1
`
` RECORD OF ORAL HEARING
` UNITED STATES PATENT AND TRADEMARK OFFICE
` - - - - - -
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` - - - - - -
` NEPTUNE GENERICS, LLC
` Petitioner
` vs.
` ELI LILLY & COMPANY
` Patent Owner
` Case Nos. IPR2016-00237 and 00240
` ---------
` SANDOZ, INC.
` Petitioner
` vs.
` ELI LILLY & COMPANY
` Patent Owner
` Case No. IPR2016-00318
` - - - - - -
` Conference Call Held: July 22, 2016
` Before: MICHAEL P. TIERNEY and TINA
` E. HULSE, Administrative Patent Judges
`
` The above-entitled matter came
` on for conference call hearing on Friday,
` July 22, 2016 before the U.S. Patent and
` Trademark Office, 600 Dulany Street,
` Alexandria, Virginia
`REPORTED BY:
`KAREN BRYNTESON, RMR, CRR, FAPR
`JOB NO: 45556
`
`
`
`
`
`
`
`Lilly Ex. 2001
`Apotex et al. v. Lilly IPR2016-01429
`
`

`
` APPEARANCES:
` (ALL PARTIES PRESENT TELEPHONICALLY)
` For Patent Owner Eli Lilly:
` WILLIAMS & CONNOLLY, LLP
` 725 12th Street, N.W.
` Washington, D.C. 20005
` BY: DOV GROSSMAN, ESQ.
` dgrossman@wc.com
` DAVID KRINSKY, ESQ.
` dkrinsky@wc.com
`
` For Petitioner Neptune:
` Skiermont Derby, LLP
` 2200 Ross Avenue, Suite 4800W
` Dallas, Texas 75201
` BY: SARAH SPIRES, ESQ.
` sspires@skiermontderby.com
`
`
` For Petitioner Sandoz:
` Brinks Gilson & Lione
` 455 N. Cityfront Plaza Drive
` Suite 3600
` Chicago, IL 60611
` BY: RALPH J. GABRIC, ESQ.
` rgabric@brinksgilson.com
` LAURA LYDIGSEN, ESQ.
` llydigsen@brinksgilson.com
` JOSHUA JAMES, ESQ.
`
`
`2
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`3
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` APPEARANCES (Continued):
` For Party Apotex:
` RAKOCZY MOLINO MAZZOCHI SIWIK, LLP
` 6 West Hubbard Street
` Suite 500
` Chicago, IL 60654
` BY: DEANNE M. MAZZOCHI, ESQ.
` dmazzochi@rmmslegal.com
` JOHN D. POLIVICK, ESQ.
` jpolivick@rmmslegal.com
`
`
` For Party Mylan:
` ALSTON & BIRD, LLP
` 90 Park Avenue, 15th Floor
` New York, New York 10016-1387
` BY: THOMAS J. PARKER, ESQ.
` thomas.parker@alston.com
`
`
` For Party Teva/Fresenius:
` GOODWIN PROCTER, LLP
` The New York Times Building
` 620 Eighth Avenue, 8th Avenue
` New York, New York 10018
` BY: CYNTHIA LAMBERT HARDMAN, ESQ.
` chardman@goodwinlaw.com
`
`
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` APPEARANCES (Continued):
` For Party Teva:
` CARLSON, CASPERS, VANDENBURGH,
` LINDQUIST & SCHULMAN, P.A.
` Capella Tower, Suite 4200
` 225 South Sixth Street
` Minneapolis, MN 55402
` BY: SAMUEL T. LOCKNER, ESQ.
` slockner@carlsoncaspers.com
`
`
`
`5
`
` P R O C E E D I N G S
` VIA CONFERENCE CALL
` (4:01 p.m.)
` JUDGE TIERNEY: This is Judge
` Tierney joining the call. And I also
` have Judge Tina Hulse with me.
` I have noticed there is a court
` reporter on the line. Is that
` correct?
` THE REPORTER: That's correct,
` Your Honor. It's Karen Brynteson.
` JUDGE TIERNEY: And you are here
` on behalf of which party?
` THE REPORTER: I am here on
` behalf of Eli Lilly.
` JUDGE TIERNEY: Okay. Is there
` a representative from Eli Lilly on the
` phone?
` MR. GROSSMAN: Yes, Your Honor.
` This is Dov Grossman from Williams &
` Connolly. And also with me is David
` Krinsky.
` JUDGE TIERNEY: Okay. Welcome
` to the call.
` MR. GROSSMAN: Thank you.
`2 (Pages 2 to 5)
`
`DAVID FELDMAN WORLDWIDE, INC.
`450 Seventh Avenue - Ste 500, New York, NY 10123 1.800.642.1099
`
`Lilly Ex. 2001
`Apotex et al. v. Lilly IPR2016-01429
`
`

`
` JUDGE TIERNEY: We have a number
` of inter partes reviews. Let me see
` if I have got all the different
` numbers.
` If I have missed one, please
` help me out there. They haven't
` updated our internal dashboard yet to
` assign certain cases.
` But the numbers I have under all
` IPRs 2016-00237, 00240, 00318, also
` 01340 and 01429. Those are the
` numbers I have been given. And is
` there any others?
` MS. SPIRES: Yes. For the
` Petitioner, Neptune, there is also
` 2016 for both of these, 01190 and
` 01341.
` JUDGE TIERNEY: Could you repeat
` the last one, please?
` MS. SPIRES: 0134 -- I'm sorry,
` I gave you the wrong one. Those are
` two others. I think you have already
` got them. Apologies.
` JUDGE TIERNEY: Again, could you
` repeat those two numbers?
`
` 2016-01190?
` MS. SPIRES: Yes. Those are the
` two joinder motions.
` JUDGE TIERNEY: Okay. I have
` not been given on my docket these
` numbers yet. That's why I am asking
` it.
` MS. SPIRES: Okay.
` JUDGE TIERNEY: So that's the
` first one. The second one is?
` MS. SPIRES: 01341.
` JUDGE TIERNEY: 01341. Okay.
` And apologies, but we -- our --
` we have changed electronic docketing
` systems, and our electronic docketing
` system internally is still being
` updated, as we speak. So not
` everything is available to me at this
` moment.
` MR. GROSSMAN: And, Your Honor,
` Dov Grossman here. And just, I think,
` to completely update this, the numbers
` you were just given, 1190 and 1341, I
` think go with the 237 IPR.
` There is also for the 240 IPR
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` that you mentioned in the beginning --
` JUDGE TIERNEY: Yes.
` MR. GROSSMAN: -- there is also
` 1191 and 1343. And there are
` actually, Your Honor, for each of the
` three main proceedings, there is one
` additional petition and motion for
` joinder in each of the proceedings
` from another party of Wockhardt, but
` they are not participating in today's
` call.
` JUDGE TIERNEY: Could you spell
` that party's name, just so I have it?
` MR. GROSSMAN: Sure. It is
` W-o-c-k-h-a-r-d-t.
` JUDGE TIERNEY: Thank you.
` MR. GROSSMAN: Would it be
` useful to give you the IPR numbers for
` those as well or is that --
` JUDGE TIERNEY: If you have
` them, I would like it to all be in the
` transcript so we have an idea of all
` the different parties. And I will see
` if they are going to be assigned to
` the same panel or how they are going
`
`8
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`9
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` to assign the cases.
` MR. GROSSMAN: Sure. So those
` are, again, all IPR-2016. It is 1335,
` 1337, and 1393.
` JUDGE TIERNEY: Thank you. Are
` there any additional cases we need to
` be aware of?
` Okay. Hearing nothing, we will
` now move on.
` All right. Thank you for
` everyone joining the conference call
` today. Obviously we have quite a few
` parties today. I would like to start
` off with the Patent Owner.
` And we will start on the cases
` 237 and 240, which involve Neptune.
` And apologies in advance if I
` misstate something, please just
` correct me. We have quite a few cases
` and quite a few numbers and quite a
` few parties here. But I would like to
` start with the 237 and 240 and have
` the Patent Owner, Eli Lilly, give us a
` brief background of what needs to be
` taken care of in those particular
`3 (Pages 6 to 9)
`
`DAVID FELDMAN WORLDWIDE, INC.
`450 Seventh Avenue - Ste 500, New York, NY 10123 1.800.642.1099
`
`Lilly Ex. 2001
`Apotex et al. v. Lilly IPR2016-01429
`
`

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` cases. And if there is any motions we
` should be expecting that they would
` like to file.
` So, Eli Lilly, you are up.
` MR. GROSSMAN: Sure. Thank you,
` Your Honor. This is Dov Grossman.
` I think at this point the only
` thing that I would point out is that
` the parties, the Patent Owner and
` Petitioner, Neptune, have filed
` stipulations regarding some of the due
` dates. There was an original one and
` then an updated one that I believe was
` filed yesterday.
` I don't believe at this point as
` between us and Neptune there are any
` issues for the Board. There are, of
` course, the pending motions for
` joinder in those proceedings, which
` our time has not yet run on to respond
` to.
` I don't know whether the Board
` wanted to address any of those today
` or whether that would come later in
` the proceeding, but I think that's --
`
`11
`
` that's the only open issue with
` respect to those two IPRs from our
` perspective.
` JUDGE TIERNEY: Okay. Before --
` before we move on to Neptune, I would
` like to understand the brief I saw
` or -- sorry -- I should say the
` petitions that I have been able to
` identify that have been filed and
` requests for joinder, they appear to
` have the same issues and the same
` exhibits.
` Are there any cases that you can
` identify that have a different set of
` exhibits, different set of challenges
` to your clients before the 237 cases?
` MR. GROSSMAN: Sure. And, Your
` Honor, if I may just, just so it is
` clear, because I don't want to step
` over any bounds here, those motions
` for joinder are from the Wockhardt
` IPRs. And their counsel, of course,
` is not on the line, so I want to flag
` that to the Board to be clear about
` that in terms of the scope of our
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` discussion.
` JUDGE TIERNEY: For purposes of
` today, you can leave those petitions
` and motions for joinder out of the
` discussion. Just thank you for
` identifying that there is an
` additional set that we need to be
` aware of.
` MR. GROSSMAN: Sure. Not a
` problem.
` It is -- you are correct, Your
` Honor, that they have raised the same
` grounds of patentability. They have
` submitted additional expert
` declarations, in, I believe, perhaps
` not all of them, but in the majority
` of them or I think -- I'm sorry, I
` should say for the Neptune IPRs, I
` believe they have submitted separate
` expert declarations.
` So -- and I am happy to kind of
` address the substantive issue as sort
` of a preview of what our motions would
` be if -- our oppositions would be if
` now is the appropriate time, or if you
`
`13
`
` prefer to do that later.
` JUDGE TIERNEY: What I would
` like to at least get a sense of is do
` you need a full three months to go
` ahead and have a Patent Owner
` preliminary response or is there a
` chance we can expedite this and see if
` issues are overlapping with the
` underlying 237 and 240?
` MR. GROSSMAN: Sure. I
` understand, Your Honor.
` I think our view is that to the
` extent that, for these additional
` parties who are on the call and who
` are proposing to join the Neptune
` proceeding, you know, to the extent
` that their joinder would effectively
` be as a silent understudy, meaning
` that there wouldn't be any new issues
` or new evidence that the attorneys for
` Neptune would be handling all the
` examination and deposition defense,
` such that, you know, the parties would
` be joined as a formal matter, but it
` effectively would not change any of
`4 (Pages 10 to 13)
`
`DAVID FELDMAN WORLDWIDE, INC.
`450 Seventh Avenue - Ste 500, New York, NY 10123 1.800.642.1099
`
`Lilly Ex. 2001
`Apotex et al. v. Lilly IPR2016-01429
`
`

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` our burden in addressing the main
` Neptune petition, that under those
` circumstances we would be willing to
` waive our POPR for those proceedings
` and proceed with those parties, again,
` joined as a formal matter but sort of
` effectively as if they weren't there
` from a substantive perspective.
` I don't know that the parties
` proposing to join the Apotex petitions
` and the Teva/Fresenius petitions are
` really that -- really in disagreement
` with that position.
` They have tried to sort of
` reserve some potential, if there is a
` unique issue that comes up or reserve
` their own expert, if they sort of need
` it, but I would submit, Your Honor,
` that to the extent that it is the same
` issue, then it is the same grounds of
` patentability, that there wouldn't be
` any need for their expert or any need
` for separate ability on their part to
` address any issues, the fact that they
` are well represented by Neptune in the
`
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` case.
` JUDGE TIERNEY: Have you been
` able to reach out and have a
` discussion with the parties seeking
` joinder that you mentioned in
` particular, Apotex and Teva, to see if
` they would be willing to enter into a
` joint stipulation?
` MR. GROSSMAN: We have not had
` that opportunity yet, Your Honor, in
` part because the timing for motions to
` join just ran last week. And so we
` were sort of waiting for everything
` before we could sort of try to address
` any parties' stipulations on this
` issue.
` JUDGE TIERNEY: But I take it
` you are willing to reach out and have
` such a discussion?
` MR. GROSSMAN: We would be happy
` to do so, Your Honor.
` JUDGE TIERNEY: I would
` appreciate it.
` Is there anything else we need
` to discuss from the Patent Owner on
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` 237 and 240?
` MR. GROSSMAN: I don't think so,
` Your Honor.
` JUDGE TIERNEY: Okay. Now I am
` going to turn to Neptune on the 237
` and 240. Counsel for Neptune, are
` there any motions that you contemplate
` filing or anything that you need to
` address?
` And we understand there is a
` joinder issue, but let's start with
` particularly your filing, your case
` right now, absent joinder, are there
` any issues we need to discuss?
` MS. SPIRES: This is Sarah
` Spires from Skiermont Derby on behalf
` of Neptune.
` No, I think counsel for Eli
` Lilly, we agree with ^ them there
` that there are no real issues between
` the parties. The stipulations have
` been filed. And we will have a pro
` hac motion or two that we will file
` coming up here in a little bit. We
` don't expect that to be any major
`
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` issue.
` I will note quickly that the
` Wockhardt, I believe, IPR joinder
` motions, we have not been served with
` those. This is the first I have
` actually heard of them.
` So if they are attempting to
` join the Neptune IPRs, if anyone has
` information about that, that would be
` great. I am not able -- I have tried
` to pull up those three numbers on the
` portal system, and it is not showing
` anything. So this one is new to us.
` JUDGE TIERNEY: Okay. Well, if
` you can have that conversation
` off-line because Wockhardt is not
` actually present and, yeah, I am not
` even sure I will be assigned those
` cases at this point in time.
` MS. SPIRES: Okay.
` JUDGE TIERNEY: So I would
` rather not get too far into the
` substance or any details on those
` cases.
` MS. SPIRES: Sure.
`5 (Pages 14 to 17)
`
`DAVID FELDMAN WORLDWIDE, INC.
`450 Seventh Avenue - Ste 500, New York, NY 10123 1.800.642.1099
`
`Lilly Ex. 2001
`Apotex et al. v. Lilly IPR2016-01429
`
`

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` JUDGE TIERNEY: All right. So
` anything you wish to discuss in
` particular with 237 and 240 besides a
` pro hac potential motion?
` MS. SPIRES: No, Your Honor.
` JUDGE TIERNEY: And just for all
` parties involved, it would be
` beneficial for the pro hac motion, if
` you can work out in advance if there
` is going to be no opposition to a pro
` hac, and I rarely see oppositions to a
` pro hac. When it is filed, allow the
` party to say that there is no
` opposition to the pro hac, it makes it
` easier when we go ahead and grant it.
` Otherwise we have to wait five
` days. And depending upon the
` schedule, sometimes we may have time
` when the motion comes in, it is very
` quick and easy to pick up and get it
` taken care of. Alternatively, it may
` be that we're too busy to take care of
` it, and we need to get -- you all ping
` us with e-mails a month later, but if
` it is unopposed and it is filed at the
`
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` time we have time, it is much easier
` to take care of at that point in time.
` With that understanding,
` Neptune, if I could now have you turn
` over to the motions for joinder that
` were filed.
` And if you have any comments or
` points you would like to discuss
` regarding the motions for joinder?
` MS. SPIRES: The Neptune has --
` is opposing the motions, same as Eli
` Lilly, I believe, who says they were,
` largely for issues of scheduling.
` Those -- Neptune's concern is
` the schedule getting pushed out based
` on the joinder motions.
` If the POPR waiver ends up
` happening, that could change Neptune's
` position. And that would -- might
` allow the schedule to continue without
` having to be changed or pushed out.
` And so we can confer with the
` counsel in the joinder and the joinder
` parties and the Eli Lilly to find out
` what happened to that.
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` JUDGE TIERNEY: Okay. So I take
` it it is fair to say that you are
` willing to discuss the issue with the
` parties seeking joinder, as well as
` discussing the issue with Eli Lilly?
` MS. SPIRES: Yes, we are.
` JUDGE TIERNEY: All right.
` Thank you.
` Is there anything else we need
` to discuss regarding the 237 and 240?
` Neptune? Lilly? Now is your chance
` before I move on.
` MR. GROSSMAN: I don't believe
` so, Your Honor. Thank you.
` MS. SPIRES: Not for Neptune.
` JUDGE TIERNEY: All right.
` We're going to now turn to the IPR
` 2016-00318.
` Sandoz, I will start again with
` Patent Owner, to see if there is
` anything in particular Patent Owner
` wishes to discuss regarding this
` particular Decision to Institute.
` MR. GROSSMAN: Sure, Your Honor.
` And with respect to the Sandoz IPR,
`
`21
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` the parties have also filed similar
` stipulations adjusting the dates, so
` those should be on the record already.
` There are, of course, the
` joinder issues there, both with
` respect to Apotex and Teva. And I
` think our position there on those is
` the same as for the Neptune IPRs.
` And if it makes sense, we can,
` you know, as the Board suggested have
` a meet-and-confer conversation with
` them off-line to see if we can reach
` some sort of stipulation related to
` the joinder.
` Patent Owner doesn't have any
` issues. I know there are a couple of
` issues that the Sandoz Petitioner
` wanted to raise, but I will leave that
` to counsel for Sandoz.
` JUDGE TIERNEY: All right. I am
` going to turn over to Sandoz now. And
` I do understand earlier in the week we
` had several e-mails, if Sandoz would
` please discuss the issues they wish to
` discuss today and explain why they
`6 (Pages 18 to 21)
`
`DAVID FELDMAN WORLDWIDE, INC.
`450 Seventh Avenue - Ste 500, New York, NY 10123 1.800.642.1099
`
`Lilly Ex. 2001
`Apotex et al. v. Lilly IPR2016-01429
`
`

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` should be granted the relief that they
` requested.
` MS. LYDIGSEN: Yes, Your Honor,
` this is Laura Lydigsen for Sandoz.
` The first of those issues is
` that Sandoz would like to seek leave
` to file a motion for additional
` discovery.
` The discovery we have requested
` from Eli Lilly consists of nine
` documents that are related to Lilly's
` new drug application for pemetrexed.
` Some of them are internal Eli Lilly
` documents; some are correspondence
` with the FDA related to the drug. And
` that is the drug product that is
` covered by the patent here, the '209
` patent.
` These documents, we believe, are
` appropriate for additional discovery
` under the Court's Garmin factors. I
` am happy to go through those factors.
` JUDGE TIERNEY: Well, before we
` go through it, have you actually
` contacted Lilly and had discussions as
`
`23
`
` to trying to obtain the document?
` MS. LYDIGSEN: Yes, we reached
` out to Lilly earlier this work. And
` Lilly responded that they wished us to
` justify the needs for the documents
` under Garmin. And we provided that
` response.
` Unfortunately, we didn't have
` time to discuss further before we had
` to get the e-mail to the Board, but we
` let Lilly know that if they wished to
` consent to discovery, we would
` withdraw the request to file the
` motion. And they have not consented
` to discovery, but I assume that means
` they oppose.
` JUDGE TIERNEY: Well, before we
` jump to conclusions here, so let's
` hear from Lilly.
` Does Lilly need more time to
` consider the request or are they going
` to oppose?
` MR. GROSSMAN: No, Your Honor,
` we are opposed to the request.
` Sort of cutting to the chase
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` here, without getting through all the
` various Garmin factors in any detail,
` the correspondence we received from
` Sandoz was essentially provide us with
` these documents or represent that you
` are not going to assert secondary
` considerations of non-obviousness or
` we're going to go to the Board.
` And it would seem to me at this
` point, Your Honor, given that we're
` two months away from our Patent Owner
` response being due, that this is
` entirely, you know, premature and not
` necessary at this stage.
` To the extent that any of these
` documents, the issues to which these
` documents related come up in our
` Patent Owner response, the parties
` could address this at some future
` point in time, but I would say at this
` point it should be -- the request
` should be denied.
` JUDGE TIERNEY: Okay. Let's cut
` to the chase then. And I understand
` Garmin factors. We can have a lengthy
`
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` discussion about whether we authorize
` the motion under Garmin, but cutting
` to the chase, can you explain -- I
` understand you say it is premature,
` but not understanding what the
` documents are, what they encompass,
` just tell me briefly why giving these
` documents over would be prejudicial to
` Lilly?
` MR. GROSSMAN: Because at this
` point, Your Honor, the -- I will point
` out two things. Number 1, I don't
` know to what extent these documents
` would actually be relevant to the
` issues in the case, and so given the
` limited scope of discovery in these
` actions, it is not clear to me why we
` should be providing these documents.
` JUDGE TIERNEY: All right.
` Let's -- let's stop there. So you
` actually have copies of the documents?
` It is not going to be hard to obtain
` the documents?
` MR. GROSSMAN: We do have copies
` of the documents. I would also
`7 (Pages 22 to 25)
`
`DAVID FELDMAN WORLDWIDE, INC.
`450 Seventh Avenue - Ste 500, New York, NY 10123 1.800.642.1099
`
`Lilly Ex. 2001
`Apotex et al. v. Lilly IPR2016-01429
`
`

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` actually suggest that Sandoz could
` itself potentially get copies of these
` documents. At least portions of the
` documents, I believe, are in the joint
` appendix that was filed on appeal in
` the Federal Circuit, which is where
` they got the information in the first
` place.
` Also, to my understanding, to
` the extent they wanted to obtain them,
` to the extent they were used as
` exhibits at trial, which was, I think,
` how any of them may have ended up in
` the joint appendix in the first place,
` they could try getting them from the
` District Court.
` JUDGE TIERNEY: Okay. But going
` back to -- so the prejudice, though,
` the first issue was you just don't
` think they are necessarily relevant.
` But if they are not actually --
` I mean, I am not seeing how that is
` really a prejudice to Lilly at this
` point, just to hand them over on that
` basis, but please continue. Is there
`
`27
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` another basis for prejudice?
` MR. GROSSMAN: Sure. And the
` basis, I think, at this point, Your
` Honor, would be just to be clear, I
` will readily concede that there are
` nine documents here, that they are
` identified trial exhibits.
` But it seems to me that given
` that we haven't submitted our Patent
` Owner response and that I don't know
` at this point exactly which of these
` documents or which portions of these
` documents we may be relying on, it
` would seem to me that for us to have
` to provide the entirety of the
` documents that may or may not be used
` in our Patent Owner response wouldn't
` be appropriate at this point.
` And I don't -- it would be, to
` the extent we're having to turn over
` materials where there is no otherwise
` sort of discovery as a matter of
` course on this issue, would seem to be
` prejudicial here.
` JUDGE TIERNEY: Okay. I just
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` want to point out, at least at this
` point I am not hearing a lot of
` prejudice, but then again I also don't
` know why the documents would need to
` be handed over.
` And, hence, I would like the
` parties to go back and try to work
` this out.
` First of all, I want to have
` Sandoz try to obtain the documents,
` due to the record that was identified
` by Eli Lilly, that is the Court
` transcript, I guess it was an appeal,
` an appendix to an appeal brief.
` MS. LYDIGSEN: Your Honor, this
` is Laura Lydigsen. We have tried to
` obtain the documents. We contacted
` the District Court before we filed our
` petition to obtain some of these
` documents and were told that we would
` need to file a motion in the District
` Court.
` We also submitted a Freedom of
` Information Act request to obtain some
` of the documents and were told it
`
`29
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` would take several years.
` JUDGE TIERNEY: Okay. That
` would be a little bit of a delay
` there.
` But coming back, the key issue
` is I want the parties to try and work
` this out. And if it is unable to work
` it out, we're going to have a call on
` this particular issue.
` And I am going to be going
` through Garmin factors. And I do want
` to know what the particular prejudice
` is.
` If it is just we don't want to
` hand them over, period, but the only
` prejudice to the party is, well, we
` just don't have to, so we don't think
` we have -- we should, you know, that's
` going to be a factor I'm going to take
` into account, if the Garmin factors
` are met and shown that there is some
` need for these documents to be given
` over.
` Again, with that background, I
` want the parties to try and discuss
`8 (Pages 26 to 29)
`
`DAVID FELDMAN WORLDWIDE, INC.
`450 Seventh Avenue - Ste 500, New York, NY 10123 1.800.642.1099
`
`Lilly Ex. 2001
`Apotex et al. v. Lilly IPR2016-01429
`
`

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` this and see if they are not able to
` work out a resolution on this and any
` other issues that come up.
` Going to the next issue, Sandoz?
` MS. LYDIGSEN: Yes, Your Honor.
` This relates to some documents that we
` sought leave to submit as supplemental
` information.
` The request was denied without
` prejudice to raise again during this
` call, and we wanted to direct it with
` Your Honor to just ensure we're
` submitting the documents in the way
` that would be best for the Court and
` for the record.
` JUDGE TIERNEY: Let's clarify.
` So the request we had in was that
` there was some objection to evidence
` and you wanted to provide the
` documents to the Board in response to
` the objection?
` MS. LYDIGSEN: Right. We have
` provided, I think, six documents to
` Lilly, ones we filed -- thought would
` be filed as supplemental information.
`
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` JUDGE TIERNEY: Why wouldn't
` this be supplemental evidence, not
` supplemental information?
` MS. LYDIGSEN: Yes, Your Honor.
` Three of the documents that we served,
` we served an responsive objection from
` Eli Lilly that the documents did not
` show the publication date, so we went
` and obtained new copies with the
` publication date clearly shown.
` That would go to the prior art
` status of the document, which at least
` in one of the Board's decisions, the
` case of Creston v. Intuitive Building
` Control, IPR2015-1379, paper 27.
` The Board held that dates of
` publications would be categorized as
` supplemental information because it
` goes to whether or not the document is
` prior art, which is sort of a
` substantive issue.
` And so we thought it was
` appropriate to seek leave to file
` those particular documents as
` information, as opposed to just
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` serving them as evidence. They could
` be submitted as replacement exhibits,
` because the initial petition only
` cites to the original publication page
` number, as opposed to the Bates
` number, so it would not affect the
` pagination in this decision.
` JUDGE TIERNEY: All right. Let
` me see if I can pull up the actual
` supplemental information, to make sure
` I have got this correct.
` But I am still not understanding
` why you couldn't just submit this
` evidence in your reply?
` MS. LYDIGSEN: Yes, we could,
` Your Honor, if th