`
`
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`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 IPR2018-01712
`Patent 9,884,908 B2
`_____________________
`
`TEVA PHARMACEUTICALS INTERNATIONAL
`GMBH’S MOTION TO EXCLUDE
`
`
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`
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`Case IPR2018-01712
`Patent No. 9,884,908
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`TABLE OF CONTENTS
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`
`
`I.
`
`II.
`
`Exhibit 1287 lacks foundation and should be excluded. ................................ 2
`
`Lilly relies upon inadmissible deposition testimony. ......................... 7
`
`III. Multiple exhibits are not relevant and/or prejudicial. ...................... 12
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`IV. Portions of Exhibits 1018, 1236, 1341, and 1342 are irrelevant,
`prejudicial, and lack probative value. ........................................................... 13
`
`V.
`
`
`Conclusion .................................................................................................... 15
`
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`Case IPR2018-01712
`Patent No. 9,884,908
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`Teva Pharmaceuticals International GmbH (“Teva”) submits this motion
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`pursuant to 37 C.F.R. §§ 42.62 and 42.64(c) and in accordance with Due Date 5 of
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`the Scheduling Order (Paper 12). Teva requests exclusion of the entirety of
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`Exhibits 1098, 1261-1262, 1264-1265, 1267-1279, 1286-1287, 1291-1293, 1296,
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`1311, 1313-1314, 1316-1317, 1331, 1335-1336, 1344, 1347, and 1349, and
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`portions of Exhibits 1018, 1236, 1301-1304, 1341-1343, and 1345. Teva timely
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`objected to all of these exhibits either through written Objections to Evidence or
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`during deposition proceedings.
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`The Federal Rules of Evidence (FRE) govern the admissibility of evidence
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`in inter partes review proceedings. 37 C.F.R. § 42.62. As shown herein, the
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`challenged exhibits contain irrelevant and prejudicial information under FRE 401,
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`402, and 403, and/or are unauthenticated in violation of FRE 901. Accordingly, the
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`Board should exclude the objected-to exhibits in their entirety for the reasons that
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`follow.
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`The Board should not dismiss this Motion as moot if the Board does not rely
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`on the inadmissible evidence in reaching its Final Written Decision. Instead, Teva
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`respectfully requests that the Board rule on the motion so that petitioner Eli Lilly
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`and Company (“Lilly”) cannot continue to rely upon the exhibits and paragraphs
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`identified herein on appeal. Not excluding the exhibits would force Teva to address
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`them again, e.g., on appeal, thereby wasting judicial and party resources.
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`Case IPR2018-01712
`Patent No. 9,884,908
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`I.
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`Exhibit 1287 lacks foundation and should be excluded.
`
`Teva moves to exclude Exhibit 1287 under FRE 901 because Lilly has failed
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`to provide sufficient evidence indicating the origin of the exhibit and has not
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`provided sufficient information regarding its authenticity as a publicly accessible
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`document. Teva objected to Exhibit 1287 in a timely manner (Paper 33, 2-3;
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`EX1303, 176:2-18), and Lilly’s efforts to correct the evidentiary deficiencies with
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`supplemental evidence only serve to highlight why Exhibit 1287 should be
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`excluded from this proceeding.
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`Exhibit 1287 is purported to be the doctoral thesis of Keith Tan from the
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`University of Cambridge. The public accessibility of EX1287 is an essential part of
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`the foundation analysis because “the sufficiency of the foundation evidence must
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`be assessed in light of the nature of the documents at issue.” Conoco Inc. v. Dep’t
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`of Energy, 99 F.3d 387, 392 (Fed. Cir. 1996), as amended on reh’g in part (Jan. 2,
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`1997). And “[w]hether a reference is publicly accessible is determined on a case-
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`by-case basis based on the ‘facts and circumstances surrounding the reference’s
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`disclosure to members of the public.’” Actavis, Inc. v. Research Corp. Techs., Inc.,
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`IPR2014-01126, DI, 9 (citing In re Lister, 583 F.3d 1307, 1311 (Fed. Cir. 2009))
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`(holding that the proponent “provide[d] no competent evidence to show that the
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`library allows public access to the thesis”). For a thesis allegedly found within a
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`library, “[d]etermining public accessibility of a thesis for prior art purposes
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`Patent No. 9,884,908
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`requires a showing of both shelving and meaningful indexing/cataloging” at that
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`library. Kayak Software Corp. v. International Business Machines Corp.,
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`CBM2016-00076, Paper 16, 8 (citing In re Cronyn, 890 F.2d 1158, 1161 (Fed. Cir.
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`1989); In re Hall, 781 F.2d 897, 899 (Fed. Cir. 1986); In re Bayer, 568 F.2d 1357,
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`1358–59 (CCPA 1978)). Further, evidence relating to public accessibility at a
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`library must be “sufficiently probative of [the] Library’s indexing/cataloging
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`practices” on the asserted prior art date. Kayak Software, CBM2016-00076, Paper
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`16, 8. And if a proponent of evidence provides evidence of current library practice,
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`the proponent must then also “provide[] some analysis as to how the [evidence]…
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`could be interpreted as supporting the conclusion that an analogous cataloging
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`system existed [on the asserted prior art date].” Id. at 10.
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`Lilly introduced Exhibit 1287 late in this proceeding, during the deposition
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`of Teva’s expert Dr. Ferrari on August 15, 2019. EX1303, 176:2-18. Teva
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`immediately objected to its use as lacking foundation (among other objections). Id.
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`As originally presented to Dr. Ferrari, Exhibit 1287 contained no indication of
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`where the document came from or how it was obtained, no indication of whether it
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`was publicly accessible, and no indication of when (if ever) the document became
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`publicly available before November 14, 2005. EX1303, 176:2-24. Lilly
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`subsequently filed a version of Exhibit 1287 with Lilly’s Reply (Paper 31) that was
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`allegedly the same as that presented during Dr. Ferrari’s deposition. Teva then
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`Patent No. 9,884,908
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`renewed its objection to Exhibit 1287 as lacking foundation under FRE 901. Paper
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`33, 2. After receiving Teva’s renewed objection, Lilly served supplemental
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`evidence on Teva in the form of a new version of Exhibit 1287 (i.e., Exhibit
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`1287A)1 and a declaration from Michael P. Carney, a Research Analyst in the
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`employ of counsel for Lilly. EX1307, ¶2. The dates in Mr. Carney’s declaration
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`related to EX1287A present a confusing picture about when Mr. Carney obtained
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`EX1287A: Mr. Carney claims to have obtained the thesis on August 30, 2019
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`(EX1307, ¶13), while Exhibit 1287A contains a reference to being delivered
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`September 5, 2019 (EX1307, 19), and Mr. Carney provided a catalog listing dated
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`September 3, 2019 (EX1307, 296). None of these dates precede Lilly’s
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`introduction of Exhibit 1287 on August 15, 2019.
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`Moreover, Mr. Carney’s declaration and the new version of Exhibit 1287 do
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`not cure the deficiencies in the authentication of Exhibit 1287. A large portion of
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`Mr. Carney’s declaration deals only with his opinion regarding “Standard Library
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`Practice” and a two-paragraph explanation of MARC Records. EX1307, ¶¶6-12.
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`1 EX1287A appears to differ from EX1287 only in that it contains an
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`additional page at the beginning, purporting to be a receipt for supplying Keith
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`Tan’s thesis to “Michel Carney” after he ordered a copy “for the purposes of
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`parliamentary or judicial proceedings.” EX1287A, 1.
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`Patent No. 9,884,908
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`This testimony has little relevance to the issue at hand, as Mr. Carney does not
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`present any proof that such standard practice or that MARC Records were used by
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`the Cambridge University Library (“CUL”), the purported source of EX1287, as of
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`November 2005.
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`Mr. Carney also appended a September 3, 2019 CUL catalog entry
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`(EX1307, Exhibit C2) and a purported MARC Record for the Tan thesis allegedly
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`from CUL’s web page (Id., Exhibit D3). These purported 2019 entries refer to
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`multiple different dates, which, at best, indicate creation of a catalog entry. The
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`present-day catalog entries, however, do not establish that Exhibit 1287 was
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`publicly available before November 2005. Neither the present-day catalog entries
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`nor the Carney Declaration in general provides any evidence to demonstrate actual
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`shelving in the CUL or even meaningful indexing of the Tan thesis before
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`November 14, 2005.
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`To establish a connection between catalog entries and public availability, it
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`is necessary to provide information regarding a library’s indexing and cataloging
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`
`2 Mr. Carney avers he accessed Exhibit C on August 27, which is not the
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`same September 3 date shown on Exhibit C. Lilly did not file a copy of Exhibit C
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`from August 27.
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`3 Exhibit D does not contain any source information or date of access.
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`practice to its making a thesis available. Kayak Software, Paper 16, 8-10. Lilly fails
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`to provide such necessary information. Lilly, and its declarant Mr. Carney,
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`produced only an email exchange with the CUL asking to “obtain[] a declaration of
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`date availability” from that library.4 EX1307, 300. But neither Mr. Carney nor
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`Lilly has presented such a declaration from CUL. Instead, Mr. Carney appended an
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`email from Louise Clarke, the apparent “Superintendent, Manuscripts Reading
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`Room” at CUL, to his declaration. This email exchange (EX1307, Exhibit E) fails
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`to cure any of these evidentiary deficiencies.
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`First, Ms. Clarke’s email reply is the epitome of hearsay. It is an out-of-court
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`statement (an email) offered to prove the truth of whether CUL made the Tan
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`thesis publicly available. Ms. Clarke has not offered sworn testimony, and Teva
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`has not been presented the opportunity to depose Ms. Clarke.
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`Second, Lilly has not established that Ms. Clarke is qualified to testify to
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`CUL’s shelving or indexing practices now or before 2005. Nor has Lilly
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`4 Exhibit E, containing Mr. Carney’s purported email exchange with CUL,
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`appears incomplete, as his August 9, 2019 solicitation of “a declaration of date
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`availability” refers to a “similar . . . attached deceleration [sic] for this
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`dissertation.” EX1307, 300. Exhibit E does not contain a copy of the referenced
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`“similar” declaration.
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`established that Ms. Clarke is qualified to testify to when the public would have
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`access to a shelved or indexed thesis.
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`Third, even if Ms. Clarke’s email reply is considered, it does not support Mr.
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`Carney’s arguments about availability. Ms. Clarke was unable to offer any
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`documentation about the Tan thesis and expressly stated that “[w]e do not have the
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`paperwork with the date of deposit of the thesis in the University Library, which is
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`when the thesis would’ve become publically available.” EX1307, 300. It is unclear
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`who or what “we” refers to in Ms. Clarke’s email and whether “we” refers to an
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`entity with actual knowledge of CUL practice. Id. And Ms. Clarke also did not
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`profess to know the CUL filing and accessibility standards when the Tan thesis
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`was allegedly submitted to the library or, indeed, at any time before November
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`2005. Id. She stated only what the current processes “are” and hazarded a guess as
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`to what would have been “most likely” to occur. Id.
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`Beyond Ms. Clarke’s email, Mr. Carney offers no evidence as to what
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`CUL’s policy was regarding indexing and cataloging practice or whether (much
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`less when) Tan’s thesis would have actually been made publicly available before
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`November 14, 2005. Accordingly, Lilly has not established sufficient foundation
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`for Exhibit 1287 under FRE 901, and it should be excluded from this proceeding.
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`II. Lilly relies upon inadmissible deposition testimony.
`Teva also moves to exclude various sections of expert deposition testimony
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`based on improper questioning by Lilly. As discussed in detail below, the improper
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`form of the questions asked in these portions of testimony means that the testimony
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`is meaningless, prone to misunderstanding, and/or beyond the scope of the experts’
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`direct testimony. These flaws mean that the testimony outlined below would be
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`prejudicial to Teva if it were not excluded from the proceeding, as well as
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`potentially confusing the issues and wasting the time of the parties and Board.
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`Accordingly, the identified portions of testimony are inadmissible under FRE 403
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`and should be excluded. Objectionable portions of testimony include:
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` EX1301, 115:9-116:21 – Teva objected to a question in this passage because
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`it called for unfounded speculation about the state of mind of others.
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` EX1301, 154:24-156:21 – Teva objected to a question in this passage as
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`lacking relevance and being out of scope, because it called for legal analysis
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`of claim scope of antagonists disclosed in a non-prior art paper.
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` EX1301, 211:16-21 – Teva objected to the question in this passage for
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`improper form because ambiguity about the identity of the “therapeutic
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`antibodies” and the meaning of “strong” and “desirable” makes the question
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`prone to misunderstanding and makes the given answer unclear.
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` EX1302, 45:20-46:19, 81:9-82:2 – Teva objected to the passage starting on
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`page 45 for improper form because of its vagueness and ambiguity with
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`respect to the meaning of “patent portfolio license.” And Teva objected to
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`the passage starting on page 81 as mischaracterizing the witness’s previous
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`testimony.
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` EX1302, 179:14-180:19 – Teva objected to this passage, because it was
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`beyond the scope of the declarant’s direct testimony in that it related to legal
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`analysis of a contract hypothetical.
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` EX1303, 25:11-17 – Teva objected to this question for lack of foundation
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`regarding discussion of sumatriptan’s effects on blood pressure.
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` EX1303, 54:12-23 – Teva objected to the question in this passage, because it
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`was beyond the scope of the declarant’s direct testimony in that it related to
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`toxicity studies in animals.
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` EX1303, 61:15-65:12 – Teva objected to questions within this passage for
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`being outside the scope of the witness’ direct testimony and for improper
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`form, in that they contained vague language regarding the effects of cAMP.
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` EX1303, 69:10-16 – Teva objected to the question in this passage, because
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`the definition of “antibody serum” is outside the scope of this proceeding.
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` EX1303, 73:8-18 - Teva objected to the question in this passage for
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`improper form because of vagueness with regard to what type of clinical
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`trial was being discussed and with regard to what the question meant with
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`regard to “sufficiently safe.”
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` EX1303, 102:9-106:19 – Teva objected to questions within this passage for
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`improper form, in that they were compound questions or contained vague
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`language regarding “significance.”
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` EX1303, 108:25-133:7 – Teva objected to many questions by Lilly in this
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`extremely large cite for, inter alia, improper form because of vagueness,
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`compound questions, lack of foundation for discussion of experimental
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`results, and calling for legal conclusions regarding claim scope.
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` EX1303, 193:3-10 – Teva objected to the question in this passage for
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`improper form because of vagueness with regard to what subpopulation of
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`patients was being discussed and with regard to what the question meant
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`with regard to “the percentage of patients.”
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` EX1304, 59:23-71:17 – Teva objected to this section of testimony as lacking
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`relevance and being out of the scope of the declarant’s direct testimony, in
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`that it related to treatment of a different condition and different therapeutic
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`than those of concern to this proceeding.
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` EX1304, 74:17-75:12 – Teva objected to this passage for form because of
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`the compound nature of the questions and vagueness with respect to the
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`types of headaches being referenced.
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` EX1304, 82:17-134:18 – Teva objected to many questions by Lilly in this
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`extremely large cite for, inter alia, improper form, in that they were
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`compound questions or contained vague language, and asking a range of
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`questions beyond the scope of direct testimony (which was limited to
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`objective indicia of nonobviousness).
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` EX1304, 119:1-15 – Teva objected to the question in this passage as being
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`beyond the scope of direct testimony.
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` EX1304, 142:1-8 – Teva objected to the questions in this passage for
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`improper form because of vagueness regarding what was meant by
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`“block[ing] the CGRP pathway.” Teva also objected to this question because
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`it was premised on a mischaracterization of the witness’s previous
`
`testimony.
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` EX1343, 33:17-34:6 – Teva objected to the question in this passage for
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`improper form because vagueness regarding the meaning of “change” and
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`“any clinical effect” makes the question prone to misunderstanding and
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`makes the given answer unclear.
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` EX1343, 76:12-77:8 – Teva objected to the question in this passage for
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`improper form because vagueness regarding the degree of “crossing” the
`
`blood brain barrier and to what “normal circumstances” refers makes the
`
`question prone to misunderstanding and makes the given answer unclear.
`
` EX1345, 61:5-65:2 – Teva objected to questions in this passage for improper
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`form because of vagueness regarding the meaning of “peripheral” and
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`because they called for unfounded speculation about the state of mind of
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`others.
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` EX1345, 52:6-54:7 – Teva objected to questions in this passage for improper
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`form because vagueness regarding terms such as “increases” and “effects”
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`makes the questions prone to misunderstanding and makes the given
`
`answers unclear.
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`III. Multiple exhibits are not relevant and/or prejudicial.
`Lilly submitted many exhibits that it failed to cite in its Petition or Reply,
`
`rendering them irrelevant and/or prejudicial. Exhibits 1098, 1261-1262, 1264-
`
`1265, 1267-1279, 1286, 1291-1293, 1296, 1311, 1313-1314, 1316-1317, 1331,
`
`1335-1336, 1344, 1347, and 1349 appear nowhere in either Lilly’s Petition or eply.
`
`Evidence is relevant if it “has any tendency to make a fact more or less probable
`
`than it would be without the evidence” and “the fact is of consequence in
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`determining the action.” FRE 401. Lilly’s failure to cite Exhibits 1098, 1261-1262,
`
`1264-1265, 1267-1279, 1286, 1291-1293, 1296, 1311, 1313-1314, 1316-1317,
`
`1331, 1335-1336, 1344, 1347, and 1349 demonstrates that these exhibits do not
`
`have a tendency to make any fact of consequence more or less probable. If these
`
`exhibits were relevant to this proceeding, Lilly should have cited them in the
`
`Petition or Reply. This evidence is, therefore, inadmissible as irrelevant. See FRE
`
`402 (“Irrelevant evidence is not admissible.”).
`
`If this evidence was actually submitted for the Board to consider, then this
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`evidence should be excluded under FRE 403 as unfairly prejudicial. Exhibits 1098,
`
`1261-1262, 1264-1265, 1267-1279, 1286, 1291-1293, 1296, 1311, 1313-1314,
`
`1316-1317, 1331, 1335-1336, 1344, 1347, and 1349 were not cited or discussed in
`
`the Petition or Reply, so Lilly would have vastly overshot the word limits of its
`
`Petition and Reply had these exhibits been appropriately cited and discussed.
`
`Because “[a]rguments must not be incorporated by reference from one document
`
`into another document,” 37 C.F.R. § 42.6(a)(3), any attempt by Lilly to rely upon
`
`these exhibits is prejudicial to Teva. Teva would be prejudiced if Lilly is allowed
`
`to disregard the rules and effectively incorporate this information by reference.
`
`Accordingly, Exhibits 1098, 1261-1262, 1264-1265, 1267-1279, 1286,
`
`1291-1293, 1296, 1311, 1313-1314, 1316-1317, 1331, 1335-1336, 1344, 1347, and
`
`1349 should be excluded as irrelevant and/or prejudicial.
`
`IV. Portions of Exhibits 1018, 1236, 1341, and 1342 are irrelevant,
`prejudicial, and lack probative value.
`
`Multiple paragraphs in Lilly’s supporting expert declarations (Exhibits 1018,
`
`1236, 1341 and 1342) were never cited in Lilly’s Petition or Reply. Accordingly,
`
`Teva moves to exclude paragraphs 40-50, 64, 67, 71-74, 82, 87, 89-90, 92-93, 109,
`
`122, 151, 156, 158, 160, 165, 190-191, and 193 in Exhibit 1018; paragraphs 27,
`
`71-72, 75-77, 81-83, 87-88, 91, 135, 137, and 143 in Exhibit 1236; paragraphs 1-
`
`14 in Exhibit 1341; and paragraphs 1-4 in Exhibit 1342 as irrelevant, prejudicial,
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`and lacking probative value. Teva timely objected to these paragraphs of Exhibits
`
`1018, 1236, 1341, and 1342, and Lilly failed to cure these objections. Paper 13, 1-
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`2; Paper 33, 1-2.
`
`Evidence is relevant if it “has any tendency to make a fact more or less
`
`probable than it would be without the evidence” and “the fact is of consequence in
`
`determining the action.” FRE 401. Lilly’s failure to cite these paragraphs
`
`demonstrates that they do not have a tendency to make any fact of consequence
`
`more or less probable. If these portions of the declarations were relevant to this
`
`proceeding, Lilly should have cited them in the Petition or Reply. These portions
`
`of Exhibits 1018, 1236, 1341, and 1342 are, therefore, inadmissible as irrelevant.
`
`See FRE 402 (“Irrelevant evidence is not admissible.”).
`
`Also, it is unlikely that Lilly could have properly discussed the omitted
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`paragraphs in the space it had left in its Petition or Reply. If these paragraphs were
`
`relevant, Lilly’s attempt to incorporate them by reference into the Petition or Reply
`
`should be rejected as prejudicial under FRE 403.
`
`Teva also moves to exclude paragraphs 37-38 of Exhibit 1341 and
`
`paragraphs 14, 18-20, 22, 33, 93, 113, and 142-143 of Exhibit 1342 to the extent
`
`that they rely on evidence that is excluded for the reasons discussed elsewhere in
`
`this motion. Paper 33, 1-2. Inclusion of these paragraphs of the declaration would
`
`be irrelevant and prejudicial to Teva, and accordingly, those paragraphs should be
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`excluded under FRE 403.
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`V. Conclusion
`For the foregoing reasons, the challenged evidence does not meet the
`
`threshold for admissibility and should be excluded from the record.
`
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`
`Deborah A. Sterling, Ph.D.
`Date: December 11, 2019
`1100 New York Avenue, N.W. Registration No. 62,732
`Washington, D.C. 20005-3934
`Lead Counsel for Patent Owner
`(202) 371-2600
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`
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`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
`
`The undersigned hereby certifies that the above-captioned “Teva
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`Pharmaceuticals International GmbH’s Motion to Exclude” was served in its
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`entirety on December 11, 2019, via electronic mail upon the following counsel for
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`Petitioner:
`
`
`
`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
`
`
`
`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
`
`
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`
`
`Deborah A. Sterling, Ph.D.
`Date: December 11, 2019
`1100 New York Avenue, N.W. Registration No. 62,732
`Washington, D.C. 20005-3934
`Lead Counsel for Patent Owner
`(202) 371-2600
`
`
`14251980.1
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