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’ REPLY IN SUPPORT OF THEIR 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’ REPLY IN SUPPORT OF THEIR 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
`
`
`Amneal’s motion to exclude showed that Almirall’s uncited evidence was
`
`both irrelevant and prejudicial. Almirall failed to rebut either point. Amneal
`
`established that the mountain of Almirall’s uncited evidence should be excluded as
`
`irrelevant. Almirall did not explain why its uncited evidence made a fact of
`
`consequence more or less probable (see FRE 401(b)) and instead asks the Board to
`
`“simply not rely on” it. The Board should exclude the uncited evidence.
`
`Next, Almirall did not rebut the prejudice to Amneal from the uncited
`
`evidence; it opted instead to incorrectly claim that Amneal “fail[s] to explain how
`
`these paragraphs are unfairly prejudicial to Petitioners.” Paper 39, 3, 5. Amneal
`
`explained the prejudice of both (1) dealing with this evidence on appeal and (2)
`
`Almirall far exceeding its word limits by retaining this evidence without properly
`
`citing or discussing it. Paper 39, 1-2, 4-5. Almirall simply ignores these points.
`
`Almirall concedes that EX2044 should be excluded, but opposes exclusion
`
`of EX2043. EX2043 is improper because it is either used for its truth to
`
`“corroborate” other evidence, or it is irrelevant. Almirall is wrong that EX2043 is
`
`“self-authenticating” under FRE 901. But FRE 902 governs self-authentication;
`
`Almirall’s reading of FRE 901 would render FRE 902 meaningless.
`
`I.
`
`Almirall’s uncited evidence is irrelevant and prejudicial.
`
`Almirall’s uncited evidence is irrelevant and prejudicial, and Almirall has
`
`come forward with no meaningful basis to not exclude them. Almirall’s reliance on
`
`
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`Case IPR2018-00608
`Patent 9,161,926 B2
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`SK Hynix Inc. v. Netlist, Inc., IPR2017-00562, Paper 36 (PTAB Jul. 5, 2018) is
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`misplaced. There, the Board did not exclude uncited evidence because the
`
`Petitioner specifically explained (1) why each paragraph/exhibit was submitted but
`
`not cited, (2) why the evidence was relevant, and (3) why the evidence was not
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`unfairly prejudicial. SK Hynix, Paper 36 at 48. Almirall did none of this.
`
`First, Almirall never explains why the uncited evidence was submitted but
`
`not cited, and its unsupported claim of relevance falls short. Almirall argues
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`“relevance” through bullet points that vaguely describe the uncited evidence. Paper
`
`39, 3-4 (stating that certain paragraphs offer “conclusion,” “context,”
`
`“background,” or an expert’s “understanding”). But describing those paragraphs,
`
`without connecting them to any fact in this case, does not make any fact of
`
`consequence more or less probable.
`
`This deficiency is crystallized by Almirall’s misstatement of FRE 401. To be
`
`relevant, evidence must both (1) have a tendency to make a fact more or less
`
`probable than it would be without the evidence; and (2) that fact must be “of
`
`consequence in determining the action.” FRE 401. Almirall’s opposition ignores
`
`the second prong of FRE 401. Almirall’s uncited evidence is not consequential
`
`because Almirall never explained how this evidence has any bearing on its case.
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`Paper 39, 3-5. Almirall still fails to offer any explanation for how its uncited
`
`evidence makes a fact of consequence more or less probable, and thus has waived
`
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`Case IPR2018-00608
`Patent 9,161,926 B2
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`its opportunity to establish relevance. For example, Almirall stated that paragraphs
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`202-217 of Dr. Klibanov’s declaration (EX2003) are relevant to respond to
`
`Amneal’s expert testimony that the “unexpected results” evidence submitted
`
`during prosecution is factually and legally flawed. Paper 39, 3. But Dr. Klibanov’s
`
`paragraphs cannot be relevant; Almirall did not argue any objective indicia of
`
`nonobviousness in its Patent Owner Response. Paper 23, 27-28.
`
`Second, Amneal explained that allowing Almirall to maintain the uncited
`
`evidence in this proceeding is unfairly prejudicial to Amneal because (1) failure to
`
`exclude the evidence allows Almirall the potential opportunity to rely upon the
`
`evidence during appeal, and (2) Almirall would have vastly overshot the word
`
`limits if the evidence was cited and meaningfully discussed. Paper 34, 2, 4-5; see
`
`Cisco Sys., Inc. v. C-Cation Techs., LLC, IPR2014-00454, Paper 12 (PTAB Aug.
`
`29, 2014) (“Incorporation by reference amounts to a self-help increase in the length
`
`of the brief.”) (quotations and citations omitted). Almirall’s sole response was to
`
`repeat that Amneal “fail[ed] to explain how these paragraphs are unfairly
`
`prejudicial.” Paper 39, 3, 5. That is false, so Amneal’s prejudice is unrebutted.
`
`Almirall next, to divert attention away from its own failings, argues (for the
`
`first time) that Amneal’s papers contain uncited evidence, which should similarly
`
`be excluded. Paper 39, 7. But Almirall waived any such argument by not moving
`
`on this basis. Moreover, Amneal’s “uncited” exhibits are relevant: it was either
`
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`Case IPR2018-00608
`Patent 9,161,926 B2
`
`cited directly or indirectly in its papers, or, in the case of AMN1006, was a legally
`
`required submission under 37 C.F.R. § 42.63(b). Conversely, Almirall’s uncited
`
`exhibits are often cited only in its uncited expert testimony. Compare Paper 39, 6
`
`(listing paragraphs citing exhibits) with id., 2-5 (uncited paragraphs). This leaves
`
`both Amneal and the Board to work “like pigs, hunting for truffles buried in” the
`
`record. United States v. Dunkel, 927 F.2d 955, 956 (7th Cir. 1991).
`
`Almirall’s uncited evidence should be excluded under FRE 401-403.
`
`II. Exhibits 2043 and 2044 should be excluded.
`Amneal objected to EX2043 and EX2044 on relevance, hearsay, and
`
`authentication grounds. Almirall consents to exclusion of EX2044, but contends
`
`that EX2043 should not be excluded because it is (1) relevant, (2) authentic, and
`
`(3) not hearsay. Almirall is wrong for at least the reasons below.
`
`First, Amneal demonstrated both that (1) the “date of report” on the face of
`
`EX2043 was hearsay and (2) EX2043 was irrelevant if Almirall could not establish
`
`that it had been published before the ’926 patent’s priority date. Paper 39, 5-7.
`
`Unable to rebut this showing, Almirall shifts to now argue that EX2043 is relevant
`
`because it “corroborat[es]” other unchallenged exhibits, and that “the date is not
`
`being presented for the truth of the matter asserted.” Paper 39, 7. Both assertions
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`are wrong. Dr. Harper expressly relied on the “publication date.” EX2022, ¶144,
`
`n.6. And in order to “corroborate” Almirall’s other exhibits, EX2043 must
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`Case IPR2018-00608
`Patent 9,161,926 B2
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`necessarily be offered for its truth. If, on the other hand, EX2043 is actually not
`
`being offered for its truth, as Almirall newly contends, then EX2043 has no
`
`purpose and its disclosures are irrelevant. That is, either EX2043 is hearsay, or it is
`
`irrelevant. Either way, it should be excluded.
`
`Second, Almirall’s reliance on FRE 901(b)(4) to argue that EX2043 is “self-
`
`authenticating” is misplaced. FRE 901(b)(4) simply identifies “exampl[ary]”
`
`manners of authenticating a document. See FRE 901(b). But Almirall failed to
`
`“produce [any] evidence” to support a finding that EX2043 is what Almirall claims
`
`it is because Almirall did not present any evidence that there are any “distinctive
`
`characteristics” of EX2043 that support its authenticity. See FRE 901(b)(4).
`
`Instead, Almirall offers untimely attorney argument; but none of the signatories on
`
`EX2043 testified in this case, and none of Almirall’s experts testified to having any
`
`first-hand knowledge of EX2043.
`
`Next, Almirall is wrong that simply showing “distinctive characteristics”
`
`means EX2043 is “self-authenticating.” Self-authentication is governed by FRE
`
`902 and Almirall does not apply this Rule. See Paper 39, 8.What is more, accepting
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`Almirall’s position—that a document is self-authenticating if containing
`
`signatures—would mean that nearly every document is self-authenticating. Such a
`
`reading of FRE 901 threatens to swallow FRE 902, and cannot be correct.
`
`EX2043 should be excluded as irrelevant, unauthentic hearsay.
`
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`Case IPR2018-00608
`Patent 9,161,926 B2
`
`
`Respectfully submitted,
`
`
`
`
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`
`
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`
`Dennies Varughese (Reg. No. 61,868)
`Lead Attorney for Petitioners
`
`
`Date: May 15, 2019
`1100 New York Avenue, N.W.
`Washington, D.C. 20005-3934
`(202) 371-2600
`
`10363877_1.docx
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`- 6 -
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`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
`
`The undersigned hereby certifies that the above-captioned “Petitioners’
`
`Reply in Support of Their Motion To Exclude Evidence” was served in its entirety
`
`on May 15, 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 15, 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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