UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`LIQUIDIA TECHNOLOGIES, INC.,
`
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`
`Patent Owner.
`
`
`Case IPR2021-00406
`Patent 10,716,793
`
`
`PETITIONER’S OPPOSITION TO PATENT OWNER’S
`MOTION TO EXCLUDE
`
`
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`LIQUIDIA TECHNOLOGIES, INC.,
`
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`
`Patent Owner.
`
`
`Case IPR2021-00406
`Patent 10,716,793
`
`
`PETITIONER’S OPPOSITION TO PATENT OWNER’S
`MOTION TO EXCLUDE
`
`
`
`
`
`
`
`
`
`
`IPR2021-00406
`Patent 10,716,793 B2
`
`I.
`
`INTRODUCTION
`
`Petitioner’s Opposition to Patent
`Owner’s Motion to Exclude
`
`Liquidia Technologies, Inc. (“Petitioner” or “Liquidia”) opposes Patent
`
`Owner’s Motion to Exclude EX1037, EX1087, EX1112 (partially), EX1114,
`
`EX1117, EX1120, EX1029, EX1050, EX1066, EX1074, and EX1078.
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`II. ARGUMENT
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`a. EX1037: English Translation of OptiNeb® User Manual 2005
`
`UTC’s motion to exclude EX1037 under Federal Rule of Evidence (“FRE”)
`
`901-902, FRE 802, FRE 402-403, or FRE 1001-1003 should be denied.
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`First, EX1037 does not constitute hearsay under FRE 802. UTC contends that
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`Petitioner’s reliance on EX1037 as evidence of the OptiNeb® nebulizer’s
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`0.6 mL/min nebulization rate and as evidence that pulsed ultrasonic nebulizers were
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`known violates FRE 802. Paper 66, 5-7. EX1037 is offered, however, as evidence
`
`of what it describes to an ordinary artisan and not for proving the truth of the matters
`
`addressed in the document. BioMarin Pharm. Inc. v. Genzyme Therapeutic Prods.
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`Ltd. P’ship, No. IPR2013-00534, 2015 WL 1009195, Paper 81 at *14 (P.T.A.B. Feb.
`
`23, 2015) (“[W]e agree with Petitioner that Ex. 1002 is offered as evidence of what
`
`it describes to an ordinary artisan, not for proving the truth of the matters addressed
`
`in the document. Accordingly, Ex. 1002 is not hearsay requiring the remedy of
`
`exclusion.”); Caterpillar Inc. v. Wirtgen Am., Inc., IPR2017-02187, Paper 42 at 16-
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`17 (P.T.A.B. May 21, 2019) (denying Patent Owner’s motion to exclude prior art
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`1
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`IPR2021-00406
`Patent 10,716,793 B2
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`manual as inadmissible hearsay because “[t]he substance of a printed publication
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`Petitioner’s Opposition to Patent
`Owner’s Motion to Exclude
`
`generally is not hearsay”).
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`Patent Owner’s citation to Chambers v. Mississippi, 410 U.S. 284 (1973) and
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`ServiceNow, Inc. v. Hewlett-Packard Co., IPR2015-00716, Paper 13 (P.T.A.B. Aug.
`
`26, 2015) is unavailing. Paper 66, 6-7. The Board’s holding in ServiceNow dealt
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`only with the printed publication’s copyright date rather than the substance of the
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`information contained in the reference. ServiceNow, IPR2015-00716, Paper 13 at
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`15-17; see also Caterpillar, IPR2017-02187, Paper 42 at 16-17. The Board,
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`moreover, did not hold that the publication’s copyright date was inadmissible
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`hearsay. ServiceNow, IPR2015-00716, Paper 13 at 15-17. The Supreme Court’s
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`1973 decision in Chambers, dealing with Mississippi evidentiary law, discussed only
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`the well-known concerns with relying on hearsay, which as explained above are
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`inapplicable here because Petitioner does not rely on EX1037 for hearsay purposes.
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`Chambers, 410 U.S. at 298.
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`Second, Patent Owner improperly disputes the public availability of EX1037
`
`in its motion to exclude. P.T.A.B. Consol. Trial Practice Guide (Nov. 2019) at 79
`
`(“A motion to exclude must explain why the evidence is not admissible (e.g.,
`
`relevance or hearsay) but may not be used to challenge the sufficiency of the evidence
`
`to prove a particular fact.”) (emphasis added); Caterpillar, IPR2017-02187, Paper
`
`42 at 17 (“Status as a prior art printed publication is a substantive issue, not an
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`evidentiary issue.”). Even assuming Patent Owner’s motion to exclude is the proper
`
`Petitioner’s Opposition to Patent
`Owner’s Motion to Exclude
`
`vehicle to dispute the public availability of EX1037, the sworn declaration of Mr.
`
`Christopher Butler (EX1087), an Office Manager at the Internet Archive,
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`demonstrates the public availability of EX1037 as of the priority date. EX1087; see
`
`also Advanced Micro Devices, Inc. v. Aquila Innovations, Inc., IPR2019-01526,
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`2021 WL 921325, Paper 37 at 29-30 (P.T.A.B. Mar. 10, 2021) (“The Butler
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`Declaration further provides evidence that the identified [prior art] was archived
`
`(e.g., catalogued) on the Wayback Machine as of May 4, 1999 . . . .”); Johns Manville
`
`Corp. v. Knauf Insulation, Inc., IPR2016-00130, Paper 35 at 20 (P.T.A.B. May 8,
`
`2017) (“Mr. Butler’s affidavit similarly indicates that, based on the available URL
`
`and date information, that Exhibit 1010 was archived in 2007.”).
`
`Third, EX1037 has been properly authenticated under FRE 901.
`
`Authentication under FRE901 is a “low bar,” and the party authenticating an exhibit
`
`need only provide a “rational basis” that the “document is what it is asserted to be.”
`
`Caterpillar Inc. v. Wirtgen Am., Inc., IPR2018-01091, Paper 49 at 72 (P.T.A.B. Nov.
`
`27, 2019) (quoting United States v. Turner, 934, F.3d 794, 798 (8th Cir. 2019) and
`
`United States v. Needham, 852 F.3d 830, 836 (8th Cir. 2017)). The sworn
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`declaration at the end of EX1037 alone provides a “rational basis” that EX1037 “is
`
`what it is asserted to be.” EX1037, 33.
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`3
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`Petitioner’s Opposition to Patent
`Owner’s Motion to Exclude
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`Patent Owner asserts incorrectly that Petitioner has not provided the original
`
`German-language manual underlying EX1037 (Paper 66, 7-9) and consequently
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`failed to authenticate EX1037 and meet the requirements of 37 C.F.R. § 42.63(b).
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`Patent Owner overlooks, however, that Petitioner attached the underlying German-
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`language manual as Exhibit E to Mr. Butler’s declaration (EX1087). Petitioner
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`further attaches another certified translation of the underlying German-language
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`manual as EX1086,1 which includes both the English-language translation and
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`underlying German-language manual in one document. Sumitomo Elec. Indus., Ltd.
`
`v. United Techs. Corp., IPR2017-00966, Paper 29 at 12 (P.T.A.B. Sept. 12, 2018)
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`(“We see nothing in Rule 42.63(b) that prohibits a party to revisit, or even modify,
`
`its translation at a later date, given sufficient notice and opportunity to respond by
`
`the opposing party.”). Petitioner has met the “low bar” of FRE 901 by providing a
`
`“rational basis” that EX1037 “is what it is asserted to be.” Caterpillar, IPR2018-
`
`01091, Paper 49 at 72 (citations omitted).
`
`Lastly, Patent Owner asserts erroneously that EX1037 is “not relevant” and
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`“may cause confusion” because of alleged date discrepancies between EX1007 and
`
`EX1008 with EX1037. Paper 66, 8. Petitioner disagrees with Patent Owner’s
`
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`1 EX1086 was properly served by Petitioner on September 8, 2021 in response to
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`Patent Owner’s August 25, 2021 objections to evidence.
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`4
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`characterization because, as the Board found in its Institution Decision, EX1037 is
`
`Petitioner’s Opposition to Patent
`Owner’s Motion to Exclude
`
`at the very least relevant “general knowledge in the art at around the time of the
`
`invention.” Paper 18, 24. Patent Owner’s argument as to alleged date discrepancies,
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`moreover, go to weight rather than admissibility of evidence. P.T.A.B. Consol. Trial
`
`Practice Guide (Nov. 2019) at 79 (“A motion to exclude must explain why the
`
`evidence is not admissible (e.g., relevance or hearsay) but may not be used to
`
`challenge the sufficiency of the evidence to prove a particular fact.”) (emphasis
`
`added).
`
`b. EX1087: Butler Affidavit
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`UTC’s motion to exclude EX1087 under FRE 401, FRE 403, and FRE 602
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`should be denied.
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`UTC’s assertion that Mr. Butler does not have personal knowledge as to what
`
`German-language document was allegedly translated as EX1037 mischaracterizes
`
`Mr. Butler’s declaration. Paper 66, 9-10. Mr. Butler’s declaration simply testifies
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`as to specific documents that were archived by the Internet Archive, as well as the
`
`general workings of the Internet Archive’s Wayback Machine. See generally
`
`EX1087. Put simply, Mr. Butler “need not be the person who prepared or
`
`maintained the records, or even an employee of the record-keeping entity, as long as
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`[he] understands the system used to prepare the records.” Conoco Inc. v. Dep’t. of
`
`Energy, 99 F.3d 387, 391 (Fed. Cir. 1997).
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`Petitioner’s Opposition to Patent
`Owner’s Motion to Exclude
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`Patent Owner’s criticisms of Mr. Butler’s declaration, moreover, go to
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`sufficiency of the evidence establishing EX1037 as prior art, rather than
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`admissibility. Paper 66, 9-10. The Board has rejected similar attempts to exclude
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`declarations from employees of the Internet Archive, including declarations from
`
`Mr. Butler himself. Mylan Pharms. Inc. v. Biogen MA Inc., IPR2018-01403,
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`Paper 99 at 3-4 (P.T.A.B. Feb. 5, 2020) (“[W]e agree with Petitioner that ‘[Patent
`
`Owner’s] attacks on the Butler Decl. and [prior art] go directly to the sufficiency of
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`the evidence to establish the [prior art] as prior art,’ which is improper. Mr. Butler’s
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`testimony does not aver that he has personal knowledge as to whether the printouts
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`attached to his affidavit were actually posted at an accessible location on the Internet.
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`Mr. Butler’s testimony instead is directed to the general workings on the Internet
`
`Archive’s Wayback Machine. [Butler Declaration] will not be excluded.”).
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`Further, Mr. Butler testified that he attached multiple Internet Archive
`
`screenshots to his declaration because he was following a set of archived links to get
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`to the OptiNeb manual, and that each of those links may not have been archived on
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`the exact same day, thus explaining that Exhibit D is a capture from 2005, while
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`Exhibit E was a capture from 2004. EX2095, 17:6-23:3 (“I would say that all of
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`these files were not archived on the same date, and hence, it is information combined
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`from different dates and times . . . .”). Nonetheless, Mr. Butler testified that all the
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`links he provided were dated before 2006 (the priority date at issue), and that based
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`on the recordkeeping practices of the Wayback Machine, as of July 18, 2004, the
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`Petitioner’s Opposition to Patent
`Owner’s Motion to Exclude
`
`Internet Archive “received [Exhibit E] responsive to that request via the public
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`internet.” EX2095, 33:4-34:9. Patent Owner’s argument mischaracterizes these
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`dates as “inconsistencies” (Paper 66, 6, 10) while ignoring the explanation Mr.
`
`Butler provided for the record. Mr. Butler’s declaration should not be excluded.
`
`c. EX1112: Reply Declaration of Sylvia Hall-Ellis, Ph.D. to the Extent
`Relies on EX1114, EX1117, and EX1120
`UTC’s partial motion to exclude EX1112 to the extent Dr. Sylvia Hall-Ellis
`
`relies on EX1114, EX1117, and EX1120 under FRE 702 and FRE 802 should be
`
`denied. As an initial matter, UTC’s attempt to rehash its public accessibility
`
`arguments under the guise of evidentiary objections in over three pages of argument
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`should not be permitted. Paper 66, 10-14. PTAB Trial Practice Guide at 79 (“A
`
`motion to exclude must explain why the evidence is not admissible (e.g., relevance
`
`or hearsay) but may not be used to challenge the sufficiency of the evidence to prove
`
`a particular fact.”) (emphasis added). Patent Owner has spent voluminous pages
`
`and imposed several days of depositions on Petitioner disputing the public
`
`accessibility of two abstracts (Voswinckel JESC and Voswinckel JAHA), which
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`were both undeniably published in two prominent journals in the pulmonary
`
`hypertension field over a year before the priority date. Patent Owner’s attempt to
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`impose even more time and expense on Petitioner and the Board by framing its
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`Petitioner’s Opposition to Patent
`Owner’s Motion to Exclude
`
`public accessibility arguments as evidentiary objections is improper.
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`Neither the Petition nor Petitioner’s Reply cite or discuss EX1114, EX1117,
`
`nor EX1120. As such, Petitioner relies on EX1114, EX1117, and EX1120 only to
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`the extent Dr. Hall-Ellis bases her opinion on them. Under FRE 703, “[i]f experts
`
`in the particular field would reasonably rely on those kinds of facts or data in forming
`
`an opinion on the subject, they need not be admissible for the opinion to be
`
`admitted.” Fed. R. Evid. 703. Therefore, FRE 703 permits Dr. Hall-Ellis to rely on
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`those documents in forming her opinion if experts in her field would reasonably rely
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`on those kinds of facts or data in forming an opinion on the subject.
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`Dr. Hall-Ellis has over fifty years of experience in the field of library and
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`information resources. EX1036, ¶ 7; see also EX1036, Ex. A. Considering all three
`
`exhibits are searches on major publication websites and search engines—that is, the
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`American Heart Association website (EX1114), the National Library of Medicine’s
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`PubMed search engine (EX1117), and the Web of Science™ search engine
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`(EX1120)—experienced librarians would reasonably rely on EX1114, EX1117, and
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`EX1120 in forming their opinions. Dr. Hall-Ellis included an Archive.org
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`declaration authenticating EX1114, and explained in detail how the Internet Archive
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`works and how it is “among the types of information reasonably relied upon by
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`experts in [her] field for the purposes of forming opinions or inferences on matters
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`that are the subject of their work.” See EX1112, ¶¶11-14, 39. Additionally, Dr.
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`Petitioner’s Opposition to Patent
`Owner’s Motion to Exclude
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`Hall-Ellis has personal knowledge as to the contents of EX1117 and EX1120,
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`because ran the searches herself as a librarian who regularly conducts these sorts of
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`searches, and attached the search results as exhibits to her declaration. See EX1112,
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`¶¶60, 87. Therefore, Dr. Hall-Ellis’s reliance on EX1114, EX1117, and EX1120 is
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`fully justified under FRE 703, and is not inadmissible hearsay.
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`Additionally, EX1114, EX117, and EX1120 are not hearsay because they are
`
`being offered as evidence that a certain search would lead to a link to the supplement
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`containing the Voswinckel abstracts, rather than as evidence as to the truth of
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`website’s contents. See Neste Oil Oyj v. REG Synthetic Fuels, LLC, IPR2013-00578,
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`Paper 53 at 5 (P.T.A.B. Mar. 12, 2015) (finding that website search records, when
`
`accessed by the declarant attaching those records, were properly authenticated and
`
`not hearsay because they are offered as evidence that a set of links lead to the
`
`retrieval of another exhibit). For example, EX1117 provides a link to the supplement
`
`containing EX1008. Compare EX1117, 17 (identifying “Abstracts from the 2004
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`Scientific Sessions of the American Heart Association, November 7-10, 2004, New
`
`Orleans, Louisiana, USA”), with EX1008 (same). And EX1120 shows that EX1007
`
`can be easily located on the database Web of Science (EX1120, 5 (Entry 34), which
`
`is in direct contradiction to Ms. Wyman’s testimony that the EHJ Supplement is not
`
`indexed in “common databases for clinical research and POSAs.” EX2041, ¶ 37.
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`Petitioner’s Opposition to Patent
`Owner’s Motion to Exclude
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`Patent Owner’s other contentions regarding EX1114, EX1117, and EX1120
`
`mischaracterize the facts and go to weight rather than admissibility, which are
`
`improper to address in a motion to exclude. In particular, Patent Owner’s arguments
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`as to when those searches were conducted, or what hit number the supplements
`
`containing the Voswinckel abstracts were (Paper 66, 10-14) go to the weight, not
`
`admissibility, of those exhibits in Dr. Hall-Ellis’s ultimate conclusion that the
`
`abstracts were publicly available.2
`
`d. EX1029: Ventavis® Label 2004
`
`Patent Owner’s motion to exclude EX1029 under FRE 901 and FRE 902
`
`should be denied. Paper 66, 14-15. Offering only bare attorney argument, Patent
`
`Owner provides no indication that EX1029 is not “what it is asserted to be.”
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`Caterpillar, IPR2018-01091, Paper 49 at 72 (citation omitted). The authenticity of
`
`EX1029 is established by the “most basic investigation” of the Ventavis® Drug
`
`
`2 The two cases cited by Patent Owner—that is, Apple Inc. v. DSS Technology
`Management, Inc., IPR2015-00373, Paper 8 (P.T.A.B. June 25, 2015) and
`ServiceNow, Inc. v. Hewlett-Packard Co., IPR2015-00716, Paper 13 (P.T.A.B. Aug.
`26, 2015)—are inapplicable because were outside the context of FRE 702 and
`involved dates relied on for the truth of the matter asserted. Apple, IPR2015-00373,
`Paper 8 at 10-11; ServiceNow, IPR2015-00716, Paper 13 at 15-17.
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`Approval Package on the FDA website,3 dated December 29, 2004, which provides
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`Petitioner’s Opposition to Patent
`Owner’s Motion to Exclude
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`a complete copy of the approved Ventavis® labeling.4 New World Med., Inc. v.
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`Microsurgical Tech., Inc., IPR2020-01573, Paper 63 at 9 (P.T.A.B. Feb. 16, 2022)
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`(finding poster abstract authenticated by “most basic investigation” of meeting
`
`website).
`
`EX1029, moreover, is authenticated by the “appearance, contents, substance,
`
`internal patterns, or other distinctive characteristics” of the document. Fed. R.
`
`Evid. 901(b)(4). EX1029 provides the New Drug Application No. 21-779 for
`
`Ventavis®, detailed descriptions of the Clinical Pharmacology, Indications and
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`Usage, Contraindications, Warnings, Precautions, Adverse Reactions, Dosage and
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`Administration, and a copy of the Patient Information. See generally EX1029. The
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`Board has similarly found “appearance, contents, substance, internal patterns, or
`
`other distinctive characteristics” sufficient to authenticate documents. New World,
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`IPR2020-01573, Paper 63 at 8-9 (quoting Fed. R. Evid. 901 (b)(4)).
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`Lastly, Dr. Nicholas Hill who has prescribed inhaled prostacyclin, including
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`treprostinil (Tyvaso®) and iloprost (Ventavis®), to many dozens of pulmonary
`
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`3 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-779_ventavis.cfm
`(last visited April 22, 2022).
`4 https://www.accessdata.fda.gov/drugsatfda docs/nda/2004/21-
`779 Ventavis prntlbl P1.pdf (last visited April 22, 2022).
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`hypertension patients (EX1002, ¶ 10) authenticates EX1029 by citing the document
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`Petitioner’s Opposition to Patent
`Owner’s Motion to Exclude
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`as the “Ventavis Label 2004” (id., ¶¶ 36, 41-42). Similarly, UTC’s clinical expert
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`Dr. Aaron Waxman, who has been practicing as a pulmonary and critical care doctor
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`for over 20 years (EX2001, ¶ 1), cited EX1029 approvingly, stating “Ventavis® was
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`approved for a single event dose of 2.5 micrograms or 5 micrograms to be taken 6
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`to 9 times per day.” EX2052, ¶ 100. Neither Dr. Hill nor Dr. Waxman have provided
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`any indication that EX1029 is not “what it is asserted to be.” Caterpillar, IPR2018-
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`01091, Paper 49 at 72 (citation omitted).
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`e. EX1050 (Pulmozyme® Label), EX1066 (AccuNeb® Label),
`EX1074 (Orenitram® Label), and EX1078 (Azmacort® Label
`2003)
`Patent Owner’s motion to exclude EX1050, EX1066, EX1074, and EX1078
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`under FRE 901 and FRE 902 should be denied. Offering only bare attorney
`
`argument, Patent Owner provides no indication that EX1050, EX1066, EX1074, and
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`EX1078 are not “what it is asserted to be.” Caterpillar, IPR2018-01091, Paper 49
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`at 72 (citation omitted). Contrary to Patent Owner’s contention that EX1050,
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`EX1066, EX1074, and EX1078 “do not identify a date” (Paper 66, 15), all four labels
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`identify a date. EX1050, 2 (“Revision Date: April 2005”); EX1066, 1 (“June 2005”);
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`EX1074, 1 (“Revised: 10/2019”); EX1078, 1 (“Rev. May 2003”).
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`All four exhibits moreover are authenticated by their “appearance, contents,
`
`substance, internal patterns, or other distinctive characteristics” of the document.
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`Fed. R. Evid. 901(b)(4); see New World, IPR2020-01573, Paper 63 at 8-9 (finding
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`Petitioner’s Opposition to Patent
`Owner’s Motion to Exclude
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`exhibit authenticated by “appearance, contents, substance, internal patterns, or other
`
`distinctive characteristics”) (citation omitted). All four exhibits provide, for
`
`example, detailed descriptions of the Clinical Pharmacology, Indications and Usage,
`
`Contraindications, Warnings, Precautions, Adverse Reactions, Dosage and
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`Administration, and a copy of the Patient Information. See generally EX1050
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`(Pulmozyme® Label); EX1066 (AccuNeb® Label); EX1074 (Orenitram® Label);
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`EX1078 (Azmacort® Label 2003). Surely, this meets the “low bar” of
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`authentication by providing a “rational basis” that the “document is what it is
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`asserted to be.” Caterpillar, IPR2018-01091, Paper 49 at 72 (citations omitted).
`
`Dr. Gonda authenticated EX1050 (Pulmozyme® Label) and EX1066
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`(AccuNeb® Label) during his deposition. EX2056 (Gonda Dep.) at 115:6-16 (“Q.
`
`And this is the label or—yeah, I guess the label for Pulmozyme, correct? A. That
`
`is correct.”), 112:1-17 (“Q. And this is instructions for use for AccuNeb inhalation
`
`solution, correct? A. Yes, correct.”).
`
`Lastly, EX1074 (Orenitram® Label) is the label of Patent Owner’s own
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`treprostinil product: Orenitram®. See EX1074 (Orenitram® Label) at 17.
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`Puzzlingly, Patent Owner objects to EX1074 (Orenitram® Label)’s authenticity
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`without identifying any specific facts indicating that the label of its own product is
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`inauthentic.
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`III. CONCLUSION
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`Petitioner’s Opposition to Patent
`Owner’s Motion to Exclude
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`For these reasons, Petitioner respectfully requests that the Board deny Patent
`
`Owner’s Motion to Exclude EX1037, EX1087, EX1112 (partially), EX1114,
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`EX1117, EX1120, EX1029, EX1050, EX1066, EX1074, and EX1078.
`
`
`Dated: April 27, 2022
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`COOLEY LLP
`ATTN: Patent Group
`1299 Pennsylvania Avenue NW
`Suite 700
`Washington, DC 20004
`Tel: (212) 479-6840
`Fax: (212) 479-6275
`
`
`
`By:
`
`
`
`
`
`/Erik B. Milch/
`Erik B. Milch
`Reg. No. 42,887
`Counsel for Petitioner
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`
`CERTIFICATE OF SERVICE
`foregoing
`the
`The undersigned hereby certifies
`that a copy of
`PETITIONER’S OPPOSITION TO PATENT OWNER’S MOTION TO
`EXCLUDE was served on counsel of record on April 27, 2022, by delivering a copy
`via email to the counsel of record for the Patent Owner at the following address:
`
`UT-793@foley.com
`Stephen B. Maebius (smaebius@foley.com)
`FOLEY & LARDNER
`UTCvLiquidia-IPR@mwe.com
`
`
`
`Dated: April 27, 2022
`
`COOLEY LLP
`ATTN: Patent Group
`1299 Pennsylvania Avenue NW
`Suite 700
`Washington, DC 20004
`Tel: (212) 479-6840
`Fax: (212) 479-6275
`
`
`
`
`By:
`
`
`
`
`
`/Erik B. Milch/
`Erik B. Milch
`Reg. No. 42,887
`Counsel for Petitioner
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