN, JR., ESQ., and MELANIE R. RUPERT, ESQ. (New York, New York) and JONES DAY BY: F. DOMINIC CERRITO, ESQ. (New York, New York) Counsel for Plaintiffs

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APPEARANCES:

(Continued)

MORRIS JAMES, LLP BY: MARY MATTERER, ESQ. and RAKOCZY MOLINO MAZZOCHI SIWIK, LLC BY: NEIL A. BENCHELL, ESQ. (Chicago, Illinois) Counsel for Cobalt Laboratories BAYARD, P.A. BY: RICHARD D. KIRK, ESQ. and

10 11 12 13 14 15 and 16 17 18 Counsel for Upsher-Smith Laboratories Inc. 19 20 21 and 22 23 24 25 Counsel for Wockhardt USA Inc. and Wockhardt Limited SUGHRUE MION, PLLC BY: MARK BOLAND, ESQ. (Washington, District of Columbia) RICHARDS, LAYTON & FINGER, P.A. BY: JEFFREY L. MOYER, ESQ., and KELLY E. FARNAN, ESQ. ROBINS, KAPLAN, MILLER & CIRESI, L.L.P. BY: DAVID E. MARDER, ESQ. (Boston, Massachusetts) Counsel for Lupin Pharmaceuticals USA, Inc., and Lupin, Ltd. RICHARDS, LAYTON & FINGER, P.A. BY: ANNE SHEA GAZA, ESQ. SCHIFF HARDIN, LLP BY: D. CHRISTOPHER OHLY, ESQ. (Washington, District of Columbia)

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APPEARANCES: (Continued)

POTTER ANDERSON & CORROON, LLP BY: RICHARD L. HORWITZ, ESQ. and LATHAM & WATKINS, LLP BY: TERRENCE J. CONNOLLY, ESQ. (New York, New York) Counsel for Orchid Pharmaceuticals, Inc., Orchid Chemicals and Pharmaceuticals Ltd. (d/b/a Orchid Healthcare) STEVENS & LEE, P.C. BY: THOMAS G. WHALEN, JR., ESQ. and

11 12 13 and 14 15 16 Counsel for Teva Pharmaceuticals USA, Inc. 17 18 19 20 21 22 23 24 25 Counsel for Pliva d.d., Pliva-Hrvatska d.o.o., Barr Laboratories, Inc., and Barr Pharmaceuticals, Inc. POTTER ANDERSON & CORROON, LLP BY: RICHARD L. HORWITZ, ESQ. and WILLKIE FARR & GALLAGHER LLP BY: EUGENE L. CHANG, ESQ. GENEVIEVE BLAKE, ESQ. (New York, New York) KENYON & KENYON LLP BY: STEVEN J. LEE, Ph.D., ESQ. (New York, New York) KENYON & KENYON LLP BY: MICHAEL M. SHEN, ESQ. (Washington, District of Columbia)

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APPEARANCES:

(Continued)

POTTER ANDERSON & CORROON, LLP BY: RICHARD L. HORWITZ, ESQ. and BUDD LARNER BY: LOUIS H. WEINSTEIN, ESQ. (Short Hills, New Jersey) Counsel on behalf of Dr. Reddy's Laboratories, Inc., Dr. Reddy's Laboratories, Ltd., Interpharm Holdings, Inc., Interpharm, Inc. ABRAMS & LASTER, LLP BY: JOHN M. SEAMAN, ESQ. and WINSTON & STRAWN, LLP BY: CHARLES B. KLEIN, ESQ., JAY L. LEVINE, ESQ., and JOVIAL WONG, ESQ. (Washington, District of Columbia) Counsel for Sun India Pharmaceutical Industries Ltd. BALICK & BALICK, LLC BY: JOSEPH S. NAYLOR, ESQ. and WILSON SONSINI GOODRICH & ROSATI BY: ROGER J. CHIN, ESQ. (San Francisco, California) Counsel for Mylan Pharmaceuticals Inc., Genpharm ULC, and Genpharm, L.P.

Brian P. Gaffigan Official Court Reporter

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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 second name? MR. BENCHELL: B-E-N-C-H-E-L-L. Judge Stark.

- oOo P R O C E E D I N G S (REPORTER'S NOTE: The following telephone

conference was held in chambers, beginning at 10:04 a.m.) THE COURT: Good morning, counsel. This is

Let's begin with a roll call.

Who is here for

the plaintiffs, please? MR. BLUMENFELD: Good morning, Your Honor. Jack

Blumenfeld from Morris Nichols for the plaintiffs.

And on

with me are Gerald Flattmann and Melanie Rupert from Kirkland & Ellis, Dominic Cerrito from Jones Day, and Charles Ryan who is in-house from Forest Labs. THE COURT: behalf today? MR. BLUMENFELD: THE COURT: the Cobalt case? MS. MATTERER: This is Mary Matterer, Your Mr. Flattmann. And for the defendant in And who will be speaking on your

All right.

Honor, from Morris James; and I have on the line Neil Benchell from the Rakoczy Molino law firm. MR. BENCHELL: THE COURT: Good morning, Your Honor. Could you repeat the

I'm sorry.

Yes, it's Neil Benchell.

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THE COURT:

Okay.

Thank you.

And are there

other defendants in the Cobalt case? MR. BENCHELL: THE COURT: MR. OHLY: That is all. Okay.

That is all?

Your Honor there are many other You just heard I

defendants on the Cobalt case in the line. from Cobalt.

This is Chris Ohly from Schiff Hardin.

represent Lupin Pharmaceuticals.

Richard Kirk is our local

counsel and he is on the line as well. THE COURT: MR. KIRK: THE COURT: MS. GAZA: Okay. Good morning, Your Honor. Good morning. Your Honor, it's Anne Gaza from I

Richards Layton on behalf of Upsher-Smith Laboratories. believe with me is David Marder from Robins Kaplan. MR. MARDER: THE COURT: MS. FARNAN: That's correct. Okay. Good morning. It's

Good morning, Your Honor.

Jeff Moyer and Kelly Farnan from Richards Layton & Finger on behalf of Wockhardt. And I also have my co-counsel, Mark

Boland from Sughrue Mion. MR. BOLAND: THE COURT: Good morning. Good morning. Your Honor, it's Richard Horwitz

MR. HORWITZ:

from Potter Anderson & Corroon for Orchid; and with me is

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Terry Connolly from Latham & Watkins. THE COURT: Good morning. Good morning. Tom

MR. CONNOLLY: MR. WHALEN:

Good morning, Your Honor.

Whalen from Stevens & Lee on behalf of Teva.

With me on the

phone is Michael Shen and Steven Lee from Kenyon & Kenyon. THE COURT: MR. SHEN: THE COURT: case? No? I'm not hearing any. How about of the defendants in the Barr Okay. Good morning.

Good morning. Any other defendants in the Cobalt

Okay. Laboratories case?

MR. CHANG:

Your Honor, this is Eugene Chang and

Genevieve Blake, Willkie Farr & Gallagher for the Barr defendants. Anderson. MR. HORWITZ: THE COURT: Good morning again, Your Honor. Our legal counsel is Rich Horwitz from Potter

Good morning again.

And are there additional defendants in the Barr case? MR. CHANG: THE COURT: No, Your Honor. How about for the defendants in the

Dr. Reddy's Laboratories case? MR. HORWITZ: Your Honor, it's Rich Horwitz

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again.

And with me for both Dr. Reddy and Interpharm are

Lou Weinstein from the Budd Larner firm in New Jersey. THE COURT: in that third case? MR. SEAMAN: Your Honor, John Seaman from Abrams And with me on the Okay. Is that it for the defendants

Laster on behalf of the Sun defendants.

line I believe is Charles Klein from Winston & Strawn. MR. KLEIN: Wong. THE COURT: Okay. Good morning to all of you. We also have Jay Levine and Jovial

(The attorneys respond, "Good morning.") THE COURT: Dr. Reddy's defendants? case, I should say. MR. WEINSTEIN: from Budd Larner. Interpharm. THE COURT: Okay. Good morning. This is Louis Weinstein. I'm Is there anyone else on the call for Or defendants in the Dr. Reddy's

I'm on the phone for Dr. Reddy and

MR. WEINSTEIN: THE COURT:

Good morning.

Is there anybody else who hasn't had

a chance to say "good morning" that wants to? MR. CHIN: This is Roger -- from Wilson Sonsini

on behalf of Mylan and Genpharm. THE COURT: MR. CHIN: I'm sorry, I missed your last name. Chin, C-H-I-N.

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THE COURT: MR. CHIN: THE COURT: MR. NAYLOR:

Good morning to you. Good morning. Is that everyone? Your Honor, this is Joe Naylor from

Balick & Balick, also on for Genpharm and Mylan. THE COURT: Anybody else? All right. Okay. No? Good morning to you all. All

Okay.

Well, this is the time that I set

for a status teleconference in these three cases, Forest Labs versus Cobalt Laboratories, et al., Forest Labs versus Barr Laboratories, et al, and Forest Labs versus Dr. Reddy's Labs, et al. It's our case numbers 08-21, 08-22, and 08-52,

all of which are assigned to Judge Sleet and referred to me for certain purposes. We do, of course, have a court reporter here so I'll ask you, given the large number of folks on the call, if you would identify yourself before you speak, please. Basically what I wanted to do was get just a very quick sense of what these cases are about, how, if at all, they are related, and the parties' suggestions as to how we should proceed, particularly whether I should be looking to entering a single scheduling order or multiple scheduling orders or perhaps some other procedure. And so I'll look first to Mr. Flattmann to give me the plaintiffs' view on those issues, please.

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MR. FLATTMANN: THE COURT:

Good morning, Your Honor.

Good morning. Your Honor, as you know, this is It involves

MR. FLATTMANN:

an ANDA case under the Hatch-Waxman act.

patents on Forest and Merz Alzheimer's drug which is known under the trade name Namenda. ANDA filers here. There were 13 sets of generic

There were, as you pointed, three-related A

filed cases that are before Your Honor and Judge Sleet.

fourth related case was filed against Orgenus, one of the related Orchid defendants, late last week as well. THE COURT: Was that filed here in the District

MR. FLATTMANN: District late last week. THE COURT:

Yes, that was filed in the

Okay. The cases are all closely

MR. FLATTMANN:

They all involve the same patent that was listed They involve very

in the Orange Book by Forest and Merz.

similar infringement issues, infringement defenses and validity defenses as we can tell based on the notification letters that we received from the various defendants. strongly believe that the cases should ultimately be consolidated and that a single scheduling order should be entered. All the generic filers I believe with possibly So we

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one exception also appear to be first filers, so they all share in any potential exclusivity that could come out of this and are essentially in the same boat in terms of scheduling and progress of the case. So we think

consolidation would definitely be in order. There has been, even at this early stage, some progress on settlement. We have already reached settlement

with the Ranbaxy defendants, and we recently settled with the Synthon defendants. important. the case. That second settlement is I think

There were only two jurisdictional disputes in One was made, as you know, by the Orchid Now that we have

defendants, one by the Synthon defendants.

settled with Synthon, the only remaining jurisdictional dispute relates to the Orchid defendants. Every other

defendant has either consented to or did not contest personal jurisdiction, so the center of gravity is clearly in this District with regard to all of the defendants. we still have one remaining jurisdictional dispute. As you know from the prior call concerning the jurisdictional discovery with the Orchid defendants, that discovery is in progress. We've received responses to And

Orchid's -- rather, to our written discovery request, our doc request, interrogatories, and RFAs from Orchid late last evening. And based on our initial review, we think there

are some issues and some problems with those responses and

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we're going to try to work that out with the Orchid defendants. And if we're not able to resolve those

differences, we would request a conference with Your Honor, but that does seem to be the only outlier at this point. We'll be proceeding, just as a thumbnail sketch, with a 30(b)(6) deposition of Orchid, which is now due under Your Honor's order to be complete by June 6th. And our

opposition brief, assuming discovery is complete, under your order would be due around June 18th. So as I said, there is one outstanding disagreement concerning discovery. As Your Honor knows,

there is also some dispute regarding whether the Orgenus Orchid agent which actually filed Orchid's ANDA would be providing discovery. They had objected to providing it on

the basis they were not a party to the Delaware action. Now that that is no longer the case with the fourth filed action that I alluded to, we'll be approaching the Orchid defendants about that in an attempt to resolve our differences there as well. THE COURT: Okay. I trust you will all do your And if you don't,

best to try to resolve those differences.

you know how to reach me just as with the last time. So there were two motions pending in the Dr. Reddy action. My understanding is that those motions

will go away based on your settlement with the Synthon

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defendants. MR. FLATTMANN: That's correct, Your Honor. And

I believe the order of dismissal was entered yesterday with regard to Synthon. THE COURT: Okay. One other potential loose end we We did receive one

MR. FLATTMANN:

should bring to Your Honor's attention.

additional ANDA notification very recently from another generic filer. The 45-day deadline for us to consider

whether or not to bring suit and to bring suit would expire at about June 6th. So we'll know very, very soon whether or

not there would be one additional party in the case. THE COURT: Okay. So those are the only two open Otherwise, plaintiffs feel The cases

MR. FLATTMANN:

issues in the case as we see it.

as though the center of gravity is in Delaware. are ripe for ultimate consolidation.

And we're ready to

proceed and move forward to a scheduling conference at the Court's convenience. THE COURT: Okay. Thank you for that.

First, with respect to the defendants in the Cobalt action, have you been able to coordinate your response to these general questions or do I need to go through all of you? MR. OHLY: Your Honor, this is Chris Ohly

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speaking for Lupin.

I'm not sure I'm the right person to

speak about this but one of the defendants was kind enough to arrange a conference call, which we all had last week, and we all are coordinated in our views on a couple of issues which Your Honor has raised. I think we all agree

that the cases should be consolidated and that there should be a single order. THE COURT: Okay. And are you speaking now on

behalf of all the defendants in all three of the actions then? MR. OHLY: Except for Orchid. I think that

anybody who disagrees will speak up. THE COURT: All right. Go ahead.

MR. CONNOLLY:

Your Honor, it's Terrance

Connolly from Latham in New York on behalf of Orchid. I guess, Your Honor, I found out late yesterday about the filing of the case against Orgenus and the fact of the matter is I have not had a chance to consult with my client who is located in India with respect to that. Orchid and Orgenus are going to reserve position with respect to this. I'm not sure exactly whether this newest So

development is going to affect substantially its position. I'm just not in a position because I haven't had a chance to consult with the client, based on the timing of this new filing, to commit to a single scheduling order. And I

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believe, but do not know for certain, that we may have issues with respect to jurisdiction over Orgenus as well. apologize for not being able to speak more definitively about it but I first heard about the complaint last night about 7:00 o'clock. THE COURT: Okay. Other than for the Orchid I

defendants, are there any other defendants that have a concern about consolidation and a single scheduling order? MR. CHANG: the Barr Lab defendant. Your Honor, this is Eugene Chang for We don't have an objection to a

single scheduling order, but I did want to point out that one of our defendants, Pliva d.d. is a foreign defendant and we have objected to personal jurisdiction by the Court, but I don't think it affects going forward with a single scheduling order. THE COURT: Okay. Is there a motion pending

regarding jurisdiction for that defendant? MR. CHANG: Right now, there is not a motion.

There was an objection made as part of our answer. Depending on how things play out, we plan to file such a motion, though. THE COURT: Okay. But you are okay with a

single scheduling order and with consolation, which are the issues on the table right now? MR. CHANG: That's right, Your Honor.

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THE COURT:

Okay.

Thank you.

Any other defendants have an issue with consolidation and a single scheduling order? Okay. Mr. Connolly, I do want to hear from you

after you have had a chance to confer with your client in light of what I'm told I guess is a development as recently as yesterday. Realistically, can you have that position to

all of us by the end of this week? MR. CONNOLLY: I will certainly try to do that,

I believe that can be done but I have literally I frankly have no

not have had a chance to communicate.

idea where he is right now due to the time difference. THE COURT: And I believe Monday is a holiday so

we're going to require you to advise the Court by letter but copy everybody else by the end of the day next Tuesday, so a week from today, with what your clients, i.e. the Orchid defendants, position is with respect to consolidation of the four actions and issuance of a single scheduling order. then after we have that letter, I will get something out advising the parties how we're going to proceed. MR. CONNOLLY: you for the time. THE COURT: Okay. Is there anything else that That's fine, Your Honor. Thank And

anybody wants to raise at this point? MR. OHLY: Your Honor, this is Chris Ohly for

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Lupin again.

Since jurisdiction is now established in the

court, there were, at least against Lupin, suits find in the District of Maryland, District of Columbia. I'm wondering

whether we might be able to induce the plaintiffs to dismiss those so it's all in one court now. THE COURT: Well, Mr. Flattmann, do you want to

address that in this context? MR. FLATTMANN: I could be wrong, Your Honor, And certainly

but I believe those suits had been dismissed.

if they have not been, now that jurisdiction has been established in this court, they will be immediately if they haven't been. MR. OHLY: THE COURT: anything else? No. Well, we'll hear from Mr. Connolly And we look forward to Thank you. Thank you. All right. Is there

All right.

and then you will all hear from us. speaking with you all again.

Thank you.

(The attorneys respond, "Thank you, Your Honor.") (Telephone conference ends at 10:20 a.m.)