Claims for Patent: 7,214,658

Summary for Patent: 7,214,658

Title:	Method of delivering a TNF antagonist to the brain of a human by perispinal administration without direct intrathecal injection
Abstract:	The present invention provides specific methods of using and administering etanercept to improve cognitive function in a human, for both the treatment and prevention of cognitive impairment, or, alternatively, to enhance cognitive function including Alzheimer\'s Disease, Idiopathic Dementia, and Traumatic Brain Injury. The methods of the present invention include the perispinal administration of etanercept. For the purposes of this patent \"perispinal\" is to be considered as referring to \"perispinal extrathecal;\" therefore direct intrathecal administration is excluded. Perispinal administration leads to enhanced delivery of etanercept to the brain in a therapeutically effective amount, via the vertebral venous system and/or the cerebrospinal fluid. Delivery of etanercept to the brain utilizing the methods of the present invention includes the use of the vertebral venous system to deliver etanercept to the brain via retrograde venous flow. Physical maneuvers are used to enhance delivery of etanercept to the brain via this route.
Inventor(s):	Tobinick; Edward L. (Los Angeles, CA)
Assignee:	Tact IP, LLC (Highland Beach, FL)
Application Number:	11/016,047
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,214,658
Patent Claims:	1. A method for delivering a TNF antagonist to the brain of a human for treating Alzheimer's related dementia, comprising administering the TNF antagonist etanercept parenterally into the perispinal space of said human without direct intrathecal injection, and thereafter positioning said human in a Trendelenburg position, for delivery of said TNF antagonist etanercept to the brain via the human's vertebral venous system (VVS). 2. The method of claim 1, wherein said TNF antagonist etanercept is administered in a dosage which comprises sterile water without a preservative. 3. The method of claim 1, wherein said TNF antagonist is delivered to the brain of the human to perform one or more of the following: reduce inflammation or improve cognition. 4. The method of claim 1, wherein said administered etanercept bypasses the blood-brain barrier to reach the brain. 5. The method of claim 1, wherein the head of the human is maintained in the Trendelenburg position for five to ten minutes. 6. A method for delivering etanercept to a human with Alzheimer's related dementia, comprising: perispinally administering an amount of a TNF antagonist etanercept to the human without direct intrathecal injection, and wherein said perispinal administration results in retrograde delivery of the TNF antagonist etanercept to the brain via the human's vertebral venous system in an amount of TNF antagonist etanercept to the brain effective to treat Alzheimer's related dementia. 7. The method of claim 6, further comprising positioning the human in a Trendelenburg position after administering said TNF antagonist etanercept. 8. The method of claim 6, wherein said TNF antagonist etanercept is administered in a dosage of no greater than 100 mg. 9. The method of claim 6, wherein said TNF antagonist etanercept is administered in a dosage of no greater than 50 mg. 10. The method of claim 6, further comprising administering said TNF antagonist etanercept in multiple dosages, wherein said dosages are administered on a weekly basis. 11. The method of claim 6, further comprising administering said TNF antagonist etanercept on a daily basis. 12. A method of delivering the TNF antagonist etanercept to the brain of a human, comprising administering said etanercept into the perispinal space of the human without direct intrathecal injection, and thereafter positioning said human in a Trendelenburg position to enable said etanercept to reach the brain via the human's vertebral venous system (VVS). 13. A method of delivering the TNF antagonist etanercept to the brain of a human, comprising administering said etanercept into the perispinal space of the human without direct intrathecal injection, and then positioning the plane of said human's head below horizontal. 14. The method of claim 13, wherein the plane of said human's head is maintained below horizontal for five to ten minutes. 15. The method of claim 13, wherein said etanercept is delivered to the brain. 16. A method of delivering etanercept to the brain of a human, comprising administering said etanercept into the perispinal space of said human without direct intrathecal injection; and positioning of said human with the head downward below horizontal to facilitate retrograde flow of said etanercept to the brain. 17. The method of claim 16, wherein said etanercept is delivered to the brain. 18. A method for delivering the TNF antagonist etanercept to the cerebrospinal fluid of a human, comprising administering said etanercept parenterally into the perispinal space of said human without direct inthrathecal injection, and thereafter positioning said human in a Trendelenburg position for delivery of said etanercept to the cerebrospinal fluid. 19. A method for delivering a TNF antagonist to the brain of a human for treating mild cognitive impairment, Alzheimer's related dementia, or vascular dementia, comprising administering the TNF antagonist etanercept parenterally into the perispinal space of said human without direct intrathecal injection, and thereafter positioning said human in a Trendelenburg position, for delivery of said etanercept to the brain via the human's vertebral venous system (VVS). 20. The method of claim 19, wherein said administered etanercept bypasses the blood-brain barrier to reach the brain. 21. A method for delivering a TNF antagonist etanercept to the brain of a human for treating Alzheimer's related dementia, comprising administering the TNF antagonist etanercept parenterally into the perispinal space of said human without direct intrathecal injection, and thereafter positioning said human in a Trendelenburg position, for delivery of said TNF antagonist etanercept to the brain. 22. The method of claim 21, wherein said etanercept is delivered to the brain via retrograde flow of said etanercept in the vertebral venous system of the human. 23. A method for delivering a TNF antagonist etanercept to the brain of a human for treating mild cognitive impairment, Alzheimer's related dementia, or vascular dementia, comprising administering the TNF antagonist etanercept parenterally into the perispinal space of said human without direct intrathecal injection, and thereafter positioning said human in a Trendelenburg position, for delivery of said etanercept to the brain. 24. A method for delivering a TNF antagonist etanercept to the brain of a human for treating a TNF mediated dementia, comprising administering the TNF antagonist etanercept parenterally into the perispinal space of said human without direct intrathecal injection, and thereafter positioning said human in a Trendelenburg position, for delivery of said TNF antagonist etanercept to the brain via the human's vertebral venous system (VVS). 25. The method of claim 24, wherein said human has a TNF mediated dementia selected from the group consisting of mild cognitive impairment, possible Alzheixner's related dementia, probable Alzheimer's related dementia, Alzheimer's related dementia, senile dementia/Alzheimer's disease, and vascular dementia. 26. A method for delivering etanercept to a human with Alzheimer's related dementia, comprising administering said etanercept parenterally into the perispinal space of said human without direct intrathecal injection, and thereafter positioning said human in a Trendelenburg position. 27. A method for delivering etanercept to a human, comprising administering said etanercept parenterally into the perispinal space of said human without direct intrathecal injection, and thereafter positioning said human in a Trendelenburg position. 28. The method of claim 27, wherein said human has Alzheimer's related dementia. 29. A method for delivering etanercept to a human with Alzheimer's related dementia, comprising administering said etanercept parenterally into the perispinal space of said human without direct intrathecal injection; and then positioning the plane of said human's head below horizontal after administration of said etanercept. 30. A method for delivering etanercept to a human with Alzheimer's disease, comprising administering said etanercept parenterally into the perispinal space of said human without direct intrathecal injection, and thereafter positioning said human in a Trendelenburg position. 31. A method for delivering a TNF antagonist to the brain of a human for treating Alzheimer's related dementia, comprising administering the TNF antagonist etanercept parenterally into the perispinal space of said human without direct intrathecal injection, and thereafter positioning the plane of the human's head below horizontal, for delivery of said TNF antagonist etanercept to the brain.

Details for Patent 7,214,658

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Immunex Corporation	ENBREL	etanercept	For Injection	103795	11/02/1998		2019-02-24
Immunex Corporation	ENBREL	etanercept	For Injection	103795	05/27/1999		2019-02-24
Immunex Corporation	ENBREL	etanercept	Injection	103795	09/27/2004		2019-02-24
Immunex Corporation	ENBREL	etanercept	Injection	103795	02/01/2007		2019-02-24
Immunex Corporation	ENBREL MINI	etanercept	Injection	103795	09/14/2017		2019-02-24
Immunex Corporation	ENBREL	etanercept	Injection	103795			2019-02-24