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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`______________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`______________________
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`ELI LILLY AND COMPANY,
`Petitioner,
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`v.
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`TEVA PHARMACEUTICALS INTERNATIONAL GMBH,
`Patent Owner.
`______________________
`
`
`Case IPR2018-01427
`Patent 8,597,649 B2
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`______________________
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`PATENT OWNER’S MOTION TO STRIKE IMPROPER REPLY
`ARGUMENTS AND EVIDENCE
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`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
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`I. Introduction
`Pursuant to the Board’s September 20, 2019 Order, Patent Owner Teva
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`IPR2018-01427
`Patent 8,597,649 B2
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`
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`moves to strike the following arguments and evidence from Lilly’s Reply:
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` Reply arguments on pages 3, 9, 11-12, 20;
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` Exhibits 1082, 1240, 1287, 1309;
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` Paragraphs 15-34, 38, 51, 52, 54, 60, 69 of Exhibit 1329; and
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` Paragraphs 17, 31, 74, and 77 of Exhibit 1330.
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`These are not rebuttal arguments and evidence; rather, they represent Lilly’s
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`impermissible attempt to present new evidence and theories of invalidity. “[A]
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`reply that raises a new issue or belatedly presents evidence may not be
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`considered.” Trial Practice Guide at 40 (emphasis added). Permitting Lilly to
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`introduce these new arguments and evidence on Reply would prejudice Teva.
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`Petitioners are required to provide “[a] full statement of the reasons for the
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`relief requested, including a detailed explanation of the significance of the
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`evidence including material facts,” in the Petition, in the first instance, not in the
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`Reply. 37 C.F.R. § 42.22(a)(2); see also Tietex Int’l v. Precision Fabrics Group,
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`IPR2014-01248, Paper 39 at 14-15 (PTAB Feb. 27, 2016). A Reply is for rebuttal,
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`not to rehabilitate flawed theories in a Petition, as Lilly attempts here by
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`introducing new arguments and evidence—including the declaration of an entirely
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`new expert to proffer the same opinions as its first, and since discredited, expert.
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`IPR2018-01427
`Patent 8,597,649 B2
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`37 C.F.R. § 42.23 (“A reply may only respond to arguments raised in the
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`corresponding opposition.”); Trial Practice Guide at 40; see also Henny Penny
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`Corp. v. Frymaster LLC, No. 2018-1596, slip. op. at *9 (Fed. Cir. Sept. 12, 2019).
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`Having failed to rely upon these new arguments and evidence in its Petition, Teva
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`respectfully requests that the Board strike them.
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`II. Lilly improperly puts forth a new theory and evidence related to
`Exhibit 1287.
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`For the first time on Reply, Lilly improperly puts forth new Exhibit 1287 to
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`supplement its motivation to humanize the claimed anti-CGRP antagonist
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`antibodies argument. This exhibit should have been filed with Lilly’s Petition.
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`Exhibit 1287 is an entirely new 275-page dissertation, which was not cited
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`previously, was not relied upon by any of Lilly’s experts, and, importantly, was not
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`even shown to be a publicly-available printed publication prior to November 14,
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`2005. Lilly cites to Exhibit 1287 for motivation in two sections in its Reply. First,
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`in a three-sentence paragraph beginning: “Providing further motivation …” as an
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`alleged “contemporaneous” teaching of motivation. Reply at 3, citing EX1287, 247
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`(emphasis added). Second, to allege that “there was ‘no reason’ why humanized
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`anti-CGRP monoclonal antibodies should not be investigated.” Reply at 11, citing
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`EX1287, 247. By citing to this dissertation by Dr. Tan, who was not even a POSA
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`as of his studies, Lilly aims to insert new evidence to bolster its original invalidity
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`theories. But any arguments and evidence as to motivation must have been made in
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`the Petition, not newly advanced for the first time on Reply.
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`IPR2018-01427
`Patent 8,597,649 B2
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` Exhibit 1287 is not used to rebut an argument, but instead to plug a glaring
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`deficiency in Lilly’s original evidence on purported motivation. Lilly has given no
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`reason why it could not have included Exhibit 1287 in its Petition. Permitting Lilly
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`to introduce it now to cure flaws in the Petition would be improper. Thus, the
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`Board should strike Lilly’s Reply arguments relating to Exhibit 1287 (pp. 3, 11-12)
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`and the entirety of Exhibit 1287.
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`III. Lilly improperly presents a new expert (Dr. Balthasar) to rehabilitate
`the discredited testimony of its first expert (Dr. Charles).
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`In the Petition, Lilly relied on Dr. Charles’s expert testimony to support its
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`allegations regarding the effectiveness of Tan 1995’s full-length antibody.
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`EX1002, e.g., ¶¶56-59, 68-71, 115-123. This argument was central to Lilly’s prima
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`facie obviousness case because Lilly relies on efficacy of Tan’s antibody to argue
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`motivation to combine. Petition at e.g., 19-21, 30-32.
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`But on cross examination, Dr. Charles was shown to be unqualified to
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`proffer these opinions, and his testimony was discredited. POR, 3-4. Lilly’s other
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`expert, Dr. Vasserot, undermined Dr. Charles’ opinions, testifying that certain data
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`in Tan 1995 are “something that [he] would take with caution and would need to
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`repeat.” POR, 16-18; EX2191, 118:21- 119:1. Thus, Lilly’s Petition Declarants did
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`not support Lilly’s Petition arguments. And Teva’s experts fully explained that Tan
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`1995’s data does not demonstrate efficacy. EX2054, ¶52; EX2137, ¶88.
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`IPR2018-01427
`Patent 8,597,649 B2
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`Faced with this vital failure in its Petition, Lilly on Reply seeks to introduce
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`
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`the testimony of a brand new expert, Dr. Balthasar, on the same efficacy issue Dr.
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`Charles failed to support in its Petition. Reply, 20; EX1329, ¶¶15-34. Remarkably,
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`multiple paragraphs in Dr. Balthasar’s declaration on Tan’s full-length antibody
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`mirror Dr. Charles’s testimony on the same point. Compare EX1329, ¶¶16-18, 20,
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`22, 24-26, 29-30, 32-33 with EX1002, ¶¶49-51, 56-57, 70, 121, 126, 131-132, 138,
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`162. This clearly evidences Lilly’s blatant attempt to shore up the same arguments
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`that Lilly relied on in its Petition through new expert testimony on Reply.
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`Lilly’s belated introduction of Dr. Balthasar’s declaration to further support
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`its original argument that there was motivation to arrive at the claimed antibodies
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`based on Exhibit 1022 is impermissible at this stage. Dr. Balthasar’s declaration
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`testimony on this point (EX1329, ¶¶15-34) and Lilly arguments based on the same
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`(Reply, 20) should be stricken.
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`IV. Lilly improperly puts forth a new theory and evidence relating to
`aptamers.
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`Teva’s POR revealed that none of the art in Lilly’s Petition demonstrates
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`that a POSA would have considered a long-acting anti-CGRP drug, like the
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`claimed full-length antibody, safe and effective. Unable to find any support to
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`rebut that showing, Lilly on Reply advances new evidence, new expert testimony,
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`and new art involving “aptamers”—oligonucleotides directed to the CGRP
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`ligand—to newly argue that the “prior art demonstrated that longer acting anti-
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`IPR2018-01427
`Patent 8,597,649 B2
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`CGRP drugs were desirable and indicated as safe.” Reply at 9; EX1082; EX1240;
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`
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`EX1309; EX1329, ¶¶38, 51, 52, 54, 60, 69; EX1330, ¶¶17, 31, 74, 77.
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`Notably, however, nowhere in its Petition or supporting declarations does
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`Lilly discuss aptamers. Lilly’s aptamer-argument is entirely new, and is not proper
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`rebuttal argument or evidence. Lilly’s Petition centered exclusively on art
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`pertaining to antibodies to argue that a longer half-life is desirable. Petition, 56,
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`citing EX1056, EX1062, EX1070, EX1074 and EX1075. Lilly cannot now
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`supplement or replace its original argument with an entirely new theory based on
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`aptamers, which should have been presented in the Petition. Thus, Lilly’s new
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`“aptamer” argument in the Reply (Page 9), new related exhibits (EX1082,
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`EX1240, EX1309), and expert testimony (EX1329, ¶¶38, 51, 52, 54, 60, 69;
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`EX1330, ¶¶17, 31, 74, 77) should be stricken.
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`V. Conclusion
`For the foregoing reasons, Teva moves to strike the entirety of Lilly’s Reply
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`arguments on pages 3, 9, 11-12, 20; Exhibits 1082, 1240, 1287, 1309; ¶¶15-34, 38,
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`51, 52, 54, 60, 69 of Exhibit 1329; and ¶¶17, 31, 74, and 77 of Exhibit 1330 as
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`impermissible on Reply because they are not provided in rebuttal but instead are
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`provided to attempt to shore up Lilly’s deficient prima facie case in the Petition.
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`Date: September 30, 2019
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`Respectfully submitted,
`/Deborah A. Sterling/
`Deborah A. Sterling, Ph.D. (Reg. No. 62,732)
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`IPR2018-01427
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`Patent 8,597,649 B2
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`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
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`The undersigned hereby certifies that the above-captioned “Motion to Strike
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`Improper Reply Arguments and Evidence” was served in its entirety on September
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`30, 2019, upon the following parties via electronic mail:
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`William B. Raich
`Erin M. Sommers
`Pier D. DeRoo
`Yieyie Yang
`John M. 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
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`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
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`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
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`Date: September 30, 2019
`1100 New York Avenue, NW
`Washington, DC 20005
`(202) 371-2600
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`
`
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`Deborah Sterling, Ph.D.
`Lead Attorney for Patent Owner
`Registration No. 62,732
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