`
`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 IPR2018-01422 (Patent No. 9,340,614)
`Case IPR2018-01423 (Patent No. 9,266,951)
`Case IPR2018-01424 (Patent No. 9,346,881)
`Case IPR2018-01425 (Patent No. 9,890,210)
`Case IPR2018-01426 (Patent No. 9,890,211)
`Case IPR2018-01427 (Patent No. 8,597,649)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 is filed in each proceeding identified in the caption. Citations refer to
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`papers filed in IPR2018-01422. Emphases are added unless otherwise noted.
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`
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`IPR2018-01422, -01423, -01424, -01425, -01426, -01427
`
`I.
`
`Introduction
`
`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).
`
`Lilly’s Reply does not overcome these fatal deficiencies, nor otherwise provide
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`any 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
`
`Lilly states unremarkably that the examiner did not combine the specific
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`references cited in the Petition—Tan 1995, Wimalawansa, Queen, and Doods.2
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`Reply 1-2. This, however, is legally irrelevant because the teachings from Lilly’s
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`cited references are the same as, or cumulative of, those the examiner considered.
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`The Board routinely denies institution under § 325(d) for this reason. Cultec Inc. v
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`Stormtech LLC, IPR2017-00777, Paper 7 (PTAB Aug. 22, 2017); see also Unified
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`Patents Inc. v. John L. Berman, IPR2016-01571, Paper 10 (PTAB Dec.14, 2016);
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`Dorco Co. v. Gillette Co, IPR2017-00500, Paper 7 (PTAB June 21, 2017); and
`
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`2 Lilly admits that Queen’s teachings are in the patents’ specification, adding
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`nothing material to its arguments. Petition, 7-8; Reply, 4. Lilly does not dispute
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`that the examiner filed an IDS noting the date on which he considered Doods
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`(EX2040, 350), conceding that Doods was already considered during prosecution.
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`- 1 -
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`
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`IPR2018-01422, -01423, -01424, -01425, -01426, -01427
`
`Indivior Inc. v. Rhodes Pharms, L.P., IPR2018-00795, Paper 23 (PTAB Oct. 4,
`
`2018). The Board should deny institution here.
`
`1. Wimalawansa is cumulative of art the examiner considered
`and applied in prosecution
`Lilly asserts that Wimalawansa “advocated for making and using humanized
`
`anti-CGRP antagonist antibodies for therapeutic purposes.” Reply, 2 (emphasis in
`
`original). However, the examiner relied on other references—Frobert and
`
`Pisegna—for that same proposition, when initially rejecting all claims as obvious.
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`EX2005, 162-64; EX2050, 10. Indeed, Lilly acknowledges that Frobert teaches
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`anti-CGRP antibodies (EX2050, 10-11) and that Pisegna taught that “humanized
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`antibodies are desirable for therapeutic applications,” just like Wimalawansa. Id.,
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`11. Notably, Teva even highlighted this exact teaching for the examiner during
`
`prosecution. EX2005, 181-182. Tellingly, Wimalawansa suffers from the same
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`deficiency as Pisegna: it focused on targeting CGRP receptors, not CGRP itself.
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`EX1096, 568 (“[T]he antagonist must be extremely specific to the CGRP receptors
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`… to avoid potential deleterious side effects caused by blocking other … CGRP
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`receptors.”). Lilly is incorrect that Wimalawansa provides a “critical” disclosure
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`missing from the art before the examiner. Instead, Lilly simply seeks to substitute
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`the general, but deficient teaching from one reference with the same general, but
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`deficient teaching in another reference. Wimalawansa is cumulative of the prior art
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`teachings already considered and applied in prosecution.
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`- 2 -
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`
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`IPR2018-01422, -01423, -01424, -01425, -01426, -01427
`
`2.
`
`The examiner expressly considered Tan 1995 during
`prosecution and Lilly does not show that the examiner erred
`when doing so
`
`Lilly readily admits that a number of Tan’s teachings are cumulative to
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`Frobert. Reply, 3. Yet, Lilly argues—ineffectively—that Tan 1995 is not “fully”
`
`cumulative to Frobert and Pisegna. Id., 3-4. Even assuming Lilly is correct—which
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`it is not—its argument is irrelevant because Tan 1995 itself was squarely before the
`
`Office and discussed during prosecution, as fully explained in the POPR. POPR,
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`15-17. The patents’ specification cites Tan 1995 for teaching anti-CGRP antibodies
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`(EX1001, 25:66-26:1) and when describing the rat saphenous nerve assay (id.,
`
`55:65-56:1). Moreover, Applicant expressly highlighted that Tan 1995’s rat
`
`saphenous nerve assay results provided no motivation to humanize an anti-CGRP
`
`antibody in response to an Office Action. POPR 16-17; EX2005, 1823. Thus, there
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`can be no dispute that the examiner already considered Tan 1995’s disclosure of
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`anti-CGRP antagonist antibodies and the rat saphenous nerve assay, the key
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`disclosures upon which Lilly hangs its challenge.
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`The filed IDS noting the date on which Tan 1995 was considered (EX2040,
`
`362) is additional dispositive evidence that Tan 1995 was fully considered. Instead
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`3 In Microsoft Corp. v. Koninklijke Philips N.V., the Board considered
`
`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 at 8-18.
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`- 3 -
`
`
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`IPR2018-01422, -01423, -01424, -01425, -01426, -01427
`
`of refuting this evidence, Lilly simply disagrees with the examiner’s decision to
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`allow Teva’s patents; but that does not justify institution. Apotex Inc. v. Celgene
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`Corp., IPR2018-00685, Paper 8 at 26 (PTAB Sept. 27, 2018). Lilly’s reliance on
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`Navistar (Reply 1-2, and 5) and Vizio (Reply at 4, 5) is misplaced. Both cases are
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`readily distinguishable.
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`In Navistar and Vizio, the examiner presented no §§ 102/103 rejections
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`evincing consideration of the prior art teachings. Navistar Inc. v. Fatigue Fracture
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`Tech., LLC, IPR2018-00853, Paper 13 at 17; Vizio Inc. v. Nichia Corp., IPR2017-
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`00551, Paper 9 at 8. Here, in contrast, the record demonstrates that the examiner
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`considered prior art teachings and addressed arguments the same as, or cumulative
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`to, those presented in the Petition, confirmed by the examiner’s rejections and
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`Teva’s response thereto. POPR, 15-24. This case is therefore much closer to the
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`facts before the Board in Microsoft and Indivior, where the Board exercised its
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`discretion to deny institution under § 325(d) given the extensive prosecution before
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`the examiner, the overlapping and cumulative references cited in the petition, and
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`the examiner’s signed IDS. See, e.g., Microsoft, IPR2018-00279, Paper 11 at 8-18;
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`Indivior, IPR2018-00795, Paper 23 at 9.
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`Finally, Lilly has not demonstrated that the examiner erred when considering
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`Tan 1995. To the contrary, Lilly actually admits that the sections from Tan 1995
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`presented to the examiner during prosecution “appear to support [a] contention”
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`- 4 -
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`
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`IPR2018-01422, -01423, -01424, -01425, -01426, -01427
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`that Tan teaches away. Petition, 40. Nevertheless, Lilly wants this Board to
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`disregard those teachings, and instead rely upon unsupported speculation that Lilly
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`cobbled together from Tan 1995. The Board should not do so.
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`B.
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`Teva has not reversed its position about the teachings of the prior art
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`In an attempt to create a factual dispute where none exists, Lilly’s Reply
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`disingenuously contends that Teva reversed its position concerning the prior art
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`teachings. Reply 2-3. Not so. Teva has consistently advanced, both in prosecution
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`and in this proceeding, the same position: the prior art teachings raised in
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`prosecution—in Frobert, Pisegna, and Tan 1995—do not provide any motivation to
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`humanize an anti-CGRP antibody. Although Frobert taught anti-CGRP antibodies
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`and Pisegna suggested humanizing anti-CGRP receptor antibodies, Tan’s rat
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`saphenous nerve assay results taught away from humanizing an anti-CGRP
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`antibody for therapeutic purposes. EX2005, 182. Those same teachings in this IPR,
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`through Wimalawansa and Tan 1995, still do not provide motivation to humanize
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`an anti-CGRP antibody. POPR, 34-62. Teva’s positions remain consistent.
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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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`
`/Deborah A. Sterling/
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C
`Deborah A. Sterling, Ph.D. (Reg. No. 62,732)
`
`
`
`Date: January 4, 2019
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`- 5 -
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`
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`IPR2018-01422, -01423, -01424, -01425, -01426, -01427
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`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
`
`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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`January 4, 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: January 4, 2019
`1100 New York Avenue, N.W. Registration No. 62,732
`Washington, D.C. 20005-3934
`Lead Attorney for Patent Owner
`(202) 371-2600
`
`
`
`- 6 -
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