`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`—————X
`
`WATSON LABORATORIES,
`
`INC.,
`
`Petitioner,
`
`UNITED THERAPEUTICS,
`
`INC.,
`
`Patent Owner.
`
`Case No.
`
`IPR201T—01621
`
`Patent No. 9,358,240
`
`Case No.
`
`IPR201T—01622
`
`Patent No. 9,339,507
`
`
`
`Friday, February 23, 2018
`
`Washington, DC,
`
`CONFERENCE CALL
`
`held at the offices of Foley & Lardner LLP, 3000 K
`
`Street, N.W., Suite 600, Washington, D.C. 2000?,
`
`beginning at 1:00 p.m., before LORA M. GREEN, ERICA A.
`
`FRANKLIN and DAVID COTTA, Administrative Patent Judges,
`
`and reported by Frances M. Freeman, a Court Stenographer
`
`for the District of Columbia, when were present on
`
`behalf of the respective parties:
`
`Job No. 138118
`
`'I‘SG Reporting - Worldwide
`
`877—702-9580
`
`UNITED THERAPEUTICS, EX. 2032
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201T-01621 and |PR2017—D1622
`Page 1 of 18
`
`
`
`ANDREW SUMMER, ESQUIRE (Telephonically)
`
`KURT MATHAS, ESQUIRE (Telephonically)
`
`Winston & Strawn
`
`1700 K Street, N.W.
`
`WATSON LABORATORIES V. UNITED THERAPEUTICS
`
`Page 2
`
`APPEARANCES:
`
`For the Petitioner:
`
`Washington, D.C. 20006
`
`'I‘SG Reporting - Worldwide
`
`877—702-9580
`
`UNITED THERAPEUTICS, EX. 2032
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201T-O1621 and |PR2017—D1622
`Page 2 of 18
`
`
`
`STEPHEN MAEBIUS, ESQUIRE
`
`GEORGE QUILLIN, ESQUIRE
`
`NATASHA IYER, ESQUIRE (Telephonically)
`
`Foley & Lardner
`
`3000 K Street, N.W.
`
`Washington, D.C. 2000?
`
`RICHARD TORCZON, ESQUIRE (Telephonically)
`
`Wilson Sonsini Goodrich & Rosati
`
`1700 K Street, N.W.
`
`WATSON LABORATORIES V. UNITED THERAPEUTICS
`
`Page 3
`
`APPEARANCES:
`
`(Continued)
`
`For the Patent Owner:
`
`Washington, D.C. 20006
`
`'I‘SG Reporting - Worldwide
`
`877—702-9580
`
`UNITED THERAPEUTICS, EX. 2032
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201T-O1621 and |PR2017—D1622
`Page 3 of 18
`
`
`
`Proceedings
`
`Page 5
`
`EXHIBITS
`
`WATSON LABORATORIES V. UNITED THERAPEUTICS
`
`Page 4
`
`C O N T E N T S
`
`
`
`'I‘SG Reporting - Worldwide
`
`877—702-9580
`
`UNITED THERAPEUTICS, EX. 2032
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201T-O1621 and |PR2017—D1622
`Page 4 of 18
`
`
`
`WATSON LABORATORIES V. UNITED THERAPEUTICS
`
`
`
`
`P R O C H H
`)
`
`N G S
`
`Page 5
`
`THE COURT: Good afternoon.
`
`Judge Cotta
`
`speaking. With me on the line are Judges Green and
`
`Franklin. This is a conference call concerning
`
`IPR2017—Ol621 and IPR2017—01622.
`
`I would like to begin with a roll call. Who do
`
`we have on line for the petitioner?
`
`MR. SOMMER: Your Honor,
`
`for petitioner,
`
`this is
`
`Andrew Sommer. With me is my colleague, Kurt Mathas.
`
`Kurt currently has a pro hac vice pending before the
`
`panel.
`
`I believe the time has run for any opposition to
`
`that.
`
`If your Honors don't mind, Mr. Mathas will
`
`address the issues pending before the Board today.
`
`THE COURT: That's acceptable to me. Any
`
`objections from the patent owner?
`
`
`
`MR. MAEBIUS: None here, Your Honor.
`
`THE COURT: And who do we have on line for the
`
`patent owner?
`
`MR. MAEBIUS: Good afternoon. This is Steve
`
`Maebius from Foley & Lardner.
`
`I'm here with George
`
`Quillin also from Foley & Lardner on behalf of
`
`continental United Therapeutics. And with us we also
`
`have a court reporter to transcribe today's call.
`
`THE COURT:
`
`Can you please provide a transcript
`
`'I‘SG Reporting - Worldwide
`
`877—702-9580
`
`UNITED THERAPEUTICS, EX. 2032
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201T-01621 and |PR2017—D1622
`Page 5 of 18
`
`
`
`WATSON LABORATORIES V. UNITED THERAPEUTICS
`
`Page 6
`
`of the call to petitioner and file it with the Board
`
`once you receive it?
`
`MR. MAEBIUS: Yes, Your Honor, we will.
`
`Let me Check to see if anybody else is on the
`
`line on behalf of patent owner.
`
`If they could identify
`
`themselves, please.
`
`MR. TORCZON: Richard Torczon from Wilson is
`
`also on the call.
`
`
`
`
`
`MS.
`
`IYER: Natasha Iyer from Foley is also on
`
`the call.
`
`THE COURT:
`
`Thank you.
`
`Is there anyone else on
`
`line who hasn't identified themselves?
`
`Okay.
`
`So this call was initiated because
`
`petitioner had requested authorization to file two
`
`motions. First, a motion to submit supplemental
`
`information pursuant to 37 CFR 42.123(a), and second, a
`
`motion for additional discovery under 37 CFR
`
`42.51(b)(2).
`
`We understand that patent owner opposes both
`
`requests for authorization to file these motions.
`
`Is
`
`that right?
`
`MR. MAEBIUS: That's correct, Your Honor.
`
`THE COURT: Okay. And further to our request,
`
`petitioner has provided a brief description of the
`
`'I‘SG Reporting - Worldwide
`
`877—702-9580
`
`UNITED THERAPEUTICS, EX. 2032
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201?-01621 and |PR2017—D1622
`Page 6 of 18
`
`
`
`WATSON LABORATORIES V. UNITED THERAPEUTICS
`
`Page 7
`
`factual basis for the motions to be filed.
`
`Petitioner, let's start with you.
`
`Do you have
`
`anything to add as to why we should authorize both
`
`motions to be filed?
`
`MR. MATHAS: Yes, Your Honor. This is Kurt
`
`Mathas on behalf of the petitioner.
`
`Just to provide a little additional detail on
`
`the statement in the e—mail to the Board about
`
`the
`
`
`
`factual basis, we're seeking to submit three pieces of
`
`evidence as supplemental
`
`information under the 42.123(a)
`
`as Your Honor mentioned.
`
`All three of the pieces of evidence relate to
`
`the issue of the contribution of the named inventors to
`
`the challenged claims of the patents here.
`
`We believe, Your Honors,
`
`that that issue is
`
`relevant to one of the main issues that is appearing
`
`between the parties as to the prior art status of the
`
`Ghofrani reference, and, namely, whether certain authors
`
`on the Ghofrani reference are others under 1 of 2(a).
`
`The documents fall under two categories.
`
`The
`
`first is the declaration from the prosecution history of
`
`the parent patent here that attaches some correspondence
`
`between one of the named inventors and some individuals
`
`at the patent owner's company related to contributions
`
`'I‘SG Reporting - Worldwide
`
`877—702-9580
`
`UNITED THERAPEUTICS, EX. 2032
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201?-01621 and |PR2017—D1622
`Page 7 of 18
`
`
`
`WATSON LABORATORIES V. UNITED THERAPEUTICS
`
`Page 8
`
`of inventorship of certain of the named inventors.
`
`The other two documents arise out of some state
`
`court litigation in Maryland in which a different named
`
`inventor has challenged inventorship and ownership of
`
`the challenged patents.
`
`And so in our view,
`
`the issue of inventorship of
`
`the challenged claims is plainly relevant to the
`
`analysis of whether or not the prior art Ghofrani paper
`
`is by another to a different inventive entity or not.
`
`Patent owner,
`
`I think,
`
`takes a different view on
`
`the relevance of those documents to that question. But
`
`we think under the case law the inventorship of the
`
`challenged claim is relevant.
`
`The second issue, Your Honor,
`
`the discovery
`
`motion also relates to one of the three documents that
`
`we seek to submit as supplemental
`
`information. And
`
`that's the patent prosecution history declaration.
`
`The
`
`publicly—available version of the file history
`
`declaration, Your Honors, attaches as some exhibits
`
`e—mails between one of the named inventors and
`
`
`
`individuals at patent owner.
`
`And certain of the information in the
`
`substantive portions of the e—mail has been redacted as
`
`well as certain information such as personal identifying
`
`'I‘SG Reporting - Worldwide
`
`877—702-9580
`
`UNITED THERAPEUTICS, EX. 2032
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201T-01621 and |PR2017—D1622
`Page 8 of 18
`
`
`
`WATSON LABORATORIES V. UNITED THERAPEUTICS
`
`Page 9
`
`information.
`
`We are not seeking the personal identifying
`
`information to be in an unredacted form, but we are
`
`seeking the substance of the e—mails in an unredacted
`
`form from the related context. And it appears that the
`
`discussion is related to, among other things,
`
`the
`
`contribution of certain of the named inventors against
`
`claims here.
`
`
`
`Specifically,
`
`there is some discussion in which
`
`one of the named inventors suggests that perhaps that
`
`several of the named inventors could just be withdrawn
`
`or removed from the pending application. And then there
`
`is certain redacted information that we believe is
`
`related to that same discussion that, obviously, we're
`
`unaware of what is behind the redactions and is why
`
`we're seeking the unredacted version.
`
`We think the request fully complies with all of
`
`the Garmin factors that the Board looks at in
`
`determining whether additional discovery meets the
`
`interest of justice. And we believe that such document
`
`should be produced.
`
`THE COURT: Okay.
`
`Thank you.
`
`Patent owner, can I hear your basis for opposing
`
`authorization to file?
`
`'I‘SG Reporting - Worldwide
`
`877—702-9580
`
`UNITED THERAPEUTICS, EX. 2032
`WATSON LABORATORIES V. UNITED THERAPEUTICS, lPR201?-01621 and IPR2017-D1622
`Page 9 of 18
`
`
`
`WATSON LABORATORIES V. UNITED THERAPEUTICS
`
`Page 10
`
`MR. MAEBIUS: Yes, Your Honor.
`
`We don't think that petitioner has established
`
`enough of a showing of relevance to warrant being
`
`authorized to file these motions and subject the parties
`
`and the Board to the time and expense that would be
`
`entailed with briefing and deciding the motions.
`
`And with respect to 42.123(a),
`
`this requires
`
`that the supplemental information be relevant to a claim
`
`on which there has been an institution decision. And
`
`neither the documents from the Rubin litigation nor the
`
`Rule 147(a) petition suggest that there is any
`
`disagreement about inventorship as to the noninventor
`
`Ghofrani coauthors who are also not even identified in
`
`any of the documents, and, certainly, no suggestion that
`
`noninventor Ghofrani coauthors should have been listed
`
`
`
`as inventors in either the '50? or '240 patents. And
`
`none of the documents relate to the lT—patient study
`
`that represents the relevant portion of the Ghofrani
`
`publication.
`
`So it's hard to see how these could be relevant
`
`to that part of the Ghofrani publication. Specifically,
`
`the Rule l.47(a) petition, which was submitted to accept
`
`the inventors' oath in a prior application with
`
`nonsigning inventors, which is from US Serial Number
`
`'I‘SG Reporting - Worldwide
`
`877—702-9580
`
`UNITED THERAPEUTICS, EX. 2032
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201T-O1621 and IPR2017-D1622
`Page 10 of 18
`
`
`
`WATSON LABORATORIES V. UNITED THERAPEUTICS
`
`Page II
`
`11/748205,
`
`is not relevant to whether Ghofrani is a
`
`publication by another.
`
`As that petition itself indicates,
`
`the refusal
`
`to sign was not based on a disagreement about
`
`inventorship, but, rather, it reflected the desire of
`
`certain coinventors to receive more compensation.
`
`And,
`
`in fact, all of the inventors in that
`
`earlier application eventually did sign an inventor
`
`declaration confirming that they all agreed that they
`
`were coinventors as to those claims in that particular
`
`application.
`
`
`
`And the claims of that particular application to
`
`which this petition related are quite different from the
`
`claims of the '507 and the '240 patents in the present
`
`IPRs.
`
`Even if the document did raise a question about
`
`contribution of certain inventors to those claims,
`
`that
`
`question would not necessarily relate to the claims at
`
`issue in these IPRs.
`
`And lastly about this earlier application,
`
`I
`
`would like to point out that it was later abandoned.
`
`Turning to the Rubin complaint and the Rubin
`
`declaration,
`
`the Rubin complaint is just a complaint and
`
`not evidence of any kind.
`
`'I‘SG Reporting - Worldwide
`
`877—702-9580
`
`UNITED THERAPEUTICS, EX. 2032
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201T-01621 and IPR2017-D1622
`Page 11 of 18
`
`
`
`WATSON LABORATORIES V. UNITED THERAPEUTICS
`
`Page 12
`
`In fact,
`
`in that matter, Rubin lost.
`
`The case
`
`was dismissed. And is now subject to a pending motion
`
`for attorneys' fees. And the same is true with this
`
`declaration.
`
`So neither of those documents provided any
`
`discussion about the work or failure to work with the
`
`Giesen inventors who are listed on the Ghofrani
`
`publication.
`
`
`
`And also,
`
`the Rubin complaint confirms that, as
`
`of around 2003, all of the work was being done
`
`collaboratively among the various inventors. And there
`
`wasn't any separate discussion once again of the
`
`17—patient study in Ghofrani.
`
`So the Rubin declaration,
`
`like the complaint, does not reference the Ghofrani
`
`group of authors at all.
`
`And with respect to the motion for additional
`
`discovery under 42.51(b)(2), it's patent owner's
`
`position that the petitioner hasn't satisfied the Garmin
`
`factors.
`
`In particular,
`
`the first Garmin factor, which
`
`is that there has to be more than a possibility and mere
`
`allegation that something useful might be discovered,
`
`because these documents in the Rule 47(a) petition don't
`
`
`reference the relevant subject matter of the Ghofrani
`
`publication. And that is the l7—patient study.
`
`Those
`
`'I‘SG Reporting - Worldwide
`
`877—702-9580
`
`UNITED THERAPEUTICS, EX. 2032
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201T-01621 and IPR2017-D1622
`Page 12 of 18
`
`
`
`WATSON LABORATORIES V. UNITED THERAPEUTICS
`
`Page 13
`
`petition documents simply don't relate to the relevant
`
`portion of Ghofrani.
`
`The petition is not relevant to whether the
`
`Ghofrani noninventor coauthors are inventors, but,
`
`rather, it relates to a contractual dispute under which
`
`some of the inventors refused to sign the declaration at
`
`one point in time because they believed they were
`
`entitled to additional compensation.
`
`The request to obtain the unredacted documents
`
`from the 47(a) petition would also violate a second of
`
`the Garmin factors. And that is the factor that the
`
`request for additional discovery cannot seek the other
`
`party's litigation position or underlying basis for
`
`
`
`those positions.
`
`It's clear that,
`
`from the context,
`
`that those
`
`redactions —— that they would relate to positions of the
`
`patent owner pertaining to this contractual dispute.
`
`For those reasons, we don't believe there is
`
`enough of a showing to warrant authorization for either
`
`of petitioner's motions.
`
`THE COURT:
`
`Thank you.
`
`Petitioner, would you like to respond briefly?
`
`MR. MATHAS: Yes, briefly.
`
`Thank you, Your
`
`'I‘SG Reporting - Worldwide
`
`877—702-9580
`
`UNITED THERAPEUTICS, EX. 2032
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201T-U1621 and |PR2017—D1622
`Page 13 of 18
`
`
`
`WATSON LABORATORIES V. UNITED THERAPEUTICS
`
`Page 14
`
`Just a couple points.
`
`I think that in our view
`
`patent owner is taking an overly narrow view of
`
`relevance here and what is relevant to the question that
`
`will be before the Board, which is:
`
`Is the Ghofrani
`
`reference by another.
`
`And as part of that analysis,
`
`the Board will
`
`undertake to determine the contribution of the authors
`
`to the Ghofrani paper as well as how that compares to
`
`the inventive entity of the challenged claims.
`
`These three pieces of evidence are directly
`
`relevant to the inventive entity of the challenged
`
`claims. And,
`
`therefore, will be relevant to the trial
`
`in this matter.
`
`
`
`At this point, Your Honor,
`
`the patent owner
`
`submitted with its preliminary response certain
`
`declarations from certain of the inventors that make
`
`certain claims about inventorship and contribution of
`
`the relative individuals. This information in the
`
`supplemental
`
`information will speak directly to those
`
`issues, Your Honor, and is part of development of the
`
`full record here before the trial, which is why we had
`
`sought to add them at this point so that the full record
`
`can be developed and that the Board can decide the issue
`
`on the full merits.
`
`'I‘SG Reporting - Worldwide
`
`877—702-9580
`
`UNITED THERAPEUTICS, EX. 2032
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201?-01621 and |PR2017—D1622
`Page 14 of 18
`
`
`
`WATSON LABORATORIES V. UNITED THERAPEUTICS
`
`Page 15
`
`THE COURT: Okay.
`
`And patent owner, anything
`
`MR. MAEBIUS: Nothing further, Your Honor.
`
`THE COURT: Okay.
`
`So if we were to authorize
`
`the motions to be filed, petitioner, how many pages
`
`would you be seeking and when would you be prepared to
`
`file?
`
`MR. SOMMER: Your Honor,
`
`this is Andrew Sommer
`
`for petitioner. And I can speak to that. We would look
`
`to file these as a consolidated motion.
`
`The documents
`
`between the two motions overlap. And we would submit
`
`that we can get this done in 10 pages. And get it on
`
`file in the next 10 days.
`
`THE COURT: And patent owner,
`
`I assume that if
`
`we were to grant the motion, you would like the
`
`opportunity to file an opposition?
`
`MR. MAEBIUS: Yes, we would, Your Honor.
`
`THE COURT: Okay.
`
`How much time would you need
`
`for that?
`
`
`
`MR. MAEBIUS:
`
`I would say two weeks.
`
`THE COURT: Okay.
`
`I presume you would also be
`
`looking for 10 pages?
`
`MR. MAEBIUS: Yes.
`
`10 pages.
`
`COURT: Okay.
`
`If you don't mind,
`
`I would
`
`'I‘SG Reporting - Worldwide
`
`877—702-9580
`
`UNITED THERAPEUTICS, EX. 2032
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201T-01621 and |PR2017—D1622
`Page 15 of 18
`
`
`
`WATSON LABORATORIES V. UNITED THERAPEUTICS
`
`Page 16
`
`like to pause briefly to confer with the panel and get
`
`back to you in a second.
`
`Thank you.
`
`(Pause.)
`
`
`
`further?
`
`THE COURT: Okay, counsel, we're back on line.
`
`I have had the opportunity to confer with the panel.
`
`We're going to take the matter under advisement, and we
`
`will be issuing an order in due course.
`
`If there is nothing else,
`
`I would like to
`
`adjourn this call.
`
`MR. MAEBIUS: Your Honor,
`
`just one thing from
`
`patent owner. We appreciate the e—mail from Andrew
`
`Kellogg authorizing a reply to petitioner's response to
`
`the hearing request. We just wanted to confirm because
`
`the e—mail said petitioner is authorized to file a
`
`reply. We presume that it means patent owner is
`
`authorized to file a reply?
`
`THE COURT: Yes, that's correct.
`
`MR. MAEBIUS:
`
`Thank you.
`
`THE COURT: Petitioner, do you have anything
`
`'I‘SG Reporting - Worldwide
`
`877—702-9580
`
`UNITED THERAPEUTICS, EX. 2032
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201?-01621 and |PR2017—D1622
`Page 16 of 18
`
`
`
`WATSON LABORATORIES V. UNITED THERAPEUTICS
`
`Page 17
`
`MR. SOMMER: No, Your Honor.
`
`THE COURT: Okay.
`
`Thank you. This call is
`
`adjourned.
`
`1:24 p.m.)
`
`(Whereupon,
`
`the conference call concluded at
`
`'I‘SG Reporting - Worldwide
`
`877—702-9580
`
`UNITED THERAPEUTICS, EX. 2032
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201T-01621 and |PR2017—D1622
`Page 17 of 18
`
`
`
`WATSON LABORATORIES V. UNITED THERAPEUTICS
`
`Page 18
`
`
`
`CERTIFICATE OF STENOTYPE REPORTER
`
`FRANCES M. FREEMAN
`
`I, Frances M. Freeman, Stenotype Reporter, do
`
`hereby certify that the foregoing proceedings were
`
`reported by me in stenotypy,
`
`transcribed under my
`
`direction and are a verbatim record of the proceedings
`
`had.
`
`Dated: 2—26—2018
`
`
`
`TSG Reporting - Worldwide
`
`877—702-9580
`
`UNITED THERAPEUTICS, EX. 2032
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201T-01621 and |PR2017—D1622
`Page 18 of 18
`
`