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 IPR2018-00608
`U.S. Patent No. 9,161,926 B2
`___________________
`
`PETITIONERS’ MOTION TO EXCLUDE EVIDENCE
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`
`AMNEAL PHARMACEUTICALS LLC AND
`AMNEAL PHARMACEUTICALS OF NEW YORK, LLC,
`Petitioners,
`
`v.
`
`ALMIRALL, LLC,
`Patent Owner.
`
`___________________
`
`Case IPR2018-00608
`U.S. Patent No. 9,161,926 B2
`___________________
`
`PETITIONERS’ MOTION TO EXCLUDE EVIDENCE
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`
`Case IPR2018-00608
`Patent 9,161,926 B2
`
`
`Petitioners Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals of
`
`New York, LLC (“Amneal”) file this motion pursuant to 37 C.F.R. §§ 42.62 and
`
`42.64(c) and in accordance with Due Date 4 of the Scheduling Order (Paper 11).
`
`Amneal requests exclusion of Exhibits 2004, 2015, 2019, 2023, 2027, 2028, 2030-
`
`2035, 2038, 2040, 2041, and 2043-2047; paragraphs 1-40, 43, 61, 62, 64, 66-68,
`
`71-80, 88-90, 92-98, 100, 104-112, 116-122, 125-143, 146-148, 152-158, 161-171,
`
`173, 175-181, 183-192, 194-196, 200, and 202-218 of Exhibit 2003; and
`
`paragraphs 1-32, 35-39, 65, 78-80, 85-94, 96-112, 115, 132, 150, 163, and 173-200
`
`of Exhibit 2022, each of which it timely objected to through written Objections to
`
`Evidence.
`
`The Federal Rules of Evidence (FRE) govern the admissibility of evidence
`
`in inter partes review proceedings. 37 C.F.R. § 42.62. As shown herein, the
`
`challenged exhibits contain irrelevant information under FRE 401, 402, and 403;
`
`hearsay under FRE 801 and 802; and are unauthenticated in violation of FRE 901.
`
`Accordingly, the Board should exclude the objected-to exhibits in their entirety for
`
`the reasons that follow.
`
`It is not enough for the Board to find that this Motion is moot if the Board
`
`does not rely on the inadmissible evidence in reaching its Final Written Decision.
`
`If the exhibits and paragraphs identified herein remain in the record, Almirall could
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`Case IPR2018-00608
`Patent 9,161,926 B2
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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.
`
`ARGUMENT
`
`I. MULTIPLE EXHIBITS AND HUNDREDS OF PARAGRAPHS OF
`EXPERT DECLARATIONS ARE NOT RELEVANT AND/OR ARE
`PREJUDICIAL.
`
`Almirall submitted dozens of exhibits that it failed to cite in its Patent
`
`Owner’s Response or Sur-Reply, rendering them irrelevant and/or prejudicial.
`
`Exhibits 2004, 2015, 2019, 2023, 2027, 2028, 2030-2035, 2038, 2040, 2041, and
`
`2043-2047 appear nowhere in either Almirall’s Response or Sur-reply and only
`
`appear buried in its expert declarations (Exhibits 2003 and 2022) submitted with
`
`the Response. Similarly, more than 250 paragraphs out of a total of 418
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`paragraphs in Almirall’s supporting expert declarations (Exhibits 2003 and 2022)
`
`were never cited in Almirall’s Response or Sur-Reply.
`
`Evidence is relevant if it “has a tendency to make a fact more or less
`
`probable than it would be without the evidence” and “the fact is of consequence in
`
`determining the action.” FRE 401. Almirall’s failure to cite Exhibits 2004, 2015,
`
`2019, 2023, 2027, 2028, 2030-2035, 2038, 2040, 2041, and 2043-2047
`
`demonstrates that these exhibits do not have a tendency to make any fact of
`
`consequence more or less probable. If these exhibits were relevant to this
`
`proceeding, Almirall should have cited them in the Response or Sur-reply. This
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`Case IPR2018-00608
`Patent 9,161,926 B2
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`evidence is, therefore, inadmissible as irrelevant. See FRE 402 (“Irrelevant
`
`evidence is not admissible.”).
`
`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 2004,
`
`2015, 2019, 2023, 2027, 2028, 2030-2035, 2038, 2040, 2041, and 2043-2047 were
`
`not cited or discussed in the Response or Sur-reply, so Almirall would have vastly
`
`overshot the word limits of its Patent Owner’s Response and its Sur-reply had
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`these exhibits been appropriately cited and discussed. Because “[a]rguments must
`
`not be incorporated by reference from one document into another document,” 37
`
`C.F.R. § 42.6(a)(3), any attempt by Almirall to reply upon these exhibits is
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`prejudicial to Amneal. Amneal has followed the Board’s rules throughout this
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`proceeding, and would be prejudiced if Almirall is allowed to disregard those rules
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`and incorporate this information by reference.
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`Paragraphs 1-40, 43, 61, 62, 64, 66-68, 71-80, 88-90, 92-98, 100, 104-112,
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`116-122, 125-143, 146-148, 152-158, 161-171, 173, 175-181, 183-192, 194-196,
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`200, and 202-218 of Exhibit 2003, and paragraphs 1-32, 35-39, 65, 78-80, 85-94,
`
`96-112, 115, 132, 150, 163, and 173-200 of Exhibit 20221 are likewise irrelevant
`
`
`1 These 263 paragraphs constitute an astounding 63% of Almirall’s 418 total
`
`paragraphs of expert testimony.
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`Case IPR2018-00608
`Patent 9,161,926 B2
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`and/or prejudicial. These paragraphs are not cited in either Almirall’s Response or
`
`Sur-Reply. As with the improper exhibits, Almirall should have cited these
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`paragraphs in its Response or Sur-reply. Almirall chose not to cite those
`
`paragraphs, so they must now be excluded from the record pursuant to FRE 401
`
`and 402. Also of note, it is highly unlikely that Almirall could have properly
`
`discussed the omitted 263 paragraphs in the space it had left in its Response or Sur-
`
`reply. If these paragraphs were relevant, Almirall’s attempt to incorporate them
`
`into the Response or Sur-reply should be rejected as prejudicial under FRE 403.
`
`Accordingly, Exhibits 2004, 2015, 2019, 2023, 2027, 2028, 2030-2035,
`
`2038, 2040, 2041, and 2043-2047; paragraphs 1-40, 43, 61, 62, 64, 66-68, 71-80,
`
`88-90, 92-98, 100, 104-112, 116-122, 125-143, 146-148, 152-158, 161-171, 173,
`
`175-181, 183-192, 194-196, 200, and 202-218 of Exhibit 2003; and paragraphs 1-
`
`32, 35-39, 65, 78-80, 85-94, 96-112, 115, 132, 150, 163, and 173-200 of Exhibit
`
`2022 should be excluded as irrelevant and/or prejudicial.
`
`II. EXHIBITS 2043 AND 2044 SHOULD BE EXCLUDED AS
`INADMISSIBLE ON MULTIPLE GROUNDS.
`A. Exhibit 2043 is irrelevant, unauthenticated hearsay.
`Exhibit 2043 is document entitled “A Phase II, Randomized, Partial-Blind,
`
`Parallel-Group, Active and Vehicle-Controlled, Multicenter Study of the Safety
`
`and Efficacy of AczoneTM (Dapsone) Gel, 5% in Subjects With Papulopustular
`
`Rosacea.” Ex. 2043, 1.
`
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`Case IPR2018-00608
`Patent 9,161,926 B2
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`First, this document was not cited in Almirall’s Response or Sur-Reply and
`
`therefore should be rejected on the grounds above.
`
`Second, this document is not relevant under FRE 401. Almirall’s expert Dr.
`
`Harper asserts that Exhibit 2043 was published on February 5, 2007. Ex. 2022,
`
`¶144, n.6 (“(QLT Inc. publ., Feb. 5, 2007)”). Almirall has provided no evidence in
`
`the record to show that this document was publicly available prior to the invention
`
`date, much less on February 5, 2007, which is the date that Dr. Harper identifies as
`
`the date of publication. That date, however, is merely the “Date of Report”
`
`identified on the face of Exhibit 2043. But this date is not its date of publication.
`
`Ex. 2043, 1. In fact, the document explicitly contradicts the claim that it was
`
`publicly disseminated by February 5, 2007 by including on every page of the
`
`document a “CONFIDENTIAL” stamp. See generally Ex. 2043. Internal
`
`documents intended to be confidential are not printed publications. See MPEP, §
`
`2128.01 (citing Northern Telecom Inc. v. Datapoint Corp., 908 F.2d 931, 936-37
`
`(Fed. Cir. 1990). Thus, Exhibit 2043 does not “ha[ve] a tendency to make a fact
`
`more or less probable” given the lack of evidence of public dissemination, and
`
`should be excluded. See FRE 401, FRE 402.
`
`Third, Exhibit 2043 should be excluded as inadmissible hearsay. Even
`
`assuming Almirall (and Dr. Harper) are correct that “Date of Report” means “Date
`
`of Publication”—it does not—Almirall and Dr. Harper rely upon an out-of-court
`
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`Case IPR2018-00608
`Patent 9,161,926 B2
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`statement (the date identified on the face of Exhibit 2043) for the truth of the
`
`matter asserted (that certain information was publicly known about topical dapsone
`
`as of the date of the report). Given that Exhibit 2043 is an out-of-court statement
`
`used for the truth of the matter asserted, it is inadmissible hearsay and should be
`
`excluded under FRE 403. See, e.g., ServiceNow, Inc. v. Hewlett-Packard Co.,
`
`IPR2015-00707, slip op. at 9-10 (PTAB Nov. 2, 2015) (Paper 14) (copyright date
`
`entitled to no greater weight than hearsay in determining public accessibility);
`
`Standard Innovation Corp. v. Lelo, Inc., IPR2014-00148, slip op. at 15-16 (PTAB
`
`Apr. 23, 2015) (Paper 412) (dates printed on documents are inadmissible hearsay to
`
`the extent relied on to prove publication). No hearsay exception applies.
`
`Fourth, Exhibit 2043 is inadmissible under FRE 901 as inauthentic. FRE
`
`901(a) requires “the proponent [to] produce evidence sufficient to support a finding
`
`that the item is what the proponent claims it is.” But Almirall has offered no
`
`evidence of what Exhibit 2043 is. Almirall failed to offer testimony from a witness
`
`with knowledge of Exhibit 2043 that could testify as to the authenticity of the
`
`document. Accordingly, Exhibit 2043 is inadmissible as not authentic.
`
`Exhibit 2044 is irrelevant, unauthenticated hearsay.
`
`B.
`Exhibit 2044 appears to resemble a clinical study summary that contains the
`
`same title as Exhibit 2043 (“A Phase II, Randomized, Partial-Blind, Parallel-
`
`2 This document is identified as Paper 42 on PTAB E2E.
`
`
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`Case IPR2018-00608
`Patent 9,161,926 B2
`
`Group, Active- and Vehicle-Controlled, Multicenter Study of the Safety and
`
`Efficacy of Aczone™ (dapsone) Gel, 5% in Subjects with Papulopustular
`
`Rosacea”). Ex. 2044, 1.
`
`First, the document was not cited in Almirall’s Response or Sur-Reply and
`
`should be rejected for the reasons stated above.
`
`Second, this document is irrelevant under FRE 401. Unlike Exhibit 2043, Dr.
`
`Harper did not even attempt to claim a publication date for this exhibit. See Ex.
`
`2022, ¶144, n.6. Accordingly, there is no allegation, much less evidence, that this
`
`document was available to the public before the invention date. Thus, Exhibit 2044
`
`does not “ha[ve] a tendency to make a fact more or less probable” given the lack of
`
`evidence of public dissemination and should be excluded. See FRE 401, FRE 402.
`
`Third, Exhibit 2044 should be excluded as inadmissible hearsay. Here, it is
`
`not clear for what purpose Dr. Harper cites the exhibit, as the exhibit is cited to
`
`support the statement “[r]esults of [a] clinical trial are also reported in … a results
`
`summary.” Ex. 2022, ¶144, n.6. To the extent that she relies on any “results”
`
`conveyed or summarized in Exhibit 2044, those summaries are hearsay because
`
`they are out-of-court statements and Dr. Harper relies on them for the truth of the
`
`matter asserted (that Exhibit 2044 accurately conveys a summary of any clinical
`
`study results). No hearsay exception applies.
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`Case IPR2018-00608
`Patent 9,161,926 B2
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`Fourth, Exhibit 2044 should be excluded as inauthentic under FRE 901.
`
`Almirall has offered no evidence of what Exhibit 2044 is, and Almirall failed to
`
`offer testimony from a witness with knowledge of Exhibit 2044 that could testify
`
`as to the authenticity of the document. Accordingly, Exhibit 2044 is inadmissible
`
`as not authentic.
`
`CONCLUSION
`
`For the foregoing reasons, the challenged evidence does not meet the
`
`threshold for admissibility and should be excluded from the record.
`
`
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`
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`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`Respectfully submitted,
`
`
`Dennies Varughese (Reg. No. 61,868)
`Lead Attorney for Petitioners
`
`
`Date: May 1, 2019
`1100 New York Avenue, N.W.
`Washington, D.C. 20005-3934
`(202) 371-2600
`
`10363877_1.docx
`
`
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`- 9 -
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`
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`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
`
`
`
`The undersigned hereby certifies that the above-captioned “Petitioners’
`
`Motion To Exclude Evidence” was served in its entirety on May 1, 2019, upon the
`
`following parties via electronic mail:
`
`
`
`
`
`
`
`
`
`
`
`James Trainor
`Vanessa Park-Thompson
`FENWICK & WEST LLP
`902 Broadway, Suite 14
`New York, NY 10010
`
`Telephone (212) 430-2600
`Facsimile (650)938-5200
`jtrainor@fenwick.com
`vpark-thompson@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
`
`
`
`
`
`
`
`
`
`
`
`
`Elizabeth B. Hagen
`FENWICK & WEST LLP
`1191 Second Avenue, 10th Floor
`Seattle, WA 98101
`Telephone (206) 389-4510
`Facsimile (206)389-4511
`ehagan@fenwick.com
`
`
`STERNE, KESSLER, GOLDSTEIN & FOX L.L.C.
`
`Dennies Varughese, Pharm.D.
`Date: May 1, 2019
`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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