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.
`Petitioner,
`v.
`
`Apotex Technologies, Inc.
`Patent Owner
`
`
`
`Patent No. 7,049,328 B2
`
`Title: USE FOR DEFERIPRONE
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`Inter Partes Review No. IPR2017-01446
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`PETITIONER’S UPDATED EXHIBIT LIST
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`List of Exhibits for U.S. Patent No. 7,049,328 Petition for Inter Partes Review
`
`Exhibit No. Description
`U.S. Patent No. 7,049,328, Spino et al., Use for Deferiprone, Issued
`1001
`on May 23, 2006, (’328 Patent)
`
`Declaration of Jayesh Mehta, M.D.
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`Curriculum Vitae of Jayesh Mehta, M.D.
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`Prosecution History of U.S. Patent No. 7,049,328
`
`Olivieri et al., Reduction of Tissue Iron Stores and Normalization of
`Serum Ferritin During Treatment with the Oral Iron Chelator L1 in
`Thalassemia Intermedia, BLOOD, 79(10):2741–48, 1992 (“Olivieri
`1992”)
`
`Hoffbrand & Wonke, Iron Chelation Therapy, JOURNAL OF
`INTERNAL MEDICINE, 242 (Supplement 740): 37–41, 1997
`(“Hoffbrand 1997”)
`
`Hoffbrand et al., Long-Term Trial of Deferiprone in 51 Transfusion-
`Dependent Iron Overloaded Patients, BLOOD, 91(1):295–300, 1998
`(“Hoffbrand 1998”)
`
`U.S. Patent No. 5, 922,761, Lai, Methods for In Vivo Reduction of
`Iron Levels and Compositions Useful Therefor, Issued on July 13,
`1999 (“Lai ’761”)
`
`Current Index of Medical Specialities, Vol. 21, No. 2, Apr-Jun
`1998, CIMS 61 (“CIMS 1998”)
`
`Olivieri et al., First Prospective Randomized Trial of the Iron
`Chelators Deferiprone (L1) And Deferoxamine, Abstract 983:
`Hemoglobinopathies and Thalassemias II, 249a, PROGRAM OF THE
`37TH ANNUAL MEETING OF THE AMERICAN SOCIETY OF
`HEMATOLOGY, December 1995 (“Olivieri Abstract 1995”)
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`1002
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`1003
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`1004
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`1005
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`1006
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`1007
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`1008
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`1009
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`1010
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`Agarwal, Deferiprone (Kelfer): A Report of 22 Patients Who Have
`Taken it For Over a Decade, 10TH INTERNATIONAL CONFERENCE ON
`ORAL CHELATORS IN THE TREATMENT OF THALASSEMIA AND OTHER
`DISEASES AND BIOMED MEETING, March 2000 (“Agarwal 2000”)
`
`Olivieri et al., Iron-Chelation Therapy with Oral Deferiprone in
`Patients with Thalassemia Major, N. ENGL. J. MED., 332:918–22,
`1995 (“Olivieri 1995”)
`
`Nathan, Prospective on Thalassemia, Pediatrics, 102(1):281–89,
`1998 (“Nathan 1998”)
`
`Olivieri et al., Survival in Medically Treated Patients with
`Homozygous β-Thalassemia, N. ENGL. J. MED., 331:547–78, 1994
`(“Olivieri 1994”)
`
`Nathan & Gunn, Thalassemia: The Consequences of Unbalanced
`Hemoglobin Synthesis, AMERICAN JOURNAL OF MEDICINE, 41:815–
`30, 1966 (“Nathan 1966”)
`
`Bannerman et al., Thalassemia Intermedia, with Iron Overload,
`Cardiac Failure, Diabetes Mellitus, Hypopituitarism and
`Porphyrinuia, AMERICAN JOURNAL OF MEDICINE, 476–86, 1967
`(“Bannerman 1967”)
`
`Barman Balfour & Foster, Deferiprone: A Review of its Clinical
`Potential in Iron Overload in β-Thalassemia Major and Other
`Transfusion-Dependent Diseases, DRUGS 58(3):553–78, 1999
`(“Barman Balfour 1999”)
`
`Barry et al., Long-term Chelation Therapy in Thalassemia Major:
`Effect on Liver Iron Concentration, Liver Histology, and Clinical
`Progress, BMJ, 2:16–20, 1974 (“Barry 1974”)
`
`Kontoghiorghes, Oral Iron Chelation is Here, BMJ, 303:1279–80,
`1991 (“Kontoghiorghes 1991”)
`
`Nathan, An Orally Active Iron Chelator, N. ENGL. J. MED.,
`332(14):953–54, 1995 (“Nathan 1995”)
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`1011
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`1012
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`1013
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`1014
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`1015
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`1016
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`1017
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`1018
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`1019
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`1020
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`1021
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`1022
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`1023
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`1024
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`1025
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`1026
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`1027
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`1028
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`1029
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`1030
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`1031
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`GB 2 118 176, Pharmaceutically Active 3-Hydroxypyrid-2-and-4-
`ones, Published on October 1983 (“Hider Patent”)
`
`Diav-Citrin & Koren, Oral Iron Chelation with Deferiprone, NEW
`FRONTIERS IN PEDIATRIC DRUG THERAPY, 44(1):235–47, 1997
`(“Diav-Citrin 1997”)
`
`Prescribing Information for Ferriprox® (deferiprone) tablets, for
`oral use (Revised 10/2011) (“Deferiprone Label 2011”)
`
`Olson et al., Endomyocardial Biopsy in Hemochromatosis:
`Clinicopathologic Correlates in Six Cases, JACC, 13(1):116–20,
`1989 (“Olson 1989”)
`
`Kontoghiorghes et al., L1-Deferiprone Worldwide Update and New
`Strategies for Improving its Therapeutic Efficiency, 10TH
`INTERNATIONAL CONFERENCE ON ORAL CHELATORS IN THE
`TREATMENT OF THALASSEMIA AND OTHER DISEASES AND BIOMED
`MEETING, March 2000 (“Kontoghiorghes 2000”)
`
`Faa & Crisponi, Iron Chelating Agents in Clinical Practice,
`COORDINATION CHEMISTRY REVIEWS, 184:291–310, 1999 (“Faa
`1999”)
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`Borgna-Pignatti, Survival and Disease Complications in
`Thalassemia Major, ANNALS NEW YORK ACADEMY OF SCIENCES,
`227–31, 1998 (“Borgna-Pignatti 1998”)
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`McDonald, Deferoxamine and Diethylenetriaminepentaacetic Acid
`(DTPA) in Thalassemia, THE JOURNAL OF PEDIATRICS 69(4):563–
`71, 1966 (“McDonald 1966”)
`
`Cerami, “Propper” Use of Desferrioxamine, N. ENGL. J. MED,
`294(26): 1456-57, 1976 (“Cerami 1976”)
`
`European Patent Register Opposition to EP1294379, A New Use for
`Deferiprone, Application published on January 10, 2002
`
`Morrison, Diagnosis and Management of Hereditary
`Hemochromatosis, JOURNAL OF CLIN. OUTCOMES MANAGEMENT,
`Vol 6, No. 5, (1999). (“Morrison”)
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`1038
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`1043
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`1044
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`1045
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`1046
`1047
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`1048
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`Kratz, Normal Reference Laboratory Values, NEW ENGLAND
`JOURNAL OF MEDICINE, Vol. 339, No. 15 (1998) (“Kratz’).
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`Mehta et al., Deaths in Patients Receiving Oral Iron Chelator L1,
`BR. J. HAEMATOL., 85:430–31, 1993
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`Mehta et al., Deferiprone in Iron Overload, N. ENGL. J. MED.,
`333:597–99, 1995
`Mehta et al., Oral Iron Chelator L1 and Autoimmunity, BLOOD,
`81:1970–71, 1993
`March 23, 2018 Telephonic Hearing Transcript
`PROTECTIVE ORDER MATERIAL
`October 8, 2009 Letter from ApoPharma to FDA
`PROTECTIVE ORDER MATERIAL
`October 7, 1999 Email from M. Spino to F. Tricta with attachments
`PROTECTIVE ORDER MATERIAL
`October 8, 1999 Email from F. Tricta to M. Spino with attachment
`PROTECTIVE ORDER MATERIAL
`April 3, 2000 Email from M. Spino to J. Furedy, copying F. Tricta
`with attachment
`PROTECTIVE ORDER MATERIAL
`January 1, 2000 Email from M. Spino to S. Mandell with
`attachments
`PROTECTIVE ORDER MATERIAL
`November 8, 2017 Deposition Transcript of Michael Spino
`PROTECTIVE ORDER MATERIAL
`November 7, 2017 Deposition Transcript of Fernando Tricta, M.D.
`PROTECTIVE ORDER MATERIAL
`Opening Expert Report of Thomas D. Coates, M.D.
`PROTECTIVE ORDER MATERIAL
`Opening Expert Report of Dudley J. Pennell, M.D.
`PROTECTIVE ORDER MATERIAL
`Intentionally Left Blank
`MODULE 2, SECTION 2.7.3, SUMMARY OF CLINICAL
`EFFICACY FOR FERRIPROX® (deferiprone)
`PROTECTIVE ORDER MATERIAL
`MODULE 2, SECTION 2.7.5, LITERATURE REFERENCES FOR
`FERRIPROX® (deferiprone)
`PROTECTIVE ORDER MATERIAL
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`Clinical Study Report, Trial of Deferiprone in Thalassemia (LA-02)
`PROTECTIVE ORDER MATERIAL
`[REDLINE] Modified Default Standing Protective Order
`Modified Default Standing Protective Order
`U.S. Patent No. 4,840,958, Hider et al., Novel 3-Hydroxyprid-2-ones
`and 3-Hydroxyprid-4-ones Useful in Treating Patients Having a
`Toxic Concentration of Iron, Issued on June 20, 1989
`(“Hider ’958”)
`Cohen et al., Safety Profile of the Oral Iron Chelator Deferiprone:
`A Multicentre Study, BRITISH JOURNAL OF HAEMATOLOGY, 108:305-
`312, 2000 (“Cohen 2000”)
`Wood et al., Physiology and Pathophysiology of Iron
`Cardiomyopathy in Thalassemia, ANN NY ACAD SCI, 1054:386-
`395, 2005 (“Wood 2005”)
`Mavrogeni, Myocardial Iron Deposition in β-Thalassemia Studied
`by Magnetic Resonance Imaging, INTERNATIONAL JOURNAL OF
`CARDIAC IMAGING, 14:117-122, 1998 (“Mavrogeni 1998”)
`Papanikolaou et al., NON-INVASIVE MYOCARDIAL IRON
`ASSESSMENT IN THALASSAEMIC PATIENTS, T2 Relaxometry
`and Magnetization Transfer Ratio Measurements, ACTA
`RADIOLOGICA, 41:348-351, 2000 (“Papanikolaou 2000”)
`Pennell et al., Randomized Controlled Trial of Deferiprone or
`Deferoxamine in Beta-Thalassemia Major Patients with
`Asymptomatic Myocardial Siderosis, BLOOD, 107(9):3738-3744,
`May 2006 (“Pennell 2006”)
`April 26, 2018 Deposition Transcript of Thomas D. Coates, M.D.
`June 6, 2018 Deposition Transcript of Dudley J. Pennell, M.D.
`Expert Declaration of Dr. Jayesh Mehta in Support of Petitioner’s
`Reply (Third Declaration of Jayesh Mehta, M.D.)
`Piga et al., Comparative effects of deferiprone and deferoxamine on
`survival and cardiac disease in patients with thalassemia major: a
`retrospective analysis, HAEMATOLOGICA/JOURNAL OF
`HEMATOLOGY, 88(05): 489–496, May 2003 (“Piga 2003”)
`Liu et al., Quantification of cardiac and tissue iron by nuclear
`magnetic resonance relaxometry in a novel murine thalassemia-
`cardiac iron overload model, CAN. J. CARDIOL., 12(2):155-164,
`February 1996 (“Liu 1996”)
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`Fabron et al., Terapia quelante oral com deferiprona em pacientes
`com sobrecarga de ferro, REV. BRAS. HEMATOL. HEMOTER.,
`25(3):177-188, 2003 (“Fabron 2003”)
`English translation of Exhibit 1063 (“Fabron 2003, English
`translation”)
`Questions and Answers on MRI: T2 vs T2*, What is the difference
`between T2 and T2*?, http://mriquestions.com/t2-vs-t2.html
`May 13, 1996 Letter from Peter Liu to Graham Sher (“Liu Letter
`1996”)
`The American Heritage College Dictionary 3rd ed., Houghton
`Mifflin Co., p. 1085 (1993)
`Supplemental Declaration of Jayesh Mehta, M.D. (Fourth
`Declaration of Jayesh Mehta, M.D.)
`Settlement Agreement
`PROTECTIVE ORDER MATERIAL
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`1063
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`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. § 42.6(e), I certify that on this 6th day of August, 2018,
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`I caused to be served a true and correct copy of the foregoing “PETITIONER’S
`
`UPDATED EXHIBIT LIST” be served via electronic mail on the following
`
`attorneys of record:
`
`W. Blake Coblentz
`Aaron S. Lukas
`Barry Golob
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`Email:
`wcoblentz@cozen.com
`alukas@cozen.com
`bgolob@cozen.com
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`By: /Sarah Fink/
` Sarah Fink
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