Surgery – Diagnostic testing
Reexamination Certificate
2006-11-28
2006-11-28
Hindenburg, Max F. (Department: 3736)
Surgery
Diagnostic testing
C128S920000, C705S002000
Reexamination Certificate
active
07141018
ABSTRACT:
Methods for delivering a drug to a patients in need of the drug, while restricting access to the drug by patients for whom the drug may be contraindicated are disclosed. The methods are of the type in which prescriptions for the drug are filled by a pharmacy only after a computer readable storage medium has been consulted to retrieve a prescription approval code. Embodiments are provided wherein the patients are assigned to risk groups based upon the risk that taking the drug will lead to an adverse side effect, and certain additional information, such as periodic surveys and diagnostic tests probative of the ongoing risk of the side effect developing are obtained before prescriptions for the drug are approved.
REFERENCES:
patent: 5299121 (1994-03-01), Brill et al.
patent: 5594637 (1997-01-01), Eisenberg et al.
patent: 5619991 (1997-04-01), Sloane
patent: 5660176 (1997-08-01), Iliff
patent: 5832449 (1998-11-01), Cunningham
patent: 5845255 (1998-12-01), Mayaud
patent: 5974203 (1999-10-01), Tadokoro et al.
patent: 6014631 (2000-01-01), Teagarden et al.
patent: 6045501 (2000-04-01), Elsayed et al.
patent: 6055507 (2000-04-01), Cunningham
patent: 6063026 (2000-05-01), Schauss et al.
patent: 6128620 (2000-10-01), Pissanos et al.
patent: 6131090 (2000-10-01), Basso, Jr. et al.
patent: 6202923 (2001-03-01), Boyer et al.
patent: 6315720 (2001-11-01), Williams et al.
patent: 6561976 (2003-05-01), Elsayed et al.
patent: 6561977 (2003-05-01), Williams et al.
patent: 6755784 (2004-06-01), Williams et al.
patent: 6767326 (2004-07-01), Elsayed et al.
patent: 6869399 (2005-03-01), Williams et al.
patent: 6908432 (2005-06-01), Elsayed et al.
patent: 2005/0090425 (2005-04-01), Reardan et al.
patent: 2005/0216309 (2005-09-01), Reardan et al.
patent: 2005/0222874 (2005-10-01), Reardan et al.
patent: 2 352 619 (2003-01-01), None
patent: WO 98/13783 (1998-04-01), None
patent: WO 98/58338 (1998-12-01), None
patent: WO 99/10829 (1999-03-01), None
patent: WO 00/51053 (2000-08-01), None
patent: WO 02/35440 (2002-05-01), None
Bruera, E., and Neumann, C. M., “The uses of psychotropics in symptom management in advanced cancer,”Psycho-Oncology., 1998, 7, 346-358.
Clark, T. E.., et al., “Thalidomide Capsules, A review of the first 18 months of spontaneous postmarketing adverse event surveillance, including off-label presrcribing,”Drug Safety., 2001, 24(2), 87-117.
Dimopoulis, M. A., and Eleutherakis-Papaiakovou, V., “Adverse effects of Thalidomide administration in patients with neoplastic diseases,”Am. J. Med., Oct. 1, 2004, 117, 508-515.
Patt, Y.Z, et al., “Durable Clinical response of refractory hepatocellular to orally administered thalidomide,”Am. J. Clin. Oncol. (CCT., 2000, 23(3), 319-321.
Richardson, P, et al., “Thalidomide: Emerging role in cancer medicine,”Annu. Rev. Med., 2002, 53, 629-657.
Richardson, P., et al., “Thalidomide: The revival of a drug with Therapeutic promise in the treatment of cancer”, In: Cancer: Principles and Practice of Oncology, 6thEd., DeVita VT, Hellman S, Rosenberg SA, editors. Lippincott, Williams, and Wilkins, Philadelphia PA, 2001, 1-18.
Singhal, S. and Mehta, J., “Peer Viewpoint,”J. Supportive Oncology, 1(3), Sep./Oct. 2003, 200-201.
Somers, G. F., “Pharmacological Properties of Thalidomide (α-Phalidimido Glutarimide) a New Sedative-Hypnotic Drug,”Brit. J. Pharmacol., 1960, 15, 111-116.
Teo, S. K., et al., “Clinical pharmacokinetics of thalidomide,”Clin Pharmacokinetics, Apr. 2004, 43(5), 311-327.
Thomas, M. and Doss, D, “Thalidomide Nursing Roundtable Update,”American Academy of CME, Inc. and OmegaMed Inc., publishers., Sep. 2002.
Bakken, K., et al., “Local monitoring center for clozapine therapy: quality assurance of drug treatment in a group of psychiatric patients,”Tidsskr Nor Laegeforen nr., 1998, 118, 1076-1078 (English abstract middle of p. 1076).
Bastani, B., et al., “Development of the clozaril patient management system,”Psychopharmacology, 1989, 99, S122-S125.
Behm, G. A., Jr., No Title,Am. Pharmacy 13thAPhA Annual Meeting Highlights, 1990,NS30(6), p. 7.
Bender, K.J., “FDA approves reduced clozapine monitoring; increased patient access versus increased risk,”Psychiatric Times, 1998,vol. XV, Issue 5.
Black, L.L., et al., “A centralized system for monitoring clozapine use in British Columbia,”Psychiatric Services, 1996, 47(1), 81-83.
Freeman, D.J., et al., “Will routine therapeutic drug monitoring have a place in clozapine therapy?,”Clinical Pharmacokinetics, 1997, 32(2), 93-100.
Honigfeld, G., et al., “Reducing clozapine-related morbidity and mortality: 5 years of experience with the clozaril national registry,”J. Clin. Psychiatry, 1998, 59(Suppl.3), 3-7.
Kumar, V., “Clozaril monitoring systems, registry data and analyses,” Presentation,Novartis, 2002, 44 pages.
Lieberman, J.A., et al., “A report of clozapine—induced agranulocytosis in the United States (Incidence and risk factors),”Drug Safety, Proceedings of a symposium held in London, 1991, Hoffbrand, A. V, et al. (Eds.), 1-2.
Love, D.J., et al., “Computerized relational database for monitoring clozapine therapy,”Am. J. Hosp. Pharm., 1993, 1657-1662.
Martin, S., “APhA says plan continues to interfere with pharmacists' practice prerogatives,”Am. Pharmacy, 1991,NS31(5), 30-31.
Mordue, H.W., “Rational approach to clozaril distribution,”Am. Pharmacy, 1990,NS30(6), p. 7.
Oyesanmi, O., et al., “Hematologic side effects of psychotropics,”Psychosomatics, 1999, 40, 414-421.
Peck, C.C., et al., “FDA's position on the clozaril patient management system,”Hospital&Community Psychiatry, 1990, 41(8), 876-877.
Kaminski Joseph K.
Williams Bruce A.
Astorino Michael
Celgene Corporation
Hindenburg Max F.
Woodcock & Washburn LLP
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