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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`AMNEAL PHARMACEUTICALS LLC AND
`AMNEAL PHARMACEUTICALS OF NEW YORK, LLC,
`Petitioners,
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`v.
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`ALMIRALL, LLC
`Patent Owner.
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`Case IPR2018-00608
`Patent No. 9,161,926 B2
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`PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE UNDER
`37 C.F.R §42.64
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`IPR2018-00608
`Patent Owner’s Motion to Exclude
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`I.
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`INTRODUCTION
`Pursuant to 37 C.F.R. § 42.64(c), Patent Owner Almirall, LLC (“Almirall”)
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`moves to exclude from evidence, in their entirety, Exhibits 1041, 1042, 1043,
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`1044, 1045, 1046, 1047, and 1048, which were submitted by Petitioners Amneal
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`Pharmaceuticals LLC and Amneal Pharmaceuticals of New York, LLC (together,
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`“Amneal”) with its Reply (Paper 29). This motion is timely pursuant to the
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`Scheduling Order dated August 29, 2018 (Paper 11).
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`II.
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`STATEMENT OF MATERIAL FACTS
`In its Reply, Amneal cited Exhibits 1041–1047 in a single footnote as
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`purported evidence of “pay or benefits” Almirall’s expert Dr. Julie Harper received
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`for “promotional activities for ACZONE® Gel 5%.” Paper 29 at 5 n.3. Exhibit
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`1048 is not cited in Amneal’s Reply. These exhibits all appear to be printouts from
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`webpages of which Dr. Harper has no personal knowledge. Amneal has submitted
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`no evidence or testimony regarding the authenticity of these documents.
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`Following service of Amneal’s Reply, Almirall timely objected to Exhibits 1041–
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`1048 by filing objections pursuant to 37 C.F.R. § 42.64(b)(1) on March 25, 2019.
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`Paper 32. Amneal did not serve Supplemental Evidence in response to Almirall’s
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`objections to these exhibits.
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`IPR2018-00608
`Patent Owner’s Motion to Exclude
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`III. LEGAL STANDARDS
`The Federal Rules of Evidence govern the admissibility of evidence and
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`expert testimony in an inter partes review. 37 C.F.R. § 42.62(a). Evidence is
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`relevant if: (1) it has any tendency to make a fact more or less probable than it
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`would be without the evidence; and (2) the fact is of consequence in determining
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`the action. Fed. R. Evid. 401. Irrelevant evidence is not admissible. Fed. R. Evid.
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`402. Moreover, “the proponent must produce evidence sufficient to support a
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`finding that the item is what the proponent claims it is.” Fed. R. Evid. 901.
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`IV. ARGUMENT
`A. Exhibits 1041, 1042, 1043, 1044, 1045, 1046, and 1047 and Related
`Argument Should Be Excluded as Unauthenticated and Irrelevant
`Exhibits 1041 and 1042 appear to be webpage printouts or partial printouts
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`titled “Dollars for Docs. Exhibits 1043, 1044, 1045, 1046, and 1047 appear to be
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`webpage printouts or partial printouts titled “Open Payments Data.” All of these
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`exhibits purport to show compensation that Dr. Harper, a practicing dermatologist,
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`received from various pharmaceutical companies, including Allergan, in various
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`years. See, e.g., Ex. 1043 at 3 (listing items including “Food and Beverage” or
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`“Consulting Fee” from Abbvie, Inc. and Allergan Inc.). Amneal presented no
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`evidence establishing that the content of these printouts is true and correct.
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`Accordingly, Amneal has not met its burden to provide evidence sufficient to
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`IPR2018-00608
`Patent Owner’s Motion to Exclude
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`support a finding that these exhibits are admissible under Federal Rule of Evidence
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`901.
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`Nor are these exhibits relevant to whether the challenged claims of U.S.
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`Patent No. 9,161,926 (Ex. 1001) are unpatentable as obvious over the prior art
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`asserted by Amneal. That a leading dermatologist has received lunches and
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`consulting fees from pharmaceutical companies is not surprising, but has no
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`bearing whatsoever on the patentability of the challenged claims under 35 U.S.C.
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`§ 103. As these exhibits are not relevant, they and any related argument should be
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`excluded as inadmissible under Federal Rules of Evidence 401 and 402.
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`B.
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`Exhibit 1048 Should Be Excluded as Unauthenticated and
`Irrelevant
`Exhibit 1048 appears to be a further webpage printout or partial printout
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`titled “Dollars for Docs.” It purports to show compensation that various doctors
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`have received related to Aczone from August 2013 to December 2016. Ex. 1048
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`at 1. Amneal presented no evidence establishing that the content of this printout is
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`true and correct. Accordingly, Amneal has not met its burden to provide evidence
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`sufficient to support a finding that this exhibit is admissible under Federal Rule of
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`Evidence 901.
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`Nor is this exhibit relevant to whether the challenged claims of U.S. Patent
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`No. 9,161,926 (Ex. 1001) are unpatentable as obvious over the prior art asserted by
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`IPR2018-00608
`Patent Owner’s Motion to Exclude
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`Amneal. That a leading dermatologist has received lunches and consulting fees
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`from pharmaceutical companies is not surprising, but has no bearing whatsoever
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`on the patentability of the challenged claims under 35 U.S.C. § 103. Amneal did
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`not even bother to cite this exhibit in its Reply. As Exhibit 1048 is not relevant, it
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`should be excluded as inadmissible under Federal Rules of Evidence 401 and 402.
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`V. CONCLUSION
`Given the lack of evidence that these unauthenticated webpage printouts are
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`what they purport to be, and moreover their utter lack of relevance, Almirall
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`requests that Exhibits 1041–1048, and all argument related thereto, be excluded
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`from evidence in their entirety and expunged from the record.
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`Dated: May 1, 2019
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`Respectfully submitted,
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`FENWICK & WEST LLP
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`By:/James S. Trainor/
`James S. Trainor (Reg. No. 52,297)
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`Attorneys for Patent Owner
`Almirall, LLC
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`IPR2018-00608
`Patent Owner’s Motion to Exclude
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6, I hereby certify that on May 1, 2019, the
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`foregoing PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE was
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`served by electronic mail on the following counsel of record for petitioner:
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`Dennies Varughese (dvarughe-PTAB@skgf.com)
`Adam C. LaRock (alarock-PTAB@skgf.com)
`PTAB@skgf.com
`Sterne, Kessler, Goldstein & Fox
`1100 New York Avenue, NW, Suite 600
`Washington, DC 20005
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`Dated: May 1, 2019
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`Respectfully submitted,
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`FENWICK & WEST LLP
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`By:/James S. Trainor/
`James S. Trainor (Reg. No. 52,297)
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`Attorneys for Patent Owner
`Almirall, LLC
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