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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`
`AMNEAL PHARMACEUTICALS LLC AND
`AMNEAL PHARMACEUTICALS OF NEW YORK, LLC,
`Petitioners,
`
`v.
`
`ALMIRALL, LLC,
`Patent Owner.
`
`___________________
`
`Case IPR2019-00207
`U.S. Patent No. 9,517,219
`___________________
`
`PETITIONERS’ MOTION TO EXCLUDE EVIDENCE
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`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`

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`Case IPR2019-00207
`Patent 9,517,219 B2
`
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`Petitioners Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals of
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`New York, LLC (“Amneal”) file this motion pursuant to 37 C.F.R. §§ 42.62 and
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`42.64(c) and in accordance with Due Date 5 of the Scheduling Order (Paper 14).
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`Amneal requests exclusion of Exhibits 2010-2011, 2013, 2017-2018, 2021, 2024,
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`2026-2027, 2029, 2032, 2038-2040, and 2050-2052; pages 289-293 of Exhibit
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`1017; paragraphs 1-19, 21-22, 83-93, 95, 98-100, 102-105, and 113-114 of Exhibit
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`2055; and paragraphs 1-37, 87-88, 109, 173-174, 165, 175-181, 190, 192-194 and
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`197 of Exhibit 2057, each of which it timely objected to through written
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`Objections to Evidence.
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`The Federal Rules of Evidence (FRE) govern the admissibility of evidence
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`in inter partes review proceedings. See 37 C.F.R. § 42.62. As shown herein, the
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`challenged exhibits contain irrelevant information under FRE 401, 402, and 403,
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`improper expert testimony under FRE 702 and 703, and hearsay under FRE 801
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`and 802. Accordingly, the Board should exclude the objected-to exhibits in their
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`entirety for the reasons that follow.
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`It is not enough for the Board to find that this Motion is moot if the Board
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`does not rely on the inadmissible evidence in reaching its Final Written Decision.
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`If the exhibits and paragraphs identified herein remain in the record, Almirall could
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`continue to rely upon them on appeal, and Amneal would be unfairly forced to
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`address them again.
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`Case IPR2019-00207
`Patent 9,517,219 B2
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`
`ARGUMENT
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`I. MULTIPLE EXHIBITS AND PARAGRAPHS OF EXPERT
`DECLARATIONS ARE NOT RELEVANT AND/OR ARE
`PREJUDICIAL.
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`Almirall submitted several exhibits that it failed to cite in its Patent Owner’s
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`Response or Sur-Reply, rendering them irrelevant and/or prejudicial. Exhibits
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`2010-2011, 2013, 2017-2018, 2021, 2024, 2026-2027, 2029, 2032, 2038-2040, and
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`2050-2052 appear nowhere in either Almirall’s Response or Sur-reply and only
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`appear buried in its expert declarations (Exhibits 2055 and 2057) submitted with
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`the Response.
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`Evidence is relevant if it “has a tendency to make a fact more or less
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`probable than it would be without the evidence” and “the fact is of consequence in
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`determining the action.” See FRE 401. Almirall’s failure to cite Exhibits 2010-
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`2011, 2013, 2017-2018, 2021, 2024, 2026-2027, 2029, 2032, 2038-2040, and
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`2050-2052 demonstrates that these exhibits do not have a tendency to make any
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`fact of consequence more or less probable. If these exhibits were relevant to this
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`proceeding, Almirall should have cited them in the Response or Sur-reply. This
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`evidence is, therefore, inadmissible as irrelevant. See FRE 402 (“Irrelevant
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`evidence is not admissible.”).
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`If this evidence was actually submitted for the Board to consider, then this
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`evidence should be excluded under FRE 403 as unfairly prejudicial. Exhibits 2010-
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`Case IPR2019-00207
`Patent 9,517,219 B2
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`2011, 2013, 2017-2018, 2021, 2024, 2026-2027, 2029, 2032, 2038-2040, and
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`2050-2052 were not cited or discussed in the Response or Sur-reply, so Almirall
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`would have overshot the word limits of its Patent Owner’s Response and its Sur-
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`reply had these exhibits been appropriately cited and discussed. Because
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`“[a]rguments must not be incorporated by reference from one document into
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`another document,” 37 C.F.R. § 42.6(a)(3), any attempt by Almirall to reply upon
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`these exhibits is prejudicial to Amneal. Amneal has followed the Board’s rules
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`throughout this proceeding, and would be prejudiced if Almirall is allowed to
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`disregard those rules and incorporate this information by reference.
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`Additionally, paragraphs 1-19, 21-22, 83-93, 95, 98-100, 102-105, and 113-
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`114 of Exhibit 2055, and paragraphs 1-37, 87-88, 109, 173-174, and 197 of Exhibit
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`2057 are likewise irrelevant and/or prejudicial. These paragraphs are not cited in
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`either Almirall’s Response or Sur-Reply. As with the improper exhibits, Almirall
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`should have cited these paragraphs in its Response or Sur-reply if they were
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`relevant. Almirall chose not to cite those paragraphs, so they must now be
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`excluded from the record pursuant to FRE 401 and 402. Also of note, it is highly
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`unlikely that Almirall could have properly discussed the omitted paragraphs in the
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`space it had left in its Response or Sur-reply. If these paragraphs were relevant,
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`Almirall’s attempt to incorporate them into the Response or Sur-reply should be
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`rejected as prejudicial under FRE 403.
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`Case IPR2019-00207
`Patent 9,517,219 B2
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`Accordingly, Exhibits 2010-2011, 2013, 2017-2018, 2021, 2024, 2026-2027,
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`2029, 2032, 2038-2040, and 2050-2052; paragraphs 1-19, 21-22, 83-93, 95, 98-
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`100, 102-105, and 113-114 of Exhibit 2055; and paragraphs 1-37, 87-88, 109, 173-
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`174, and 197 of Exhibit 2057 should be excluded as irrelevant and/or prejudicial.
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`II. THE WARNER DECLARATION IN EXHIBIT 1017 AND DR.
`OSBORNE’S RELIANCE ON THE WARNER DECLARATION IN
`EXHIBIT 2057 ARE INADMISSIBLE HEARSAY.
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`Almirall’s expert declarant, Dr. Osborne, relies on a declaration from co-
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`inventor Kevin Warner (pages 289-293 of Exhibit 1017, herein “Warner
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`Declaration”) as the sole evidence of alleged unexpected results. Amneal had no
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`opportunity to cross-examine Dr. Warner on his declaration because Almirall did
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`not offer Dr. Warner for deposition in the first instance and Almirall then violated
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`the Board’s December 31, 2019 order by failing to provide Dr. Warner for
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`deposition before January 17, 2020. Without the opportunity to cross-examine Dr.
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`Warner, his declaration is inadmissible out-of-court testimony used for its truth and
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`should be excluded.
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`The Warner Declaration (Exhibit 1017, 289-293) is inadmissible hearsay
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`under FRE 801 and 802. The Warner Declaration contains out-of-court statements
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`from Dr. Warner about his observations of dapsone compositions that were not
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`under oath and were not subject to cross-examination. Ex. 1017, 289-293. Almirall
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`relies upon this document for its truth—that one embodiment of the ’219 patent’s
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`Case IPR2019-00207
`Patent 9,517,219 B2
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`claims exhibits unexpected results. See POR at 59-64. Almirall’s expert declarant,
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`Dr. Osborne, also relies upon the Warner Declaration for its truth. See Ex. 2057 at
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`¶¶165, 175-181, 190, and 192-194 (opining that the “statements and evidence in
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`Dr. Kevin Warner’s declaration show unexpected results”). Indeed, Dr. Osborne
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`testified that he had no personal knowledge of what Dr. Warner described in the
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`Warner Declaration, and that Dr. Osborne was solely reliant upon Dr. Warner for
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`any purported unexpected results. Ex. 1040, 76:23-86:13.
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`To date, Amneal has not had an opportunity to subject the declarant (Dr.
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`Warner) to cross examination.1 This is important because the Board previously
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`found that it was beyond speculation that something useful would be discovered
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`from Dr. Warner’s deposition. See Paper 39, 4-5. And based on the fact that
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`something useful would come from Dr. Warner’s deposition, Amneal sought Dr.
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`Warner’s deposition in September 2019. Ex. 1036, 4. Almirall refused to provide
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`him. Ex. 1036, 2. Amneal then moved for additional discovery, which the Board
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`1 In violation of the Board’s December 31, 2019 order to provide Dr. Warner for
`deposition by January 17, Almirall was only able to offer Dr. Warner for
`deposition on January 30—slightly more than a week before the February 7 oral
`hearing. This date is unacceptable as it is incredibly prejudicial to Amneal.
`Conducting Dr. Warner’s deposition on January 30 does not give the parties
`sufficient time to meaningfully engage in the supplemental briefing on unexpected
`results that the Board ordered and to get those briefs to the Board in sufficient time
`before the hearing for the Board to consider them. See Paper 39. This prejudice is
`entirely of Almirall’s making, as it has been aware that Amneal sought Dr.
`Warner’s deposition since September 2019 yet appears to have first contacted the
`witnesses eight days after the Board’s December 31 order. See AMN1077.
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`Case IPR2019-00207
`Patent 9,517,219 B2
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`granted, ordering Almirall to provide Dr. Warner for deposition by January 17,
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`2020. Paper 39, 8-9. Almirall failed to comply with the Board’s order.
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`No hearsay exception applies to Almirall’s reliance on the Warner
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`Declaration. In fact, given Almirall’s heavy reliance on the Warner Declaration
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`coupled with Almirall’s repeated unwillingness to provide Dr. Warner for
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`deposition, Almirall appears to be trying to shield Dr. Warner from scrutiny.
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`In addition to the Warner Declaration, Dr. Osborne, in paragraphs 165, 175-
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`181, 190, and 192-194 of Exhibit 2057, relies solely on the Warner Declaration for
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`the truth of the matter asserted (i.e., that purported unexpected results exist), and is
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`therefore inadmissible under FRE 801, 802, and 805. Dr. Osborne had no personal
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`knowledge of the information in the Warner Declaration, so Almirall cannot
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`simply have Dr. Osborne regurgitate Dr. Warner to avoid the prohibition on
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`hearsay. Again, no hearsay exception applies.
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`To the extent the Board does not exclude the Warner Declaration or
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`paragraphs 165, 175-181, 190, and 192-194 of Exhibit 2057, because Almirall did
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`not produce Dr. Warner for cross-examination at deposition the Board should give
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`the Warner Declaration little to no weight as Amneal has not been offered a fair
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`opportunity to challenge his testimony. See Fed. R. Evid. 801 and 802.
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`Case IPR2019-00207
`Patent 9,517,219 B2
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`III. PARAGRAPHS 165, 175-181, 190, AND 192-194 OF DR. OSBORNE’S
`DECLARATION
`(EXHIBIT 2057) ARE IMPROPER EXPERT
`TESTIMONY.
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`Paragraphs 165, 175-181, 190, and 192-194 of Exhibit 2057 should be
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`excluded as improper expert testimony under FRE 702 and 703. Under FRE 702,
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`an expert may testify in the form of an opinion if (a) the expert’s specialized
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`knowledge will help determine a fact in issue; (b) the testimony is based on
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`sufficient facts or data; (c) the testimony is the product of reliable principles and
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`methods; and (d) the expert has reliably applied those principles and methods to
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`the facts of the case. Under Rule 703, an expert may base an opinion on facts or
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`data that the expert has been made aware of or personally observed.
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`Dr. Osborne relies solely on the Warner Declaration for his opinions as to
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`purported unexpected results. But the Warner Declaration has critical flaws: (1) it
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`does not disclose what is meant by Dr. Warner’s statement that the prior art
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`dapsone compositions show purported “undesired polymer aggregates” or the basis
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`on which that determination was made, and (2) it does not disclose how the
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`dapsone compositions described in the Warner Declaration were prepared even
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`though the prior art informs that the preparation method will impact both polymer
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`aggregation and particle size. At his deposition, Dr. Osborne did not know the
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`missing information. See Ex. 1040, 76:23-86:13. Nor did Dr. Osborne know who
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`actually conducted the testing described in the Warner Declaration (the declaration
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`Case IPR2019-00207
`Patent 9,517,219 B2
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`simply says that testing was conducted under Dr. Warner’s “supervision”), nor
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`what their level of skill was. See Ex. 1040, 107:15-108:15. Crucially, Dr. Osborne
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`conceded that there was additional information he would have liked to know about
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`the Warner Declaration. See Ex. 1040, 108:11-15.
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`Given (1) Dr. Osborne’s heavy reliance on the Warner Declaration as the
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`sole piece of evidence for any purported unexpected results coupled with (2) the
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`deficiencies in the Warner Declaration and (3) Dr. Osborne’s lack of personal
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`knowledge about the missing information, Dr. Osborne’s testimony does not
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`disclose the underlying facts or data to properly provide expert testimony. And for
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`these same reasons, Dr. Osborne similarly has not shown that his opinions on
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`purported unexpected results are the product of reliable principles and methods or
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`that he reliably applied those principles and methods to the facts of the case.
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`Additionally, Almirall nor Dr. Osborne have shown that the scant
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`information from the Warner Declaration, that Dr. Osborne even admits lacks
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`information he would like to see, is the type of information that experts in the field
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`would rely on in forming an opinion, as required by FRE 703.
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`Therefore, Exhibit 2057 is inadmissible under FRE 702 and 703 and should
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`be excluded. Even if Dr. Osborne’s opinions on purported unexpected results are
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`not excluded, such expert testimony that does not disclose the underlying facts or
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`data is entitled to “little or no weight.” See 37 CFR § 42.65(a).
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`Case IPR2019-00207
`Patent 9,517,219 B2
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`IV. CONCLUSION
`For the foregoing reasons, the challenged evidence does not meet the
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`threshold for admissibility and should be excluded from the record.
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`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
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`Respectfully submitted,
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`
`Date: January 17, 2020
`1100 New York Avenue, N.W.
`Washington, D.C. 20005-3934
`(202) 371-2600
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`
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`
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`Dennies Varughese (Reg. No. 61,868)
`Lead Attorney for Petitioners
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`Case IPR2019-00207
`Patent 9,517,219 B2
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`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
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`
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`The undersigned hereby certifies that the above-captioned “Petitioners’
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`Motion To Exclude Evidence” was served in its entirety on January 17, 2020, upon
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`the following parties via electronic mail:
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`
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`James Trainor
`
`
`RJ Shea
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`FENWICK & WEST LLP
`902 Broadway, Suite 14
`New York, NY 10010
`
`Telephone (212) 430-2600
`Facsimile (650)938-5200
`jtrainor@fenwick.com
`rshea@fenwick.com
`
`Jennifer R. Bush
`FENWICK & WEST LLP
`801 California Street
`Mountain View, CA 94041
`Telephone (650) 988-8500
`Facsimile (650) 938-5200
`jbush@fenwick.com
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`Elizabeth B. Hagan
`FENWICK & WEST LLP
`1191 Second Avenue, 10th Floor
`Seattle, WA 98101
`Telephone (206) 389-4510
`Facsimile (206)389-4511
`ehagan@fenwick.com
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`
`STERNE, KESSLER, GOLDSTEIN & FOX L.L.C.
`
`Dennies Varughese, Pharm.D.
`Date: January 17, 2020
`1100 New York Avenue, N.W. Registration No. 61,868
`Washington, D.C. 20005-3934
`Lead Attorney for Petitioners
`(202) 371-2600
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