UNITED STATES PATENT AND TRADEMARK OFFICE
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`—————
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`—————
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`SLAYBACK PHARMA LLC,
`Petitioner,
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`v.
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`EYE THERAPIES, LLC,
`Patent Owner.
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`—————
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`Case No.: IPR2022-00142
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`U.S. Patent No.: 8,293,742
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`—————
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`PETITIONER’S MOTION TO EXCLUDE EVIDENCE
`37 C.F.R. § 42.64(c)
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`—————
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`—————
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`SLAYBACK PHARMA LLC,
`Petitioner,
`
`v.
`
`EYE THERAPIES, LLC,
`Patent Owner.
`
`—————
`
`Case No.: IPR2022-00142
`
`U.S. Patent No.: 8,293,742
`
`—————
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`PETITIONER’S MOTION TO EXCLUDE EVIDENCE
`37 C.F.R. § 42.64(c)
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`Pursuant to 37 C.F.R. §§ 42.62 and 42.64(c), Petitioner Slayback Pharma
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`LLC, respectfully submits this motion to exclude evidence submitted by Patent
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`Owner. Petitioner requests exclusion of the entirety of Exhibits 2152–2156 and
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`portions of Exhibits 2023 and 1052. Petitioner timely objected to these exhibits
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`through written objections (see Paper 34) and/or during the relevant deposition.
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`The Federal Rules of Evidence (“FRE”) govern the admissibility of
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`evidence and expert testimony in inter partes review proceedings. 37 C.F.R.
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`§ 42.62(a). The party moving to exclude the evidence bears the burden of
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`establishing that the material requested to be excluded is inadmissible under the
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`FRE. See Microsoft Corp. v. FG SRC LLC, IPR2018-0605, Paper 72, 11 (P.T.A.B.
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`Apr. 9, 2020). As shown herein, the exhibits that are the subject of this motion
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`should be excluded as containing inadmissible hearsay under FRE 802 or as
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`improper testimony under FRE 701, 702, and/or 703.
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`The Board should not dismiss this motion as moot even if the Board does
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`not rely on the inadmissible evidence in reaching its Final Written Decision.
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`Rather, Petitioner respectfully requests that the Board grant the motion so that
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`Patent Owner cannot continue to rely upon the exhibits identified herein on appeal.
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`Not excluding the exhibits at issue in this motion would force Petitioner to address
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`them again on appeal, thus wasting judicial and party resources. To the extent that
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`any exhibit or portion of an exhibit is not excluded, use of the exhibit should be
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`1
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`restricted by the Board to the use for which it was originally submitted. See FRE
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`105.
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`I. Paragraph 7 of Exhibit 2023 and Portions of Exhibit 1052
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`Paragraph 7 of Exhibit 2023 and the portion of Exhibit 1052 appearing at
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`page 105, line 10 through page 107, line 16 should be excluded as improper
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`testimony under FRE 701, 702, and/or 703.
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`Exhibit 2023 is the declaration of John Ferris, an employee within the
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`Bausch + Lomb family of companies (“Bausch”). See Ex. 2023, ¶ 3. Bausch &
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`Lomb, Inc. and Bausch & Lomb Ireland are real parties in interest in this
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`proceeding. Paper 4 at 2. Mr. Ferris’s testimony relates to the marketing and
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`commercial performance of Lumify, an alleged embodiment of certain claims of
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`the challenged patent. Patent Owner has made no attempt to qualify Mr. Ferris as
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`an expert in this case. Mr. Ferris did not include his curriculum vitae or resume
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`with his declaration, and his declaration does not identify any “knowledge, skill,
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`experience, training or education” that would qualify Mr. Ferris as an expert in this
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`proceeding. FRE 702; see also Ex. 2023. As a non-expert witness, any opinion
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`testimony from Mr. Ferris cannot be “based on scientific, technical, or otherwise
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`specialized knowledge.” FRE 701(c).
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`In Paragraph 7 of Ex. 2023, Mr. Ferris recites specific statistics about the use
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`of Lumify, but his testimony does not point to any support for these statements.
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`2
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`Ex. 2023, ¶ 7. At his deposition, Mr. Ferris confirmed that the statements in
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`Paragraph 7 were not based on his personal knowledge, but on data from a study
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`performed by a third party, IQVIA. Ex. 1051, 17:16–18:15. The study allegedly
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`supporting these statistics, however, was not submitted as an exhibit in this
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`proceeding, as confirmed by Mr. Ferris and Patent Owner’s counsel. Id., 18:16–
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`20:5. As a result, Paragraph 7 of Mr. Ferris’s declaration (Ex. 2023) is, at best,
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`inadmissible opinion testimony from a lay witness under FRE 701 because it is
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`based on scientific, technical, or specialized knowledge and Mr. Ferris is not
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`qualified to provide such an opinion regarding the precise outcome of a study, as
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`described above. FRE 701(c). Therefore, Paragraph 7 should be excluded as
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`improper testimony under FRE 701. Even if the Board finds that Mr. Ferris is
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`qualified to provide opinion testimony in this proceeding, however, the statements
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`in Paragraph 7 should still be excluded because they are not based on sufficient
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`facts or data that are in the record of this case. The underlying document was not
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`produced, and Petitioner had no ability to challenge the basis for these data.
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`Therefore, Paragraph 7 of Exhibit 2023 fails to be proper opinion testimony under
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`FRE 702. FRE 702(b).
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`Patent Owner attempted to circumvent the deficiencies in Paragraph 7 of Mr.
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`Ferris’s declaration by having Dr. Jarosz state the information in response to re-
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`direct questioning at Dr. Jarosz’s deposition. Specifically, Patent Owner’s counsel
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`3
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`asked Dr. Jarosz to look at Paragraph 7 of Mr. Ferris’s declaration (Exhibit 2023)
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`and repeat the same unsupported data and statistics that appear in that paragraph.
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`Ex. 1052, 105:5–107:17. This gamesmanship should not be permitted. The
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`testimony at Exhibit 1052, 105:5–107:17 remains unsupported by any facts or data
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`that are in the record of this proceeding. Given this lack of disclosure of the
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`supporting documents, the testimony appearing in Exhibit 1052, 105:5-107:17 is
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`not based on sufficient facts or data as required by FRE 702(b), and Mr. Jarosz’s
`redirect testimony should be excluded.
`II. Exhibit 2156 and Paragraphs 14-18 of Exhibit 2023
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`Petitioner respectfully requests the Board to exclude Exhibit 2156 as
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`impermissible hearsay under FRE 802. Petitioner similarly seeks to exclude
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`Paragraphs 14–18 of Exhibit 2023, which exclusively rely on Exhibit 2156, as
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`containing inadmissible hearsay and as improper testimony under FRE 701, 702,
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`and/or 703.
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`A. Exhibit 2156
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`Patent Owner relies on Exhibit 2156 to prove Lumify’s market performance.
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`Exhibit 2156 is a presentation of third party Ipsos’s analysis of data from a survey
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`it performed.1 Ex. 1051, 27:5–16, 30:6–20. Thus, Exhibit 2156 contains out of
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`1 Mr. Ferris’s declaration states that Bausch “conducted” the study, but he clarified
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`4
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`court statements offered for their truth. Patent Owner has not presented any
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`evidence that establishes Exhibit 2156 as falling into an exclusion or exception to
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`the rule against hearsay. Therefore, Exhibit 2156 is inadmissible hearsay under
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`FRE 802 and should be excluded.
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`Patent Owner may attempt to rely on FRE 803(17) to establish Exhibit 2156
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`under the “Market Report and Similar Commercial Publication” exception, but this
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`rule is not applicable to Exhibit 2156. FRE 803(17) is a narrow exception to the
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`rule against hearsay and is directed only to “compilations of data, not to narrative
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`and potentially subjective assessments.” See Telebrands Corp v. Tinnus Enters.,
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`LLC, PGR2016-00030, Paper 91, 58–59 (P.T.A.B. Feb. 7, 2018) (accepting a
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`narrow scope of Rule 803(17) and excluding a portion of an exhibit because it
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`“contain[ed] a substantial amount of subjective analysis”) (quoting Bianco v.
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`Globus Med., Inc., No. 2:12-CV-00147-WCB, 2014 WL 119284, at *1 (E.D. Tex.
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`Jan. 12, 2014)). As explained above, Exhibit 2156 is not simply a compilation of
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`“easily ascertainable facts,” but contains Ipsos’s analysis of the data. See JIPC
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`at deposition that Ipsos conducted the study at Basuch’s request. Ex. 1051, 22:17–
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`23:7. While the document contains “Bausch” branding, Mr. Ferris confirmed that
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`Ipsos presented Exhibit 2156 to the commercial organization at Bausch. Ex. 1051,
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`24:14–25:4.
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`5
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`Mgmt., Inc. v. Incredible Pizza Co., No. CV 08-04310 MMM (PLAx), 2009 WL
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`8591607, at *24 (C.D. Cal. July 14, 2009). Exhibit 2156 contains characterizations
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`of the results (e.g., Ex. 1051, 31:20–32:8) and statistical analyses of the data (e.g.,
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`Ex. 1051, 33:18–34:14). This subjective assessment does not fall into the narrow
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`Market Report hearsay exception, and therefore, Patent Owner cannot establish
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`Exhibit 2156 as falling within the exception to the rule against hearsay in FRE
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`803(17).
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`Patent Owner may also try to establish Ex. 2156 as a business record under
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`FRE 803(6), but this argument similarly fails. As established above, Ex. 2156 was
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`generated by a third party, and Patent Owner must supply a foundational witness to
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`establish how the report was created and kept. See FRE 803(6)(D). However,
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`Patent Owner has supplied no foundational testimony from the third party to
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`establish how the document was generated. The only information that Patent
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`Owner presented regarding how Exhibit 2156 was compiled is from Mr. Ferris,
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`who confirmed that he has never been employed by Ipsos and has no knowledge of
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`how they create or retain their documents. Ex. 1051, 23:8–24:3. Patent Owner,
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`therefore, cannot establish that Exhibit 2156 is admissible hearsay under the
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`business record exception (FRE 803(6)). See In re Lyman Good Dietary
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`Supplements Litig., No. 17-CV-8047 (VEC), 2020 WL 3414927, at *3–6
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`(S.D.N.Y. June 22, 2022) (third-party reports excluded because no witness was
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`6
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`produced to lay proper foundation); Fambrough v. Walmart Stores, Inc., 611 Fed.
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`App’x 322, 329 (6th Cir. 2015) (records were inadmissible hearsay because
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`declarants did not have personal knowledge of the records).
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`B.
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`Paragraphs 14-18 of Exhibit 2023
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`Petitioner similarly seeks exclusion of Paragraphs 14–18 of Exhibit 2023
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`(Declaration of John Ferris). In Paragraphs 14–18 of his declaration, Mr. Ferris
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`relies exclusively on information from Exhibit 2156. Ex. 2023, ¶¶ 14–18; see also
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`Ex. 2156. As explained in detail above, the subject matter of Exhibit 2156 is
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`inadmissible hearsay, so Mr. Ferris’s recitation of the same data is also
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`inadmissible hearsay under FRE 802. Mr. Ferris confirmed at his deposition that
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`he was not personally involved in the preparation of the Ipsos study. Ex. 1051,
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`24:14–20. As explained above, Patent Owner has not presented evidence to
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`establish that Mr. Ferris has the knowledge, skill, experience, training or education
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`in a field that would allow him to opine on the data in Exhibit 2156. Indeed, Mr.
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`Ferris confirmed that he did not have the expertise to testify regarding the
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`statistical analysis presented in the study report. Ex. 1051, 33:18–34:14.
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`Therefore, paragraphs 14–18 of Exhibit 2023 should be excluded as inadmissible
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`hearsay under FRE 802.
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`Additionally, paragraphs 14–18 of Exhibit 2023 should be excluded as
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`inappropriate testimony under 701, 702, and/or 703. As explained above, Mr.
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`7
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`Ferris does not have personal knowledge that would allow him to provide
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`testimony as to the facts presented in paragraph 14–18 of Exhibit 2023. As a lay
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`witness, Mr. Ferris’s testimony cannot include opinions that rely on hearsay or on
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`scientific or technical knowledge. FRE 701. The statements in paragraphs 14–18
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`of Exhibit 2023 are specific representations of data and statistics, requiring
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`scientific or technical knowledge to interpret. Therefore, Mr. Ferris should not be
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`permitted to offer the statements in paragraphs 14–18 as lay opinions. FRE 701.
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`Nevertheless, even if the Board finds that Mr. Ferris is qualified to provide opinion
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`testimony under FRE 702 in this proceeding, neither Exhibit 2156 nor Mr. Ferris’s
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`testimony provides sufficient information regarding the underlying data or how the
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`analysis was performed to make paragraphs 14–18 of Exhibit 2023 admissible
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`opinion testimony under FRE 702. FRE 702(b); see, e.g., Ex. 1051, 28:3–10.
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`Therefore, Mr. Ferris’s recitation of the information in Exhibit 2156 should also be
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`excluded as hearsay under FRE 802 and as improper testimony under FRE 701,
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`702, and/or 703.
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`III.
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`Exhibits 2152–2155 and Paragraph 6 of Exhibit 2023
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`Exhibits 2152 through 2155 are screenshots of various websites and should be
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`excluded under FRE 802 as impermissible hearsay. Patent Owner relies on these
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`exhibits to prove that Lumify has “received multiple awards and recognitions since
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`launch,” as stated in the Exhibits. Ex. 2023, at 2–3. Therefore, Exhibits 2152–
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`8
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`2155 are out-of-court statements offered to show the truth of the matter stated
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`therein, meeting the definition of hearsay under FRE 801(c). Patent Owner has not
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`made any showing that these Exhibits fall within an exclusion or exception to the
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`rule against hearsay. Additionally, Mr. Ferris cannot opine on the contents of these
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`Exhibits under FRE 703 because Mr. Ferris is not qualified as an expert in this
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`proceeding, as explained above. Therefore, Exhibits 2152–2155 should be
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`excluded from evidence in this proceeding.
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`Paragraph 6 of Exhibit 2023 (the Ferris Declaration) relies on Exhibits
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`2152–2155. Therefore, Paragraph 6 of Exhibit 2023 should be similarly excluded
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`from this proceeding because these paragraphs repeat the hearsay statements from
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`Exhibits 2152–2155.
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`IV.
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`Conclusion
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`For the reasons set forth above, Petitioner respectively requests that the
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`Board grant this motion to exclude the entirety of Exhibits 2152–2156 and portions
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`of Exhibits 2023 and 1052.
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`
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`Dated: February 6, 2023
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`Respectfully submitted,
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`
`
`
`
`
`By: /Linnea P. Cipriano/
`Linnea P. Cipriano
`(Reg. No. 67,729)
`Goodwin Procter LLP
`620 Eighth Avenue
`New York, NY 10018
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`9
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`Phone: (212) 813-8800
`Cell: (443) 235-1739
`Fax: (212) 937-2204
`lcipriano@goodwinlaw.com
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`Counsel for Petitioner Slayback
`Pharma LLC
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`10
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing Petitioner’s
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`Motion to Exclude was served on February 6, 2023, by electronic mail to:
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`Bryan Diner
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` bryan.diner@finnegan.com
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`Justin Hasford
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`Justin.hasford@finnegan.com
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`Caitlin O’Connell caitlin.o’connell@finnegan.com
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`Christina Yang christina.yang@finnegan.com
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`
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`February 6, 2023
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`Respectfully submitted,
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`
` /Linnea P. Cipriano/
`Linnea P. Cipriano
`(Reg. No. 67,729)
`Goodwin Procter LLP
`620 Eighth Avenue
`New York, NY 10018
`Phone: (212) 813-8800
`Cell: (443) 235-1739
`Fax: (212) 937-2204
`lcipriano@goodwinlaw.com
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`
`
`Counsel for Petitioner Slayback
`Pharma LLC
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`11
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