`
`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`ELI LILLY AND COMPANY,
` Petitioner
`
`v.
`
`TEVA PHARMACEUTICALS INTERNATIONAL GMBH,
`Patent Owner
`
`_____________________
`
`Case IPR2018-01423
`Patent 9,266,951 B2
`_____________________
`
`TEVA PHARMACEUTICALS INTERNATIONAL
`GMBH’S REPLY IN SUPPORT OF THE 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
`
`
`
`Case IPR2018-01423
`Patent No. 9,266,951
`
`TABLE OF CONTENTS
`
`
`
`I.
`
`II.
`
`Exhibit 1287 lacks foundation and should be excluded. ................................ 1
`
`Lilly relies upon inadmissible deposition testimony. ......................... 4
`
`III. Multiple exhibits are irrelevant, prejudicial, and lack probative
`value. ............................................................................................................... 4
`
`IV. Conclusion ...................................................................................................... 5
`
`
`
`- i -
`
`
`
`Case IPR2018-01423
`Patent No. 9,266,951
`The Board should grant Teva’s Motion to Exclude Evidence (“Motion”)
`
`because Lilly’s Opposition to the Motion (“Opposition”) misrepresents the law and
`
`offers irrelevant arguments that fail to rebut Teva’s showing that the challenged
`
`evidence is inadmissible, as explained below.
`
`I.
`
`Exhibit 1287 lacks foundation and should be excluded.
`
`Teva’s Motion addresses and identifies several reasons why Exhibit 1287 is
`
`inadmissible in these proceedings and should be excluded under FRE 901. Motion,
`
`2-7. Significantly, the evidentiary flaws associated with authentication of EX1287
`
`remain unrebutted. Id. Lilly’s Opposition does not address the lack of evidence
`
`regarding the cataloguing and shelving practices of the Cambridge University
`
`Library (“CUL”), the confusion and inconsistency regarding EX1287’s purported
`
`dates of availability and cataloguing, Lilly’s provision of inadmissible hearsay
`
`evidence as supplemental evidence (Ms. Clarke’s email), or the fact that even her
`
`hearsay statement casts doubt on the authenticity of EX1287. None of Lilly’s
`
`arguments in reply remedy the foundational defects for EX1287.
`
`First, Lilly argues that because Teva refers to EX1287 as a “dissertation by
`
`Dr. Tan,” “Teva does not dispute that Exhibit 1287 is Dr. Tan’s doctoral thesis.”
`
`Opposition, 1 (citing Teva’s Motion to Strike, Paper 43, 2). Reference to the
`
`purported identity of an exhibit, however, does not indicate acceptance of that
`
`identity. Id. As is apparent from Teva’s Motion, Teva has consistently objected to
`
`- 1 -
`
`
`
`Case IPR2018-01423
`Patent No. 9,266,951
`and maintained that Lilly has not authenticated EX1287 as Dr. Tan’s thesis.
`
`Motion, 3; EX1303, 176:2-18; Paper 39, 2.
`
`Next, Lilly casts Teva’s arguments regarding EX1287 as one of public
`
`accessibility, “not properly raised in a motion to exclude.” Opposition, 2. But Lilly
`
`itself linked EX1287’s foundation to “public availability” after Teva objected.
`
`EX1307, ¶19. Authentication necessarily requires producing evidence sufficient to
`
`support a finding that the item (a thesis) is what the proponent claims it is—a
`
`document, which in Lilly’s words, purports to be evidence from “actual researchers
`
`in the field before November 2005.” FRE 901(a); Opposition, 2-3. Teva cited to
`
`cases relating to public availability because those cases identify the evidence that is
`
`necessary to establish the origin and public availability of EX1287 before 2005.
`
`Opposition, 2. And as explained in Teva’s Motion, the absence of such evidence
`
`undermines Lilly’s efforts to authenticate EX1287 under FRE 901—Lilly’s Reply
`
`provides nothing to supplement that lack of evidence.
`
`Faced with a gap in its authentication evidence, Lilly argues that it used
`
`EX1287 for purposes that don’t require prior art status. Id., 2-3. Lilly’s assertion is
`
`irrelevant—a document must be authenticated regardless of Lilly’s intended use.
`
`Further, Lilly supports its flawed assertion by a selective and misleading quotation
`
`from a single non-precedential decision. Id., 2 (citing Chi. Mercantile Exch., Inc. v.
`
`5th Mkt., Inc., CBM2014-00114, Paper 35 (PTAB Aug. 18, 2015) (“CME”)). The
`
`- 2 -
`
`
`
`Case IPR2018-01423
`Patent No. 9,266,951
`CME panel acknowledged that “a motion to exclude is not the proper vehicle to
`
`challenge the sufficiency of the evidence used to demonstrate that [an exhibit]
`
`qualifies as a prior art printed publication within the meaning of § 102(b).” Chi.
`
`Mercantile Exch., CBM2014-00114, Paper 35 at 52. However, Lilly neglected to
`
`disclose that the panel then held that “addressing the admissibility of evidence,
`
`e.g., authenticity or hearsay, underlying the factual determinations of whether [the
`
`exhibit] is a prior art printed publication may be the subject of a motion to
`
`exclude.” Id. The CME panel properly analyzed whether there was “credible or
`
`sufficient evidence as to where [the exhibit in question was] obtained” and when it
`
`“was made available publicly.” Id., 53. Applying just such an analysis—as
`
`performed in Teva’s Motion—shows that EX1287 lacks sufficient foundation.
`
`Finally, Lilly’s argument that EX1287 is a “self-authenticating ancient
`
`document” also lacks merit. Opposition, 1-2. Lilly offers a conclusory assertion
`
`sans support that a Cambridge thesis purportedly from 1994 would qualify as an
`
`ancient document. Id. Lilly’s assertion suffers from a critical flaw: Lilly has not
`
`presented sufficient evidence to establish the baseline facts regarding EX1287’s
`
`identity or date of publication. Nor has Lilly established that such date of
`
`publication would be considered “ancient.” Therefore, Lilly has not adequately
`
`authenticated EX1287 or established it as a self-authenticating document. The
`
`Board should exclude EX1287 from this record.
`
`- 3 -
`
`
`
`Case IPR2018-01423
`Patent No. 9,266,951
`II. Lilly relies upon inadmissible deposition testimony.
`Lilly’s Opposition fails to remedy the evidentiary defects resulting from
`
`Lilly’s improper questioning of Teva’s experts. Instead, Lilly has improperly used
`
`ten pages of its Opposition to offer further argument on why it believes the
`
`evidence to be “highly probative.” Opposition, 3-13.1 But whether the evidence is
`
`probative does not address or cure the flaws in Lilly’s questioning. Teva objected
`
`because the improper form of the questions asked means that the testimony is
`
`meaningless and prone to misunderstanding. Motion, 7-8. These serious flaws
`
`render the testimony highly prejudicial to Teva, regardless of why Lilly views it as
`
`useful. Indeed, Lilly’s reliance on misinterpreted or misrepresented evidence is a
`
`hallmark of its approach in this case. See, e.g., POR, 3-4, 15-19; Surreply, 7-8.
`
`Further, the purported relevance is not pertinent to Teva’s scope objections
`
`because cross-examination may not go beyond the subject matter of the direct
`
`testimony. FRE 611. Thus, the testimony to which Teva offered scope objections
`
`should be excluded regardless of the degree of relevance. FRE 611.
`
`III. Multiple exhibits are irrelevant, prejudicial, and lack probative
`
`1 Lilly’s Opposition arguments regarding the purported relevance of
`
`evidence should be given no weight because they are belated new arguments that
`
`are not presented elsewhere (e.g., in its Reply). See, e.g., Smith & Nephew, Inc. v.
`
`Conformis, Inc., IPR2017-00115, Paper 33 (PTAB Apr. 19, 2018).
`
`- 4 -
`
`
`
`Case IPR2018-01423
`Patent No. 9,266,951
`value.
`
`Teva objected to all or part of Exhibits 1004, 1005, 1247, 1261, 1262, 1264,
`
`1265, 1267-1279, 1281, 1286, 1293, 1296, 1311, 1313, 1314, 1316, 1317, 1321,
`
`and 1322 as irrelevant, prejudicial, and lacking probative value. Lilly’s Opposition
`
`provides broad and vague descriptions of how these exhibits were introduced into
`
`this proceeding. While there is no “requirement” that a petitioner cite evidence for
`
`it to be relevant, that does not mean all evidence introduced via expert declarations
`
`is admissible despite being irrelevant, prejudicial, and lacking probative value.
`
`Activision Blizzard, Inc. v. Acceleration Bay, LLC, IPR2015-01953, Paper 107, 75
`
`(PTAB Mar. 23, 2017). Neither Teva nor the Board should have to hunt along a
`
`trail from Lilly’s papers, to declarations cited in those papers, and to exhibits cited
`
`in those declarations, to discern relevance. “Judges are not like pigs, hunting for
`
`truffles buried in briefs.” adidas AG v. Nike, Inc., IPR2016-00922, Paper 31, 52
`
`(PTAB Feb. 19, 2019) (quoting United States v. Dunkel, 927 F.2d 955, 956 (7th
`
`Cir. 1991)).
`
`IV. Conclusion
`Accordingly, the challenged evidence does not meet the threshold of
`
`admissibility and should be excluded from the record.
`
`Date: November 8, 2019
`14093774
`
`STERNE, KESSLER, GOLDSTEIN & FOX L.L.C.
`/Deborah A. Sterling/
`Deborah A. Sterling, Ph.D.
`
`- 5 -
`
`
`
`Case IPR2018-01423
`Patent No. 9,266,951
`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
`
`The undersigned hereby certifies that the above-captioned “Teva
`
`Pharmaceuticals International GmbH’s Reply in Support of the Motion to
`
`Exclude” was served in its entirety on November 8, 2019, via electronic mail upon
`
`the following counsel for Petitioner:
`
`Sanjay M. Jivraj
`Mark J. Stewart
`Eli Lilly and Company
`Lilly Corporate Center Patent Dept.
`Indianapolis, IN 46285
`jivraj_sanjay@lilly.com
`stewart_mark@lilly.com
`
`
`
`
`William B. Raich
`
`
`Erin M. Sommers
`
`
`Pier D. DeRoo
`
`
`
`Yieyie Yang
`
`
`
`John Williamson
`
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, LLP
`
`
`901 New York Avenue, NW
`
`Washington, DC 20001
`william.raich@finnegan.com
`erin.sommers@finnegan.com
`pier.deroo@finnegan.com
`yieyie.yang@finnegan.com
`john.williamson@finnegan.com
`
`
`
`STERNE, KESSLER, GOLDSTEIN & FOX L.L.C.
`
`
`
`Deborah A. Sterling, Ph.D.
`Date: November 8, 2019
`1100 New York Avenue, N.W. Registration No. 62,732
`Washington, D.C. 20005-3934
`Lead Counsel for Patent Owner
`(202) 371-2600
`
`
`
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
