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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.,
`Petitioner,
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`v.
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`UNITED THERAPEUTICS CORPORATION,
`Patent Owner.
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`_______________
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`Case IPR2020-00770
`Patent 9,604,901
`_______________
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`PATENT OWNER’S REPLY TO
`OPPOSITION TO MOTION TO EXCLUDE
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`4823-2778-4685.1
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`Case IPR2020-00770
`Patent 9,604,901
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`Patent Owner’s Reply to
`Opposition to Motion to Exclude
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`I.
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`EX1002: PURPORTED WINKLER DECLARATION
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`Liquidia contends its failure to file a sworn expert declaration with its
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`Petition should be excused because (1) the objections lacked “sufficient
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`particularity” and (2) the failure was “cured.” Neither contention withstands
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`scrutiny.
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` First, Liquidia means that the initial objection was too “generic,” but the
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`initial objections (Paper No. 10) expressly put Liquidia on notice that its purported
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`declaration was not authentic. Liquidia does not state that it did not understand the
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`objection (in depositions they are far terser), that it sought clarification from UT, or
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`that it could not identify how the exhibit lacked authentication. Significantly,
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`Liquidia represented the exhibit as an IPR-specific declaration: essentially the only
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`way a purported declaration could fail to be what it was represented to be would be
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`by failing to meet the statutory and rule-based requirements for declarations. Yet
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`Liquidia cannot claim ignorance of the applicable rules, which it followed for
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`concurrently-filed EX1015 without any similar objection from UT (Paper No. 10).
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`Rather than address the deficiency on which the objection is based, Liquidia
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`objects to the objection. This defect is fatal. The failure to impress upon a witness
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`that a statement is under oath goes to the heart of its reliability as evidence.
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`Paper 31, citing Chambers v. Mississippi, 410 U.S. 284, 298 (1973).
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`4823-2778-4685.1
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`Case IPR2020-00770
`Patent 9,604,901
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`Patent Owner’s Reply to
`Opposition to Motion to Exclude
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` Second, Liquidia cites authority for the Board authorizing correction of an
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`omitted oath belatedly, but tellingly does not identify where Liquidia sought
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`authorization to file supplemental (and belated) evidence with its reply. Instead,
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`Liquidia simply ignored the defect. Even now, Liquidia presents its belated filing
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`as a fait accompli rather than risk moving for relief.
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` Congress offered declarations as an alternative to testimony under oath as a
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`convenience to the filer, but the requirements that come with that convenience are
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`not optional. Similarly, the Director promulgated rules requiring procedural
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`regularity and electing to require the Federal Rules of Evidence to protect the
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`efficiency and integrity of these proceedings. 35 U.S.C. §316(b). UT is entitled to
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`rely on Liquidia’s failure to file timely supplemental evidence in filing its
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`Response. Liquidia makes no attempt to show its flouting of the rules to file
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`belated surprise evidence is in the interest of justice. The statute and rules must
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`retain their explicit meaning.
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` Regarding Dr. Winkler’s competence, Liquidia attempts to enlist the Board
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`to do what it should have done: separate Dr. Winkler’s wheat from his chaff. Paper
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`No. 32, 4 n.2. This is not the Board’s role as a neutral adjudicator, nor is the Final
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`Written Decision the place for UT to learn what Liquidia should have made clear
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`in its Petition.
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`4823-2778-4685.1
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`Case IPR2020-00770
`Patent 9,604,901
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`Patent Owner’s Reply to
`Opposition to Motion to Exclude
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`Indeed, Liquidia provides a great example in its opposition. Paper No. 32, 3
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`n.1. Liquidia jettisoned Dr. Hall-Ellis’s testimony undermining Dr. Winkler’s
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`relevance to testify in this proceeding. (If Liquidia’s sworn testimony is now
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`admittedly unreliable, how much less can its unsworn testimony be trusted?)
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`Liquidia argues that UT should have known Dr. Hall-Ellis’s testimony was
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`nonsense from the context (id.), but Dr. Winkler’s statements on which Liquidia
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`continues to rely suffers the same defect. Yet Liquidia expressly shifts the burden
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`to UT and the Board to figure out what is reliable (Paper 32, 4-5 n.2), ignoring
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`Justice Scalia’s admonition that discretion over how to determine expert reliability
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`is not discretion over whether to exclude unreliable information. Paper 31, citing
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`526 U.S. at 159. Again and again, Dr. Winkler’s statements about relevant
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`technologies are wrong or inconsistent, revealing an inability or unwillingness to
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`provide reliable testimony. Both UT and the reviewing court are entitled to the
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`Board’s express determination of this unreliability.
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` Liquidia’s opposition provides a second example in its discussion of
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`polymorphs. Rather than rebut Dr. Pinal’s careful, qualified explanation of why Dr.
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`Winkler’s testimony on polymorphs is utterly wrong, Liquidia simply says it is not
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`relevant. Paper 32, 6 n.3. Yet recall Dr. Winkler’s lack of understanding about
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`polymorphs is at the heart of his testimony about stability in the prior art. Paper 1,
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`4823-2778-4685.1
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`Case IPR2020-00770
`Patent 9,604,901
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`Patent Owner’s Reply to
`Opposition to Motion to Exclude
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`27, 43-44, 51-52, 68-69. Liquidia procured institution on the basis of relative
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`polymorph stability, but now—after the close of briefing and faced with evidence
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`undermining its arguments— Liquidia decides that its evidence is irrelevant. Dr.
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`Winkler is unable to testify accurately on key technical concepts in this
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`proceeding, or else is willing to change his testimony as suits, but either way his
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`statements are unreliable.
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`II. EX1012: PURPORTED KAWAKAMI APPLICATION
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`Once again, this exhibit is not what it purports to be: a certified Japanese
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`application. Instead, Liquidia filed an uncertified English “translation” without
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`filing the foreign-language application at all, much less a certified translation.
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`37 CFR §42.63(b). Liquidia responds by belatedly filing exhibits purporting to
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`cure these defects. Once again, Liquidia does not bother with seeking
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`authorization, but instead, engages in self-help sandbagging long after the close of
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`briefing on the merits. Liquidia pleads that UT is not prejudiced because the
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`unfiled materials appear in a different proceeding (without explaining how, for
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`example, UT would cross-examine a declarant in the other proceeding for this
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`case). Liquidia again ignores the discussed case law. As the motion explains,
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`materials in a different—even if related—proceeding do not cure failure to file in
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`the present proceeding. Paper 31, 10-11, citing Stevens v. Tamai, 366 F.3d 1325,
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`4823-2778-4685.1
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`Case IPR2020-00770
`Patent 9,604,901
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`Patent Owner’s Reply to
`Opposition to Motion to Exclude
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`1334 (Fed. Cir. 2004) (reversing decision to ignore translation requirement).
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`Indeed, the failure in this case is worse than in Stevens because Liquidia not only
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`omitted the certification: it also omitted the underlying exhibit.
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`III. CONCLUSION
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` Congress imposed tight deadlines on the Board. In response, the Office
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`adopted exacting rules with little discovery to ensure efficiency. The efficiency and
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`integrity of these proceedings require that Liquidia follow rather than flout them.
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`Liquidia’s cool disregard for the rules prejudices both UT and the Board. The rules
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`should be followed in this case, which requires exclusion of these exhibits.
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`Respectfully submitted,
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`Date: June 8, 2021
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`/Stephen B. Maebius/
`Stephen B. Maebius
`Registration No. 35,264
`Counsel for Patent Owner
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`4823-2778-4685.1
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`5
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`Case IPR2020-00770
`Patent 9,604,901
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`Patent Owner’s Reply to
`Opposition to Motion to Exclude
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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 Reply to Opposition to Motion to Exclude was served on counsel of
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`record on June 8, 2021, by filing this document through the PTAB E2E System as
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`well as delivering a copy via email to the counsel of record for the Petitioner at the
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`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 8, 2021
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`/Stephen B. Maebius/
`Stephen B. Maebius
`Foley & Lardner LLP
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`4823-2778-4685.1
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`6
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