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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 IPR2018-01710
`Patent 8,586,045 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 October 15, 2019 Order, Patent Owner Teva moves
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`IPR2018-01710
`Patent 8,586,045
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`to strike the following arguments and evidence from Lilly’s Reply:
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` Reply arguments on pages 6, 10-11, and 15;
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` Exhibit 1287; and
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` Paragraphs 22, 24-25, and 30-33 of Exhibit 1337.
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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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`37 C.F.R. § 42.23 (“A reply may only respond to arguments raised in the
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`IPR2018-01710
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`Patent 8,586,045
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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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`Because Lilly failed to rely upon these new arguments and evidence in its Petition,
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`Teva 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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`Teva’s Response exposed a hole in Lilly’s Petition: Tan 1995 is a basic
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`science pharmacology paper that draws no therapeutic or clinical conclusions.
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`POR, 14-15. The authors intended simply “to investigate immunoblockade as an
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`alternative strategy for probing the role of CGRP as a vasodilator in vivo.”
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`EX1022, Abstract. Thus, Tan 1995 was trying to elucidate CGRP’s role in
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`vasodilation in an experimental animal; not whether an anti-CGRP antibody could
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`be safely developed for human therapeutic use. EX2265, ¶¶83, 121; EX2268, ¶137.
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`Facing this hole in its primary case, Lilly improperly puts forth new Exhibit
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`1287 for the first time on Reply to supplement its deficient motivation argument to
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`humanize the claimed anti-CGRP antagonist antibodies. This exhibit should have
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`been filed with Lilly’s Petition. Exhibit 1287 is an entirely new 275-page
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`dissertation, which was not cited previously, was not relied upon by any of Lilly’s
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`experts, and, importantly, was not even shown to be a publicly-available printed
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`publication prior to November 14, 2005.
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`Lilly relies on EX1287 in Reply to allege that “there [was] ‘no reason’ why
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`- 2 -
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`IPR2018-01710
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`Patent 8,586,045
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`humanized anti-CGRP antagonist antibodies should not be developed and used for
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`treating migraine.” Reply at 6, citing EX1287, 247; see also Reply, 15. By citing to
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`this dissertation by Tan, who was a student and not a POSA as of his writing, Lilly
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`aims to insert new evidence necessary to its original invalidity theories. But any
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`arguments and evidence as to motivation must have been made in the Petition, not
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`newly advanced for the first time on Reply. Intelligent Bio-Sys., Inc. v. Illumina
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`Cambridge Ltd., 821 F.3d 1359, 1369-70 (Fed. Cir. 2016) (indicating that a reply
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`or reply evidence may be excluded if it introduces new evidence that is necessary
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`to make out a prima facie case of unpatentability).
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`Exhibit 1287 is not used to rebut an argument, but instead to plug a
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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. 6 and
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`15) 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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`EX1014, e.g., ¶¶56-59, 70-71, 135-136. 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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`- 3 -
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`IPR2018-01710
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`Patent 8,586,045
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`motivation to combine. Petition at e.g., 16-17, 24, 26-27, 30-32, 38-40.
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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, 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, 3-4, 15-17; EX2191, 118:21- 119:1. Thus, Lilly’s Petition
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`Declarants did not support Lilly’s Petition arguments. And Teva’s experts fully
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`explained that Tan 1995’s data does not demonstrate efficacy. EX2265, ¶¶84-85;
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`EX2268, ¶91.
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`Faced with this vital failure in its Petition, Lilly on Reply seeks to introduce
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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, 10-11; EX1337, ¶¶22, 24-25, 30-33;
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`EX1014, ¶¶56-59. This clearly evidences Lilly’s attempt to shore up the same
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`arguments that Lilly relied on in its Petition through new expert testimony on
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`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 methods
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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 (EX1337, ¶¶22, 24-25, 30-33) and Lilly’s arguments based
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`on the same (Reply, 10-11) should be stricken.
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`- 4 -
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`IV. Conclusion
`For the foregoing reasons, Teva moves to strike the entirety of Exhibit 1287;
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`IPR2018-01710
`Patent 8,586,045
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`paragraphs 22, 24-25, and 30-33 of Exhibit 1337; and Lilly’s Reply arguments on
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`pages 6, 10-11, and 15 based on the same, as impermissible on Reply because they
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`are not provided in rebuttal but instead are provided to attempt to shore up Lilly’s
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`deficient prima facie case in the Petition.
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` Respectfully submitted,
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`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
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`Date: October 22, 2019
`1100 New York Avenue, NW
`Washington, DC 20005
`(202) 371-2600
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`
`
`Deborah Sterling, Ph.D.
`Lead Attorney for Patent Owner
`Registration No. 62,732
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`- 5 -
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`IPR2018-01710
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`Patent 8,586,045
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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 October
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`22, 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: October 22, 2019
`1100 New York Avenue, NW
`Washington, DC 20005
`(202) 371-2600
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`
`
`Deborah Sterling, Ph.D.
`Lead Attorney for Patent Owner
`Registration No. 62,732
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`- 6 -
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