`
`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`AMNEAL PHARMACEUTICALS LLC, AMNEAL
`PHARMACEUTICALS OF NEW YORK, LLC, and MYLAN
`PHARMACEUTICALS INC.,
` Petitioners
`
`v.
`
`ALMIRALL, LLC,
`Patent Owner
`
`_____________________
`
`Case IPR2019-002071
`Patent 9,517,219
`_____________________
`
`PETITIONERS’ REPLY IN SUPPORT OF THEIR
`MOTION TO EXCLUDE
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`1 Cases IPR2019-00207 and IPR2019-01095 have been joined in this proceeding.
`
`
`
`Case IPR2019-00207
`Patent No. 9,517,219
`
`TABLE OF CONTENTS
`
`
`
`I.
`
`II.
`
`The Warner Declaration is hearsay and should be excluded. ......................... 1
`
`No hearsay exception applies to the Warner Declaration. ............................. 2
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`III. Dr. Osborne’s reliance on the Warner Declaration should be excluded. ....... 5
`
`IV. The uncited exhibits and paragraphs should be excluded. ............................. 5
`
`V.
`
`
`Conclusion ...................................................................................................... 5
`
`
`- i -
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`
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`Case IPR2019-00207
`Patent No. 9,517,219
`The Board should grant Petitioners’ Motion to Exclude Evidence.
`
`I.
`
`The Warner Declaration is hearsay and should be excluded.
`
`Almirall first argues that the Warner Declaration is an “opposing party’s
`
`statement” under Federal Rules of Evidence 801(d)(2)(A), (C), and (D). This is
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`illogical. The Warner Declaration is not a statement offered against Almirall or Dr.
`
`Warner. Rather, the Warner Declaration was offered by Almirall against the patent
`
`examiner during prosecution and again by Almirall against Amneal here. POR, 60-
`
`62; AMN1017, 282-285, 289-293. Therefore, FRE 801(d)(2) is inapplicable.
`
`Second, Almirall argues that they and their expert declarant Dr. Osborne
`
`take the Warner Declaration at face value, rather than rely on it for its truth. This
`
`makes no sense. As Patent Owner, Almirall and Dr. Osborne need to meet their
`
`burden of production of secondary considerations by relying on Dr. Warner’s
`
`Declaration for its truth. They both do exactly that. EX2057, ¶¶173-181 (“the
`
`statements and evidence in Dr. Kevin Warner’s Declaration show unexpected
`
`results of the claimed formulation.”) (emphasis added); POR, 60 (“the Warner
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`Declaration showed that the topical pharmaceutical compositions as claimed had
`
`improved properties ….”) (emphasis added). Almirall cannot have it both ways—
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`either the Warner Declaration is used for its truth, in which case it is hearsay, or it
`
`is not used for its truth, in which case there is no actual evidence of unexpected
`
`results.
`
`- 1 -
`
`
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`Case IPR2019-00207
`Patent No. 9,517,219
`Almirall’s last argument is that Petitioners’ objection was untimely because
`
`the declaration was filed as part of the prosecution history of the ’219 patent with
`
`the Petition. Petitioners submitted the declaration “solely for rebuttal purpose”
`
`only, as they are required to do. Actelion Pharms Ltd. v. Icos Corp., IPR2015-
`
`00561, Paper 50 at 40 (PTAB Aug. 3, 2016). Petitioners timely objected to the
`
`Warner Declaration once Almirall used its contents for their truth. Paper 21, 14-16.
`
`II. No hearsay exception applies to the Warner Declaration.
`Almirall first argues that the public records exception applies because the
`
`declaration was part of the prosecution history. Unlike an Office Action or some
`
`other document representing the duties of the Patent Office, the Warner
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`Declaration is not “a record or statement of a public office” and does not “set out
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`the [examiner’s] activities.” See FRE 803(8)(a). The document was created by a
`
`third party, and the Board already agreed that significant questions are unanswered
`
`about its contents, so it also lacks trustworthiness. See FRE 803(8)(b); Paper 39, 5-
`
`6.
`
`Second, the declaration does not qualify as former testimony of an
`
`unavailable witness exception under FRE 804(b)(1). Dr. Warner is not unavailable
`
`under FRE 804(a)(5)(A). As the statement’s proponent, Almirall failed to show
`
`that it was unable to procure Dr. Warner “by process or other reasonable means.”
`
`Rather, Almirall was in contact with the witness but simply failed to comply with
`
`- 2 -
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`
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`Case IPR2019-00207
`Patent No. 9,517,219
`the Board’s order to produce Dr. Warner for deposition. Paper 44, 2-3; EX2070,
`
`8:20-13:8. Next, the declaration is not “former testimony” as it was not given at a
`
`witness at a trial, hearing, or deposition. See FRE 804(b)(1)(A). Nor is Amneal a
`
`party who had “an opportunity and similar motive to develop it by direct, cross-, or
`
`redirect examination” (see FRE 804(b)(1)(B)) because Amneal did not have a
`
`meaningful opportunity to develop it. Therefore, this exception does not apply.
`
`Third, the declaration is not a statement offered against a party (i.e.,
`
`Amneal) that wrongfully caused Dr. Warner’s unavailability under FRE 804(b)(6).
`
`Dr. Warner’s unavailability had nothing to do with Amneal and everything to do
`
`with Almirall’s lack of diligence. Almirall knew since September 2019 that a
`
`deposition of Dr. Warner was possible but now faults the Board for failing to issue
`
`an order for “two and a half months.” Paper 50, 8; AMN1036, 4. Almirall had
`
`ample time to secure Dr. Warner’s availability. Nor did Amneal fail to cooperate,
`
`as Almirall suggests. Almirall even admitted that the modified schedule it
`
`proposed to accommodate Dr. Warner’s deposition on Jan. 30 was “suicidal” and
`
`“chaotic.” EX2070, 14:3-12, 26:23-27:6. Therefore, Amneal did not “wrongfully
`
`cause” Dr. Warner’s unavailability.
`
`Last, the residual hearsay exception does not apply. The residual exception
`
`is not “a broad license on trial judges to admit hearsay statements that do not fall
`
`within one of the other exceptions.” Conoco Inc. v. Dep’t of Energy, 99 F.3d 387,
`
`- 3 -
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`
`
`Case IPR2019-00207
`Patent No. 9,517,219
`392 (Fed. Cir. 1996). The Warner Declaration has no guarantee of trustworthiness.
`
`Legitimate questions exist about the contents of the Warner Declaration and even
`
`Almirall’s declarant Dr. Osborne said he would have liked to know more about Dr.
`
`Warner’s experiments. AMN1040, 108:11-15. Almirall cites to Apple v. VirnetX,
`
`but this case is inapposite. The Patent Owner there chose not to seek the
`
`opportunity to cross-examine the declarant, and the Board there found
`
`circumstantial guarantees of trustworthiness because the witness was available for
`
`cross-examination. Paper 29, 80-81. Not so here, as Amneal sought to cross-
`
`examine Dr. Warner, but Almirall repeatedly tried to shield him from scrutiny.
`
`The remaining requirements of the residual exception fare no better.
`
`Almirall failed to give Amneal a meaningful opportunity to depose Dr. Warner, so
`
`the Warner Declaration is not more probative than what Almirall could have
`
`obtained through reasonable efforts—i.e., diligently providing Dr. Warner for
`
`deposition in compliance with the Board’s Dec. 31, 2019 order. And, admitting Dr.
`
`Warner’s declaration is not “in the interests of justice” because Almirall does not
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`come with clean hands having failed to comply with the Board’s Dec. 31 order.
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`If the Board denies Amneal’s motion to exclude, the Board should give the
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`Warner Declaration little to no weight because his out-of-court statements are used
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`for their truth and he was not subject to cross-examination. Mexichem Amanco
`
`Holdings v. Honeywell Int’l, Inc., IPR2013-00576, Paper 36 (Sept. 5, 2014).
`
`- 4 -
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`
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`Case IPR2019-00207
`Patent No. 9,517,219
`III. Dr. Osborne’s reliance on the Warner Declaration should be excluded.
`The Warner Declaration does not disclose any underlying facts or data and
`
`an expert in this field would not reasonably rely on the sparse facts and data in
`
`forming an opinion on unexpected results. Dr. Osborne himself agreed. AMN1040,
`
`108:11-15. Thus, FRE 703 holds that if the facts or data would otherwise be
`
`inadmissible, Almirall may only disclose them if their probative value substantially
`
`outweighs their prejudicial effects. Petitioners argue that this evidence is
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`prejudicial because the findings in the declaration were not subject to cross-
`
`examination in this proceeding.
`
`IV. The uncited exhibits and paragraphs should be excluded.
`For the first time in its opposition, Almirall tries to show why its uncited
`
`evidence may be relevant. Paper 50, 12-15. Not only is it too late for Almirall’s
`
`explanation, but the Board and Amneal should not have to hunt through Almirall’s
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`papers, to its declarations, and to its exhibits, to discern relevance. adidas AG v.
`
`Nike, Inc., IPR2016-00922, Paper 31, 52 (PTAB Feb. 19, 2019).
`
`V. Conclusion
`The challenged evidence should be excluded from the record.
`
`
`
`Date: January 31, 2020
`1100 New York Avenue, N.W.
`Washington, D.C. 20005-3934
`
`Respectfully submitted,
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C
`/Dennies Varughese/
`Dennies Varughese, Pharm.D.
`Registration No. 61,868
` Lead Attorney for Petitioners.
`
`- 5 -
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`
`
`Case IPR2019-00207
`Patent No. 9,517,219
`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
`
`I certify that the above-captioned "Petitioners’ Reply in Support of Their
`
`Motion to Exclude,” upon the following parties via electronic mail:
`
`
`
`James Trainor
`
`
`RJ Shea
`
`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
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`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
`
`
`
`
` STERNE, KESSLER, GOLDSTEIN & FOX L.L.C.
`
`
`
`
`Dennies Varughese, Pharm.D.
`Date: January 31, 2020
`1100 New York Avenue, N.W. Registration No. 61,868
`Washington, D.C. 20005-3934
`Lead Attorney for Petitioners
`(202) 371-2600
`
`
`
`14484326.2
`
`
`
`
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