Organic compounds -- part of the class 532-570 series – Organic compounds – Carbohydrates or derivatives
Reexamination Certificate
1999-12-23
2009-06-16
Peselev, Elli (Department: 1623)
Organic compounds -- part of the class 532-570 series
Organic compounds
Carbohydrates or derivatives
C536S027100
Reexamination Certificate
active
07547776
ABSTRACT:
The present invention generally relates to a fludarabine-phosphate with a purity of at least 99.5%.
REFERENCES:
patent: 3703507 (1972-11-01), Haskell et al.
patent: 4188378 (1980-02-01), Montgomery
patent: 4210745 (1980-07-01), Montgomery
patent: 4357324 (1982-11-01), Montgomery et al.
patent: 5110919 (1992-05-01), Blumbergs et al.
patent: 5296589 (1994-03-01), Blumberg
patent: 5506352 (1996-04-01), Butler et al.
patent: 6046322 (2000-04-01), Tilstam et al.
patent: 6174873 (2001-01-01), Wrenn, Jr.
patent: 19543052 (1997-05-01), None
patent: 1047704 (2000-11-01), None
patent: 2124901 (1984-02-01), None
patent: WO 91/08215 (1991-06-01), None
patent: WO 94/12514 (1994-06-01), None
patent: WO 97/18211 (1997-05-01), None
Notice of Opposition to European Patent No. 1 047 704, Application No. 98965703.6, Mayne Pharma Pty, Ltd., Date of Mention Jan. 29, 2003.
Declaration of Donald Corcoran, dated Oct. 27, 2003.
Letter from Alltech Association Australia Pty, Ltd., dated Oct. 22, 2003 with declaration attached from Dr. Phillip J. Anevski, dated Oct. 23, 2003.
Letter from Boult Wade Tennant dated Oct. 29, 2003.
The Nucleic Acids Chemistry and Biology, vol. 1, 1955, chapter 6, pp. 211-241.
Exhibit C, Fludarabine Phosphate >99.5% Pure After Dowex 1X4 Column, Jul. 24, 2003, with attached, Waldo E. Cohn, The Anion-Exchange Separation of Ribonucleotides, 72 J. Am. Chem. Soc., pp. 1471-1478 (1950).
Waldo E. Cohn, Methods of Isolation and Characterization of Mono and Polynucleotides by Ion Exchange Chromatography, 107 Methods in Enzymology, pp. 724-743 (1967).
In the House of Lords,Biogen Inc.v.Medeva PLC, dated Oct. 31, 1996, pp. 1-54.
Henry Herbert Cobb III, Stability of Fludarabine Phosphate, Pentostatin, and Amsacrine in Commonly Used Infusion Solutions and After Filtration, and Osmolality of Various Constituted Chemotherapeutic Agents pp. 20-48 (1995).
Boards of Appeal of The European Patent Office, Decision, Previously Presented. 20-48, Case No. T 0990/96-3.3.1. (Feb. 12, 1998).
The MERCK Index, Twelfth Edition, 1996, Fludarabine.
Official Monographs, USP 26, Fludarabine Phosphate, pp. 3096-3097 (1996).
Notice of Opposition to European Patent No. EP 1047704, App. No. 98965703.6, by Curtis, Phillip Anthony, Nov. 11, 2003.
Notice of Opposition to European Patent No. EP 1047704, App. No. 98965703.6, by Sicor, Inc., Date of Mention Jan. 29, 2003.
EP-B-1047704 Opposition by SICOR Inc., in European Patent No. 1047704, App. No. 98965703.6, Experimental Report, dated Oct. 29, 2003.
Information Statement 98965703.6; Jun. 15, 2005.
Letter to European Patent Office (from Boult Wade Tennant); Jun. 13, 2005.
Letter to European Patent Office (from J.A. Kemp & Co.); Apr. 14, 2005.
Letter to European Patent Office (from Boult Wade Tennant), Apr. 14, 2005.
Declaration of Dr. Andrew Malcolm Knill; Apr. 6, 2005.
Curriculum Vitae of Dr. Harald Rabe; Apr. 13, 2005.
Curriculum Vitae of Dr. Ulf Peter Tilstam; Apr. 13, 2005.
EPO appeal, oral proceedings (Jun. 2005) and results, pp. 1-73.
Patentee grounds for appeal of Nov. 30, 2005.
“Fludarabine Phosphate,” European Pharmacopoeia 5.1; Apr. 2005:1781. (OD30).
Tabelle 1; Nov. 30, 2005. (OD31).
Tabelle 2; Nov. 30, 2005. (OD32).
Report on the Public Hearing of the Technical Board of Appeals Mar. 3, 2008 on Mar. 8, 2007.
Ruling of the Technical Board fo Appeals Mar. 3, 2008 of Mar. 8, 2007.
Weickmann & Weickmann letter to European Patent Office Feb. 8, 2007 regarding Appeal No. T1393/05-Mar. 3, 2008.
Statement by Dr. Michael Harre, In Re EP 1 047 704 B1 of Jan. 30, 2007.
Statement by Dr. Thomas Wessa, In Re EP 1 047 704 B1 of Feb. 2, 2007.
Statement by Professor Siegfried Blechert, In Re EP 1 047 704 B1 of Feb. 2, 2007.
Statement by Professor Reinhard Schomacker, In Re EP 1 047 704 B1 of Feb. 1, 2007.
Statement by Professor Ulf Tilstam, In Re EP 1 047 704 B1 of Feb. 1, 2007.
Tentative opinion of Technical Board of Appeals (2007).
Appeal Observation (Opponent 01) in EP-B- 1047704, Opposition—Apr. 24, 2006.
Observation by Opponent III in Appeal in EP-B- 1047704, Opposition—Jun. 19, 2006.
Additional Krill Declaration (OD33) in EP-B- 1047704, Opposition—Apr. 24, 2006.
Bigatti Declaration (Ex. A and B) (OD35) in EP-B- 1047704, Opposition—Jun. 12, 2006.
James M. Foran, David Oscier, Jennifer Orchard, Pharmacokinetic study of single doses of oral fludarabine phosphate in patients with “low-grade” non-hodgkin's lymphoma,Journal of Clinical Oncology, May 1999, pp. 1574-1579.
Nickisch Klaus
Schmitz Thomas
Tilstam Ulf
Bayer Schering Pharma Aktiengesellschaft
Mullen, White, Zelano, Branigan, P.C.
Peselev Elli
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