초록 ▼

The invention comprises systems, methods and a computerized data management device for creating and using data relating to a medical or non-medical product or device to enhance the safety of the product or device. A vast amount of data regarding adverse events associated with a particular product or

The invention comprises systems, methods and a computerized data management device for creating and using data relating to a medical or non-medical product or device to enhance the safety of the product or device. A vast amount of data regarding adverse events associated with a particular product or device is analyzed to identify new essential adverse events associated with the product or device. At least one database of new essential adverse event information is created and utilized, and new characteristics of or uses for the product or device related to the new essential adverse event information are determined. Adverse event information is gathered for a large number of population sub-groups. The system may also be programmed to incorporate the information into intellectual property and contract documents. Manufacturers and/or distributors can include the proprietary information in consumer safety information, which accompanies the product or device, or which is provided to patients, users, consumers and the like, or in the case of certain medical products or devices, to prescribers of those products or devices. The system and methods also provide for commercializing the essential adverse event information.

대표청구항 ▼

What is claimed is: 1. A method of generating and commercializing newly-identified proprietary data about a proprietary or nonproprietary product or device, wherein the method comprises the steps of: accessing at least one adverse event data source that stores adverse event data associated with the

What is claimed is: 1. A method of generating and commercializing newly-identified proprietary data about a proprietary or nonproprietary product or device, wherein the method comprises the steps of: accessing at least one adverse event data source that stores adverse event data associated with the product or device; analyzing the adverse event data to identify at least one new essential adverse event associated with the product or device, wherein the essential adverse event is one regulated by a regulatory agency requiring disclosure of the event in a package insert or data sheet accompanying the product or device; creating at least one essential adverse event information database, wherein the creating step comprises analyzing data from the at least one adverse event data source to identify at least one new proprietary characteristic or use for the product or device responsive to identification of the at least one new essential adverse event associated with the product or device, wherein the creating step further comprises storing essential adverse event information, and wherein the essential adverse event information includes the at least one proprietary new use or characteristic and data related thereto; and commercializing the proprietary essential adverse event information stored at the essential adverse event information database, which step comprises exclusive disclosure of the newly-identified proprietary essential adverse event information which, once identified, must then accompany the product or device. 2. The method of claim 1, wherein accessing further comprises accessing the at least one adverse event data source comprising raw data from a plurality of different adverse events. 3. The method of claim 1, wherein accessing further comprises accessing data from the at least one adverse event data source comprising adverse event information regarding exposure to or use of the product or device. 4. The method of claim 3, wherein accessing further comprises accessing the at least one adverse event data source further comprising information regarding adverse events selected from at least two categories selected from the group consisting of death, illness, hospitalization, missed work, medical costs, abnormal laboratory results and surgeries. 5. The method of claim 1, further accessing at least one data source comprising information relating to patents and patent applications. 6. The method of claim 1, further accessing at least one data source comprising information relating to raw commercial or sales data. 7. The method of claim 1, further comprising providing the at least one adverse event data source comprising adverse event data gathered from at least 5000 subjects. 8. The method of claim 7, further comprising providing the at least one adverse event data source comprising information regarding amount of use of the product or device or duration of exposure to the product or device by each subject. 9. The method of claim 7, further comprising providing the at least one adverse event data source comprising information regarding product post-exposure adverse event data, which is recorded in selected time increments, ranging from less than one hour to more than ten years. 10. The method of claim 1, wherein commercializing further comprises selling, leasing or licensing the newly identified product information. 11. The method of claim 1, wherein commercializing further comprises protecting the intellectual property interest in the newly identified product information. 12. The method of claim 1, wherein commercializing further comprises formatting the data relating to at least one new adverse event associated with exposure to, or use of the product or device, or documenting same, such that a manufacturer or distributor of the product or device must inform consumers, users or individuals responsible for the user, physicians or prescribers about at least one new adverse event associated with exposure to or use of the product or device. 13. The method of claim 1, further comprising determining the value of commercializing the at least one new characteristic or use determined from the at least one identified essential adverse event. 14. The method of claim 1, further identifying the at least one new use of the product or device as a restricted use in at least one population subgroup when there is observed to be a high risk of at least one adverse event associated with exposure to or use of the product or device. 15. The method of claim 1, wherein the product or device is commercially available, and further identifying the new use as comprising restricting exposure of the product or device to one of the high risk associated groups selected from the group consisting of high or low temperatures, chemicals, surfaces, pressures, electricity and sparks; or contact of the product or device with one of the group selected from the group consisting of skin, eyes, ears, respiratory surfaces, gastrointestinal surfaces and mucous membranes of the consumer; or exposure to a subpopulation group selected from the group consisting of children, pregnant women, consumers with specific allergies or medical conditions and animals; or exposure to a subpopulation defined by at least one consumer-identifying characteristic selected from the group consisting of sex, weight, age, race, genetic characteristics, medical condition, pregnancy status, presence of allergies, and use of medicines or medical devices. 16. A proprietary product or device created using the method of claim 1. 17. The product of claim 1, wherein the product is medical. 18. The product of claim 16, wherein the product is medical. 19. The product of claim 17, wherein the medical product is a generic drug. 20. The product of claim 18, wherein the medical product is a generic drug. 21. The product of claim 1, wherein the product is non-medical. 22. The product of claim 16, wherein the product is non-medical. 23. The device of claim 1, wherein the device is medical. 24. The device of claim 16, wherein the device is medical. 25. The device of claim 1, wherein the device is non-medical. 26. The device of claim 16, wherein the device is non-medical. 27. A proprietary kit containing a product or device, and labeling notifying a user of at least one new essential adverse event for the product or device, wherein the kit is created in accordance with claim 1. 28. A proprietary kit containing a product or device, and labeling notifying a user of at least one new essential adverse event for the product or device, wherein the kit is created in accordance with claim 14. 29. The method comprising using the proprietary kit of claim 27 in accordance with a proprietary new characteristic of, or use for, a product or device. 30. The method comprising using the proprietary kit of claim 28 in accordance with a proprietary new characteristic of, or use for, a product or device. 31. A proprietary new use for a commercially available product or device, wherein the new use is determined from the data provided by the method of claim 1. 32. The proprietary new use for a commercially available product or device according to claim 31, wherein the new use is protected as an intellectual property. 33. The proprietary new use for a commercially available product or device according to claim 31, wherein the new use comprises a restricted use in at least one population subgroup when there is observed to be a high risk of at least one adverse event associated with exposure to or use of the product or device. 34. The proprietary new use of the product or device according to claim 33, wherein at least one new adverse event comprises a drug interaction. 35. The proprietary new use of the product or device according to claim 33, wherein at least one new adverse event is based upon neither a drug interaction, nor a chronic immune mediated disorder. 36. The method of claim 1, further comprising establishing a new safety data sheet for a commercially available product or device, wherein the safety data sheet identifies at least one new essential adverse event for the at least one product or device. 37. The method of claim 1, further comprising establishing a new safety data sheet, removed from which is at least one proprietary non-essential adverse event for the at least one product or device. 38. The safety data sheet produced in accordance with claim 36. 39. The safety data sheet produced in accordance with claim 37. 40. The method of claim 1, further comprising using the method to produce lower costs for development of the product or device, or quicker time to market, or an expected higher return for development costs associated with the product or device, or any combination thereof. 41. The method of claim 36, further comprising using the method to produce lower costs for development of the product or device, or quicker time to market, or an expected higher return for development costs associated with the product or device, or any combination thereof. 42. The method of claim 37, further comprising using the method to produce lower costs for development of the product or device, or quicker time to market, or an expected higher return for development costs associated with the product or device, or any combination thereof. 43. The method of claim 1, further comprising using the method to develop at least one essential proprietary new method of screening a product or device for safety. 44. The method of claim 36, further comprising using the method to develop at least one essential proprietary new method of screening a product or device for safety. 45. The method of claim 37, further comprising using the method to develop at least one essential proprietary new method of screening a product or device for safety. 46. The method of claim 1, wherein commercialization comprises facilitating documentation of inventorship. 47. The method of claim 46, further comprising documenting date of inventorship. 48. The method of claim 46, wherein the product or device is commercially available and further comprising identifying the new use as a restricted use in at least one population subgroup when there is observed to be a high risk of at least one adverse event associated with exposure to or use of the product or device. 49. The method of claim 47, wherein the product or device is commercially available and further comprising identifying the new use as a restricted use in at least one population subgroup when there is observed to be a high risk of at least one adverse event associated with exposure to or use of the product or device. 50. The product or device of claim 16, wherein the product or device is commercially available and wherein the new use comprises a restricted use in at least one population subgroup when there is observed to be a high risk of at least one adverse event associated with exposure to or use of the product or device. 51. The method of using the proprietary kit of claim 27 comprising providing a proprietary new characteristic of, or use for the product of device, wherein the product or device is commercially available, and wherein the new use comprises a restricted use in at least one population subgroup when there is observed to be a high risk of at least one adverse event associated with exposure to or use of the product or device. 52. The method of claim 1, wherein the at least one adverse event data source is part of a system for creating and using data associated with a product or device, comprising: at least one adverse event data source for storing adverse event data associated with a commercially available product or device; processor for accessing and analyzing data from the at least one adverse event data source to assist in identifying new essential adverse events associated with the product or device and to assist in identifying at least one new useful characteristic of, or use for, the product or device responsive to identification of at least one new essential adverse event associated with the product or device; adverse event information database storage device for storing the new essential adverse event data identified with the assistance of the processor; user computer for making requests for essential adverse event information to, and for receiving adverse event information from, the processor; and user interface for interfacing the processor and the user computer. 53. The method of claim 52, wherein accessing further comprises accessing the at least one adverse event data source further comprising information regarding adverse events selected from at least two categories selected from the group consisting of death, illness, hospitalization, missed work, medical costs, abnormal laboratory results and surgeries. 54. The method of claim 52, further accessing at least one data source comprising information relating to raw commercial or sales data. 55. The method of claim 52, further identifying the at least one new use of the product or device as a restricted use in at least one population subgroup when there is observed to be a high risk of at least one adverse event associated with exposure to or use of the product or device. 56. The method of claim 52, wherein the product or device is commercially available, and further identifying the new use as comprising restricting exposure of the product or device to one of the high risk associated groups selected from the group consisting of high or low temperatures, chemicals, surfaces, pressures, electricity and sparks; or contact of the product or device with one of the group selected from the group consisting of skin, eyes, ears, respiratory surfaces, gastrointestinal surfaces and mucous membranes of the consumer; or exposure to a subpopulation group selected from the group consisting of children, pregnant women, consumers with specific allergies or medical conditions and animals; or exposure to a subpopulation defined by at least one consumer-identifying characteristic selected from the group consisting of sex, weight, age, race, genetic characteristics, medical condition, pregnancy status, presence of allergies, and use of medicines or medical devices. 57. The product of claim 52, wherein the product is medical. 58. The product of claim 57, wherein the medical product is a generic drug. 59. A proprietary kit containing a product or device, and labeling notifying a user of at least one new essential adverse event for the product or device, wherein the kit is created in accordance with claim 52. 60. A proprietary kit containing a product or device, and labeling notifying a user of at least one new essential adverse event for the product or device, wherein the kit is created in accordance with claim 55. 61. A proprietary new use for a commercially available product or device, wherein the new use is determined from the data provided by the method of claim 52. 62. The proprietary new use for a commercially available product or device according to claim 61, wherein the new use comprises a restricted use in at least one population subgroup when there is observed to be a high risk of at least one adverse event associated with exposure to or use of the product or device. 63. The method of claim 52, wherein commercialization comprises facilitating documentation of inventorship. 64. The method of claim 63, wherein the product or device is commercially available and further comprising identifying the new use as a restricted use in at least one population subgroup when there is observed to be a high risk of at least one adverse event associated with exposure to or use of the product or device. 65. The method of claim 1, wherein the commercializing step further comprises profiting from use of the method wherein the required disclosure of the newly-identified proprietary essential adverse event information accompanying the product or device is not freely available to a competitor.