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` UNITED STATES PATENT AND TRADEMARK OFFICE
`_________________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`TRANSCRIPT OF PROCEEDINGS
`Before the Honorable Christopher L.
`Crumbley, the Honorable Lora M. Green, and the
`Honorable Robert A. Pollock, Administrative
`Patent Judges, via conference call, on the 17th
`day of June, 2016; commencing at 11:04 a.m.,
`the following cases were called:
`
`PAR PHARMACEUTICAL, INC.
`Petitioner
`v.
`NOVARTIS AG
`Patent Owner
`
`Case IRP2016-00084
`U.S. PATENT NO. 5,665,772
`
`Reported by:
`KATHERINE P. FORD, RPR
`JOB NO. 109270
`
`Breckenridge Exhibit 1034
`IPR2016-01023
`Breckenridge v. Novartis AG
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` UNITED STATES PATENT AND TRADEMARK OFFICE
`_________________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`TRANSCRIPT OF PROCEEDINGS
`Before the Honorable Christopher L.
`Crumbley, the Honorable Lora M. Green, and the
`Honorable Robert A. Pollock, Administrative
`Patent Judges, via conference call, on the 17th
`day of June, 2016; commencing at 11:04 a.m.,
`the following cases were called:
`
`PAR PHARMACEUTICAL, INC.
`Petitioner
`v.
`NOVARTIS AG
`Patent Owner
`
`Case IRP2016-00084
`U.S. PATENT NO. 5,665,772
`
`Reported by:
`KATHERINE P. FORD, RPR
`JOB NO. 109270
`
`Breckenridge Exhibit 1034
`IPR2016-01023
`Breckenridge v. Novartis AG
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` PAR PHARMACEUTICAL, INC.
` Petitioner
` v.
` NOVARTIS AG
` Patent Owner
`
` CASE IRP2016-01059
`
` U.S. Patent No. 5,665,772
`
`BRECKENRIDGE PHARMACEUTICAL, INC.
` Petitioner
` v.
` NOVARTIS AG
` Patent Owner
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` CASE IRP2016-01023
` U.S. Patent No. 5,665,772
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`BRECKENRIDGE PHARMACEUTICAL, INC.
` Petitioner,
` v.
` NOVARTIS AG
` Patent Owner
`
` CASE NO. TO BE ASSIGNED
`
` U.S. Patent No. 5,665,772
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` ROXANE LABORATORIES, INC.
` Petitioner
` v.
` NOVARTIS AG
` Patent Owner
`
` CASE NO. TO BE ASSIGNED
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` U.S. PATENT NO. 5,665,772
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`A P P E A R A N C E S:
`(Via telephone)
` LATHAM & WATKINS
` Attorneys for the Petitioner Par
` Pharmaceutical, Inc.
` 555 Eleventh Street, NW
` Washington, DC 20004
` BY: JONATHAN STRANG, ESQUIRE
` MARC ZUBICK, ESQUIRE
` MERCHANT & GOULD
` Attorneys for Petitioner Breckenridge
` Pharmaceutical, Inc.
` 1900 Duke Street
` Alexandria, VA 22314
` BY: MATTHEW FEDOWITZ, ESQUIRE
` MARY BRAM, ESQUIRE
` GOODWIN PROCTER
` Attorneys for Petitioner Roxane
` Laboratories, Inc.
` The New York Times Building
` 620 Eighth Avenue
` New York, NY 10018
` BY: KEITH ZULLOW, ESQUIRE
` FITZPATRICK, CELLA, HARPER & SCINTO
` Attorneys for Patent Owner Novartis
` 1290 Avenue of the Americas
` New York, NY 10104
` BY: NICHOLAS KALLAS, ESQUIRE
` RAYMOND MANDRA, ESQUIRE
` CHRISTINA SWARZ, ESQUIRE
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`--------------------I N D E X------------------
` PAGE
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`Opening Remarks by Judge Crumbley 8
`Comments by Mr. Strang 9
`Comments by Mr. Kallas 13
`Comments by Mr. Strang 22
`Comments by Mr. Kallas 24
`Closing Remarks by Judge Crumbley 26
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` P R O C E E D I N G S
`
` JUDGE CRUMBLEY: On the record. And
`as I always say, just -- I assume, Mr.
`Strang, you retained the reporter?
` MR. STRANG: Yes, Your Honor. And
`as before, I assume that you want us to
`submit it under our own exhibit numbers as
`soon as we have the final transcript?
` JUDGE CRUMBLEY: You took the words
`right out of my mouth. Let's go on the
`record. This is a call for a series of
`five IPRs, IPR2016-00084, 01023, 01059,
`01102, and 01103.
` As I said, I am Judge Crumbley. I
`have Judges Green and Pollock on with me.
`Can we get the appearances of the parties,
`starting with counsel for Par
`Pharmaceuticals?
` MR. STRANG: Yes, Your Honor, for
`Par Pharmaceuticals we have John Strang
`from Latham & Watkins, and with me I have
`Marc Zubick, also of Latham.
` JUDGE CRUMBLEY: Very good. And who
`do we have from Petitioner Breckenridge?
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` MR. FEDOWITZ: On behalf of
`Breckenridge, this is Matthew Fedowitz from
`Merchant & Gould. I also have Mary Bram.
` JUDGE CRUMBLEY: All right. And who
`do we have from Roxane?
` MR. ZULLOW: On behalf of Roxane
`this is Keith Zullow of Goodwin Procter.
` JUDGE CRUMBLEY: And who do we have
`on the line for Patent Owner Novartis?
` MR. KALLAS: We have Nick Kallas,
`Judge Crumbley, from Fitzpatrick Cella.
`With me is Ray Mandra and Christina Swarz.
`I do want to mention that Ms. Swarz is pro
`hac, admission is pending. While she is
`present, she obviously won't participate in
`the call.
` JUDGE CRUMBLEY: Right. And I was
`going to actually point that out at the
`beginning of the call, I know we have the
`pro hac pending. I don't believe I've seen
`any opposition to that motion. Is that
`right, Mr. Strang?
` MR. STRANG: That's correct, Your
`Honor. We do not oppose.
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` JUDGE CRUMBLEY: I also know we have
`a request for rehearing pending in the
`00084 case that we are considering and we
`will issue a decision on that in due
`course, but don't think we've forgotten
`about either of those.
` To get to the issue at hand today, I
`have an email from the parties, a rather
`substantial email with charts here that I'm
`trying to make heads or tails of, but
`that's why we wanted to have the call today
`was to sort of walk through this and make
`sure that the Board understands the
`parties' positions on this.
` I don't think we are going to get to
`a ruling on the phone today on the schedule
`because I think this requires some study,
`but I want to give the parties a chance to
`at least put -- give us a summary of where
`things stand right now and sort of where
`the major disagreements are so then we can
`make an informed decision about how to
`schedule these cases going forward.
` I guess the best thing to do is let
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`each party just give us a rundown of their
`summary. I guess I should say at the
`outset I do appreciate the parties'
`efforts. It's clear that you did meet and
`confer on this in trying to work out your
`differences, and the Board does appreciate
`the fact that you did that and hopefully we
`can resolve these final issues and get to
`some sort of agreement that we're all
`somewhere in the same ballpark.
` Mr. Strang, why don't you just start
`us off by giving us a summary of where we
`are and what your client's position is on
`the schedule going forward.
` MR. STRANG: Yes, Your Honor. This
`is John Strang from Petitioner Par. We are
`very close to an agreement. The parties
`have met and conferred on multiple
`occasions and our only hesitation has been
`to, rather than agree to a joint proposal
`for moving back a full six months, we have
`instead proposed a moving back of the 00084
`argument by two months, which we recognize
`that the parties cannot stipulate to. That
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`would require the board to agree to that or
`to order that.
` But we think that gives a reasonable
`amount of time after the delay that
`Novartis needs for their POR and then gives
`us a reasonable amount of time to prepare
`our reply for the bulk of the case, all but
`Claim 7. Then there will be a pause.
`During that pause, the Claim 7 portions of
`the proceedings would then be able to catch
`up.
` And to be clear, if we don't -- we
`did not mean to imply that there was wasn't
`going to be a POPR for any of the
`instituted proceedings. In our view, that
`the POPR and the institution time frame can
`be compressed enough to get us onto that
`two-month time schedule.
` JUDGE CRUMBLEY: Right. That was
`one thing I noticed in the chart is that
`you have a July 1, 2016 in your initial
`proposal, but that corresponding box is
`blank from the revised proposal. Were you
`meaning to carry your July 1 proposal over
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`or was there something -- are you going to
`July 29? What was intended for the claims
`that have already been instituted on?
` MR. STRANG: Well, for all of the
`POPRs, Your Honor, we don't have a problem
`with the July 29 date. We think the July
`21 will give the Board more time to move
`forward on Claims 1 through 3 and 8 through
`9 and allow the Board plenty of time for an
`institution decision. That will allow the
`joined parties to drop right into the
`instituted decision -- the instituted
`proceeding, pardon me, at an earlier date.
` But we are fine with the POPR at
`either one of those dates, July 1 or July
`29 for Claims 1 through 3 and 8 through 9.
` JUDGE CRUMBLEY: Okay. Just so I am
`clear, the date, due date one for the
`Patent Owner's response, the 84 case, the
`instituted case, the parties appear to be
`in agreement on September 16th for that
`date?
` MR. STRANG: We are fine with
`September 16, but we -- I don't want to
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`speak for Novartis, but I believe they have
`some contingency for that.
` JUDGE CRUMBLEY: And I noticed there
`are some contingencies on the -- if the
`other cases have been instituted before
`that, et cetera, et cetera, but at least if
`we are looking at it sort of in a vacuum,
`I've seen September 16th for the parties
`across the way.
` Let me ask you this: For the
`Petitioners, that's -- you can live with
`that date if we were to push the schedule
`back to that?
` MR. STRANG: Certainly, Your Honor,
`September 16th is great.
` JUDGE CRUMBLEY: All right.
`Anything else you want to say about your
`proposals? I think the panel sees it right
`now what the urgent things we need to
`decide are when the preliminary responses
`are due in the newer cases and what we are
`doing about the schedule in the instituted
`case, at least for due dates one and two of
`that. And maybe that's all we need to
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`decide right now, and then on the rest of
`this, I think it is a good framework for us
`when we're looking at whether joinder is a,
`you know, is a good idea, whether to
`exercise our discretion to permit joinder
`in these cases, but I'm not sure that we
`need to set these dates until we actually
`get the preliminary responses in and decide
`whether we are going to join these other
`cases.
` Am I understanding that correctly?
` MR. STRANG: Yes, Petitioner agrees
`exactly with that, Your Honor.
` JUDGE CRUMBLEY: Well, unless there
`is something else, I will turn it over to
`Mr. Kallas and he can give us his position
`and then I can ask him a few questions as
`well.
` MR. KALLAS: Thank you, Judge
`Crumbley. For the record, this is Nick
`Kallas for Patent Owner. The parties have
`met and conferred as the Board has
`required. And as you see, we have a chart
`here which we tried to set forth the
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`parties' positions. The first column is
`the current schedule. And just to note
`that under the current schedule, we have
`various due dates for Patent Owner's
`preliminary response that range from August
`15th all the way to September 6th.
` And then the only other key points I
`think Your Honor has raised is is Patent
`Owner is in agreement that if 84 was a
`standalone proceeding, that our due date
`one would be September 16th. We are, we
`believe we have agreement with Par on that
`and we were operating on that basis,
`although as I will mention in a moment, we
`have a slightly alternative proposal to
`that.
` But let me cover what I will call
`Plaintiff's or Petitioner's initial
`proposal, which is column two.
` Now, this was set by Petitioner
`initially trying to cram all of the other
`IP -- late filed IPRs into the schedule for
`the 84 case, keeping due date six and seven
`as currently scheduled for the 84 case.
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`I'm not certain whether Petitioner still is
`proposing this or not. They didn't take it
`off the table, but frankly, we think it is
`unworkable. I don't believe petitioner is,
`from what I've heard, is going forward with
`it or asking about it, so maybe I won't
`talk about it.
` We ourselves could not come up with
`a schedule that was fair and not
`prejudicial to Patent Owner to cram
`everything into the current schedule of 84.
`I don't think that's workable. And all of
`the other proposals made by both parties or
`all parties, Your Honor, require the Board
`to properly adjust due date six and seven.
` JUDGE CRUMBLEY: I understand that.
`So I mean, I think what I would like to
`hear from you is what your proposal is. I
`mean, those sort of center columns. And
`like I said, I'm not entirely sure that we
`need to talk much about the due dates past
`due date two at this point.
` There might be something you want to
`point out to us at this point, but I don't
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`think we need to get into setting those
`dates, especially since a lot of it seems
`to be contingent on when we institute and
`what we institute.
` MR. KALLAS: So let me give our
`proposal, it's labeled in columns 3 and 4
`called Novartis' Proposal for Joined
`Proceedings.
` And what we've looked at all the
`IPR, excuse me -- all of the due dates for
`the preliminary response. And based upon
`our current schedule and expectation, we
`can commit to providing our preliminary
`response on August 12th.
` Now, obviously if we have our papers
`done earlier, we will file them, but that's
`the best date we could give as of today.
` With that in mind, that would result
`in an institution or a joinder decision
`from the Board no later than November 14.
` Now, our proposal then is to set the
`schedule for the 84 case and for any IPRs
`that are instituted enjoined off of the
`November 14, 2016 date and what we're
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`saying is our response, the Patent Owner's
`response, would be due three months later.
` The reason we suggest that is very
`simple: This proceeding should be
`efficient for the Patent Owner and for the
`Board. And what we think is best is we
`have one response including all of the
`claims rather than having the Claim 7 go
`off on its own -- go off on its own
`proceeding or its own schedule as if it was
`a separate proceeding. And therefore our
`proceeding takes that into account.
` It would require, however, the Board
`to stay somewhat from September 16th to a
`few months later the 84 case to make all
`the cases consolidated if that's going to
`occur.
` Now, we understand that there's a
`lot of moving parts and a lot of
`uncertainty here. I mean, none of the four
`later-filed proceedings have been
`instituted or joined. It is possible that
`none of them are instituted and none of
`them are joined.
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` Also as Judge Crumbley, you
`mentioned, there is a motion for
`reconsideration.
` Now, with all of that uncertainty,
`obviously it isn't easy to come up with a
`schedule. However, what is most efficient
`and beneficial to Patent Owner is one set
`of papers, not multiple sets of papers, and
`certainly the Board would appreciate having
`one set of papers rather than multiple sets
`of papers on all of the issues that finally
`end up in this -- in this case.
` JUDGE CRUMBLEY: Okay. And I
`appreciate that. And you know, I think I,
`we understand the position that some of
`these dates may not be able to be set at
`this point. I think the goal of this
`discussion is to ensure that we know what
`the parties view the schedule after its
`institution if we do decide to institute.
` So that when we determine whether,
`whether joinder is a feasible thing to do
`we can have some proposed schedules in
`mind. So I do appreciate your position and
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`I understand that there is a lot of
`uncertainty here, but this has been helpful
`just to let us know what you envision if
`the cases were to all be instituted.
` MR. KALLAS: May I add one
`additional thing?
` JUDGE CRUMBLEY: Of course.
` MR. KALLAS: This is for the record
`for Patent Owner, Nick Kallas.
` Under our proposal where you have
`August 12th as our date for our preliminary
`response, and you wouldn't expect to get an
`institution decision until November 14th,
`even with the cases that have the claims
`for the 84 case, we would have to file our
`Patent Owner response on September 16th,
`which is even before the date we know
`whether the other cases are instituted,
`which is kind of a unique situation and we
`would like to avoid that if possible.
` JUDGE CRUMBLEY: Just give me a
`little bit more discussion on the
`preliminary response date. As I see it,
`right now your earliest preliminary
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`response is due on the 15th of August.
`That's on the same claims that have already
`been instituted on in the 84 case. And yet
`you're still taking almost the full three
`months for that for August 12th.
` Could we move that up maybe, you
`know, to the middle of July and get some
`sort of -- just so we can start thinking
`about getting these all shortened up a
`little bit.
` I think that -- as I see it, the
`Petitioners are giving you something in
`the -- in moving back the Patent Owner
`response date in the 84 case to accommodate
`your concerns about the trial schedule in
`the district court. So I'm trying, I would
`like to see if we could move the
`preliminary response dates a little
`earlier, especially since I think this is a
`lot of ground that we've already plowed in
`the 84 case.
` So I don't know that we need to
`reinvent the wheel and take a full three
`months for the preliminary response in
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`those cases.
` MR. KALLAS: I hear you, Judge
`Crumbley, but unfortunately, based upon our
`current situation and our current workload
`and the fact that the rules have changed
`between the initial case and this case in
`that we are allowed an extra report, we're
`not in a position to say we can do it
`earlier today.
` Obviously, we're going to try to, if
`we get it done earlier we will file it
`earlier, but we cannot commit to something
`earlier today. I wish we could. But
`because of, you know, and this is not a
`situation -- I just want to remind
`everybody, this is not a situation that the
`Patent Owner brought about. It is
`Petitioner's late filing that brought this
`about and our schedule and our schedule of
`the expert or experts we intend to use in
`our preliminary response does not work for
`something in mid July. Just unfortunately
`will not give us enough time.
` And I know you made the statement
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`that it was ground you plowed before, but I
`think the rule has changed now very
`differently because we get an expert to
`explain to you maybe better than we could
`why the petition should not be instituted.
` JUDGE CRUMBLEY: All right. And I
`take your point on that. I do want to get
`a response from Mr. Strang on that. I'm
`concerned about a move to July 1st. I
`think that does seem short.
` And do you have any other sort of
`response on Mr. Kallas's point on the
`preliminary responses?
` MR. STRANG: Yes, Your Honor. This
`is John Strang for Petitioner Par. Our
`latest proposal was July 29th, we are fine
`with that. If all of the parties, the
`extent of the disagreement between the
`parties was July 29 versus August 12.
` We would just agree to August 12
`because we think that we could make it work
`even from an August 12 POPR date to smooth
`in all of the proceedings and sync them up
`with an additional two months with the oral
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`argument date.
` That said, we are not in a big
`hurry. We are not trying to speed things
`up inordinately. We just did not feel
`comfortable asking the Board for a six-
`month extension of the 0084 proceedings or
`argument date.
` JUDGE CRUMBLEY: Right, I understand
`that and I think we -- that's something we
`want to avoid as well. And I think that
`there is room here for some flexibility. I
`just want to make sure that, you know, we
`get the parties the time they need, but
`also, you know, make sure that it's fair
`that if, you know, we are moving certain
`dates around at the request of one party
`that the other party may concede something
`as well. That seems like the fair and
`equitable outcome here. So, all right.
` Is there anything else we need to
`discuss? I mean, I don't know that, I
`guess, I don't think there's -- I'm not
`going to give us new dates on the phone
`today just because this is something that I
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`need to sit down and the panel needs to sit
`down with a calendar and try to make sure
`where we are. What we will do is issue an
`order shortly with a schedule in it.
` But before we conclude the call, I
`want to give the parties one last chance to
`say anything. I will start with Mr. Kallas
`since it is your turn.
` MR. KALLAS: Thank you, Judge
`Crumbley. I just want to make certain it
`is clear because I think it's clear to us
`here from Patent Owner, but can we go on
`the basis that the July 29 date for the 84
`case has been temporarily stayed and
`whatever decision the Board makes that
`proceeding will or that due date one will
`not be earlier than September 16th?
` That's what I heard from the
`conversation today, but I want to make that
`crystal clear.
` JUDGE CRUMBLEY: Well, in all
`honesty, I don't need to be involved in
`that. If the parties are in agreement that
`September 16th is a workable date for due
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`date one of the 84 case, you are free to
`stipulate to that between yourselves. I
`was -- what I'm trying to do now is if we
`are coming to some sort of global agreement
`on all of these cases, that's where I am
`trying to get.
` So if maybe September 16 doesn't
`quite work when I sit down with the
`calendar and we maybe slide the date a
`little bit, but if the parties are all in
`agreement that July 29th is not the
`operative date anymore and you are just
`waiting on us for what the exact new date
`is going to be, that is within your power
`to do by stipulation.
` MR. KALLAS: Judge Crumbley, may I
`ask Par's counsel, do they agree that the
`July 29th date is off the table?
` JUDGE CRUMBLEY: I was just about to
`do that. Mr. Strang, does that sound
`reasonable to you? It sounds like this is
`something we can all agree on is that --
`maybe September 16 isn't the exact date we
`want, but the parties are in agreement that
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`the July 29th date is going to get pushed?
` MR. STRANG: Yes, the parties are
`definitely in agreement that the July 29th
`date needs to get pushed, Your Honor. We
`were hoping to get a little quid pro quo
`and not just provide quid in this agreement
`and arrive at a global agreement as Your
`Honor suggested.
` JUDGE CRUMBLEY: That is why I am a
`little hesitant to just say let's set that
`date because I do want to do this sort of
`as a holistic resolution. So why don't we
`do that: I hear that the parties are in
`agreement that the July 29th date, nothing
`needs to be filed in the 84 case on the
`July 29th date. So that's fine with the
`Board if the parties are in agreement on
`that.
` And then in the next, I'm going to
`say week or so, we will be able to get an
`order out on the sort of more global issue
`of the schedule in all of the five cases.
` Is there anything else, Mr. Strang,
`that you think we need to talk about today?
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` MR. STRANG: Nothing from
`Petitioners, Your Honor.
` JUDGE CRUMBLEY: Okay, I know I left
`Mr. Zullow and Mr. Fedowitz out of the
`conversation. Is there anything else that
`the other Petitioners want to discuss?
` MR. FEDOWITZ: Nothing on behalf of
`Breckenridge. We completely agree.
` MR. ZULLOW: Same here, Your Honor,
`on behalf of Roxane. We have nothing to
`add right now.
` JUDGE CRUMBLEY: Mr. Kallas, any
`last issues or are we -- can we call it a
`week?
` MR. KALLAS: We can call it a week.
`Thank you, Judge Crumbley.
` JUDGE CRUMBLEY: Very good.
`Everyone have a good weekend. Watch next
`week for the revised schedule or some sort
`of order on the schedule and we will also
`be issuing the decisions on the pro hac
`motion and the request for a hearing
`shortly as well.
` So if there is nothing else, we will
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`stand adjourned. Thank you very much.
` (Time Noted: 11:29 p.m.)
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` C E R T I F I C A T E
`
`COMMONWEALTH OF VIRGINIA)
` ) ss.:
`COUNTY OF ROANOKE )
`
` I, KATHERINE P. FORD, RPR, a Notary
` Public within and for the Commonwealth of
` Virginia, do hereby certify:
` That the Telephonic Proceedings as
` hereinbefore set forth, were duly reported
` by me and that such Transcript is a true
` record of the Proceedings.
` I further certify that I am not
` related to any of the parties to this
` action by blood or marriage; and that I am
` in no way interested in the outcome of this
` matter.
` IN WITNESS WHEREOF, I have hereunto
` set my hand this 22nd day of June, 2016.
` -------------------------
` KATHERINE P. FORD, RPR
`
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