Petitioner’s Motion to Submit Supplemental Evidence
`IPR2020-00770
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`LIQUIDIA TECHNOLOGIES, INC.,
`
`Petitioner
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`
`Patent Owner
`
`
`
`
`Inter Partes Review No. IPR2020-00770
`U.S. Patent No. 9,604,901
`
`
`PETITIONER’S MOTION TO SUBMIT SUPPLEMENTAL EVIDENCE
`
`
`
`
`
`
`
`
`IPR2020-00770
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`LIQUIDIA TECHNOLOGIES, INC.,
`
`Petitioner
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`
`Patent Owner
`
`
`
`
`Inter Partes Review No. IPR2020-00770
`U.S. Patent No. 9,604,901
`
`
`PETITIONER’S MOTION TO SUBMIT SUPPLEMENTAL EVIDENCE
`
`
`
`
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`Page
`
`
`
`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
`
`
`B.
`
`
`
`i
`
`
`
`Petitioner’s Motion to Submit Supplemental Evidence
`IPR2020-00770
`
`RELIEF REQUESTED
`
`I.
`
`Petitioner Liquidia Technologies, Inc. (“Liquidia”) respectfully moves to
`
`submit, as supplemental information, the transcript and order from the Markman
`
`hearing that occurred on June 4, 2021 in United Therapeutics Corporation v.
`
`Liquidia Technologies, Inc., C.A. No. 20-755 (RGA) (District Court for the District
`
`of Delaware). The Markman hearing involved construction of claim terms from U.S.
`
`Patent No. 9,604,901 that are also at issue in the instant proceeding, and the
`
`transcript contains statements relevant to inconsistencies in Patent Owner United
`
`Therapeutic Corporation (“UTC”)’s positions between the tribunals.
`
`II.
`
`LEGAL STANDARD
`
`A motion to submit supplemental information may be filed under § 42.123(b)
`
`when more than one month has passed from the date the trial is instituted and “[t]he
`
`supplemental information [is] relevant to a claim for which the trial has been
`
`instituted.” 37 C.F.R. § 42.123(a)-(b). A party seeking to submit supplemental
`
`information under § 42.123(b) bears the burden of showing: first, that the
`
`information reasonably could not have been obtained earlier, and second, that
`
`consideration of the supplemental information would be in the interests of justice.
`
`Id.
`
`For claim construction documents from other tribunals, “[n]ormally, the
`
`Board will permit such information to be filed, as long as the final oral hearing has
`
`1
`
`
`
`Petitioner’s Motion to Submit Supplemental Evidence
`IPR2020-00770
`not taken place.” PTAB Consolidated Trial Practice Guide (Nov. 2019) (“Guide”),
`
`48. This is because the “Board, in its claim construction determinations, will
`
`consider statements regarding claim construction made by patent owners and by a
`
`petitioner filed in other proceedings, if the statements are timely made of record.”
`
`Id. (citing Aylus Networks, Inc. v. Apple Inc., 856 F.3d 1353, 1360–61 (Fed. Cir.
`
`2017) (extending the prosecution disclaimer doctrine to include patent owner’s
`
`statements made in a preliminary response that was submitted in a prior AIA
`
`proceeding)). The “Board may take into consideration statements made by a patent
`
`owner or petitioner about claim scope.” Id.
`
`Accordingly, the Board has advised that “[p]arties should submit a prior claim
`
`construction determination by a federal court . . . as soon as that determination
`
`becomes available.” Id., 47. In fact, submission of a prior claim construction
`
`determination is mandatory under 37 C.F.R. § 42.51(b), if it is “relevant information
`
`that is inconsistent with a position advanced by the party during the proceeding.” Id.
`
`III.
`
`ARGUMENT
`
`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
`
`oral hearing transcript on June 9, 2021. Petitioner then promptly communicated with
`
`Patent Owner on June 10, 2021, which indicated that it will oppose this Motion.
`
`Petitioner subsequently requested authorization from the Board to file this Motion
`
`2
`
`
`
`Petitioner’s Motion to Submit Supplemental Evidence
`IPR2020-00770
`on June 11, 2021. On June 15, 2021, the parties filed a proposed claim construction
`
`order based on district Judge Andrews’s rulings at the hearing. EX1054. The oral
`
`argument in this proceeding is scheduled for June 23, 2021, so Petitioner has moved
`
`to submit this supplemental information now, to give the parties adequate time to
`
`brief the Motion and to make sure the information is submitted before the hearing.
`
`Petitioner requests permission to file the district court’s final claim construction
`
`order as soon as it is entered by the Court—which is likely to occur on or before
`
`June 21, 2021, when Patent Owner’s opposition to this Motion is due.
`
`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
`
`claim terms are at issue in the proceeding before the Board. See, e.g., Intel Corp. v.
`
`VLSI Tech. LLC, IPR2019-01199, Paper 11 at 2 (P.T.A.B. Nov. 19, 2019); GoPro,
`
`Inc. v. Contour IP Holding LLC, IPR2015-01080, Paper 74 at 5 (P.T.A.B. Feb. 14,
`
`2019) (citing Knowles Elecs. LLC v. Iancu, 886 F.3d 1369, 1376 (Fed. Cir. 2018)
`
`(“[I]n some circumstances, previous judicial interpretations of a disputed claim term
`
`may be relevant to the PTAB’s later construction of that same disputed term. . . .
`
`While ‘the [PTAB] is not generally bound by a previous judicial interpretation of a
`
`disputed claim term[, this] does not mean . . . that it has no obligation to acknowledge
`
`3
`
`
`
`Petitioner’s Motion to Submit Supplemental Evidence
`IPR2020-00770
`that interpretation or to assess whether it is consistent with the [PTAB’s
`
`construction] of the term.’” (citation omitted))).
`
`Adding the district court’s Markman hearing transcript and order to this IPR
`
`record is in the interest of justice for four reasons. First, the parties addressed the
`
`same issues present here related to the person of ordinary skill in the art for the ’901
`
`patent. See, e.g., EX1053, 21:5-22:14.
`
`Second, the parties and district court addressed the construction of multiple
`
`terms at
`
`issue
`
`in
`
`this proceeding,
`
`including “ambient
`
`temperature,”
`
`“stored/storing/storage,” “pharmaceutical batch,” and “contacting the solution
`
`comprising treprostinil from step (b) with a base to form a salt of treprostinil.” Id.,
`
`27:4-130:2. Two of these terms (“stored/storing/storage” and “contacting the
`
`solution comprising treprostinil from step (b) with a base to form a salt of
`
`treprostinil”) are at issue in Petitioner’s pending Motion to Strike. See Paper 29.
`
`Third, under the same Phillips claim construction standard that the Board now
`
`applies,
`
`the
`
`district
`
`court
`
`construed
`
`“ambient
`
`temperature”
`
`and
`
`“stored/storing/storage.” EX1053, 97:2-98:20 (construing “ambient temperature” as
`
`“room temperature” “in the range of 15 to 30 degrees but it could be narrower”),
`
`98:21-99:10, 112:12-19, 122:21-123:14 (refusing to adopt UTC’s construction of
`
`“stored/storing/storage,” the same proposed in this IPR, and instead giving the term
`
`“stored/storing/storage” its “plain meaning”); EX1054. The Court also stated that it
`
`4
`
`
`
`Petitioner’s Motion to Submit Supplemental Evidence
`IPR2020-00770
`was not inclined to adopt UTC’s construction of “pharmaceutical batch” that imports
`
`FDA standards, which is the same construction UTC proposes here, and discussed
`
`why the term did not seem to require exclusion of purification before salt formation.
`
`Id., 28:3-15; see also id., 53:10-18 (stating “impression” of no disclaimer regarding
`
`the exclusion of purification for “pharmaceutical batch,” i.e., the ’901 claims do not
`
`require exclusion of purification between steps (b) and (c)). Additionally, the Court
`
`found that there have been “disclaimer[s] up and down” by Patent Owner regarding
`
`whether the ’901 claims exclude isolation before the “contacting the solution
`
`comprising treprostinil from step (b) with a base to form a salt of treprostinil.” Id.,
`
`53:19-54:5. The Court sought additional briefing from the parties regarding the
`
`claim construction positions in this IPR, particularly on UTC’s attempted
`
`withdrawal of certain positions in its IPR Sur-Reply (Paper 25, 9-10) and the
`
`subsequent Joint Paper on Petitioner’s Motion to Strike ordered by the Board (Paper
`
`29).
`
`Finally, the hearing transcript contains further evidence of Patent Owner’s
`
`inconsistencies in its claim construction positions between the tribunals, and the
`
`district court’s evaluation of those inconsistencies as likely disclaimer. Below is a
`
`5
`
`
`
`Petitioner’s Motion to Submit Supplemental Evidence
`IPR2020-00770
`list of relevant excerpts1 for the Board’s consideration, by claim term:
`
` “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).
`
`
`
`
`1 At the Markman hearing, Mr. Carsten, Mr. Burrowbridge, and Mr. Jackson
`
`represented Defendant/Patent Owner UTC, and Mr. Sukduang and Mr. Davies
`
`represented Plaintiff/Petitioner Liquidia.
`
`6
`
`
`
`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).
`
` “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
`
`
`
`Petitioner’s Motion to Submit Supplemental Evidence
`IPR2020-00770
`
`“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”).
`
`Submission of supplemental information that evidences such inconsistences (and
`
`evidences another tribunal’s treatment of those inconsistencies) is warranted under
`
`37 C.F.R. § 42.123(b). See Kingston Tech. Co. v. Spex Techs., Inc., IPR2017-01021,
`
`Paper 31 at 4-5 (P.T.A.B. May 29, 2018); R.J. Reynolds Vapor Co. v. Fontem
`
`Holdings 1 B.V., IPR2016-01692, Paper 41 at 3 (P.T.A.B. Oct. 23, 2017).
`
`IV.
`
`CONCLUSION
`
`Accordingly, Patent Owner has timely moved to submit the Markman hearing
`
`transcript as EX1053 and the parties’ proposed claim construction order as EX1054
`
`(and will submit the final order once entered), and it would be in the interests of
`
`justice for the Board to accept this supplemental information—so that the Board can
`
`consider it in deciding the level of skill in the art and claim construction issues in
`
`this proceeding.
`
`8
`
`
`
`Petitioner’s Motion to Submit Supplemental Evidence
`IPR2020-00770
`Respectfully submitted,
`
`COOLEY LLP
`
`By: /Ivor R. Elrifi/
`Ivor R. Elrifi
`Reg. No. 39,529
`Counsel for Petitioner
`
`Dated: June 15, 2021
`
`COOLEY LLP
`ATTN: Patent Group
`1299 Pennsylvania Ave., NW, Suite 700
`Washington, DC 20004
`Tel: (212) 479-6840
`Fax: (212) 479-6275
`
`
`
`
`
`
`9
`
`
`
`Petitioner’s Motion to Submit Supplemental Evidence
`IPR2020-00770
`
`CERTIFICATE OF SERVICE
`
`I hereby certify, pursuant to 37 C.F.R. §§ 42.6(e) and 42.105(b), that a
`
`complete and entire copy of this PETITIONER’S MOTION TO SUBMIT
`
`SUPPLEMENTAL EVIDENCE and related documents, are being served on the
`
`15th day of June, 2021, via electronic mail upon counsel of record for the Patent
`
`Owner as follows:
`
`UTC-901@foley.com
`Stephen B. Maebius (smaebius@foley.com)
`George Quillin (gquillin@foley.com)
`Jason Mock (jmock@foley.com)
`FOLEY & LARDNER LLP
`
`Douglas Carsten (dcarsten@mwe.com)
`April E. Weisbruch (aweisbruch@mwe.com)
`Judy Mohr (jmohr@mwe.com)
`MCDERMOTT WILL & EMERY LLP
`
`Richard Torczon (rtorczon@wsgr.com)
`WILSON, SONSINI, GOODRICH & ROSATI
`
`Shaun R. Snader (ssnader@unither.com)
`UNITED THERAPEUTICS CORP.
`
`
`/Ivor R. Elrifi/
`Ivor R. Elrifi
`Reg. No. 39,529
`
`By:
`
`
`
`
`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
`
`
`
`
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
