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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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`Case No. IPR2020-00770
`U.S. Patent No. 9,604,901
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`PETITIONER’S OPPOSITION TO PATENT OWNER’S
`MOTION TO EXCLUDE
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`Petitioner’s Opposition to Patent Owner’s Motion to Exclude
`IPR2020-00770
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`I.
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`INTRODUCTION
`Liquidia Technologies, Inc. (“Petitioner” or “Liquidia”) opposes Patent
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`Owner’s Motion to Exclude Exs. 1002 and 1012.
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`II. ARGUMENT
`A. Ex. 1002
`First, UTC’s motion to exclude Ex. 1002 under 35 U.S.C. § 25, 37 CFR
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`§ 42.2, and/or as hearsay should be denied. Paper 31 at 3-4. UTC contends that
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`Dr. Winkler inadvertently omitted the oath at the end of his declaration and, as such,
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`his declaration should be excluded.
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`As an initial matter, UTC waived its argument regarding Dr. Winkler’s
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`declaration under 37 C.F.R. § 42.63, because it did not timely object to the issue
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`with “sufficient particularity . . . to allow correction in the form of supplemental
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`evidence.” See Campbell Soup Co. v. Gamon Plus, Inc., IPR2017-00091, Paper 84
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`at 52 (P.T.A.B Apr. 11, 2018) (“Although Daubert is related to FRE 702,
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`challenging an expert as generally not being ‘qualified’ (Paper 16, 1) does not
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`provide the ‘sufficient particularity’ as required by 37 C.F.R. § 42.64(b)(1) ‘to allow
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`correction in the form of supplemental evidence.’”). In its objections filed after the
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`Institution Decision, UTC only generically restated FRE 802, 901, and 902, and
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`never identified the oath as the issue. Paper 10 at 3 (“Patent Owner objects to Exhibit
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`1002 under FRE 802 as hearsay without exception. Patent Owner objects to Exhibit
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`1
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`Petitioner’s Opposition to Patent Owner’s Motion to Exclude
`IPR2020-00770
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`1002 under FRE 901-902 as lacking authentication and not self-authenticating
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`because it lacks sufficient indicia that the exhibit is what it purports to be.”). Because
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`UTC failed to preserve the objection asserted here, the Board should “not consider
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`these arguments in [the] Motion to Exclude because they have been waived.”
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`Campbell Soup Co., Paper 84 at 52.
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`Regardless, as addressed in Petitioner’s Reply, any omissions in Dr. Winkler’s
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`declaration with respect to the oath or perjury statement were harmless and have
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`been cured. Paper 15 at 1-2. UTC deposed him on the opinions he presented therein.
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`See generally EX2026; see also Google LLC v. CyWee Grp. Ltd., IPR2018-01257,
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`Paper 69 at 2-4 (P.T.A.B. Sept. 6, 2019) (granting party authorization to correct
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`unsworn declaration when opposing party cross-examined the expert); Fid. Info.
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`Servs., LLC v. Mirror Imaging, LLC, CBM2017-00064, Paper 54 at 5-8 (P.T.A.B.
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`Jan. 2, 2019) (same). Dr. Winkler also refiled Ex. 1002 as Ex. 1039 with no changes
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`other swearing to the truth of his statements therein. See EX1039, ¶241 (declaring
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`that “all statements made herein are identical to my declaration filed as Ex. 1002”).
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`Importantly, UTC has not moved to exclude Ex. 1039 or any Dr. Winkler’s opinions
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`therein. UTC is exalting form over substance in renewing this objection before oral
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`argument. Accordingly Ex. 1002 should not be excluded under 35 U.S.C. §25, 37
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`CFR §42.2, and/or as hearsay.
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`2
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`Petitioner’s Opposition to Patent Owner’s Motion to Exclude
`IPR2020-00770
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`Second, UTC’s argument that Dr. Winkler is unqualified to testify on the
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`relevant subject matter under Federal Rules of Evidence 701 and 702 should be
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`denied. UTC is utilizing its motion to exclude as another opportunity to repeat
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`arguments from the parties’ briefing regarding whether Dr. Winkler meets UTC’s
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`expert’s1 definition of a person of ordinary skill in the art, and otherwise argues
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`issues directed to the weight, not admissibility of his testimony.
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`UTC’s argument is without merit. The Board stated that “for purposes of this
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`Decision, . . . the level of ordinary skill in the art is reflected by the prior art,
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`including Phares and Moriarty.” Paper 7 at 22 (citing In re GPAC Inc., 57 F.3d
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`1573, 1579 (Fed. Cir. 1995) (“The person of ordinary skill in the art is a hypothetical
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`1 UTC’s citation to Dr. Hall-Ellis’s declaration is a distraction. Paper 31 at 4 (citing
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`EX1015, ¶16). Dr. Hall-Ellis made a typographical mistake in her definition of a
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`person of ordinary skill in art by inadvertently taking a definition from a different
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`IPR proceeding. See EX1052, ¶5. This is evident from her definition referring to
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`“radiation oncology,” which clearly is unrelated to the ’901 patent at issue. Dr. Hall-
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`Ellis has filed a supplemental declaration correcting this error and explaining that
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`her opinion relied on the same skilled artisan definition as Petitioner and Dr.
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`Winkler. Id. at ¶¶6-8. Neither Petitioner nor its expert submitted any substantive
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`testimony or argument relying on Dr. Hall-Ellis’s typographical mistake.
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`3
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`Petitioner’s Opposition to Patent Owner’s Motion to Exclude
`IPR2020-00770
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`person who is presumed to know the relevant prior art.”)). Dr. Winkler was qualified
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`and accepted as a person of skill in the art in a prior IPR proceeding involving UTC,
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`the ’901 patent’s parent, and the same “relevant prior art” Phares and Moriarty (Ex.
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`1008 and 1009). See, e.g., EX1005 at 49, 27-28, 71 (Final Written Decision finding
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`that the “level of ordinary skill in the art is reflected by the prior art of record” and
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`repeatedly citing to Dr. Winkler’s declaration). For the same reasons, Dr. Winkler
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`similarly qualifies as a POSA here, as reflected by the same prior art.
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`Further, as detailed in Petitioner’s Reply, UTC’s repeated attempts to inflate
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`the level of ordinary skill in the art is without support in the claims or specifications
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`of the ’901 patent. See Paper 15 at 8-10. UTC does the same again in referring to
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`“manufacturing requirements in the United States” or “development considerations”
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`(Paper 31 at 5-6),2 without any connection to the language in the ’901 Patent claims.
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`2 UTC follows in the footsteps of its expert in mischaracterizing Dr. Winkler’s
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`testimony, stating that Dr. Winkler was “unable to answer” counsel’s questions
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`(Paper 31 at 5-6), simply because counsel did not like or disagreed with Dr.
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`Winkler’s answers. Such self-serving attorney argument is not a basis for exclusion
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`of expert opinions. The Board is fully capable of reading Dr. Winkler’s testimony
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`for itself and assessing what weight to accord it. EX1005 at 85 (“UTC has not
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`explained adequately why we should exclude conclusory expert testimony, instead
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`4
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`Petitioner’s Opposition to Patent Owner’s Motion to Exclude
`IPR2020-00770
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`Regardless, there is plenty of evidence in the record that Dr. Winkler qualifies as a
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`skilled artisan under even UTC’s inflated definition of a skilled artisan. See, e.g.,
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`EX1017 at ¶¶ 7-14 (describing qualifications as organic and process chemistry
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`expert who has repeatedly developed greater than 2.9 gram quantities of chemical
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`compounds, including “scale-up of drug production of API for both in vitro testing
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`and animal studies”), 27 (stating, “I have consulted for process chemistry groups of
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`several pharmaceutical companies, worked for Bristol Myers Squibb advising their
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`medicinal and process chemistry groups, and have overseen the scale-up of drugs
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`developed in my laboratory for commercial use (e.g., as startup company drug
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`candidates), including for the claimed ‘at least 2.9 gram’ quantities.”); EX1003 (Dr.
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`Winkler’s CV); EX2026, 24:13-25:18 (testifying as to process chemistry
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`experience), 26:5-16 (testifying “we certainly have done many, many reactions, and
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`published them” involving “multi gram quantities of chemicals and their
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`intermediates”), 27:5-21 (testifying as to commercial-scale production experience),
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`29:23-30:21 (same).
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`of giving it little or no weight.” (citing Donnelly Garment Co. v. N.L.R.B., 123 F.2d
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`215, 224 (8th Cir. 1941) (“One who is capable of ruling accurately upon the
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`admissibility of evidence is equally capable of sifting it accurately after it has been
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`received . . . .”)).
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`5
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`Petitioner’s Opposition to Patent Owner’s Motion to Exclude
`IPR2020-00770
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`Finally, UTC asks the Board to exclude hundreds of paragraphs consisting of
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`Dr. Winkler’s opinions and testimony, only on the basis that UTC’s expert, Dr. Pinal,
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`disagrees with Dr. Winkler or asserts his opinions are “unreliable.” Paper 31 at 6-
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`8.3 That two experts disagree is not a basis to exclude testimony. At most, UTC
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`presents classic “battle of the experts” disputes appropriately raised in briefing (not
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`motion practice), that go to the weight, not admissibility, of Dr. Winkler’s
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`declaration Ex. 1002. See, e.g., Juniper Networks, Inc. v. Chrimar Sys., Inc.,
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`IPR2016-01389, Paper No. 69 at 96 (P.T.A.B. Jan. 23, 2018) (denying motion to
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`exclude declaration where party did not demonstrate that the declaration “lacks
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`relevance” but instead made arguments “directed to the merits of the testimony,”
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`3 In his Reply Declaration, Dr. Winkler specifically addressed Dr. Pinal’s criticisms
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`that Patent Owner now points to. See, e.g., Ex. 1017, ¶¶ 90-91 (explaining the ’075
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`patent describes synthesis of treprostinil), 96 (explaining Dr. Pinal’s attempt to
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`complicate the record with extensive discussion of differential scanning calorimetry
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`is “ultimately irrelevant” because the patent does not claim a specific polymorph),
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`103 (explaining that Dr. Pinal’s argument that a POSA would have to first neutralize
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`KOH before adding diethanolamine is incorrect), 156 (explaining Dr. Pinal’s
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`arguments that relate to the stability of one polymorph over another are irrelevant
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`because the claims are not specific to one polymorph).
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`6
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`Petitioner’s Opposition to Patent Owner’s Motion to Exclude
`IPR2020-00770
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`which “raise[d] a question of the weight, not admissibility”). Moreover, Dr. Pinal
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`has not established that a POSA would consider Dr. Winkler’s opinions and
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`testimony “unreliable,” only that in Dr. Pinal’s opinion, a POSA would reach a
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`different conclusion. Again, this is not a basis to exclude testimony.
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`In sum, Dr. Winkler’s opinions in Ex. 1002 have been authenticated, he has
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`been deposed on them, his status as a person of ordinary skill in the art has been
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`previously confirmed and fully briefed for the Board, and the alleged “unreliability”
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`of his opinions is classic expert and party disagreement going to the weight, not
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`admissibility of the exhibit. Accordingly, UTC’s motion to exclude Ex. 1002 should
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`be denied.
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`B.
`Ex. 1012
`Ex. 1012 is exactly the same Kawakami document that was submitted in the
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`IPR2016-00006 as Ex. 1007. Compare Ex. 1012, with Ex. 1048 (IPR2016-00006
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`Kawakami English translation); see EX1005 at 6 & n.9 (Board citing Kawakami in
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`final written decision invalidating ’901 patent’s parent patent). UTC knows this
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`reference and should recognize it as such, because it was the Patent Owner in both
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`that and this IPR proceeding. Liquidia notes that UTC did not move to exclude the
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`identical Kawakami translation in IPR2016-00006, and the Board relied on the same
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`translation for an entire ground in its final written decision. See EX1005 at 7, 84.
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`7
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`Petitioner’s Opposition to Patent Owner’s Motion to Exclude
`IPR2020-00770
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`UTC now disingenuously asks the Board to exalt form over substance in moving to
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`exclude the exhibit here.
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`Nonetheless, Liquidia attaches additional documentation from IPR2016-
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`00006, which UTC and the Board are already aware of, including the original
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`Japanese version of Kawakami and declarations attesting to and confirming the
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`accuracy of the translation. Ex. 1047-1051 (filed as Exhibits 1006, 1007, 1011,
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`1019, and 1020 in IPR2016-00006).
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`The filing of these exhibits remedies any failure to comply with § 42.63(b) or
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`FRE 902(3), which in any event is harmless error. See L’Oréal USA, Inc. v. Liqwd,
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`Inc., PGR2017-00012, Paper 119 at 42 (P.T.A.B. Dec. 9, 2020) (“failure to file the
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`required affidavit . . . was remedied when Petitioner filed [exhibits including] a
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`declaration”); Perfect Surgical Techs., Inc. v. Olympus Am., Inc., 841 F.3d 1004,
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`1006-07 (Fed. Cir. 2016) (finding that Board’s acceptance of the partially-translated
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`document was harmless error); Mexichem Amanco Holdings S.A. v. Honeywell Int’l,
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`Inc., IPR2013-00576, Paper 50 at 30 (P.T.A.B Feb. 26, 2015) (Board has discretion
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`to waive the requirements of § 42.63(b) under 37 C.F.R. § 42.5(b)). Accordingly,
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`the Board should deny UTC’s motion to exclude Ex. 1012.
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`III. CONCLUSION
`For these reasons, Petitioner respectfully requests that the Board to deny
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`Patent Owner’s Motion to Exclude Exhibits 1002 and 1012.
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`8
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`Petitioner’s Opposition to Patent Owner’s Motion to Exclude
`IPR2020-00770
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`Dated: June 1, 2021
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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
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`Respectfully submitted,
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`/Ivor R. Elrifi/
`Ivor R. Elrifi
`Reg. No. 39,529
`Counsel for Petitioner
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`By:
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`9
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`Petitioner’s Motion for Pro Hac Vice Admission
`IPR2020-00770
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. §§42.6(e)(4)(i) et seq., a complete copy of the attached
`PETITIONER’S OPPOSITION TO PATENT OWNER’S MOTION TO
`EXCLUDE, and related documents are being served via email on the 1st day of
`June 2021, upon Patent Owner’s attorneys of record:
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`UTC-901@foley.com
`Stephen B. Maebius (smaebius@foley.com)
`George Quillin (gquillin@foley.com)
`Daniel R. Shelton (dshelton@foley.com)
`FOLEY & LARDNER LLP
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`Douglas Carsten (dcarsten@mwe.com)
`April E. Weisbruch (aweisbruch@mwe.com)
`Judy Mohr (jmohr@mwe.com)
`MCDERMOTT WILL & EMERY LLP
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`Richard Torczon (rtorczon@wsgr.com)
`WILSON, SONSINI, GOODRICH & ROSATI
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`Shaun R. Snader (ssnader@unither.com)
`UNITED THERAPEUTICS CORP.
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`By:
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`/Ivor R. Elrifi/
`Ivor R. Elrifi
`Reg. No. 39,529
`Counsel for Petitioner
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`Dated: June 1, 2021
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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
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`10
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