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`Paper No. ___
`Filed: August 27, 2015
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`__________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
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`COALITION FOR AFFORDABLE DRUGS IV LLC
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`Petitioner
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`v.
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`PHARMACYCLICS LLC
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`Patent Owner
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`__________________
`
`
`Case IPR2015-01076
`Patent No. 8,754,090
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`__________________
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`PATENT OWNER’S UNOPPOSED MOTION FOR WITHDRAWAL AND
`SUBSTITUTION OF COUNSEL
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`PATENT OWNER’S UPDATED EXHIBIT LIST
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`Pharmacyclics
`Exhibit No.
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`DESCRIPTION
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`2001
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`2002
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`2003
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`2004
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`2005
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`2006
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`2007
`2008
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`2009
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`2010
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`2011
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`FDA Press Release, “FDA Approves Imbruvica For Rare Blood
`Cancer” (Nov. 13, 2013), available at
`http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncement
`s/ucm374761.htm
`Howard, O., “Mantle Cell Lymphoma.” Malignant Lymphomas
`Ed. Grossbard, ML London: BC Decker Inc. 2002 135-51)
`Wang, M., et al., Targeting BTK with Ibrutinib in Relapsed or
`Refractory Mantle-Cell Lymphoma, 369 N. Eng. J. Med. 507
`(2013)
`European Medicines Agency, “Assessment Report for Torisel”
`(August 25, 2009), available at
`http://www.ema.europa.eu/docs/en_GB/document_library/EPAR
`_-_Assessment_Report_-
`_Variation/human/000799/WC500039918.pdf
`Ohio State University Medical Center. "Drug shows surprising
`efficacy as treatment for chronic leukemia, mantle cell
`lymphoma." ScienceDaily (June 19, 2013) available at
`www.sciencedaily.com/releases/2013/06/130619195217.htm.
`Johnson & Johnson Press Release, “Ibrutinib Receives Two
`Oncology Breakthrough Therapy Designations from U.S. Food
`and Drug Administration” (Feb. 12, 2013), available at
`http://www.jnj.com/news/all/ibrutinib-receives-two-oncology-
`breakthrough-therapy-designations-from-us-food-and-drug-
`administration
`S. 3187 Prescription Drug User Fee Amendments of 2012
`Office Action, Non-Final Rejection (March 13, 2013), U.S.
`Patent App. No. 13/340,522
`Notice of Allowability (March 31, 2014), U.S. Patent App. No.
`13/340,522
`Chang, B.Y., et al “Egress of CD191CD51 cells into peripheral
`blood following treatment with the Bruton tyrosine kinase
`inhibitor ibrutinib in mantle cell lymphoma patients” Blood,
`122(14): 2412-2424
`Schlette, E., et al, “CD23 Expression in Mantle Cell Lymphoma:
`Clinicopathologic Features of 18 Cases” Am J. Clin. Pathol.
`2003;120:760-766
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`Pharmacyclics
`Exhibit No.
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`
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`DESCRIPTION
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`2012
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`2013
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`2014
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`2015
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`2016
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`2017
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`2018
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`2019
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`2020
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`2021
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`2022
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`2023
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`Form ADV Brochure of Hayman Capital Management L.P. (Mar.
`30, 2015)
`Form ADV of Hayman Capital Management L.P. (Mar. 30,
`2015)
`Delaware Certificates of Formation for Coalition for Affordable
`Drugs (ADROCA) LLC and Coalition for Affordable Drugs II
`LLC through XV
`Request for Continued Examination and Information Disclosure
`Statement (January 31, 2014), U.S. Patent App. No. 13/340,522
`Argyriou, A.A., et al., “Bortezomib-induced peripheral
`neurotoxicity: an update,” Arch Toxicol (2014) 88:1669–1679
`PRNewswire, “Pharmacyclics Reports Fourth Quarter and Full
`Year 2014 Financial Results and Provides Business Updates”
`(Feb. 18, 2015), available at http://www.prnewswire.com/news-
`releases/pharmacyclics-reports-fourth-quarter-and-full-year-
`2014-financial-results-and-provides-business-updates-
`300038067.html
`Highlights of Prescribing Information: Imbruvica (ibrutinib),
`available at
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/2031
`47s000lbl.pdf
`The Wall Street Journal, “New Hedge Fund Strategy: Dispute the
`Patent, Short the Stock;” (2015) available at
`http://www.wsj.com/articles/hedge-fund-manager-kyle-bass-
`challenges-jazz-pharmaceuticals-patent-1428417408.
`Law360, “Shire Drugs Are Next Targets of Hedge Fund’s AIA
`Reviews;” (2015), available at
`http://www.law360.com/articles/638836/shire-drugs-are-next-
`targets-of-hedge-fund-s-aia-reviews.
`Hayman Capital Management, L.P. “Statement of J. Kyle Bass
`Chief Investment Officer, Hayman Capital Management, L.P.;”
`(2015).
`Delaware Department of State: Division of Corporations,
`“Coalition for Affordable Drugs IV LLC – Entity Details”
`IP Watchdog, “Senator Coons – Patents Are about the American
`Dream;” (2015), available at
`http://www.ipwatchdog.com/2015/03/05/senator-coons-patents-
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`Pharmacyclics
`Exhibit No.
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`2024
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`2025
`2026
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`
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`DESCRIPTION
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`are-about-the-american-dream/id=55442/.
`Pharma: The Catalyst, “What They Are Saying: Close Patent
`Loopholes That Threaten Innovation for Patients;” (2015),
`available at http://catalyst.phrma.org/what-they-are-saying-close-
`patent-loopholes-that-threaten-innovation-for-patients.
`Affidavit of Lauren M. Nowierski
`Email from Patent Trial and Appeal Board Authorizing Patent
`Owner's Motion to Withdraw and Substitute Counsel (Aug. 26,
`2015)
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`I.
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`RELIEF REQUESTED
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`Pursuant to 37 C.F.R. § 42.10(e) and the Patent Trial and Appeal Board’s
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`August 26, 2015 email authorizing this motion (Ex. 2026), Patent Owner
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`Pharmacyclics LLC respectfully requests that the Board authorize withdrawal of its
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`current counsel, John M. Desmarais, Kevin K. McNish, and Lauren M. Nowierski
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`(admitted pro hac vice), and authorize designation of Steven P. O’Connor and M.
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`Paul Barker as Patent Owner’s lead and back-up counsel.
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`II. REASONS FOR REQUESTED RELIEF
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`Patent Owner appointed John M. Desmarais and Kevin K. McNish on May
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`11, 2015, and Lauren M. Nowierski on July 29, 2015, as its attorneys in this inter
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`partes review. Patent Owner now requests that its currently designated counsel be
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`allowed to withdraw from the proceeding, and its new counsel, Steven P.
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`O’Connor (Reg. No. 41,225) and M. Paul Barker (Reg. No. 32,013), be designated
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`as lead and back-up counsel, respectively, to represent Patent Owner in this
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`proceeding. Patent Owner is filing a substitute power of attorney for Patent
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`Owner’s new counsel contemporaneously with this Motion.
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`At this time, good cause exists for withdrawal. Patent Owner desires
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`representation by its new counsel. As registered practitioners, Patent Owner’s new
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`counsel meets the requirements of 37 C.F.R. § 42.10(c). In addition, Patent
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`Owner’s new counsel is prepared to take over representation of Patent Owner in
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`this proceeding, and therefore, withdrawal can be accomplished without material
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`adverse effect on the interests of the client. 37 C.F.R. § 11.116(b)(1). Moreover,
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`Patent Owner believes that granting this motion will not hinder the economy, the
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`integrity of the patent system, the efficient administration of the Office, or the
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`ability of the Office to timely complete this proceeding. See 35 U.S.C. § 316(b).
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`Patent Owner does not request any extension of time in connection with this
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`Motion. Counsel for Petitioner indicated that it would not oppose this Motion.
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`III. CONCLUSION
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`Patent Owner respectfully requests that the Board grant this Motion to
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`authorize withdrawal of counsel and permit substitution of new counsel. Upon
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`grant of this Motion, new counsel for the Patent Owner will promptly file a Third
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`Amended Patent Owner’s Mandatory Notices.
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`Date: August 27, 2015
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`Respectfully submitted,
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`/kkm/
`Kevin K. McNish (Reg. No. 65,047)
`kmcnish@desmaraislp.com
`DESMARAIS LLP
`230 Park Avenue
`New York, NY 10169
`Telephone: 212-351-3400
`Facsimile: 212-351-3401
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`2
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), the undersigned certifies that on August 27,
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`2015, a complete copy of the foregoing was served on counsel of record for the
`Petitioner by filing this document through the Patent Review Processing System
`and by sending this document via electronic mail to the following addresses:
`
`Jeffrey S. Ward
`Registration No. 32,774
`MERCHANT & GOULD, P.C.
`10 E. Doty Street
`Suite 600
`Madison, WI 53703-3376
`Telephone: (608) 280-6751
`Facsimile: (612) 332-9081
`jward@merchantgould.com
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`Jeffrey D. Blake, Esq.
`Registration No. 58,884
`MERCHANT & GOULD, P.C.
`191 Peachtree Street N.E.
`Suite 4300
`Atlanta, GA 30303
`Telephone: (404) 954-5040
`Facsimile: (404) 954-5099
`jblake@merchantgould.com
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`Brent E. Routman
`(Pro Hac Vice)
`MERCHANT & GOULD, P.C.
`3200 IDS Center
`80 South 8th Street
`Minneapolis, MN 55402-2215
`Telephone: (612) 332-5300
`Facsimile: (612) 332-9081
`broutman@merchantgould.com
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`Shane A. Brunner
`(Pro Hac Vice)
`MERCHANT & GOULD, P.C.
`10 E. Doty Street
`Suite 600
`Madison, WI 53703-3376
`Telephone: (608) 280-6753
`Facsimile: (612) 332-9081
`sbrunner@merchantgould.com
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`Dated: August 27, 2015
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`Respectfully submitted,
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`/kkm/
`Kevin K. McNish (Reg. No. 65,047)
`kmcnish@desmaraisllp.com
`DESMARAIS LLP
`230 Park Avenue
`New York, NY 10169
`Telephone: 212-351-3400
`Facsimile: 212-351-3401
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`3
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