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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`LIQUIDIA TECHNOLOGIES, INC.,
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`Patent Owner.
`
`
`_______________
`
`Case IPR2020-00770
`Patent 9,604,901
`_______________
`
`
`PATENT OWNER’S MOTION TO EXCLUDE
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`
`4819-8264-4971.1
`4819-8264-4971.1
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`
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`Case IPR2020-00770
`Patent 9,604,901
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`
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`Motion to Exclude
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`I. INTRODUCTION
`United Therapeutics Corporation (“UT”) moves to exclude Petitioner’s
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`Exhibits 1002 and 1012 under 37 C.F.R. § 42.64(c) and the Scheduling Order
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`(Paper 8) on the following grounds:
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`Exhibit
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`Description
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`Reason to Exclude
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`EX1002
`
`Declaration of Jeffrey D.
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`Not authenticated; hearsay; not
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`Winkler, Ph.D. (in its entirety)
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`reliable
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`EX1012
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`Kawakami (JP 56 –122328 A) Not authenticated; no verified
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`translation
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`
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`Petitioner relied on these exhibits in its Petition (Paper No. 1) and Petitioner’s
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`Reply (Paper No. 15), and thus, Patent Owner also moves to exclude the portions
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`of Petitioner’s Petition and Reply that rely on these exhibits.
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`II. PATENT OWNER TIMELY OBJECTED
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`A. EX1002: Winkler Declaration
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` UT timely objected to EX1002 under Federal Rule of Evidence (“FRE”)
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`701, 702, 802, 901, and 902. Paper 10, 2-3. This exhibit should be excluded under
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`each of these rules. No supplemental evidence was timely filed to address these
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`objections.
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`4819-8264-4971.1
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`Patent 9,604,901
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`Motion to Exclude
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`B. EX1012: Kawakami (JP 56 –122328 A)
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`UT timely objected to EX1012 under FRE 402, 403, 802, 803-807, 901, 902,
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`1001-1003, 1012. Paper 10, 2-3. This exhibit should be excluded under each of
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`these rules. No supplemental evidence was timely filed to address these objections.
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`
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`III. ARGUMENT
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`A. EX1002 Should Be Excluded
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` EX1002 purports to be a declaration, but without authentication because it
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`lacks the statutorily-required oath or caveat for a declaration. 35 U.S.C. §25;
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`37 CFR §42.2. As such, EX1002 falls short of the statutory threshold for a legally-
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`cognizable declaration. This is not mere pedantry. Statements lacking the required
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`oath or caveat “thwart the purpose of our rules regarding affidavits/declarations,
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`and forgo the guarantee of truthfulness imparted by a declarant’s acknowledgment
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`of the possible consequences––fine, imprisonment, or penalty of perjury.” Int’l
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`Bus. Machs. Corp. v. Intellectual Ventures II LLC, IPR2015-01323, Paper 38, 9-11
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`(2016) (sustaining objection, noting failure to file supplemental evidence).
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` Similarly, EX1002 constitutes hearsay without exception because it
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`represents an out-of-Board statement not “made under oath or other circumstances
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`that impress the speaker with the solemnity of his statements.” Chambers v.
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`4819-8264-4971.1
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`Patent 9,604,901
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`Mississippi, 410 U.S. 284, 298 (1973) (“The hearsay rule . . . is based on
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`experience and grounded in the notion that untrustworthy evidence should not be
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`presented to the triers of fact.”).
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` Finally, Dr. Winkler is unqualified to testify on the relevant subject matter
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`and bases his testimony, whether by mistake or design, on materials no expert in
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`pharmaceutical manufacturing would consider probative. FRE 701, 702. Dr.
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`Winkler’s self-serving assertions of qualifications in a relevant field are belied by
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`the testimony of experts offered by both Liquidia and UT: Dr. Hall-Ellis and Dr.
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`Pinal, respectively.
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`Dr. Hall-Ellis explains the education and experience of a person of ordinary
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`skill in the art:
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`a person of ordinary skill in this subject matter or art would typically be
`someone who is a medical physicist with a Ph.D. (or similar advanced degree)
`in physics, medical physics, or a related field, and two or more years of
`experience in radiation oncology physics, treatment planning, treatment plan
`optimization related to radiation oncology applications, and computer
`programming associated with treatment plan optimization (or equivalent degree
`or experience).
`EX1015, ¶16. Yet, Liquidia provides no evidence that Dr. Winkler has any of these
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`qualifications, and even Dr. Winkler does not claim to possess these qualifications.
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`4819-8264-4971.1
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`Patent 9,604,901
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`Motion to Exclude
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`Dr. Pinal explained (with corroborating evidence) why Dr. Winkler lacks
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`relevant qualifications to address the issues that faced a person of ordinary skill in
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`the art:
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`Organic and medicinal chemists have a particular set of skills to
`address synthetic or drug design problems. They do not, however,
`have the requisite skill set for the large-scale manufacture of the same
`synthetic drugs nor either pharmaceutical compositions or
`pharmaceutical products. See EX2008 (Stahl), vii (noting “the
`majority of medicinal chemists working in the pharmaceutical
`industry are organic chemists whose main concern is to design and to
`synthesize novel compounds as future drug entities. While they focus
`on this challenging primary goal, salt formation is often restricted to a
`marginal activity with the short term aim of obtaining nicely
`crystalline material. Moreover, chemists are not explicitly trained in
`the various aspects of pharmaceutical salts”), 250 (“The preparation of
`pharmaceutical salts is usually not a matter of university teaching, and
`most of the organic chemists are not trained to prepare salts.”).
`EX2002, 92. Dr. Winkler testified he did not know whether manufacturing
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`pharmaceutical products presented problems in the art. EX2026, 72:23-73:9. He
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`was unable to answer accurately even the most basic questions about
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`manufacturing requirements in the United States (id., 72:23-74:23) or development
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`considerations (see, e.g., EX2032, 171:23-175:5 (acid neutralization), 250:11-
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`252:16 (bioavailability), 252:18-274:22 (counterion selection), 287:6-296:19
`5
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`Case IPR2020-00770
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`Motion to Exclude
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`(clinical safety) 321:1-322:9 (crystal morphology)), despite his vague assertions
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`about “consulting” with pharmaceutical companies. See, e.g., EX2026, 47:12-20
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`(asserting that, measuring from 1983, close to 40 years ago, Dr. Winkler
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`“probably” has “at least five years accumulated experience in dealing with issues
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`in process chemistry”); see also EX2025, ¶15 (“These lines of testimony
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`underscore the misguided focus of Dr. Winkler’s analyses in this case, and lack of
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`understanding of the field pertinent to the claims of the ’901 patent. I note for
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`example that in the pharmaceutical field, terms such as ‘batch’ have a clear
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`regulatory definition”).
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`Instead, Dr. Winkler based his testimony on his understanding of “Organic
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`Chemistry 101”—simple academic exercises carefully selected for
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`undergraduates—rather than the real-world problems of real-world practitioners in
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`the relevant field. EX1002, ¶5; EX2025, ¶¶49-50. Indeed, Dr. Winkler makes
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`elementary mistakes in interpreting Phares’ differential scanning calorimetry traces
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`by comparing different polymorphs, which even he had previously indicated he
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`knew was wrong. Id., ¶¶126-36 (explaining error and noting EX2007, 193:3-14);
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`see also id., ¶206 (“Dr. Winkler conflates two different aspects of stability, namely,
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`thermodynamic and kinetic stability. This makes it easy to mislead someone
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`untrained in the field. I note however, that the important difference between
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`Motion to Exclude
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`thermodynamic and kinetic stability is something the POSA would have been
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`acutely aware of”), ¶247 (describing Dr. Winkler’s “creative[]” but “tortured,
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`illogical, and scientifically incorrect discussion of endothermic events as measured
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`using differential scanning calorimetry”).
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`As Dr. Pinal explained, Dr. Winkler’s testimony is replete with such basic
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`mistakes:
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`Dr. Winkler testified that “a POSA reading this experimental
`procedure for the formation of 7, would understand that Moriarty, in
`fact, is preparing a salt of treprostinil.” EX2026 (Winkler Depo.),
`130:4-8. However, in his testimony, Dr. Winkler leaves out that the
`solution he is referring to has “pH 10-12,” too high for the solution to
`be useful for any practical pharmaceutical application, such that “a
`POSA reading this experimental procedure” would understand that the
`mixture Dr. Winkler is referring to is an intermediate mixture in the
`process of Moriarty. Moreover, Dr. Winkler testified, “I would say
`that that aqueous layer is, which is described on . . . the third line of
`the right-hand column of page 13, that aqueous layer is, in fact,
`treprostinil potassium salt, a solution of it.” Id., 129:1-11. It is
`remarkable that in referring to the “aqueous layer” in Moriarty, Dr.
`Winkler’s testimony leaves out the fact that the very sentence he is
`pointing at teaches (actually starts as): “The aqueous layer was
`acidified to pH 2-3 by addition of 3 M HCl.” EX1009, 13. Any
`chemist, regardless of area of specialization, would understand that
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`Motion to Exclude
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`acidification of the aqueous layer precludes the formation of any salt
`of treprostinil. Dr. Winkler further testified that the “steps of Moriarty
`and of the ’901 in both starting with the benzidene triol, alkylating
`and then hydrolyzing are identical, yes.” EX2026 (Winkler Depo.),
`131:1-3. This is one more instance in which Dr. Winkler takes very
`general concepts (alkylation, hydrolysis) and misrepresents them as
`very specific teachings.
`EX2025, ¶232; see also, e.g., id., ¶¶185 (“any chemist would know that simply
`
`adding diethanolamine in the presence of KOH would not result in the
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`diethanolamine salt”), 185-86 (“Dr. Winkler finishes his analysis…cit[ing]
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`EX1014 (’075 patent), . . . asserting that it teaches selective alkylation of the
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`treprostinil triol intermediate. EX1002, ¶¶82-83. It does not.”), 187-88 (“Dr.
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`Winkler also refers to this exhibit in asserting that Phares cites to the ’075 patent
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`for teaching this alleged alkylation of the triol. It does not.”), 205-07 (Dr. Winkler
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`attempts to support his arguments regarding storage “us[ing] a teaching of relative
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`thermodynamic stabilities” of polymorphs, which “is not a scientifically valid
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`conclusion”).
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`In sum, Dr. Winkler lacks knowledge and experience in the relevant art and, in
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`any case, applies fundamentally inappropriate analyses in constructing his
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`opinions.
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`4819-8264-4971.1
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`Patent 9,604,901
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`Motion to Exclude
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`The Board must ensure that expert testimony is both relevant and reliable.
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`Kumho Tire Co. v. Carmichael, 526 U.S. 137, 147 (1999). Whether testimony is
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`based on experience or knowledge, it must employ the level of intellectual rigor
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`characterizing experts in the field. Id., 152-153 (the district court “excluded the
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`testimony because, despite those qualifications, it initially doubted, and then found
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`unreliable” the methodology and the “basis, if any”). The question is not general
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`reliability, but reliability for the proffered purpose. Id., 154. Subjective, uncertain,
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`or inconsistent testimony supports exclusion. Id., 54-56; see also 37 C.F.R.
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`§42.65(a) (unsupported expert testimony entitled to little or no weight). Indeed,
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`unreliable evidence should be excluded whatever the expert’s qualifications might
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`be. Kumho, 526 U.S. at 154-55; see also id., 159 (Scalia, J., concurring)
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`(emphasizing “trial-court discretion in choosing the manner of testing expert
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`reliability [] is not discretion to abandon the gatekeeping function.”).
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` EX1002 is unreliable as a declaration because it lacks the most basic (and
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`statutorily required) elements of a declaration. Moreover, despite his degrees and
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`experience in other fields, Dr. Winkler is unqualified to testify on the subject
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`matter in this proceeding and, in any case, has demonstrated his unreliability by
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`offering opinions that he knows, or should know based on his experience, to be
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`wrong. Because the authentication, hearsay, and expert-qualification failings apply
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`4819-8264-4971.1
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`Motion to Exclude
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`to the entire exhibit, the entire exhibit should be excluded to ensure the integrity of
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`the proceeding and a clear record for review.
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`
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`B.
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`EX1012 Should Be Excluded
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`EX1012 purports to be a translation of Kawakami, JP No. 56- 122328A, but is
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`objectionable for a variety of reasons:
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` Liquidia did not establish that EX1012 is a true and accurate
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`representation of the original purported Japanese-language patent (FRE
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`802; 37 C.F.R. § 42.63(b)); and
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` EX1012 lacks sufficient indicia to support a finding that it is what it
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`purports to be and is not self-authenticating (FRE 901 & 902).
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`Despite these objections, Liquidia took no action and failed to serve any
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`supplemental evidence relating to EX1012.
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` EX1012 contains neither the purported Japanese document being translated,
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`nor a verified translator’s declaration. Even where an English translation of a
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`document has been submitted in earlier prosecution by Patent Owner, a Petitioner
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`must provide a verified translator’s declaration relating to a translated reference it
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`wishes to rely upon. Norman Int’l Inc. v. Andrew J. Testamentary Trust, IPR2014-
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`00283, Paper 52 at 13 (P.T.A.B., June 18, 2015) (citing 37 C.F.R. § 42.63(b)
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`separate requirement for translation); accord Stevens v. Tamai, 366 F.3d 1325,
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`1334 (Fed. Cir. 2004) (error to accord priority without certified translation in trial
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`record, even though a translation appeared in the prosecution history).
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`Moreover, § 42.63(b) is an additional requirement, not authorization to file a
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`translation instead of the original document. Indeed, a foreign public document
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`must be certified by the appropriate foreign certifying authority. FRE 902(3). By
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`omitting the filing of the purported Japanese document, Liquidia necessarily also
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`omitted the required certification of the purported foreign document. Liquidia
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`made no effort to cure these defects, which must be strictly enforced. United States
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`v. Perlmuter, 693 F.2d 1290, 1292 (9th Cir. 1982) (“Although the trial court was
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`correct in finding that neither Rule 901 nor 902(3) was complied with, the court
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`did abuse its discretion in holding the evidence authentic and admissible.”); id. at
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`1293 (“[C]ertainly it is not enough that the documents present an ‘aura of
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`authenticity.’ Thus, the trial court abused its discretion by admitting the
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`unauthenticated documents into evidence.”).
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`For these reasons, EX1012 should be excluded in its entirety. Similarly, the
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`Petition at pp. 23-24 and 55, and also the Winkler Declaration (EX1002) at par. 49
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`and 157, which cite to EX1012, should be excluded (in addition to the reasons for
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`excluding the entire Winkler Declaration set forth above).
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`4819-8264-4971.1
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`Patent 9,604,901
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`IV. CONCLUSION
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`
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`Motion to Exclude
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`For at least the reasons provided above, Patent Owner urges the Board to grant
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`this motion and exclude Exhibits 1002 and 1012, as well as the arguments of
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`Petitioner that rely on these exhibits as set forth above.
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`Respectfully submitted,
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`Date: May 24, 2021
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`/Stephen B. Maebius/
`Stephen B. Maebius
`Registration No. 35,264
`Counsel for Patent Owner
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`Patent 9,604,901
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`Motion to Exclude
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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 Motion to Exclude was served on counsel of record on May 24, 2021, by
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`filing this document through the PTAB E2E System as well as delivering a copy
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`via email to the 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: May 24, 2021
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`/Stephen B. Maebius/
`Stephen B. Maebius
`Foley & Lardner LLP
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`4819-8264-4971.1
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