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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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`
`_______________
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`Case IPR2021-00406
`Patent 10,716,793
`_______________
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`PATENT OWNER’S OBJECTIONS TO PETITIONER’S EVIDENCE
`SUBMITTED WITH PETITIONER REPLY
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`4854-0897-4095.1
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`IPR2021-00406
`Patent 10,716,793 B2
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`Patent Owner’s Objections to Evidence
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`Patent Owner United Therapeutics Corporation (“Patent Owner”) hereby
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`objects to the admissibility of certain evidence cited in support of the Reply in
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`Support of Petition for Inter Partes Review filed on February 10, 2022 (“Reply”).
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`Patent Owner’s objections are based on the Federal Rules of Evidence (“FRE”),
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`relevant case law, federal statute, and the Patent Trial and Appeal Board (“PTAB”)
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`Rules. Patent Owner’s objections are set forth with particularity below.
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`EXHIBIT 1087
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`Exhibit 1087 is described as “Affidavit of Christopher Butler.” This Exhibit
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`was served as supplemental evidence in response to Patent Owner’s objections to
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`the Petition, so it is improper for Petitioner to cite to this document in its Reply.
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`Patent Owner objects to the extent it includes subject matter that is not permitted
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`pursuant to FRE 602, including without limitation, to the extent that the declaration
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`presents as “facts” information that is outside the personal knowledge of the
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`declarant. Exhibit 1087 is also objected to as irrelevant under FRE 401 and 402
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`because it does not make any facts at issue in the inter partes review more or less
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`probable than it would have been without the evidence. Patent Owner objects to
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`Exhibit 1087, and the exhibits thereto, as unfairly prejudicial, confusing the issues,
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`and a waste of time under FRE 403. Patent Owner also objects to Exhibit 1087 as
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`Patent 10,716,793 B2
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`Patent Owner’s Objections to Evidence
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`it should have been included with the Petition and, thus, does not meet the
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`requirements of Rule 104(b)(5).
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`EXHIBITS 1089-1096, 1113, 1121
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`Exhibits 1089-1096 purport to be portions of larger volumes comprising
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`collections of abstracts. Exhibit 1113 is described as “JAHA Supplement Author
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`Index.” Exhibit 1121 is described as “Ghofrani 2005, British Library.” Patent
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`Owner objects to page 12 of Exhibit 1089 which appears to be different than page
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`11 and not an accurate representation of the source document. Patent Owner
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`objects to these exhibits under FRE 901-902 as lacking authentication and not self-
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`authenticating because they lack sufficient indicia that the exhibits are what they
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`purport to be. Patent Owner further objects to these exhibits under FRE 106 and
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`401-403 as incomplete, irrelevant, waste of time, and likely to cause confusion
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`because they contain only abstracts of the underlying articles. Patent Owner also
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`objects to Exhibits 1089-1099 as they should have been included with the Petition
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`and, thus, do not meet the requirements of Rule 104(b)(5). Patent Owner objects to
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`Exhibit 1121 under FRE 604 as, aside from an abstract, it is presented in German.
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`EXHIBITS 1088-1105, 1113, 1114, and 1118-1131
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`Patent Owner objects to these exhibits under FRE 901-902 as lacking
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`authentication and not self-authenticating because they lack sufficient indicia that
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`4854-0897-4095.1
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`IPR2021-00406
`Patent 10,716,793 B2
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`Patent Owner’s Objections to Evidence
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`the exhibits are what they purport to be. Patent Owner further objects to these
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`exhibits because Petitioner relies on these exhibits to prove the truth of the matter
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`asserted therein, but they fail to meet the requirements of any hearsay exception or
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`exemption under FRE 803-807.
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`EXHIBIT 1100
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`Exhibit 1100 is described as “Ventavis EU Summary of Product
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`Characteristics.” Patent Owner objects to Exhibit 1100 under FRE 901-902 as
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`lacking authentication and not self-authenticating because it lacks sufficient indicia
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`that the exhibit is what it purports to be. In particular, Exhibit 1100 lacks
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`information as to if, when, where, or how it was published. Patent Owner objects
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`to Exhibit 1100 under FRE 802 as the Petitioner relies on this exhibit to prove the
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`truth of the matter asserted therein, but it fails to meet the requirements of any
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`hearsay exception or exemption under FRE 803-807. Patent Owner also objects to
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`Exhibit 1100 as it should have been included with the Petition and, thus, does not
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`meet the requirements of Rule 104(b)(5).
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`EXHIBITS 1104-1105
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`Exhibits 1104-1105 are described as “Sulica, R. and Poon, M., ‘Medical
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`therapeutics for pulmonary arterial hypertension: from basic science and clinical
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`trial design to evidence-based medicine,’ Expert Rev. Cardiovasc. Ther. 3(2),
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`Patent 10,716,793 B2
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`Patent Owner’s Objections to Evidence
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`(2005) (“Sulica 2005”)” and “European Society of Cardiology Annual Report
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`2005.” Patent Owner objects to these Exhibits under FRE 802 as the Petitioner
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`relies on them to prove the truth of the matter asserted therein, but it fails to meet
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`the requirements of any hearsay exception or exemption under FRE 803-807.
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`Patent Owner objects to these exhibits, which should have been included with the
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`Petition and, thus, do not meet the requirements of Rule 104(b)(5).
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`EXHIBIT 1106
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`Exhibit 1106 is described as “Reply Declaration of Nicholas Hill, M.D.”
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`Patent Owner objects to Exhibit 1106 under FRE 702 and 703 on the basis that the
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`testimony is not based on sufficient facts or data or the product of reliable
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`principles and methods reliably applied in this case (pp. 11-76). In addition,
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`Exhibit 1106 contains numerous legal arguments that are proffered as expert
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`opinions (pp. 11-76).
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`EXHIBIT 1107
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`Exhibit 1107 is described as “Reply Declaration of Igor Gonda, Ph.D.”
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`Patent Owner objects to Exhibit 1107 under FRE 702 and 703 on the basis that the
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`testimony is not based on sufficient facts or data or the product of reliable
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`principles and methods reliably applied in this case (pp. 5-43). Patent Owner
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`Patent Owner’s Objections to Evidence
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`further objects to Exhibit 1107’s reliance on Exhibit 1100 has not been properly
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`authenticated appears to be irrelevant.
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`EXHIBITS 1108-1110
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`Exhibits 1108-1110 are described as “Transcript from the January 8, 2022
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`Deposition of Aaron Waxman, M.D., Ph.D., Liquida [sic] Technologies, Inc. v.
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`United Therapeutics Corp., IPR2021-00406,” “Transcript from the January 11,
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`2022 Deposition of Jason McConville, Liquida [sic] Technologies, Inc. v. United
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`Therapeutics Corp., IPR2021-00406,” and “Transcript from the December 29,
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`2021 Deposition of Lyndsey Pilar Wyman, Liquida [sic] Technologies, Inc. v.
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`United Therapeutics Corp., IPR2021-00406,” respectively. Petitioner objects to
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`these Exhibits to the extent Petitioner relies on any portion, or that the transcripts
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`involve testimony involving, objectionable Exhibits, including without limitation
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`EX1089-EX1096, discussed above.
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`EXHIBIT 1112
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`Exhibit 1112 is described as “Reply Declaration of Sylvia Hall-Ellis, Ph.D.”
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`Patent Owner objects to Exhibit 1112, under FRE 701, because the opinion
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`testimony contained in this exhibit reaches legal conclusions for which the
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`declarant has not established that she is capable of providing. Patent Owner also
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`objects to Exhibit 1112 under FRE 702, on the basis that the testimony is not based
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`IPR2021-00406
`Patent 10,716,793 B2
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`Patent Owner’s Objections to Evidence
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`on sufficient facts and is based on other informal and unpublished documents
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`including its attached exhibits that are hearsay under FRE 802, have not been
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`authenticated under FRE 901, are not self-authenticating under FRE 902, and are
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`not duplicates as defined by FRE 1001(e). Patent Owner objects to Exhibit 1112 to
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`the extent it includes subject matter that is not permitted pursuant to FRE 602 or
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`701, including without limitation, to the extent that the declaration presents as
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`“facts” information that is outside the personal knowledge of the declarant, and/or
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`to the extent that the document offers improper lay opinion testimony. Exhibit
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`1112 is also objected to as irrelevant under FRE 401 and 402 because it does not
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`make any facts at issue in the inter partes review more or less probable than it
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`would have been without the evidence. Patent Owner objects to Exhibit 1112, and
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`the exhibits thereto, as unfairly prejudicial, confusing the issues, and a waste of
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`time under FRE 403. Patent Owner objects to the portions of Exhibit 1112 that
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`cite or reproduce an exhibit objected to herein for the reasons stated herein.
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`EXHIBIT 1114
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`Exhibit 1114 is described as “American Heart Association 2004 Online
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`Archive . . . .” Patent Owner objects to Exhibit 1114 under FRE 901-902 as
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`lacking authentication and not self-authenticating because it lacks sufficient indicia
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`that the exhibit is what it purports to be. Patent Owner objects to Exhibit 1114
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`IPR2021-00406
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`Patent Owner’s Objections to Evidence
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`under FRE 802 as the Petitioner relies on this exhibit to prove the truth of the
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`matter asserted therein, but it fails to meet the requirements of any hearsay
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`exception or exemption under FRE 803-807. Patent Owner also objects to Exhibit
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`1114 as it should have been included with the Petition and, thus, does not meet the
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`requirements of Rule 104(b)(5).
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`EXHIBITS 1089-1096, 1104-1105 AND 1113-1129
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`Patent Owner also objects to these exhibits as they should have been
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`included with the Petition and, thus, do not meet the requirements of Rule
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`104(b)(5). Further, Patent Owner objects to the portions of Petitioner’s Reply and
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`Exhibits 1106, 1108-1110, 1112, and 1132 that rely upon these exhibits.
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`EXHIBIT 1115
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`Exhibit 1115 is described as “Affidavit of Duncan Hall, December 7, 2021.”
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`Patent Owner objects to the extent it includes subject matter that is not permitted
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`pursuant to FRE 602, including without limitation, to the extent that the declaration
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`presents as “facts” information that is outside the personal knowledge of the
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`declarant. Exhibit 1115 is also objected to as irrelevant under FRE 401 and 402
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`because it does not make any facts at issue in the inter partes review more or less
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`probable than it would have been without the evidence. Patent Owner objects to
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`Exhibit 1115, and the exhibits thereto, as unfairly prejudicial, confusing the issues,
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`Patent 10,716,793 B2
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`Patent Owner’s Objections to Evidence
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`and a waste of time under FRE 403. Patent Owner also objects to Exhibit 1115 as
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`it should have been included with the Petition and, thus, does not meet the
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`requirements of Rule 104(b)(5).
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`EXHIBIT 1116
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`Exhibit 1116 is described as “Voswinckel JAHA British Library
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`Declaration.” Patent Owner objects to the extent it includes subject matter that is
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`not permitted pursuant to FRE 602, including without limitation, to the extent that
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`the declaration presents as “facts” information that is outside the personal
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`knowledge of the declarant. Exhibit 1116 is also objected to as irrelevant under
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`FRE 401 and 402 because it does not make any facts at issue in the inter partes
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`review more or less probable than it would have been without the evidence. Patent
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`Owner objects to Exhibit 1116, and the exhibits thereto, as unfairly prejudicial,
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`confusing the issues, and a waste of time under FRE 403. Patent Owner also
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`objects to Exhibit 1116 as it should have been included with the Petition and, thus,
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`does not meet the requirements of Rule 104(b)(5). Patent Owner also objects to
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`Exhibit 1116 as it is not a “declaration” executed under penalty of perjury.
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`EXHIBIT 1117
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`Exhibit 1117 is described as “Voswinckel JAHA Supplement PubMed
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`Search Results.” Patent Owner objects to Exhibit 1117 under FRE 901-902 as
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`IPR2021-00406
`Patent 10,716,793 B2
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`Patent Owner’s Objections to Evidence
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`lacking authentication and not self-authenticating because it lacks sufficient indicia
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`that the exhibit is what it purports to be. Patent Owner objects to Exhibit 1117
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`under FRE 802 as the Petitioner relies on this exhibit to prove the truth of the
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`matter asserted therein, but it fails to meet the requirements of any hearsay
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`exception or exemption under FRE 803-807.
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`EXHIBIT 1118
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`Exhibit 1118 is described as “PubMed.gov search results for Sulica, R. and
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`Poon, M. . . . .” Patent Owner objects to Exhibit 1118 under FRE 901-902 as
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`lacking authentication and not self-authenticating because it lacks sufficient indicia
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`that the exhibit is what it purports to be. Patent Owner objects to Exhibit 1118
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`under FRE 802 as the Petitioner relies on this exhibit to prove the truth of the
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`matter asserted therein, but it fails to meet the requirements of any hearsay
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`exception or exemption under FRE 803-807.
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`EXHIBIT 1119
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`Exhibit 1119 is described as “Voswinckel JESC British Library
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`Declaration.” Patent Owner objects to the extent it includes subject matter that is
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`not permitted pursuant to FRE 602, including without limitation, to the extent that
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`the declaration presents as “facts” information that is outside the personal
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`knowledge of the declarant. Exhibit 1119 is also objected to as irrelevant under
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`4854-0897-4095.1
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`IPR2021-00406
`Patent 10,716,793 B2
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`Patent Owner’s Objections to Evidence
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`FRE 401 and 402 because it does not make any facts at issue in the inter partes
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`review more or less probable than it would have been without the evidence. Patent
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`Owner objects to Exhibit 1119, and the exhibits thereto, as unfairly prejudicial,
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`confusing the issues, and a waste of time under FRE 403. Patent Owner also
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`objects to Exhibit 1119 as it should have been included with the Petition and, thus,
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`does not meet the requirements of Rule 104(b)(5). Patent Owner also Objects to
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`Exhibit 1119 as it is not a “declaration” executed under penalty of perjury.
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`EXHIBIT 1120
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`Exhibit 1120 is described as “Voswinckel JESC Web of Science Search
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`Results.” Patent Owner objects to Exhibit 1120 under FRE 901-902 as lacking
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`authentication and not self-authenticating because it lacks sufficient indicia that the
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`exhibit is what it purports to be. Patent Owner objects to Exhibit 1120 under FRE
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`802 as the Petitioner relies on this exhibit to prove the truth of the matter asserted
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`therein, but it fails to meet the requirements of any hearsay exception or exemption
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`under FRE 803-807.
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`EXHIBIT 1122
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`Exhibit 1122 is described as “Ghofrani 2005 Search Results.” Patent Owner
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`objects to Exhibit 1122 under FRE 901-902 as lacking authentication and not self-
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`authenticating because it lacks sufficient indicia that the exhibit is what it purports
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`IPR2021-00406
`Patent 10,716,793 B2
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`Patent Owner’s Objections to Evidence
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`to be. Patent Owner objects to Exhibit 1122 under FRE 802 as the Petitioner relies
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`on this exhibit to prove the truth of the matter asserted therein, but it fails to meet
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`the requirements of any hearsay exception or exemption under FRE 803-807.
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`EXHIBITS 1123-1129
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`Exhibits 1123-1129 are described as being library records. Patent Owner
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`objects to Exhibits 1123-1129 under FRE 901-902 as lacking authentication and
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`not self-authenticating because it lacks sufficient indicia that the exhibit is what it
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`purports to be. Patent Owner further objects to Exhibits 1123-1129 under FRE 802
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`as the Petitioner relies on this exhibit to prove the truth of the matter asserted
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`therein, but it fails to meet the requirements of any hearsay exception or exemption
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`under FRE 803-807. In particular, these exhibits purport to be circulation records
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`for various libraries but there is not proper evidence that exhibits are what they
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`purport to be.
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`EXHIBIT 1132
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`Exhibit 1132 is described as “Transcript from the January 15, 2022
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`deposition of Aaron B. Waxman, M.D., Ph.D., United Therapeutics Corp. v.
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`Liquidia Technologies, Inc., Case No. 1:20-cv-00755 (D. Del.).” Patent Owner
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`objects to this exhibit under FRE 401-403 as not being relevant and unduly
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`prejudicial. The district court deposition concerned a different expert report and
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`IPR2021-00406
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`Patent Owner’s Objections to Evidence
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`involved different issues and scope from what is at issue in this proceeding and
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`what is permitted within the scope of questioning under the PTAB Trial Practice
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`Guide. The use of deposition testimony from another proceeding is also improper
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`under Rule 42.53. Patent Owner also objects pursuant to FRE 403 and 106 as
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`misrepresenting the contents of Dr. Waxman’s testimony and further, as an
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`incomplete document in omitting other portions of the transcript, and other
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`documents, that should also be considered.
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`EXHIBITS 1094, 1100-1103, 1114-1129, AND 1131
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`Petitioner objects to Exhibits 1094, 1100-1103, 1114-1129, and 1131-1132 for
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`not being cited in the Reply. As such, these exhibits are in violation of Rule
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`104(b). Additionally, Patent Owner objects to these exhibits under FRE 402 and
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`403 as lacking any tendency to make any fact at issue in this proceeding more or
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`less probable, rendering it irrelevant. Patent Owner also objects to these exhibits
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`under FRE 901-902 as lacking authentication.
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`Date: February 17, 2022
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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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`IPR2021-00406
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`Patent Owner’s Objections to Evidence
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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 Objections to Petitioner’s Evidence Submitted With Petitioner’s Reply
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`was served on counsel of record on February 17, 2022, by filing this document
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`through the PTAB E2E System as well as delivering a copy via email to the
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`counsel of record for the Petitioner at the 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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`Date: February 17, 2022
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` /Stephen B. Maebius/
`Stephen B. Maebius
`Foley & Lardner LLP
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`4854-0897-4095.1
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