`
`IPR2016-01370
`U.S. Patent No. 8,664,231
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`KOIOS PHARMACEUTICALS LLC,
`Petitioner
`
`v.
`
`MEDAC GESELLSCHAFT FUER KLINISCHE
`SPEZIALPRÄPARATE MBH,
`Patent Owner
`____________
`
`Case No. IPR2016-01370
`Patent Number 8,664,231
`____________
`
`Before JACQUELINE WRIGHT BONILLA, TONI R. SCHEINER,
`and ERICA A. FRANKLIN, Administrative Patent Judges
`
`PATENT OWNER’S SUBMISSION OF TRANSCRIPT OF TELEPHONE
`CONFERENCE ON SEPTEMBER 29, 2017
`
`Pursuant to the Board’s October 4, 2017 Order (Paper 42), Patent Owner
`
`files the attached transcript of the September 29, 2017 telephone conference in the
`
`above-captioned matter.
`
`
`
`
`
`1
`
`
`
`
`Dated: October 5, 2017
`
`IPR2016-01370
`U.S. Patent No. 8,664,231
`
`
`
`Respectfully submitted,
`
`HALEY GUILIANO LLP
`
`/James F. Haley, Jr./
`
`James F. Haley, Jr. (Lead Counsel)
`75 Broad Street, Suite 1000
`New York, NY 10004
`T: 212-973-2502 / F: 646-219-6229
`james.haley@hglaw.com
`
`Attorneys/Agents For Patent Owner
`
`
`
`
`2
`
`
`
`
`
`IPR2016-01370
`U.S. Patent No. 8,664,231
`
`CERTIFICATE OF SERVICE
`The undersigned hereby certifies that the foregoing PATENT OWNER’S
`
`SUBMISSION OF TRANSCRIPT OF TELEPHONE CONFERENCE ON
`
`SEPTEMBER 29, 2017 have been served in their entirety by filing this document
`
`through the Patent Trial and Appeal Board End to End (PTAB E2E), as well as
`
`providing courtesy copies via e-mail to the following attorneys of record for the
`
`Petitioners listed below:
`
`Lead Counsel:
`
`DeAnn F. Smith, Reg. No. 36,683
`Foley Hoag LLP
`155 Seaport Blvd.
`Boston MA 02210-2600
`T: 617-832-1230
`F: 617-832-7000
`dsmith@foleyhoag.com
`
`ipr2016-01370@foleyhoag.com
`Back-up Counsel: William Rothwell, Reg. No. 72,522
`Noroozi PC
`2245 Texas Dr. Suite 300
`Sugar Land, TX 77479
`T: 281-566-2685
`F: 844-975-7074
`william@noroozipc.com
`
`Kayvan B. Noroozi
`Noroozi PC
`1299 Ocean Ave., Suite 450
`Santa Monica, CA 90401
`kayvan@noroozipc.com
`T.: 1 (310) 975-7074
`
`
`
`
`
`
`3
`
`
`
`
`
`Dated: October 5, 2017
`
`
`
`
`
`
`IPR2016-01370
`U.S. Patent No. 8,664,231
`
`
`
`By:/Crena Pacheco/
`Name: Crena Pacheco
`
`ROPES & GRAY LLP
`
`
`
`
`
`4
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`Page 1
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` KOIOS v. MEDAC
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`KOIOS PHARMACEUTICALS LLC, )
` ) Case IPR2016-01370
` Petitioner, )
` ) Patent 8,664,231
` vs. )
` )
`MEDAC GESELLSCHAFT FUER )
`KLINISCHE SPEZIALPRAPARATE )
`MBH, )
` )
` Patent Owner. )
`_____________________________)
`
` TRANSCRIPT OF PROCEEDINGS
` HELD VIA CONFERENCE CALL
` Friday, September 29, 2017
`
`Before:
` JACQUELINE WRIGHT BONILLA, Presiding,
` TONI R. SCHEINER
` and
` ERICA A. FRANKLIN,
` Administrative Patent Judges
`
`Reported by:
`Carol L. Naughton, RPR, CCR
`Job Number 131469
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` KOIOS v. MEDAC
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`Page 2
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` September 29, 2017
` 2:32 p.m.
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` Transcript of proceedings held via
` conference call, before Carol L. Naughton,
` Registered Professional Reporter, Certified
` Court Reporter, and a Notary Public of the
` Commonwealth of Virginia.
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` KOIOS v. MEDAC
`A P P E A R A N C E S:
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`Page 3
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` NOROOZI
` Attorneys for Petitioner
` 1299 Ocean Avenue
`
` Santa Monica, California 90401
` BY: KAYVAN NOROOZI, ESQUIRE
`
` ROPES & GRAY
` Attorneys for Patent Owner
` 1211 Avenue of The Americas
` New York, New York 10036
` BY: JAMES HALEY, JR., ESQUIRE
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` KOIOS v. MEDAC
` P R O C E E D I N G S
` (Proceedings commenced at 2:32 p.m.)
` THE COURT: We understand that
` patent owner has requested the call in
` relation to a request to file a sur-reply.
` Would you like to lead us in that
` discussion?
` MR. HALEY: Sure. So basically,
` there are, I'll say, two buckets where we
` think that a sur-reply is needed to respond
` to the paper that's been filed by
` petitioner.
` One of those buckets is the reliance
` by petitioner on only parts of answers in
` their response. And I'll take you through
` three examples of that so you can get a
` sense.
` The first one relates to the reply
` on Pages 4 and 5. On Page 5, you'll see
` that there is a block quote that goes from,
` I guess, line 1 of Page 111 of the Zizic
` transcript, which is Exhibit 1039, down to
` 25.
` And you can see on line 25, it says,
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` KOIOS v. MEDAC
` "whether it's problematic or not." Well,
` in fact, when you look at Exhibit 1039, the
` quote continues for three or four more
` lines on 115 explaining Dr. Zizic's view as
` to why it would be problematic to
` administer this amount of material.
` And we think that in order to
` understand exactly what this quote is
` saying, we ought to be able to show the
` full quote and the context in which it was
` asked.
` THE COURT: Okay. So that's the
` general gist of what you would like for the
` sur-reply, is to be able to point out one
` or two of those types of things in the
` reply?
` MR. HALEY: That's right, Your
` Honor.
` THE COURT: Okay. You said there
` were two buckets.
` MR. HALEY: There are three examples
` of these truncated quotes, but with one
` bucket, we'll just leave it at the one
` example.
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` KOIOS v. MEDAC
` The second bucket are misleading
` quotes, and one example of that -- I think
` it appears on Page 2 of the reply, where
` petitioner refers to Dr. Zizic talking
` about a concentration -- an amount of 50 mg
` would be useful and convenient to treat
` disease.
` They quote from Exhibit 1039, from
` Page 119 to Page 122, and nowhere does that
` mention 50 mg. What it mentions is could
` you use a 50 -- sorry -- 50 mg/ml -- could
` you use a 1-gram vial in order to deliver
` 35 mg.
` And so again, the 50 mg kind of
` comes out of the air. The witness never
` said that. So that's an example of -- it's
` misleading from what the actual testimony
` is.
` THE COURT: Okay. Petitioner, would
` you like to respond?
` MR. NOROOZI: I would, Your Honor.
` Thank you.
` THE COURT: And just so you know,
` this is in relation to whether there should
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` KOIOS v. MEDAC
` be a sur-reply, not so much to argue the
` matter, per se.
` MR. NOROOZI: Of course. And that
` is the thrust of my response, Your Honor,
` about the appropriateness of a sur-reply
` for precisely the type of arguments and
` assertions the patent owner would now like
` to make.
` As a starting point, the federal
` circuit has recognized, and the board well
` knows, that, quote, no rule provides patent
` openers the right to file sur-replies to
` petitioner's reply. And that's from the
` Belden v. Berk-Tek case, 805 F.3rd 1064
` Federal Circuit 2015.
` Where sur-replies are granted, which
` is rare, they typically are granted for
` only two reasons. The first is where
` there's an issue on which patent owner
` bears the burden of proof, and the second
` is to address new arguments or evidence put
` in the reply by petitioner.
` Neither of those situations applies
` here. First of all, there's no issue as to
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` KOIOS v. MEDAC
` which patent owner bears the burden of
` proof, and patent owner did not argue that
` just now. And secondly, there's no new
` argument here, and there's no assertion of
` a new argument. All we've done is make use
` of Dr. Zizic's testimony, and if that were
` the type of new evidence that would trigger
` a sur-reply, then there would be a
` sur-reply pretty much for every IPR in
` response to every petitioner reply, and we
` know that's not the case.
` So moving on to the grounds that the
` patent owner has raised -- and I apologize
` for the noise. I'm in an airport here.
` Unfortunately, it's the only place in which
` I could take this call, and I hope that my
` voice is coming through.
` The justification the patent owner
` relies on for seeking a sur-reply here is
` that petitioner has allegedly
` mischaracterized the testimony of patent
` owner's expert or, alternatively, that
` petitioner has not cited the entirety of
` what patent owner contends is the relevant
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` KOIOS v. MEDAC
` testimony from Dr. Zizic.
` The board has repeatedly heard that
` type of argument from patent owners in
` sur-replies and has repeatedly refused to
` grant a sur-reply on those bases. I cite
` to the decision here in Packers Plus versus
` Baker Hughes, which is particularly
` instructive.
` That decision came in IPR2016-01000,
` Paper 21, on May 30, 2017. And in that
` context, patent owner sought a sur-reply in
` order to, quote, respond to petitioner's
` characterizations of deposition testimony
` on the meaning of "counter" by patent
` owner's expert. And the quote ends there.
` And the board refused to grant the
` sur-reply stating that petitioner raises a
` valid objection. A sur-reply is not a
` proper mechanism to address
` characterization of deposition testimony,
` that the time for redirect has passed, and
` the board is capable of parsing out any
` alleged mischaracterizations which patent
` owner may address and bring to our
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` KOIOS v. MEDAC
` attention during oral argument.
` The reasoning in Packers Plus, Your
` Honors, apply with full force here. First
` of all, patent owner had an opportunity to
` redirect Dr. Zizic. They did so. That
` testimony is also in the transcript.
` Secondly, of course, the board knows
` how to read the transcript and knows how to
` form opinions as to what it believes is
` relevant, where relevant testimony begins
` and ends, what is fairly characterized and
` mischaracterized testimony. And those are
` all well within, not only the board's
` competency, but its routine conduct in
` these proceedings.
` And third of all, patent owner
` certainly can make the assertion that it
` wants to make at oral argument, and there's
` no reason at this point to give several
` pages of argumentative briefing to patent
` owner to try to recant or recast
` Dr. Zizic's testimony.
` So for those reasons, we would ask
` that the board deny the request.
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` KOIOS v. MEDAC
` THE COURT: Thank you. I'll give
` patent owner an opportunity to respond.
` MR. HALEY: Sure. Thank you, Your
` Honor.
` So I don't think this is about
` characterization of testimony. I think
` when the board reads the petitioner's last
` paper, they are entitled to rely on the
` petitioner having correctly quoted from the
` transcript.
` And then when the petitioner ends in
` the middle of an answer without completing
` the full answer, to me, that's not a
` mischaracterization. That's a total
` misquote.
` It's not clear to me that the board
` would immediately think I better go back
` and see what this says because there may be
` a dispute. The board has to trust the
` petitioner to have done the right thing,
` and that's not the case here.
` In each of the three cases that I
` say are in bucket number 1, the quote has
` been truncated in ways that miss the full
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` KOIOS v. MEDAC
` scope of the witness's answer.
` On the things in the second bucket,
` again, the petitioner says the quote says
` 50 mg, and yet when you look at the quote,
` it doesn't say that at all. So again, the
` board in reading this has no reason to go
` back and look at it because they don't know
` that it's in dispute. They have to rely on
` what the petitioner has done. And to me,
` what the petitioner has done is obscured
` the fact that these things are actually not
` in the testimony.
` And that's why a sur-reply to point
` that out would be, to me, in my mind,
` respectfully submitted, would be important
` for the board to know as they are looking
` at the reply paper.
` THE COURT: Okay. Great. Thank you
` so much. I'm going to take just a moment
` to confer with the panel, and we will be
` back with you shortly. Hold on one second.
` (Pause)
` THE COURT: Okay. The judges are
` back on. We have conferred, and as
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` KOIOS v. MEDAC
` petitioner points out, it's not a matter of
` right in terms of having a sur-reply, but
` it is something that we can authorize if we
` think it would be useful to us.
` We have decided, under the
` circumstances, that we think that it might
` actually be useful for us for patent owner
` to file a short sur-reply just for this
` limited purpose of identifying parts of the
` transcript that they think they have been
` identified in the reply, but somehow has
` either been truncated in a way that is --
` sends a different message or is misleading.
` Patent owner, we were thinking about
` the idea of maybe having some kind of chart
` where you would identify the portion of the
` reply that you think has a problem in terms
` of that transcript, and then pointing us to
` what the actual part of the transcript is
` and that particular exhibit that you want
` us to take a look at. We do think that
` that will be helpful.
` The sur-reply wouldn't necessarily
` contain any argument, but it would identify
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` KOIOS v. MEDAC
` the full parts of the transcript that you
` want to make sure that we see in relation
` to what has been cited or quoted in the
` reply.
` If we were to allow you to do
` something of that nature, how many pages do
` you think you would need in order to put
` together something like that for us?
` MR. HALEY: Certainly under five,
` Your Honor. I think it will be less. I'm
` just thinking about having three columns of
` the statement in the reply, what's been
` quoted or cited in the transcript and
` what's actually in the reply, and then
` what's actually in the transcript.
` So three columns. I can't imagine
` it will be five pages, but because some of
` these quotes go on for a page and a half in
` the transcript, it could be a little bit
` longer than that.
` THE COURT: Okay.
` MR. HALEY: It will just be here's
` what we said in the reply, here's the quote
` or the cite, and here's what the actual
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` KOIOS v. MEDAC
` transcript says.
` MR. NOROOZI: Your Honor, may
` petitioner be heard as well when time is
` appropriate?
` THE COURT: What do you mean
` exactly?
` MR. NOROOZI: I'd like to make a
` request to the board as well in relation to
` how we move forward with respect to this
` approach.
` THE COURT: Okay. Go ahead.
` MR. NOROOZI: First of all, I'd like
` to ask that any such submission be entirely
` non-argumentative. I have seen in prior
` instances where this type of issue has come
` up. The board has sometimes granted the
` type of filing that you've mentioned here.
` And in my experience, what I've seen is
` that the board makes clear that patent
` owner's submission has to be
` non-argumentative.
` And with respect to the pages, I
` mean, what they really need to do, if
` anything, is simply identify a page and
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` KOIOS v. MEDAC
` line number of deposition testimony from
` Dr. Zizic that they believe we left out or
` that the board needs to consider. They
` don't need to actually quote and paste all
` the testimony into their sur-reply-type
` document. The testimony is already in the
` deposition. So I think a page and line
` number would suffice.
` In addition, I would ask that
` petitioner be allowed to file a response so
` that we can point to relevant sections of
` Dr. Zizic's testimony that do support the
` assertions we've made. And I say that for
` a particular reason.
` For example, the example the patent
` owner gave was we cite to a quote in which
` Dr. Zizic purportedly doesn't say exactly
` 50 mg/ml. As patent owner said, Dr. Zizic
` is clearly talking about the 1-gram vial of
` Wyeth in that discussion.
` The 1-gram vial of Wyeth is a
` 50 mg/ml concentration, and that was
` discussed at length with Dr. Zizic. Yet he
` agreed with that throughout his deposition
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` KOIOS v. MEDAC
` many times. And, in fact, it was asked on
` redirect by patent owner's lawyer who
` essentially said, Well, Mr. Noroozi asked
` you about whether he would administer Wyeth
` in the 1-gram format, and I suppose he
` meant 50 mg/ml; right? And Dr. Zizic said
` yes, that was his understanding.
` So there's testimony like that which
` we'd like to point back to if this is
` really the dispute that we're having.
` MR. HALEY: Just quickly, Your
` Honor, we don't intend to have any
` argument. It will be a quote from the
` reply. It will be a quote from the page
` and line numbers that the petitioner cited
` to, and it will be a quote from the
` deposition transcript that we think should
` have been included. But that's all we're
` going to do.
` THE COURT: Thank you very much.
` Give me just one minute, please.
` (Pause)
` THE COURT: This is Judge Bonilla.
` We're back on again. Thank you very much
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` KOIOS v. MEDAC
` for laying the issues out for us and
` everything.
` We are going to authorize patent
` owner to file a short sur-reply in the
` manner that we talked about.
` Patent owner, just so you know, what
` we need from you, actually, are simply just
` citations; so page, line numbers, both in
` the reply and in the transcript, itself.
` We don't need the block quotes. I think
` that that will just get too bulky.
` And we'll be looking at the reply
` and the transcript anyway. So you might as
` well just give us just literally the
` citation that you want us to look at in
` both of those documents. That would be
` helpful to us.
` There will be absolutely no argument
` whatsoever. We'll just take a look at the
` passages that you would like us to take a
` look at.
` Petitioner, we are not going to
` authorize what would effectively be a
` sur-sur-reply, but we did want to bring to
`
`TSG Reporting - Worldwide 877-702-9580
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`Page 19
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` KOIOS v. MEDAC
` your attention that if you think there is
` something in there that the message isn't
` getting across, you will have an
` opportunity to raise that with us in the
` oral hearing. So that won't be the end of
` the road.
` But at this point, we can keep going
` back and forth on reply, reply, reply. So
` we don't want to -- we do want to stop it.
` But to the point that we believe that this
` identification of the transcript will be
` helpful for us, we're going to go forward
` on the sur-reply.
` Does anybody have any questions
` before we sign off?
` MR. HALEY: Thank you very much,
` Your Honor. We have no questions for the
` patent owner.
` MR. NOROOZI: None from petitioner,
` Your Honor. Thank you for hearing this.
` THE COURT: Okay. Hold on one
` second. As far as logistics, I'm still
` conferring with the panel.
` (Pause)
`
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`Page 20
`
` KOIOS v. MEDAC
` THE COURT: One quick question for
` patent owner. How much time do you think
` that you will need in order to turn this
` around?
` MR. HALEY: I think by Thursday of
` next week, if that's all right, Your Honor.
` THE COURT: Yeah. I think that's
` fine. So we'll go ahead, and we'll put
` that in the order, that this paper will be
` due by a week -- next Thursday.
` MR. HALEY: Fine. Thank you.
` THE COURT: We will issue an order
` in due course. Thank you very much for the
` call, and we will talk with you at the
` hearing, I guess.
` MR. HALEY: Thanks very much. Have
` a great weekend.
` THE COURT: Thank you. You too.
` MR. NOROOZI: Thank you.
` (Off the record at 2:54 p.m.)
`
`TSG Reporting - Worldwide 877-702-9580
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` KOIOS v. MEDAC
` COURT REPORTER'S CERTIFICATE
`
`Page 21
`
` I, Carol L. Naughton, RPR, CCR, certify
`that I recorded verbatim by stenotype the
`proceedings in the captioned cause before
`JACQUELINE WRIGHT BONILLA, TONI R. SCHEINER, AND
`ERICA A. FRANKLIN, Administrative Patent Judges,
`taken via teleconference, on the 29th of
`September, 2017.
` I further certify that to the best of my
`knowledge and belief, the foregoing transcript
`constitutes a true and correct transcript of the
`said proceedings.
` Given under my hand this 2nd day of
`October, 2017, at Norfolk, Virginia.
`
` _____________________________
` Carol L. Naughton
` Notary Registration No. 7208068
`
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`
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