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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. IPR2018-01711
`Patent No. 9,884,907
`______________________
`
`PETITIONER’S OPPOSITION TO
`PATENT OWNER’S MOTION TO STRIKE
`
`
`
`IPR2018-01711
`Patent No. 9,884,907
`
`I.
`
`Introduction
`Lilly’s Reply, accompanying exhibits, and supporting declarations respond to
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`new issues raised in Teva’s POR and by Teva’s experts and therefore are within the
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`proper scope of a reply. Teva claims that Lilly’s Reply and exhibits “present new
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`evidence and theories of invalidity,” but there is nothing to support those conclusory
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`statements. Instead, Teva uses its Motion to argue its substantive validity positions
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`and level unsupported attacks on Lilly’s experts. Teva’s Motion should be denied.
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`II. Argument
`A petitioner in an IPR proceeding may introduce arguments at the reply stage
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`in response to arguments raised in a POR. Anacor Pharm., Inc. v. Iancu, 889 F.3d
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`1372, 1380-81 (Fed. Cir. 2018); 37 C.F.R. § 42.23(b). The Board routinely allows
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`new evidence, including declarations from new experts, in reply. See, e.g., Belden
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`Inc. v. Berk–Tek LLC, 805 F.3d 1064, 1078 (Fed. Cir. 2015). New reply evidence is
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`also appropriate if it is used “to document the knowledge that skilled artisans would
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`bring to bear in reading the prior art identified as producing obviousness.” Anacor,
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`889 F.3d at 1380-81.
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`Striking portions of a party’s brief is “an exceptional remedy” not warranted
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`here. See Trial Practice Guide Update, 17-18 (August 2018). A reply or reply
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`evidence may be excluded if it introduces an entirely new theory of obviousness or
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`new evidence that is necessary to make out a prima facie case of patentability.
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`1
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`
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`IPR2018-01711
`Patent No. 9,884,907
`Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369-70 (Fed.
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`Cir. 2016) (“Illumina”). By contrast, exclusion is inappropriate where, as here, a
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`reply “expands the same argument made in its Petition.” Ericsson Inc. v. Intellectual
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`Ventures I LLC, 901 F.3d 1374, 1381 (Fed. Cir. 2018).
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`A. Exhibit 1287 and Related Sections of Lilly’s Reply
`Exhibit 1287 and Lilly’s related argument (Reply, 6, 16) are directly
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`responsive to assertions newly made in Teva’s POR. Tan 1995 reports on the in vivo
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`activity of anti-CGRP antibodies with defined specificity, known affinity,
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`reproducibility, and unlimited availability. Pet. 16-17. Teva and its experts
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`nevertheless incorrectly argued that Tan 1995, an asserted reference, was a “basic
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`research paper” that would not have motivated a POSA to make humanized
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`antibodies. POR, 2, 4, 15; Ex. 2269 ¶¶ 138, 140; Ex. 2266 ¶¶ 15, 83, 87, 92. Teva
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`further alleged to have personal knowledge of co-authors of the Tan references,
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`implying they never considered antibody humanization. Ex. 2269 ¶ 147. Teva also
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`argued that certain blood pressure data presented in Tan 1995 would have
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`discouraged further research. POR, 5, 27-28.
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`Exhibit 1287, which was written by Dr. Tan in 1994 and describes his and his
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`co-authors’ work in Tan 1995, directly contradicts Teva’s arguments. With first-hand
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`knowledge of the blood pressure results in Tan 1995, Dr. Tan wrote there was “no
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`reason” why humanized anti-CGRP monoclonal antibodies should not be
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`2
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`IPR2018-01711
`Patent No. 9,884,907
`investigated and used as “therapeutic agents” for migraine. Ex. 1287, 247; Reply, 16.
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`Contradicting Teva’s reliance on purported personal knowledge of Tan 1995’s
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`authors, Exhibit 1287 makes clear that Dr. Tan believed humanized anti-CGRP
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`antagonist antibodies should be developed notwithstanding the blood pressure data
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`Teva focused on in its POR. Exhibit 1287 is therefore proper reply evidence.
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`Moreover, Lilly’s use of Exhibit 1287 does not require it to qualify as a “printed
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`publication,” as Teva contends (although Teva’s Motion fails to undermine public
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`availability). See Mot., 2.
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`Contrary to Teva’s argument, Exhibit 1287 is not “filling a hole” in Lilly’s
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`primary case. The Illumina decision relied on by Teva is illustrative. There, the
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`petition asserted that there was motivation to use reaction conditions disclosed in
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`Zavgorodny (a prior art reference). 821 F.3d at 1368-69. Reversing course,
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`petitioner’s reply asserted there was no motivation to use the Zavgorodny reaction
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`conditions; rather, the reply argued one would modify the disclosure in Zavgorodny,
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`citing an entirely new expert report and supporting evidence. Id.
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`Here, the Petition’s strong case of obviousness stands on its own. Lilly’s Reply
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`maintains the same positions and relies on the same core prior art. The Reply uses
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`Exhibit 1287 to correct Teva’s post-hoc characterizations of Tan 1995 as well as
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`Teva’s allegation that the authors of Tan were not considering “targeting CGRP,
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`much less targeting CGRP with an antibody for clinical use in human patients.” Ex.
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`3
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`IPR2018-01711
`Patent No. 9,884,907
`2269, ¶ 147. Since Teva created this inaccurate portrayal, it is only appropriate that
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`Dr. Tan’s own statements be allowed to correct the record. Belden, 805 F.3d at 1082
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`(“the function of rebuttal [is] to explain, repel, counteract, or disprove the evidence
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`of the adverse party”).
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`B. Dr. Balthasar’s Declaration and Related Sections of Lilly’s Reply
`Teva raised new arguments related to antibody distribution to the synaptic
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`cleft (POR, 36-37; Ex. 2266, ¶¶ 82-91), and now incorrectly seeks to strike portions
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`of Lilly’s Reply and Dr. Balthasar’s declaration addressing this issue (Reply, 10-12;
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`Ex. 1339, ¶¶ 22, 24-25, 30-33).
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`Tan 1995 states that “IgG should eventually distribute to interstitial space and
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`achieve . . . concentrations required for immunoblockade.” Ex. 1022, 571. It further
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`states that antibody “clearly diffuses into the synaptic cleft.” Id.; Pet. 45. Teva and
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`its expert Dr. Foord nevertheless argued that antibody would not reach the synaptic
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`cleft. POR, 37; Ex. 2266, ¶¶ 82-91.
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`Lilly’s Reply and Dr. Balthasar’s declaration respond to Teva’s argument with
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`evidence that, consistent with the statements in Tan 1995, a POSA would have
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`expected longer distribution times and/or higher doses to improve distribution of
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`full-length antibodies to the synaptic cleft. Reply, 10-11; Ex. 1339 ¶¶ 24-34; Ex.
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`1022, 571; Ex. 1247, 3972. The challenged portions of Lilly’s Reply and Dr.
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`Balthasar’s declaration detail the errors and shortcomings of Teva’s and Dr. Foord’s
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`4
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`
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`IPR2018-01711
`Patent No. 9,884,907
`analyses, making them plainly responsive. Reply, 11 (Teva’s “synaptic cleft
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`arguments are meritless”); Ex. 1339, ¶ 22 (“Dr. Foord’s arguments about antibody
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`distribution are incorrect.”).
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`Moreover, the record does not support Teva’s criticism of Dr. Charles or its
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`argument that Dr. Balthasar’s testimony is used to “shore up” Lilly’s invalidity
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`arguments. In support of Lilly’s Petition, Dr. Charles opined that a full-length
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`antibody would be expected to achieve immunoblockade by distributing to its site
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`of action. Ex. 1016, ¶ 60. Now Dr. Balthasar properly “expands the same argument
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`made in the Petition” concerning antibody efficacy, specifically that full-length
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`antibodies would distribute to the synaptic cleft. Ericsson, 901 F.3d at 1381. That
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`Dr. Balthasar’s declaration “further support[s] its original argument that there was
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`motivation to arrive at the claimed methods” (Mot., 4) is permissible, and indeed,
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`unsurprising. Belden, 805 F.3d at 1079 (“Evidence admitted in rebuttal to respond to
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`the patent owner’s criticisms will commonly confirm the prima facie case.”)
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`III. Conclusion
`Because Teva seeks to strike Lilly’s argument and evidence that directly
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`respond to arguments raised in Teva’s POR and supporting exhibits, the Motion to
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`Strike should be denied.
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`Respectfully submitted,
`
`Date: October 29, 2019
`
`By: / William B. Raich /
`William B. Raich (Reg. No. 54,386)
`
`
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`5
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`IPR2018-01711
`Patent No. 9,884,907
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`CERTIFICATE OF SERVICE
`The undersigned certifies that a copy of the foregoing Petitioner’s
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`Opposition to Patent Owner’s Motion to Strike was served electronically via
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`email on October 29, 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.
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`
`
`By: / William Esper /
`William Esper
`Litigation Legal Assistant
`
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`
`
`
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`Date: October 29, 2019
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