Claims for Patent: 6,045,501

Summary for Patent: 6,045,501

Title:	Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug
Abstract:	Novel methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug. Embodiments are provided in which the involved prescribers, pharmacies and patients are registered in one or more computer databases. Embodiments are also provided in which registered patients receive counseling information concerning the risks attendant to foetal exposure to the drug. Male patients and female patients who are not pregnant may, in certain circumstances, receive the drug.
Inventor(s):	Elsayed; Marc (Bridgewater, NJ), Williams; Bruce (Flemington, NJ)
Assignee:	Celgene Corporation (Warren, NJ)
Application Number:	09/143,569
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 6,045,501
Patent Claims:	1. A method for delivering a teratogenic drug to patients in need of the drug while avoiding the delivery of said drug to a foetus comprising: a. registering in a computer readable storage medium prescribers who are qualified to prescribe said drug; b. registering in said medium pharmacies to fill prescriptions for said drug; c. registering said patients in said medium, including information concerning the ability of female patients to become pregnant and the ability of male patients to impregnate females; d. retrieving from said medium information identifying a subpopulation of said female patients who are capable of becoming pregnant and male patients who are capable of impregnating females; e. providing to the subpopulation, counseling information concerning the risks attendant to fetal exposure to said drug; f. determining whether patients comprising said subpopulation are pregnant; and g. in response to a determination of non-pregnancy for said patients, authorizing said registered pharmacies to fill prescriptions from said registered prescribers for said non-pregnant registered patients. 2. The method of claim 1 wherein said drug is thalidomide. 3. The method of claim 1 further comprising including in said registering information concerning male patients who are capable of impregnating females and including said males within said subpopulation. 4. The method of claim 1 wherein said determination comprises pregnancy testing. 5. The method of claim 1 wherein the issuance and fulfillment of said prescriptions are recorded in said computer readable storage medium. 6. The method of claim 1 wherein refilling of said prescriptions is authorizable only in response to information contained on said computer readable storage medium. 7. The method of claim 1 wherein said prescriptions are filled for no more than about 28 days. 8. The method of claim 1 wherein said prescriptions are filled together with distribution of literature warning of the effects of said drug upon foetuses. 9. The method of claim 1 further comprising providing said patients with contraception counseling. 10. The method of claim 1 further comprising: h. providing to said patients who are capable of becoming pregnant a contraceptive device or formulation.