IPR2015-00902 - 00903; IPR2015-01097, 01099, 01100, 01105; IPR2015-01871; IPR2016-00089 - 00091
`Conference Call
`December 11, 2015
`
`1
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` _______________________
`INNOPHARMA LICENSING, INC., INNOPHARMA LICENSING LLC,
` INNOPHARMA INC. INNOPHARMA LLC,
` MYLAN PHARMACEUTICALS INC., and MYLAN INC.,
` Petitioner,
` v.
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC.,
` and BAUSCH & LOMB PHARMA HOLDINGS CORP.,
` Patent Owner.
` _____________
` Case IPR2015-00902
` Patent 8,669,290
` _____________
` Case IPR2015-00903
` Patent 8,129,431
` _____________
` Case IPR2016-00089
` Patent 8,754,131 B2
` _____________
` Case IPR2016-00090
` Patent 8,871,813 B2
` _____________
` Case IPR2016-00091
` Patent 8,927,606 B1
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`
`www.hendersonlegalservices.com
`
`SENJU EXHIBIT 2007
`LUPIN v. SENJU
`IPR2015-01871
`
`Page 1 of 50
`
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`Conference Call
`December 11, 2015
`
`1
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` _______________________
`INNOPHARMA LICENSING, INC., INNOPHARMA LICENSING LLC,
` INNOPHARMA INC. INNOPHARMA LLC,
` MYLAN PHARMACEUTICALS INC., and MYLAN INC.,
` Petitioner,
` v.
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC.,
` and BAUSCH & LOMB PHARMA HOLDINGS CORP.,
` Patent Owner.
` _____________
` Case IPR2015-00902
` Patent 8,669,290
` _____________
` Case IPR2015-00903
` Patent 8,129,431
` _____________
` Case IPR2016-00089
` Patent 8,754,131 B2
` _____________
` Case IPR2016-00090
` Patent 8,871,813 B2
` _____________
` Case IPR2016-00091
` Patent 8,927,606 B1
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`
`www.hendersonlegalservices.com
`
`SENJU EXHIBIT 2007
`LUPIN v. SENJU
`IPR2015-01871
`
`Page 1 of 50
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`December 11, 2015
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` _______________________
` LUPIN LTD. and LUPIN PHARMACEUTICALS, INC.,
` Petitioner,
` v.
` SENJU PHARMACEUTICAL CO., LTD.,
` Patent Owner.
` _____________
` Case IPR2015-01097
` Patent 8,754,131 B2
` _____________
` Case IPR2015-01099
` Patent 8,669,290 B2
` _____________
` Case IPR2015-01100
` Patent 8,927,606 B1
` _____________
` Case IPR2015-01105
` Patent 8,871,813 B2
` _____________
` Case IPR2015-01871
` Patent 8,129,431
` Telephonic Conference Call
` Before The Patent Trial And Appeal Board
` Washington, D.C.
` Friday, December 11, 2015, 2:01 p.m.
`
`Reported by: Donna A. Peterson
`
`202-220-4158
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`Henderson Legal Services, Inc.
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`Conference Call
`December 11, 2015
`
` A P P E A R A N C E S
`
`3
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` ADMINISTRATIVE PATENT JUDGE GRACE KARAFFA
` OBERMANN
` ADMINISTRATIVE PATENT JUDGE ERICA A. FRANKLIN
` ADMINISTRATIVE PATENT JUDGE FRANCISCO C. PRATS
` PATENT TRIAL AND APPEAL BOARD
` UNITED STATES PATENT AND TRADEMARK OFFICE
` 600 Dulaney Street
` Alexandria, Virginia 22314-5796
`
` ON BEHALF OF INNOPHARMA LICENSING, INC.,
` INNOPHARMA LICENSING LLC, MYLAND
` PHARMACEUTICALS INC., and MYLAN INC.,
` PETITIONER:
` JITENDRA MALIK, Ph.D., ATTORNEY at LAW
` HIDETADA JAMES ABE, ATTORNEY at LAW
` ALSTON & BIRD, LLP
` Suite 400, 4721 Emperor Boulevard
` Durham, North Carolina 27703-8580
` Telephone: (202) 783-5070
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` A P P E A R A N C E S C O N T I N U E D
` ON BEHALF OF SENJU PHARMACEUTICAL CO., LTD.,
` BAUSCH & LOMB, INC., and BAUSCH & LOMB PHARMA
` HOLDINGS CORP., PATENT OWNER:
` BRYAN C. DINER, ATTORNEY at LAW
` JUSTIN J. HASFORD, ATTORNEY at LAW
` JOSHUA L. GOLDBERG, ATTORNEY at LAW
` ELIZABETH D. FERRIL, ATTORNEY at LAW
` FINNEGAN, HENDERSON, FARABOW,
` GARRETT & DUNNER, LLP
` 901 New York Avenue, N.W.
` Washington, D.C. 20001
` Telephone: (202) 408-4000
`
` ON BEHALF OF LUPIN LTD. and LUPIN
` PHARMACEUTICALS INC., PETITIONER:
` DEBORAH H. YELLIN, ATTORNEY at LAW
` JONATHAN LINDSAY, ATTORNEY at LAW
` CROWELL & MORING, LLP
` 1001 Pennsylvania Avenue, N.W.
` Washington, D.C. 20004-2595
` Telephone: (202) 624-2947
`
`202-220-4158
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`Conference Call
`December 11, 2015
`
` C O N T E N T S
` PAGE
` Hearing: Global Schedule 6
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`Conference Call
`December 11, 2015
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` P R O C E E D I N G S
` JUDGE OBERMANN: Good afternoon.
` This is Judge Obermann. I have Judge
`Franklin and Judge Prats on the phone with me.
` This is a telephone conference in a series
`of ten IPR's. I'll read them into the record:
`IPR2015-00902, IPR2015-00903, IPR2015-01097,
`IPR2015-01099, IPR2015-01100, IPR2015-01105,
`IPR2015-01871, IPR2016-00089, IPR2016-00090 and
`IPR2016-00091.
` I understand we have a court reporter.
`Which party engaged the court reporter, please?
` MR. DINER: That would be Senju, et al.,
`Your Honor.
` JUDGE OBERMANN: Thank you. Is that
`Mr. Diner?
` MR. DINER: Yes, it is, Your Honor. Good
`afternoon, by the way.
` JUDGE OBERMANN: Good afternoon.
` Mr. Diner, will you please file a copy of
`the transcript as an exhibit in due course?
` MR. DINER: Yes, we will, Your Honor.
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` JUDGE OBERMANN: Thank you.
` Mr. Diner, do you have anyone else
`appearing with you on behalf of Senju today?
` MR. DINER: I do, Your Honor.
` JUDGE OBERMANN: Okay.
` MR. DINER: The first person is Justin
`Hasford.
` JUDGE OBERMANN: Okay. Anyone else?
` MR. DINER: Yes, Your Honor. Joshua
`Goldberg.
` THE JUDGE: All right.
` MR. DINER: And Elizabeth Ferrill, spelled
`F-E-double R-I-double L.
` JUDGE OBERMANN: Okay, thank you,
`Mr. Diner.
` Who's appearing today for Petitioner
`Lupin?
` MS. YELLIN: Hello, Your Honor.
` This is Deborah Yellin, from Crowell and
`Moring, here for Lupin, and with me is Jonathan
`Lindsay.
` JUDGE OBERMANN: Thank you, Ms. Yellin.
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` And do we have someone here from
`Innopharma?
` MR. MALIK: Yes, Your Honor. Good
`afternoon, Your Honor.
` My name is Jitendra Malik, I'm counsel for
`Innopharma. With me is James Abe.
` JUDGE OBERMANN: Thank you very much.
` Okay, I understand that a conference call
`was requested regarding a proposed global schedule,
`and the e-mail came in from Mr. Diner on behalf of
`Senju, so I'll ask Mr. Diner to please proceed.
` MR. DINER: Okay, Your Honor, thank you.
` Well, Your Honor, we received the e-mail
`from Ms. Bignone on Wednesday, December 9th, and we
`see how you have things set out here.
` Would you like us to jump right to
`paragraphs number four, or is there a particular way
`that you would like us to -- would you like us to
`address anything up front, like the global
`consolidation, or I guess I'll ask you how you would
`like us to address the issues, based on your e-mail
`or what?
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` JUDGE OBERMANN: Well, we intentionally
`sent you the e-mail because we wanted to be able to
`focus today and, as you can see, we are not inclined
`to move the schedule in an IPR that is not the
`subject of a motion to join. We didn't see a reason
`to move the dates in the IPR 903. You're welcome to
`address that if all three parties disagree or even if
`one of you disagree, you can use the time as you
`like. We're open to hearing what you have to say,
`but we wanted to let you know sort of where we are,
`based on the record that's been developed so far.
` We wanted to let you know that we didn't
`see a reason to roll those first two filed
`proceedings into this global schedule. Obviously if
`you're able to, you know, come up with a compelling
`reason why we should, we're opening to listening to
`you. So I will, you know, sort of let you, having
`hopefully absorbed where the board is at this stage,
`let you tell us what you think could be done at this
`point.
` The other concern the board has is that
`you're asking us to -- it appeared that you seemed to
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`be asking us to enter a schedule in the last three
`IPR's, actually the last four, which haven't been
`instituted yet. So we'd like you to sort of address
`what you think can be done at this point to help us
`and the parties because we do want to, you know, get
`the parties, to the extent possible, on the same
`schedule so that you can work together. But, at the
`same time, we have to work within the constraints of
`the fact that these were, you know, filed in a
`staggered fashion.
` So with that, if that helps at all,
`Mr. Diner, maybe you can proceed.
` MR. DINER: Yeah, that's helpful, I think
`it does. Let me take a shot at the very first issue
`on the global coordination.
` As you know, we did have a meet and confer
`and all the parties did agree on it. We recognize
`that the board was looking for a compelling reason.
`We weren't sure if all parties agreeing on it was
`compelling enough, but I think your e-mail perhaps
`addressed that, certainly if not directly,
`implicitly.
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` But we did have another meet and confer,
`and I think, if anything can be said about the
`parties, I think we are kind of getting along and
`trying to work things out and -- and cooperating with
`one another. And pursuant to that meet and confer
`that we had this morning, I think my colleague from
`Innopharma, Mr. Malik, may want to, did you want to
`take a first shot and talk about --
` MR. MALIK: Yes.
` MR. DINER: -- global coordination or how,
`would you like me to proceed and then --
` MR. MALIK: Sure.
` MR. DINER: -- jump back in afterwards?
` MR. MALIK: Thank you, Bryan.
` Your Honor, this is Jitendra Malik,
`counsel for Innopharma.
` As Mr. Diner mentioned, we did have a call
`this morning to meet and confer basically before this
`call so that the parties could try to come to some
`kind of understanding as to how best to approach the
`hearing today, in light of the board's guidance in
`the e-mail that we received on Wednesday. What we --
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`what we talked about is obviously with the board
`deciding with the three seven -- deciding the 902,
`903 cases, leaving the schedule undisturbed, and then
`there are an additional seven that are still open,
`the time pressures are no longer quite there because
`the reason the parties wanted to bring it to the
`board's attention sooner, rather than later, was
`because the 902 and the 903 cases are on an earlier
`schedule, compared to the others. Being now that
`they are split, we don't have quite the time
`pressures in connection with the other three.
` Some of the points that raised in your
`e-mail in connection with point four are directly
`kind of related to Innopharma's exposition. We did
`inform the other parties that given Innopharma was
`not otherwise time barred in filing its later three
`IPR's, the ones that we filed on, I believe, November
`11th that we were not inclined to -- to not use our
`expert Dr. Laskar and go only with Dr. Lawrence. So
`in connection with point "A," we weren't inclined to
`take a backseat role and take understudy role, based
`on the fact that we weren't time barred.
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` When we -- when we told Senju that, one of
`the discussions that we had was that Senju raised,
`perhaps if Innopharma was willing to only proceed on
`ground one and drop grounds two and three that they
`would not oppose using two experts in this case,
`Dr. Laskar and Dr. Lawrence, for Lupin, in connection
`with the -- Innopharma's case 89, 90 and 91. And
`what -- what, where we left it is given the time
`pressure's no longer there that we, in essence, would
`-- that we, that Innopharma would go back to our
`client with that proposal. And, perhaps, if our
`client agrees with just using ground one, maybe that
`would be a way to kind of resolve everything,
`bringing the last three Innopharma IPR's on the same
`schedule as the previously ones -- previous schedule
`proposed by Lupin, and that hopefully should -- and
`if the board obviously goes with that proposal,
`hopefully that should resolve things.
` JUDGE OBERMANN: Mr. Malik, I want to
`interrupt you for a second because I'm not completely
`following what you're proposing.
` You're proposing that in the -- in the
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`last three actions, 89, 90 and 91, that Innopharma
`trim its petition down to just one ground and retain
`their expert and do what?
` MR. MALIK: In essence, move forward with
`that one ground with our expert.
` JUDGE OBERMANN: So you would try to join
`the Lupin IPR's?
` MR. MALIK: Yes.
` JUDGE OBERMANN: And you would still want
`to have a separate expert?
` MR. MALIK: Yes. And -- and, as I
`mentioned, the proposal was only put forward this
`morning, so --
` JUDGE OBERMANN: Okay.
` MR. MALIK: -- I'd have to go back to my
`client, but that's -- and if that, if Innopharma
`agrees, Senju has also agreed not to file a
`preliminary response and hopefully that would move
`things forward.
` JUDGE OBERMANN: Okay. So we don't yet
`know Innopharma's ability to propose that because you
`haven't spoken to your client.
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` Do we know what Lupin's position is on
`that?
` MS. YELLIN: Your Honor, this is Deborah
`Yellin, for Lupin.
` We're certainly fine with Innopharma
`proceeding in that way, as long as we're, of course,
`allowed to use our original expert which we used in
`our original filing, Dr. Lawrence. If we're able to
`do that and take our leading role in the proceedings,
`we're fine with them joining in that fashion and
`we're fine with them using Dr. Laskar, as well.
` JUDGE OBERMANN: Okay. Thank you,
`Ms. Yellin.
` Going back to Mr. Malik. Under your
`proposal, you would basically still want to have
`seven pages additional briefing, or would you be
`taking seven pages of Lupin's briefing?
` MR. MALIK: We haven't discussed logistics
`amongst the party, but if the board has a preference,
`obviously we can, you know, we certainly would defer
`to the board. But I think seven pages additional
`briefing, to the extent the issues are not
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`duplicative. Obviously if the issues are
`duplicative, and, you know, Innopharma and Lupin will
`work together. We're not here to give the board more
`briefing just for the sake of additional pages. But
`to the extent there's a unique issue for Innopharma,
`we certainly would be -- brief that on additional
`pages.
` JUDGE OBERMANN: Okay. Well, it sounds
`maybe like this is maybe a little premature to
`discuss because we haven't gotten everything ironed
`out in that regard, especially since you haven't run
`it by your client. I'm a little confused about how
`it would look like.
` I guess -- I guess this conference, this
`conference is on the record, so I guess we'll have to
`talk about that because we would need a way to modify
`the filing. You know, the petition has been filed
`and the motion to join has been filed, so we'll need
`to make, if it comes to fruition and you're able to
`get permission from your client to do it this way and
`all three parties agree, I guess the biggest concern
`I would have, I want to make sure Senju is totally on
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`board with the abbreviated discovery schedule,
`notwithstanding the fact there would be two extra
`experts and extra briefing. And then we would need
`to, you know, just come up with a mechanism so that
`Innopharma's intention is clear, so that we can rule
`on this sort of modified petition and motion to join
`in a way that makes the record clear. Because right
`now, what we have in the file is, you know, a full
`petition on everything.
` Okay, unless you have something to add on
`that particular point, Mr. Malik, I will turn to
`Mr. Diner because usually when we -- when we face
`joiner, it's the patent owner who's really crunched.
`It seems here that Mr. Diner is on board with this,
`but I just want to make sure.
` MR. DINER: Thank you for turning to me,
`Your Honor. This is Bryan Diner. Yeah, I'll handle
`it one by one.
` So on the issue of the seven pages
`additional, of course, if they're gonna have seven
`pages, then we would like to have equal seven pages
`to respond to that. And I guess we can work that out
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`as to what you're proposing when we submit that to
`you.
` JUDGE OBERMANN: Okay.
` MR. DINER: On the issue of -- of aligning
`the Innopharma's last three petitions with Lupin's
`previous four, as Mr. Malik mentioned, we would like
`to see, subject, I guess, to his client's approval of
`that from his standpoint, we think it makes sense
`that their petition get aligned on the same grounds
`that you've instituted both in the previous four
`petitions on.
` And then with regard to their use of
`Dr. Laskar, we're okay with Lupin having Dr. Lawrence
`and Innopharma having Dr. Laskar, just so long as
`it's understood that it will be on the single ground
`that the board has instituted Lupin's petition back
`in October of this year.
` JUDGE OBERMANN: I have to say that I
`share your concern because what usually happens when
`we join, we get the parties into sort of, as we did
`with 1871, into a condition where we can grant the
`later-filed petition and immediately terminate it in
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`the same order, so that there's no confusion about
`what -- what constitutes the record at that point.
`The record is constrained to the earlier-filed
`petition.
` What we're describing here is a little bit
`different. It doesn't mean it can't be done, we
`would have to give it some careful thought. But
`I'm -- because Innopharma is not time barred, I think
`what makes sense at this point is to make sure that,
`first of all, everyone's on board with this. But I
`don't think we can do it willy-nilly. I think we're
`going to need, if this comes to fruition, we're gonna
`need Innopharma, perhaps, to file a motion asking to
`file a modified petition. And we would want to see
`exactly what that petition looks like, so that we can
`determine how best, you know, if it's in condition
`for joinder, to actually join it, so that there's no
`confusion because I think that -- I think the
`declaration would need to change, as well, because
`you'd be trimming out -- you'd be trimming out part
`of that testimony that goes to grounds that are
`withdrawn.
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` MR. MALIK: Yes, Your Honor.
` JUDGE OBERMANN: Alternatively, you could
`file -- I'm just throwing this out here, but perhaps
`Innopharma could file something in the three last,
`the three last proceedings, 89, 90 and 91, a paper
`that withdraws grounds. Maybe that would be a
`cleaner way to do it, if you're simply withdrawing
`grounds.
` MR. DINER: Your Honor, this is Bryan
`Diner. I'm sorry to jump in on you, I just had a
`thought.
` You raised a moment ago, you know, the
`fact that Dr. Laskar's declaration would be
`addressing those multiple grounds. How would you
`handle that? You can handle the petition easily
`enough with the paper that you suggested. Would it
`also work, as well, with Dr. Laskar's declaration
`that --
` JUDGE OBERMANN: Yeah. I haven't looked
`at the declaration that carefully, but I would want
`to make sure that when we join this, we can do it
`very cleanly. And if we are moving -- this is very
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`unusual because usually we demand that the same
`declaration be used, so it's one of the reasons --
`and I'm not saying that we're gonna do it in this
`case. We're not going to rule on that today,
`obviously. I do want to talk this over, to the
`extent we can, so you have some direction going
`forward, figuring out what to do.
` I will tell you, it's quite unusual to
`join where we're not dropping an expert. So we would
`want to be persuaded in some sort of filing that
`you've trimmed down that declaration in some fashion,
`either by -- I don't know what it looks like now,
`whether you can just file an unopposed motion to
`replace the declaration with something that's much
`more trimmed down. I think the parties need to get
`together and figure this out because what we would be
`doing would be granting the later-filed -- we would
`need to make sure that the petition in the
`later-filed actions warrant institution. And if
`you've put them in condition so that they basically
`repeat grounds, essentially repeat grounds that are
`stated in the earlier ones, it's very easy to do that
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`because we've already ruled on those earlier ones.
` But if you're adding much material to
`those later-filed ones and if you're not willing to
`let go of all your nuts, so to speak, if you're a
`squirrel and you don't want to let go of your nuts,
`Innopharma in the second-filed petition, that really
`complicates things because then the board has to look
`more carefully at whether your petition really
`warrants review because it brings forward different
`grounds. And then when we join, it's going to be a
`much more complicated record because we would have a
`second declaration.
` But my concern is, I don't want to blur
`these proceedings, I don't want to just fold
`everything up together if what you're telling me is
`the sum of the material that's been filed in the 89,
`the 90 and the 91 action are now going to be
`basically withdrawn. We need to make that clear in
`the record.
` MR. DINER: Your Honor, this is Bryan
`Diner again.
` One of my colleagues just whispered to me
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`that one of the -- they were involved in a situation
`like this in District Court they did a
`strike-through. Maybe that's something we can work
`out with Innopharma and see how that works. We could
`work together and try --
` JUDGE OBERMANN: Yes. Well,
`strike-throughs are nice as an exhibit, but when I'm
`reading the briefs, I want to be able to look at
`something that's clean.
` MR. DINER: I hear you. I hear you.
` MR. MALIK: We will submit a clean and a
`strike-through copy, if that were amenable.
` JUDGE OBERMANN: Sure, yes. Yes. We'll
`have to, you know, get our heads together. You know,
`if the parties have really reached this agreement,
`and especially if Senju wants to go forward in this
`fashion and doesn't mind complicating their very
`short discovery period with multiple experts, then I
`would like to find a way that we can do this, if
`possible. But I think the parties do need to get
`together and do some work on figuring out how it can
`be done efficiently and in a manner that's not going
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`to confuse the record.
` MR. DINER: Okay.
` You mentioned a couple things, Your Honor,
`that the parties still need to address. Can you just
`summarize them, so we're all on the same page going
`forward? Obviously it's what we just discussed in
`terms of the petition and the declaration, but what
`else was there? Was there the -- the page, extra
`pages?
` JUDGE OBERMANN: The extra pages.
`Obviously we prefer not to have extra pages. Lupin
`would have to be willing -- what usually happens and
`what I've seen in the other cases is that the -- the
`second filer reserves, you know, the right to
`disagree with the first filer. So if there's a -- if
`they disagree with particular arguments made in a
`filing, they put in a couple extra pages, just
`pointing out the areas of disagreement.
` If that's going to expand all of the
`filings, because I heard Mr. Diner say that he would
`want extra pages, as well, you know, that's not
`ideal. I really hope that the parties can get
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`together and figure out a way to avoid expanding the
`page lengths of the briefs.
` MR. DINER: How about, then, if we took up
`your previous suggestion you mentioned, going the
`other way, which is the -- which would be that
`Innopharma takes seven pages within Lupin's allotted,
`within the 20 pages, 16, whatever it is.
` JUDGE OBERMANN: It depends, it depends.
`If you have a -- it depends. If you have a motion,
`it's a certain page limit, replies have a certain
`page limit.
` MR. DINER: Right, right.
` JUDGE OBERMANN: So you would have to --
`you know, my ideal, if the parties can truly work
`together, if Lupin and Innopharma can work together,
`what would be ideal is if you can figure out a way to
`cough up a couple pages, if there's a disagreement,
`and keep it within the page limit. I understand if
`you can't do that.
` The other thing I heard you mention,
`Mr. Malik, I think, was that there could be a
`circumstance where there would be an issue that
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`relates solely to Innopharma, and usually that is
`something that would require pre-authorization, where
`you would come to us and say, you know, something's
`arisen and it affects only us and we would like an
`opportunity to address it. I suppose it could arise
`in the context of -- well, it gets slippery because
`if you're not truly taking a backseat and the first
`petitioner comes in and starts talking about their
`own products, you could decide you want to talk about
`your products and you could want a whole bunch of
`pages on that.
` I don't want to get into a situation where
`we're dealing with a great deal more material than we
`would be in the unjoined proceedings. You see what
`I'm saying?
` MR. DINER: I do.
` JUDGE OBERMANN: So we nee
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