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`Paper No. ___
`Filed: August 3, 2015
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`
`COALITION FOR AFFORDABLE DRUGS IV LLC
`Petitioner
`
`
`v.
`
`
`PHARMACYCLICS LLC
`Patent Owner
`
`__________________
`
`
`Case IPR2015-01076
`U.S. Patent No. 8,754,090
`
`_________________
`
`
`PATENT OWNER’S MOTION FOR PRO HAC VICE ADMISSION OF
`LAUREN M. NOWIERSKI UNDER 37 C.F.R. § 42.10
`
`
`
`
`
`
`
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`Pharmacyclics
`Exhibit No.
`
`DESCRIPTION
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`2008
`
`2009
`
`2010
`
`2011
`
`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
`
`i
`
`
`
`
`
`Pharmacyclics
`Exhibit No.
`
`2012
`
`2013
`
`2014
`
`2015
`
`2016
`
`2017
`
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`
`DESCRIPTION
`
`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-
`
`ii
`
`
`
`
`
`Pharmacyclics
`Exhibit No.
`
`2024
`
`2025
`
`
`
`DESCRIPTION
`
`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
`
`
`iii
`
`
`
`
`
`I.
`
`
`
`STATEMENT OF PRECISE RELIEF REQUESTED
`
`Pursuant to 37 C.F.R. § 42.10(c), Patent Owner Pharmacyclics LLC
`
`(“Pharmacyclics”) respectfully requests that the Patent Trial and Appeal Board
`
`(“Board”) admit Lauren M. Nowierski pro hac vice to act as back-up counsel for
`
`Pharmacyclics in this proceeding, IPR2015-01076.
`
`II.
`
`STATEMENT OF REASONS FOR THE RELIEF REQUESTED
`
`a. GOVERNING LAW, RULES, AND PRECEDENT
`
`
`
`Pursuant to 37 C.F.R. § 42.10(c),
`
`The Board may recognize counsel pro hac vice during a
`
`proceeding upon a showing of good cause, subject to the
`
`condition that lead counsel be a registered practitioner
`
`and to any other conditions as the Board may impose.
`
`For example, where the lead counsel is a registered
`
`practitioner, a motion to appear pro hac vice by counsel
`
`who is not a registered practitioner may be granted upon
`
`showing that counsel is an experienced litigating attorney
`
`and has an established familiarity with the subject matter
`
`at issue in the proceeding.
`
`The Board authorized the parties to file pro hac vice motions in its April 30, 2015
`
`Notice of Filing Date Accorded to Petition, Paper No. 4, at 2. Unified Patents, Inc.
`
`v. Parallel Iron, LLC, Case IPR2013-00639, Paper No. 7 (“Order – Authorizing
`
`Motion For Pro Hac Vice Admission – 37 C.F.R. § 42.10”) (Oct. 15, 2013)
`
`1
`
`
`
`
`
`(hereinafter “Order”) provides the procedure for moving for pro hac vice
`
`admission in inter partes reviews, which updated and superseded the prior order
`
`setting forth the procedure, Motorola Mobility LLC v. Arnouse, Case IPR2013-
`
`00010, Paper No. 6 (Oct. 15, 2012).
`
` The Order provides that a motion for pro hac vice admission must be filed
`
`“no sooner than twenty one (21) days after the service of the petition. Order at 2.
`
`That motion must “[c]ontain a statement of facts showing there is good cause for
`
`the Board to recognize counsel pro hac vice during the proceeding;” and 3) “[b]e
`
`accompanied by an affidavit or declaration of the individual seeking to appear
`
`attesting to the following:
`
`i. Membership in good standing of the Bar of at least
`
`one State or the District of Columbia;
`
`ii.
`
`No suspensions or disbarments from practice
`
`before any court or administrative body;
`
`iii. No application for admission to practice before
`
`any court or administrative body ever denied;
`
`iv. No sanctions or contempt citations imposed by any
`
`court or administrative body;
`
`v.
`
`The individual seeking to appear has read and will
`
`comply with the Office Patent Trial Practice Guide
`
`and the Board’s Rules of Practice for Trials set
`
`forth in part 42 of the C.F.R.;
`
`2
`
`
`
`
`
`vi.
`
`The individual will be subject to the USPTO Rules
`
`of Professional Conduct set forth in 37 C.F.R.
`
`§ 11.101 et seq. and subject to the Office’s
`
`disciplinary
`
`jurisdiction
`
`under
`
`37 C.F.R.
`
`§ 11.19(a);
`
`vii. All other proceedings before the Office for which
`
`the individual has applied to appear pro hac vice in
`
`the last three (3) years; and
`
`viii. Familiarity with the subject matter at issue in the
`
`proceeding.
`
`Order, at 3.
`
`b. STATEMENT OF MATERIAL FACTS
`
`
`
`Supported by the Affidavit of Lauren M. Nowierski filed concurrently
`
`herewith (Ex. 2025), Pharmacyclics respectfully shows the following facts:
`
`Pharmacyclics filed this motion on July 24, 2015, more than 21 days after
`
`service of the petition on April 20, 2015. Pharmacyclics’s lead counsel, John M.
`
`Desmarais, is a registered practitioner (Reg. No. 39,655).
`
`Ms. Nowierski is an associate at the law firm of Desmarais LLP, an
`
`intellectual property litigation firm. (Ex. 2025, ¶ 11.) Ms. Nowierski is an
`
`experienced patent litigation attorney and has significant experience litigating
`
`patents in the pharmaceutical and life sciences fields. She has practiced patent
`
`litigation for approximately five and a half years. (Id. ¶ 11.)
`
`3
`
`
`
`
`
`Ms. Nowierski has an established familiarity with the subject matter at issue
`
`in this proceeding. The patent involved in this proceeding is U.S. Patent No.
`
`8,754,090, and Ms. Nowierski has reviewed U.S. Patent No. 8,754,090 and its
`
`prosecution file history. (Id. ¶ 9.) Ms. Nowierski has also reviewed the Petition
`
`filed in Case IPR2015-01076 and the exhibits attached thereto. (Id.)
`
`Ms. Nowierski is a member in good standing of the State Bars of New York
`
`and New Jersey, as well as the United States District Court for the Southern
`
`District of New York. (Id. ¶ 2.) Ms. Nowierski has never been suspended or
`
`disbarred from practice before any court or administrative body. (Id. ¶ 3.) Ms.
`
`Nowierski has never been denied admission to practice before any court or
`
`administrative body. (Id. ¶ 4.) No court or administrative body has ever imposed
`
`contempt sanctions against Ms. Nowierski. (Id. ¶ 5.)
`
`Ms. Nowierski has read and has sworn she will comply with the Office
`
`Patent Trial Practice Guide and the Board’s Rules of Practice for Trials set forth in
`
`37 C.F.R. § 42. (Id. ¶ 6.) Ms. Nowierski understands that she will be subject to
`
`the USPTO Rules of Professional Conduct set forth in 37 C.F.R. § 11.101 et seq.
`
`and subject to the Office’s disciplinary jurisdiction under 37 C.F.R. § 11.19(a).
`
`(Id. ¶ 7.)
`
`Ms. Nowierski has not sought pro hac vice admission in any previous
`
`proceedings before the USPTO in the last three (3) years. (Id. ¶ 8.)
`
`4
`
`
`
`
`
`
`
`c. THE BOARD SHOULD ADMIT MS. NOWIERSKI PRO HAC
`VICE AS BACK-UP COUNSEL IN THIS PROCEEDING.
`
`The Board permits an attorney not registered to practice before the USPTO
`
`to be admitted pro hac vice as back-up counsel in connection with an Inter Partes
`
`review proceeding, upon a showing of good cause, subject to the condition that
`
`lead counsel be a registered practitioner and subject to any other conditions the
`
`Board may impose. 37 C.F.R. § 42.10(c). The Order, Paper No. 7 in Case
`
`IPR2013-00639, provides the other conditions the Board has imposed for
`
`admission pro hac vice.
`
`Here, the facts Pharmacyclics identified above, along with the facts in the
`
`Ms. Nowierski’s Affidavit (Ex. 2025), show that all conditions imposed by the
`
`Board are met, and accordingly, there is good cause to admit Ms. Nowierski pro
`
`hac vice. First, the registered practitioner lead counsel condition is met. Lead
`
`counsel for Pharmacyclics, John M. Desmarais, is a registered practitioner (Reg.
`
`No. 39,655). In addition, the Board’s “experienced litigator” and “familiarity with
`
`the subject matter of the proceeding” requirements are met. Ms. Nowierski, for
`
`whom Pharmacyclics seeks pro hac vice admission as back-up counsel, is an
`
`experienced litigator with an established familiarity with the subject matter of this
`
`proceeding. Ms. Nowierski has practiced patent litigation, including patent
`
`litigation the pharmaceutical and life sciences fields, for approximately five and a
`
`half years. In connection with this proceeding, Ms. Nowierski has also reviewed
`
`5
`
`
`
`
`
`the Petition; the exhibits to the Petition; U.S. Patent No. 8,754,090; and the file
`
`history for U.S. Patent No. 8,754,090. In addition, Ms. Nowierski has provided a
`
`declaration attesting to the facts set forth in Unified Patents, Inc. v. Parallel Iron,
`
`LLC, Case IPR2013-00639, Paper No. 7 (“Order – Authorizing Motion For Pro
`
`Hac Vice Admission – 37 C.F.R. § 42.10”) (Oct. 15, 2013), including that she
`
`agrees to abide by all Board rules and the USPTO Rules of Professional Conduct.
`
`Finally, admitting Ms. Nowierski pro hac vice in this matter will aid the
`
`representation of Patent Owner Pharmacyclics in this proceeding.
`
`
`
`For at least those reasons, the Board should admit Ms. Nowierski pro hac
`
`vice as back-up counsel in this proceeding.
`
`III. AFFIDAVIT OR DECLARATION OF INDIVIDUAL SEEKING TO
`APPEAR
`
`This Motion for Pro Hac Vice Admission is accompanied by the required
`
`Affidavit of Lauren M. Nowierski (Ex. 2025).
`
`IV.
`
` CONCLUSION
`
`
`
`For the foregoing reasons, Pharmacyclics respectfully requests that Ms.
`
`Nowierski be admitted pro hac vice as back-up counsel in this proceeding.
`
`
`
`
`
`6
`
`
`
`
`
`Dated: August 3, 2015
`
`
`
`
`
`
`
`Respectfully submitted,
`
`/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
`
`Counsel for Patent Owner
`Pharmacyclics LLC
`
`
`
`
`
`
`
`7
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), the undersigned certifies that on August 3,
`
`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
`
`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
`
`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
`
`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
`
`Dated: August 3, 2015
`
`
`
`Respectfully submitted,
`
`/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
`
`Counsel for Patent Owner
`Pharmacyclics, Inc.
`
`
`
`8
`
`
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