UNITED STATES PATENT AND TRADEMARK OFFICE
`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`
`TEVA PHARMACEUTICALS USA, INC.
`Petitioner,
`v.
`CORCEPT THERAPEUTICS, INC.
`Patent Owner.
`
`___________________
`
`PGR2019-00048
`Patent 10,195,214 B2
`___________________
`
`PETITIONER’S OPPOSITION TO PATENT OWNER’S
`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
`
`
`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`
`TEVA PHARMACEUTICALS USA, INC.
`Petitioner,
`v.
`CORCEPT THERAPEUTICS, INC.
`Patent Owner.
`
`___________________
`
`PGR2019-00048
`Patent 10,195,214 B2
`___________________
`
`PETITIONER’S OPPOSITION TO PATENT OWNER’S
`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
`
`
`
`PGR2019-00048
`Petitioner’s Opposition to Patent Owner’s Motion to Exclude
`
`
`TABLE OF CONTENTS
`
`I.
`II.
`
`B.
`
`INTRODUCTION .......................................................................................... 1
`ARGUMENT .................................................................................................. 1
`A.
`Corcept’s motion
`improperly challenges
`the public
`accessibility—not the evidentiary admissibility—of the 1992
`Van der Lelij Thesis and should be denied for that reason
`alone. ..................................................................................................... 1
`The 1992 Van der Lelij Thesis was publicly accessible
`before the March 2017 priority date. ..................................................... 3
`III. CONCLUSION ............................................................................................... 7
`
`
`
`
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`- i -
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`
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`I.
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`PGR2019-00048
`Petitioner’s Opposition to Patent Owner’s Motion to Exclude
`INTRODUCTION
`Corcept’s motion to exclude Teva’s Exhibit 1075 (“the 1992 Van der Lelij
`
`Thesis”) should be denied for two independent reasons.
`
`First, Corcept’s motion does not contest the admissibility of the thesis at all;
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`instead, Corcept argues that the thesis is not a prior-art printed publication because
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`it was not publicly available before the priority date. This is a sufficiency-of-the-
`
`evidence argument, not an evidentiary one. It is therefore plainly improper under
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`the Board’s rules. See Trial Practice Guide, 79 (Nov. 2019) (“A motion to exclude
`
`. . . may not be used to challenge the sufficiency of the evidence to prove a
`
`particular fact.”). Corcept’s motion is a transparent attempt to belatedly bolster a
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`deficient merits argument (and to flout the sur-reply page limit in the process).
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`Second, Corcept’s public-accessibility argument fails on its own terms. The
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`evidence shows that the 1992 Van der Lelij Thesis has been publicly available and
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`indexed in the Central Catalogue of Dutch Libraries for nearly 30 years and
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`available online since 2013. The reference thus qualifies as a prior-art printed
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`publication under well-established Federal Circuit precedent.
`
`II. ARGUMENT
`A. Corcept’s motion improperly challenges the public accessibility—
`not the evidentiary admissibility—of the 1992 Van der Lelij
`Thesis and should be denied for that reason alone.
`Corcept’s motion to exclude purports to request exclusion of the 1992 Van
`
`der Lelij Thesis for lack of authentication under Rule 901. See MTE, 1. But the
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`- 1 -
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`
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`PGR2019-00048
`Petitioner’s Opposition to Patent Owner’s Motion to Exclude
`issue of authentication goes to whether the proponent has “produce[d] evidence
`
`sufficient to support a finding that the item is what the proponent claims it is.” Fed.
`
`R. Evid. 901(a). Corcept does not actually dispute that the thesis is what Teva
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`claims it is: namely, a 1992 thesis by Aart Johannes van der Lelij entitled “Aspects
`
`of Medical Therapy of Neuroendocrine Disorders.” This, standing alone, is fatal to
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`Corcept’s motion: Teva has presented evidence that Exhibit 1075 is a copy of the
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`thesis in question, which Teva’s counsel obtained from the online Erasmus
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`University Repository, see TEVA1077; TEVA1081, ¶4, and Corcept does not even
`
`try to show otherwise.1
`
`Corcept’s actual argument has nothing to do with authentication. Instead,
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`Corcept contends that Teva has not “establish[ed] that this thesis was publicly
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`available before the March 2017 priority date.” MTE, 2 (emphasis added). But “a
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`motion to exclude is not the proper vehicle to challenge the sufficiency of the
`
`evidence used to demonstrate that [a reference] qualifies as a prior art printed
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`publication within the meaning of § 102(b).” Chicago Mercantile Exch., Inc. v. 5th
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`Mkt., Inc., CBM2014-00114, Paper 35, 52 (P.T.A.B. Aug. 18, 2015); see Trial
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`Practice Guide, 79 (Nov. 2019) (“A motion to exclude . . . may not be used to
`
`
`1 In any event, since the thesis is more than 20 years old, it would qualify as
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`a self-authenticating ancient document under Rule 901(8).
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`- 2 -
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`
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`PGR2019-00048
`Petitioner’s Opposition to Patent Owner’s Motion to Exclude
`challenge the sufficiency of the evidence to prove a particular fact.”).2 Corcept’s
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`arguments as to the public accessibility of the 1992 Van der Lelij Thesis should
`
`have been presented in its Patent Owner Sur-Reply—“not a motion to exclude.”
`
`Chicago Mercantile Exch., CBM2014-00114, Paper 35, 52. Corcept’s sur-reply
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`limited its argument on this issue to a single conclusory assertion, devoid of any
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`supporting analysis. See POSR, 20. The present motion thus represents a
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`transparent attempt by Corcept to supplement its deficient argument on public
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`accessibility through an improper vehicle, in violation of the Board’s rules. The
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`Board should deny the motion for that reason alone.
`
`B.
`
`The 1992 Van der Lelij Thesis was publicly accessible before the
`March 2017 priority date.
`In any event, Corcept’s public-accessibility argument lacks merit. The
`
`Federal Circuit squarely held in In re Hall, 781 F.2d 897 (Fed. Cir. 1986)—and has
`
`reaffirmed in many cases since—that a thesis that is indexed and catalogued in a
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`university library and “available for general use” qualifies as a prior-art printed
`
`
`2 To be sure, a motion to exclude may properly be used to address the
`
`admissibility of evidence that underlies a factual determination about public
`
`accessibility. See Chicago Mercantile Exch., CBM2014-00114, Paper 35, 52. But
`
`that is not what Corcept’s motion does: Corcept simply argues that the thesis was
`
`not available to the public before the priority date.
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`- 3 -
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`
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`PGR2019-00048
`Petitioner’s Opposition to Patent Owner’s Motion to Exclude
`publication. See id. at 898–900; accord, e.g., In re Enhanced Sec. Research, LLC,
`
`739 F.3d 1347, 1354 (Fed. Cir. 2014) (noting that Hall is the “leading case on
`
`public accessibility” and that the Hall court “concluded that a single cataloged
`
`thesis in one university library constitutes sufficient accessibility to those
`
`interested in the art exercising reasonable diligence”) (quotation marks omitted);
`
`Seaberry N. Am. Inc. v. Lincoln Global, Inc., IPR2016-00840, Paper No. 11, 7–8
`
`(P.T.A.B. Oct. 6, 2016) (informative) (concluding for purposes of institution that
`
`thesis “indexed in the national library system” qualified as a prior-art printed
`
`publication). The 1992 Van der Lelij Thesis meets this standard, and then some.
`
`The National Library of the Netherlands has confirmed that the thesis has been
`
`indexed in the Central Catalogue of Dutch libraries for the past 28 years and has
`
`been available online since 2013. TEVA1076 (May 7, 2020 e-mail from National
`
`Library); see also TEVA1077 (Erasmus University Repository listing); Jazz
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`Pharm., Inc. v. Amneal Pharm., LLC, 895 F.3d 1347, 1358 (Fed. Cir. 2018)
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`(finding public accessibility where materials in question had been available on a
`
`public website for an extended period of time). Corcept does not dispute that the
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`thesis is indexed and catalogued, nor that it is available online through the Erasmus
`
`University Repository. That should be the end of the matter.3
`
`3 Contrary to Corcept’s suggestion, see MTE, 2, “indexing is not ‘a
`
`necessary condition for a reference to be publicly accessible.’” Voter Verified, Inc.
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`- 4 -
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`
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`PGR2019-00048
`Petitioner’s Opposition to Patent Owner’s Motion to Exclude
`Corcept instead criticizes Teva’s reliance on the National Library’s e-mail,
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`contending that it is inadmissible hearsay. See MTE, 3–4. Corcept is wrong. As
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`numerous courts have held, e-mails from public entities concerning the activities
`
`carried on by the entity (here, the National Library’s cataloguing and indexing of
`
`the 1992 Van der Lelij Thesis) are subject to the public-records exception to the
`
`rule against hearsay. See Fed R. Evid. 803(8) (“record or statement of a public
`
`office” is not subject to rule against hearsay if “it sets out[ ] the office’s
`
`activities”); Lester v. Natsios, 290 F. Supp. 2d 11, 26 (D.D.C. 2003) (admitting e-
`
`mails of public agency over party’s objection because they were public records
`
`admissible under Rule 803(8)); Portus Singapore PTE LTD v. Kenyon & Kenyon
`
`LLP, 2020 WL 1501886, at *8 n.9 (S.D.N.Y. Mar. 30, 2020) (similar); Neelon v.
`
`Krueger, 2015 WL 13677813, at *5 (D. Mass. Sept. 8, 2015) (similar); Winslow v.
`
`Cty. of Aroostook, 2013 WL 594760, at *7 n.3 (D. Me. Feb. 15, 2013) (similar);
`
`Paeste v. Gov’t of Guam, 2013 WL 11241271, at *2 n.1 (D. Guam Jan. 30, 2013)
`
`(similar), aff’d, 798 F.3d 1228 (9th Cir. 2015). Exhibit 1076 is an admissible
`
`public record, and it conclusively demonstrates that the 1992 Van der Lelij Thesis
`
`v. Premier Election Sols., Inc., 698 F.3d 1374, 1380 (Fed. Cir. 2012) (emphasis
`
`added); accord In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). But,
`
`under Hall, indexing is sufficient to show public accessibility where a thesis
`
`available in a public library is concerned.
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`- 5 -
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`
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`PGR2019-00048
`Petitioner’s Opposition to Patent Owner’s Motion to Exclude
`was publicly accessible years before the priority date.
`
`Corcept cites Eli Lilly & Co. v. Teva Pharmaceuticals International,
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`IPR2018-01710, Paper 69, 157 (P.T.A.B. Mar. 31, 2020), in support of its
`
`contention that the National Library e-mail is inadmissible. But the Board excluded
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`the e-mail in question as inadmissible only because the petitioner “d[id] not
`
`provide any arguments for its admissibility.” Id. Notably, Corcept has not even
`
`moved to exclude the National Library e-mail here, making its reliance on Eli Lilly
`
`moot on this point. Regardless, Teva has shown that the National Library e-mail is
`
`admissible under the public-records exception to the hearsay rule, in contrast to the
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`lack of any showing of admissibility in Eli Lilly.
`
`Moreover, in Eli Lilly, the public-records exception would not have been
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`available to the petitioner in any event because the e-mail itself indicated a lack of
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`reliability. See Fed. R. Evid. 803(8)(b) (public-records exception is unavailable if
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`the opponent of the evidence shows that the “circumstances indicate a lack of
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`trustworthiness”). There, the library employee stated that she did not have
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`paperwork indicating when the thesis was deposited with the library and instead
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`hazarded guesses about what would have been “most likely” done when the thesis
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`was allegedly submitted to the library. Eli Lilly, IPR2018-01710, Paper 51, 7.
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`Here, in contrast, the National Library unambiguously confirmed that the 1992
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`Van der Lelij Thesis has been available in the library and catalogued since 1992.
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`- 6 -
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`
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`PGR2019-00048
`Petitioner’s Opposition to Patent Owner’s Motion to Exclude
`Corcept’s only substantive response to the National Library’s e-mail is to
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`assert that Teva has not shown “what it means to be ‘included’ in the ‘Central
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`Catalog of Dutch libraries.’” MTE, 5. Corcept’s feigned inability to understand the
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`meaning of the word “included” is not credible. And Corcept’s speculation that a
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`document included in the national library catalogue of the Netherlands might
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`somehow not be “meaningfully catalogued (so that persons of ordinary skill in the
`
`art could find it),” id., is baseless. Library catalogues exist so that interested
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`persons can find books. Corcept’s suggestion that the national library catalogue of
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`a major European country somehow failed to fulfill its most basic purpose should
`
`be rejected out of hand.
`
`III. CONCLUSION
`The Board should deny Corcept’s motion to exclude.
`
`
`
`
`
`Respectfully submitted,
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C
`
`
`
`Date: August 6, 2020
`1100 New York Avenue, N.W.
`Washington, D.C. 20005-3934
`(202) 371-2600
`
`Deborah A. Sterling, Ph.D.
`Registration No. 62,732
`Lead Attorney for Petitioner
`
`- 7 -
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`
`
`
`
`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
`I certify that the above-captioned PETITIONER’S OPPOSITION TO
`
`PATENT OWNER’S MOTION TO EXCLUDE was served in its entirety upon
`
`the Patent Owner on August 6, 2020, upon the following parties via email:
`
`F. Dominic Cerrito
`Eric C. Stops
`John P. Galanek
`Frank C. Calvosa
`Daniel C. Wiesner
`Quinn Emanuel Urquhart & Sullivan, LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`nickcerrito@quinnemanuel.com
`ericstops@quinnemanuel.com
`johngalanek@quinnemanuel.com
`frankcalvosa@quinnemanuel.com
`danielwiesner@quinnemanuel.com
`
`
`Respectfully submitted,
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C
`
`
`
`Deborah A. Sterling, Ph.D.
`Registration No. 62,732
`Lead Attorney for Petitioner
`
`
`
`
`
`Date: August 6, 2020
`1100 New York Avenue, N.W.
`Washington, D.C. 20005-3934
`(202) 371-2600
`
`
`15364400.4
`
`
`
`
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