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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
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`LIQUIDIA TECHNOLOGIES, INC.,
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`Petitioner,
`
`v.
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`UNITED THERAPEUTICS CORPORATION,
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`Patent Owner.
`
`
`_______________
`
`Case IPR2021-00406
`Patent 10,716,793
`_______________
`
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`PATENT OWNER’S OBJECTIONS TO PETITIONER’S EVIDENCE
`SUBMITTED WITH PETITION
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`4829-5394-4566.1
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`
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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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`
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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 Petition for
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`Inter Partes Review filed on January 7, 2021 (“Petition”). Patent Owner’s
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`objections are based on the Federal Rules of Evidence (“FRE”), relevant case law,
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`federal statute, and the Patent Trial and Appeal Board (“PTAB”) Rules. Patent
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`Owner’s objections are set forth with particularity below.
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`EXHIBIT 1002
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`Exhibit 1002 is described as “Declaration of Dr. Nicholas Hill.” Patent
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`Owner objects to Exhibit 1002, under FRE 702 and 703, because it lacks an
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`appropriate basis—for example, Dr. Hill’s calculations for inhalation dosing
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`contain scientific errors and are based on unfounded assumptions. See, e.g., Ex.
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`1002, ¶¶ 67, 99. Patent Owner also objects to Exhibit 1002 under FRE 702 and
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`703 on the basis that the testimony is not based on sufficient facts or data. See,
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`e.g., Ex. 1002, ¶¶ 29-193. 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. Additionally, to the extent Patent
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`Owner’s confidential information is introduced in this proceeding, Patent Owner
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`objects to Dr. Hill being given access to such information. Patent Owner has
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`concerns as to the closeness of his relationship with Petitioner.
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`4829-5394-4566.1
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`2
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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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`EXHIBIT 1004
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`Exhibit 1004 is described as “Declaration of Igor Gonda, Ph.D.” Patent
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`Owner objects to Exhibit 1004 under FRE 702 and 703 on the basis that the
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`testimony is not based on sufficient facts or data. Petitioner relies on this exhibit to
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`prove the truth of the matter asserted therein, but it fails to meet the requirements
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`of any hearsay exception or exemption under FRE 803-807.
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`EXHIBIT 1007
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`Exhibit 1007 is described as “Voswinckel, R., et al., Abstract 218: ‘Inhaled
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`treprostinil is a potent pulmonary vasodilator in severe pulmonary hypertension,’
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`European Heart Journal 25:22 (2004).” Patent Owner objects to Exhibit 1007
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`under FRE 901-902 as lacking authentication and not self-authenticating because it
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`lacks sufficient indicia that the exhibit is what it purports to be. Patent Owner
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`further objects to Exhibit 1007 under FRE 106 and 401-403 as incomplete,
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`irrelevant, waste of time, and likely to cause confusion because it contains only an
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`abstract of the article.
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`EXHIBIT 1008
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`Exhibit 1008 is described as “Robert Voswinckel, Beate Enke, Andre
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`Kreckel, Frank Reichenberger, Stefanie Krick, Henning Gall, Tobias Gessier,
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`Thomas Schmehl, Markus G. Kohstall, Friedrich Grimminger, Hossein A.
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`4829-5394-4566.1
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`3
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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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`
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`Ghofrani, Werner Seeger, and Horst Olschewski, Abstract 1414: ‘Inhaled
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`Treprostinil Sodium (TRE) For the Treatment of Pulmonary Hypertension,’
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`Abstracts from the 2004 Scientific Sessions of the American Heart Association,
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`Circulation, 110(17 Suppl.):III-295 (October 26, 2004).” Patent Owner objects to
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`Exhibit 1008 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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`to be. Patent Owner further objects to Exhibit 1008 under FRE 106 and 401-403
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`as incomplete, irrelevant, waste of time, and likely to cause confusion because it
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`contains only an abstract of the article.
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`EXHIBIT 1009
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`Exhibit 1009 is described as “Robert Voswinckel, Hossein A. Ghofrani,
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`Friedrich Grimminger, and Werner Seeger, ‘Clinical Observations’ on ‘Inhaled
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`Treprostinil for Treatment of Chronic Pulmonary Arterial Hypertension,’ ‘Letters’
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`Section of the Annals of Internal Medicine, 144(2):149-50 (January 2006).” Patent
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`Owner objects to Exhibit 1009 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 Exhibit 1009 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 it contains only an abstract of the article.
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`4829-5394-4566.1
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`4
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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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`EXHIBIT 1010
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`Exhibit 1010 is described as “Hossein Ardeschir Ghofrani, Robert
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`Voswinckel, et al., Neue Therapieoptionen in der Behandlung der
`
`pulmonalarteriellen Hypertonie, 30(4) HERZ, 30(4):296–302 (June 2005)
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`(‘Ghofrani’) (Foreign article and English translation attached).” Patent Owner
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`objects to Exhibit 1010 under FRE 802, including to the extent Petitioner has
`
`asserted that the translation is a true and accurate representation of the original
`
`document. Petitioner relies on this exhibit to prove the truth of the matter asserted
`
`therein, but it fails to meet the requirements of any hearsay exception or exemption
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`under FRE 803-807. Patent Owner further objects to this exhibit under FRE 402
`
`and 403 because an inadequate translation renders the exhibit irrelevant.
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`EXHIBIT 1036
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`Exhibit 1036 is described as “Declaration of Sylvia Hall-Ellis, Ph.D.”
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`Patent Owner objects to Exhibit 1036, 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 1036 under FRE 702, on the basis that the testimony is not based
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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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`4829-5394-4566.1
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`5
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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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`
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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 1036 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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`1036 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 1036, 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 1036 that
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`cite or reproduce an exhibit objected to herein for the reasons stated herein.
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`EXHIBIT 1037
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`Exhibit 1037 is described as “English translation of OptiNeb® User Manual
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`2005.” Patent Owner objects to Exhibit 1037 under FRE 802, including to the
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`extent Petitioner has asserted that the translation is a true and accurate
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`representation of the original German-language manual and to the extent Petitioner
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`has asserted that Exhibit 1037’s statements regarding or relating to whether certain
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`practices or procedures were well-known, routine, or conventional, the level of
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`4829-5394-4566.1
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`6
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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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`
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`skill in the art, and/or the underlying chemical and physical principles discussed
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`therein are true and accurate. Patent Owner further objects to Petitioner not
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`including the original German version of the manual. Petitioner relies on this
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`exhibit to prove the truth of the matter asserted therein, but it fails to meet the
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`requirements of any hearsay exception or exemption under FRE 803-807. Patent
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`Owner further objects to this exhibit under FRE 402 and 403 because an
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`inadequate translation renders the exhibit irrelevant and because this exhibit lacks a
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`publication date. Patent Owner further objects to this exhibit under FRE 901 and
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`902 because Exhibit 1037 lacks sufficient indicia to support a finding that it is
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`what it purports to be and is not self-authenticating. Patent Owner further objects
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`to this exhibit under FRE 1001-1003 because Exhibit 1037 is not an original
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`writing and genuine questions regarding its authenticity and the circumstances of
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`its production make it unfair to admit.
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`EXHIBITS 1022-1026, 1050-1062, 1064-1068, 1070-1071, AND 1073-1079
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`Petitioner objects to Exhibits 1022-1026, 1050-1062, 1064-1068, 1070-1071,
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`and 1073-1079 for not being cited in the Petition. As such, these exhibits are in
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`violation of Rule 104(b). Additionally, Patent Owner objects to these exhibits
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`under FRE 402 and 403 as lacking any tendency to make any fact at issue in this
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`4829-5394-4566.1
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`7
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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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`
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`proceeding more or less probable, rendering it irrelevant. Patent Owner also
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`objects to these exhibits under FRE 901-902 as lacking authentication.
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`EXHIBIT 1029
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`Patent Owner objects to this exhibit under FRE 901-902 as lacking
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`authentication.
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`
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`Date: August 25, 2021
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`Respectfully submitted,
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`
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`/Stephen B. Maebius/
`Stephen B. Maebius
`Registration No. 35,264
`Counsel for Patent Owner
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`4829-5394-4566.1
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`8
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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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`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 Petition was served
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`on counsel of record on August 25, 2021, by filing this document through the
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`PTAB E2E System as well as delivering a copy via email to the counsel of record
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`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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`
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`Date: August 25, 2021
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` /Stephen B. Maebius/
`Stephen B. Maebius
`Foley & Lardner LLP
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`4829-5394-4566.1
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`
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