UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
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`LIQUIDIA TECHNOLOGIES, INC.,
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`Patent Owner.
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`
`_______________
`
`Case IPR2020-00770
`Patent 9,604,901
`_______________
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`PATENT OWNER’S OPPOSITION TO PETITIONER’S MOTION TO
`SUBMIT SUPPLEMENTAL INFORMATION
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`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`LIQUIDIA TECHNOLOGIES, INC.,
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`Patent Owner.
`
`
`_______________
`
`Case IPR2020-00770
`Patent 9,604,901
`_______________
`
`
`PATENT OWNER’S OPPOSITION TO PETITIONER’S MOTION TO
`SUBMIT SUPPLEMENTAL INFORMATION
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`Case IPR2020-00770
`Patent 9,604,901
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`
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`Opposition to Supplemental Information
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`I.
`INTRODUCTION
`United Therapeutics Corporation (“UT”) does not oppose submitting what is
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`arguably relevant—the district court’s1 claim construction order—but UT does
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`oppose Petitioner’s motion to flood the record with ancillary material—Exhibits
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`1053 (Markman hearing transcript) and 1054 (proposed Markman order) (Paper 38
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`or “Motion”).2 Specifically, UT submits with this paper and with Petitioner’s
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`consent, Exhibit 2035, the district court’s Markman order for certain terms of the
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`patent at issue, U.S. Patent No. 9,604,901. But admission of the hearing transcript
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`and now-superseded order is not in the interests of justice, and Petitioner has failed
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`to meet its high burden under 37 C.F.R. § 42.123(b).
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`Aside from claim construction rulings made orally during the hearing (which
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`are now formalized in the order of Exhibit 2035), Petitioner’s other citations to the
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`hearing transcript amount to attempts to supplement the record with its own further
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`1 United Therapeutics Corporation v. Liquidia Technologies, Inc., C.A. No. 20-755
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`(RGA) (D. Del.).
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`2 Despite the title of Petitioner’s motion, UT treats the filing as a motion to submit
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`supplemental information.
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`2
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`Case IPR2020-00770
`Patent 9,604,901
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`Opposition to Supplemental Information
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`attorney argument and engage in a game of gotcha regarding allegedly inconsistent
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`statements. Moreover, Petitioner cites only a handful of portions of the transcript
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`despite requesting submission of over 100 pages. The Board should not be
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`required to scour the transcript for a nugget of relevance. Likewise, UT should not
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`be ambushed with new attorney arguments imported from another proceeding.
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`The parties have had extensive opportunity to submit evidence and argument
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`relating to claim construction, including evidence and argument from the parallel
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`district court case. Dumping another 100+ pages of transcript from another
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`proceeding does nothing to aid in resolving the issues at hand here.
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`II. LEGAL STANDARDS
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`Petitioner’s Motion is governed by 37 C.F.R. § 42.123(b). Petitioner must
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`show that the information could not be submitted earlier and submission is in the
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`interests of justice. No interest of justice is served by raising new issues (like
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`indefiniteness) and loading up the record with redundant and unsupported attorney
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`argument, particularly when UT has no opportunity to respond with argument and
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`evidence in turn. 5 U.S.C. § 554 (requiring notice and opportunity to respond
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`meaningfully).
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`3
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`Case IPR2020-00770
`Patent 9,604,901
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`III. ARGUMENT
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`Opposition to Supplemental Information
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`Petitioner has failed to demonstrate that submission of Exhibits 1053 and 1054
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`is in the interests of justice. The draft Markman order (Exhibit 1054) has now
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`been superseded by the actual order (Exhibit 2053), and justice does not benefit
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`from dumping 100+ pages of attorney argument from another proceeding into the
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`record on the eve of the oral hearing. Indeed, this supplemental evidence adds a
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`host of issues not briefed in this proceeding, such as Petitioner’s allegation of
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`indefiniteness in the parallel proceeding—the very type of material, inconsistent
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`position that Petitioner claims UT has engaged in.
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`A. Exhibit 2035 Should Be Admitted in Lieu of Exhibits 1053 and
`1054
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`Exhibit 1054 is merely a proposed order that was submitted to the Court after
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`the Markman hearing. In view of the signed Markman order submitted herewith as
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`Exhibit 2035, there is no reason to admit Exhibit 1054 as supplemental information
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`– it is merely an unsigned proposed order that has no relevance or provenance in
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`this proceeding. The parties agree that Exhibit 2035 can be submitted.
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`Similarly, the issued order also obviates the need to admit the hearing
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`transcript (Exhibit 1053) as evidence of the Court’s Markman rulings, since these
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`rulings are now formalized in the issued order of Exhibit 2035.
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`4
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`Case IPR2020-00770
`Patent 9,604,901
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`Opposition to Supplemental Information
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`Petitioner’s motion to admit Exhibits 1053 and 1054 should therefore be
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`denied in favor of admitting Exhibit 2035 as the most direct evidence of the district
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`court’s claim construction rulings.3
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`B.
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`Petitioner’s Attempted Reliance on Exhibit 1053 Demonstrates
`that its Admission Is Not in the Interests of Justice
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`Petitioner has failed to demonstrate that submission of the evidence Exhibits
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`1053 and 1054 is in the interests of justice. Rather, Petitioner seeks to flood the
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`record with its own attorney argument as “evidence” and manufacture
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`inconsistencies on the eve of oral hearing. Justice does not condone, much less
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`require, submission of Exhibits 1053 and 1054 in these circumstances.
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`1.
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`Petitioner should not be permitted to supplement the record
`with its own attorney argument
`Petitioner’s first argument for admitting Exhibit 1053 is that “the parties
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`addressed the same issues present here related to the person of ordinary skill in the
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`3 While UT does not object to Exhibit 2035 being introduced as evidence in this
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`proceeding, UT doubts that the Court’s “plain and ordinary meaning” constructions
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`are particularly helpful to the Board here, since the Board must serve as the
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`ultimate trier of fact and determine what the actual “plain and ordinary meanings”
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`are sufficiently to resolve the invalidity disputes in this proceeding.
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`5
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`Case IPR2020-00770
`Patent 9,604,901
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`Opposition to Supplemental Information
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`art for the ’901 patent.” Mot. at 4. However, the transcript portion cited by
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`Petitioner consists solely of Petitioner’s own counsel arguing “level of skill” to the
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`district court. It can hardly be in the interests of justice to allow Petitioner to
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`further supplement the record in this proceeding with its own attorney argument
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`from another proceeding.
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`2.
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`Petitioner has failed to offer any explanation justifying
`submission of the entire transcript
`Petitioner argues that the parties and the Court discussed multiple claim terms
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`at issue in this proceeding. Id. In support of this proposition, Petitioner merely
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`provides a blanket citation to over 100 pages of the transcript (27:4-130:2), with no
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`further explanation. Petitioner apparently expects the Board to sift through
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`essentially the entire transcript with the mere possibility of finding some
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`potentially relevant discussions. Again, this fails to establish that admitting the
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`transcript is in the interests of justice.
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`3.
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`The Markman order supersedes the transcript and draft
`order
`Petitioner points to the three terms the court ruled on during the hearing, while
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`noting that the court sought additional briefing on the remaining terms. Id. at 4-5.
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`These oral rulings do not merit admission of Exhibit 1053 as supplemental
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`information because the court’s claim construction rulings on the three terms are
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`6
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`Case IPR2020-00770
`Patent 9,604,901
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`Opposition to Supplemental Information
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`now memorialized in the order of Exhibit 2035 (for whatever relevance they may
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`have here (see supra, note 3)). The court’s request for additional briefing is simply
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`irrelevant here.
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`4.
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`Petitioner should not be permitted to manufacture non-
`existent “inconsistencies” on the eve of the oral hearing
`Petitioner points to alleged “inconsistencies” in UT’s claim construction
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`positions in the two tribunals. Id. at 5-8. None of Petitioner’s citations support its
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`characterization or argument. Petitioner further cites to Exhibit 1053 in slides 14,
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`22, and 25 of its proposed Demonstratives despite it not even being part of the
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`record. This improper use of a proposed new exhibit in Demonstratives violates
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`the interest of justice and denies UT the right to meet these arguments with
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`counterarguments and evidence, e.g., testimony from the experts whose testimony
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`is being misrepresented. 5 U.S.C. § 554 (requiring notice and an opportunity to
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`respond meaningfully).
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`i.
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`“Pharmaceutical batch”
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`The court has not yet issued a construction for “pharmaceutical batch” (see
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`Exhibit 2035). The court’s discussion of the issue (EX1053, 28:3-15) does not
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`reveal any inconsistency in UT’s positions. Further, Petitioner’s citation to 33:14-
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`7
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`Case IPR2020-00770
`Patent 9,604,901
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`Opposition to Supplemental Information
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`44:13 of the transcript (Mot. at 6) is just another instance of trying to import into
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`the record here its own attorney argument from another proceeding.
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`Petitioner cites to 44:13-53:18 of the transcript (id.) in an apparent attempt to
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`tarnish the integrity of UT’s counsel. But this effort is both odious and
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`substantively incorrect. As evidenced by that portion of the transcript, UT’s
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`counsel explained the circumstances that led to some misstatements in the Patent
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`Owner Response filed here, and further explained the steps that have been taken to
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`rectify the situation (including the filing of Paper 29 in this proceeding).
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`Lastly, Petitioner cites 54:21-57:8 of the transcript, but this merely involves a
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`discussion with the district court about the timing of various events in the PTAB
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`proceeding. Such discussions do not involve any “inconsistency” in UT’s
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`positions and are simply irrelevant here.
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`ii.
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` “contacting the solution comprising treprostinil
`from step (b) with a base to form a salt of
`treprostinil”
`Petitioner cites the same transcript portion (44:13-53:18) again here (Mot. at
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`7), but, as described above, this discussion merely involves UT’s counsel
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`explaining the circumstances leading to UT’s agreement to strike certain portions
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`of the Patent Owner Response per Paper 29. The Board has already heard directly
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`8
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`Case IPR2020-00770
`Patent 9,604,901
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`Opposition to Supplemental Information
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`from the parties on this issue, and Petitioner does not point to any “inconsistency”
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`in UT’s explanation.
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`To be clear, UT’s position is that even though the claims of the ’901 patent do
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`not expressly recite intermediate purification steps, this does not mean that such
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`steps are affirmatively excluded. UT regrettably overstated certain sentences in its
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`Patent Owner Response in this regard and promptly took action to act with candor
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`and correct this mistake—agreeing to strike these statements. See Paper 29. The
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`somewhat confused back-and-forth between the district court and Petitioner’s
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`counsel during the Markman hearing further illustrates the intricacies of this issue.
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`See EX1053, 34:6-44:15.
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`Petitioner lastly cites to 57:9-75:6 of the transcript, which involves further
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`discussions with the court about this claim term. However, Petitioner fails to point
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`to a single “inconsistency” or other statement in this portion of the transcript as
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`being specifically relevant to this proceeding. Thus, Petitioner again fails to
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`identify any portions of the transcript that satisfy its admission here under the
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`“interests of justice” standard.
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`iii.
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`“stored/storing/storage”
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`Petitioner cites 99:5-7, 113:9-13, 119:17-19, and 123:6-14 (Mot. at 7-8) in
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`support of its suggestion that the court allegedly disparaged UT’s proposed
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`9
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`Case IPR2020-00770
`Patent 9,604,901
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`Opposition to Supplemental Information
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`construction for this claim term. In the end, however, the court simply adopted
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`“plain-and-ordinary meaning” for the construction of this term (see Exhibit 2035).
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`While that approach can be followed in a district court proceeding where the fact-
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`finder at trial can there consider additional evidence and make a determination,
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`here, the PTAB is the ultimate fact-finder and will have to sufficiently construe
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`this term to resolve the parties’ dispute over its meaning/scope in the context of the
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`prior art. The transcript portions cited by Petitioner therefore have little to no
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`relevance to the Board’s decision-making required here.
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`Petitioner cites the transcript at 115:24 for the proposition that UT allegedly
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`argued the product being “good” for even “one day” is sufficient for storage as
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`claimed by the ’901 patent. Mot. at 7. But even a cursory review of this portion of
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`the transcript shows that UT made no such argument. Instead, UT was merely
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`pointing out that if a product is known to be stable for at least three months, then
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`this logically leads to an understanding that the product is stable for shorter
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`periods, such as two months, one month, two days, one day, etc. However, UT’s
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`statements to the district court never included an argument that a product being
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`stable for one day equated to “storage” as called for in the claims, as is apparent
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`from the transcript itself. Petitioner thus significantly distorts the record in arguing
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`otherwise (as it does in the further cited transcript portions at 117:1-121:8), and
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`10
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`Case IPR2020-00770
`Patent 9,604,901
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`Opposition to Supplemental Information
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`such bare distortions should not be allowed to support Petitioner’s burden in
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`meeting the “in the interests of justice” standard.
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`In sum, even if the submission of supplemental information can be justified
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`where that information evidences inconsistences in a party’s arguments before two
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`different tribunals, that is simply not the situation here. The only potential
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`inconsistencies were the accidental overstatements contained in certain parts of the
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`Patent Owner Response, and UT has already taken steps to clarify and cure. In any
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`event, the Markman hearing transcript reveals no new information or inconsistent
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`positions being taken by UT.
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`IV. CONCLUSION
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`For at least the reasons provided above, Petitioner’s Motion should be denied
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`and Exhibits 1053 and 1054 should not be admitted as supplemental information,
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`particularly in view of UT’s submission herewith of the district court’s formal
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`Markman order as Exhibit 2035.
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`Respectfully submitted,
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`Date: June 21, 2021
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`/Stephen B. Maebius/
`Stephen B. Maebius
`Registration No. 35,264
`Counsel for Patent Owner
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`11
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`Case IPR2020-00770
`Patent 9,604,901
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`Opposition to Supplemental Information
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing Patent
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`Owner’s Opposition to Petitioner’s Motion to Submit Supplemental Information
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`was served on counsel of record on June 21, 2021, by filing this document through
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`the PTAB E2E System as well as delivering a copy via email to the counsel of
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`record for the Petitioner at the following addresses:
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`zLiquidiaIPR@cooley.com
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`ielrifi@cooley.com
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`emilch@cooley.com
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`dkannappan@cooley.com
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`Date: June 21, 2021
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`/Stephen B. Maebius/
`Stephen B. Maebius
`Foley & Lardner LLP
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`4852-4065-9439.1
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