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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
` BEFORE PATENT TRIAL AND APPEAL BOARD
`
`APOTEX INC., APOTEX CORP., and,
`ARGENTUM PHARMACEUTICALS LLC
`Petitioners,
`v.
`NOVARTIS AG.,
`Patent Owner.
`
`Case IPR2017-00854
`Patent 9,187,405 B2
`__________________________________________
`
`Teleconference
`January 24, 2017
`1:02 p.m.
`
`Transcript of Proceedings
`
`Apotex v. Novartis
`IPR2017-00854
`NOVARTIS 2087
`
`212-279-9424
`
`Veritext Legal Solutions
`www.veritext.com
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`212-490-3430
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
` BEFORE PATENT TRIAL AND APPEAL BOARD
`
`APOTEX INC., APOTEX CORP., and,
`ARGENTUM PHARMACEUTICALS LLC
`Petitioners,
`v.
`NOVARTIS AG.,
`Patent Owner.
`
`Case IPR2017-00854
`Patent 9,187,405 B2
`__________________________________________
`
`Teleconference
`January 24, 2017
`1:02 p.m.
`
`Transcript of Proceedings
`
`Apotex v. Novartis
`IPR2017-00854
`NOVARTIS 2087
`
`212-279-9424
`
`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
`
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`A P P E A R A N C E S:
`Presiding:
` The Honorable ROBERT A. POLLOCK,
` Administrative Patent Judge
`Attorneys for Petitioner Apotex:
` STEVEN W. PARMELEE, ESQ.
` JAD MILLS, ESQ.
` Wilson Sonsini Goodrich & Rosati
` 701 Fifth Avenue, Suite 5100
` Seattle, WA 98104-7036
` E-mail: sparmellee@wsgr.com
` jmills@wsgr.com
`Attorneys for Patent Owner Novartis AG:
` JANE M. LOVE, PhD
` ROBERT TRENCHARD, ESQ.
` Gibson, Dunn & Crutcher, LLP
` 200 Park Avenue
` New York, New York 10166-0193
` E-mail: jlove@gibsondunn.com
` rtrenchard@gibsondunn.com
`Attorneys for Petitioner Argentum
`Pharmaceuticals:
` DEBRA YELLIN, ESQ.
` SHANNON M. LENTZ, ESQ.
` Crowell & Moring LLP
` 1001 Pennsylvania Avenue NW
` Washington, D.C. 20004-2595
` E-mail: dyellin@crowell.com
` Slentz@crowell.com
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`A P P E A R A N C E S: (Continued)
`Attorneys for Petitioner Sun
`Pharmaceutical:
` SAMUEL PARK, ESQ.
` Winston & Strawn LLP
` Metlife Building
` 200 Park Avenue
` New York, New York 10166
` E-mail: spark@winston.com
`Attorneys for Petitioner Teva Actavis
` AMANDA HOLLIS, ESQ.
` Kirland & Ellis LLP
` 300 North LaSalle
` Chicago, IL 60654
` E-mail: Amanda.hollis@kirkland.com
`ALSO PRESENT:
` JUDGE LORA M. GREEN
` JUDGE CHRISTOPHER N. KAISER
` * * *
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` HON. POLLOCK: Good afternoon,
` ladies and gentlemen. This call is in
` relation to IPR2017-00854. This is
` Judge Pollock. I have with me Judges
` Green and Kaiser. I would like to
` start with a role call. Who do I have
` for Petitioner Apotex?
` MR. PARMELEE: Good afternoon,
` Your Honor. This is Steve Parmelee
` and Jad Mills for Petitioner Apotex.
` HON. POLLOCK: Good afternoon.
` Petitioner Argentum?
` MS. LENTZ: Yes, good afternoon,
` Your Honor. This is Shannon Lentz and
` Debra Yellin.
` HON. POLLOCK: Petitioner Teva
` Actavis.
` MS. HOLLIS: Good afternoon.
` This is Amenda Hollis from Kirkland &
` Ellis for those Petitioners.
` HON. POLLOCK: And Petitioner
` Sun Pharma.
` MR. PARK: This is Sam Park from
` Winston & Strawn for Sun Pharm.
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` HON. POLLOCK: And who is on the
` line for Patent Owner Novartis?
` MR. TRENTCHARD: Good afternoon,
` Your Honor. This is Robert Trenchard
` and Jane Love from Gibson Dunn &
` Crutcher. And for Your Honor's
` information, we do have a court
` reporter. Her name is Lisa. She is
` on the line.
` HON. POLLACK: Excellent. And
` Patent Owner Novartis, you engaged the
` court reporter today?
` MR. TRENCHARD: We did, Your
` Honor, and we will file the transcript
` as soon as we get it.
` HON. POLLOCK: All right. If
` you would file that as an exhibit when
` it is available. But in addition, if
` you have access to a rough draft of
` the transcript, kindly forward a
` courtesy copy to us via the trial's
` e-mail as soon as possible.
` MR. TRENCHARD: Absolutely, Your
` Honor.
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` HON. POLLOCK: Patent Owner has
` requested this call seeking
` authorization to file a motion to
` strike Petitioner's January 22, 2018
` motion for additional discovery
` because it seeks discovery the Phase 3
` clinical protocol referenced in
` Exhibit 2065.
` Patent Owner, would you please
` state your position.
` MR. TRENCHARD: Yes, Your Honor.
` Our position I think is pretty
` straight forward. And, Your Honor, at
` the January 10th conference that we
` had with Your Honors, there were only
` three documents that were discussed as
` being the subject of the discovery
` that the Petitioners are interested
` in.
` As a result, Your Honors on
` January 11th issued an order that
` permitted discovery of the three
` documents that had been discussed at
` the January 10th conference. Those
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` documents did not include this
` protocol mentioned in Exhibits 2065.
` As a result, we as the Patent
` Owner limited our briefs that we
` exchanged simultaneously with the
` other side on January 22nd to the
` three documents that the Board had
` authorized additional discovery on in
` its January 11th order. We did not
` address this fourth document that the
` Petitioners have put into their brief
` in our view in violation of that order
` and without authorization.
` We do appreciate as the
` Petitioners pointed out that before
` the call they had said that this
` additional document was a subject of
` interest to them. But to our mind as
` a result of the January 10th call,
` they appear to drop that request.
` That is not the first time they have
` raised something in an e-mail with us
` and then stopped pursuing it.
` The rules here are pretty
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` straight forward under 37 CFR 42.7.
` The Board may expunge any paper that
` is submitted without authorization or
` in violation of a Board order. We
` think that this motion easily
` qualifies and that striking or
` expunging the brief is the only
` sensible procedure at this point
` because as Your Honors will recall,
` the briefs were exchanged
` simultaneously.
` And so at this point, allowing
` Petitioners to re-file their brief
` either with or without this fourth
` document would give them the unfair
` advantage of having seen our brief
` which is something that the Board did
` not originally contemplate.
` In addition, the brief that they
` submitted and if you look at pages 6
` through 8, it discusses in particular
` the first and most important Garmin
` Factor of the idea that the discovery
` being sought is useful to the
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` Petitioners. And it discuses all of
` the documents together as a synthetic
` whole and uses the arguments for all
` of them to support discovery as to all
` of them.
` And so, we don't think the Board
` should be in a position to have to
` parse through one request versus
` another request when they are all
` presented as a synthetic whole in the
` brief.
` So we think that the logical
` sensible simple solution is to strike
` or expunge their brief. Their reply
` brief is due next week, so we don't
` see any way to re-brief this in a
` timely fashion, nor do we think it
` would be fair given that the parties
` have already exchanged their briefs.
` So simply put, we think that by
` neither raising this additional
` document on the January 10th call nor
` after the Board issued its January
` 11th order going back to the Board to
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` ask for permission to add this fourth
` document, we think that the
` Petitioners have waived these
` requests. That is our position.
` HON. POLLOCK: Okay. Mr.
` Parmelee, I do not recall hearing
` about the Phase 3 clinical protocol at
` the conference call discussing your
` motion for additional discovery, nor
` does it mention in the order
` authorizing that briefing. Would you
` please explain how it found its way
` into your motion?
` MR. PARMELEE: Yes, Your Honor.
` Actually in the phone call we had with
` the Board, we in the context of
` additional discovery, we didn't talk
` about any of the particular documents
` as I recall, except maybe that e-mail
` thread which was 2063. So we didn't
` address them specifically. Most of
` our discussion during that call was
` why these documents should be made
` available to us under routine
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` discovery.
` So that is I think if you look
` at the transcript, you will see that
` there is no discussion of particular
` documents as additional discovery.
` And that is why when we saw the order,
` we wanted to make clear and included
` in our e-mail to the Board, our
` follow-up e-mail on January 4th which
` asked for the clinical trial protocol
` because we had established through
` deposition testimony that this
` document has been relied upon by Dr.
` Lublin as we point out in our motion.
` And then turning to the order
` itself, the bulk of the order
` authorizing the discovery motion deals
` with our belief that the first three
` documents should have been produced as
` part of routine discovery and only at
` the end of the order does the Board
` address additional discovery and then
` not in the context of any particular
` documents. It simply authorizes a
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` motion for additional discovery for
` the requested documents I think was
` the language without specifying. And
` because we had asked for that document
` specifically in our e-mail on January
` 4th, we thought that that was
` appropriately included within the
` scope of the Board's order as one of
` the requested documents.
` So we think our request was
` clear and because the Board's order
` did not specify that any of the
` requested documents under the
` additional discovery portion and
` certainly not excluding anything that
` we had asked for, we thought it was
` included. So that is our position.
` I think the Patent Owner's
` proposed remedy, I mean if the Board
` were to disagree with our position and
` Patent Owner's proposed remedy, that
` the entire motion be expunged is
` really goes way beyond what is
` reasonable in the particular
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` circumstances.
` Our discussion at that
` particular clinical trial protocol I
` think is about eight lines in total,
` maybe one paragraph that the Board can
` easily discern for itself where it is
` raised. So we think if the Board
` disagrees with our position that they
` can easily ignore that portion of the
` motion.
` Another aspect that I would like
` to raise is that there was basically
` again no meet and confer. Patent
` Owner simply fired off an e-mail, an
` argumentative e-mail to the Board.
` Had the Patent Owner actually
` contacted us to discuss its
` interpretation of the order and our
` underlying request, perhaps there was
` a possibility that we could have
` reached some accommodation and come to
` the Board with some kind of proposal.
` But that never happened and that is
` pretty consistent in this particular
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` IPR.
` So I just would like to note
` that objection that I have to the way
` this has been conducted and that
` perhaps by a meet and confer we could
` have resolved this and come to the
` Board with a proposal of some kind.
` HON. POLLOCK: Do you have a
` proposal, Mr. Parmelee?
` MR. PARMELEE: Well, we had
` considered allowing the Patent Owner
` to have an additional eight lines of
` briefing and come to the Board with
` that proposal to basically address the
` document that we had that they hadn't
` had the opportunity to address. And
` of course that would require the
` Board's authorization for that, but
` they would have then the benefit of
` reviewing our briefing which they are
` objecting to us re-filing our brief
` because we have had the benefit of
` reviewing their briefing.
` So we would be willing to allow
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` them the benefit of reviewing our
` briefing and filing an additional
` eight lines of argument on this
` particular document.
` HON. POLLOCK: Mr. Trenchard,
` any response?
` MR. TRENCHARD: Yes, Your Honor.
` First off, it is not correct that the
` January 11th order does not limit the
` requests for additional discovery to
` the three documents. Paragraph one of
` that order says that there was a
` January 10th meeting before your three
` Your Honors and to discuss Apotex's
` request for routine or additional
` discovery of one, two, three
` documents. And that is the additional
` discovery that is then talked about in
` the decretal paragraph at the end of
` the order.
` So it is a false premise to
` suggest that the order was not limited
` on its face to those three documents,
` the ones that we addressed in our
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` brief.
` With respect to a meet and
` confer, Your Honor, it's not for the
` parties to meet and confer among
` themselves about how to modify an
` order of this Board. The Board is in
` control of its orders, not the
` parties. Whatever e-mails were
` exchanged, it is up to the Board and
` the right procedure. If Mr. Parmelee
` had made a mistake in not mentioning
` this fourth document in the January
` 10th document, when he read the order
` he could have gone back to the Board
` with or without consulting with us,
` brought the mistake to the Board's
` attention and the Board could have
` either modified its order or not, and
` we would have possibly gone through
` the same sort of preliminary
` discussion that we went through on
` January 10th with respect to these
` three documents on this new document
` that is being sought.
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` That is a nontrivial step in
` this instance, Your Honor. The
` documents they are seeking is a
` clinical trial protocol. Clinical
` trial protocols are not static. They
` are constantly evolving as new
` information becomes available. So
` there are very serious issues with
` respect to this document that we would
` have to investigate about the burden
` of identifying what documents they are
` actually seeking, which version of the
` protocol was at issue.
` We have done none of that work
` because it was our understanding after
` the January 10th discussion that this
` document was off the table. And that
` is also why this idea of additional
` briefing does not work because we
` would need some amount of time to
` figure out the answer to that
` question.
` Many of the employees who were
` involved in the back and forth in
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` Exhibits 2065 in which the protocol is
` discussed are no longer with Novartis.
` Their e-mails may or may not exist
` anymore in Novartis' system, and we
` would need to figure out what the
` protocol is in fact an issue something
` we have not done. I think that that
` is the entirety of my response unless
` Your Honor has any questions.
` HON. POLLOCK: Thank you, Mr.
` Trenchard. No questions. We're going
` to go offline now and the Panel will
` confer. Please hold.
` (There was a pause in the
` proceeding.)
` HON. POLLOCK: Judge Pollock
` again. We're back on. Counsel for
` Apotex still present?
` MR. PARMELEE: Yes, Your Honor.
` HON. POLLOCK: Counsel for
` Novartis?
` MR. TRENCHARD: Yes, Your Honor.
` HON. POLLOCK: The Board has
` conferred. Mr. Parmelee, I'm not
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` pleased with Apotex' creative reading
` of our order authorizing this motion
` for additional discovery. With that
` said, the thrust of the request for
` discovery appears to relate to the
` rationale including an 0.5 milligram
` dose of Novartis clinical trials.
` With that in mind, I note
` Apotex's citation to Dr. Lovelin's
` testimony at pages four and five of
` your briefing indicating the rationale
` for administering 0.5 milligram dose
` could be found in Section 11 of the
` Phase 3 clinical protocol which would
` seem to support Garmin Factor One.
` Accordingly, Novartis' request
` for authorization to strike is denied;
` however, because Patent Owner quite
` reasonably interpreted our order less
` broadly than Petitioner Apotex did, we
` will issue an order authorizing Patent
` Owner to submit a five-page
` supplementary brief directed to the
` Phase 3 clinical protocol. Patent
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` Owner's supplementary brief will be
` due one week from today. Any
` questions?
` MR. TRENCHARD: No questions
` from Patent Owner, Your Honor. We do
` have one other brief issue we would
` like to raise separately with the
` Board's indulgence. On January 19th
` we sent a separate e-mail to the Board
` asking for a conference on a different
` issue.
` HON. POLLOCK: Was this Dr.
` Lublin's testimony?
` MR. TRENCHARD: Yes, it is, Your
` Honor. And if Your Honors do not want
` to discuss that now, we certainly
` understand, but we just wanted to make
` sure it didn't get lost in the
` shuffle.
` HON. POLLOCK: I understand that
` Dr. Lublin made an inaccurate
` statement during his deposition
` regarding the timing of his access to
` other experts' testimony, and Patent
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` Owner wishes to correct that
` misstatement by submitting an errata
` or supplemental declaration. Mr.
` Trenchard, is that summary inaccurate?
` MR. TRENCHARD: That is correct,
` Your Honor. We're in the rather
` unusual position of as outside counsel
` we have firsthand knowledge of the
` error and so we of course under Model
` Rule 3.3 we have an ethical obligation
` to bring the mistake to the Board's
` attention and to try to remedy it.
` HON. POLLOCK: I understand that
` the Petitioner opposes the correction
` of the record and in the alternative
` requests an extension of the schedule
` to re-depose Dr. Lublin and possibly
` other witnesses. Mr. Parmelee, this
` seems to be a minor factual issue
` easily resolved by a brief
` supplemental declaration and at most a
` short telephonic deposition of
` Dr. Lublin. Would you care to explain
` your position?
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` MR. PARMELEE: Your Honor, I
` will ask Mr. Mills to address this.
` He's more familiar with the specific
` facts than I am. So if I may.
` MR. MILLS: Your Honor, this is
` Jad Mills. And first I would like to
` provide a little bit of context
` regarding Patent Owner's request and
` the parties' meet and confer on this
` issue. Patent Owner originally
` identified Dr. Lovelin's testimony in
` conjunction with a transcription error
` in the Schnell transcript and proposed
` that the parties simply "agree to
` correct the transcripts" by asking the
` court reporters to reissue them.
` After reviewing the transcripts
` in conjunction with the deposition
` video, Petitioner confirmed that there
` was no transcription error in the
` cited portion of the Lublin transcript
` and informed Patent Owner of that fact
` and asked Patent Owner to identify
` whether there was any authority
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` permitting the parties to agree to
` altering an accurate transcription of
` the witness's testimony.
` Patent Owner never responded
` with any such authority and
` subsequently generally proposed
` amending Dr. Lovelin's answer by way
` of an errata sheet or short
` declaration. The Patent Owner never
` provided to Petitioner with a specific
` proposed amendment. Explained
` counsel's basis for concluding that
` the sworn testimony was an error or
` that such a substantive change can be
` entered by the means requested. Nor
` did they explain why Patent Owner's
` lead and backup counsel failed to
` address the issue during the Lublin
` deposition. Both counsel were present
` at the deposition and even took a
` recess to decide whether to ask any
` redirect questions. Counsel for
` Patent Owner decided not to ask any
` redirect questions.
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` It is our opinion and the
` opinion of the Board in the decision
` in Garmin v. Pacing Technologies, this
` is with APJ's Jameson Lee, Michael
` Cherney and Josiah Cocks that there's
` important value in obtaining the
` dynamic and contemporary response of
` the witness and that a deposition does
` not have the characteristic of an
` interrogatory to be answered at home
` after thorough study over a long
` period of time.
` Petitioner would also note that
` Patent Owner waited to raise this
` issue until January 8, 2018. In fact,
` at 7:14 a.m., Patent Owner e-mailed to
` point out that Petitioners had never
` noticed the deposition of Dr. Jusko
` which had originally been scheduled to
` take place two days after this e-mail.
` At 2:15 p.m. that same day,
` Patent Owner for the first time
` reached out and attempted to alter
` Dr. Lovelin's testimony under the
`
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` guise of the transcription errors.
` Petitioner had made strategic
` choices about which of the duplicative
` and cumulative witnesses to
` cross-examine based on the testimony
` that was given. And when the Patent
` Owner evaluated those choices, it then
` decided that it wanted to change
` Dr. Lovelin's testimony. We believe
` that that is the very definition of
` prejudice to the Petitioner.
` HON. POLLACK: Patent Owner.
` MR. TRENCHARD: Your Honor, I'm
` not entirely sure I follow the
` prejudice argument, but this is as
` Your Honor points out a very simple
` question.
` We assume that the Petitioners
` want to litigate on a record that is
` truthful rather than not. And as
` outside counsel responsible for
` communicating with Dr. Lublin, we went
` back to our records, we checked our
` e-mails after we got the final
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` transcript from Dr. Lovelin's
` deposition, and we concluded that that
` bit of testimony over I think it was
` two questions or about a bit of a page
` was factually inaccurate.
` To provide some meaningful
` context, of course Dr. Lublin is an
` expert witness, he has some historical
` knowledge that matters as well, but he
` is an expert witness. None of what we
` are talking about could have changed
` the substance of what his testimony is
` about, either his opinion or
` historical recollection of Novartis
` over the Phase 3 trial. This is
` simply to correct when he saw what he
` saw and to make it clear that was in
` fact after he submitted his
` declaration.
` MR. PARMELEE: Your Honor, if I
` may be heard. So if this change in
` testimony is based on counsel's
` information or testimony and counsel's
` records, then we would want discovery
`
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` into those records and that testimony
` and that process.
` I would also like to point out
` that during the deposition of
` Dr. Lublin this is not a case where a
` leading question was asked of
` Dr. Lublin about him having reviewed
` the Steinman declaration for instance.
` There was a nonleading question about
` whether he had reviewed any
` declarations of any other witnesses
` prior to signing his declaration. He
` brought up Steinman and Jusko on his
` own. He supplied the information. He
` testified at length regarding it.
` And it is only now weeks later
` after Petitioner had made its
` litigation decisions and reliance on
` that testimony that the Patent Owner
` is attempting to change the substance
` of that testimony.
` MR. TRENCHARD: And, Your Honor,
` just to briefly address that. Of
` course that question was asked and
`
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` Dr. Lublin did not have with him his
` computer. After the deposition and
` after we got the transcript and saw
` that statement, and it seemed odd to
` us, we and Dr. Lublin went back and
` looked at our records and discovered
` that he had made this very simple
` factual error.
` HON. POLLACK: Mr. Parmelee, if
` we authorize a supplemental
` declaration of Dr. Lublin and a
` re-deposition of him, what else would
` you need to alleviate any other
` alleged prejudice?
` MR. MILLS: This is Jad Mills.
` So to be honest, Your Honors, because
` Patent Owner never came to us during
` the meet and confer process
` identifying the nature of the error
` and the basis for it or the nature of
` the specific remedy they were
` proposing, we can't give a definitive
` answer on what would be required to
` address the prejudice, but it very
`
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` well may include extending the
` schedule to be able to depose not only
` Dr. Lublin but it may alter
` Petitioners' decision not to depose
` doctors Jusko and Steinman and may
` require extending the schedule so that
` those two witnesses can be deposed as
` well.
` HON. POLLOCK: They have not
` been deposed as of yet, Jusko and
` Steinman?
` MR. MILLS: That's correct.
` MR. TRENCHARD: That is correct,
` Your Honor. We have dates for them
` and the Petitioners elected not to go
` forward on those dates. Dr. Lublin
` never interacted with Dr. Steinman or
` Dr. Jusko in the process of preparing
` a declaration, we don't understand how
` that could possibly be appropriate or
` relevant frankly to the decision to
` depose or not to depose an expert
` witness.
` Again, this is a very simple
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` factual error and Mr. Mills is
` mistaken. In January 8th in our
` e-mail, we specified that Dr. Lublin
` testified that he "reviewed" the
` declaration of Dr. Steinman and the
` second declaration from Dr. Jusko
` before Dr. Lublin signed his
` declaration. Dr. Lublin was mistaken.
` Dr. Lublin did not receive either of
` those declarations in final or draft
` form before signing his second
` declaration.
` Dr. Lovelin's brief summary in
` paragraph 58 of the second
` declaration. So we described exactly
` what the nature of what we view as a
` pretty minor change was and exactly
` how we proposed to fix it. And we
` don't see any possible prejudice from
` this nonsubstantive correction. But
` we of course under the ethical rules
` have an obligation to try to fix it
` when we know there's a mistake in
` sworn testimony.
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` Dr. Lublin is prepared to submit
` a short declaration explaining that he
` in fact did not see these declarations
` before signing his second declaration.
` And of course if Your Honors would
` like, we will make him available for a
` short telephonic deposition on the
` narrow subject of when he saw the
` declarations.
` MR. MILLS: Your Honors, if I
` may be heard?
` HON. POLLOCK: Mr. Mills, go
` ahead.
` MR. MILLS: So first of all, the
` question during the deposition did not
` relate to paragraph 58. Dr. Lublin
` was not pointed to paragraph 58 and
` asked him how he knew what
` Dr. Steinman, his declaration said.
` He was asked the open-ended question
` as I pointed out before. But in each
` of the -- sorry, but I need to start
` over on this issue or just on this
` next point.
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` When Patent Owner served their
` Patent Owner response and their three
` declarations, Petitioner timely
` objected that those three declarants
` were providing duplicative and
` cumulative testimony on the same issue
` which is the issue the Board
` identified in its institution
` decisions as a critical issue to
` Patent Owner's case which is their
` argument that the web reference
` teaches away from the 0.5 milligram
` dose.
` Each of the witnesses goes
` through and provides cumulative
` testimony. We objected that
` needlessly increases the costs of the
` litigation of the IPR and is
` inefficient.
` Each of those three witnesses
` also testified in their declarations
` that Novartis wrote their declarations
`
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