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` UNITED STATES PATENT AND TRADEMARK OFFICE
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`KASHIV PHARMA, LLC, )
`
` )
`
` Petitioner, )
`
` ) Case Nos.
`
` vs. ) IPR2018-00625
`
` ) IPR2018-00717
`
`PURDUE PHARMA L.P., THE )
`
`P.F. LABORATORIES, INC., ) Patent No.
`
`and PURDUE PHARMACEUTICALS ) 9,492,393 B2
`
`L.P., )
`
` )
`
` Patent Owners. )
`
`-------------------------- )
`
` PTAB CONFERENCE CALL
`
` Thursday, June 7, 2018
`
`Reported by:
`
`Stacey L. Daywalt
`
`JOB NO. 143292
`
`TSG Reporting - Worldwide 877-702-9580
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`REDACTED
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` UNITED STATES PATENT AND TRADEMARK OFFICE
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`KASHIV PHARMA, LLC, )
`
` )
`
` Petitioner, )
`
` ) Case Nos.
`
` vs. ) IPR2018-00625
`
` ) IPR2018-00717
`
`PURDUE PHARMA L.P., THE )
`
`P.F. LABORATORIES, INC., ) Patent No.
`
`and PURDUE PHARMACEUTICALS ) 9,492,393 B2
`
`L.P., )
`
` )
`
` Patent Owners. )
`
`-------------------------- )
`
` PTAB CONFERENCE CALL
`
` Thursday, June 7, 2018
`
`Reported by:
`
`Stacey L. Daywalt
`
`JOB NO. 143292
`
`TSG Reporting - Worldwide 877-702-9580
`
`REDACTED
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`Page 2
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` Thursday, June 7, 2018
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` 1:30 p.m.
`
` PTAB Conference Call, held before
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`Administrative Patent Judges Christopher G.
`
`Paulraj, Jacqueline T. Harlow and Kristi R.
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`Sawert, before Stacey L. Daywalt, a Court
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`Reporter and Notary Public of the District of
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`Columbia.
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`Page 3
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`A P P E A R A N C E S:
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`(All appearances are telephonic)
`
` LERNER, DAVID, LITTENBERG,
`
` KRUMHOLZ & MENTLIK
`
` Attorneys for Petitioner
`
` 600 South Avenue West
`
` Westfield, New Jersey 07090
`
` BY: TEDD VAN BUSKIRK, ESQ.
`
` NICHOLE VALEYKO, ESQ.
`
` JONES DAY
`
` Attorneys for Patent Owners
`
` 250 Vesey Street
`
` New York, New York 10281
`
` BY: GASPER LAROSA, ESQ.
`
` LISAMARIE LOGIUDICE, ESQ.
`
` JOHN NORMILE, ESQ.
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` ADMINISTRATIVE PATENT JUDGE: Good
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`afternoon. This is a conference call in
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`IPR2018-00625 and -00717.
`
` This is Judge Paulraj. And with me
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`on the call I have Judges Harlow and Sawert.
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` Can we get roll call, starting with
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`Patent Owners' side and then Petitioner's
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`counsel?
`
` MR. LAROSA: Definitely, Your Honor.
`
`This is Gasper LaRosa from Jones Day on behalf
`
`of the Patent Owner.
`
` I believe Lisamarie LoGiudice and
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`John Normile are also on the phone from
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`Jones Day on behalf of the Patent Owner.
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` I'd also just like to advise the
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`Court that we have a court reporter on the line
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`today.
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` ADMINISTRATIVE PATENT JUDGE: All
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`right. Thank you, Mr. LaRosa.
`
` Will you be speaking on behalf of
`
`Patent Owner?
`
` MR. LAROSA: I will, Your Honor.
`
`Thank you.
`
` ADMINISTRATIVE PATENT JUDGE: Okay.
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` Petitioner's counsel?
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` MR. VAN BUSKIRK: Hi, good
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`afternoon, Your Honors. This is Tedd
`
`Van Buskirk of the Lerner David firm. And I
`
`have my colleague Nichole Valeyko here as well
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`for the Petitioner Kashiv.
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` ADMINISTRATIVE PATENT JUDGE: All
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`right. Thank you, Mr. Van Buskirk.
`
` Do you have a court reporter as
`
`well, or is it just Patent Owner?
`
` MR. VAN BUSKIRK: It's just Patent
`
`Owner, Your Honor.
`
` ADMINISTRATIVE PATENT JUDGE: All
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`right.
`
` So since we do have a court
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`reporter, at the end of this call, whenever we
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`do have a final transcript, I'll ask Patent
`
`Owner to go and file that as an exhibit.
`
` Is that okay?
`
` MR. LAROSA: Yes, Your Honor. Thank
`
`you.
`
` ADMINISTRATIVE PATENT JUDGE: All
`
`right. Thanks.
`
` So the purpose of this call was a
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`request for a motion for discovery raised by
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`Patent Owner.
`
` So Mr. LaRosa, I'll let you start.
`
` MR. LAROSA: Thank you, Your Honors.
`
` As you mentioned, we're seeking a
`
`leave to file a motion for discovery regarding
`
`the real party in interest issues in this case,
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`the -- in particular, that it's our contention
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`that Petitioner failed to name Amneal
`
`Pharmaceutical as a real party in interest in
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`this proceeding.
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` Amneal is an affiliate of the
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`Petitioner Kashiv companies, which are commonly
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`owned and controlled. Amneal has been involved
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`in litigation with the Patent Owner for three
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`years concerning patents covering the same
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`technology.
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` Your Honor will remember that we
`
`were before you. Mr. Van Buskirk was
`
`representing Amneal --
`
` THE REPORTER: I apologize for
`
`interrupting, but I can barely hear you.
`
` This is the court reporter.
`
` MR. LAROSA: Is that better?
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` THE REPORTER: Yes.
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` The last thing I heard was "Mr. Van
`
`Buskirk was."
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` MR. LAROSA: Mr. Van Buskirk was
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`representing Amneal Pharmaceuticals in those
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`prior proceedings, IPR2016-1027, for example.
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`And in those proceedings, Kashiv was named as a
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`real party in interest.
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` So the -- in these cases, Kashiv is
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`the Petitioner, and it is our contention that
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`the reason for that is, earlier this year,
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`Amneal Pharmaceutical had entered into a merger
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`agreement with another company called Impax
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`pharmaceutical. And that created a problem for
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`Amneal with respect to challenging these
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`patents, in that Impax had a prior agreement
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`not to challenge these patents.
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` And in fact, what has happened here
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`is Amneal is using its affiliate Kashiv to do
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`what it is not able to do itself, which is
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`challenge these patents.
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` So we had -- there was two things we
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`were seeking when we first sought the call.
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` In the District Court cases, Amneal
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`and Kashiv have produced certain documents to
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`us that we would like to use in these
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`proceedings.
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` During a call yesterday, Kashiv's
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`counsel informed us that neither Amneal or
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`Kashiv would object to us using those documents
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`in this proceeding, so I believe that dispute
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`has been resolved.
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` What remains is our request to seek
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`two depositions. The first is of Chirag Patel,
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`who is an owner of both Amneal and Kashiv. And
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`we're seeking his testimony concerning the
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`influence and control Amneal has over its
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`affiliate Kashiv.
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` His testimony is particularly
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`important because the documents that we're
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`aware of that have been produced to us that
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`we'd like to use in this case and plan to use
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`show that Kashiv is owned by
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`. And this is very
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`much a black box. We don't know who owns or
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`controls
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` other than that contact
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`with respect to
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` can be made
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`through
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`, so we want to question
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` concerning the control
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` exerts
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`over Kashiv and its management.
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` The second person we'd like to
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`depose is Dr. Shah. He is the sole individual
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`at Kashiv who's responsible for the management
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`of that company. He has a longstanding
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`relationship with Amneal, and Chirag Patel in
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`particular, and we believe his testimony will
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`show that he continues to report to Amneal
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`management, and in particular Chirag Patel.
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` ADMINISTRATIVE PATENT JUDGE: So who
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`was that second individual again, Mr. LaRosa?
`
` MR. LAROSA: Navnit Shah.
`
` ADMINISTRATIVE PATENT JUDGE: Okay.
`
`Thank you.
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` MR. LAROSA: And so the information
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`we have is that Kashiv works exclusively for
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`Amneal, and we will seek testimony from Kashiv
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`and from him that Kashiv is operating under the
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`direction, supervision and control of Amneal
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`management.
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` ADMINISTRATIVE PATENT JUDGE: Okay.
`
`And before I turn it over to Mr. Van Buskirk, I
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`did want to ask you how soon were you
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`anticipating taking these depositions, because
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`I did note that I believe your Patent Owner
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`preliminary response is due June 22nd. Is that
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`right?
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` MR. LAROSA: Yes, Your Honor.
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` We can be ready to take the
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`depositions as soon as the witnesses can be
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`made available.
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` We do understand that the board
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`likes to address these issues as soon as
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`possible, so we can be prepared to take them as
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`soon as the witnesses can be made available.
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` ADMINISTRATIVE PATENT JUDGE: All
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`right.
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` And is the real party in interest
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`issue tied to a time bar issue?
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` You may have said that already. I
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`may have missed it.
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` But is that --
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` MR. LAROSA: I believe it is, Your
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`Honor, in that the date by which -- they no
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`longer will be able to get a filing date that
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`would allow them to meet the statutory
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`deadline.
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` ADMINISTRATIVE PATENT JUDGE: Okay.
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` With that, let me turn it over to
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`Mr. Van Buskirk.
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` MR. VAN BUSKIRK: Thank you very
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`much, Your Honor. I'd first like to note that
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`this same request to depose these two
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`individuals has been pending before the
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`District Court in Delaware in the parallel
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`litigation since February, and we think that,
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`to the extent there is any issue, we should
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`allow the District Court to handle that; and if
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`there's something there, maybe there's
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`something there.
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` The second point though is, we, as
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`Mr. LaRosa pointed out, agreed to produce these
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`585 pages, or not necessarily produce. They
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`already had them. We are allowing them to use
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`them for whatever argument they want to make
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`here.
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` But if they can't make a case out of
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`585 pages of documents, which include all the
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`agreements between Kashiv and Amneal, as well
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`as deposition transcripts of two Kashiv
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`employees, numerous written discovery responses
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`provided by Kashiv, Amneal and the very two
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`executives who they wish to depose now, we
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`would submit that there's no case to be made.
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` Mr. LaRosa also pointed out that
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`Dr. Shah is the sole decision maker at Kashiv.
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`That's what the documents show. There's
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`nothing more to be had there.
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` If he's the decision maker, this
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`entire idea that somehow Amneal is pulling the
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`strings or behind the curtain is nothing more
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`than speculation.
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` We have provided an entire body of
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`documents that tell the entire story. Purdue
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`doesn't want to believe that story and is
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`seeking to go on a fishing expedition.
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`Purdue's trying to paint a picture that there's
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`some sham going on, but they don't have any
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`basis for that beyond mere speculation.
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` Kashiv was, and is, the real party
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`in interest here. It owns the oxycodone
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`product at issue. It owns the ANDA for it, and
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`it has and continues to direct and control and
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`fund these IPRs.
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` So we would respectfully ask the
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`board to deny any request for additional
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`discovery and let this case proceed forward on
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`the merit.
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` ADMINISTRATIVE PATENT JUDGE: Now,
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`Mr. Van Buskirk mentioned a prior lawsuit
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`involving Amneal. And I know the parties were
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`here, or lead counsel was here, in a prior set
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`of IPRs involving Amneal.
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` But I guess I'm trying to get a
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`sense of the picture as to who's being sued as
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`to these particular patents or is there a
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`lawsuit to these particular patents involving
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`either Amneal and/or Kashiv.
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` MR. LAROSA: Yes, Your Honor. This
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`is Gasper LaRosa.
`
` With respect to these particular
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`patents, there's a lawsuit currently pending
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`between Purdue and Kashiv.
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` I would like to address, however,
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`the point that Mr. Van Buskirk made, which is
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`that somehow this discovery is currently
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`pending in a related litigation. So --
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` ADMINISTRATIVE PATENT JUDGE: Hold
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`on, Mr. LaRosa. Let me -- and I appreciate you
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`answering my question.
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` Let me make sure Mr. Van Buskirk is
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`done before I turn it back to you. And I will
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`give you the chance to briefly rebut the points
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`Mr. Van Buskirk said.
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` So first of all, Mr. Van Buskirk,
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`did you have anything further on what you
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`wanted to respond to Mr. LaRosa's initial
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`points?
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` MR. VAN BUSKIRK: Other than to
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`state that I don't think any of the Garmin
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`factors are met here, Your Honor, I will let
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`Mr. LaRosa proceed and address your question
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`and any others you may have.
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` ADMINISTRATIVE PATENT JUDGE: Okay.
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` So before I do that, one question I
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`had is: In the event that we were to order the
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`two depositions that Patent Owner is seeking --
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`and it appears that that's the extent to which
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`they're seeking discovery, since the documents
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`have already been produced -- is there a time
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`frame when these two individuals can be made
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`available? Because we are facing a deadline,
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`and so I am concerned about that.
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` MR. VAN BUSKIRK: Your Honor, I have
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`no idea about the availability of either
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`Dr. Shah or Mr. Patel.
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` Dr. Shah is the president and chief
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`scientific officer of Kashiv.
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` Chirag Patel is a cofounder and a
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`cochairman of Amneal, although since this
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`merger, he has stepped away from any day-to-day
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`decision-making.
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` I don't know their whereabouts. I
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`don't know their schedule. What I can tell you
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`is -- and I'm sure you're aware and
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`appreciate -- getting high-level management
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`executives like this is not an easy thing to
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`do.
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` ADMINISTRATIVE PATENT JUDGE:
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`Understood.
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` But I am a little concerned that
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`you're saying you don't know their whereabouts
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`and don't know their schedule. That's
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`something that I think as their -- you know,
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`since they do appear to be officers of your
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`clients, I would expect you to reach out and
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`try to at least make that determination.
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` And, you know, I understand we
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`haven't decided whether or not to order that
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`deposition, but I would ask you to at least
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`look into their availability in the event that
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`we do order a deposition. So let me put that
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`out there.
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` MR. VAN BUSKIRK: I can certainly do
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`that, Your Honor. And I wasn't -- I only
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`received these documents myself yesterday.
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` Obviously, Mr. LaRosa is far more
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`familiar with this, because he is also counsel
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`in litigation. So I'm a little bit behind the
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`eight ball here. I will look into it as far as
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`Kashiv.
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` I'd like to point out that I don't
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`represent Amneal, and Amneal isn't the party
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`here.
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` Mr. LaRosa made the point that we
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`agreed to produce the documents on behalf of
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`Kashiv and Amneal. I don't represent Amneal in
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`this proceeding, and I didn't represent to him
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`that I was.
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` I'd just like that clarification,
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`please.
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` ADMINISTRATIVE PATENT JUDGE: So to
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`be clear, you did represent Amneal in the prior
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`set of IPRs that were before us, but not in
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`this proceeding?
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` MR. VAN BUSKIRK: That's correct.
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`Amneal is not a party here.
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` I know that that's the whole point
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`of where Mr. LaRosa is going. But again, we
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`submit that Kashiv was and is the real party in
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`interest for purpose of these IPRs.
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` ADMINISTRATIVE PATENT JUDGE: Okay.
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` And I think more to the point, would
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`you be able to -- so going to Mr. Patel and
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`Mr. Shah, is one an employee of Kashiv and
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`one's an employee of Amneal?
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` MR. VAN BUSKIRK: Dr. Shah is the
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`president and chief science officer of Kashiv,
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`and the papers show that he is the sole
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`decision maker for Kashiv.
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` Mr. Patel, I don't know whether he's
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`considered an employee, but he was the
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`cofounder and cochairman of Amneal.
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` ADMINISTRATIVE PATENT JUDGE: What's
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`his relationship to Kashiv right now?
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` MR. VAN BUSKIRK: None that I'm
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`aware of, Your Honor.
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` ADMINISTRATIVE PATENT JUDGE: In the
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`event that we were to require a deposition of
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`Dr. Shah, are you the person to go through in
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`order to be able to obtain his deposition or is
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`there a third party counsel involved?
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` MR. VAN BUSKIRK: I would -- there
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`is additional counsel from the litigation who
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`is more familiar with the circumstances than I.
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` But between myself and other
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`counsel, we can figure out how to get Dr. Shah,
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`if needed.
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` ADMINISTRATIVE PATENT JUDGE: Okay.
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` Mr. LaRosa, let me turn it back to
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`you. I think you wanted to respond to
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`Mr. Van Buskirk's point.
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` MR. LAROSA: Sure, Your Honor. I
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`appreciate that.
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` First, I'll just point out that
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`Mr. Van Buskirk indicated he didn't get these
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`documents till yesterday.
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` I can say we copied him on May 25th
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`in our request to use these documents that we
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`sent to litigation counsel. So he has been
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`aware that these -- that this issue was out
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`there for some time.
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` Separate and apart from that, I'll
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`just say that, as he mentioned, the request for
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`discovery in the District Court has been
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`pending since February.
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` We don't -- we had hoped that that
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`would be resolved and we would have the
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`depositions we requested well in advance of
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`putting in our Patent Owner response. But it
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`is abundantly clear now that that's not going
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`to be the case, and that's why we are here.
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`Given the time frame before the PTAB, we
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`think -- we thought that we had really no
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`choice but to now seek the discovery here. So
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`that's why we're requesting it.
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` The final thing I'll say is that to
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`the extent that there is somehow an argument
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`that, you know, Mr. Patel is not involved in
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`the Kashiv corporation, I'll just reiterate
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`that this is the exact reason why we need his
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`deposition, because they have gone to great
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`lengths to try to hide the control that the
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`Patel family has over this Kashiv entity by
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`couching the ownership in the context of
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` and not telling us who
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` is
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`except to suggest that if we need to contact
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`, we need to do it through
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`.
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` So that's why we need his
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`deposition, to try to understand exactly -- you
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`know, this is a company that was under the
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`control of Amneal for years. They worked
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`directly with Dr. Shah. They continue to work
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`with Dr. Shah. And the suggestion that somehow
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` of Kashiv and they
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`had nothing to do with that corporation and
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`nothing to do with the control of these
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`proceedings, I think at a minimum it should be
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`a basis upon which we should be able to get a
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`deposition of these individuals to find out
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`exactly what's going on.
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` ADMINISTRATIVE PATENT JUDGE: I am
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`concerned generally about the timing.
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` So let me -- how soon -- if we were
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`to order a motion for discovery, because I
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`don't think we can decide the issue just based
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`on what's been said here.
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` So how soon could you get a motion
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`for discovery on file with us?
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` MR. LAROSA: Certainly by Monday, or
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`if it needs to be by tomorrow, we could do it.
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` ADMINISTRATIVE PATENT JUDGE: Okay.
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` All right. Let me put the parties
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`on hold and confer with the panel real quick.
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` (Recess was taken from 1:47 p.m. to
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`1:52 p.m.)
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` ADMINISTRATIVE PATENT JUDGE:
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`Counsel, this is Judge Paulraj again. I
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`conferred with the other panel members, and
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`this is what we're going to do.
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` So we're going to have Patent Owner
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`file a motion for discovery that's going to be
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`filed no later than tomorrow. And in that
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`motion we would definitely want to know what's
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`currently in the documents that would justify
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`the additional discovery under Garmin factor 1,
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`because depositions, as you recognize, are
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`definitely a big undertaking, especially before
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`the institution phase. So please highlight
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`exactly what's in the current documents that
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`would justify the further depositions that
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`you're seeking.
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` And Petitioner will have until
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`Tuesday, June 12th to file a response.
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` I know that's a fairly expedited
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`schedule, but we are concerned about that
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`June 22nd deadline for the Patent Owner
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`preliminary response.
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` So with that, is Counsel okay with
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`that proposed schedule?
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` MR. LAROSA: Yeah. I mean, I --
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`thank you, Your Honor. I think we can make
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`that schedule work. I think we'd prefer to
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`have it -- the weekend to put the briefing
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`together, considering we're going to need to
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`focus on what you're suggesting.
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` But if you'd prefer us to have it in
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`tomorrow, we'll make it happen.
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` ADMINISTRATIVE PATENT JUDGE: Yeah.
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`And I understand that, Mr. LaRosa, but
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`unfortunately I think this is an issue that you
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`have raised, and I think you'll -- I'm sure you
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`have plenty of team members that can help you
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`out with this.
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` So I understand that this is a
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`fairly expedited schedule, but yeah, if you can
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`get it to us tomorrow and then Patent -- or
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`Petitioner respond by Tuesday, then that will
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`give the panel enough time to at least consider
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`the option of -- consider the issue before the
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`preliminary response.
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` So in the meantime, I do want to --
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`and let me turn it to back to Mr. Van Buskirk
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`real quick.
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` Is Tuesday an okay time frame for
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`your response, Mr. Van Buskirk?
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` MR. VAN BUSKIRK: I guess it will
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`have to be.
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` If we could have an extra day. As I
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`said, I'm really trying to get up to speed on
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`these issues in a way that Mr. LaRosa and his
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`team had a leg up here.
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` THE ADMINISTRATIVE JUDGE: Okay.
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` MR. VAN BUSKIRK: And again, I
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`realize that you're -- the board is asking to
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`have this done given the deadline.
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` I guess we're all presupposing that
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`Patent Owner is, in fact, going to file a
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`Patent Owner preliminary response, but we don't
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`know that for a fact.
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` ADMINISTRATIVE PATENT JUDGE: Yeah.
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`At this time, I think we are assuming that
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`Patent Owner is going to file a preliminary
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`response, especially since it's raising an RPI
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`issue, and that that's at least going to be
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`part of the preliminary response.
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` I'll tell you what. I will give you
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`an extra day. I think I'm a little more
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`sympathetic to the fact that this issue is not
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`your issue. It's something that Patent Owner
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`has raised. So frankly, I think Patent Owner
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`should have at least the outline for a motion
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`already prepared, if they already requested a
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`motion before us.
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` So I'll give until the 13th for
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`Petitioner to file a response. But the motion
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`and the response will be limited to 15 pages.
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`We're not going to authorize any reply.
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` In the meantime, I am also going to
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`order the parties to confer. And
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`Mr. Van Buskirk, specifically you to determine
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`the availability of these witnesses for a
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`deposition, and if need be, a deposition that
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`will occur as soon as possible, preferably
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`before the 22nd deadline.
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` So if that's not a feasible option,
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`I would like to get an explanation in your
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`response as to when a deposition would be
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`feasible, if we were to order one.
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` In terms of timing, I am, again,
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`very concerned about how soon we can get all
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`this done, given the statutory deadlines that
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`are coming up.
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` So is that clear?
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` MR. VAN BUSKIRK: It is, Your Honor.
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`Thank you.
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` ADMINISTRATIVE PATENT JUDGE: All
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`right.
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` Let me put the parties on hold, and
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`if the panel has anything else, we'll get back
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`to you.
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` MR. VAN BUSKIRK: Actually, Judge
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`Paulraj, one further thing, if I may?
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` ADMINISTRATIVE PATENT JUDGE: Yes?
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` MR. VAN BUSKIRK: Given that these
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`documents from the litigation were produced
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`under a protective order and marked highly
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`confidential, I believe we will need a
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`protective order in place here in the IPR to
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`similarly protect these documents.
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` ADMINISTRATIVE PATENT JUDGE: That's
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`reasonable.
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` So the parties shall confer, and if
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`it's going to be the standard protective order
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`set forth in our Trial Practice Guide, that's
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`fine.
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` If you want to confer on a modified
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`protective order, you can do that. And then
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`any document that should be filed shall be
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`filed or an exhibit that's under District Court
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`protective orders can be filed under seal in
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`this proceeding.
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` MR. VAN BUSKIRK: Very good. Thank
`
`you.
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` ADMINISTRATIVE PATENT JUDGE: All
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`right.
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` And let me put the parties on hold.
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` (Recess was taken from 1:58 p.m. to
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`1:58 p.m.)
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` ADMINISTRATIVE PATENT JUDGE:
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`Counsel, the panel has nothing further.
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` So again, we have our schedule for
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`the motion and the response.
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` And if you could file the transcript
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`for this call, that will serve as our record of
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`this call.
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` So I think the panel has nothing
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`else, so we'll adjourn. Thank you.
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` MR. LAROSA: Thank you, Your Honor.
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` MR. VAN BUSKIRK: Thank you, Your
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`Honors.
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` ADMINISTRATIVE PATENT JUDGE: Thank
`
`you, Counsel.
`
` (Time Noted: 1:59 p.m.)
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`Page 28
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`District of Columbia, to wit:
`
` I, Stacey L. Daywalt, a Notary
`
`Public of the District of Columbia, do hereby
`
`certify that the proceedings were recorded
`
`stenographically by me and this transcript is a
`
`true record of the proceedings.
`
` I further certify that I am not of
`
`counsel to any of the parties, nor an employee
`
`of counsel, nor related to any of the parties,
`
`nor in any way interested in the outcome of
`
`this action.
`
` As witness my hand and Notarial Seal
`
`this 14th day of June, 2018.
`
` _________________________________________
`
` Stacey L. Daywalt, Notary Public
`
` My Commission Expires: 4/14/2021
`
`TSG Reporting - Worldwide 877-702-9580
`
`Purdue - IPR2018-00625; IPR2018-00717, Ex. 2017
`28 of 28
`
`
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