Filed on behalf of: Eli Lilly and Company
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`Filed: December 24, 2018
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`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
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`ELI LILLY AND COMPANY
`Petitioner
`
`v.
`
`TEVA PHARMACEUTICALS INTERNATIONAL GMBH
`Patent Owner
`______________________
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`
`
`
`
`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
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`_____________________
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`PETITIONER’S REPLY TO PATENT OWNER’S POPR
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`1
`The word-for-word identical paper is filed in each proceeding identified in
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`the caption, pursuant to the Board’s order. For the Board’s convenience, citations
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`refer to papers filed in IPR2018-01422 involving Teva’s Patent No. 9,340,614.
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`Emphases are added unless otherwise noted.
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Filed: December 24, 2018
`
`______________________
`
`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
`
`_____________________
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`PETITIONER’S REPLY TO PATENT OWNER’S POPR
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`1
`The word-for-word identical paper is filed in each proceeding identified in
`
`the caption, pursuant to the Board’s order. For the Board’s convenience, citations
`
`refer to papers filed in IPR2018-01422 involving Teva’s Patent No. 9,340,614.
`
`Emphases are added unless otherwise noted.
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`
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`
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`IPR2018-01422, -01423, -01424, -01425, -01426, -01427
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`I.
`
`Introduction2
`Teva’s § 325(d) arguments are unavailing. First, none of Lilly’s asserted
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`references was used to reject any of the claims of the Teva patents during
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`prosecution. Second, the asserted references are not cumulative of those used to
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`reject the claims. Indeed, Lilly’s asserted references and expert testimony establish
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`an explicit motivation to humanize anti-CGRP antagonist antibodies, which Teva
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`argued was missing during prosecution. Third, Lilly also specifically addressed,
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`inter alia, how Teva’s one-sided arguments during prosecution regarding Tan 1995
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`were incorrect. Thus, the Becton factors strongly favor institution.
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`II. Lilly’s Asserted References Were Not Used to Reject Any Claims
`During prosecution of the six challenged patents, the Examiner did not reject
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`any claims over—or even mention—any of the asserted references: Tan 1995,
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`Queen, Wimalawansa, and Doods. Ex. 2005, 159-66. In fact, as Lilly’s cited
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`evidence demonstrates, Wimalawansa was not even of record until the last-to-issue
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`’210 and ’211 patents. Pet., 58 (citing Exs. 1176-1181); Ex. 2043, 255; Ex. 2042,
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`260. Thus, the Examiner did not consider Wimalawansa during examination of the
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`’649, ’614, ’881, and ’951 patents, much less in combination with Tan 1995,
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`Queen, and/or Doods. These facts weigh heavily against a § 325(d) denial.
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`Navistar, Inc. v. Fatigue Fracture Tech., LLC, IPR2018-00853, Paper 13 at 16-17
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`
`2
`Lilly does not acquiesce to any of Teva’s arguments not addressed herein.
`1
`
`
`
`
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`IPR2018-01422, -01423, -01424, -01425, -01426, -01427
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`(PTAB Sept. 12, 2018) (“[T]he fact that [references] were of record, but not
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`applied in any rejection by the Examiner . . . provides little impetus for us to
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`exercise our discretion” under §325(d)).3
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`III. Lilly’s Asserted References Are Not Cumulative of Pisegna and Frobert
`Wimalawansa is also not cumulative of the Pisegna and Frobert references
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`used to reject certain claims during prosecution of the ’649 patent. Teva asserts
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`that a “critical issue regarding patentability of the [challenged] patent[s] is whether
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`a POSA would have had a reason to humanize an anti-CGRP antibody.” POPR,
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`22-23 (emphasis in original). Wimalawansa provides that purportedly “critical”
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`disclosure, expressly describing humanized anti-CGRP antibodies (Ex. 1096, 567)
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`and stating that they “should be explored” for a variety of therapeutic applications
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`(id., 570). As explained by Dr. Charles in unrebutted expert testimony,
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`Wimalawansa “advocated for making and using humanized anti-CGRP antagonist
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`antibodies for therapeutic purposes.” Ex. 1008, ¶ 106 (emphasis in original). That
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`is precisely what Teva argued was missing from Pisegna and Frobert during
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`prosecution, contradicting Teva’s argument that Wimalawansa is cumulative. Ex.
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`1136, 3-4 (“Pisegna also does not cure the failure of Frobert to teach or suggest a
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`3
`Teva’s reliance on Omega and Microsoft v. Multi-Tech Sys., Inc. (POPR,
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`14-15) is misplaced. Those cases concern claim construction and prosecution
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`history estoppel, not § 325(d).
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`
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`2
`
`
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`IPR2018-01422, -01423, -01424, -01425, -01426, -01427
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`human or humanized anti-CGRP antagonist antibody”). Teva’s reversal of its
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`position about the teachings of the prior art, unsupported by expert testimony,
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`compels a trial on the merits. Coherus Biosci. Inc. v. AbbVie Biotech. Ltd.,
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`IPR2016-00172, Paper 9 at 19 (PTAB May 17, 2016) (“factual disputes [are] best
`
`resolved during trial”).4
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`Tan 1995 is also not cumulative of Frobert and Pisegna. Teva incorrectly
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`attempts to cabin Lilly’s reliance on Tan 1995 to its disclosure of murine anti-
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`CGRP antibodies. POPR, 23. But, as Lilly and its experts have established, Tan
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`1995 is not so limited. Indeed, Tan 1995 establishes that anti-CGRP antibodies (1)
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`may selectively bind human α-CGRP (and not amylin) (Pet., 17, 23); (2)
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`effectively block the CGRP pathway in vivo; (3) “clearly diffuse[] into the synaptic
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`cleft,” i.e., the site of action that Teva alleges is necessary for in vivo effectiveness
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`(Pet. 38-43; Ex. 1022, 571); and (4) were known alternatives to using receptor
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`4
`Sveinsson, Salmon, and the ’438 patent, like Wimalawansa, further
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`demonstrate the motivation in the art to humanize anti-CGRP antibodies. Pet.,
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`24-27, 43. Teva did not respond to these references under § 325(d) and instead
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`incorrectly argued that the Board should ignore them. POPR, 29-30; Genzyme
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`Therapeutic Prods. Ltd. P’ship v. Biomarin Pharm. Inc., 825 F.3d 1360, 1369
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`(Fed. Cir. 2016) (the Board should consider references illustrating the state of the
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`art under § 103).
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`
`
`3
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`
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`IPR2018-01422, -01423, -01424, -01425, -01426, -01427
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`antagonists—a class of compounds Teva discusses at length (POPR, 4-10)—for
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`blocking the CGRP pathway. Pet., 17-18, 23, 27-29, 38-43; Ex. 1008, ¶ 114 (citing
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`Ex. 1022, 571).
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`Neither Frobert nor Pisegna contains any of these disclosures. Nor do they
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`describe Tan 1995’s in vivo testing or its guidance to use higher doses and longer
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`distribution times, which Teva followed in its specification’s examples. Pet., 38-
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`43; Ex. 1008, ¶¶ 91-103. Rather, Frobert relates to an immunoassay for measuring
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`CGRP, while Pisegna describes antibodies targeting the CGRP receptor as Teva
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`argued during prosecution (rather than anti-CGRP antibodies like Tan 1995 and
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`Wimalawansa). Ex. 1032, 275; Ex. 2005, 181-82; e.g., Ex. 2049, ¶¶ [0002], [0009].
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`Teva’s argument about Queen’s humanization processes is also irrelevant
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`because Teva itself concedes that preparing humanized antibodies was “known”
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`and “conventional.” POPR, 19; Pet., 7 (citing Ex. 1001, 27:61-67, 29:8-31).
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`Teva also fails to explain how the one art-based rejection made in the
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`earliest application is applicable to all the claims (no matter the limitations) that
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`issued from the same family. Vizio, Inc. v. Nichia Corp., IPR2017-00551, Paper 9
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`at 8 (PTAB July 7, 2017) (rejecting § 325(d) argument where there was “no
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`evidence that the Examiner considered[] [the prior art] in the context of the claims
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`of the [challenged] patent”). In contrast, Lilly addresses each claim limitation and
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`how the prior art renders obvious the claims as a whole. Pet., §§ VII-VIII.
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`
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`4
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`IPR2018-01422, -01423, -01424, -01425, -01426, -01427
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`IV. Lilly’s Petition and Experts Addressed the Errors in Prosecution
`Teva incorrectly asserts that Lilly did not explain how the Examiner erred in
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`allegedly evaluating Tan 1995 during prosecution of the ’649 patent. POPR, 24.
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`Teva’s assertions are misleading because the Examiner failed to make any
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`statements about Tan 1995 (or Wimalawansa, Queen, or Doods). See Ex. 2005.
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`Nevertheless, Lilly addressed Teva’s one-sided arguments to the Examiner based
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`on selected portions of Tan 1995, explaining that Teva’s arguments were
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`incomplete and incorrect. Pet., 38-43 (citing Ex. 1008, ¶¶ 91-103, 122; Ex. 1009,
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`¶¶ 87-88). Lilly submits that it would be inappropriate to exercise discretion here,
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`where there is “no evidence that the Examiner considered . . . the particular
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`disclosures [of Tan 1995] cited by Petitioner in the Petition or addressed arguments
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`similar to those Petitioner now presents before the Board.” Vizio, IPR2017-00551,
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`Paper 9 at 8; see also Navistar, IPR2018-00853, Paper 13 at 18 (declining to
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`speculate on whether the Examiner considered a reference).
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`V. Conclusion
`Lilly respectfully submits that the Becton factors weigh in favor of
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`institution and requests that the Board grant Lilly’s Petitions.
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`Respectfully submitted,
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`Date: December 24, 2018
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`By: /William B. Raich/
`William B. Raich (Reg. No. 54,386)
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`
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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
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`The undersigned certifies that a copy of the foregoing Petitioner’s Reply to
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`Patent Owner’s POPR was served electronically via email on December 24,
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`2018, in its entirety on the following:
`
`Deborah A. Sterling
`Robert C. Millonig
`Gaby L. Longsworth
`Jeremiah B. Frueauf
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`1100 New York Avenue, NW
`Washington, DC 20005
`dsterling-PTAB@sternekessler.com
`bobm-PTAB@sternekessler.com
`glongs-PTAB@sternekessler.com
`jfrueauf-PTAB@sternekessler.com
`
`
`Patent Owner has consented to service by email.
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`
`
`Date: December 24, 2018
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`
`
`
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`By: /William Esper/
`William Esper
`Litigation Legal Assistant
`
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
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`
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