`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`Taro Pharmaceuticals U.S.A., Inc.
`Petitioner,
`v.
`
`Apotex Technologies, Inc.
`Patent Owner
`
`
`
`Patent No. 7,049,328 B2
`
`Title: USE FOR DEFERIPRONE
`
`
`
`Inter Partes Review No. IPR2017-01446
`
`
`PETITIONER’S UPDATED EXHIBIT LIST
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`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.
`
`Curriculum Vitae of Jayesh Mehta, M.D.
`
`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”)
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`
`
`
`
`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”)
`
`
`
`1011
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`
`
`
`
`
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`
`
`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”)
`
`Borgna-Pignatti, Survival and Disease Complications in
`Thalassemia Major, ANNALS NEW YORK ACADEMY OF SCIENCES,
`227–31, 1998 (“Borgna-Pignatti 1998”)
`
`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”)
`
`
`
`
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`
`1041
`
`1042
`
`1043
`
`1044
`
`1045
`
`1046
`1047
`
`1048
`
`
`
`Kratz, Normal Reference Laboratory Values, NEW ENGLAND
`JOURNAL OF MEDICINE, Vol. 339, No. 15 (1998) (“Kratz’).
`
`Mehta et al., Deaths in Patients Receiving Oral Iron Chelator L1,
`BR. J. HAEMATOL., 85:430–31, 1993
`
`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
`
`
`
`Clinical Study Report, Trial of Deferiprone in Thalassemia (LA-02)
`PROTECTIVE ORDER MATERIAL
`[REDLINE] Modified Default Standing Protective Order
`Modified Default Standing Protective Order
`
`
`
`
`
`1049
`
`1050
`1051
`
`
`
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. § 42.6(e), I certify that on this 16th day of April, 2018,
`
`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
`
`
`Email:
`wcoblentz@cozen.com
`alukas@cozen.com
`bgolob@cozen.com
`
`
`By: /Ryan Curiel/
` Ryan Curiel
`
`
`
`