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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 IPR2021-00406
`Patent 10,716,793
`_______________
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`PATENT OWNER’S REPLY IN SUPPORT OF
`ITS MOTION TO EXCLUDE
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`Case IPR2021-00406
`U.S. Patent 10,716,793
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`Patent Owner’s Reply in Support of
`Its Motion to Exclude
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`I.
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`EX1037 Is not the Same Manual as EX1086 or Exhibit E to EX1087
`Petitioner argues that EX1037 identified as an “English translation of
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`OptiNeb User Manual 2005” is offered “as evidence of what it describes to an
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`ordinary artisan.” EX1037 however, is an undated, purported English translation
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`of “an Optineb manual” and not self-authenticating (FRE 902). Petitioner failed to
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`timely provide the underlying German document that was allegedly translated, or
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`an affidavit attesting to the accuracy of the translation filed with the document.
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`In an attempt to cure the evidentiary deficiencies of EX1037, Petitioner
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`asserts that the German document and translation attached to EX1086 and 1087
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`(served as supplemental evidence) establish that EX1037 “is what it is asserted to
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`be.” Paper No. 68, 4. However, they do not cure any deficiencies.
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`First, Petitioner relied upon EX1037 for a purported nebulization rate of “0.6
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`mL/min” (Petition, 23; Institution Decision, Paper No. 18, 24), but EX1087 and
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`EX1086 recite a different nebulization rate in a range of “<0.6 mL/min.” EX1037,
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`28; EX 1087, 27 and EX1086, 31 and 50.1 A specific rate of “0.6 mL/min” is not
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`1 Liquidia’s EX1086 was served as supplemental evidence, used to cross-
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`examine Dr. Hill, and filed as an attachment to EX2108 (Hill deposition
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`transcript). EX1086 is cited in the opposition (Paper 68, 4), but was not filed by
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`Liquidia.
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`1
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`Case IPR2021-00406
`U.S. Patent 10,716,793
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`equivalent to a range of “<0.6 mL/min.” Petitioner has failed to establish that
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`Patent Owner’s Reply in Support of
`Its Motion to Exclude
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`EX1086 and EX1087 are the same documents and further, that the translation is
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`accurate.
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`Second, Petitioner’s identification of a 2005 date for EX1037 is misleading
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`and inconsistent with the submitted supplemental evidence. Although Petitioner
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`asserts EX1037 is a 2005 manual (Petition, vii), the manual provided in Exhibit E
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`to EX1087 is from 2004 (see EX1087, ¶7), and EX1086 corresponds to that
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`document (EX1086, 35).
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`Petitioner’s undated translation of some Optineb manual is in direct
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`contravention of 37 C.F.R. § 42.63(b) and should therefore be excluded.
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`II. EX1029 Should Be Excluded Under FRE 902
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`EX1029 (alleged Ventavis label) should be excluded. Petitioner bore the
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`burden to prove authenticity, which it describes as a “low bar,” but failed to do so.
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`EX1029 does not identify a date, and Petitioner failed to explain where it was kept
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`or how it was obtained. Paper No. 66, 14-15. Petitioner tries to correct these
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`deficiencies by belatedly providing new evidence in its Opposition (Paper No. 68,
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`11, n.3-4). This new evidence is untimely, and these websites were accessed on
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`April 22, 2022, not before the priority date or contemporaneously with the Petition
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`or its supporting declarations. Petition, 17; EX1002, ¶¶36, 41, 42; EX1004, ¶¶33,
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`92, 104, 108, 131, n.4-6. Petitioner references the approval date for Ventavis, but
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`2
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`U.S. Patent 10,716,793
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`this has no bearing on whether that version of a drug’s label existed at a given
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`Patent Owner’s Reply in Support of
`Its Motion to Exclude
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`point or whether it is authentic.
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`Petitioner’s next argument asserts that EX1029 is an authentic drug label
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`because it looks like a drug label. If that argument is sufficient, it provides yet
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`more support for admissibility of EX2100-2103.
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`Regardless, because Petitioner provided new evidence of alleged
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`authenticity for the first time with its Opposition, Patent Owner is only now able to
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`evaluate the evidence. While public accessibility is not addressed in a Motion to
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`Exclude, Patent Owner has no other opportunity to address the issue other than this
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`reply. Petitioner has failed to provide any evidence that EX1029 would have been
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`“indexed and thereby findable by a search engine” at the time it asserts (2004).
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`Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1350 (Fed. Cir. 2016). Mere
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`publication to the internet is not a sufficient showing to establish public
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`accessibility. See Celltrion, Inc. v. Biogen, Inc., IPR2016-01614, Paper No. 65 at
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`17-20 (PTAB Feb. 21, 2018) (citation omitted).2 In Celltrion, the Petitioner
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`2 Petitioner relies on New World Med., Inc. v. Microsurgical Tech., Inc.,
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`IPR2020-01573, Paper 63 at 9 (PTAB Feb. 16, 2022). However, New World
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`addresses accessibility of abstracts, not drug labels. The Celltrion case provides the
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`standards for authenticating the public availability of online drug labels.
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`3
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`U.S. Patent 10,716,793
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`similarly asserted that a copy of a label posted on a website along with an Internet
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`Patent Owner’s Reply in Support of
`Its Motion to Exclude
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`Archive declaration was an authenticated printed publication. Id. at 17. The Board
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`disagreed, stating that even if the declaration establishes that the reference was
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`online before the priority date, petitioner failed to adequately support its contention
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`that the label was publicly accessible prior to the critical date. Id. at 20. Here,
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`there is not even an Internet Archive declaration. Accordingly, Petitioner has not
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`shown EX1029 was publicly accessible by the date it asserts.
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`III. EX1050, EX1066, EX1074, and EX1078 Should Be Excluded
`Petitioner presents EX1050, EX1066, EX1074, and EX1078 as labels for
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`various drugs, but the exhibits do not identify where they were kept or how they
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`were obtained, are not self-authenticating under FRE 902, and Petitioner has not
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`provided evidence these versions were publicly accessible by any given dates.
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`Dates printed on the documents are not sufficient. Celltrion, Paper No. 65, 20. The
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`fact that the experts prescribe or use the products relating to a label on patients has
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`no bearing on whether a specific version of that product’s label existed on a
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`website or otherwise had an identifiable source to allow for authentication. There is
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`insufficient evidence to authenticate any of these exhibits or show they were
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`publicly accessible. Id.
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`IV. EX1114, 1117, 1120, and the Portions of EX1112 Relying Thereon
`Should Be Excluded
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`Petitioner’s claim that it does not rely on these exhibits or testimony to prove
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`the Abstracts’ date of public availability (Pet. Opp. at 8) is nonsensical. That is
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`Patent Owner’s Reply in Support of
`Its Motion to Exclude
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`exactly how Petitioner uses them. Paper 44 at 3, 8-9 (citing EX1112, ¶¶ 39, 87).
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`Further, the Neste Oil case cited by Petitioner contradicts its own arguments.
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`While the Board admitted certain navigational pages, it excluded the documents
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`proffered to prove the date of public availability. See IPR2013-00578, Paper 53 at
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`4-6 (excluding printouts and date stamps). The same should occur here.
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`Finally, while experts can sometimes rely on hearsay, those requirements are
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`not met here. First, Dr. Hall-Ellis never testified that “experienced librarians would
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`reasonably rely on [these exhibits] in forming their opinions” in order to satisfy
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`FRE 703. Second, Hall-Ellis did not use these exhibits to find EX1007 or EX1008
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`and Petitioner cannot point to a single instance of any of these exhibits actually
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`leading to the Abstracts themselves. This lack of evidence demonstrates why these
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`exhibits and Dr. Hall-Ellis’ testimony relying on them should be excluded under
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`FRE 702. There is no evidence Dr. Hall-Ellis’ unproven claims to the contrary are
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`the product of reliable principles and methods.
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`V. CONCLUSION
`For at least the reasons provided above and in Paper No. 66, Patent Owner
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`respectfully requests the Board to grant its motion and exclude EX1037, 1029,
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`1050, 1066, 1074, and 1078, as well as the arguments of Petitioner that rely on
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`these exhibits in the Petition and in its Reply. Paper No. 69, 2, 3, 5, and 15.
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`5
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`Case IPR2021-00406
`U.S. Patent 10,716,793
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`Date: May 4, 2022
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`Patent Owner’s Reply in Support of
`Its Motion to Exclude
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`Respectfully submitted,
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`/Stephen B. Maebius/
`Stephen B. Maebius
`Registration No. 35,264
`Counsel for Patent Owner
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`6
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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 In Support of Its Motion to Exclude was served on counsel of record on
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`May 4, 2022, by filing this document through the PTAB E2E System, as well as
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`delivering a copy via email to the counsel of record for the Petitioner at the
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`following address:
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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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`ssukduang@cooley.com
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`Date: May 4, 2022
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`/Stephen B. Maebius/
`Stephen B. Maebius
`Foley & Lardner LLP
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`4879-4754-4606
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