From: Stringham, Jared [mailto:Jstringham@fchs.com]
`Sent: Tuesday, August 15, 2017 4:16 PM
`To: Trials@uspto.gov
`Cc: #ZortressAfinitorIPR <ZortressAfinitorIPR@fchs.com>; Brown, Daniel (NY) <Daniel.Brown@lw.com>;
`Strang, Jonathan (DC) <Jonathan.Strang@lw.com>; Danek, Brenda (CH) <brenda.danek@lw.com>
`Subject: Par v. Novartis, IPR2016-01479
`
`Dear Judges Green, Crumbley, and Pollock,
`
`On August 3rd, Petitioner served its reply in IPR2016-01479 (Paper 21) along with 39 new exhibits and
`an expert declaration. The reply includes untimely and improper new arguments based on new
`evidence and theories that could and should have been raised in the petition. It would be highly
`prejudicial to permit Petitioner to introduce these new arguments and evidence, examples of which are
`provided below, at this late stage in the proceeding. Accordingly, Patent Owner respectfully requests a
`meaningful opportunity to explain to the Board why Petitioner’s arguments and evidence are new in a
`brief motion to strike or alternatively to respond substantively in a limited surreply. In re NuVasive, Inc.,
`841 F.3d 966, 972-73 (Fed. Cir. 2016).
`Petitioner’s improper new arguments and evidence include, inter alia:
`
`· Newly relying on the disclosures of the ’224 Patent (the patent at issue in the IPR), along with new
`exhibits, to assert that rapamycin and rapamycin analogs would allegedly have the same activity (reply
`pp. 8-10);
`
`· Asserting a new legal theory for why a POSA would allegedly have a reasonable expectation of
`success (reply pp. 12-13, 19);
`
`· Asserting a new basis for why Duran would allegedly provide a reasonable expectation of success
`(reply p. 16);
`
`· Relying on a new cell line not referenced in the petition (reply p. 17); and
`
`· Newly asserting based on new evidence that CA20948 was widely used as a model for targeted
`therapies in NETs (reply p. 17).
`
`Patent Owner has conferred with Petitioner about Petitioner’s improper new arguments and evidence,
`including Patent Owner’s intent to request a motion to strike or surreply. Petitioner indicated that it
`would oppose Patent Owner’s request.
`
`Patent Owner is available for a conference call on Wednesday August 16 or Thursday August 17, or on
`an alternate day that is convenient for the Board and Petitioner. Patent Owner appreciates the Board’s
`consideration of this request and looks forward to its response.
`
`Very truly yours,
`
`Jared
`
`Jared Stringham
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`T 212-218-2523
`F 212-218-2200
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`1
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`Jstringham@fchs.com
`http://www.fitzpatrickcella.com
`Bio
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`From: brenda.danek@lw.com [mailto:brenda.danek@lw.com]
`Sent: Tuesday, August 15, 2017 5:35 PM
`To: Jstringham@fchs.com; Trials <Trials@USPTO.GOV>
`Cc: ZortressAfinitorIPR@fchs.com; Daniel.Brown@lw.com; Jonathan.Strang@lw.com;
`paripractions.lwteam@lw.com
`Subject: RE: Par v. Novartis, IPR2016-01479
`
`Dear Judges Green, Crumbley, and Pollock,
`
`Petitioner disagrees with and oppose Patent Owner’s request. Also, Petitioner objects to Patent Owner’s
`repeated strategy of requesting relief from the Board without seeking a meet and confer and, if the
`parties cannot come to an agreement on the issue, a time when all counsel are available for a call with
`the Board.
`
`Petitioner further objects to Patent Owner ignoring PTAB guidance and using the Trials email address for
`substantive communications with the Board. By doing so, Patent Owner has already granted itself more
`relief than is warranted. The Board regularly allows patent owners in this situation to file a “sequentially
`numbered, itemized list, containing no more information than citations to the paper/exhibit number…of
`the material the Patent Owner alleges exceeds the proper scope of the Reply,” and gives petitioners an
`opportunity to respond similarly. E.g., Google v. Intellectual Ventures II, IPR2014-00787 (Paper 29, June
`4, 2015). Petitioners would have agreed to this, as it is fair to the parties.
`
`Patent Owner, however, has already impermissibly and without leave submitted citations, commentary
`on why it believes the material exceeded the scope of the Reply, and most egregiously, additional
`substantive argument on the merits.
`
`The Board cannot unring this bell. Accordingly, Petitioner requests permission to file a five-bullet
`response addressing Patent Owner’s five bullet points. Patent Owner’s allegations are demonstrably
`false and can be disposed of at oral argument without going beyond the already filed briefs.
`
`Should the Board desire a conference call, and because Patent Owner did not inquire as to our
`availability before sending its improper email, Petitioner is available the afternoon of Thursday, August
`17 or the afternoon of Friday, August 18.
`
`Very Respectfully,
`
`Brenda
`Brenda L. Danek
`LATHAM & WATKINS LLP
`330 North Wabash Avenue, Suite 2800
`Chicago, IL 60611
`Direct Dial: +1.312.876.7646
`Fax: +1.312.993.9767
`Email: brenda.danek@lw.com
`http://www.lw.com
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`From: Vignone, Maria [mailto:Maria.Vignone@USPTO.GOV] On Behalf Of Trials
`Sent: Friday, August 18, 2017 1:56 PM
`To: brenda.danek@lw.com; Stringham, Jared; Trials
`Cc: #ZortressAfinitorIPR; Daniel.Brown@lw.com; Jonathan.Strang@lw.com;
`paripractions.lwteam@lw.com; uspto
`Subject: RE: Par v. Novartis, IPR2016-01479
`
`Counsel: The Patent Owner is authorized to file, on or before Due Date 3 (September 5, 2017), a sur-
`reply not to exceed five (5) pages. The sur-reply may substantively address the evidence and arguments
`submitted with the Reply, or explain why the evidence and arguments are untimely. No new evidence
`may be submitted with the sur-reply. No further briefing is authorized at this time.
`
`Thank you,
`Maria Vignone
`Paralegal Operations Manager
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`703-756-1288
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`From: Stringham, Jared [mailto:Jstringham@fchs.com]
`Sent: Friday, August 25, 2017 8:43 AM
`To: 'Trials' <Trials@USPTO.GOV>
`Cc: #ZortressAfinitorIPR <ZortressAfinitorIPR@fchs.com>; Brown, Daniel (NY) <Daniel.Brown@lw.com>;
`Strang, Jonathan (DC) <Jonathan.Strang@lw.com>; #C-M PAR IPR ACTIONS - LW TEAM
`<paripractions.lwteam@lw.com>; uspto <uspto@fchs.com>; Danek, Brenda (CH)
`<brenda.danek@lw.com>
`Subject: RE: Par v. Novartis, IPR2016-01479
`
`Dear Judges Green, Crumbley, and Pollock,
`
`In view of the Board’s authorization for Patent Owner to file a limited sur-reply (1:56 PM Email of August
`18, 2017), Patent Owner writes to request guidance regarding (1) the proper scope of the Motion for
`Observation on Cross-Examination, and (2) whether cross-examination testimony may be cited in the
`sur-reply.
`
`By way of background, Patent Owner has noticed a deposition of Petitioner’s reply witness for August
`28, 2017. The Board has authorized Patent Owner to file a limited sur-reply on or before Due Date 3
`(September 5, 2017). Pursuant to the Scheduling Order filed by the Board (Paper 9), any Motion for
`Observation of cross-examination testimony is due on Due Date 4 (September 25, 2017).
`
`As Patent Owner’s sur-reply will be due after the deposition of Petitioner’s reply witness, is Patent
`Owner authorized to file a Motion for Observation directed to issues that are not addressed in Patent
`Owner’s sur-reply, as no further substantive paper will be permitted on these issues? Authorizing
`Patent Owner to file a Motion for Observation directed to issues not addressed in Patent Owner’s sur-
`reply is consistent with the Board’s decision in another proceeding and the Trial Practice Guide. See LG
`Elecs., Inc. v. ATI Techs. ULC, IPR2015-00325, Paper 52 at 4 (Jan. 25, 2016) (stating that the Patent Owner
`“also could have filed a motion for observation on other issues” that were not addressed in the limited
`sur-reply); Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,767–68 (Aug. 14, 2012) (describing
`a motion for observation on cross-examination that “occurs after a party has filed its last substantive
`paper on an issue,” not an entire proceeding (emphasis added)).
`
`In addition, Patent Owner respectfully requests guidance regarding whether Patent Owner’s sur-reply
`may cite the cross-examination testimony of Petitioner’s reply witness, to be taken on August 28, 2017,
`related to the limited issues addressed in the sur-reply. As Patent Owner is not permitted to raise any
`issue in the Motion for Observation that is addressed in the sur-reply (see LG Elecs., IPR2015-00325,
`Paper 52 at 2-4; Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768 (explaining that a Motion for
`Observation “is not an opportunity to … re-argue issues”)), the sur-reply would be Patent Owner’s only
`opportunity to draw the Board’s attention to testimony relevant to the issues in the sur-reply.
`
`Patent Owner appreciates the Board’s guidance on these issues.
`
`Kind regards,
`
`Jared
`
`Jared Stringham
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`T 212-218-2523
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`F 212-218-2200
`Jstringham@fchs.com
`http://www.fitzpatrickcella.com
`Bio
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`From: Jonathan.Strang@lw.com [mailto:Jonathan.Strang@lw.com]
`Sent: Friday, August 25, 2017 9:55 AM
`To: Jstringham@fchs.com; Trials <Trials@USPTO.GOV>
`Cc: ZortressAfinitorIPR@fchs.com; Daniel.Brown@lw.com; paripractions.lwteam@lw.com;
`uspto@fchs.com; brenda.danek@lw.com
`Subject: RE: Par v. Novartis, IPR2016-01479
`
`Dear Judges Green, Crumbley, and Pollock,
`
`Petitioner opposes Patent Owner’s request. A motion for observations may be filed only if the last
`substantive brief on the merits is filed before the relevant cross-examination:
`
`A motion for observation on cross-examination provides the petitioner with a mechanism to draw the
`Board’s attention to relevant cross-examination testimony of a reply witness, since no further
`substantive paper is permitted after the reply.
`
`Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,769 (Aug. 14, 2012). Here, the Board has already
`authorized Patent Owner to file a “sur-reply [that] may substantively address the evidence and
`arguments submitted with the Reply,” which is a substantive paper that will be filed after the cross-
`examination.
`As the Board explained in LG Electronics v. ATI Technologies, IPR-2015-00326:
`
`Patent Owner will need to choose between filing (1) a Sur-Reply, which may contain argument, or (2) a
`Motion for Observations on Cross Examination, which may not contain argument.
`
`(Paper 32 at 3, Feb. 4, 2016, further explaining the -00325 decision cited by Patent Owner) (attached).
`
`Accordingly, Petitioner asks the Board to deny Patent Owner’s request to file both a sur-reply after
`cross-examination and a motion for observations.
`
`Very Respectfully,
`Jonathan M. Strang
`Attorney for Petitioner
`Jonathan M. Strang
` LATHAM & WATKINS LLP
`555 Eleventh Street, NW
`Suite 1000
`Washington, D.C. 20004-1304
`Direct Dial: +1.202.637.2362
`Fax: +1.202.637.2201
`Email: jonathan.strang@lw.com
`http://www.lw.com
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`From: Trials
`Sent: Thursday, August 31, 2017 2:25 PM
`To: Jonathan.Strang@lw.com; Jstringham@fchs.com
`Cc: ZortressAfinitorIPR@fchs.com; Daniel.Brown@lw.com; paripractions.lwteam@lw.com;
`uspto@fchs.com; brenda.danek@lw.com
`Subject: RE: Par v. Novartis, IPR2016-01479
`
`Counsel,
`
`The Board previously authorized Patent Owner to file a sur-reply to “substantively address the evidence
`and arguments submitted with the Reply, or explain why the evidence and arguments are untimely.” In
`doing so, Patent Owner may cite the cross-examination testimony of Petitioner’s reply declarant.
`
`Patent Owner may also, if desired, file observations on the cross-examination testimony, as authorized
`in the Scheduling Order. As Petitioner’s email acknowledges, however, Patent Owner may not avail
`itself of both opportunities on the same issue. The observations may only address issues on which
`Patent Owner did not file the last substantive paper.
`
`Furthermore, if Patent Owner chooses to file both a sur-reply and observations, the number of pages
`permitted for the observations (15) shall be reduced by a page for each page used in the sur-reply (up to
`5). In other words, the total number of pages used for the sur-reply and observations shall be no more
`than 15.
`
`The Board will issue a formal Order setting forth these instructions.
`
`Sincerely,
`Eric Hawthorne
`Supervisory Paralegal Specialist
`Patent Trial and Appeal Board
`
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