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`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 No. IPR2018-01425
`Patent No. 9,890,210
`______________________
`
`PETITIONER’S OPPOSITION TO
`PATENT OWNER’S MOTION TO STRIKE
`
`
`
`IPR2018-01425
`Patent No. 9,890,210
`
`I.
`
`Introduction
`Lilly’s Reply, accompanying exhibits, and supporting declarations respond to
`
`new issues raised in Teva’s POR and by Teva’s experts and therefore are within the
`
`proper scope of a reply. Teva claims that Lilly’s Reply and exhibits “present new
`
`evidence and theories of invalidity,” but there is nothing to support those conclusory
`
`statements. Instead, Teva uses its Motion to argue its substantive validity positions
`
`and level unsupported attacks on Lilly’s experts. Teva’s Motion should be denied.
`
`II. Argument
`A petitioner in an IPR proceeding may introduce arguments at the reply stage
`
`in response to arguments raised in a POR. Anacor Pharm., Inc. v. Iancu, 889 F.3d
`
`1372, 1380-81 (Fed. Cir. 2018); 37 C.F.R. § 42.23(b). The Board routinely allows
`
`new evidence, including declarations from new experts, in reply. See, e.g., Belden
`
`Inc. v. Berk–Tek LLC, 805 F.3d 1064, 1078 (Fed. Cir. 2015). New reply evidence is
`
`also appropriate if it is used “to document the knowledge that skilled artisans would
`
`bring to bear in reading the prior art identified as producing obviousness.” Anacor,
`
`889 F.3d at 1380-81.
`
`Striking portions of a party’s brief is “an exceptional remedy” not warranted
`
`here. A reply or reply evidence may be excluded if it introduces an entirely new
`
`theory of obviousness or new evidence that is necessary to make out a prima facie
`
`case of patentability. Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d
`
`1
`
`
`
`IPR2018-01425
`Patent No. 9,890,210
`1359, 1369-70 (Fed. Cir. 2016). By contrast, exclusion is inappropriate where, as
`
`here, a reply “expands the same argument made in its Petition.” Ericsson Inc. v.
`
`Intellectual Ventures I LLC, 901 F.3d 1374, 1381 (Fed. Cir. 2018).
`
`A. Exhibit 1287 and Related Sections of Lilly’s Reply
`Exhibit 1287 and Lilly’s related argument (Reply, 3, 11) are directly
`
`responsive to assertions newly made in Teva’s POR. Teva and its experts incorrectly
`
`argued that Tan 1995, an asserted reference, was a “basic research paper” that would
`
`not have motivated a POSA to make humanized antibodies. POR, 2, 4, 14, 39, 42;
`
`Ex. 2213, ¶¶ 61, 63-64; Ex. 2231, ¶¶ 50, 77. Teva further alleged to have personal
`
`knowledge of co-authors of the Tan references, implying they never considered
`
`antibody humanization. POR, 42; Ex. 2213, ¶¶ 70, 76. Teva also argued that certain
`
`blood pressure data presented in Tan 1995 would have discouraged further research.
`
`POR, 22-25, 38-39.
`
`Exhibit 1287, which was written by Dr. Tan in 1994 and describes his and his
`
`co-authors’ work in Tan 1995, directly contradicts Teva’s arguments. With first-hand
`
`knowledge of the blood pressure results in Tan 1995, Dr. Tan wrote there was “no
`
`reason” why humanized anti-CGRP monoclonal antibodies should not be
`
`investigated and used as “therapeutic agents” for migraine and other diseases.
`
`Ex. 1287, 247; Reply, 11. Exhibit 1287 is therefore proper reply evidence.
`
`2
`
`
`
`IPR2018-01425
`Patent No. 9,890,210
`Teva’s Motion mischaracterizes Lilly’s Reply as using Ex. 1287 as “an alleged
`
`‘contemporaneous’ teaching of motivation.” The actual text of Lilly’s Reply is clear:
`
`for “further motivation,” it cites only the Petition, Tan 1994 (Ex. 2021), Tan 1995
`
`(Ex. 2022), and Ex. 1303. Reply, 3. Exhibit 1287 is included to provide contextual
`
`information, made necessary by Teva’s allegations that blood pressure readouts
`
`reported in Tan 1995 would have raised safety concerns. See, e.g., Ex. 2231, ¶¶ 77-
`
`82. This is explained at page 11 of Lilly’s Reply, which Teva fails to address.
`
`Thus, Ex. 1287 and its use in Lilly’s Reply are plainly proper rebuttal. Belden,
`
`805 F.3d at 1082 (“the function of rebuttal [is] to explain, repel, counteract, or
`
`disprove the evidence of the adverse party”).
`
`B.
`
`Lilly’s Evidence and Discussion of Aptamers Is Properly
`Responsive to Teva’s POR
`Teva incorrectly seeks to strike evidence and reply briefing concerning
`
`CGRP-binding aptamers (Reply, 9; Ex. 1082; Ex. 1240; Ex. 1309; Ex. 1325, ¶¶ 38,
`
`51, 52, 54, 60, 69; Ex. 1326, ¶¶ 17, 31, 74, 77). But Lilly properly used that evidence
`
`to directly respond to multiple Teva arguments.
`
`Teva argued that a POSA would have had safety concerns associated with
`
`directly antagonizing CGRP, particularly for compounds with a long half-life. POR,
`
`20-29; Ex. 2231, ¶¶ 73-82; Ex. 2213, ¶¶ 12, 27-70. Teva further argued a POSA
`
`would not have targeted CGRP, as opposed to its receptor, because of (1)
`
`hypothetical safety concerns about preventing CGRP from binding to receptors other
`
`3
`
`
`
`IPR2018-01425
`Patent No. 9,890,210
`than the CGRP-receptor (cross-binding) and (2) hypothetical efficacy concerns
`
`based on the “spare receptor theory.” POR, 29-31; Ex. 2231, ¶¶ 23-42, 88-95.
`
`Lilly rebuts those positions in part with evidence that CGRP-binding
`
`aptamers—recognized in the prior art as “analogs to antibodies”—were being
`
`developed to treat migraine. These aptamers had long half-lives yet displayed no
`
`safety risks. Reply, 9; Ex. 1082; Ex. 1240; Ex. 1309; Ex. 1325, ¶¶ 48-70; Ex. 1326,
`
`¶¶ 17, 31, 74, 77. Lilly’s Reply further cites this aptamer evidence to illustrate the
`
`unsupported and hypothetical nature of Teva’s “spare receptor” and cross-binding
`
`arguments, as notwithstanding Teva’s purported concerns researchers were actually
`
`developing anti-migraine agents targeting CGRP directly. Reply, 16-18; Ex. 1325,
`
`¶¶ 40-47; Ex. 1326, ¶¶ 17, 65-75.
`
`Teva misleadingly refers to Lilly’s rebuttal evidence related to aptamers as
`
`“an entirely new theory based on aptamers.” Teva is incorrect. The fact that evidence
`
`related to aptamers contradicts more than one of Teva’s new arguments does not
`
`make it a “new theory.” Moreover, Teva ignores Dr. Charles’s (and Tan’s) position
`
`that targeting the CGRP ligand or its receptor were “alternative, complementary
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`strategies.” Ex. 1010, ¶ 115; Ex. 1022, 566, 571. Researchers’ pursuit of CGRP-
`
`binding aptamers provides further objective evidence that CGRP antagonism and
`
`CGRP-receptor antagonism were in fact considered alternatives.
`
`Thus, Lilly’s Reply arguments and evidence relating to aptamers are wholly
`
`4
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`
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`IPR2018-01425
`Patent No. 9,890,210
`
`proper and there is no basis to strike them.
`
`C. Dr. Balthasar’s Declaration and Related Sections of Lilly’s Reply
`Teva raised new arguments related to antibody distribution to the synaptic
`
`cleft (POR, 37-38; Ex. 2231, ¶¶ 49-55), and now incorrectly seeks to strike portions
`
`of Lilly’s Reply and Dr. Balthasar’s declaration addressing this issue (Reply, 19-20;
`
`Ex. 1325, ¶¶ 15-34).
`
`The record does not support Teva’s criticism of Dr. Charles or its argument
`
`that Dr. Balthasar’s testimony is used to “shore up” Lilly’s invalidity arguments. Dr.
`
`Balthasar, an antibody pharmacology expert, responds to arguments raised in Dr.
`
`Foord’s declaration, as Teva has acknowledged. See Ex. 2262, 10:7-11. Dr.
`
`Balthasar’s declaration properly contradicts Dr. Foord’s unsupported opinions,
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`explaining how Tan’s encouraging results were consistent with known antibody
`
`pharmacokinetics and how access to the synaptic cleft would not have been a
`
`concern to a POSA. Ex. 1325, ¶¶ 15-34. Moreover, Teva’s admission that Drs.
`
`Charles’s and Balthasar’s testimony is consistent undercuts Teva’s view of Dr.
`
`Charles, as both his opinions and those of Dr. Balthasar are rooted in the prior art.
`
`III. Conclusion
`Teva’s Motion to Strike should be denied.
`
`Respectfully submitted,
`
`Date: October 9, 2019
`
`By: / William B. Raich /
`William B. Raich (Reg. No. 54,386)
`
`
`
`5
`
`
`
`IPR2018-01425
`Patent No. 9,890,210
`
`CERTIFICATE OF SERVICE
`The undersigned certifies that a copy of the foregoing Petitioner’s
`
`Opposition to Patent Owner’s Motion to Strike was served electronically via
`
`email on October 9, 2019, in its entirety on the following:
`
`Deborah A. Sterling
`Robert C. Millonig
`Gaby L. Longsworth
`Jeremiah B. Frueauf
`Olga A. Partington
`Dennies Varughese
`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
`opartington-PTAB@sternekessler.com
`dvarughe-PTAB@sternekessler.com
`
`
`Patent Owner has consented to service by email.
`
`
`
`
`
`
`
`By: / William Esper /
`William Esper
`Litigation Legal Assistant
`
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`
`
`
`
`Date: October 9, 2019
`
`
`
`
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