Computer algorithms and methods for product safety

• US 7,984,069 B2
• Filed: 02/21/2002
• Issued: 07/19/2011
• Est. Priority Date: 02/22/2001
• Status: Expired due to Fees

• Current Assignee: Classen Immunotherapies Incorporated
• Original Assignee: Classen Immunotherapies Incorporated
• Inventors: Classen, John Barthelow
• Primary Examiner(s): LEROUX, ETIENNE PIERRE
• Application Number:
  US10/081,705
• Publication Number:
  US 20020083080A1
• Time in Patent Office: 3,435 Days
• Field of Search: 707/1, 707/2, 707/10, 707/104.1, 707/200, 707/9, 707/5, 707/3, 707/790, 705/3, 705/26, 700/108
• US Class Current: 707/790
• CPC Class Codes: G06F 16/284 Relational databases
• CPC Class Codes: G06Q 30/02 Marketing; Price estimation or determination; Fundraising
• CPC Class Codes: G06Q 50/184 Intellectual property management
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 70/60 relating to pathologies

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.

Claims

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

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 stores at least one record related to at least one of;

a patent, patent application, patent publication, or data contained in at least one patent, patent application or patent publication, wherein said at least one patent, patent application, patent publication, or data contained in at least one patent, patent application or patent publication, 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, and

wherein 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, wherein commercializing means creating profit from the exclusive disclosure.

2. The method of claim 1, further comprises determining value of commercializing the at least one use determined from the at least one identified essential adverse event, wherein the value depends on a potential value of making a generic product or device into a proprietary product or device, or preventing a proprietary product or device from becoming a generic product or device.

3. The method of claim 2, wherein the commercializing step further comprises generating information for incorporation into documents for selling, leasing or licensing the identified product information.

4. The method of claim 2, wherein the product is commercially available at the time of the analyzing step.

5. The method of claim 2, wherein the step of commercializing further comprises formatting the data relating to at least one 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 adverse event associated with exposure to or use of the product or device.

6. The method of claim 1, wherein the product or device is commercially available at the time of the analyzing step, and wherein the at least one data source comprises information relating to patents and patent applications.

7. The method of claim 1, wherein the product or device is commercially available at the time of the analyzing step, and wherein the at least one data source comprises information relating to raw commercial or sales data, wherein said raw data is commercial or sales data before being processed and analyzed.

8. The method of claim 2, wherein the at least one adverse event comprises a drug interaction.

9. The method of claim 8, wherein the at least one data source comprises information relating to raw commercial or sales data, wherein said raw data is commercial or sales data before being processed and analyzed.

10. The method of claim 1, wherein the steps of establishing the use of the essential adverse event data are proprietary.

11. The method of claim 1, wherein the product is medical.

12. The method of claim 2, wherein the product is medical.

13. The method of claim 12, wherein the medical product is a generic drug.

14. The method of claim 1, wherein the product is non-medical.

15. The method of claim 2, wherein the product is non-medical.

16. The method of claim 1, wherein the device is medical.

17. The method of claim 2, wherein the device is medical.

18. The method of claim 1, wherein the device is non-medical.

19. The method of claim 2, wherein the device is non-medical.

20. A proprietary kit containing a product or device, and labeling listing the information which once identified, must accompany the product or device thus notifying a user of at least one previously unreported essential adverse event for the product or device, wherein the information to be listed on the labeling is determined in accordance with the method of claim 1.

21. A proprietary kit containing a product or device, and labeling listing the information which once identified, must accompany the product or device thus notifying a user of at least one previously unreported essential adverse event for the product or device, wherein information to be listed on the labeling is determined in accordance with the method of claim 9.

22. The method of claim 1, wherein the proprietary method of use is 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.

23. The method of claim 3, wherein the proprietary method of use is 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.

24. The method of claim 1, wherein the at least one adverse event is a drug interaction.

25. The method of claim 24, wherein the product or device is commercially available at the time of the analyzing step.

26. The method of claim 25, wherein the proprietary method of 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.

27. The method of claim 25, wherein at least one data source comprises information relating to raw commercial or sales data, wherein said raw data is commercial or sales data before being processed and analyzed.

28. The method of claim 27, wherein at least one previously unreported essential adverse event is other than a chronic immune mediated disorder.

29. The method of claim 27, the steps further comprising determining value of commercializing the at least one proprietary method of use determined from the at least one identified essential adverse event, wherein the value depends on a potential value of making a generic product or device into a proprietary product or device, or preventing a proprietary product or device from becoming a generic product or device.

30. The method of claim 1, wherein at least one previously unreported essential adverse event comprises a drug interaction, wherein at least one data source comprises information relating to patents and patent applications, and wherein at least one data source comprises information relating to raw commercial or sales data, wherein said raw data is commercial or sales data before being processed and analyzed.

31. The method of claim 2, wherein at least one previously unreported essential adverse event comprises a drug interaction, wherein at least one data source comprises information relating to patents and patent applications, and wherein at least one data source comprises information relating to raw commercial or sales data, wherein said raw data is commercial or sales data before being processed and analyzed.

32. The method of claim 1, wherein the at least one adverse event data source comprises information regarding product postexposure adverse event data, which is recorded in selected time increments, ranging from less than one hour to more than ten years.

33. The method of claim 1, wherein the at least one adverse event data source comprises information regarding amount of use of the product or device or duration of exposure to the product or device by subjects.

35. The method of claim 2, wherein the at least one proprietary method of using the product or device is a restricted use in at least one population subgroup, where 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 and the previously unreported essential adverse event is one other than a chronic immune mediated disorder.

36. The method of claim 1, wherein the product or device is commercially available, the steps further comprising identifying the proprietary method of 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.

37. The method of use claim 2, wherein the product or device is commercially available, the steps further comprising identifying the proprietary method of 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.

38. The method of claim 9, wherein the product or device is commercially available, the steps further comprising identifying the proprietary method of 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.

39. The method of claim 1, the steps further comprising documenting date of inventorship and storing information relating to the documented date of inventorship in the database of proprietary essential adverse event information.

40. The method of claim 1, wherein at least one adverse event data source comprises raw data from a plurality of different adverse events, wherein said raw data is commercial or sales data before being processed and analyzed.

41. The method of claim 1, wherein the product or device is commercially available, and the proprietary method of use is further identified as comprising restricting exposure of the product or device to at least one factor selected from the group consisting of high temperatures, low temperatures, chemicals, surfaces, pressures, electricity sparks;

contact with an anatomical element selected from the group consisting of skin, eyes, ears, respiratory surfaces, gastrointestinal surfaces and mucous membranes of the user;

exposure to a subpopulation group selected from the group consisting of children, pregnant women, users with specific allergies, users with specific medical conditions, and animals;

exposure to subpopulations defined by at least one user identifying characteristic selected from the group consisting of sex, weight, age, race, genetic characteristics, medical condition, pregnancy status, presence of allergies, use of drugs, use of tobacco, use of alcohol, and use of medical devices.

42. The method of claim 1, wherein at least one database of essential adverse event information is computerized.

43. The method of claim 1, wherein at least one data source comprises human adverse event data.

44. The method of claim 1, further comprising utilizing least one controlled clinical trial and or epidemiological study to discover at least one previously unreported essential adverse event.

45. The method of claim 1, wherein the step of establishing the adverse event is one other than an abnormal laboratory value.

46. The method of claim 1, wherein the use is one other than a new dosing regimen.

47. The method of claim 1, wherein the use further comprises providing printed product safety information in connection with product packaging.

48. The method of claim 2, wherein the use further comprises providing printed product warning information in connection with product packaging.

49. The method of claim 1, wherein the step of documenting the inventorship comprises storing information relating to the documented inventorship in the database of proprietary essential adverse event information.

34. The method of 1, wherein the at least one proprietary method of using the product or device is a restricted use in at least one population subgroup, where 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 and the previously unreported essential adverse event is one other than a chronic immune mediated disorder.

50. A method of commercializing at least one previously unreported proprietary method of using a product of manufacture or device, 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

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 stores at least one record related to at least one of;

a patent, patent application, patent publication, or data contained in at least one patent, patent application or patent publication, wherein 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 the at least one previously unreported method of use, and

wherein the at least one previously unreported proprietary method of use 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, wherein the at least one previously unreported proprietary method of use is not a pharmacogenomic technique for screening; and

commercializing the at least one previously unreported proprietary method of use, 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, wherein commercializing means creating profit from the exclusive disclosure.