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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`AMNEAL PHARMACEUTICALS )
`LLC, AMNEAL )
`PHARMACEUTICALS OF NEW )
`YORK, LLC and MYLAN )
`PHARMACEUTICALS INC., )
` ) Case No.
` Petitioners, ) IPR2019-00207
` )
` vs. ) Patent No.
` ) 9,517,219 B2
`ALMIRALL, LLC, )
` )
` Patent Owner. )
`-------------------------- )
`
` PTAB CONFERENCE CALL
` Friday, January 17, 2020
`
`Reported by:
`Stacey L. Daywalt
`JOB NO. 175332
`
`TSG Reporting - Worldwide
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`Almirall EXHIBIT 2070
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`Amneal v. Almirall
`IPR2019-00207
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`AMNEAL PHARMACEUTICALS )
`LLC, AMNEAL )
`PHARMACEUTICALS OF NEW )
`YORK, LLC and MYLAN )
`PHARMACEUTICALS INC., )
` ) Case No.
` Petitioners, ) IPR2019-00207
` )
` vs. ) Patent No.
` ) 9,517,219 B2
`ALMIRALL, LLC, )
` )
` Patent Owner. )
`-------------------------- )
`
` PTAB CONFERENCE CALL
` Friday, January 17, 2020
`
`Reported by:
`Stacey L. Daywalt
`JOB NO. 175332
`
`TSG Reporting - Worldwide
`
`1 of 62
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`Almirall EXHIBIT 2070
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`Amneal v. Almirall
`IPR2019-00207
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`Page 2
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` Friday, January 17, 2020
` 2:00 p.m.
`
` PTAB Conference Call, held before
`Administrative Patent Judges Ryan H. Flax,
`Susan L.C. Mitchell and Christopher G. Paulraj,
`before Stacey L. Daywalt, a Court Reporter and
`Notary Public of the District of Columbia.
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`A P P E A R A N C E S:
`(All appearances are telephonic)
`
` STERNE, KESSLER, GOLDSTEIN & FOX
` Attorneys for Petitioner
` 1100 New York Avenue North West
` Washington, DC 20005
` BY: ADAM LAROCK ESQ.
`
` FENWICK & WEST
` Attorneys for Patent Owner
` 902 Broadway
` New York, New York 10010
` BY: JAMES TRAINOR ESQ.
` RJ SHEA ESQ.
` ELIZABETH HAGAN ESQ.
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` ADMINISTRATIVE PATENT JUDGE: Hello. 02:00
`This is Judge Flax. 02:00
` MR. TRAINOR: Hello, Your Honor. 02:00
` This is James Trainor of Fenwick & 02:00
`West on behalf of the Patent Owner. 02:00
` MS. HAGAN: Elizabeth Hagan of 02:00
`Fenwick & West is also present. 02:00
` MR. LAROCK: And Adam LaRock for 02:00
`Petitioners is also -- 02:00
` ADMINISTRATIVE PATENT JUDGE: Can 02:00
`you say that last one one more time? 02:00
` I didn't catch the second person. 02:00
` MS. HAGAN: Elizabeth Hagan for 02:00
`Patent Owner. 02:00
` MR. SHEA: And RJ Shea for the 02:00
`Patent Owner is also here. 02:00
` ADMINISTRATIVE PATENT JUDGE: Okay. 02:00
`And I understand there's going to be a court 02:00
`reporter on this call. Is that correct? 02:00
` MR. TRAINOR: I believe so, Your 02:00
`Honor. 02:01
` MS. HAGAN: We had arranged for one. 02:01
` THE REPORTER: I am here. 02:01
` ADMINISTRATIVE PATENT JUDGE: Okay. 02:01
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`Great. Hello there. Welcome to the call. 02:01
` So to get started, it is 2:01 p.m. 02:01
`on January 17, 2020. We are here discussing 02:01
`IPR2019-00207 concerning Patent 9,517,219. 02:01
` This conference call is in response 02:01
`to a request from Patent Owner, who e-mailed 02:01
`the Board wanting to discuss modifying the 02:01
`December 31st, 2019 order relating to 02:01
`Dr. Warner's deposition timing, also relating 02:01
`to an extension of Due Date 5 to allow parties 02:01
`to submit motions to exclude on a different 02:01
`schedule, and also relating to guidance 02:02
`regarding Dr. Warner's testimony live at oral 02:02
`arguments. 02:02
` Patent Owner, have I summarized your 02:02
`e-mail correctly? 02:02
` MR. TRAINOR: Yes, you have, Your 02:02
`Honor. 02:02
` ADMINISTRATIVE PATENT JUDGE: So go 02:02
`ahead and let us know what you're wanting to 02:02
`talk about today. 02:02
` MR. TRAINOR: Okay, Your Honor. 02:02
` And as you articulated, in the 02:02
`e-mail request, we've tried to present this as 02:02
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`those three issues or three questions. I would 02:02
`say that, given certain developments with 02:02
`respect to communicating with this potential 02:02
`witness and conferring with the Petitioner, 02:02
`those issues may have crystallized a little bit 02:02
`more, so maybe I could just sort of walk 02:02
`through them. 02:02
` With regard to the first issue about 02:02
`modification of the December 31st order itself, 02:02
`I think I would start by saying the issue is 02:02
`that the Patent Owner, Almirall, is unable to 02:03
`comply in full with the order. So -- and 02:03
`there's a -- the request in general was to sort 02:03
`of seek some guidance and hopefully maybe to 02:03
`advise my client as to what the ramifications 02:03
`or implications of the inability to fully 02:03
`comply would be. But let me just sort of walk 02:03
`through that, if you will. 02:03
` And I should have said thank you 02:03
`very much for the time and for the opportunity 02:03
`to be heard today. Very much appreciated. 02:03
` ADMINISTRATIVE PATENT JUDGE: You're 02:03
`welcome. 02:03
` And I should have also said at the 02:03
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`beginning that we also have Judges Mitchell and 02:03
`Paulraj on the phone. 02:03
` MR. TRAINOR: Oh, I'm sorry. 02:03
` ADMINISTRATIVE PATENT JUDGE: Okay. 02:03
` MR. TRAINOR: Good afternoon, Your 02:03
`Honors. 02:03
` ADMINISTRATIVE PATENT JUDGE: I 02:03
`didn't mention it earlier. 02:03
` But go ahead. So you were saying 02:03
`that you're unable to fully comply with the 02:03
`order. 02:03
` MR. TRAINOR: Yes. 02:03
` ADMINISTRATIVE PATENT JUDGE: Why 02:03
`don't you expand on that. 02:03
` MR. TRAINOR: Let me explain, Your 02:03
`Honor. 02:03
` So there are essentially -- in the 02:03
`main, there are two components of the relief 02:04
`that were granted. The first was for the 02:04
`production of the transcript of testimony by 02:04
`Dr. Warner provided by deposition in a prior, 02:04
`no longer pending litigation against a nonparty 02:04
`to this IPR. 02:04
` I want to note that that has been 02:04
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`produced to the Petitioner, and I think it 02:04
`bears noting that the Petitioner -- the client 02:04
`Petitioner, Amneal, is also engaged in parallel 02:04
`litigation with the Patent Owner in the 02:04
`District of Delaware. A transcript had been 02:04
`provided previously, you know, previous to the 02:04
`order, I believe previous to the request or 02:04
`somewhere in between, with a few redactions for 02:04
`confidential information belonging to the then 02:04
`Patent Owner. 02:04
` I understand that there was a 02:05
`protective order in place, so the Petitioner's 02:05
`position here was that that was not unavailable 02:05
`for use even though the same party had it, 02:05
`which we understand. But they now have been 02:05
`provided that formally in this proceeding. So 02:05
`in that respect, we have complied with the 02:05
`Court's order. 02:05
` With respect to the live deposition 02:05
`testimony sought of Dr. Warner in this case, 02:05
`that is the portion of the order that we're 02:05
`unable to comply with. 02:05
` So I would just say a few facts that 02:05
`sort of are relevant to why and maybe might 02:05
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`inform the guidance of the Board here. 02:05
` First of all, as we -- you know, we 02:05
`denied the request originally. We obviously 02:05
`opposed the motion. And I want to make sure -- 02:05
`that's partially why I had the court reporter 02:05
`on. We want to make -- be very, very clear 02:05
`that we've sort of maintained the Patent 02:05
`Owner's position that this deposition of a fact 02:05
`witness who's offered no evidence in this 02:06
`proceeding is improper. I'm not sure how that 02:06
`evidence would necessarily be admissible. But 02:06
`of course we respect the Board's decision and 02:06
`we've been trying to comply with the order. 02:06
` The relevant facts are that 02:06
`Dr. Warner is the former employee of the 02:06
`predecessor in interest of this patent, which 02:06
`was a drug company called Allergan. 02:06
` And Allergan -- Dr. Warner left the 02:06
`employ of Allergan in 2017. And in September 02:06
`of 2018, you know, well after that happened, my 02:06
`client Almirall, which is a Spanish 02:06
`pharmaceutical company, acquired a set of 02:06
`assets relating to dermatology from Allergan 02:06
`which included the patent that's in dispute in 02:06
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`this proceeding. 02:07
` So in other words, Dr. Warner is the 02:07
`former employee of the former owner of my 02:07
`Spanish client who is currently living and 02:07
`working in Salt Lake City for a company called 02:07
`Alucent Biomedical, which has no connection 02:07
`whatsoever to Almirall. Dr. -- 02:07
` ADMINISTRATIVE PATENT JUDGE: You 02:07
`said he lives in Salt Lake City. Is that 02:07
`correct? 02:07
` MR. TRAINOR: Yes, that is correct. 02:07
` And Dr. Warner is not presently 02:07
`under the control or under any obligation to 02:07
`cooperate with our client. 02:07
` As a former employee of Allergan, he 02:07
`was -- that deposition, for example, the 02:07
`transcript in the prior litigation at that 02:07
`time, he was engaged in some sort of way that 02:07
`gave control over that witness to the former 02:07
`owner, Allergan. But that's not the case at 02:07
`the moment. 02:07
` Now, I have reached out to 02:07
`Dr. Warner. I was -- first, we received the 02:07
`order on December 31st. You know, sort of with 02:08
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`the holiday period the way that it was this 02:08
`year, then having spoken to the clients about 02:08
`the order and then tracking down Dr. Warner, 02:08
`who's very gracious, and I tried to explain the 02:08
`situation and the urgency because on the 02:08
`December 31st order he was ordered to be 02:08
`deposed by today, which obviously is not 02:08
`happening. 02:08
` Dr. -- excuse me. And I just -- 02:08
`sort of to reorient the Board, the motion that 02:08
`the Petitioner made for this discovery, you'll 02:08
`recall, was made prior to the reply submitted 02:08
`by the Petitioner, which was submitted without 02:08
`a decision on that motion. And then the 02:08
`sur-reply had been filed. 02:08
` So with -- other than with respect 02:08
`to the motions to exclude, the case was all 02:08
`trial ready when we received this order over 02:08
`the holidays. 02:08
` In any event, I contacted 02:09
`Dr. Warner. Notwithstanding sort of our 02:09
`objection to, you know, the relevance or 02:09
`admissibility of any testimony he might provide 02:09
`or has provided previously, I said, listen, I'd 02:09
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`like to try to comply with this order. 02:09
` Unfortunately, his present employer 02:09
`where he's the vice president of pharmaceutical 02:09
`development at Alucent Biomedical -- I don't 02:09
`want to get into the confidential business that 02:09
`he's involved in there, but what I would just 02:09
`say is that he and the company are in the midst 02:09
`of a very critical sort of stage in their 02:09
`business. They're a startup emerging company, 02:09
`and I'll just sort of leave it there. 02:09
` All of this to say that the very 02:09
`best that Dr. Warner could do -- at first I 02:09
`think I must have misunderstood him and thought 02:09
`that we might be able to get him available in 02:09
`Salt Lake City next Friday. I misunderstood 02:09
`that. 02:09
` But I am clear now that the only -- 02:10
`the earliest time that he might be available 02:10
`for a deposition in this case, if it were to 02:10
`proceed, would be January 30th, which is, I 02:10
`believe, ten days before the trial. 02:10
` So those are sort of the facts. And 02:10
`you know, again, we really just respectfully 02:10
`did not anticipate the order coming down as it 02:10
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`did, and you know, I just -- there was really 02:10
`sort of no way to prepare him way in advance 02:10
`even if he could make this work with his 02:10
`schedule. 02:10
` So I just wanted to mention that the 02:10
`bottom line is that we will be unable to comply 02:10
`with the order in full. 02:10
` And in the meet and confer that was 02:10
`ordered and we -- wasn't the only time that the 02:10
`Petitioner and Patent Owner have conferenced in 02:10
`the wake of the order. I think sort of where 02:10
`we're at now is that there are -- I would say 02:11
`that we're in agreement that there are at least 02:11
`two options, and I would like to offer a third. 02:11
` It seems like the first option would 02:11
`be for the Petitioner to take the position that 02:11
`the failure to comply with the order is what it 02:11
`is and could serve as the basis for a motion to 02:11
`exclude evidence. I'm not sure what that would 02:11
`be at the moment, but that would be due today. 02:11
` And so in other words, just sort of 02:11
`accept the fact that we can't comply with the 02:11
`order and then that could be the basis for a 02:11
`motion to exclude evidence that the Petitioners 02:11
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`believe is excludable for that reason. 02:11
` Alternatively, we could pursue the 02:11
`deposition at the first available date that 02:11
`Dr. Warner has in Salt Lake City, but of course 02:11
`that would lead us to a situation in dealing 02:11
`with the supplemental briefing that's 02:11
`contemplating by the order and some issues with 02:12
`the motion to exclude in a matter of time that 02:12
`is sort of somewhere between hectic and 02:12
`chaotic. That would be the Thursday of the 02:12
`week before the trial. 02:12
` What I had proposed to the 02:12
`Petitioners on our meet and confer was the only 02:12
`reasonable way I can see this working is if we 02:12
`modified the dates such that Thursday the 30th 02:12
`he would be deposed. We would need -- you 02:12
`know, they'd need at least a day, I think, to 02:12
`get a transcript. They could file the opening 02:12
`ten-page supplemental brief, I'll call it, as 02:12
`contemplated by the order on Monday of that 02:12
`following week. 02:12
` We would respond with our 02:12
`ten-page -- the Patent Owner would respond with 02:12
`a ten-page response contemplated by the order 02:12
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`on Wednesday. 02:12
` And then insofar as there were 02:12
`motions to exclude that are specifically tied 02:12
`to, you know, whatever testimony would come out 02:12
`in that scenario, because the movant would get 02:13
`a reply brief in the normal course, then there 02:13
`would be -- I guess Thursday, the day before 02:13
`the trial, they could submit any reply in 02:13
`connection with a specific motion to exclude 02:13
`anchored to the deposition testimony. 02:13
` And I guess I should just say the 02:13
`other part of that proposal was the Court had 02:13
`asked us to talk about, you know, Dates 5, 6 02:13
`and 7 in the scheduling order, which 02:13
`collectively are just the three briefing dates 02:13
`of the motion to exclude. 02:13
` I think we're in agreement -- 02:13
`obviously, you'll hear from the Petitioner -- 02:13
`that -- I mean, from our point of view, we 02:13
`ought to just stick to the schedule as it is 02:13
`and make all motions to exclude today and 02:13
`follow the -- that's Date 5 -- and then follow 02:13
`the rest of the briefing schedule with 02:14
`demonstratives and everything else, with the 02:14
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`trial going forward on February 7th, and try to 02:14
`find some way -- if there is a motion to 02:14
`exclude that comes out of this last bit of 02:14
`discovery, if it were accepted, you know, for a 02:14
`very late deposition, that that could be 02:14
`handled in conjunction with that supplemental 02:14
`briefing that was ordered. 02:14
` In other words, if the Petitioner 02:14
`had a motion to exclude -- well, I mean, 02:14
`they're the ones seeking the evidence. 02:14
` But if the Patent Owner had a motion 02:14
`to exclude that came out of, you know, an 02:14
`understanding that some of the deposition 02:14
`testimony was going to be presented at trial, 02:14
`that that would be subsumed within the ten 02:14
`pages that the Board has allotted the parties 02:14
`to -- connected to the discovery that was 02:14
`sought and ordered. 02:14
` So that's really sort of where we 02:14
`are, I think, on really Issue No. 1, and we 02:14
`sort of talked through, as a practical matter, 02:15
`how this would all work. 02:15
` I want to address this more fully, 02:15
`which is Issue No. 3. But I would also say, 02:15
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`and I had suggested to counsel for the 02:15
`Petitioner, that an alternative option, given 02:15
`the time crunch and sensitivity with the 02:15
`witness and all of the circumstances here, 02:15
`would be simply to just at least reserve the 02:15
`right to bring Dr. Warner to the trial. And 02:15
`then the Petitioner could have its focused 02:15
`cross-examination live and then any redirect 02:15
`examination live in front of the Board rather 02:15
`than, you know, a deposition in Salt Lake City. 02:15
` I don't think that the Petitioners 02:15
`agree with that, but I would just say that that 02:15
`is a third alternative to trying to comply with 02:15
`the order, albeit in an untimely fashion. So 02:15
`that is all, I think, under No. 1. 02:15
` As a -- the second question is sort 02:16
`of all wrapped up in that because the second 02:16
`issue that was presented by the Patent Owner 02:16
`was how do we deal with the fact that the 02:16
`supplemental briefing as it was set forth and 02:16
`required in the order would postdate the 02:16
`motions to exclude in the normal course under 02:16
`the scheduling order. 02:16
` But I think I've sort of addressed 02:16
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`that as part of the overall problem and sort of 02:16
`the facts of where we are in terms of 02:16
`compliance with this order. 02:16
` And then the third request that we 02:16
`had with regard to live testimony, I want to 02:16
`say that -- and I want to disconnect this from 02:16
`it being a possible alternative to just getting 02:16
`the discovery in the first instance. 02:16
` But what we were seeking to raise 02:16
`with the Court -- and I'm not suggesting that 02:16
`we would go forward with this, because we 02:16
`acknowledge that there's an inconsistency with 02:17
`maintaining that this discovery is 02:17
`inappropriate and any discovery resulting would 02:17
`be inadmissible. But at the same time, there's 02:17
`really no vehicle for reconsideration or 02:17
`anything. 02:17
` So if we go forward in good faith 02:17
`and just comply with the order and let the 02:17
`evidence sort itself out, we believe that this 02:17
`may be the rare instance where, according to 02:17
`the Trial Practice Guide, live testimony may 02:17
`just be appropriate. 02:17
` And just drawing from the highlights 02:17
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`there, the examples that the Board has provided 02:17
`for in guiding when live testimony might be 02:17
`appropriate is when a fact witness, which is 02:17
`sort of undeniable that this is a fact witness, 02:17
`and also when the witness's testimony may be 02:17
`the dispositive issue in the case. 02:17
` It's very difficult for us to know 02:17
`in the context of an IPR with two counts on the 02:17
`basis of obviousness what evidence will or will 02:18
`not be dispositive obviously until the Board 02:18
`decides. But you know, there are certainly 02:18
`scenarios where the Board may think it's a very 02:18
`close case and it would come down to whether 02:18
`they're persuaded that the examiner was correct 02:18
`in calling what was reflected in his 02:18
`declaration of prosecute history evidence of 02:18
`unexpected results or whether the Petitioners' 02:18
`expert who disagrees with that a conclusion is 02:18
`more persuasive to the Court. 02:18
` But in any event, I don't understand 02:18
`exactly what Dr. Warner's subjective testimony 02:18
`as the maker of that declaration and the person 02:18
`involved with the experiments underlying it, I 02:18
`don't know what facts would bear on the 02:18
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`questions before the Board that is sort of 02:18
`embraced by our opposition. But if there are 02:18
`facts -- if the question is whether his sworn 02:19
`declaration was in fact fraudulent or if the 02:19
`question is, you know, whether there is 02:19
`something underlying that declaration that, you 02:19
`know, but for the disclosure of that underlying 02:19
`information, the examiner wouldn't have had the 02:19
`take-away or the conclusion from that 02:19
`declaration that he did, then those are facts. 02:19
` And what I would say is that, you 02:19
`know, if this case really depends upon that 02:19
`sort of thing, which I don't believe it does, I 02:19
`mean, this -- the announcement should be done 02:19
`from a hypothetical person of ordinary skill in 02:19
`the art looking what's in the public intrinsic 02:19
`record just like everyone else who is trying to 02:19
`assess validity. 02:19
` But in the event that the Board 02:19
`finds and the Petitioner is able to suggest 02:19
`that there are facts underlying that 02:19
`declaration that should influence the decision 02:19
`in this case, then I think it would be 02:20
`prejudicial to the Patent Owner not for the 02:20
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`Board to have this witness in front of them and 02:20
`put their own eyes on this witness and try to 02:20
`establish whether he is credible or not. 02:20
` And again, I don't believe the 02:20
`credibility of this witness or his testimony is 02:20
`relevant or admissible. But to the extent the 02:20
`Board and the Petitioners think otherwise, then 02:20
`this is not an expert witness, and you can read 02:20
`the declaration. He's submitted nothing in 02:20
`this case. 02:20
` And I'm not saying that we would 02:20
`provide the witness live, but I would ask for 02:20
`the opportunity to at least reserve that right 02:20
`or have the Board consider it, because that 02:20
`would be important. If it's fair to take his 02:20
`testimony and somehow use it as evidence that 02:20
`the claims that are in dispute are obvious, and 02:20
`him being a fact witness, I think it would be 02:20
`at least fair for us to present him and let the 02:20
`Board sort of, you know, make its own 02:21
`determinations as to the credibility of this 02:21
`gentleman. 02:21
` So that's where we're at, and 02:21
`perhaps I will sort of stop there. 02:21
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` I think no matter what happens, we 02:21
`will need a little bit of guidance on some of 02:21
`the procedural loose ends, depending on where 02:21
`we go. But I would submit that if -- I think 02:21
`it would be important and proper for the 02:21
`Petitioner and/or the Board to decide sort of 02:21
`now, if possible, whether -- which route 02:21
`they're going to go. 02:21
` I mean, if we don't consider the 02:21
`live testimony in lieu of the deposition as I 02:21
`mentioned earlier, then we have the two options 02:21
`of trying to pursue it and complying with the 02:21
`order, albeit untimely, or just the Petitioner 02:21
`electing to say, I'll avail myself of the 02:21
`benefit that you failed to comply and use that 02:21
`in support of excluding evidence that they 02:22
`think should be excluded because they were 02:22
`denied that deposition testimony. 02:22
` But I think we're in agreement, I 02:22
`believe we're in agreement, that it's got to be 02:22
`one or the other. In other words, if they're 02:22
`going to move to exclude on that basis when the 02:22
`papers are filed today, then we can eliminate 02:22
`the business of scrambling to try to take this 02:22
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`deposition as we're also preparing for trial. 02:22
` But if they're not going to -- if 02:22
`they would like to pursue the deposition and we 02:22
`can somehow make it happen on a really -- on 02:22
`the schedule that I discussed, then, you know, 02:22
`conversely it should not be the basis of any 02:22
`motion to exclude, and that will sort of guide 02:22
`where we go and how we prepare from this point. 02:22
` And maybe I'll stop there. And I 02:22
`appreciate you giving me the time to sort of 02:22
`explain where we are at at the moment, because 02:22
`it's obviously not our client's intent or 02:22
`desire to willfully not comply with any order 02:23
`of the Board, whether we agree with it or not. 02:23
`I mean, that's -- I want to be very, very clear 02:23
`about that. 02:23
` ADMINISTRATIVE PATENT JUDGE: Okay. 02:23
`Understand. 02:23
` Petitioner, do you have anything you 02:23
`want to add? 02:23
` MR. LAROCK: Yes, Your Honor. Thank 02:23
`you. 02:23
` This is Adam LaRock for Petitioners. 02:23
` So it's our position that a 02:23
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`deposition on January 30th just isn't going to 02:23
`be workable, given the changes to the schedule 02:23
`that would need to take place to accommodate 02:23
`that deposition all before the oral hearing. 02:23
` And you know, I think it's important 02:23
`to think about that the deposition would only 02:23
`take place five business days before the oral 02:23
`hearing, and we would need to submit multiple 02:23
`motions and rounds of briefing between 02:23
`January 30 and February 7. 02:23
`
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