`IPR2020-00770
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`LIQUIDIA TECHNOLOGIES, INC.,
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`Petitioner
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`v.
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`UNITED THERAPEUTICS CORPORATION,
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`Patent Owner
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`Inter Partes Review No. IPR2020-00770
`U.S. Patent No. 9,604,901
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`PETITIONER’S MOTION TO SUBMIT SUPPLEMENTAL EVIDENCE
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`TABLE OF CONTENTS
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`Page
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`RELIEF REQUESTED .................................................................................. 1
`I.
`LEGAL STANDARD .................................................................................... 1
`II.
`III. ARGUMENT .................................................................................................. 2
`A.
`The Markman Hearing Transcript and Order Could Not Have
`Been Obtained Earlier .......................................................................... 2
`Adding the Markman Hearing Transcript and Order to the
`Record for the Board’s Consideration is in the Interests of
`Justice ................................................................................................... 3
`IV. CONCLUSION ............................................................................................... 8
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`B.
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`i
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`Petitioner’s Motion to Submit Supplemental Evidence
`IPR2020-00770
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`RELIEF REQUESTED
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`I.
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`Petitioner Liquidia Technologies, Inc. (“Liquidia”) respectfully moves to
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`submit, as supplemental information, the transcript and order from the Markman
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`hearing that occurred on June 4, 2021 in United Therapeutics Corporation v.
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`Liquidia Technologies, Inc., C.A. No. 20-755 (RGA) (District Court for the District
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`of Delaware). The Markman hearing involved construction of claim terms from U.S.
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`Patent No. 9,604,901 that are also at issue in the instant proceeding, and the
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`transcript contains statements relevant to inconsistencies in Patent Owner United
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`Therapeutic Corporation (“UTC”)’s positions between the tribunals.
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`II.
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`LEGAL STANDARD
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`A motion to submit supplemental information may be filed under § 42.123(b)
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`when more than one month has passed from the date the trial is instituted and “[t]he
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`supplemental information [is] relevant to a claim for which the trial has been
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`instituted.” 37 C.F.R. § 42.123(a)-(b). A party seeking to submit supplemental
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`information under § 42.123(b) bears the burden of showing: first, that the
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`information reasonably could not have been obtained earlier, and second, that
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`consideration of the supplemental information would be in the interests of justice.
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`Id.
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`For claim construction documents from other tribunals, “[n]ormally, the
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`Board will permit such information to be filed, as long as the final oral hearing has
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`1
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`Petitioner’s Motion to Submit Supplemental Evidence
`IPR2020-00770
`not taken place.” PTAB Consolidated Trial Practice Guide (Nov. 2019) (“Guide”),
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`48. This is because the “Board, in its claim construction determinations, will
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`consider statements regarding claim construction made by patent owners and by a
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`petitioner filed in other proceedings, if the statements are timely made of record.”
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`Id. (citing Aylus Networks, Inc. v. Apple Inc., 856 F.3d 1353, 1360–61 (Fed. Cir.
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`2017) (extending the prosecution disclaimer doctrine to include patent owner’s
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`statements made in a preliminary response that was submitted in a prior AIA
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`proceeding)). The “Board may take into consideration statements made by a patent
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`owner or petitioner about claim scope.” Id.
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`Accordingly, the Board has advised that “[p]arties should submit a prior claim
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`construction determination by a federal court . . . as soon as that determination
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`becomes available.” Id., 47. In fact, submission of a prior claim construction
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`determination is mandatory under 37 C.F.R. § 42.51(b), if it is “relevant information
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`that is inconsistent with a position advanced by the party during the proceeding.” Id.
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`III.
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`ARGUMENT
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`A. The Markman Hearing Transcript and Order Could Not Have
`Been Obtained Earlier
`The Markman hearing occurred on June 4, 2021, and Petitioner received the
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`oral hearing transcript on June 9, 2021. Petitioner then promptly communicated with
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`Patent Owner on June 10, 2021, which indicated that it will oppose this Motion.
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`Petitioner subsequently requested authorization from the Board to file this Motion
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`2
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`Petitioner’s Motion to Submit Supplemental Evidence
`IPR2020-00770
`on June 11, 2021. On June 15, 2021, the parties filed a proposed claim construction
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`order based on district Judge Andrews’s rulings at the hearing. EX1054. The oral
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`argument in this proceeding is scheduled for June 23, 2021, so Petitioner has moved
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`to submit this supplemental information now, to give the parties adequate time to
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`brief the Motion and to make sure the information is submitted before the hearing.
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`Petitioner requests permission to file the district court’s final claim construction
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`order as soon as it is entered by the Court—which is likely to occur on or before
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`June 21, 2021, when Patent Owner’s opposition to this Motion is due.
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`B. Adding the Markman Hearing Transcript and Order to the
`Record for the Board’s Consideration is in the Interests of
`Justice
`The Board regularly accepts filing of Markman documents when the same
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`claim terms are at issue in the proceeding before the Board. See, e.g., Intel Corp. v.
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`VLSI Tech. LLC, IPR2019-01199, Paper 11 at 2 (P.T.A.B. Nov. 19, 2019); GoPro,
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`Inc. v. Contour IP Holding LLC, IPR2015-01080, Paper 74 at 5 (P.T.A.B. Feb. 14,
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`2019) (citing Knowles Elecs. LLC v. Iancu, 886 F.3d 1369, 1376 (Fed. Cir. 2018)
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`(“[I]n some circumstances, previous judicial interpretations of a disputed claim term
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`may be relevant to the PTAB’s later construction of that same disputed term. . . .
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`While ‘the [PTAB] is not generally bound by a previous judicial interpretation of a
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`disputed claim term[, this] does not mean . . . that it has no obligation to acknowledge
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`3
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`Petitioner’s Motion to Submit Supplemental Evidence
`IPR2020-00770
`that interpretation or to assess whether it is consistent with the [PTAB’s
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`construction] of the term.’” (citation omitted))).
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`Adding the district court’s Markman hearing transcript and order to this IPR
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`record is in the interest of justice for four reasons. First, the parties addressed the
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`same issues present here related to the person of ordinary skill in the art for the ’901
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`patent. See, e.g., EX1053, 21:5-22:14.
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`Second, the parties and district court addressed the construction of multiple
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`terms at
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`issue
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`in
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`this proceeding,
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`including “ambient
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`temperature,”
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`“stored/storing/storage,” “pharmaceutical batch,” and “contacting the solution
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`comprising treprostinil from step (b) with a base to form a salt of treprostinil.” Id.,
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`27:4-130:2. Two of these terms (“stored/storing/storage” and “contacting the
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`solution comprising treprostinil from step (b) with a base to form a salt of
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`treprostinil”) are at issue in Petitioner’s pending Motion to Strike. See Paper 29.
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`Third, under the same Phillips claim construction standard that the Board now
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`applies,
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`the
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`district
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`court
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`construed
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`“ambient
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`temperature”
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`and
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`“stored/storing/storage.” EX1053, 97:2-98:20 (construing “ambient temperature” as
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`“room temperature” “in the range of 15 to 30 degrees but it could be narrower”),
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`98:21-99:10, 112:12-19, 122:21-123:14 (refusing to adopt UTC’s construction of
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`“stored/storing/storage,” the same proposed in this IPR, and instead giving the term
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`“stored/storing/storage” its “plain meaning”); EX1054. The Court also stated that it
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`4
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`Petitioner’s Motion to Submit Supplemental Evidence
`IPR2020-00770
`was not inclined to adopt UTC’s construction of “pharmaceutical batch” that imports
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`FDA standards, which is the same construction UTC proposes here, and discussed
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`why the term did not seem to require exclusion of purification before salt formation.
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`Id., 28:3-15; see also id., 53:10-18 (stating “impression” of no disclaimer regarding
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`the exclusion of purification for “pharmaceutical batch,” i.e., the ’901 claims do not
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`require exclusion of purification between steps (b) and (c)). Additionally, the Court
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`found that there have been “disclaimer[s] up and down” by Patent Owner regarding
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`whether the ’901 claims exclude isolation before the “contacting the solution
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`comprising treprostinil from step (b) with a base to form a salt of treprostinil.” Id.,
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`53:19-54:5. The Court sought additional briefing from the parties regarding the
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`claim construction positions in this IPR, particularly on UTC’s attempted
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`withdrawal of certain positions in its IPR Sur-Reply (Paper 25, 9-10) and the
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`subsequent Joint Paper on Petitioner’s Motion to Strike ordered by the Board (Paper
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`29).
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`Finally, the hearing transcript contains further evidence of Patent Owner’s
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`inconsistencies in its claim construction positions between the tribunals, and the
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`district court’s evaluation of those inconsistencies as likely disclaimer. Below is a
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`5
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`Petitioner’s Motion to Submit Supplemental Evidence
`IPR2020-00770
`list of relevant excerpts1 for the Board’s consideration, by claim term:
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` “pharmaceutical batch”: The
`to UTC’s
`relate
`following excerpts
`inconsistency as to whether the ’901 claims exclude purification, such as
`column chromatography, before salt formation. UTC argues that the claims
`do require such exclusion in order to overcome the prior art here, but argue
`that the claims do not require such exclusion in order to save their
`infringement case in district court.
`o EX1053, 28:3-15 (Court stating “You know, I’ve done a lot of these
`cases, I’ve never seen before where somebody tried to put FDA
`definition of something in as – you know, for a patent, you know, and
`if it helps, I mean -- to me it seems like the issue boils down to here as
`to whether I should give it its plain meaning, which after all is what the
`defendants proposed that they add in the same step that we’re talking
`about. And this is in the ’901 patent . . . .).
`o EX1053, 33:14-44:13 (back and forth between Court and Liquidia’s
`counsel on UTC’s IPR statements, adopted in Liquidia’s district court
`proposed construction, versus the construction for which UTC is
`advocating in the district court).
`o EX1053, 44:13-53:18 (back and forth between Court and UTC’s
`counsel regarding attempted withdrawal of disclaimer statements that
`are the subject of Paper 29 in this proceeding, the delayed timing of that
`withdrawal and the Court’s “surprise” that counsel from this IPR was
`also arguing at the hearing because it put the counsel “in a difficult
`position”).
`o EX1053, 54:21-57:8 (discussing timing of Board’s consideration of
`UTC’s inconsistencies and attempted withdrawal in Paper 25, oral
`argument, and final written decision in this proceeding).
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`1 At the Markman hearing, Mr. Carsten, Mr. Burrowbridge, and Mr. Jackson
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`represented Defendant/Patent Owner UTC, and Mr. Sukduang and Mr. Davies
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`represented Plaintiff/Petitioner Liquidia.
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`6
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`Petitioner’s Motion to Submit Supplemental Evidence
`IPR2020-00770
` “contacting the solution comprising treprostinil from step (b) with a base
`to form a salt of treprostinil”: UTC’s inconsistency as to whether the ’901
`claims exclude isolation of the treprostinil intermediate prior to “contacting
`the solution comprising treprostinil from step (b) with a base to form a salt
`of treprostinil.”
`o EX1053, 44:13-53:18 (back and forth between Court and UTC’s
`counsel regarding attempted withdrawal of disclaimer statements that
`are the subject of Paper 29 in this proceeding, the delayed timing of that
`withdrawal and the Court’s “surprise” that counsel from this IPR was
`also arguing at the hearing because it put the counsel “in a difficult
`position”).
`o EX1053, 57:9-75:6 (back and forth between Court and both parties’
`counsel, where UTC argues that excluding isolation is not required by
`the ’901 claims, after arguing repeatedly that the prior art in this
`proceeding does not obviate the ’901 claims because it includes
`isolation).
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` “stored/storing/storage”: UTC’s inconsistency regarding the amount of time
`the ’901 claims require the product to be stored, or if the claims even require
`the product to be stored at all.
`o EX1053, 99:5-7 (Court stating that it “[did]n’t think the plaintiff’s
`proposal is based on anything that makes any sense”).
`o EX1053, 113:9-13 (Court stating that UTC’s construction “doesn’t
`even sound close to anybody’s normal understanding of what stored or
`storing or storage means”).
`o EX1053, 115:24 (UTC counsel arguing that the product being “good”
`for even “one day” is sufficient for storage as claimed by the ’901
`patent).
`o EX1053, 117:1-121:8 (Liquidia counsel pointing to UTC’s shifting
`positions between prosecution and district court proceeding on length
`of time sufficient to be “storage” as claimed).
`o EX1053, 119:17-19 (Court stating that it “wasn’t going to” read
`7
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`Petitioner’s Motion to Submit Supplemental Evidence
`IPR2020-00770
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`“stability” into the construction).
`o EX1053, 123:6-14 (Court finding “plain meaning” of the term, as a
`“fairly common word,” and not finding indefiniteness despite “shifting
`positions of the plaintiff”).
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`Submission of supplemental information that evidences such inconsistences (and
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`evidences another tribunal’s treatment of those inconsistencies) is warranted under
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`37 C.F.R. § 42.123(b). See Kingston Tech. Co. v. Spex Techs., Inc., IPR2017-01021,
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`Paper 31 at 4-5 (P.T.A.B. May 29, 2018); R.J. Reynolds Vapor Co. v. Fontem
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`Holdings 1 B.V., IPR2016-01692, Paper 41 at 3 (P.T.A.B. Oct. 23, 2017).
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`IV.
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`CONCLUSION
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`Accordingly, Patent Owner has timely moved to submit the Markman hearing
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`transcript as EX1053 and the parties’ proposed claim construction order as EX1054
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`(and will submit the final order once entered), and it would be in the interests of
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`justice for the Board to accept this supplemental information—so that the Board can
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`consider it in deciding the level of skill in the art and claim construction issues in
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`this proceeding.
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`8
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`Petitioner’s Motion to Submit Supplemental Evidence
`IPR2020-00770
`Respectfully submitted,
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`COOLEY LLP
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`By: /Ivor R. Elrifi/
`Ivor R. Elrifi
`Reg. No. 39,529
`Counsel for Petitioner
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`Dated: June 15, 2021
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`COOLEY LLP
`ATTN: Patent Group
`1299 Pennsylvania Ave., NW, Suite 700
`Washington, DC 20004
`Tel: (212) 479-6840
`Fax: (212) 479-6275
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`9
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`Petitioner’s Motion to Submit Supplemental Evidence
`IPR2020-00770
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`CERTIFICATE OF SERVICE
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`I hereby certify, pursuant to 37 C.F.R. §§ 42.6(e) and 42.105(b), that a
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`complete and entire copy of this PETITIONER’S MOTION TO SUBMIT
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`SUPPLEMENTAL EVIDENCE and related documents, are being served on the
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`15th day of June, 2021, via electronic mail upon counsel of record for the Patent
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`Owner as follows:
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`UTC-901@foley.com
`Stephen B. Maebius (smaebius@foley.com)
`George Quillin (gquillin@foley.com)
`Jason Mock (jmock@foley.com)
`FOLEY & LARDNER LLP
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`Douglas Carsten (dcarsten@mwe.com)
`April E. Weisbruch (aweisbruch@mwe.com)
`Judy Mohr (jmohr@mwe.com)
`MCDERMOTT WILL & EMERY LLP
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`Richard Torczon (rtorczon@wsgr.com)
`WILSON, SONSINI, GOODRICH & ROSATI
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`Shaun R. Snader (ssnader@unither.com)
`UNITED THERAPEUTICS CORP.
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`/Ivor R. Elrifi/
`Ivor R. Elrifi
`Reg. No. 39,529
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`By:
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`Dated: June 15, 2021
`Cooley LLP
`ATTN: Patent Docketing
`1299 Pennsylvania Ave. NW,
`Suite 700
`Washington, D.C. 20004
`Tel: (212) 479-6840
`Fax: (212) 479-6275
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