UNITED STATES DISTRICT COURT

DISTRICT OF NEW JERSEY

TRENTON DIVISION

HELSINN HEALTHCARE S.A.,and ) Docket No. 3:11-cv-03962-MLC-DEA 

ROCHE PALO ALTO LLC, ) (Consolidated)

)

 Plaintiffs, )

)

versus ) Courtroom No. 6W 

) Clarkson S. Fisher Building 

DR. REDDY'S LABORATORIES INC., ) & U.S. Courthouse 

DR. REDDY'S LABORATORIES LTD, ) 402 East State Street 

SANDOZ INC., TEVA ) Trenton, New Jersey 08608 

PHARMACEUTICALS USA, INC., and ) 

TEVA PHARMACEUTICAL ) 

INDUSTRIES, LTD., ) 

) July 30, 2014 

Defendants. ) 11:40 A.M. 

TRANSCRIPT OF TELEPHONE CONFERENCE

BEFORE HONORABLE DOUGLAS E. ARPERT

UNITED STATES MAGISTRATE JUDGE

APPEARANCES:

For Helsinn Healthcare Saul Ewing LLP

S.A.: By: CHARLES M. LIZZA, ESQ.

WILLIAM C. BATON, ESQ.

One Riverfront Plaza, Suite 1520

Newark, New Jersey 07102-5426

Paul Hastings LLP

By: ERIC W. DITTMANN, ESQ.

75 East 55th Street

New York, NY 10022

ESR/Courtroom Deputy: Charmaine Ellington

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435 Riverview Circle

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Proceedings recorded by electronic sound recording, transcript

produced by transcription service.

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APPEARANCES

(Continued)

For Teva Pharmaceuticals Lite DePalma Greenberg, LLC

Industries, Ltd: By: MAYRA VELEZ TARANTINO, ESQ.

Two Gateway Center, Suite 1201

Newark, New Jersey 07102

Winston & Strawn LLP

By: JOVIAL WONG, ESQ.

1700 K Street, N.W.

Washington, D.C. 20006-3817

For Dr. Reddy’s Budd Larner, PC

Laboratories, Inc., By: STUART SENDER, ESQ.

et al.: MICHAEL IMBACUAN, ESQ.

150 John F. Kennedy Parkway 

Short Hills, New Jersey 07078-2703

For Sandoz, Inc.: Hill Wallack, LLP

By: ERIC ABRAHAM, ESQ.

202 Carnegie Center

CN 5226

Princeton, NJ 08540

Morrison & Foerster LLP

By: MATTHEW D’AMORE, ESQ.

JAYSON COHEN, ESQ.

250 West 55th Street 

New York, NY 10019-9601

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1 TRENTON, NEW JERSEY JULY 30, 2014 2:48 P.M.

2 (Call to order of the Court)

3 THE COURT: Hello, good morning.

4 UNIDENTIFIED ATTORNEY: Good morning, Your Honor.

5 UNIDENTIFIED ATTORNEY: Good morning, Your Honor.

6 THE COURT: This is counsel on the Helsinn DRL case?

7 UNIDENTIFIED ATTORNEY: That’s correct.

8 THE COURT: And who’s on for Helsinn, please? Enter

9 your appearances.

10 MR. LIZZA: Sure, Your Honor. Charlie Lizza and Bill

11 Baton of the Saul Ewing law firm.

12 THE COURT: Good morning.

13 MR. DITTMANN: And, good morning, Your Honor. This

14 is Eric Dittmann from Paul Hastings, also on behalf of Helsinn.

15 THE COURT: Good morning, Mr. Dittmann.

16 And who wants to be heard for DRL?

17 MR. SENDER: Stuart Sender and Michael Imbacuan.

18 THE COURT: Good morning, Mr. Sender, Mr. Imbacuan. 

19 Okay.

20 MR. IMBACUAN: Good morning, Your Honor.

21 THE COURT: Good morning. And who else is on the

22 line this morning?

23 MS. TARANTINO: Good morning. For Teva is Mayra

24 Tarantino from Lite DePalma Greenberg, LLC. And joining me is 

25 Jovial Wong from Winston & Strawn.

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1 THE COURT: Good morning, Ms. Tarantino. Okay. And

2 who else? Someone from Sandoz, I assume?

3 MR. ABRAHAM: Yes, Judge, good morning. This is Eric

4 Abraham from Hill Wallace. And I also have Matthew D’Amore and

5 Jayson Cohen from Morrison Foerster.

6 THE COURT: Good morning, Mr. Abraham.

7 MR. ABRAHAM: Good morning.

8 THE COURT: Other than some housekeeping, which we’ll

9 get to in a minute, the item on my agenda for this morning is

10 defendants’ request that the Court compel Helsinn to produce a

11 witness for a 30(b)(6) deposition on certain identified topics

12 in their notice which -- to which plaintiff has objected based,

13 in large part, on the parties’ agreement not to conduct

14 duplicative discovery and, in more specific terms, the Court’s

15 order -- joint stipulation and order consolidating these

16 actions which was entered on May 29th. The specific provision

17 of which states that the parties agree to limit fact discovery

18 to new infringement, validity, and enforcability issues raised

19 by the asserted claims of the ‘219 patent. And the essential

20 difference, as far as I can telling having read the parties’

21 joint submission dated July 3rd, is whether the topics and

22 subject matter of the proposed 30(b)(6) deposition is within

23 the parameters agreed to by the parties and ordered by the

24 Court, that being new infringement, validity, and enforcability

25 issues raised by the ‘219 patent. Defendants taking the

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1 position that it is new; plaintiff taking the position that

2 this is more of the same, which has been exhaustively discussed

3 at a series of over a dozen prior depositions, and contending

4 that defendants can point to nothing new here to substantiate

5 the present request.

6 Mr. Dittmann, have I captured the essence of the

7 issue? And is there anything more you want to say on the

8 subject?

9 MR. DITTMANN: I think you’ve captured the essence,

10 Your Honor, yes. And I’d be happy to elaborate, but I think

11 Your Honor seems to have a very good handle on the dispute

12 between the parties.

13 THE COURT: Okay. Well, I appreciate that.

14 How about from -- how about from the defendants’

15 perspective? Let me be a little more pointed: What are the

16 plaintiffs missing here? And I’ll even tip my hand a little

17 bit, what am I missing here having fairly extensively reviewed

18 the language of the ‘219 patent and the lead patents, I’m

19 having a hard time seeing the areas of difference about which

20 you seek to inquire.

21 MR. D’AMORE: Your Honor, this is -- thank you for

22 your question. This is Matthew D’Amore from Morrison &

23 Foerster for Sandoz.

24 I’m actually going to turn the microphone over to my

25 associate, Jayson Cohen, who you haven’t spoke with yet, and I

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1 wanted to introduce him, and then let him answer Your Honor’s

2 question --

3 THE COURT: All right.

4 MR. D’AMORE: -- if that’s all right.

5 THE COURT: Thank you. Good morning, Mr. Cohen.

6 MR. COHEN: Good morning, Your Honor. This is Jayson

7 Cohen for Sandoz.

8 I wanted to speak directly to Your Honor’s question. 

9 I think one way to frame this is if we -- if you have the July

10 3rd letter in front of you, what was submitted as Exhibit G to

11 that letter, I think there’s a numbering issue in the exhibit

12 book. What was submitted as Exhibit G was a chart of the

13 different claims that have been asserted against the

14 defendants.

15 THE COURT: Okay. I’m with you.

16 MR. COHEN: So I wanted to -- so on Page 3 of that

17 exhibit, the claims for the ‘219 patent. And what we’ve done

18 here is we’ve highlighted the terms that are unique -- the new

19 terms that are unique to the ‘219 patent. And our -- our view

20 is that, number one, we have promised not to repeat discovery

21 from the first case, and I think we’ve stuck with that so far. 

22 And, in fact, we have not noticed any depositions of people who

23 were deposed in the first case, et cetera.

24 In looking here at Page 3 of Exhibit G, we’ve

25 highlighted the new claim elements in the ‘219 patent. And

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1 it’s really -- our 30(b)(6) deposition notice is really

2 directed at these new elements of the claim. And the

3 deposition testimony that we want is to get specifically

4 plaintiffs’ knowledge and positions with respect to, for

5 example, the conception and reduction to practice of the new

6 aspects of these claims that do not appear in the first -- in

7 the claims of the first three patents.

8 And so I guess sort of to frame this further, you

9 know, this patent was filed only as of May 23rd, 2013. At that

10 point in time, fact discovery on the first three patents had

11 closed. And that’s just when the -- that’s just when the

12 patent application was filed. It didn’t issue until December,

13 2013. It wasn’t asserted against us until February of 2014.

14 So there was no point in the first case where the

15 parties or the defendants had any reason to believe that they

16 need to focus discovery on the new claim elements that only

17 appeared once the ‘219 patent issued.

18 And so let me -- as I said, Your Honor, let me

19 directly -- direct you to Exhibit B of the letter, which are

20 the -- which are the topics, and specifically on Pages 7

21 through 9. And I’d like to group together certain of these

22 topics. Topics 1 through 5, 7 and 8. So, six of the seven

23 topics at issue here are really focused on the conception and

24 reduction to practice and the development of the newly created

25 inventions in the ‘219 patent.

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1 And to the extent Your Honor feels that we haven’t

2 narrowed this sufficiently to focus only on those new claim

3 elements, we’re certainly willing to do so today.

4 But we -- our intent here is really to get

5 plaintiffs’ knowledge, get their positions on the new claim

6 elements. Let me take a couple of the claim elements, in

7 particular, that are important to this case:

8 For the first time in the ‘219 patent, the patent’s

9 claiming the amount of the active ingredient of the product. 

10 In the previous three patents, the amount in the product was

11 not actually a limitation of the claims. And so this further

12 narrows the claims from what was at issue in the first three

13 cases, but it also changes the focus on -- of discovery to that

14 specific dose, and how that was -- how it came about. What the

15 -- who, what, when, where, and why with respect to specifying a

16 specific dose of the active ingredient. And that wasn’t

17 necessary in the first case.

18 A second element here is in the preamble, the

19 plaintiffs are claiming that the limitation -- or the language

20 that says, “for intravenous administration to a human to reduce

21 the likelihood of cancer chemotherapy-induced nausea and

22 vomiting.”

23 Their -- plaintiffs are taking the position that

24 that’s a claim element of the claim, their claim

25 (indiscernible) of the claim and that element does not appear

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1 in any of the previous patents.

2 And how that really gets translated into discovery in

3 this case is the parties in this first case did not have to

4 focus on specifically this claim element, and specifically the

5 work relating to showing “intravenous administration to a human

6 to reduce the likelihood of cancer chemotherapy-induced nausea

7 and vomiting.” And so our topics, 1 through 5, 7, and 8, are

8 geared towards discovery information specifically about that

9 element.

10 And so these are really -- we feel these are plain

11 vanilla topics, they’re not broad topics. And specifically

12 with respect to, you know, the development of their claimed

13 invention and the conception and reduction to practice of those

14 claim elements, and so that’s why we feel we’re entitled to --

15 we believe we’re entitled to get that discovery as to those new

16 claim elements.

17 In addition to being related to our on sale bar

18 defense in this case, these specific topics, 1 through 5, 7,

19 and 8, also relate to the obviousness defense. Because now the

20 issue -- when did information become publically available? 

21 Specifically about -- for example, the dose of palonosetron

22 that would be effective specifically to reduce the likelihood

23 of cancer chemotherapy-induced nausea and vomiting.

24 And so, you know, it’s with that in mind that we’re

25 seeking the depositions.

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1 THE COURT: Let me ask --

2 MR. COHEN: There’s only one more -- go ahead, Your

3 Honor.

4 THE COURT: Let me ask you whether these are issues

5 or subjects which could be addressed in the -- by the experts

6 in this case, rather than additional fact depositions.

7 MR. COHEN: With respect to the Helsinn’s knowledge

8 as to what happened when, and who was involved, you know, we

9 believe that that’s -- that’s really knowledge that’s specific

10 to the plaintiffs. It’s fact information that their experts

11 might use, but it’s still information that comes from Helsinn

12 and doesn’t -- isn’t generated by their experts.

13 THE COURT: How -- what is your projection of the

14 duration of this deposition? How long is it going to take you

15 to cover this limited field of information?

16 MR. COHEN: We had hoped to receive from Your Honor a

17 seven-hour deposition on all the topics.

18 THE COURT: Okay.

19 MR. COHEN: So we felt we could easily finish this

20 within a day. We’re not asking for a multiple day deposition

21 here.

22 And we’re not asking for individual fact witnesses on

23 this. We have our -- we’re --

24 THE COURT: Yeah.

25 MR. COHEN: We’ve decided to streamline this case to

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1 that only for a 30(b)(6) deposition. 

2 I’d like to mention the last topic, Your Honor,

3 because the last topic is also a very common topic in patent

4 litigation, Topic 4, which is on the patent prosecution. And

5 the way this topic is listed in Exhibit B here on Page 7, we’ve

6 already narrowed this. And while we’ve offered it -- we’re

7 only interested in the patent prosecution for this patent and

8 suit and its immediate parent application because there are

9 strong ties between those two.

10 But this -- the (indiscernible) patent family is very

11 big here now, and we’re not asking for discovery on all of

12 that. Only those two patent prosecutions.

13 And this is directly relevant to our equitable

14 defenses in the case. We have set forth the basis for our

15 equitable defenses in answering plaintiffs’ interrogatories. 

16 And asking about having a 30(b)(6) witness from plaintiff to

17 ask him about the patent prosecution is meant to provide

18 information that we believe is relevant to our equitable

19 defenses in the case.

20 THE COURT: All right. Thank you.

21 MR. COHEN: And with that, Your Honor -- yes?

22 THE COURT: Yeah, with that, go ahead. Conclude. 

23 I’m sorry, I cut you off.

24 MR. COHEN: I’m sorry. Your Honor, I think that

25 basically we believe that getting this 30(b)(6) deposition is a

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1 very streamlined efficient way to get the basic discovery that

2 we believe we need in the case with respect to those new patent

3 claim elements in the ‘219 patent.

4 And with that, Your Honor, I’ll, you know, hand it

5 back to you. And if you have any questions, I’d be happy to

6 answer them.

7 THE COURT: Thank you, Mr. Cohen. Mr. Dittmann,

8 based on what you heard today from Mr. Cohen, do you want to

9 respond to the suggestion that these are new claim elements in

10 the ‘219 patent, very limited and discreet inquiry into those

11 subjects or those claim elements along the lines that Mr. Cohen

12 suggested, all of which can be done with a single witness in a

13 single day?

14 MR. DITTMANN: Sure. No, I would be happy to, Your

15 Honor.

16 I guess there -- the first point about a single

17 witness in a single day, and these are some disparate topics,

18 some are referring to the confidential work that Helsinn had

19 done over the course of five, six years. And others are

20 referring to legal prosecution documents where the scientists

21 that were involved in the work wouldn’t -- not really much of a

22 connection to the recent prosecution events. So that’s sort of

23 the first issue.

24 But to address the claims themselves, as we set forth

25 in Footnote 8 of the joint letter, these are not new claim

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1 elements. These are elements that directly correlate to

2 Helsinn’s marketed product, Aloxi. That’s really been the

3 focus of discovery from day one in this case, and has been the

4 central focus of defendants’ on sale bar defense. And

5 defendants admit on Page 4 of the letter that they’ve already

6 had a corporate deposition testimony with respect to Helsinn’s

7 marketed product. That’s the product that has a 0.25

8 milligrams dose amount to five milliliter volume. And, in

9 fact, that deposition took 1.5 days. If you’ll remember, Your

10 Honor, last year you suggested a compromise, and we ended up

11 offering Dr. Calderari for both the entire day Friday, and part

12 of the day Saturday, and he was extensively questioned. And we

13 cited some exemplary portions of that testimony where he was

14 squarely asked about the five milliliter volume, the 0.25

15 milligram dose, how those were determined, who determined them. 

16 This is extensively discovery in the first case. And really

17 this is a lot about fairness. You know, we came to defendants

18 and we gave up two patents, these two process patents. Where

19 the patents the defendants had focused on originally to say

20 they needed fact discovery because the processes were somewhat

21 new we said, okay, well, look, we want to move this forward. 

22 We will give you the two patents, which is, frankly, you know,

23 quite a lot to give in any case. And more than that, we also

24 reduced the asserted claims to all of the patents, including

25 the original patents, in half.

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1 And as part of the exchange, we received defendants’

2 commitment to limit discovery to new issues. And all we’re

3 hearing about is well, there are some new claim elements. 

4 Which, first of all, we don’t agree with, Your Honor.

5 But even if there were any parts of the claims that

6 are new that -- new issues is not the same as new claims. And

7 really what defendants are attempting to do is to get a second

8 bite at the apple on the original on sale bar defense which, by

9 the way, their invalidity contentions show exactly the same. 

10 They focused on the same formations, the same alleged sale

11 transaction, nothing has changed there.

12 And really what we’re talking about is the same set

13 of facts defendants already have. There’s nothing new, Your

14 Honor. We have nothing more to tell them about our development

15 of this Aloxi invention.

16 The -- what they’re seeking is precisely what Your

17 Honor foreshadowed, is this is really about extra discovery. 

18 It’s applying those facts to new claim elements, that’s what

19 experts are for. Fact witnesses aren’t going to talk about

20 claim limitations. They’re going to talk about what they did,

21 and we’ve already done that.

22 They’ve deposed the inventors. They’ve gotten Dr.

23 Calderari as a 30(b)(6) witness for a day and a half, and

24 they’ve had exhaustive discovery on all of these new claim

25 elements.

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1 And briefly with respect to obviousness, we heard

2 something about information, and they want to know when

3 information became publicly available. That has nothing to do

4 with the 30(b)(6) topics they’re asking about, which is

5 Helsinn’s confidential work. Which, by the way, as we pointed

6 out in Footnote 11 of the letter, is irrelevant as a matter of

7 Federal Circuit law.

8 But really the point is that they received this

9 discovery, an extensive amount, so it violates the parties’

10 original agreement in March to avoid duplicative discovery. 

11 But then more than that, we then had an agreement after

12 agreeing not to duplicate discovery. And as part of that

13 agreement, we gave valuable consideration. And really the --

14 what we obtained from that was the consolidated schedule and

15 the agreement to limit fact discovery. And that would be

16 eviscerated by having to go through another seven-hour

17 deposition which, again, could never cover -- one deposition

18 could never cover all of these topics which is a problem,

19 number one.

20 And, number two, the witness who would have to

21 address these topics is not available until mid-September

22 because of holiday plans, Helsinn shutdown in August, and his

23 commitments as President of the company upon his return.

24 But then very briefly on the last point, the

25 prosecution topic, you know, first of all, this is the first

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1 we’ve ever heard from defendants essentially justifying why

2 this very broad topic is relevant to anything. They’re

3 mentioning their equitable defense, which we just received a

4 description of in an interrogatory response about a week or so

5 ago.

6 But the problem with this, Your Honor, is a

7 deposition on the prosecution documents would be very wasteful. 

8 Other than the documents themselves, the work that led to them

9 is going to be privileged. And these depositions, inevitably,

10 end up in a number of instructions not to answer for privileged

11 reasons. And for that reason, in the original case, defendants

12 have an identical topic on prosecution events, and the parties

13 agreed that there would be no need for a 30(b)(6) topic on

14 this. And we submit again that, you know, this would be a

15 wasteful separate deposition that would be needed.

16 And I think, Your Honor, I believe I’ve addressed the

17 points that you were interested in. But I’d be more than happy

18 to address any further questions you have.

19 THE COURT: I appreciate that. Anybody else want to

20 be heard?

21 (No audible response heard)

22 THE COURT: Okay. I am -- I’m going to deny the

23 defendants’ request for this additional deposition of a

24 30(b)(6) witness on the topics that are set forth in the

25 defendants’ notice.

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1 I largely adopt the plaintiffs’ position as

2 articulated, both in the letter of July 3rd, and by Mr.

3 Dittmann on this call, that while Mr. Cohen has pointed perhaps

4 to arguably new claim elements in the ‘219 patent, these are

5 not new issues. These are issues which have been exhaustively,

6 as I said earlier, discovered through at least a dozen

7 depositions in this case.

8 Moreover, I think to the extent there are nuances for

9 arguments to be made related to the ‘219 patent, that those

10 nuances or differences can be addressed in the course of expert

11 discovery.

12 The Court has the authority to manage discovery to

13 the end of the case to be prosecuted efficiently, economically,

14 and fairly. And I believe that in the totality of the

15 circumstances presented here, that the limitation established

16 by the parties’ agreement and incorporated into the Court’s

17 case management order of May 29th limiting additional discovery

18 to new issues is not met by the request for this deposition. 

19 So I would deny the request to compel that deposition.

20 The housekeeping matter to which I referred earlier

21 comes in a letter dated July 28 with a series of modifications

22 to the existing case management schedule. And I’ve reviewed

23 those. They are all relatively modest, and I will sign that

24 order today and include a series of telephone status

25 conferences. I’ll review the prior order, and either adopt the

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1 dates that were already on that order or modify them. But

2 we’ll operate henceforth from the proposed schedule attached to

3 the July 28th letter. Okay? Today’s the 30th, I’ll sign it

4 now.

5 MR. LIZZA: Your Honor --

6 THE COURT: All right. 

7 MR. LIZZA: -- this is --

8 THE COURT: Are there any other -- go ahead.

9 MR. LIZZA: Your Honor, Charlie Lizza here.

10 Just, again, along the lines of housekeeping, I think

11 we have a schedule -- telephone conference in August, and I

12 assume that this order now will supersede the need for that

13 conference.

14 THE COURT: Unless anybody thinks differently, that

15 was my plan. I will vacate -- I’ll essentially vacate the

16 prior schedule with respect to conferences. And the new

17 schedule will be reflected on the order that I’m signing today. 

18 Okay?

19 MR. LIZZA: All right.

20 THE COURT: All right. So you can clear your

21 calendars of any earlier dates, and -- and refer exclusively to

22 the dates that will be included on Page 3 of the order that I’m

23 going to sign and enter today. Okay? 

24 (No audible response heard)

25 THE COURT: All right. Any --

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1 UNIDENTIFIED ATTORNEY: Thank you, Your Honor.

2 THE COURT: All right. Anything else then for today,

3 folks?

4 (No audible response heard)

5 THE COURT: All right. Thank you. Enjoy the rest of

6 the summer. I’ll speak to you sometime in the fall, unless you

7 need me in the meantime, in which case, you know where to find

8 me.

9 Thank you.

10 UNIDENTIFIED ATTORNEY: Thank you, Your Honor.

11 THE COURT: All right. 

12 UNIDENTIFIED ATTORNEY: Thank you, Your Honor.

13 UNIDENTIFIED ATTORNEY: Thank you. 

14 (Whereupon, at 12:06 P.M., the hearing was adjourned.)

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TRANSCRIPTS PLUS, INC.

PHONE 215-862-1115 ! FAX 215-862-6639 ! E-MAIL CourtTranscripts@aol.com

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5 CERTIFICATE OF TRANSCRIBER

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7 I, KAREN HARTMANN, a certified Electronic Court

8 Transcriber, certify that the foregoing is a correct transcript

9 from the electronic sound recording of the proceedings in the

10 above-entitled matter.

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14 Karen Hartmann, AAERT CET**D0475 Date: August 11, 2014

15 TRANSCRIPTS PLUS, INC.

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Case 3:11-cv-03962-MLC-DEA Document 185 Filed 08/11/14 Page 20 of 20 PageID: 4660