`
`
`
`
`
`
`
`
`
`
`
`
`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. IPR2018-01710
`Patent No. 8,586,045
`______________________
`
`PETITIONER’S OPPOSITION TO
`PATENT OWNER’S MOTION TO STRIKE
`
`
`
`IPR2018-01710
`Patent No. 8,586,045
`
`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. See Trial Practice Guide Update, 17-18 (August 2018). 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.
`
`1
`
`
`
`IPR2018-01710
`Patent No. 8,586,045
`Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369-70 (Fed.
`
`Cir. 2016) (“Illumina”). 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, 6, 15) are directly
`
`responsive to assertions newly made in Teva’s POR. Tan 1995 reports on the in vivo
`
`activity of anti-CGRP antibodies with defined specificity, known affinity,
`
`reproducibility, and unlimited availability. Pet. 16-17. Teva and its experts
`
`nevertheless 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, 14-15; Ex. 2268 ¶¶ 138, 140; Ex. 2265 ¶¶ 15, 83, 87, 92. Teva
`
`further alleged to have personal knowledge of co-authors of the Tan references,
`
`implying they never considered antibody humanization. Ex. 2268 ¶ 147. Teva also
`
`argued that certain blood pressure data presented in Tan 1995 would have
`
`discouraged further research. POR, 5, 27-28.
`
`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
`
`2
`
`
`
`IPR2018-01710
`Patent No. 8,586,045
`investigated and used as “therapeutic agents” for migraine. Ex. 1287, 247; Reply, 15.
`
`Contradicting Teva’s reliance on purported personal knowledge of Tan 1995’s
`
`authors, Exhibit 1287 makes clear that Dr. Tan believed humanized anti-CGRP
`
`antagonist antibodies should be developed notwithstanding the blood pressure data
`
`Teva focused on in its POR. Exhibit 1287 is therefore proper reply evidence.
`
`Moreover, Lilly’s use of Exhibit 1287 does not require it to qualify as a “printed
`
`publication,” as Teva contends (although Teva’s Motion fails to undermine public
`
`availability). See Mot., 2.
`
`Contrary to Teva’s argument, Exhibit 1287 is not “filling a hole” in Lilly’s
`
`primary case. The Illumina decision relied on by Teva is illustrative. There, the
`
`petition asserted that there was motivation to use reaction conditions disclosed in
`
`Zavgorodny (a prior art reference). 821 F.3d at 1368-69. Reversing course,
`
`petitioner’s reply asserted there was no motivation to use the Zavgorodny reaction
`
`conditions; rather, the reply argued one would modify the disclosure in Zavgorodny,
`
`citing an entirely new expert report and supporting evidence. Id.
`
`Here, the Petition’s strong case of obviousness stands on its own. Lilly’s Reply
`
`maintains the same positions and relies on the same core prior art. The Reply uses
`
`Exhibit 1287 to correct Teva’s post-hoc characterizations of Tan 1995 as well as
`
`Teva’s allegation that the authors of Tan were not considering “targeting CGRP,
`
`much less targeting CGRP with an antibody for clinical use in human patients.” Ex.
`
`3
`
`
`
`IPR2018-01710
`Patent No. 8,586,045
`2268, ¶ 147. Since Teva created this inaccurate portrayal, it is only appropriate that
`
`Dr. Tan’s own statements be allowed to correct the record. Belden, 805 F.3d at 1082
`
`(“the function of rebuttal [is] to explain, repel, counteract, or disprove the evidence
`
`of the adverse party”).
`
`B. Dr. Balthasar’s Declaration and Related Sections of Lilly’s Reply
`Teva raised new arguments related to antibody distribution to the synaptic
`
`cleft (POR, 36-37; Ex. 2265, ¶¶ 82-91), and now incorrectly seeks to strike portions
`
`of Lilly’s Reply and Dr. Balthasar’s declaration addressing this issue (Reply, 10-11;
`
`Ex. 1337, ¶¶ 22, 24-25, 30-33).
`
`Tan 1995 states that “IgG should eventually distribute to interstitial space and
`
`achieve . . . concentrations required for immunoblockade.” Ex. 1022, 571. It further
`
`states that antibody “clearly diffuses into the synaptic cleft.” Id.; Pet. 45. Teva and
`
`its expert Dr. Foord nevertheless argued that antibody would not reach the synaptic
`
`cleft. POR, 37; Ex. 2265, ¶¶ 82-91.
`
`Lilly’s Reply and Dr. Balthasar’s declaration respond to Teva’s argument with
`
`evidence that, consistent with the statements in Tan 1995, a POSA would have
`
`expected longer distribution times and/or higher doses to improve distribution of
`
`full-length antibodies to the synaptic cleft. Reply, 10-11; Ex. 1337 ¶¶ 24-34; Ex.
`
`1022, 571; Ex. 1247, 3972. The challenged portions of Lilly’s Reply and Dr.
`
`Balthasar’s declaration detail the errors and shortcomings of Teva’s and Dr. Foord’s
`
`4
`
`
`
`IPR2018-01710
`Patent No. 8,586,045
`analyses, making them plainly responsive. Reply, 11 (Teva’s “synaptic cleft
`
`arguments are meritless”); Ex. 1337, ¶ 22 (“Dr. Foord’s arguments about antibody
`
`distribution are incorrect.”).
`
`Moreover, 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. In support of Lilly’s Petition, Dr. Charles opined that a full-length
`
`antibody would be expected to achieve immunoblockade by distributing to its site
`
`of action. Ex. 1014, ¶ 59. Now Dr. Balthasar properly “expands the same argument
`
`made in the Petition” concerning antibody efficacy, specifically that full-length
`
`antibodies would distribute to the synaptic cleft. Ericsson, 901 F.3d at 1381. That
`
`Dr. Balthasar’s declaration “further support[s] its original argument that there was
`
`motivation to arrive at the claimed methods” (Mot., 4) is permissible, and indeed,
`
`unsurprising. Belden, 805 F.3d at 1079 (“Evidence admitted in rebuttal to respond to
`
`the patent owner’s criticisms will commonly confirm the prima facie case.”)
`
`III. Conclusion
`Because Teva seeks to strike Lilly’s argument and evidence that directly
`
`respond to arguments raised in Teva’s POR and supporting exhibits, the Motion to
`
`Strike should be denied.
`
`Respectfully submitted,
`
`Date: October 29, 2019
`
`By: / William B. Raich /
`William B. Raich (Reg. No. 54,386)
`
`
`
`5
`
`
`
`IPR2018-01710
`Patent No. 8,586,045
`
`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 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.
`
`
`
`
`
`
`
`By: / William Esper /
`William Esper
`Litigation Legal Assistant
`
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`
`
`
`
`Date: October 29, 2019
`
`
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
