COMPUTER ALGORITHMS AND METHODS FOR PRODUCT SAFETY
First Claim
1. A method of commercializing at least one previously unreported proprietary method of using a product of manufacture or device, wherein the proprietary method of using the product or device is established according to the steps comprising:
- accessing one or more data sources, wherein at least one data source stores adverse event data associated with the product or device;
analyzing and comparing the stored adverse event data, with at least one previously-known adverse event associated with the product or device;
identifying at least one previously unreported essential adverse event associated with the product or device from the adverse event data, wherein an 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, and wherein an essential adverse event is unreported if it has not been reported in any known accessible database, andthen responsive to identifying of the previously unreported essential adverse event, identifying at least one previously unreported method of use for the product or device associated with said identified essential adverse event;
documenting inventorship of the at least one previously unreported method of use for the product or device; and
creating a database of proprietary essential adverse event information, wherein the database comprises at least one of;
a patent, patent application, patent publication, or data contained in at least one patent, patent application or patent publication, said at least one patent, patent application, patent publication, or data contained in at least one patent, patent application or patent publication, which discloses and relates to at least one of the at least one previously unreported method of use and the at least one essential adverse event, andwherein the at least one previously unreported proprietary method of using a product or device consists of a use selected from the group consisting of a restricted use of said product or device, providing warning(s) about the essential adverse event, providing instruction(s) for avoiding an essential adverse event, and any combination thereof; and
commercializing the at least one previously unreported proprietary method of using a product or device, the commercializing comprising exclusively disclosing the at least one previously unreported proprietary method of use and the associated at least one previously unreported essential adverse event information, which information, once identified, must then accompany the product or device.
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Accused Products
Abstract
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.
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Citations
12 Claims
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1. A method of commercializing at least one previously unreported proprietary method of using a product of manufacture or device, wherein the proprietary method of using the product or device is established according to the steps comprising:
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accessing one or more data sources, wherein at least one data source stores adverse event data associated with the product or device; analyzing and comparing the stored adverse event data, with at least one previously-known adverse event associated with the product or device; identifying at least one previously unreported essential adverse event associated with the product or device from the adverse event data, wherein an 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, and wherein an essential adverse event is unreported if it has not been reported in any known accessible database, and then responsive to identifying of the previously unreported essential adverse event, identifying at least one previously unreported method of use for the product or device associated with said identified essential adverse event; documenting inventorship of the at least one previously unreported method of use for the product or device; and creating a database of proprietary essential adverse event information, wherein the database comprises at least one of;
a patent, patent application, patent publication, or data contained in at least one patent, patent application or patent publication, said at least one patent, patent application, patent publication, or data contained in at least one patent, patent application or patent publication, which discloses and relates to at least one of the at least one previously unreported method of use and the at least one essential adverse event, andwherein the at least one previously unreported proprietary method of using a product or device consists of a use selected from the group consisting of a restricted use of said product or device, providing warning(s) about the essential adverse event, providing instruction(s) for avoiding an essential adverse event, and any combination thereof; and commercializing the at least one previously unreported proprietary method of using a product or device, the commercializing comprising exclusively disclosing the at least one previously unreported proprietary method of use and the associated at least one previously unreported essential adverse event information, which information, once identified, must then accompany the product or device. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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Specification