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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ---------------------------
` MYLAN PHARMACEUTICALS INC.,
` Petitioner,
` V.
`
` SANOFI-AVENTIS DEUTSCHLAND GMBH,
` Patent Owner.
` -------------------------------
`
` Case IPR2018-01675,
` Case IPR2018-01676 and
` Case IPR2018-01678
` --------------------------------
`
` TELEPHONIC CONFERENCE
` January 15, 2019
` HELD BEFORE ADMINISTRATIVE PATENT JUDGES
` BART A. GERSTENBLITH, JIM MAYBERRY
` and HYUN J. JUNG
`
` Reported by:
` Tiffany Valentine
` Job No. 154101
`
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`Mylan Exhibit - 1036
`IPR2018-01676 - Mylan v. Sanofi
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ---------------------------
` MYLAN PHARMACEUTICALS INC.,
` Petitioner,
` V.
`
` SANOFI-AVENTIS DEUTSCHLAND GMBH,
` Patent Owner.
` -------------------------------
`
` Case IPR2018-01675,
` Case IPR2018-01676 and
` Case IPR2018-01678
` --------------------------------
`
` TELEPHONIC CONFERENCE
` January 15, 2019
` HELD BEFORE ADMINISTRATIVE PATENT JUDGES
` BART A. GERSTENBLITH, JIM MAYBERRY
` and HYUN J. JUNG
`
` Reported by:
` Tiffany Valentine
` Job No. 154101
`
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` January 15, 2019
` 3:02 p.m.
`
` Telephonic Conference held before
` the Honorable PTAB Administrative Judges
` Bart A. Gerstenblith, Jim Mayberry and Hyun
` J. Jung. Held also before Tiffany
` Valentine, a Notary Public for the State of
` New York.
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` A P P E A R A N C E S:
`
`
` WILSON SONSINI GOODRICH & ROSATI
` Attorneys for Petitioner
` 1700 K Street NW
` Washington, DC 20006
` BY: RICHARD TORCZON, ESQ.
` TASHA THOMAS, ESQ.
` WES DERRYBERRY, ESQ.
`
`
` WEIL GOTSHAL & MANGES
` Attorneys for Patent Owner
` 767 Fifth Avenue
` New York, New York 10153
` BY: ANISH DESAI, ESQ.
` ELIZABETH WEISWASSER, ESQ.
`
`
` ALSO PRESENT:
` STEPHANIE DONAHUE, ESQ.
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`IPR2018-01676 - Mylan v. Sanofi
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` PROCEEDINGS
`
` JUDGE GERSTENBLITH: Good afternoon,
`everyone. This is Judge Gerstenblith.
`With me on the line are Judges Mayberry and
`Jung.
` This is a conference call for three
`related cases, IPR2018-01675, 01676 and
`01678.
` Let's do a quick roll call. Who is
`on the line for petitioner, please?
` MR. TORCZON: Thank you, your Honor,
`for taking the call. This is Richard
`Torczon for Mylan. I also have with me on
`the line Wes Derryberry and Tasha Thomas.
`And I should advise the Board the call is
`being transcribed.
` JUDGE GERSTENBLITH. Excellent.
`Thank you very much.
` Who do we have on the line for
`Patent Owner?
` MR. DESAI: Anish Desai for Patent
`Owner. Also on the line is Elizabeth
`Weiswasser from Weil and Stephanie Donahue
`from Sanofi.
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` PROCEEDINGS
` JUDGE GERSTENBLITH: Thank you very
`much.
` This call was requested by
`Petitioner. So Mr. Torczon, I will give
`you the floor.
` MR. TORCZON: Thank you, your Honor.
`The call is about getting a reply to the
`Patent Owner preliminarily responses.
` There are really three points we
`would like to raise in reply. The first is
`the discretionary bases proposed for
`denial. We believe that they are contrary
`to both fact and law.
` We believe if the Board wants to act
`on them, we, under both due process and
`statutory requirements, would require a
`reply before the issues could be reached.
`And most seriously, I think precisely
`because what they're proposing is so
`clearly contrary to statute. Sanofi is
`basically inviting the Board to engage in
`shenanigans.
` A second point we would like to
`reach is, at least in the 1675 petition,
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` PROCEEDINGS
`there is a typo on page 25. We cite to
`column three at lines 42 through 44 of the
`044 patent, and we should have cited to
`column three, line 62 through 64 of the
`same patent. So if appropriate, we would
`like to use some mechanism to have that
`correction reflected.
` And finally, we would like to have
`an opportunity to point out the
`overwhelming use of attorney argument.
`Most of what Sanofi is presenting as
`factual argument is in fact attorney
`argument. Not only is that inappropriate
`basis for decision, but it also highlights
`issues for trial rather than militating
`against institution.
` So those are the three points we
`would like to address. Since Sanofi spends
`about 15 pages of the discretionary bases,
`we think that would be an appropriate
`amount for the reply. And we would like to
`ask for ten business days to file.
` We would be happy to file an
`identical paper in each case to, you know,
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`reduce the burden on both Sanofi and the
`Board.
` I can get into more detailed
`argument about the discretionary bases if
`you want, or I am happy to stop there for
`the time being.
` JUDGE GERSTENBLITH: Let's just stop
`there just for a minute. You mention there
`was one -- a typo in the just in the 1675
`case?
` MR. TORCZON: Yes. Just that one
`typo we were off by 20 lines in the line
`citation; instead of 42, it should be 62.
` JUDGE GERSTENBLITH: And is that
`something that is raised by Patent Owner in
`the preliminarily response?
` MR. TORCZON: They do drop a
`footnote suggesting that the lines that we
`cited don't say what we say they say. And
`they are of course correct, because the
`statement is actually 20 lines lower down
`in the same column.
` We don't think Sanofi is surprised.
`They not only have the patent, it's their
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`patent. So we don't think there is any
`prejudice there. But just for clarity in
`the record, we are happy to correct the
`typo.
` JUDGE GERSTENBLITH: Let me just see
`one thing here -- so I just want to take a
`look at it while we're talking. The file
`is a little bit slow here. So Page 25 of
`the petition and where exactly is it?
` MR. TORCZON: I actually don't have
`the petition open in front of me.
` JUDGE GERSTENBLITH: I think there
`is only one spot. You said in column
`three, instead of citing lines 42 to 44, it
`should be 62 to 64?
` MR. TORCZON: Exactly, your Honor.
` JUDGE GERSTENBLITH: Let me just
`look at one other thing. I apologize for
`keeping everyone in suspense.
` Okay. Let's hear from -- are you
`speaking for Patent Owner?
` MR. DESAI: Yes, I am, your Honor.
` JUDGE GERSTENBLITH: Okay. Let's --
`I will let you go through your response.
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` MR. DESAI: So just to put the
`timeline here, Mylan's petitions were filed
`in September of 2018. That was about 11
`months after litigation in New Jersey
`started at the Hatch-Waxman case, and about
`nine months after Mylan served its
`invalidity contentions in that New Jersey
`case asserting the same prior art grounds.
`The New Jersey case will go to trial and it
`will have a decision well before a final
`written decision occurs in these IPR's,
`assuming institution.
` For those reasons we explained in
`our Patent Owner response, these IPR's
`would not be an efficient use for the
`Board's resources and we believe the
`applicability of 314(a) here is clear. And
`the General Plastics factors adjusted to
`account for the fact that this isn't a
`follow-up petition slightly different from
`factual scenarios favors denial.
` For Mr. Torczon's argument, I didn't
`hear an argument for why there is good
`cause for reply. General Plastics is a
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`case that was decided in 2017 in September,
`and was made precedential in October of
`that same year.
` Also, the August 2018 Trial Practice
`Guide update, on pages 10 and 11,
`specifically informed parties that there
`may be reasons for discretionary denial
`besides follow-on petitions. And
`specifically it said, "Events in other
`proceedings related to the same patent,
`either at the office, in District Courts or
`the ITC."
` And the Practice Guide specifically
`invites parties to address the issues in
`their submissions. This is, again, pages
`10 and 11 of the Trial Practice Guide.
` Mylan was certainly aware of the New
`Jersey case and all of the associated facts
`regarding that case, when it filed its
`petitions, and simply chose not to address
`the impact of that case on these IPR's.
` If you see their petitions in the
`mandatory notices, I think they address the
`New Jersey case in one sentence.
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` So it was really Mylan's choice not
`to discuss the associated litigation, even
`though the Trial Practice Guide invited
`parties to do so in their submissions.
` And, therefore, we don't see there
`is good cause for reply here. And
`certainly not good cause for 15 page reply
`that Mylan is now seeking, which would
`basically extend its page limit on its
`petition for 60 to -- or the word count on
`its petition.
` And I think we believe the Board has
`been very capable of assessing the 314(a)
`issue. Also the NHK case and how it
`applies to these facts. Mylan's desire to
`present argument after the fact now is not
`good cause.
` MR. TORCZON: May I respond, your
`Honor?
` JUDGE GERSTENBLITH: Let me just
`hear Patent Owner's position on the
`citation there.
` Is there any objection to, through
`whatever mechanism, whether it is just us
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`making a note based on this phone call,
`that that citation was -- the 4 should have
`been a 6 in each of those line cites?
` MR. DESAI: Your Honor, to be honest
`with you, we were not informed that that
`was going to be the subject of is this call
`so I haven't looked into that issue at all.
`We assumed that this reply was about the
`discretionary denial issues and we were
`never informed this is a typo and they were
`seeking to correct it.
` So on the fly here, I can't say
`whether we opposed it or not. Doesn't seem
`like it is a major issue, but it's hard for
`me to weigh in on that without having been
`informed beforehand.
` JUDGE GERSTENBLITH: Okay. Let me
`see here -- let me do this: Let me put you
`all on hold for a moment. I will give you
`another chance to respond if need be. Let
`me just put you on hold for a few minutes
`and we will can right back on, okay.
` (Whereupon, a brief pause in
`proceedings took place.)
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` JUDGE GERSTENBLITH: Mr. Torczon, we
`are back now.
` If we were to limit the reply to
`just address 314, how many pages would
`petitioner be looking for there?
` MR. TORCZON: I think there is
`actually a lot wrong with their argument
`and they have spent about 15 pages on it,
`so we would like 15 pages. You know, if it
`is less, we would prefer that it not be a
`whole lot less because as I said, I think
`there is an awful lot that's wrong with the
`argument.
` JUDGE GERSTENBLITH: Well, you asked
`for 15 when you also were going to address
`attorney argument. So I am removing that
`in the calculus of the page count.
` MR. TORCZON: Okay. We would like
`12, then.
` JUDGE GERSTENBLITH: And ten
`business days is a legitimate time for you
`to turn that around? And that would be to
`turn it around in all three cases?
` MR. TORCZON: Yes. In fact, your
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`Honor, I proposed filing an identical paper
`in each case with the Board's permission
`because we are going to be focusing on
`arguments that they have made common to all
`the cases. I just think that that limits
`the burden on the Board and the parties
`because the issues are going to be the
`same.
` JUDGE GERSTENBLITH: We certainly
`don't object to filing the same paper as
`long as you do what you need to make it
`match up with anything specific to that
`case. So we would not be combining caption
`or anything like that. But if it turns out
`that the same substance is in both,
`certainly no objection to that from us.
` MR. TORCZON: I believe we can do
`that. I believe if we need a departure we
`will note it. Otherwise I believe we can
`file the identical paper in everything.
` JUDGE GERSTENBLITH: All right. So
`I said I was going to give you another
`chance to say anything you wanted, Mr.
`Torczon.
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` Is there anything else you wanted to
`add?
` MR. TORCZON: If you're authorizing
`the reply, then we'll just save it for the
`reply. And that way we will spell out with
`citations and everything there.
` JUDGE GERSTENBLITH: Mr. Desai,
`anything else you wanted to add before I
`give you the answer for today?
` MR. DESAI: Sure. Just to the
`extent that Mylan is going to be authorized
`a reply and adding factual and legal
`arguments about this issue, since we think
`this is something that should have been
`addressed in the petition according to
`Trial Practice Guide, we would like to
`respond as well.
` So to the extent Mylan is
`authorized, Sanofi thinks they should be
`entitled to a response on this issue.
` JUDGE GERSTENBLITH: So what I would
`say is -- we will discuss the whole thing
`right now.
` So what we are going to do is
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`authorize a limited reply on the 314
`discretionary denial issue. We're going to
`authorize up to -- sorry there was an
`interruption there. We are going authorize
`up to 12 pages within ten business days of
`today, which looks like -- and somebody
`please check me on this -- looks like it
`would be Wednesday, January 30.
` Is there anybody there that thinks I
`calculated that wrong?
` MR. TORCZON: That looks right to
`me, your Honor.
` JUDGE GERSTENBLITH: Okay. And that
`will be for the three cases.
` And second point is -- again, so
`that that's limited to just 314. Second,
`we will wait to hear from Patent Owner -- I
`should say we would like Patent Owner to
`reach out back to Petitioner and have you
`discuss the citation on Page 25 of the
`petition and see if you guys can reach an
`agreement on that.
` We are flexible to what you would
`agree. So if you agree to file an exhibit
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`or something that says recognize this
`change in the petition for this citation,
`you know that we can certainly work with
`something that does not require a lot of
`additional work for anybody. So that's the
`second thing.
` Third thing, Mr. Desai, we will
`entertain requests -- we will not grant a
`sur-reply right now for Patent Owner. But
`once the reply is filed, if you think there
`is something there that warrants discussion
`of a sur-reply, then please reach back out
`to us.
` Obviously don't wait an unnecessary
`amount of time to do that because of course
`the clock to ticking on everything and we
`want to keep things moving.
` Any questions about that?
` MR. DESAI: No, your Honor.
` MR. TORCZON: Not from Mylan, your
`Honor.
` JUDGE GERSTENBLITH: Any questions
`about any of the things that I said today
`so far, from petitioner?
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` MR. TORCZON: No, your Honor.
` JUDGE GERSTENBLITH: From Patent
`Owner?
` MR. DESAI: No, your Honor.
` JUDGE GERSTENBLITH: Okay. I'm
`going to add one more thing. Who arranged
`for the court reporter?
` MR. TORCZON: Mylan did, your Honor.
` JUDGE GERSTENBLITH: Thank you very
`much. That always helps. If you would --
`you know, normally I never used to have to
`say this because folks would get
`transcripts on file within two weeks
`without having to say anything. But we
`really are looking for a within two week or
`less filing of the transcript. Not looking
`to cause unnecessary expense, but what
`happens is questions get asked and if it
`takes longer than that, we don't have the
`record for it.
` So once the transcript is ready,
`please share it with the other side. Once
`you both agree that there is no edits that
`are needed, then file it as an exhibit in
`
`TSG Reporting - Worldwide - 877-702-9580
`
`Mylan Exhibit - 1036
`IPR2018-01676 - Mylan v. Sanofi
`
`
`
`1
`2
`3
`4
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`Page 19
`
` PROCEEDINGS
`each of the three cases.
` MR. TORCZON: Will do, your Honor.
` JUDGE GERSTENBLITH: Anything that
`we didn't today that we should have talked
`about from Petitioner side?
` MR. TORCZON: No, your Honor.
` JUDGE GERSTENBLITH: Anything we
`should talk about today that we didn't talk
`about so far from Patent Owner side?
` MR. DESAI: No, your Honor.
` JUDGE GERSTENBLITH: Then with that,
`we are adjourned. Have a great week
`everyone.
` (Time Noted: 3:23 p.m.)
`
`TSG Reporting - Worldwide - 877-702-9580
`
`Mylan Exhibit - 1036
`IPR2018-01676 - Mylan v. Sanofi
`
`
`
`PROCEEDINGS
`C E R T I F I C A T E
`
`Page 20
`
` STATE OF NEW YORK
`
` COUNTY OF NASSAU
`
`)
`
`)
`
`: SS.:
`
`I, TIFFANY VALENTINE, a Notary
` Public for and within the State of New York, do
` hereby certify:
`
`That the witness whose examination
` is hereinbefore set forth was duly sworn and
` that such examination is a true record of the
` testimony given by that witness.
`
`I further certify that I am not
` related to any of the parties to this action by
` blood or by marriage and that I am in no way
` interested in the outcome of this matter.
` Dated: 1-16-2019
`
`4 ,v amz;fi,e,
`
`___________________________
`TIFFANY VALENTINE
`
`TSG Reporting - Worldwide - 877-702-9580
`
`1
`2
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`23
`
`24
`25
`
`Mylan Exhibit - 1036
`IPR2018-01676 - Mylan v. Sanofi
`
`
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