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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
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`ELI LILLY AND COMPANY
`Petitioner,
`
`v.
`
`TEVA PHARMACEUTICALS INTERNATIONAL GMBH
`Patent Owner.
`
`___________________
`
`Case IPR2018-01710 (Patent No. 8,586,045)
`Case IPR2018-01711 (Patent No. 9,884,907)
`Case IPR2018-01712 (Patent No. 9,884,908)1
`___________________
`
`
`PATENT OWNER'S SURREPLY TO PETITIONER'S REPLY TO PATENT
`OWNER'S PRELIMINARY RESPONSE
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`
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`1 This paper was authorized by email on January 16, 2019, and is filed in
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`each proceeding identified in the caption. Citations refer to papers filed in
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`IPR2018-01710. Emphases are added unless otherwise noted.
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`
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`IPR2018-01710, -01711, -01712
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`I.
`
`Introduction
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`During prosecution, the Office thoroughly considered substantially the same
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`prior art teachings and arguments in Lilly's Petition, and still found the claimed
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`subject matter patentable. These facts warrant denying institution under § 325(d).
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`Lilly's Reply does not overcome these fatal deficiencies, nor otherwise provide any
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`valid reason for the Board to wastefully redo the examiner's analysis.
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`A. The examiner reviewed the same prior art teachings and already
`rejected arguments similar to Lilly's during prosecution
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`Lilly's unremarkable statement that the examiner did not present an
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`obviousness rejection based on Olesen, Tan, or Queen (Reply, 1) is legally
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`irrelevant because the teachings from Lilly's cited references are the same as, or
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`cumulative of, those the examiner considered during prosecution of the challenged
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`patents and raised in rejections during prosecution of related patents. The Board
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`routinely denies institution under § 325(d) when the art is not new or is cumulative,
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`as the art is here. Cultec Inc. v Stormtech LLC, IPR2017-00777, Paper 7 (PTAB
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`Aug. 22, 2017); see also Unified Patents Inc. v. John L. Berman, IPR2016-01571,
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`Paper 10 (PTAB Dec.14, 2016); Dorco Co. v. Gillette Co, IPR2017-00500, Paper 7
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`(PTAB June 21, 2017); and Indivior Inc. v. Rhodes Pharms, L.P., IPR2018-00795,
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`Paper 23 (PTAB Oct. 4, 2018).
`
`1. Olesen is cumulative of teachings the examiner considered
`and applied in prosecution
`
`It is irrelevant whether Olesen itself was cited to the office when the same
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`- 1 -
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`
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`IPR2018-01710, -01711, -01712
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`teachings Lilly relies upon from Olesen are cumulative of teachings that were.
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`Olesen reported results of a clinical trial using the small molecule CGRP-receptor
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`antagonist BIBN4096BS for migraine. See generally EX1025. Teva's patent
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`specification explicitly mentions BIBN4096BS's effects on migraine via CGRP
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`involvement: "[p]ossible CGRP involvement in migraine has been the basis for the
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`development and testing of a number of compounds that ... antagonize at the
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`CGRP receptor (e.g., dipeptide derivative BIBN4096BS (Boehringer Ingelheim)."
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`EX1001, 2:14-23. It also provides data relating to Olesen's disclosures, by way of
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`Example 6, which compares the effects of BIBN4096BS to an anti-CGRP
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`antagonist antibody in an in vivo migraine model. Id., Example 6 and Figure 9.
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`And the examiner was aware of these data, as seen by Applicant's discussion of
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`Example 6's use of anti-CRGP antagonists in a migraine model when responding to
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`a rejection during the prosecution of the '045 patent. EX2034, 497. Olesen provides
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`nothing new.
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`Lilly attempts to extend Olesen beyond its small molecule receptor
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`antagonist to anti-CGRP antagonists in general.2 But, the examiner was also well
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`aware of anti-CGRP antagonists in general through Frobert and Pisegna; the
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`references the examiner used in rejections during prosecution of related patents.
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`2 Notably, Lilly supports its characterization of Olesen (and Tan) by quoting
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`its own Petition, rather than Olesen (or Tan). See Reply 2 and 4, citing Petition.
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`- 2 -
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`IPR2018-01710, -01711, -01712
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`Indeed, Lilly acknowledges that Frobert teaches anti-CGRP antibodies (Petition
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`12) and that Pisegna taught potential therapeutic antibodies that "compete with
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`each other or with other possible ligands to the CGRP-receptors." Id., 53. Thus,
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`Olesen is cumulative of the prior art teachings in the specification of the patents
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`and already considered and applied in prosecution.
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`Tellingly, Olesen's teachings suffer from the same deficiency as Pisegna:
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`they focused on targeting the CGRP receptor, not CGRP itself. Olesen does not
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`expressly mention any CGRP antagonists other than a receptor antagonist, a fact
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`that Lilly does not dispute. Indeed, Lilly admits that Olesen's focus is on
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`"BIBN4096BS, a known CGRP-receptor antagonist." Petition, 14. The Board need
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`not expend its resources reviewing these cumulative teachings of Olesen.
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`2.
`
`The examiner expressly considered Tan during prosecution;
`Lilly fails to show that the examiner erred when doing so
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`Lilly argues—ineffectively—that Tan is not cumulative to Frobert and
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`Pisegna. Id., 4. Even assuming Lilly is correct—which it is not—its argument is
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`irrelevant because Tan itself was squarely before the Office and discussed during
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`prosecution, as fully explained in the POPR. POPR, 17-20. As Lilly acknowledges,
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`the patents' specification cites Tan for teaching anti-CGRP antibodies (EX1001,
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`25:59-61) and when describing the rat saphenous nerve assay (id., 55:55-58). See
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`Petition, 7. Moreover, Applicant expressly highlighted that Tan's rat saphenous
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`nerve assay results provided no motivation to humanize an anti-CGRP antibody in
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`- 3 -
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`
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`IPR2018-01710, -01711, -01712
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`response to an Office Action. POPR 18-19; EX2005, 1823. There can be no
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`dispute: the examiner considered Tan's disclosure of anti-CGRP antagonist murine
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`antibodies and the rat saphenous nerve assay, the key teachings upon which Lilly
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`hangs its challenge4. The filed IDS noting the date on which Tan was considered
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`(EX2034, 480) is additional dispositive evidence that Tan was fully considered.
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`Instead of refuting this evidence, Lilly simply disagrees with the examiner's
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`decision to allow Teva's patents; but that does not justify institution. Apotex Inc. v.
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`Celgene Corp., IPR2018-00685, Paper 8, 26 (PTAB Sept. 27, 2018).
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`Lilly's reliance on Navistar (Reply, 5) and Vizio (Reply, 3 and 5) is
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`misplaced. Both cases are readily distinguishable. In Navistar and Vizio, the
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`examiner presented no §§ 102/103 rejections evincing consideration of the prior art
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`teachings. Navistar Inc. v. Fatigue Fracture Tech., LLC, IPR2018-00853, Paper 13
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`at 17; Vizio Inc. v. Nichia Corp., IPR2017-00551, Paper 9 at 8. Here, in contrast,
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`3 In Microsoft Corp. v. Koninklijke Philips N.V., the Board considered
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`references relied upon during prosecution of related patents relevant to its § 325(d)
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`analysis and denied institution. IPR2018-00279, Paper 11, 8-18.
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`4 Lilly ignores that the '045 patent's Corrected Notice of Allowance issued
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`the same day as the Notice of Allowance for the '649 patent. Reply FN4; EX2005,
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`278-280; EX2034, 542-544. The same examiner considered Teva's Tan arguments
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`in the '649 prosecution before allowing the '045 patent.
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`- 4 -
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`IPR2018-01710, -01711, -01712
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`the record demonstrates that the examiner considered prior art teachings and
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`addressed arguments the same as, or cumulative to, those presented in the Petition,
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`confirmed by the examiner's rejections and Teva's response thereto. POPR, 15-24.
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`This case is much closer to the facts before the Board in Microsoft and Indivior,
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`where the Board exercised its discretion to deny institution under § 325(d) given
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`the extensive prosecution before the examiner, the overlapping and cumulative
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`references cited in the petition, and the examiner's signed IDS. See, e.g., Microsoft,
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`IPR2018-00279, Paper 11, 8-18; Indivior, IPR2018-00795, Paper 23, 9.
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`Finally, Lilly has not demonstrated that the examiner erred when considering
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`Tan. To the contrary, Lilly actually admits that the sections from Tan presented to
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`the examiner during prosecution "appear to support [a] contention" that Tan
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`teaches away. Petition, 45. Nevertheless, Lilly wants this Board to disregard those
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`teachings and admissions, and instead rely upon unsupported speculation that Lilly
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`cobbled together from Tan. The Board should not do so.
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`II. Conclusion
`The POPR demonstrates that the Becton factors favor denial under § 325(d).
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`Lilly's Petition and Reply do not show otherwise.
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`Respectfully submitted,
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`
`Date: February 6, 2019
`
`
`
`Deborah A. Sterling, Ph.D. (Reg. No. 62,732)
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`- 5 -
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`
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`IPR2018-01710, -01711, -01712
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`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
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`I certify that the above-captioned "Patent Owner's Surreply to Petitioner's
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`Reply to Patent Owner's Preliminary Response" was served in its entirety on
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`February 6, 2019, upon the following parties via electronic mail:
`
`William B. Raich
`Erin M. Sommers
`Pier D. DeRoo
`Yieyie Yang
`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
`
`
`
`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 L.L.C.
`
`
`
`Deborah A. Sterling, Ph.D.
`Date: February 6, 2019
`1100 New York Avenue, N.W. Registration No. 62,732
`Washington, D.C. 20005-3934
`Lead Attorney for Patent Owner
`(202) 371-2600
`
`11153377_1.docx
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`- 6 -
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