Page 1
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`----------------------------x
`PAR PHARMACEUTICAL, INC.,
` Petitioner,
` v. Case IPR2016-01059
`NOVARTIS AG, Patent 5,665,772
` Patent Owner,
`----------------------------x
`BRECKENRIDGE PHARMACEUTICAL, INC.,
` Petitioner,
` v. Cases IPR2016-01023,
`NOVARTIS AG, IPR2016-01103
` Patent Owner. Patent 5,665,772
`-------------------------------------x
`ROXANE LABORATORIES, INC.,
` Petitioner,
` v. Case IPR2016-01102
`NOVARTIS AG, Patent 5,665,772
` Patent Owner.
`-------------------------------------x
`B E F O R E: CHRISTOPHER L. CRUMBLEY
` LORA M. GREEN
` ROBERT A. POLLOCK
`JOB NO. 115308 November 8, 2016
`
`TSG Reporting - Worldwide 877-702-9580
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`Ex. 1033-0001
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`----------------------------x
`PAR PHARMACEUTICAL, INC.,
` Petitioner,
` v. Case IPR2016-01059
`NOVARTIS AG, Patent 5,665,772
` Patent Owner,
`----------------------------x
`BRECKENRIDGE PHARMACEUTICAL, INC.,
` Petitioner,
` v. Cases IPR2016-01023,
`NOVARTIS AG, IPR2016-01103
` Patent Owner. Patent 5,665,772
`-------------------------------------x
`ROXANE LABORATORIES, INC.,
` Petitioner,
` v. Case IPR2016-01102
`NOVARTIS AG, Patent 5,665,772
` Patent Owner.
`-------------------------------------x
`B E F O R E: CHRISTOPHER L. CRUMBLEY
` LORA M. GREEN
` ROBERT A. POLLOCK
`JOB NO. 115308 November 8, 2016
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`TSG Reporting - Worldwide 877-702-9580
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`Ex. 1033-0001
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`Page 2
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`Reported by:
`Amy A. Rivera, CSR, RPR, CLR
`JOB NO. 115308
` November 8. 2016
` 1:00 p.m.
`
` Telephone conference held before
`Amy A. Rivera, Certified Shorthand Reporter,
`Registered Professional Reporter, Certified
`LiveNote Reporter, and a Notary Public of the
`State of New York.
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`Ex. 1033-0002
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`Page 3
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`A P P E A R A N C E S:
`LATHAM & WATKINS
`Attorneys for Petitioner Par Pharmaceutical
` 885 Third Avenue
` New York, New York 10022
`BY: DANIEL BROWN, ESQ.
` JONATHAN STRANG, ESQ.
`
`
`FITZPATRICK, CELLA, HARPER & SCINTO
`Attorneys for the Novartis AG
` 975 F Street, N.W.
` Washington, D.C. 20004
`BY: CHRISTINA SCHWARZ, ESQ.
` NICHOLAS KALLAS, ESQ.
`
`MERCHANT & GOULD
`Attorneys for Breckenridge Pharmaceutical, Inc.
` 1900 Duke Street
` Alexandria, Virginia 22314
`BY: MATTHEW FEDOWITZ, ESQ.
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`TSG Reporting - Worldwide 877-702-9580
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`Ex. 1033-0003
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`Page 4
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`A P P E A R A N C E S (continued):
`GOODWIN PROCTER
`Attorneys for Roxane Laboratories, Inc.
` 620 Eighth Avenue
` New York, New York 10018
`BY: KEITH ZULLOW, ESQ.
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`Ex. 1033-0004
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`Page 5
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` TELEPHONE CONFERENCE
` THE COURT: This is a call for IPR
` 201500084. 13:00
` Do we have counsel for the petitioners 13:00
` on the line? 13:00
` MR. STRANG: Yes, your Honor. This is 13:00
` Jon Strang for petitioner Par. And with me, 13:00
` I have Daniel Brown, also of Latham. He 13:00
` will be doing the majority of the talking 13:00
` for us. 13:00
` However, as a preliminary matter, 13:00
` would you like us to file -- we have a court 13:00
` reporter on the line, and would you like us 13:00
` to file a transcript under our own series of 13:00
` exhibit numbers or use the board's 3000 13:00
` series, your Honor? 13:00
` THE COURT: It's fine to just use your 13:00
` series number. 13:00
` MR. STRANG: Yes, your Honor. And 13:01
` also on line, and I'll turn it over and let 13:01
` them introduce themselves are Roxane. 13:01
` MR. FEDOWITZ: Your Honor, this is 13:01
` Matthew Fedowitz on behalf of Breckenridge. 13:01
` MR. ZULLOW: Your Honor, this is Keith 13:01
` Zullow on behalf of Roxane. 13:01
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`Ex. 1033-0005
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`Page 6
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` TELEPHONE CONFERENCE
` THE COURT: Good afternoon, everyone. 13:01
` So, Mr. Brown, I assume that if I 13:01
` don't hear anything from Mr. Fedowitz or Mr. 13:01
` Zullow, you are speaking on behalf of all 13:01
` three petitioners. Is that correct? 13:01
` MR. BROWN: I think that's correct, 13:01
` although Roxane has an independent conflict 13:01
` with the currently scheduled oral argument, 13:01
` and so they should probably address that one 13:01
` on their own. 13:01
` THE COURT: That's fine. I'm not 13:01
` saying they can't speak, I just want for the 13:01
` record to make clear that if I don't hear 13:01
` from them, I'm assuming that you're speaking 13:01
` for all three. 13:01
` MR. ZULLOW: Yes, that's correct. 13:01
` This is Keith Zullow. I just want to make 13:01
` it clear, I think it's Breckenridge that has 13:01
` the independent conflict, not Roxane. 13:01
` THE COURT: That's fine. We'll get 13:02
` into that in just a moment. I want 13:02
` Mr. Kallas to make his appearance as well. 13:02
` Mr. Kallas are you on the line? 13:02
` MS. SCHWARZ: This is Christina 13:02
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`Ex. 1033-0006
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`Page 7
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` TELEPHONE CONFERENCE
` Schwarz. I'm here with Nicholas Kallas on 13:02
` behalf of the patent owner, Novartis. 13:02
` THE COURT: All right. Ms. Schwarz, 13:02
` good to have you on the line. 13:02
` All right. So I have a request from 13:02
` the petitioners to move the scheduled date 13:02
` for oral argument, which is currently set 13:02
` for January 24th, I believe. Is that 13:02
` correct? 13:02
` MR. BROWN: Yes, that's correct, your 13:02
` Honor. 13:02
` THE COURT: All right. So -- and we 13:02
` got an e-mail from the petitioners that you 13:02
` were proposing anywhere between February 6th 13:02
` and February 9th as alternative dates. 13:02
` Do I have that right? 13:02
` MR. BROWN: That is correct, your 13:02
` Honor. 13:02
` THE COURT: Okay. And my 13:02
` understanding is that Novartis opposes 13:02
` moving the hearing date? 13:02
` MS. SCHWARZ: That's correct, your 13:02
` Honor. 13:02
` THE COURT: All right. So I guess the 13:02
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`Ex. 1033-0007
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`Page 8
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` TELEPHONE CONFERENCE
` first thing we should do is hear from the 13:02
` petitioners with the issues with the current 13:02
` date. It's the 24th of January, and then, 13:03
` you know, we'll get into it from there. 13:03
` MR. BROWN: Thank you, your Honor. 13:03
` The issue is mine. I have a trial in 13:03
` the District of Delaware starting on the 13:03
` 23rd that is scheduled for six days. We 13:03
` represent the plaintiff Mallinckrodt, and 13:03
` there are two separate defendant groups that 13:03
` are involved and I think more than 10 13:03
` experts, plus a fact witnesses that are 13:03
` scheduled for that trial. 13:03
` THE COURT: Just so I'm clear -- just 13:03
` so I'm clear, who's talking? This is 13:03
` Mr. Brown? 13:03
` MR. BROWN: Yes, this is Mr. Brown. 13:03
` Thank you, your Honor. 13:03
` THE COURT: Okay. 13:03
` MR. BROWN: And that is the conflict. 13:03
` THE COURT: You have a conflict with a 13:03
` trial starting on the 23rd? But just to be 13:03
` clear, you represent Par. You've been in 13:03
` this case from the beginning and we had this 13:03
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`Ex. 1033-0008
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`Page 9
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` TELEPHONE CONFERENCE
` scheduling order, since when we instituted 13:04
` the trial back when we did that. 13:04
` MR. BROWN: That is correct, your 13:04
` Honor. And the way -- the way this came 13:04
` about, I have some -- I have some background 13:04
` for the way this came about. 13:04
` In May, as the Court is aware, we 13:04
` filed the request for joinder of Claim 7, 13:04
` and then that was followed by the request 13:04
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` And on June 1st, there was a call with 13:04
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` scheduling impact of the motion for joinder. 13:04
` I was not on that call, but Mr. Strang from 13:04
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` And we left that call with -- I have 13:04
` the understanding that it had been discussed 13:04
` on the call that if the Claim 7 joinder 13:04
` were -- were granted, then that would likely 13:04
` necessitate a movement of the oral argument 13:04
` date. 13:05
` In the meantime, our trial was 13:05
` originally scheduled for January 9th and the 13:05
` two defendants were -- were on different 13:05
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`Ex. 1033-0009
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`Page 10
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` TELEPHONE CONFERENCE
` trial schedules, and the parties jointly 13:05
` agreed to submit a letter to the Court 13:05
` proposing that the trials be combined on the 13:05
` January 9th date or, alternatively, the 13:05
` January 16th date, and then within that 13:05
` letter, which was submitted by one of the 13:05
` defendants, not us, there was an 13:05
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` statement that we would consider any dates 13:05
` thereafter that the Court could accommodate. 13:05
` On July 1st, the Court issued an order 13:05
` setting the January 23rd date for all 13:05
` parties. I did not note the conflict at 13:05
` that time. I had a trial scheduled shortly 13:05
` thereafter in August on the validity of the 13:05
` patent that is the subject of this IPR and 13:06
` additional -- additional patents and I did 13:06
` not notice the conflict at that time. 13:06
` When I did notice the conflict, which 13:06
` was sometime in September, after the trial, 13:06
` I don't recall exactly when, we were 13:06
` awaiting the decision on a Claim 7 joinder 13:06
` issue, which we believed would -- would 13:06
` result in the dates likely being moved, and 13:06
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`Ex. 1033-0010
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`Page 11
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` TELEPHONE CONFERENCE
` so that is the -- that's the chronology that 13:06
` led to us being in the situation. And I 13:06
` think I didn't notice it because it wasn't 13:06
` one of the dates that we had suggested to 13:06
` the Court when the order came out. 13:06
` THE COURT: All right. That's fine. 13:06
` I just wanted to get a little background 13:06
` here. It sounds like you got a court date 13:06
` that you weren't exactly anticipating, so I 13:06
` understand. 13:06
` Let's hear from -- you said, 13:06
` Mr. Fedowitz? You're the one with the other 13:06
` scheduling issue as well? 13:07
` MR. FEDOWITZ: Yes, that's correct. 13:07
` Breckenridge has another oral argument 13:07
` before the board on January 24th. And that 13:07
` arises out of IPR 2016-01242 which 13:07
` Breckenridge is a joinder petitioner. 13:07
` Breckenridge was joined to IPR 13:07
` 2016-00204, and that case has a oral 13:07
` argument on January 24th, 2017. 13:07
` So the conflict is two oral arguments 13:07
` on the same day and the same individuals are 13:07
` involved in both. 13:07
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`Ex. 1033-0011
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`Page 12
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` TELEPHONE CONFERENCE
` THE COURT: I was about to say, you're 13:07
` counsel in those cases? 13:07
` MR. FEDOWITZ: That's correct. 13:07
` THE COURT: Okay. All right. 13:07
` Now, all three petitioners are 13:07
` available on -- in the February week that 13:07
` you proposed, the 6th through the 9th? 13:07
` MR. FEDOWITZ: Yes for Breckenridge. 13:08
` MR. BROWN: Yes for Par. 13:08
` MR. ZULLOW: Yes for Roxane. 13:08
` THE COURT: I just wanted to make sure 13:08
` before we go on. 13:08
` All right, Ms. Schwarz, why do we 13:08
` oppose moving the hearing date to 13:08
` accommodate these conflicts? 13:08
` MS. SCHWARZ: Well, I guess as a 13:08
` preliminary matter, we haven't yet heard 13:08
` from the petitioner as who will be doing the 13:08
` oral argument, and whether or not these are 13:08
` true -- true conflicts with the currently 13:08
` set date. 13:08
` Secondly, the petitioners have 13:08
` acknowledged they've known about these 13:08
` conflicts for some time, but have delayed in 13:08
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`Ex. 1033-0012
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`Page 13
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` TELEPHONE CONFERENCE
` letting us know about that. And in the 13:08
` meantime, we've been proceeding on the basis 13:08
` that the argument would take place on the 13:08
` 24th. We've been scheduling deadlines in 13:08
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` things like that in early February. And so 13:09
` we have a very busy February. 13:09
` In addition, we anticipate having an 13:09
` oral argument scheduled at the Federal 13:09
` Circuit the week of February 6th. 13:09
` We obviously don't have that date yet, 13:09
` but we anticipate it will be scheduled for 13:09
` that week. 13:09
` And, finally, I've been the primary 13:09
` attorney responsible for this IPR and 13:09
` anticipate being out on maternity leave 13:09
` starting at the beginning of February. 13:09
` THE COURT: Okay. So -- and you're 13:09
` right. We didn't hear from them about 13:09
` exactly who would be presenting, and I'm 13:09
` going to get to them in just a minute. 13:09
` You used a lot of "we's" there as 13:09
` well, so I want to make clear before I hand 13:09
` it back over to them. 13:09
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`Ex. 1033-0013
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`Page 14
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` TELEPHONE CONFERENCE
` When you said "We have the potential 13:09
` argument with the Federal Circuit," is that 13:09
` you or Mr. Kallas, or is that someone else 13:09
` on your team? 13:09
` MS. SCHWARZ: That's our team, 13:09
` Mr. Kallas, and Ms. Jacobson, and for the 13:09
` same client who's involved in this IPR 13:10
` proceeding. 13:10
` THE COURT: All right. And as in the 13:10
` other case, you said there was another case 13:10
` that you had ongoing discovery taking place 13:10
` during that time period? 13:10
` MS. SCHWARZ: Yes, that's right. We 13:10
` have cases ongoing with the three 13:10
` petitioners here. 13:10
` THE COURT: And it's your, at least 13:10
` currently, it's your intention to -- that 13:10
` you will be presenting the oral argument in 13:10
` this IPR, and you have potentially maternity 13:10
` leave starting in mid-February? 13:10
` MS. SCHWARZ: Yes, that's correct. I 13:10
` intend to present the argument and I plan to 13:10
` be out starting in early February. 13:10
` THE COURT: All right. So the other 13:10
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`Ex. 1033-0014
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`Page 15
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` TELEPHONE CONFERENCE
` thing that I haven't heard discussed here is 13:10
` we talked about moving it later. Is there a 13:10
` possibility on everyone's schedules of 13:10
` moving the hearing earlier? Is that 13:10
` something you have discussed amongst 13:10
` yourselves? 13:10
` MR. BROWN: Your Honor, this is 13:10
` Mr. Brown. 13:10
` I have not -- to my knowledge, we have 13:10
` not discussed moving it earlier, but that is 13:10
` acceptable for my own -- for my own schedule 13:11
` any date following -- any date the week of 13:11
` the 9th or the week of the 16th, I can 13:11
` personally accommodate. 13:11
` And to answer counsel's question, Par 13:11
` has requested that I be the one that argues 13:11
` the -- that argues the -- this oral 13:11
` argument. 13:11
` THE COURT: All right. 13:11
` MR. FEDOWITZ: Your Honor, this is 13:11
` Matthew Fedowitz on behalf of Breckenridge. 13:11
` I hadn't looked at the earlier dates. 13:11
` I do want to note something that Ms. Schwarz 13:11
` brought up stating that we were aware of 13:11
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`Ex. 1033-0015
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`Page 16
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` TELEPHONE CONFERENCE
` these dates earlier. 13:11
` With regard to Breckenridge's 13:11
` conflict, we were not aware of them earlier. 13:11
` The joinder decision in the separate matter 13:11
` that I mentioned issued on October 24th. 13:11
` THE COURT: I understand that. And I 13:12
` also understand that you and Roxane are 13:12
` subject to joinder in those cases. You 13:12
` weren't even a party to this case until -- 13:12
` In addition, I don't want to get 13:12
` bogged down into when we found out about 13:12
` these things. I just want to get to the 13:12
` bottom of let's find a date that works for 13:12
` everyone and for the board. 13:12
` But it sounds to me like we got a 13:12
` fairly hard cap in the middle of February 13:12
` that we need to try and accommodate. Again, 13:12
` my preference is to stay in the vicinity of 13:12
` where we have it set right now, and just try 13:12
` and find out what we can do otherwise. 13:12
` So I know I'm throwing out earlier and 13:12
` you may not have completely discussed this, 13:12
` but just I want to get initial reactions and 13:12
` maybe we can work out details later. 13:12
`
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`TSG Reporting - Worldwide 877-702-9580
`
`Ex. 1033-0016
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`
`
`Page 17
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` TELEPHONE CONFERENCE
` Mr. Zullow, is there anything from you 13:12
` if we want to move it earlier? 13:12
` MR. ZULLOW: No, earlier in January is 13:12
` fine with Roxane. 13:12
` THE COURT: Ms. Schwarz, that leaves 13:13
` you. How does earlier in January look? 13:13
` MS. SCHWARZ: We certainly have to 13:13
` double check with our calendars, but we can 13:13
` check for the weeks of the 9th and the 16th 13:13
` to see if we're available those weeks. I'm 13:13
` not presently aware of any conflicts. 13:13
` THE COURT: Okay. And then let me 13:13
` pull up my calendar here, briefly. 13:13
` Hold on one moment. 13:13
` (Pause.) 13:13
` THE COURT: We haven't talked about 13:13
` the week of January 30th through February 13:13
` 3rd. Is there -- does someone have a 13:13
` conflict that week? 13:13
` MR. BROWN: Your Honor, I could do any 13:13
` day that week from the -- I could do any of 13:13
` the first three days of February. Those 13:13
` days all work for me. 13:13
` THE COURT: Your trial runs to the end 13:13
`
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`TSG Reporting - Worldwide 877-702-9580
`
`Ex. 1033-0017
`
`
`
`Page 18
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` TELEPHONE CONFERENCE
` of -- end of January. Is that right? 13:14
` MR. BROWN: It's scheduled to run 13:14
` through the 30th. 13:14
` THE COURT: Right. 13:14
` MR. BROWN: So I would like to not -- 13:14
` THE COURT: We've all been there. I 13:14
` understand that. 13:14
` So I want to -- I think it's within 13:14
` the parties' power here to find a date that 13:14
` works. I don't know that you need me to sit 13:14
` down and pencil you all in on calendars. It 13:14
` doesn't sound like there's been a full 13:14
` discussion of other alternatives. 13:14
` What I would like to do, and before we 13:14
` get off the call, I want to talk with the 13:14
` Panel, but what I think I'm leaning towards 13:14
` doing is sending you guys back to the 13:14
` drawing boards here and letting you take 13:14
` another crack at finding a date with our 13:14
` sort of, you know, strong inclination that 13:14
` there ought to be a date in there somewhere 13:14
` that works for everyone, now that we sort of 13:15
` know what the parameters are. 13:15
` So is there anything we haven't 13:15
`
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`TSG Reporting - Worldwide 877-702-9580
`
`Ex. 1033-0018
`
`
`
`Page 19
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` TELEPHONE CONFERENCE
` discussed, any other conflicts that haven't 13:15
` been, you know, vocalized yet that we want 13:15
` to get out on the table before that happens? 13:15
` Not hearing anything. Give me a 13:15
` moment, and I'm going to go off the line 13:15
` real quick and discuss with the Panel and 13:15
` we'll be right back on. 13:15
` (Pause.) 13:15
` THE COURT: All right. This is Judge 13:19
` Crumbley. I took a moment so the Panel 13:19
` could talk over our schedules just so we 13:19
` can -- we can give you some idea of days 13:19
` that might work and days that you might want 13:19
` to avoid. 13:19
` I want the parties to take a look at, 13:19
` when you go back and sit down with your 13:19
` calendars, and then, you know, have further 13:19
` discussions amongst yourselves, take a hard 13:19
` look at February 2nd or 3rd. I think those 13:19
` two dates would work for the Panel. So if 13:19
` you can make those dates work, that would 13:19
` work for -- might work for us. I need to 13:19
` confirm that we have a hearing room 13:19
` available. 13:19
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`TSG Reporting - Worldwide 877-702-9580
`
`Ex. 1033-0019
`
`
`
`Page 20
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` TELEPHONE CONFERENCE
` I guess we have so many parties, I 13:19
` want to make sure that we can accommodate 13:19
` everyone in these cases. 13:19
` I need you a stay away from the 1st of 13:19
` February and the 18th of January. There are 13:20
` conflicts on those dates. So if the 2nd or 13:20
` 3rd don't work, I want you to propose some 13:20
` other dates to us, bearing in mind that 13:20
` those will have to be, you know, confirmed 13:20
` available for the hearing room and, you 13:20
` know, the Panel's availability. 13:20
` But let's see what we can do with that 13:20
` time range now that we know where everyone's 13:20
` conflicts lie. 13:20
` Is there anything that else that the 13:20
` board needs to be involved with at this 13:20
` point or do the parties have enough 13:20
` information to go and discuss amongst 13:20
` yourselves? 13:20
` MR. BROWN: I think that provides, at 13:20
` lead for Par, that provides us with 13:20
` everything we need, your Honor. 13:20
` THE COURT: Ms. Schwarz, is that all 13:20
` right with you? 13:20
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`TSG Reporting - Worldwide 877-702-9580
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`Ex. 1033-0020
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`
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`Page 21
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` TELEPHONE CONFERENCE
` MS. SCHWARZ: Yes, your Honor. 13:20
` THE COURT: Okay. So I'd like to hear 13:20
` back from you on this by the end of the week 13:21
` if you can do that for me. 13:21
` MR. BROWN: Yes. 13:21
` MS. SCHWARZ: That won't be a problem. 13:21
` THE COURT: And the earlier, the 13:21
` better. I mean, the sooner we can get on 13:21
` the calendar to make sure we have the 13:21
` hearing rooms, I think that would be useful, 13:21
` but I'd like to hear back from you no later 13:21
` than Friday, and hopefully we can get this 13:21
` moved to a time that works for everyone. 13:21
` All right. Unless there's anything 13:21
` else, we will stand adjourned. 13:21
` MR. BROWN: Thank you, your Honor. 13:21
` THE COURT: All right. Take care 13:21
` everyone. 13:21
` MS. SCHWARZ: By
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