UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`TARO PHARMACEUTICALS U.S.A., INC.,
`Petitioners,
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`v.
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`APOTEX TECHNOLOGIES INC.,
`Patent Owner.
`________________
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`Case IPR2017-01446
`U.S. Patent No. 7,049,328
`________________
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`PATENT OWNER’S MOTION FOR ADMISSION PRO HAC VICE OF
` BARRY P. GOLOB
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`IPR2017-01446
`U.S. Patent No. 7,049,328
`PATENT OWNER’S MOTION FOR ADMISSION PRO HAC VICE OF BARRY P. GOLOB
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`I.
`Statement of Precise Relief Requested
`Pursuant to 37 C.F.R. § 42.10(c) and Paper No. 4 authorizing the parties to file
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`motions for pro hac vice admission under 37 C.F.R. § 42.10(c), Patent Owner
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`Apotex Technologies Inc. requests that the Patent Trial and Appeal Board admit
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`Barry P. Golob pro hac vice in this proceeding, IPR2017-01446. Petitioners Taro
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`Pharmaceuticals U.S.A. Inc. does not oppose this motion.
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`II.
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`Statement of Facts Showing Good Case for the Board to Recognize
`Counsel Pro Hac Vice During the Proceeding
`In accordance with 37 C.F.R. § 42.10(c), the Board may recognize counsel
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`pro hac vice during a proceeding upon a showing of good cause, subject to the
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`condition that lead counsel be a registered practitioner and to any other conditions
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`the Board may impose. Section 42.10(c) indicates that, “where lead counsel is a
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`registered practitioner, a motion to appear pro hac vice by counsel who is not a
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`registered practitioner may be granted upon a showing that counsel is an
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`experienced litigating attorney and has an established familiarity with the subject
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`matter at issue in the proceeding.” The facts here establish good cause for the
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`Board to recognize Mr. Golob pro hac vice in this proceeding.
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`1. Lead counsel, W. Blake Coblentz, is a registered practitioner. Back-up
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`counsel, Aaron Lukas, is also a registered practitioner.
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`2
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`IPR2017-01446
`U.S. Patent No. 7,049,328
`PATENT OWNER’S MOTION FOR ADMISSION PRO HAC VICE OF BARRY P. GOLOB
`
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`2. Mr. Golob is an experienced litigator who has an established familiarity
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`with the subject matter at issue in the proceeding. Accompanying this motion as
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`Exhibit 2038 is the Declaration of Barry P. Golob in Support of this Motion for
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`Admission Pro Hac Vice (“Golob Decl.”). In his declaration, Mr. Golob asserts:
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`As lead counsel in the U.S. District Court litigation before the
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`United States District Court for the Eastern District of Texas
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`Marshall Division civil action no. 2:16-cv-00528-RSP
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`concerning U.S. Patent No. 7,049,328, I am familiar with
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`subject matter related to cardiac iron chelation technology.
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`Moreover, I have represented a number of life science and
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`pharmaceutical companies in many patent litigation matters
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`before federal district and appellate courts. In particular, I have
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`extensive experience litigating highly specialized Hatch-
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`Waxman actions involving prescription pharmaceutical drugs.
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`Golob Dec. ¶ 11 (Ex. 2038).
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`Mr. Golob also states that he has an established relationship with Patent Owner
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`Apotex Technologies Inc. Id. ¶ 10 (Ex. 2038). Mr. Golob also demonstrates that he
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`has a working knowledge of the relevant subject matter through his participation in
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`other proceedings involving United States Patent No. 7,049,328 and iron chelators,
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`as well as his familiarity with patent litigation concerning pharmaceutical subject
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`3
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`IPR2017-01446
`U.S. Patent No. 7,049,328
`PATENT OWNER’S MOTION FOR ADMISSION PRO HAC VICE OF BARRY P. GOLOB
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`matter as a result of participation as counsel in Hatch-Waxman cases. Id. ¶ 11 (Ex.
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`2038).
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`3. In his declaration, Mr. Golob also attests to each of the listed items
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`required by the “Order -- Authorizing Motion for Pro Hac Vice Admission” in
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`Case IPR2013-00639 pursuant to 37 C.F.R. § 42.10. See id. ¶¶ 1-12 (Ex. 2038).
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`Mr. Golob attests that he has read and will comply with the Office Patent Trial
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`Practice Guide and the Board’s Rules of Practice for Trials set forth in 37 C.F.R. §
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`42. Id. 8. Mr. Golob further attests that he agrees to be subject to the United States
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`Patent and Trademark Office’s Rules of Professional Conduct as set forth in 37
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`C.F.R. §§ 11.101 et seq. and disciplinary jurisdiction under 37 C.F.R. § 11.19(a).
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`Id. ¶ 9.
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`III. Conclusion
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`For the foregoing reasons, Petitioners respectfully request that the Board
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`admit Mr. Golob pro hac vice in this proceeding.
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`Dated: April 17, 2018
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`Respectfully Submitted,
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`/W. Blake Coblentz/
`W. Blake Coblentz
`Counsel for Patent Owners
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`COZEN O’CONNOR PC
`1200 Nineteenth St. N.W.
`Washington, D.C. 20036
`202-912-4837
`wcoblentz@cozen.com
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`IPR2017-01446
`U.S. Patent No. 7,049,328
`PATENT OWNER’S MOTION FOR ADMISSION PRO HAC VICE OF BARRY P. GOLOB
`
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`2008
`
`PATENT OWNER’S UPDATED EXHIBIT LIST (37 C.F.R. § 42.63(e))
`Exhibit
`Exhibit Name
`2001 Declaration of Thomas D. Coates, M.D.
`2002 Curriculum vitae of Thomas D. Coates, M.D.
`2003 Declaration of Dudley J. Pennell, M.D. FRCP FACC FESC FRCR
`FAHA FMedSci
`2004 Curriculum vitae of Dudley J. Pennell, M.D. FRCP FACC FESC
`FRCR FAHA FMedSci
`Intentionally left blank
`2005
`2006 Noetzli et al., “Longitudinal analysis of heart and liver iron in
`thalassemia major,” BLOOD 112(7):2973-2978 (2008)
`2007 L. Anderson et al., “[2601] Cardiac Iron Deposition Is Not Predicted
`By Conventional Markers Of Iron Overload In Homozygous β-
`Thalassemia,” ABSTRACTS OF THE 42D ANN. MTG. OF THE AMER. SOC.
`OF HEMATOLOGY, Dec. 1-5, 2000
`Internet publication dated October 14, 2011, “FDA approves
`FERRIPROX® to treat patients with excess iron in the body,” U.S. Food
`& Drug Administration, available at:
`http://www.prnewswire.com/news-releases/fda-approves-ferriprox-to-
`treat-patients-with-excess-iron-in-the-body-131876763.html (last
`accessed August 23, 2017)
`Intentionally left blank
`2009
`2010 Claim Construction Opinion and Order, D.E. 64 in Civil Action No.
`2:16-cv-0058 (E.D. Tex., May 17, 2017)
`2011 N.F. Olivieri et al., “Long-Term Safety and Effectiveness of Iron-
`Chelation Therapy With Deferiprone for Thalassemia Major,” N. ENG.
`J. MED. 339(7):417-423 (1998)
`2012 N.F. Olivieri et al., “Cardiac Failure and Myocardial Fibrosis in a
`patient with Thalassemia Major (TM) Treated with Long-Term
`Deferiprone,” BLOOD 92(10) Suppl. 1:532a (1998)
`2013 N.F. Olivieri et al., “Long-Term Trials of Deferiprone in Cooley’s
`Anemia,” ANNALS OF THE NEW YORK ACADEMY OF SCIENCES
`Vol. 850:217-222 (1998)
`Internet publication dated June 8, 2017, “Canadian Scientists Honored
`in for Role in Breakthrough Drug,” Cooley’s Anemia Foundation,
`available at: http://www.newswire.ca/news-releases/canadian-
`scientists-honored-for-role-in-breakthrough-drug-627205651.html
`(last accessed August 23, 2017)
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`2014
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`IPR2017-01446
`U.S. Patent No. 7,049,328
`PATENT OWNER’S MOTION FOR ADMISSION PRO HAC VICE OF BARRY P. GOLOB
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`2019
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`2017
`2018
`
`Exhibit Name
`Exhibit
`2015 L.J. Anderson et al., “Cardiovascular T2-star (T2*) magnetic
`resonance for the early diagnosis of myocardial iron overload,” EUR.
`HEART J. 22(23):2171-2179 (2001)
`2016 L.J. Anderson et al., “Comparison of effects of oral deferiprone and
`subcutaneous desferrioxamine on myocardial iron concentrations and
`ventricular function in beta-thalassemia,” LANCET 360:516-520
`(2002)
`Statutory Disclaimer Under 37 C.F.R. § 1.321(a)
`Statement of Right of Assignee to Take Action Under 37 C.F.R.
`§ 3.73(b)
`Patent Owner’s Notice of Deposition of Jayesh Mehta, M.D., Under
`37 C.F.R. § 42.53
`Supplemental Declaration of Jayesh Mehta, M.D.
`2020
`“Future of oral iron chelator deferiprone (L1),” LANCET 341 (1993)
`2021
`2022 V. Berdoukas et al., “Lack of correlation between iron overload
`cardiac dysfunction and needle liver biopsy iron concentration,”
`HAEMATOLOGICA 90(5):685-686 (2005)
`2023 D. Nathan, “An Orally Active Chelator,” N. ENGL. J. MED.
`332(14):953-954 (1995)
`2024 Deposition of Jayesh Mehta, M.D., dated February 15, 2018
`2025 T.D. Coates, “Physiology and pathophysiology of iron in hemoglobin-
`associated diseases,” FREE RADICAL BIOLOGY AND MEDICINE 72:23-
`40 (2014)
`Second Declaration of Dudley J. Pennell, M.D., in Support of Patent
`Owner’s Response
`2027 A. Aessopos et al., “The heart in transfusion dependent homozygous
`thalassaemia today – prediction, prevention and management,” EUR.
`J. HAEMATOLOGY 80:93-106 (2008)
`2028 N. Koonrungsesomboon et al., “Early detection of cardiac
`involvement in thalassemia: From bench to bedside perspective,”
`WORLD J. CARDIOL. 5(8):270-279 (2013)
`2029 A. Aessopos et al., “Prevention of Cardiomyopathy in Transfusion-
`Dependent Homozygous Thalassaemia Today and the Role of Cardiac
`Magnetic Resonance Imaging,” ADVANCES IN HEMATOLOGY Article
`ID 964897:1-4 (2009)
`S. Lekawanvijit et al., “Iron overload thalassemic cardiomyopathy:
`Iron status assessment and mechanisms of mechanical and electrical
`
`2026
`
`2030
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`IPR2017-01446
`U.S. Patent No. 7,049,328
`PATENT OWNER’S MOTION FOR ADMISSION PRO HAC VICE OF BARRY P. GOLOB
`
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`Exhibit
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`2033
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`Exhibit Name
`disturbance due to iron toxicity,” CAN. J. CARDIOL. 25(4):213-218
`(2009)
`2031 D.L. Johnston et al., “Assessment of tissue iron overload by nuclear
`magnetic resonance imaging,” AM. J. MED. 87(1):40-47, (1989)
`2032 W.H. Crosby, “Editorial: Serum ferritin fails to indicate
`hemochromatosis--nothing gold can stay,” N. ENGL. J. MED.
`294(6):333-334 (1976)
`S.I. Mavrogeni et al., “T2 relaxation time study of iron overload in b-
`thalassemia,” MAGMA 6(1):7-12 (1998)
`2034 G.M. Brittenham et al., “Efficacy of deferoxamine in preventing
`complications of iron overload in patients with thalassemia major,” N.
`ENGL. J. MED. 331:567-573 (1994)
`Second Declaration of Thomas D. Coates, M.D., in Support of Patent
`Owner’s Response
`2036 A.V. Hoffbrand, “Diagnosing myocardial iron overload,” EUR. HEART
`J. 22:2140-2141 (2001)
`2037 D.J. Pennell et al., “Cardiovascular Function and Treatment in β-
`Thalassemia Major: A Consensus Statement From the American Heart
`Association,” CIRCULATION 128:281-308 (2013)
`2038 Declaration of Barry P. Golob in Support of Motion for Pro Hac Vice
`Admission
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`2035
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`IPR2017-01446
`U.S. Patent No. 7,049,328
`PATENT OWNER’S MOTION FOR ADMISSION PRO HAC VICE OF BARRY P. GOLOB
`
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`CERTIFICATE OF SERVICE
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`I hereby certify that, on April 17, 2018, I caused a true and correct copy of
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`the foregoing materials:
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`- PATENT OWNER’S MOTION FOR PRO HAC VICE ADMISSION OF
`BARRY P. GOLOB
`- EXHIBIT 2038, DECLARATION OF BARRY P. GOLOB IN
`SUPPORT OF MOTION FOR PRO HAC VICE ADMISSION
`- PATENT OWNER’S UPDATED EXHIBIT LIST
`to be served via electronic mail on the following attorneys of record:
`
`Huiya Wu
`Sarah Fink
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`HWu@goodwin.law.com
`SFink@goodwinlaw.com
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`By: /s/ W. Blake Coblentz
`
`W. Blake Coblentz
`Reg. No. 57,104
`COZEN O’CONNOR
`1200 Nineteenth Street, N.W.
`Washington, DC 20036
`(202) 912-4837
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