`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`STEADYMED, LTD., )
` Petitioner, ) Case IPR2016-000006
` -v- ) Patent 8,497,393 B2
`UNITED THERAPEUTICS CORPORATION, )
` Patent Owner. )
` ------------------------------------------
` DATE: April 5, 2017
` TIME: 1:30 p.m.
`
` TELEPHONIC CONFERENCE CALL BEFORE
` the Panel among the respective parties, before
` Gail L. Inghram Verbano, BA, CRR, CLR, RDR,
` CSR-CA (No. 8635), and Notary Public.
`
` Job No. 122265
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`TSG Reporting - Worldwide 877-702-9580
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` P.1
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` UT Ex. 2062
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`
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`Page 2
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`Page 3
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`ADMINISTRATIVE PATENT JUDGES:
`Judge Jacqueline T. Harlow
`Judge Lora M. Green
`Judge Joni Y. Chang
`
`ALSO PRESENT:
`SHAUN SNADER, United Therapeutics
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`A P P E A R A N C E S:
`
` Attorneys for Petitioner:
` DLA PIPER US
` 1251 6th Avenue
` New York, New York 10020
` BY: STUART POLLACK, ESQ.
` LISA HAILE, ESQ.
`
` Attorneys for United Therapeutics:
` FOLEY & LARNDER
` Washington Harbor
` 3000 K Street NW
` Washington, D.C. 20007
` BY: STEPHEN MAEBIUS, ESQ.
` GEORGE QUILLIN, ESQ.
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`Page 4
`TELEPHONIC CONFERENCE CALL -- 4/5/17
` JUDGE HARLOW: This is a conference
`call in IPR 2016-00006, SteadyMed versus
`United Therapeutic. The purpose of
`today's call is to discuss the SteadyMed
`Request for Authorization to file a Motion
`to Request Action by the Board with regard
`to two new patents that recently issued
`from continuing applications of the '393
`patent.
` I understand that the parties have
`been introducing themselves as they've
`signed on to the call, but for the benefit
`of the court reporter, let's go ahead and
`take roll, starting with the Petitioner.
` Will counsel please introduce
`yourselves, identify anyone else who is
`present for your side, and then Patent
`Owner can proceed after that.
` MR. POLLACK: Thank you, Your Honor.
`This is Stuart Pollack on behalf of the
`Petitioner, SteadyMed. I'm joined by my
`colleague, Lisa Haile, from the same law
`firm, DLA Piper.
` MR. MAEBIUS: And on behalf of
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`TELEPHONIC CONFERENCE CALL -- 4/5/17
`Patent Owner, this is Steve Maebius with
`Foley Lardner, and I'm here with George
`Quillin; and also Shaun Snader from United
`Therapeutics Corporation is on the line.
` JUDGE HARLOW: Thank you.
` Turning to the substance of our call
`today, SteadyMed appears to seek action by
`the Board relating to the estoppel
`provisions of 37 C.F.R.
`Section 42.7(d)(3).
` Is that a fair representation,
`Mr. Pollack?
` MR. POLLACK: Yes, Your Honor.
` JUDGE HARLOW: So when you begin to
`discuss your portion, one thing I'm
`particularly curious about is how it is
`that the estoppel provisions are
`consistent with the idea of retroactively
`canceling claims in patents that issued
`prior to the decision by the Board.
` I'd also be interested to hear your
`views on how SteadyMed's request is timely
`instead of being premature, given that the
`time to appeal the final written decision
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`TSG Reporting - Worldwide 877-702-9580
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` P.2
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` UT Ex. 2062
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`
`
`Page 6
`TELEPHONIC CONFERENCE CALL -- 4/5/17
`has not yet expired.
` With that, please feel free to
`address your request.
` MR. POLLACK: Thank you, Your Honor.
`I'm going to address your second question
`first.
` Section 42.7(d)(3) does address the
`situation we're in now where a final
`written decision has issued. And that's
`because, under Section 42.7(d)(3) and
`under the other regulations and the
`statute, the claims, in fact, are
`canceled, having a final written decision
`answer.
` Now, how do I know that? Well, the
`Supreme Court has said so. The Federal
`Circuit has said so. In addition, the
`Patent Office has said so when it
`promulgated Section 42.7(d)(3).
` Let me start with the courts first.
` In the Supreme Court decision that
`we all know and are familiar with, Cuozzo,
`Speed Tech versus Lee -- that's 136
`Supreme Court 2131 from 2016. In numerous
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`TELEPHONIC CONFERENCE CALL -- 4/5/17
` So similarly, the Federal Circuit
`which, of course, is hearing an appeal at
`the first instance, has consistently said
`that the Board has canceled the claims
`with the final written decision. The
`examples are numerous so I'm just going to
`give a few. There's the Belden case,
`Belden v. Berk-Tek, in 2015, 805F.3d, 1064
`at 1072. And they say Belden appeals the
`cancellation of Claims 1 through 4.
` Another example -- and there's many
`of these -- Dell v. Acceleron, 818 F.3d
`1293 in 2016 at 1295, where they say we
`vacate the Board's cancellation of Claim
`20.
` And just last week, Intellectual
`Ventures II, LLC versus Commerce Bank
`Shares -- that's a decision on
`March 27th, 2017. It's 2017 WL 113
`02320. It's too early for the F.3d
`reported decision to come out. It says
`there at star 2, We affirm the Board's
`cancellation of Claims 26, 28, 30 to 33 in
`that proceeding. And then at star 4, For
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`Page 7
`TELEPHONIC CONFERENCE CALL -- 4/5/17
`places it states that the final written
`decision canceled Cuozzo's claims.
` For example, at page 2137 it states
`that, quote: The statute authorizes
`judicial review of a final written
`decision canceling a patent claim.
` Similarly, at 2139, ultimately, the
`Board ordered Claims 10, 14 and 17 of the
`Cuozzo patent canceled. That's obviously
`the Board's order, was the final written
`decision.
` At 2143, after arguments before a
`panel of three of the Board's
`Administrative Patent Judges, it issues --
`that is, the Board -- a final written
`decision. Perhaps more importantly, a
`decision to cancel a patent normally has
`the same effect as a district court's
`determination of a patent's invalidity.
`So the Supreme Court consistently
`describes a final written decision as the
`place where the claims are canceled
`regardless of whether there's a subsequent
`appeal.
`
`Page 9
`TELEPHONIC CONFERENCE CALL -- 4/5/17
`the foregoing reasons --
` JUDGE HARLOW: I apologize for
`interrupting you, but we're familiar with
`these cases and we understand that a final
`written decision cancels claims.
` The question I posed is a bit
`different, and that is premised on the
`idea that the Federal Circuit can, of
`course, vacate our final written decision.
`So although it is the case that our final
`written decision serves to cancel claims,
`it's also the case UTC has the opportunity
`to appeal our decision, which could
`potentially resolve in the vacatur of our
`decision.
` And what I'm asking is, given that
`we don't know whether UTC is going to
`appeal or not, isn't it a bit premature
`just now to address your request rather
`than addressing it down the road when the
`time for UTC to file an appeal has
`expired?
` MR. POLLACK: I'll address this, as
`it says in the regulation. So the
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`TSG Reporting - Worldwide 877-702-9580
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`3
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` P.3
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` UT Ex. 2062
`SteadyMed v. United Therapeutics
`IPR2016-00006
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`
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`Page 10
`TELEPHONIC CONFERENCE CALL -- 4/5/17
`regulation says that a claim that is not
`patently distinct from a canceled claim --
`so this is a canceled claim. So the
`regulation does -- the regulation language
`does connect to that.
` As far as whether there's always a
`potential appeal, that's true in every
`lawsuit, whether it's from the Patent
`Office or from a district court.
` But looking at the facts on the
`ground now, the facts on the ground now
`are that the claims have been finally
`canceled.
` Can that be turned around on an
`appeal? Of course, whether it's through
`the Federal Circuit or ultimately to the
`Supreme Court. But as things stand now,
`there is a cancellation, and that's what
`the regulation refers to, is a -- is a
`cancellation.
` JUDGE HARLOW: We understand that,
`Counsel. Perhaps it would be more
`productive to turn back to the first
`issue, which is that SteadyMed appears to
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`TELEPHONIC CONFERENCE CALL -- 4/5/17
`the administrative and judicative --
` JUDGE HARLOW: Counsel -- Counsel,
`we also understand the APA. I would
`appreciate it if you could fast forward to
`our question, which is, again, two patents
`issued; and then those patents are not the
`same as the patent that was subject to IPR
`and which we subsequently canceled claims
`for.
` So what I'm trying to understand is
`how it is that the estoppel provisions,
`which, by their nature, would apply to
`future action, can be applied to
`retroactively cancel the claim of
`different patents that issued prior to our
`decision in the instant IPR.
` MR. POLLACK: Okay. If you look at
`the regulation, it refers to not only a
`Patent Applicant but also a Patent Owner.
`So it's addressing both applications and
`owners.
` Here we have a situation where an
`agency, within the same week or within
`even a few weeks, is issuing two decisions
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`TELEPHONIC CONFERENCE CALL -- 4/5/17
`be asking the Board to retroactively apply
`our estoppel provisions.
` So perhaps you could address how it
`is that the estoppel provisions of
`Section 42.7(d)(3) would permit us to
`cancel issued claims, because that does
`not appear to be at all contemplated by
`the estoppel provisions.
` MR. POLLACK: Okay. Obviously I
`disagree with you on that, but the reason
`is as follows.
` Under the Administrative Procedure
`Act, an administrative agency is not
`really permitted to issue inconsistent
`opinions at the same time. That's why, in
`fact, the act was originally created back
`in the '30s.
` If you look at In Re: Zurko, Federal
`Circuit case going through the history of
`the APA, at 142 F.3d, 1447 and 1450, they
`actually point out that Congress created
`the APA because it was concerned -- and
`I'm quoting -- about the lack of
`uniformity and consistency in and among
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`TELEPHONIC CONFERENCE CALL -- 4/5/17
`that are inconsistent. And the whole
`point of this 42.7(d)(3) is to prevent
`that. That's why this regulation exists
`and needs to exist; else, one would have
`an APA -- a violation and a constitutional
`violation.
` Now, it only applies -- and I think
`this answers your question -- where the
`claims are not patentably distinct. And,
`obviously, on this call I won't be able to
`show you the claims and why they're not
`patentably distinct.
` What I will tell you about the
`claims that have recently issued is that
`not only would they violate the
`obviousness-type double-patenting bar but
`they would even violate the statutory
`double-patenting bar in one case, in the
`case that issued on March 14th.
` The claims are essentially identical
`other than that the compound formulas have
`been replaced by their names. So Claim 9
`had a formula. The new claims now just
`say "treprostinil." Claim 9 has a formula
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`4
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` P.4
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` UT Ex. 2062
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`
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`Page 14
`TELEPHONIC CONFERENCE CALL -- 4/5/17
`for benzidine trial. The new claims just
`say "benzidine trial"; and the word
`"product" has been replaced with
`"pharmaceutical composition." And the
`starting material, it says "the starting
`material must have impurities in it."
` And those are the only changes.
`Those aren't changes, at least from an
`invalidity standpoint, that are material
`or in any way different from Claim 9, the
`scope from -- at least from an invalidity
`standpoint is we're looking at the exact
`same treprostinil that's already been
`invalidated.
` And so that's why, in a case where
`there's no patentable distinction, this
`regulation is, I think, intended to ensure
`that there isn't an APA violation of
`the -- by the administrative agency where
`one side is issuing the same claims in the
`same week as another side of the agency is
`invalidating them.
` And I think that's why it refers to
`both patent applicant for applications and
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`TELEPHONIC CONFERENCE CALL -- 4/5/17
`judgment. And another Panel in the same
`IPR ruled that it only refers to an
`unappealable final decision.
` And part of the reason they held
`that way is because they noted the
`statutory language of Section 318(b),
`which says, if the Patent Trial and Appeal
`Board issued a final written decision
`under Subsection A and the time for appeal
`has expired or any appeal has terminated,
`then the director shall issue and publish
`a certificate canceling any claim of the
`patent finally determined to be
`unpatentable.
` So for all the reasons you mentioned
`earlier, we agree that this decision is
`not yet an unappealable final decision, so
`the rule shouldn't have effect for that
`reason.
` And in addition to that, as you
`pointed out, it applies to taking action
`after an adverse judgment. So even if you
`put aside this first issue, it can't have
`applied to the continuations which, as you
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`TELEPHONIC CONFERENCE CALL -- 4/5/17
`owners. And I think the agency certainly
`had the authority to invalidate patents
`issuing at around the same time based on
`316(a)(4), where the Patent Office was
`given the power to control its
`proceedings, included in related cases
`like this. And I think that's where the
`power for 42.7(d)(3) derived from.
` JUDGE HARLOW: Okay. Thank you.
` MR. POLLACK: Does that make sense?
` JUDGE HARLOW: It does. We
`understand your position.
` Mr. Maebius, would you like to
`respond?
` MR. MAEBIUS: Yes, Your Honor. Let
`me point out, first of all, that this rule
`has been interpreted in IPR 2014-00346
`where the Panel found that adverse
`judgment means unappealable final
`decision; and that's at Paper No. 32,
`pages 8 to 9.
` And so this specific language is
`different from the term "final written
`decision." This rule refers to an adverse
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`TELEPHONIC CONFERENCE CALL -- 4/5/17
`pointed out, have distinct claim language.
` And in addition to that, they also
`have evidence and arguments that were
`presented in the file history that weren't
`a part of the IPR file. So there's also
`further reasons why the examiner's
`decision in those cases is not
`inconsistent with the later decision.
` But we don't even think the rule
`would apply at all, because the final
`written decision hadn't come out at the
`time the examiner made these decisions.
` MR. POLLACK: Can I respond to that,
`Your Honor?
` JUDGE HARLOW: Briefly, please.
` MR. POLLACK: Yes, okay.
` MR. POLLACK: In regard to the Panel
`decision that Mr. Maebius referred to --
`and I recognize that those decisions [sic]
`made the statements that he described, the
`Patent Office itself, in promulgating this
`Rule 42.7(d)(3), in its notice and comment
`for the rule final, and that can be found
`at 77 Federal Register 46112 at page
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`5
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` P.5
`
` UT Ex. 2062
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`
`
`Page 19
`TELEPHONIC CONFERENCE CALL -- 4/5/17
` Section 42.80, provides that the
`office will issue and publish their
`certificate after the Board issues a final
`written decision or proceeding and the
`time for appeal has expired or any appeal
`has terminated; therefore, the concept of
`judgment should not be replaced by
`certificates.
` So what this means, in summary, is
`that the certificate in 318 is really a
`different issue. They have a -- there is
`a rule and a statute that says a
`certificate only issues after appeal.
` But the judgment is final at the
`final written decision, that those two
`things are different, and the -- you know,
`the authority, the director of that is
`what the director has stated. And that's
`what should be controlling here, not
`certain dicta in some Panel decisions.
` So the rule is that this is a final
`written decision and, therefore, the
`regulation does kick in at this time,
`because that is the adverse judgment of
`
`Page 21
` TELEPHONIC CONFERENCE CALL -- 4/5/17
` CERTIFICATE OF SHORTHAND REPORTER
`
` I, Gail Inghram Verbano, Registered
`Diplomate Reporter, Certified Realtime
`Reporter, Certified Shorthand Reporter (CA),
`and Notary Public, the officer before whom the
`foregoing proceedings were taken, do hereby
`certify that the foregoing transcript is a true
`and correct record of the proceedings; that
`said proceedings were taken by me
`stenographically and thereafter reduced to
`typewriting under my supervision; and that I am
`neither counsel for, related to, nor employed
`by any of the parties to this case and have no
`interest, financial or otherwise, in its
`outcome.
`DATED: 4-17-2017
`
` ___________________________________
` Gail Inghram Verbano, RDR, CRR, CSR
` CA-CSR No. 8635
`
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`TELEPHONIC CONFERENCE CALL -- 4/5/17
`48648. It's Comment 208.
` And the Patent Office wrote, "One
`comment urged the Office to eliminate the
`concept of judgment and replace it with
`certificates and requested clarification
`as to the relationships between a
`judgment, the final written decision and
`certificates."
` And in response, the Patent Office
`stated, "The comment is not adopted. The
`concepts of judgment and certificates are
`fundamentally different." So the
`certificate referred to in 318 is
`different.
` The term "judgment" -- I'm quoting
`again from the Federal Register. The term
`"judgment" is defined as a final written
`decision by the Board -- Section 42.2 --
`and that judgment disposes of all issues
`that were or were by motion reasonably
`could have been raised and decided --
`Section 42.7(d)(3) -- consistent with
`Section 318(b) as amended and 35 U.S.C.
`Section 328(b).
`
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`TELEPHONIC CONFERENCE CALL -- 4/5/17
`canceling the claims.
` So as far as timing, at least for
`that applicability of the statute, I
`believe it does apply, and I believe it's
`essential to keep an APA violation from
`occurring.
` JUDGE HARLOW: Okay. Thank you,
`Mr. Pollack. We will take the Parties'
`arguments under advisement and issue an
`order in due course. Thank you all for
`your time.
` MR. POLLACK: Thank you, Your Honor.
` MR. MAEBIUS: Thank you.
` (Time noted: 1:50 p.m.)
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`TSG Reporting - Worldwide 877-702-9580
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`6
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` P.6
`
` UT Ex. 2062
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`
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`A
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`able (1)
`13:11
`Acceleron (1)
`8:13
`act (2)
`11:14,17
`action (4)
`4:7 5:8 12:14 16:22
`addition (3)
`6:18 16:21 17:3
`address (6)
`6:4,6,8 9:20,24 11:4
`addressing (2)
`9:21 12:21
`administrative (6)
`3:3 7:15 11:13,14
`12:2 14:20
`adopted (1)
`18:11
`adverse (4)
`15:19,25 16:23 19:25
`advisement (1)
`20:10
`affirm (1)
`8:23
`agency (5)
`11:14 12:24 14:20,22
`15:2
`agree (1)
`16:17
`ahead (1)
`4:14
`amended (1)
`18:24
`answer (1)
`6:15
`answers (1)
`13:9
`APA (6)
`11:21,23 12:4 13:6
`14:19 20:6
`apologize (1)
`9:3
`appeal (15)
`1:3 5:25 7:25 8:3 9:14
`9:19,22 10:8,16
`16:8,10,11 19:6,6
`19:14
`appeals (1)
`8:10
`appear (1)
`11:8
`appears (2)
`5:8 10:25
`applicability (1)
`
`20:4
`applicant (2)
`12:20 14:25
`applications (3)
`4:9 12:21 14:25
`applied (2)
`12:14 16:25
`applies (2)
`13:8 16:22
`apply (4)
`11:2 12:13 17:11 20:5
`appreciate (1)
`12:5
`April (1)
`1:11
`arguments (3)
`7:13 17:4 20:10
`aside (1)
`16:24
`asking (2)
`9:17 11:2
`Attorneys (2)
`2:5,14
`authority (2)
`15:3 19:18
`Authorization (1)
`4:6
`authorizes (1)
`7:5
`Avenue (1)
`2:7
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`B
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`B2 (1)
`1:7
`BA (1)
`1:17
`back (2)
`10:24 11:17
`Bank (1)
`8:18
`bar (2)
`13:17,19
`based (1)
`15:4
`behalf (2)
`4:21,25
`Belden (3)
`8:8,9,10
`believe (2)
`20:5,5
`benefit (1)
`4:13
`benzidine (2)
`14:2,3
`Berk-Tek (1)
`
`8:9
`bit (2)
`9:7,19
`Board (11)
`1:3 4:7 5:9,21 7:9,16
`8:5 11:2 16:9 18:19
`19:4
`Board's (4)
`7:11,14 8:15,23
`Briefly (1)
`17:16
`
`C
`
`C (1)
`2:3
`C.F.R (1)
`5:10
`CA (1)
`21:6
`CA-CSR (1)
`21:22
`call (24)
`1:15 4:1,3,5,13 5:1,7
`6:1 7:1 8:1 9:1 10:1
`11:1 12:1 13:1,11
`14:1 15:1 16:1 17:1
`18:1 19:1 20:1 21:1
`cancel (4)
`7:18 9:12 11:7 12:15
`canceled (9)
`6:14 7:3,10,23 8:5
`10:3,4,14 12:9
`canceling (4)
`5:20 7:7 16:13 20:2
`cancellation (5)
`8:11,15,24 10:19,21
`cancels (1)
`9:6
`case (9)
`1:6 8:8 9:11,13 11:20
`13:19,20 14:16
`21:15
`cases (3)
`9:5 15:7 17:8
`certain (1)
`19:21
`certainly (1)
`15:2
`certificate (6)
`16:13 18:14 19:4,11
`19:14 21:2
`certificates (4)
`18:6,9,12 19:9
`Certified (2)
`21:5,6
`certify (1)
`
`21:9
`Chang (1)
`3:6
`changes (2)
`14:8,9
`Circuit (5)
`6:18 8:2 9:9 10:17
`11:20
`claim (11)
`7:7 8:15 10:2,3,4
`12:15 13:23,25
`14:11 16:13 17:2
`claims (21)
`5:20 6:13 7:3,9,23 8:5
`8:11,24 9:6,12
`10:13 11:7 12:9
`13:10,12,15,21,24
`14:2,21 20:2
`clarification (1)
`18:6
`CLR (1)
`1:17
`colleague (1)
`4:23
`come (2)
`8:22 17:12
`comment (4)
`17:23 18:2,4,11
`Commerce (1)
`8:18
`composition (1)
`14:5
`compound (1)
`13:22
`concept (2)
`18:5 19:7
`concepts (1)
`18:12
`concerned (1)
`11:23
`conference (20)
`1:15 4:1,2 5:1 6:1 7:1
`8:1 9:1 10:1 11:1
`12:1 13:1 14:1 15:1
`16:1 17:1 18:1 19:1
`20:1 21:1
`Congress (1)
`11:22
`connect (1)
`10:6
`consistency (1)
`11:25
`consistent (2)
`5:19 18:23
`consistently (2)
`7:21 8:4
`
`
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`TSG Reporting - Worldwide 877-702-9580TSG Reporting - Worldwide 877-702-9580
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`Page 1
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`constitutional (1)
`13:6
`contemplated (1)
`11:8
`continuations (1)
`16:25
`continuing (1)
`4:9
`control (1)
`15:6
`controlling (1)
`19:20
`Corporation (2)
`1:8 5:5
`correct (1)
`21:10
`counsel (5)
`4:16 10:23 12:3,3
`21:14
`course (4)
`8:3 9:10 10:16 20:11
`court (7)
`4:14 6:17,22,25 7:21
`10:10,18
`court's (1)
`7:19
`courts (1)
`6:21
`created (2)
`11:17,22
`CRR (2)
`1:17 21:21
`CSR (1)
`21:21
`CSR-CA (1)
`1:18
`Cuozzo (2)
`6:23 7:10
`Cuozzo's (1)
`7:3
`curious (1)
`5:17
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`D
`
`D.C (1)
`2:18
`DATE (1)
`1:11
`DATED (1)
`21:18
`decided (1)
`18:22
`decision (35)
`5:21,25 6:10,14,22
`7:3,7,12,17,18,22
`8:6,19,22 9:6,10,12
`
` P.7
`
` UT Ex. 2062
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`
`
`9:14,16 12:17 15:21
`15:25 16:4,9,17,18
`17:8,9,12,19 18:8
`18:19 19:5,16,23
`decisions (4)
`12:25 17:13,20 19:21
`defined (1)
`18:18
`Dell (1)
`8:13
`derived (1)
`15:9
`described (1)
`17:21
`describes (1)
`7:22
`determination (1)
`7:20
`determined (1)
`16:14
`dicta (1)
`19:21
`different (8)
`9:8 12:16 14:11 15:24
`18:13,15 19:12,17
`Diplomate (1)
`21:5
`director (3)
`16:12 19:18,19
`disagree (1)
`11:11
`discuss (2)
`4:5 5:16
`disposes (1)
`18:20
`distinct (4)
`10:3 13:10,13 17:2
`distinction (1)
`14:17
`district (2)
`7:19 10:10
`DLA (2)
`2:6 4:24
`double-patenting (2)
`13:17,19
`due (1)
`20:11
`
`E
`
`E (2)
`2:3,3
`earlier (1)
`16:17
`early (1)
`8:21
`effect (2)
`
`7:19 16:19
`eliminate (1)
`18:4
`employed (1)
`21:14
`ensure (1)
`14:18
`ESQ (4)
`2:9,10,19,20
`essential (1)
`20:6
`essentially (1)
`13:21
`estoppel (6)
`5:9,18 11:3,5,9 12:12
`evidence (1)
`17:4
`exact (1)
`14:13
`examiner (1)
`17:13
`examiner's (1)
`17:7
`example (2)
`7:4 8:12
`examples (1)
`8:7
`exist (1)
`13:5
`exists (1)
`13:4
`expired (4)
`6:2 9:23 16:11 19:6
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`F
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`F.3d (3)
`8:13,21 11:21
`fact (2)
`6:13 11:17
`facts (2)
`10:11,12
`fair (1)
`5:12
`familiar (2)
`6:23 9:4
`far (2)
`10:7 20:3
`fast (1)
`12:5
`Federal (7)
`6:17 8:2 9:9 10:17
`11:19 17:25 18:17
`feel (1)
`6:3
`file (4)
`4:6 9:22 17:5,6
`
`final (25)
`5:25 6:9,14 7:2,6,11
`7:16,22 8:6 9:5,10
`9:11 15:20,24 16:4
`16:9,18 17:11,24
`18:8,18 19:4,15,16
`19:22
`finally (2)
`10:13 16:14
`financial (1)
`21:16
`firm (1)
`4:24
`first (6)
`6:7,21 8:4 10:24
`15:17 16:24
`Foley (2)
`2:15 5:3
`follows (1)
`11:12
`foregoing (3)
`9:2 21:8,9
`formula (2)
`13:24,25
`formulas (1)
`13:22
`forward (1)
`12:5
`found (2)
`15:19 17:24
`free (1)
`6:3
`fundamentally (1)
`18:13
`further (1)
`17:7
`future (1)
`12:14
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`G
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`Gail (3)
`1:17 21:4,21
`George (2)
`2:20 5:3
`give (1)
`8:8
`given (3)
`5:24 9:17 15:6
`go (1)
`4:14
`going (4)
`6:6 8:7 9:18 11:20
`Green (1)
`3:5
`ground (2)
`10:12,12
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`Page 2
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`introduce (1)
`4:16
`introducing (1)
`4:12
`invalidate (1)
`15:3
`invalidated (1)
`14:15
`invalidating (1)
`14:23
`invalidity (3)
`7:20 14:10,12
`IPR (6)
`4:3 12:8,17 15:18
`16:3 17:6
`IPR2016-000006 (1)
`1:6
`issue (7)
`10:25 11:15 16:12,24
`19:3,12 20:10
`issued (9)
`4:8 5:20 6:10 11:7
`12:7,16 13:15,20
`16:9
`issues (4)
`7:15 18:20 19:4,14
`issuing (3)
`12:25 14:21 15:4
`
`J
`Jacqueline (1)
`3:4
`Job (1)
`1:23
`joined (1)
`4:22
`Joni (1)
`3:6
`Judge (13)
`3:4,5,6 4:2 5:6,15 9:3
`10:22 12:3 15:10,12
`17:16 20:8
`Judges (2)
`3:3 7:15
`judgment (12)
`15:20 16:2,23 18:5,8
`18:12,16,18,20 19:8
`19:15,25
`judicative (1)
`12:2
`judicial (1)
`7:6
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`K
`
`K (1)
`2:17
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`H
`
`Haile (2)
`2:10 4:23
`Harbor (1)
`2:16
`Harlow (11)
`3:4 4:2 5:6,15 9:3
`10:22 12:3 15:10,12
`17:16 20:8
`hear (1)
`5:22
`hearing (1)
`8:3
`held (1)
`16:5
`history (2)
`11:20 17:5
`Honor (6)
`4:20 5:14 6:5 15:16
`17:15 20:13
`
`I
`
`idea (2)
`5:19 9:9
`identical (1)
`13:21
`identify (1)
`4:17
`II (1)
`8:18
`importantly (1)
`7:17
`impurities (1)
`14:7
`included (1)
`15:7
`inconsistent (3)
`11:15 13:2 17:9
`Inghram (3)
`1:17 21:4,21
`instance (1)
`8:4
`instant (1)
`12:17
`Intellectual (1)
`8:17
`intended (1)
`14:18
`interest (1)
`21:16
`interested (1)
`5:22
`interpreted (1)
`15:18
`interrupting (1)
`9:4
`
`TSG Reporting - Worldwide 877-702-9580
`
` P.8
`
` UT Ex. 2062
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`
`
`keep (1)
`20:6
`kick (1)
`19:24
`know (4)
`6:16,23 9:18 19:17
`
`L
`
`L (1)
`1:17
`lack (1)
`11:24
`language (4)
`10:5 15:23 16:7 17:2
`Lardner (1)
`5:3
`LARNDER (1)
`2:15
`law (1)
`4:23
`lawsuit (1)
`10:9
`Lee (1)
`6:24
`let's (1)
`4:14
`line (1)
`5:5
`Lisa (2)
`2:10 4:23
`LLC (1)
`8:18
`look (2)
`11:19 12:18
`looking (2)
`10:11 14:13
`Lora (1)
`3:5
`
`M
`
`M (1)
`3:5
`Maebius (7)
`2:19 4:25 5:2 15:14
`15:16 17:19 20:14
`March (2)
`8:20 13:20
`material (3)
`14:6,7,10
`means (2)
`15:20 19:10
`mentioned (1)
`16:16
`motion (2)
`4:6 18:21
`
`N
`
`N (1)
`2:3
`names (1)
`13:23
`nature (1)
`12:13
`needs (1)
`13:5
`neither (1)
`21:14
`new (5)
`2:8,8 4:8 13:24 14:2
`normally (1)
`7:18
`Notary (2)
`1:18 21:7
`noted (2)
`16:6 20:15
`notice (1)
`17:23
`numerous (2)
`6:25 8:7
`NW (1)
`2:17
`
`O
`obviously (3)
`7:10 11:10 13:11
`obviousness-type (1)
`13:17
`occurring (1)
`20:7
`office (9)
`1:2 6:19 10:10 15:5
`17:22 18:3,4,10
`19:3
`officer (1)
`21:7
`okay (5)
`11:10 12:18 15:10
`17:17 20:8
`opinions (1)
`11:16
`opportunity (1)
`9:13
`order (2)
`7:11 20:11
`ordered (1)
`7:9
`originally (1)
`11:17
`outcome (1)
`21:17
`Owner (4)
`1:9 4:19 5:2 12:20
`
`owners (2)
`12:22 15:2
`
`P
`
`P (2)
`2:3,3
`p.m (2)
`1:12 20:15
`page (2)
`7:4 17:25
`pages (1)
`15:22
`panel (6)
`1:16 7:14 15:19 16:2
`17:18 19:21
`Paper (1)
`15:21
`part (2)
`16:5 17:6
`particularly (1)
`5:17
`parties (3)
`1:16 4:11 21:15
`Parties' (1)
`20:9
`patent (24)
`1:2,3,7,9 3:3 4:10,18
`5:2 6:19 7:7,10,15
`7:18 10:9 12:8,20
`12:20 14:25 15:5
`16:8,14 17:22 18:3
`18:10
`patent's (1)
`7:20
`patentable (1)
`14:17
`patentably (2)
`13:10,13
`patently (1)
`10:3
`patents (6)
`4:8 5:20 12:6,7,16
`15:3
`permit (1)
`11:6
`permitted (1)
`11:15
`Petitioner (4)
`1:6 2:5 4:15,22
`pharmaceutical (1)
`14:5
`Piper (2)
`2:6 4:24
`place (1)
`7:23
`places (1)
`
`7:2
`please (3)
`4:16 6:3 17:16
`point (3)
`11:22 13:3 15:17
`pointed (2)
`16:22 17:2
`Pollack (15)
`2:9 4:20,21 5:13,14
`6:5 9:24 11:10
`12:18 15:11 17:14
`17:17,18 20:9,13
`portion (1)
`5:16
`posed (1)
`9:7
`position (1)
`15:13
`potential (1)
`10:8
`potentially (1)
`9:15
`power (2)
`15:6,9
`premature (2)
`5:24 9:19
`premised (1)
`9:8
`present (2)
`3:9 4:18
`presented (1)
`17:5
`prevent (1)
`13:3
`prior (2)
`5:21 12:16
`Procedure (1)
`11:13
`proceed (1)
`4:19
`proceeding (2)
`8:25 19:5
`proceedings (4)
`15:7 21:8,10,11
`product (1)
`14:4
`productive (1)
`10:24
`promulgated (1)
`6:20
`promulgating (1)
`17:22
`provides (1)
`19:2
`provisions (6)
`5:10,18 11:3,5,9
`
`TSG Reporting - Worldwide 877-702-9580
`
`Page 3
`
`12:12
`Public (2)
`1:18 21:7
`publish (2)
`16:12 19:3
`purpose (1)
`4:4
`put (1)
`16:24
`
`Q
`question (4)
`6:6 9:7 12:6 13:9
`Quillin (2)
`2:20 5:4
`quote (1)
`7:5
`quoting (2)
`11:24 18:16
`
`R
`
`R (1)
`2:3
`raised (1)
`18:22
`RDR (2)
`1:17 21:21
`really (2)
`11:15 19:11
`Realtime (1)
`21:5
`reason (3)
`11:11 16:5,20
`reasonably (1)
`18:21
`reasons (3)
`9:2 16:16 17:7
`recognize (1)
`17:20
`record (1)
`21:10
`reduced (1)
`21:12
`referred (2)
`17:19 18:14
`refers (5)
`10:20 12:19 14:24
`15:25 16:3
`regard (2)
`4:7 17:18
`regardless (1)
`7:24
`Register (2)
`17:25 18:17
`Registered (1)
`21:4
`
` P.9
`
` UT Ex. 2062
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`
`
`regulation (9)
`9:25 10:2,5,5,20
`12:19 13:4 14:18
`19:24
`regulations (1)
`6:12
`related (2)
`15:7 21:14
`relating (1)
`5:9
`relationships (1)
`18:7
`replace (1)
`18:5
`replaced (3)
`13:23 14:4 19:8
`reported (1)
`8:22
`reporter (5)
`4:14 21:2,5,6,6
`representation (1)
`5:12
`request (5)
`4:6,7 5:23 6:4 9:20
`requested (1)
`18:6
`resolve (1)
`9:15
`respective (1)
`1:16
`respond (2)
`15:15 17:14
`response (1)
`18:10
`retroactively (3)
`5:19 11:2 12:15
`review (1)
`7:6
`road (1)
`9:21
`roll (1)
`4:15
`rule (8)
`15:17,25 16:19 17:10
`17:23,24 19:13,22
`ruled (1)
`16:3
`
`S
`
`S (1)
`2:3
`says (6)
`8:22 9:25 10:2 14:6
`16:8 19:13
`scope (1)
`14:12
`
`second (1)
`6:6
`Section (11)
`5:11 6:8,11,20 11:6
`16:7 18:19,23,24,25
`19:2
`seek (1)
`5:8
`sense (1)
`15:11
`serves (1)
`9:12
`Shares (1)
`8:19
`Shaun (2)
`3:10 5:4
`Shorthand (2)
`21:2,6
`show (1)
`13:12
`sic (1)
`17:20
`side (3)
`4:18 14:21,22
`signed (1)
`4:13
`similarly (2)
`7:8 8:2
`situation (2)
`6:9 12:23
`Snader (2)
`3:10 5:4
`specific (1)
`15:23
`Speed (1)
`6:24
`stand (1)
`10:18
`standpoint (2)
`14:10,13
`star (2)
`8:23,25
`start (1)
`6:21
`starting (3)
`4:15 14:6,6
`stated (2)
`18:11 19:19
`statements (1)
`17:21
`states (3)
`1:2 7:2,4
`statute (4)
`6:13 7:5 19:13 20:4
`statutory (2)
`13:18 16:7
`
`SteadyMed (6)
`1:5 4:3,5,22 5:8 10:25
`SteadyMed's (1)
`5:23
`stenographically (1)
`21:12
`STEPHEN (1)
`2:19
`Steve (1)
`5:2
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`think (6)
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`20:3
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`transcript (1)
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`TSG Reporting - Worldwide 877-702-9580
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` P.10
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` UT Ex. 2062
`SteadyMed v. United Therapeutics
`IPR2016-00006
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`9 (4)
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