Filed on behalf of: Corcept Therapeutics, Inc.
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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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`TEVA PHARMACEUTICALS USA, INC.,
`Petitioner
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`v.
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`CORCEPT THERAPEUTICS, INC.,
`Patent Owner
`_______________________
`
`Case PGR2019-00048
`U.S. Patent No. 10,195,214
`_______________________
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`REPLY IN FURTHER SUPPORT OF PATENT OWNER’S MOTION TO
`EXCLUDE
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
`
`TEVA PHARMACEUTICALS USA, INC.,
`Petitioner
`
`v.
`
`CORCEPT THERAPEUTICS, INC.,
`Patent Owner
`_______________________
`
`Case PGR2019-00048
`U.S. Patent No. 10,195,214
`_______________________
`
`
`REPLY IN FURTHER SUPPORT OF PATENT OWNER’S MOTION TO
`EXCLUDE
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`TABLE OF CONTENTS
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`PGR2019-00048
`U.S. Patent No. 10,195,214
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`Page
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`I.
`II.
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`Teva’s Procedural Arguments Lack Merit ...................................................... 1
`Teva’s Arguments on the Merits Are Baseless ............................................... 2
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`i
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`PGR2019-00048
`U.S. Patent No. 10,195,214
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`TABLE OF AUTHORITIES
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`Cases
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`Page
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`Alexander v. Estepp,
`95 F.3d 312 (4th Cir. 1996) ................................................................................... 3
`Chicago Mercantile Exchange, Inc. v. 5th Market, Inc.,
`CBM2014-00114, Paper 35 (P.T.A.B. Aug. 18, 2015) ..................................... 1-2
`Dalgic v. Misericordia Univ.,
`No. 3:16-cv-0443, 2019 WL 2867236 (M.D. Pa. July 3, 2019) ............................ 4
`Johns Manville Corp. v. Knauf Insulation, Inc.,
`IPR2016-00130, Paper 35 (P.T.A.B. May 8, 2017) ............................................. 1
`Seaberry N. Am. Inc. v. Lincoln Global, Inc.,
`IPR2016-00840, Paper 60 (P.T.A.B. Oct. 2, 2017) ............................................... 5
`Smith v. Isuzu Motors Ltd.,
`137 F.3d 859 (5th Cir. 1998) ............................................................................. 3-4
`
`
`Rules and Regulations
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`Fed. R. Evid. 803(8) ............................................................................................... 3-5
`Fed. R. Evid. 901 ...................................................................................................1, 5
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`Other
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`Fed. R. Evid. 803 Advisory Committee’s Notes .......................................................4
`Motion to Exclude, Eli Lilly & Co. v. Teva Pharm. Int’l,
`IPR2018-01710, Paper 51 (P.T.A.B. Dec. 11, 2019) .......................................2, 4
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`ii
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`PGR2019-00048
`U.S. Patent No. 10,195,214
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`I.
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`Teva’s Procedural Arguments Lack Merit
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`Teva preliminarily asserts that Corcept’s motion should be denied on two
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`procedural grounds. First, Teva contends that “Corcept’s motion does not contest
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`the admissibility of the thesis … and should be denied for that reason alone.”
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`Paper 45 at 1. This is demonstrably false. The Motion to Exclude contests the
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`admissibility of the thesis in no uncertain terms. See Paper 44 at 1 (“Exhibit 1075
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`should be excluded pursuant to FRE 901”); see also id. at 5.
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`Second, Teva contends that “arguments as to the public accessibility of
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`[Ex. 1075] should have been presented in [the] Patent Owner Sur-Reply.” Paper
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`45 at 3. Not so. The Board has considered public accessibility under FRE 901
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`where, as here, “authentication and hearsay issues as they relate to the printed date
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`information on [the alleged prior art] are … intertwined with admissibility.” Johns
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`Manville Corp. v. Knauf Insulation, Inc., IPR2016-00130, Paper 35 at 17
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`(P.T.A.B. May 8, 2017). The Chicago Mercantile case that Teva cites stands for
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`the same proposition—there, the Board explained that “addressing the
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`admissibility of evidence, e.g., authenticity or hearsay, underlying the factual
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`determinations of whether [the reference] is a prior art printed publication may be
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`the subject of a motion to exclude.” CBM2014-00114, Paper 35 at 52.
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`These are the same grounds on which Corcept moved to exclude Ex. 1075.
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`Corcept expressly argued that Teva “put forth insufficient evidence indicating that
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`1
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`PGR2019-00048
`U.S. Patent No. 10,195,214
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`Exhibit 1075 was cataloged in any library,” because the only “evidence” Teva
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`offered in support of its alleged availability is an email chain that the Board should
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`refuse to consider on hearsay grounds. Paper 44 at 3-4. In other words, Corcept’s
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`motion properly addresses the admissibility of the evidence “underlying the factual
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`determinations of whether [Ex. 1075] is a prior art printed publication.” Chicago
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`Mercantile, CBM2014-00114, Paper 35 at 52. Accordingly, Corcept’s motion is
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`procedurally proper under the Board’s precedent.
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`Moreover, Teva and its lead counsel agreed with and embraced this
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`approach less than one year ago in moving to exclude a thesis “under FRE 901
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`because [its proponent] … ha[d] not provided sufficient information regarding its
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`authenticity as a publicly accessible document.” Motion to Exclude, Eli Lilly &
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`Co. v. Teva Pharm. Int’l., IPR2018-01710, Paper 51 at 2 (P.T.A.B. Dec. 11, 2019).
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`Teva and its counsel advocated to the Board that “[t]he public accessibility of
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`[a thesis] is an essential part of the foundation analysis.” Id. (emphasis added).
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`Thus, Teva’s opposition on procedural grounds should be rejected.
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`II. Teva’s Arguments on the Merits Are Baseless
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`Teva’s response on the merits fares no better. Teva argues that Ex. 1075
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`was publicly available because “the thesis has been indexed in the Central
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`Catalogue of Dutch libraries for the past 28 years and has been available online
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`since 2013.” Paper 45 at 4. The only “evidence” that Teva cites in support of its
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`2
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`PGR2019-00048
`U.S. Patent No. 10,195,214
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`argument—Ex. 1076—is inadmissible hearsay that the Board cannot rely on.
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`Teva contends that Ex. 1076 is not hearsay because “e-mails from public
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`entities concerning the activities carried on by the entity… are subject to the
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`public-records exception.” Paper 45 at 5. Teva is incorrect and sees a hearsay
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`exception in FRE 803(8) that would swallow the rule. FRE 803(8)(A)(i) provides
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`that a public record is admissible if it sets out “the [public] office’s activities.” But
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`Ex. 1076 does not set forth the activities of the National Library of the Netherlands
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`in a manner contemplated by the Rule. The sort of records that traditionally have
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`been held to fall within the exception set forth in FRE 803(8)(A)(i) are not emails
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`between government employees and members of the public, but rather, records
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`that are maintained by a public agency. See, e.g., Alexander v. Estepp, 95 F.3d
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`312, 314 n.2 (4th Cir. 1996) (holding that a county registry of applicants for
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`firefighter positions was a public record under Rule 803(8)(A)).
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`In contrast, emails such as Ex. 1076 that reflect the opinion of a government
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`agent in response to a public inquiry, are typically not admitted under FRE
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`803(8)(A)(i). This is because FRE 803(8)(A)(ii)-(iii) allow for the admissibility of
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`records that set forth “a matter observed while under a legal duty to report” or
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`“factual findings from a legally authorized investigation.” Courts have recognized
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`that if informal communications that set forth “opinions of agency staff members”
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`were deemed admissible under subsection (i), it would “swallow whole” FRE
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`3
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`PGR2019-00048
`U.S. Patent No. 10,195,214
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`803(8)(ii)-(iii) and their “limitations would be meaningless.” Smith v. Isuzu
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`Motors Ltd., 137 F.3d 859, 862 (5th Cir. 1998).1 Therefore, while courts will
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`admit government reports under FRE 803(8), informal emails reflecting opinions
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`“based only on [a] review of [the] file” are not admissible. Dalgic v. Misericordia
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`Univ., No. 3:16-cv-0443, 2019 WL 2867236, at *17 (M.D. Pa. July 3, 2019).2
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`Indeed, Teva recently argued before this Board that an email from a library
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`employee to establish public availability of a thesis is “the epitome of hearsay.”
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`See IPR2018-01710, Paper 51 at 6. Teva now takes the position that its prior
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`conduct is “moot,” because “Corcept has not even moved to exclude [Ex. 1076].”
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`Paper 45 at 6. This is a red-herring. Corcept’s motion challenges the sufficiency
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`and admissibility of the evidence offered to establish foundation for Ex. 1075, i.e.
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`Ex. 1076. Teva’s previous arguments that an email from a library employee is “the
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`epitome of hearsay” and cannot be relied upon to establish public availability is not
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`1 Fed. R. Evid. 803(8) was amended in 2011, and subsections (A) through
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`(C) were renumbered as subsections (A)(i) through (iii). These amendments were
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`“stylistic only.” See Fed. R. Evid. 803 Advisory Committee’s Notes.
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`2 None of the cases cited by Teva compels a different outcome, because
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`they uniformly do not concern the interplay between FRE 803(8)(A)(i) and
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`803(8)(A)(ii)-(iii).
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`4
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`PGR2019-00048
`U.S. Patent No. 10,195,214
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`only relevant to—but dispositive of—the instant dispute.
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`Teva tries to distinguish its prior case, stating that “the public-records
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`exception would not have been available … because the e-mail itself indicated a
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`lack of reliability,” since the librarian had “hazarded guesses” about the
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`information provided. Paper 45 at 6 (citing FRE 803(8)(b)). But here, Teva has
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`also failed to provide any indicia of reliability in support of the information
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`contained within Ex. 1076. No background information is provided on the
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`declarant, nor is it clear how she allegedly knows any of the information she
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`provides. This is why, when the Board has allowed into evidence the statements of
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`third parties to support the public availability of a thesis, those statements have
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`been in the form of sworn declarations and the declarants are subject to cross
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`examination. See, e.g., Seaberry N. Am. Inc. v. Lincoln Global, Inc., IPR2016-
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`00840, Paper 60 at 15 (P.T.A.B. Oct. 2, 2017). Exhibit 1076 is neither a sworn
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`statement, nor has the declarant been made available for cross examination. The
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`unsworn statements in Ex. 1076 thus fail to rise to the requisite level of reliability
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`to fall within hearsay exception contained within FRE 803(8), and they cannot be
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`used to support the admissibility of Ex. 1075.
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`Accordingly, because Teva has put forth insufficient and inadmissible
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`“evidence” indicating that Ex. 1075 was publicly available, it should be excluded
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`for lacking foundation under FRE 901.
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`5
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`Date: August 13, 2020
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`Respectfully Submitted,
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`PGR2019-00048
`U.S. Patent No. 10,195,214
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`
`
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`F. Dominic Cerrito (Reg. No. 38,100)
`Eric C. Stops (Reg. No. 51,163
`Daniel C. Wiesner (pro hac vice)
`Frank C. Calvosa (Reg. No. 69,064)
`John Galanek (Reg. No. 74,512)
`QUINN EMANUEL URQUHART &
`SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`Tel: (212) 849-7000
`Fax: (212) 849-7100
`nickcerrito@quinnemanuel.com
`ericstops@quinnemanuel.com
`danielwiesner@quinnemanuel.com
`frankcalvosa@quinnemanuel.com
`johngalanek@quinnemanuel.com
`
`Counsel for Patent Owner
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`6
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`PGR2019-00048
`U.S. Patent No. 10,195,214
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`CERTIFICATE OF SERVICE
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`The undersigned certifies that on the date indicated below a copy of the
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`foregoing Reply in Further Support of Patent Owner’s Motion to Exclude was
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`served electronically by filing these documents through the PTAB E2E System, as
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`well as by e-mailing copies to counsel of record for Petitioners at dsterling-
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`PTAB@sternekessler.com, opartington-PTAB@sternekessler.com, jcrozendaal-
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`PTAB@sternekessler.com, ueverett-PTAB@sternekessler.com, wmilliken-
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`PTAB@sternekessler.com.
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`Date: August 13, 2020
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`Respectfully Submitted,
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`
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`F. Dominic Cerrito (Reg. No. 38,100)
`Eric C. Stops (Reg. No. 51,163
`Daniel C. Wiesner (pro hac vice)
`Frank C. Calvosa (Reg. No. 69,064)
`John Galanek (Reg. No. 74,512)
`QUINN EMANUEL URQUHART &
`SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`Tel: (212) 849-7000
`Fax: (212) 849-7100
`nickcerrito@quinnemanuel.com
`ericstops@quinnemanuel.com
`danielwiesner@quinnemanuel.com
`frankcalvosa@quinnemanuel.com
`johngalanek@quinnemanuel.com
`Counsel for Patent Owner
`
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