Claims for Patent: RE45976

Summary for Patent: RE45976

Title:	Methods of inhibiting the action of TNF for neurological conditions by administering etanercept intrathecally
Abstract:	A method for inhibiting the action of TNF for treating neurological conditions in a human by administering a TNF antagonist for reducing damage to neuronal tissue or for modulating the immune response affecting neuronal tissue of the human. The TNF antagonist administered is selected from the group consisting of etanercept and infliximab. The TNF antagonist is administered subcutaneously, intravenously, intrathecally, or intramuscularly. Methotrexate or Leflunomide may be administered concurrently with the TNF antagonist for demyelinating diseases and certain other neurological disorders.
Inventor(s):	Tobinick; Edward L. (Los Angeles, CA)
Assignee:	TACT IP, LLC (Highland Beach, FL)
Application Number:	12/344,437
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent RE45976
Patent Claims:	1. A method for inhibiting the action of TNF for treating neurological conditions in a human by administering a TNF antagonist for reducing the inflammation of neuronal tissue of said human, or for modulating the immune response affecting neuronal tissue of said human, comprising the step of: a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept and infliximab for reducing the inflammation of neuronal tissue of said human, or for modulating the immune response affecting neuronal tissue of said human..]. .[.2. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said TNF antagonist is performed subcutaneously, intravenously, intrathecally, or intramuscularly..]. .[.3. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said dosage level is for treating neurological diseases and disorders..]. .[.4. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said dosage level is for treating neurological traumas and injuries..]. .[.5. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said dosage level is for treating acute spinal cord injury..]. .[.6. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said dosage level is for treating herniated discs..]. .[.7. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said dosage level is for treating spinal cord compression..]. .[.8. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said dosage level is for treating carpal tunnel syndrome (non-RA type)..]. .[.9. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said dosage level is for treating pituitary adenoma..]. .[.10. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said dosage level is for treating primary or metastatic brain tumors..]. .[.11. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said dosage level is for treating chronic pain syndrome due to metastatic tumor..]. .[.12. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said dosage level is for treating increased intracranial pressure..]. .[.13. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said dosage level is for treating central nervous system lesions..]. .[.14. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said dosage level is for treating autoimmune neurological diseases..]. .[.15. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said dosage level is for treating multiple sclerosis..]. .[.16. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said dosage level is for treating subacute sclerosing panencephalitis..]. .[.17. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said etanercept is performed subcutaneously in said human wherein said dosage level is in the range of 10 mg to 50 mg for acute or chronic regimens..]. .[.18. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said etanercept is performed subcutaneously in said human wherein said dosage level is 25 mg for acute or chronic regimens..]. .[.19. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said etanercept is performed intramuscularly in said human wherein said dosage level is in the range of 25 mg to 100 mg..]. .[.20. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said etanercept is performed intravenously in said human wherein said dosage level produces a serum concentration in the range of 0.5 mcg/Ml to 50 mcg/ml..]. .[.21. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said etanercept is performed intravenously by infusion in said human wherein said dosage level produces a serum concentration of 10 mcg/ml..]. .[.22. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said etanercept is performed intrathecally in said human wherein said dosage level is in the range of 1 mg to 50 mg..]. .[.23. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said infliximab is performed subcutaneously in said human wherein said dosage level is in the range of 0.1 mg/kg to 2.5 mg/kg..]. .[.24. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said infliximab is performed intramuscularly in said human wherein said dosage level is in the range of 0.1 mg/kg to 2.5 mg/kg for acute or chronic regimens..]. .[.25. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said infliximab is performed intravenously in said human wherein said dosage level is in the range of 2.5 mg/kg to 20 mg/kg..]. .[.26. A method for inhibiting the action of TNF in accordance with claim 1, wherein the step of administering said infliximab is performed intrathecally in said human wherein said dosage level is in the range of 0.05 mg/kg to 1 mg/kg..]. .[.27. A method for inhibiting the action of TNF for treating neurological conditions in a human by administering a TNF antagonist for reducing the inflammation of neuronal tissue of said human, or for modulating the immune response affecting neuronal tissue of said human, comprising the steps of: a) administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept and infliximab for reducing the inflammation of neuronal tissue of said human, or for modulating the immune response affecting neuronal tissue of said human; and b) administering a therapeutically effective dosage level to said human of methotrexate or Leflunomide for reducing the inflammation of neuronal tissue of said human, or for modulating the immune response affecting neuronal tissue of said human..]. .[.28. A method for inhibiting the action of TNF in accordance with claim 27, wherein the steps of administering are performed subcutaneously, intravenously, intrathecally, orally or intramuscularly..]. .[.29. A method for inhibiting the action of TNF in accordance with claim 27, wherein the steps of administering said dosage levels are for treating neurological diseases and disorders..]. .[.30. A method for inhibiting the action of TNF in accordance with claim 27, wherein the steps of administering said dosage levels are for treating primary or metastatic brain tumors..]. .[.31. A method for inhibiting the action of TNF in accordance with claim 27, wherein the steps of administering said dosage levels are for treating chronic pain syndrome due to metastatic tumor..]. .[.32. A method for inhibiting the action of TNF in accordance with claim 27, wherein the steps of administering said dosage levels are for treating central nervous system lesions..]. .[.33. A method for inhibiting the action of TNF in accordance with claim 27, wherein the steps of administering said dosage levels are for treating autoimmune neurological diseases..]. .[.34. A method for inhibiting the action of TNF in accordance with claim 27, wherein the steps of administering said dosage levels are for treating multiple sclerosis..]. .[.35. A method for inhibiting the action of TNF in accordance with claim 27, wherein the steps of administering said dosage levels are for treating subacute sclerosing, panencephalitis..]. .[.36. A method for inhibiting the action of TNF in accordance with claim 27, wherein the step of administering said etanercept is performed subcutaneously in said human wherein said dosage level is in the range of 10 mg to 50 mg for acute or chronic regimens..]. .[.37. A method for inhibiting the action of TNF in accordance with claim 27, wherein the step of administering said etanercept is performed subcutaneously in said human wherein said dosage level is 25 mg for acute or chronic regimens..]. .[.38. A method for inhibiting the action of TNF in accordance with claim 27, wherein the step of administering said etanercept is performed intramuscularly in said human wherein said dosage level is in the range of 25 mg to 100 mg..]. .[.39. A method for inhibiting the action of TNF in accordance with claim 27, wherein the step of administering said etanercept is performed intravenously in said human wherein said dosage level produces a serum concentration in the range of 0.5 mcg/ml to 50 mcg/ml..]. .[.40. A method for inhibiting the action of TNF in accordance with claim 27, wherein the step of administering said etanercept is performed intravenously by infusion in said human wherein said dosage level produces a serum concentration of 10 mcg/ml..]. .[.41. A method for inhibiting the action of TNF in accordance with claim 27, wherein the step of administering said etanercept is performed intrathecally in said human wherein said dosage level is in the range of 1 mg to 50 mg..]. .[.42. A method for inhibiting the action of TNF in accordance with claim 27, wherein the step of administering said infliximab is performed subcutaneously in said human wherein said dosage level is in the range of 0.1 mg/kg to 2.5 mg/kg..]. .[.43. A method for inhibiting the action of TNF in accordance with claim 27, wherein the step of administering said infliximab is performed intramuscularly in said human wherein said dosage level is in the range of 0.1 mg/1 kg to 2.5 mg/kg for acute or chronic regimens..]. .[.44. A method for inhibiting the action of TNF in accordance with claim 27, wherein the step of administering said infliximab is performed intravenously in said human wherein said dosage level is in the range of 2.5 mg/kg to 20 mg/kg..]. .[.45. A method for inhibiting the action of TNF in accordance with claim 27, wherein the step of administering said infliximab is performed intrathecally in said human wherein said dosage level is in the range of 0.05 mg/kg to 1 mg/kg..]. .[.46. A method for inhibiting the action of TNF in accordance with claim 27, wherein the step of administering said methotrexate is performed orally or intramuscularly in said human wherein said dosage level is in the range of 2.5 mg to 25 mg given from once weekly to once monthly..]. .[.47. A method for inhibiting the action of TNF in accordance with claim 27, wherein the step of administering said Leflunomide is performed orally in said human wherein said dosage level is in the range of 10 mg to 100 mg per day for the first 3 days, and 5 mg to 20 mg per day thereafter..]. .Iadd.48. A method for inhibiting the action of TNF for treating neurological conditions in a human by administering a TNF antagonist for reducing the inflammation of neuronal tissue of said human, or for modulating the immune response affecting neuronal tissue of said human, comprising the step of: a) administering a therapeutically effective dosage level to said human of said TNF antagonist which is etanercept, for reducing the inflammation of neuronal tissue of said human, or for modulating the immune response affecting neuronal tissue of said human, and b) the step of administering said TNF antagonist is performed intrathecally in said human wherein said dosage level is in the range of 1 mg to 50 mg. .Iaddend. .Iadd.49. A method for inhibiting the action of TNF in accordance with claim 48, wherein the step of administering said dosage level is for treating herniated discs. .Iaddend. .Iadd.50. A method for inhibiting the action of TNF in accordance with claim 48, wherein the step of administering said dosage level is for treating spinal cord compression. .Iaddend.

Details for Patent RE45976

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998		2019-02-24
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