`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.,
`
`Petitioner
`
`v.
`
`
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`
`Patent Owner.
`
`IPR2019—00977,
`
`. 8,603,044
`
`IPR2019—00982,
`
`. 8,992,486
`
`IPR2019—00987,
`
`. 9,604,008
`
`IPR2019—01022,
`
`. 9,526,844
`
`IPR2019—01023,
`
`. 9,526,844
`
`TELEPHONIC CONFERENCE
`
`July 25, 2019
`
`REPORTED BY: CARRIE LAMONTAGNE, CSR NO. 13393
`
`JOB NO. 164992
`
`TSG Reporting - Worldwide
`
`877-702-9580
`
`Mylan Exhibit -1043
`
`Mylan v. Sanofi - |PR2018—01675
`
`Mylan Exhibit -1043
`Mylan v. Sanofi - IPR2018-01675
`
`
`
`PTAB conference call - 7/25/19
`
`June 25, 2019
`
`1:00 p.m., EST
`
`Telephonic proceedings, held before
`
`Administrative Patent Judges Hyun J. Jung, Bart A.
`
`Gerstenblith, and Lynne Browne, before Carrie
`
`LaMontagne,
`
`a Certified Court Reporter for the State
`
`of California.
`
`TSG Reporting - Worldwide
`
`877-702-9580
`
`Mylan Exhibit -1043
`
`Mylan v. Sanofi - |PR2018—01675
`
`Mylan Exhibit -1043
`Mylan v. Sanofi - IPR2018-01675
`
`
`
`PTAB conference call - 7/25/19
`
`A P P E A R A N C E S:
`
`WILSON SONSINI GOODRICH & ROSATI
`
`Attorneys for Petitioner Mylan
`
`1700 K Street NW
`
`Washington, DC 20006
`
`RICHARD TORCZON, ESQ.
`
`WESLEY DERRYBERRY, ESQ.
`
`ELHAM STEINER, ESQ.
`
`TASHA THOMAS, ESQ.
`
`SUTTON ANSLEY, ESQ.
`
`WINSTON & STRAWN
`
`Attorneys for Petitioner Pfizer
`
`1700 K Street, N.W.
`
`Washington, D.C. 20006
`
`JOVIAL WONG, ESQ.
`
`WEIL, GOTSHAL & MANGES
`
`Attorneys for Patent Owner
`
`2001 M Street, NW
`
`Washington, DC 20036
`
`TSG Reporting - Worldwide
`
`877-702-9580
`
`Mylan Exhibit -1043
`
`Mylan v. Sanofi - |PR2018—01675
`
`Mylan Exhibit -1043
`Mylan v. Sanofi - IPR2018-01675
`
`
`
`PTAB conference call - 7/25/19
`
`Page 4
`
`JUDGE JUNG: Hello. This is Judge Jung
`
`and this is a conference for cases IPR2019—00977
`
`through 982, 987, 1022, and 1023 between Petitioner
`
`Pfizer and Patent Owner Sanofi.
`
`There are pending
`
`motions to join the cases IPRs 2018—1670, 1675
`
`through 1680, 1682, 1684, and IPR2019—122. With me
`
`are Judge Browne and Judge Gerstenblith.
`
`Counsel for Petitioner Pfizer, please introduce
`
`yourself.
`
`MR. WONG:
`
`Hi there, your Honor,
`
`this is
`
`Jovial Wong of Winston & Strawn for Petitioner,
`
`Pfizer.
`
`JUDGE JUNG:
`
`Thank you, Mr. Wong. Counsel
`
`for Patent Owner, please introduce yourself.
`
`MR. ANSLEY: Hi,
`
`this is Sutton Ansley of
`
`Weil Gotshal
`
`& Manges on the line for Patent Owner.
`
`Some of my colleagues are on the line as well.
`
`
`
`JUDGE JUNG:
`
`Thank you, Mr. Ansley.
`
`And counsel for Petitioner Mylan, please
`
`introduce yourself.
`
`MR. TORCZON:
`
`I'm sorry, Your Honor,
`
`I was
`
`on mute. This is Richard Torczon.
`
`I also have
`
`colleagues, Ellie Steiner, Wes Derryberry, and
`
`Tasha Thomas on the line.
`
`TSG Reporting - Worldwide
`
`877-702-9580
`
`Mylan Exhibit -1043
`
`Mylan v. Sanofi - |PR2018—01675
`
`Mylan Exhibit -1043
`Mylan v. Sanofi - IPR2018-01675
`
`
`
`PTAB conference call - 7/25/19
`
`JUDGE JUNG: Okay.
`
`Thank you,
`
`Mr. Torczon.
`
`And, Mr. Torczon,
`
`is it correct you arranged a
`
`court reporter for this conference?
`
`MR. TORCZON:
`
`It is correct, Your Honor.
`
`She is on the line and we will get you a transcript
`
`promptly.
`
`
`
`JUDGE JUNG: Okay.
`
`Thank you.
`
`The Panel
`
`requested this conference to discuss, number one,
`
`for all the pending Pfizer versus Sanofi proceedings
`
`the claim construction standard to be applied to the
`
`joint proceedings; and number two, specifically for
`
`the 979 case,
`
`the agreement between the parties to
`
`join claim one and then withdraw the joinder for
`
`claims two and three.
`
`So I'll start with the claim construction
`
`standard for the joint proceedings.
`
`As you all know,
`
`the proceedings that Pfizer
`
`wants to join here were instituted under the
`
`broadest reasonable interpretation standard and then
`
`Pfizer filed its petitions after the board changed
`
`the standard to the one used in federal district
`
`court.
`
`And we note that the Patent Owner's already
`
`filed a response based on the broadest reasonable
`
`TSG Reporting - Worldwide
`
`877-702-9580
`
`Mylan Exhibit -1043
`
`Mylan v. Sanofi - |PR2018—01675
`
`Mylan Exhibit -1043
`Mylan v. Sanofi - IPR2018-01675
`
`
`
`PTAB conference call - 7/25/19
`
`Page 6
`
`interpretation standard in the Mylan versus Sanofi
`
`proceedings.
`
`Mr. Wong, does Pfizer have any issue with being
`
`joined for the proceeding using the broadest
`
`reasonable interpretation even though your petitions
`
`are filed after the change in claim construction
`
`standard?
`
`MR. WONG: There's no objection by Pfizer.
`
`JUDGE JUNG:
`
`And then, Mr. Ansley, does
`
`
`
`Patent Owner have any issues with the joined
`
`proceeding continuing on with the broadest
`
`reasonable interpretation standard?
`
`MR. ANSLEY: No, Your Honor.
`
`JUDGE JUNG: Okay. All right.
`
`Let me see
`
`if my Panel mates have any questions before I move
`
`on to the second topic.
`
`All right. Turning to the second topic,
`
`this
`
`is specific to the IPR2019—OO979 between Pfizer and
`
`Mylan —— and Sanofi.
`
`I've reviewed the motion for
`
`joinder,
`
`the Patent Owner responses and motion for
`
`joinder, and the reply in support of that motion,
`
`and it appears in that reply Patent Owner and
`
`Petitioner agree to the joinder of claim one but not
`
`claims two and three,
`
`to maintain the schedule we
`
`TSG Reporting - Worldwide
`
`877-702-9580
`
`Mylan Exhibit -1043
`
`Mylan v. Sanofi - |PR2018—01675
`
`Mylan Exhibit -1043
`Mylan v. Sanofi - IPR2018-01675
`
`
`
`PTAB conference call - 7/25/19
`
`have in the Mylan versus Sanofi proceedings.
`
`Is that correct, Mr. Wong?
`
`MR. WONG: Yes,
`
`that is correct, at least
`
`to my understanding, and we've been in conversations
`
`with the Patent Owner's counsel on that, yeah,
`
`there
`
`is no opposition to joining claim one,
`
`so long as
`
`claims two and three are not joined. And along
`
`those lines, Pfizer, as we said,
`
`in our reply brief
`
`has withdrawn its motion to join those claims to the
`
`Mylan proceedings.
`
`JUDGE JUNG: Okay.
`
`Thank you, Mr. Wong.
`
`Mr. Ansley,
`
`for the Patent Owner.
`
`MR. ANSLEY: That's correct, Mr. Wong's
`
`characterization of that is correct.
`
`
`
`JUDGE JUNG: Okay.
`
`Thank you, Mr. Ansley.
`
`Then turning back to Mr. Wong. Mr. Clemens'
`
`testimony, after I reviewed it briefly,
`
`seems to be
`
`substantively identical to Mr. Leinsing's testimony,
`
`the declarant in the Mylan versus Sanofi
`
`proceedings, but at the end there's some additional
`
`paragraphs about claims two and three.
`
`Is my understanding of the declaration in your
`
`petition correct, Mr. Wong?
`
`MR. WONG:
`
`That is correct. And you're
`
`TSG Reporting - Worldwide
`
`877-702-9580
`
`Mylan Exhibit -1043
`
`Mylan v. Sanofi - |PR2018—01675
`
`Mylan Exhibit -1043
`Mylan v. Sanofi - IPR2018-01675
`
`
`
`PTAB conference call - 7/25/19
`
`Page 8
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`correct,
`
`there's additional testimony on claims two
`
`and three separately, and so I
`
`think our proposal
`
`was to withdraw Mr. Clemens' declaration in this
`
`proceeding with respect to the 069 for claim one and
`
`rely on Mr. Leinsing that Petitioner Mylan is using,
`
`but
`
`then continue on and rely on Mr. Clemens'
`
`testimony on claims two and three in the
`
`proceeding —— on the claims two and three because
`
`it's not
`
`joined there.
`
`JUDGE JUNG: Okay.
`
`I just want
`
`to make
`
`sure I understand the point of agreement.
`
`Mr. Wong,
`
`just to clear it up, what happens to
`
`your declarant testimony after we join only as to
`
`claim one, do you still have any declaring testimony
`
`for claim one?
`
`(Simultaneous speaking.)
`
`MR. WONG:
`
`For unjoined claims,
`
`is that
`
`
`
`your question?
`
`JUDGE JUNG: Yes.
`
`MR. WONG:
`
`So our hope would be that we
`
`would rely on —— in Mr. Clemens' declaration we rely
`
`on those sections that relate to claims two and
`
`three, and I guess certainly,
`
`to the extent any of
`
`that's —— any of that relies on claim one, we
`
`TSG Reporting - Worldwide
`
`877-702-9580
`
`Mylan Exhibit -1043
`
`Mylan v. Sanofi - |PR2018—01675
`
`Mylan Exhibit -1043
`Mylan v. Sanofi - IPR2018-01675
`
`
`
`PTAB conference call - 7/25/19
`
`wouldn't necessarily rely on it, but it would be
`
`assumed in those —— in the further limitations
`
`regarding two and three,
`
`to the extent any of those
`
`limitations adds any patentability to claims two and
`
`three over claim one.
`
`JUDGE JUNG:
`
`I'm not quite clear what
`
`happens to your declarant testimony for the
`
`limitations of claim one that are incorporated in
`
`claims two and three by virtue of their dependency.
`
`Are you proposing to withdraw all the testimony
`
`on claim one in the unjoined proceeding?
`
`MR. WONG: That's right.
`
`So,
`
`for example,
`
`to the extent in the Mylan proceeding claim one is
`
`found to be unpatentable based on these
`
`Mr. Leinsing's, we would rely on Mr. Clemens in the
`
`unjoined proceedings on those limitations for view
`
`of limitations in claims two and three above and
`
`
`
`beyond what is in claim one.
`
`That might be the best
`
`way to approach it. Unless the Board has any
`
`further guidance,
`
`this might be easier.
`
`JUDGE JUNG:
`
`I'm trying to think ahead.
`
`And when I'm drafting the final written decision for
`
`the unjoined claims, claims two and three,
`
`seems
`
`like I would not be able to point to any declarant
`
`TSG Reporting - Worldwide
`
`877-702-9580
`
`Mylan Exhibit -1043
`
`Mylan v. Sanofi - |PR2018—01675
`
`Mylan Exhibit -1043
`Mylan v. Sanofi - IPR2018-01675
`
`
`
`PTAB conference call - 7/25/19
`
`Page 10
`
`testimony from the limitation of claim one that are
`
`incorporated into claims two and three;
`
`is that
`
`correct?
`
`MR. WONG: Yes,
`
`in a sense, yes.
`
`So if
`
`there wouldn't be any objection by Patent Owner and
`
`it was necessary for the Board to actually reach
`
`conclusions, another option would be to —— with
`
`respect to the unjoined claims, rely on Mr. Clemens'
`
`testimony for claim one to support
`
`those underlying
`
`limitations that claims two and three also have and
`
`proceed that way, if the Board were amenable to
`
`going forward on that route.
`
`JUDGE JUNG:
`
`Is there any issue with
`
`instituting the proceedings but not joining any
`
`other claims,
`
`let those proceedings proceed on its
`
`own with its own declarant testimony?
`
`MR. WONG:
`
`So the proposal would be to
`
`institute claims 1, 2, and 3, and ——
`
`JUDGE JUNG: That's correct.
`
`(Simultaneous speaking.)
`
`
`
`JUDGE JUNG:
`
`—— rely on 1, 2, and 3, but
`
`not join claim one to the Mylan proceeding.
`
`Is there any issues for Pfizer?
`
`MR. WONG: No, Your Honor, if that's what
`
`TSG Reporting - Worldwide
`
`877-702-9580
`
`Mylan Exhibit -1043
`
`Mylan v. Sanofi - |PR2018—01675
`
`Mylan Exhibit -1043
`Mylan v. Sanofi - IPR2018-01675
`
`
`
`PTAB conference call - 7/25/19
`
`Page ll
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`the Board deemed the most suitable,
`
`that would be
`
`okay for Pfizer as well.
`
`JUDGE JUNG: Okay. Let me just get
`
`the
`
`remarks from the other parties.
`
`Do you have anything to add, Mr. Ansley,
`
`for
`
`the Patent Owner as discussed with 979 case?
`
`MR. ANSLEY: We haven't considered this
`
`specific option. But right now, you know,
`
`I
`
`don't —— I'm not coming up with any objection at the
`
`moment.
`
`
`
`JUDGE JUNG: Okay. Once you have a chance
`
`to discuss it with your colleagues and maybe with
`
`also the other parties, please send us an e—mail at
`
`Trials if anything changes.
`
`And then, Mr. Torczon, do you have anything to
`
`add to what we discussed with the 979 case?
`
`MR. TORCZON:
`
`My understanding of what's
`
`been said so far is it sounds like the Board would
`
`be instituting the 979 as its own proceeding on its
`
`own timetable.
`
`That would be fine with us.
`
`I
`
`assume that that means that Pfizer wouldn't be a
`
`party at all in that case.
`
`And so I guess to the extent that there's any
`
`cross—talk between the proceedings, we would want it
`
`TSG Reporting - Worldwide
`
`877-702-9580
`
`Mylan Exhibit -1043
`
`Mylan v. Sanofi - |PR2018—01675
`
`Mylan Exhibit -1043
`Mylan v. Sanofi - IPR2018-01675
`
`
`
`PTAB conference call - 7/25/19
`
`Page 12
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`to be treated like any other unjoined case. But
`
`with that caveat, as long as it doesn't disrupt the
`
`timetable of the corresponding 1670 case for Mylan,
`
`we don't have any problem.
`
`JUDGE JUNG: Your only issue is just
`
`maintaining the schedule for the 1670 case?
`
`MR. TORCZON: Yes.
`
`(Simultaneous speaking.)
`
`MR. TORCZON: Right, we are very
`
`
`
`interested in the schedule.
`
`So, yes,
`
`that's —— that
`
`would be a basis of concern if the schedule in the
`
`Mylan IPR changed.
`
`And without that, we should be
`
`fine.
`
`JUDGE JUNG: Okay.
`
`Thank you,
`
`Mr. Torczon. Let me confer with my panel and see if
`
`they have any questions or issues.
`
`All right.
`
`Thank you both —— thank all of you
`
`for your participation in this conference.
`
`Just to
`
`be clear,
`
`the Panel will consider applying the
`
`broadest reasonable interpretation standard to the
`
`joint proceedings.
`
`And then for the 979 case, one
`
`of the options we're considering is not joining it
`
`to the 1670 case and letting it proceed on its own.
`
`If any of that presents an issue after this
`
`TSG Reporting - Worldwide
`
`877-702-9580
`
`Mylan Exhibit -1043
`
`Mylan v. Sanofi - |PR2018—01675
`
`Mylan Exhibit -1043
`Mylan v. Sanofi - IPR2018-01675
`
`
`
`PTAB conference call - 7/25/19
`
`Page 13
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`telephone conference, please contact the Board as
`
`soon as possible by e—mail at Trials.
`
`And before I adjourn this conference, any last
`
`questions, Mr. Wong?
`
`MR. WONG:
`
`Thank you, Your Honor. Nothing
`
`for Pfizer.
`
`JUDGE JUNG: Okay. Mr. Ansley,
`
`for Patent
`
`
`
`MR. ANSLEY:
`
`Thank you, Your Honor,
`
`for
`
`your time. Nothing for Patent Owner.
`
`JUDGE JUNG: Mr. Torczon.
`
`MR. TORCZON: Yes, Your Honor. When the
`
`joinder first came up, we asked a couple times for a
`
`call to present two points of opposition to the
`
`joinders.
`
`The Board has anticipated one of those
`
`issues, which is claim construction, and I
`
`understand that you're proceeding with the BRI
`
`construction so that resolves that point of
`
`opposition.
`
`The second point of opposition, we've touched
`
`on but haven't fully addressed and that is simply
`
`trial duration.
`
`The parties to the joinder case
`
`have indicated that they're no longer seeking an
`
`extension of time in the Mylan proceedings.
`
`So that
`
`TSG Reporting - Worldwide
`
`877-702-9580
`
`Mylan Exhibit -1043
`
`Mylan v. Sanofi - |PR2018—01675
`
`Mylan Exhibit -1043
`Mylan v. Sanofi - IPR2018-01675
`
`
`
`PTAB conference call - 7/25/19
`
`issue, part of the issue's been resolved.
`
`I guess one other thing I wanted to get out
`
`there,
`
`though,
`
`is I understand the Board's
`
`interpretation that joinder means there's no
`
`one—year deadline.
`
`As we've discussed in this call
`
`and as we discussed and briefed extensively in the
`
`pre—institution phase,
`
`the schedule is of
`
`significant concern to Mylan.
`
`And so to that extent, we understand that
`
`panels can change and this panel, of course,
`
`
`
`wouldn't want
`
`to tie the hands of any future panel,
`
`but
`
`I guess some sort of acknowledgment
`
`in the
`
`record that scheduling is an issue and that, you
`
`know,
`
`that the Mylan IPRs, at least, not be expanded
`
`unduly simply because there's a joinder in the case.
`
`JUDGE JUNG: Okay.
`
`Thank you,
`
`Mr. Torczon. At this point
`
`in time I don't foresee
`
`the need to extend the schedule or change the
`
`schedule in any way barring any stipulations from
`
`the parties as authorized by our scheduling order.
`
`The effective joinder on the schedule at this
`
`stage, at this point in time,
`
`seems like we'll still
`
`maintain the same schedule that has been occurring
`
`in the Mylan versus Sanofi cases.
`
`And I will also
`
`TSG Reporting - Worldwide
`
`877-702-9580
`
`Mylan Exhibit -1043
`
`Mylan v. Sanofi - |PR2018—01675
`
`Mylan Exhibit -1043
`Mylan v. Sanofi - IPR2018-01675
`
`
`
`JUDGE JUNG: Okay.
`
`Thank you,
`
`Mr. Torczon.
`
`Thank you all for your time, and this
`
`conference is adjourned. Have a good day.
`
`MR. TORCZON:
`
`You too.
`
`MR. WONG:
`
`Thank you.
`
`PTAB conference call - 7/25/19
`
`Page 15
`
`make a note of your concerns about
`
`the schedule and
`
`an order summarizing the details of this conference.
`
`MR. TORCZON: Okay.
`
`Thank you, Your
`
`Honor. That's all we can ask.
`
`(Proceedings concluded at 1:15 p.m.)
`
`TSG Reporting - Worldwide
`
`877-702-9580
`
`Mylan Exhibit -1043
`
`Mylan v. Sanofi - |PR2018—01675
`
`Mylan Exhibit -1043
`Mylan v. Sanofi - IPR2018-01675
`
`
`
`PTAB conference call - 7/25/19
`
`REPORTER'S CERTIFICATE
`
`I, Carrie LaMontagne, Certified Shorthand
`
`Reporter within and for the State of California,
`
`License No. 13393, do hereby certify that the
`
`foregoing procedure was reported by me on July 25,
`
`2019, and was thereafter transcribed with
`
`computer—aided transcription;
`
`that the foregoing is
`
`a full, complete, and true record of said
`
`proceedings.
`
`I further certify that I
`
`am not of counsel
`
`or attorney for either or any of the parties in the
`
`foregoing proceedings and caption named or in any
`
`way interested in the outcome of the cause in said
`
`
`
`caption.
`
`IN WITNESS WHEREOF,
`
`I have hereunto set my
`
`hand and official seal this 25th day of July, 2019.
`
`CARRIE LAMONTAGNE, CSR #13393
`
`TSG Reporting - Worldwide
`
`877-702-9580
`
`Mylan Exhibit -1043
`
`Mylan v. Sanofi - |PR2018—01675
`
`Mylan Exhibit -1043
`Mylan v. Sanofi - IPR2018-01675
`
`