Claims for Patent: 8,580,264

Summary for Patent: 8,580,264

Title:	Subcutaneously administered anti-IL-6 receptor antibody
Abstract:	The present application discloses methods for treating an IL-6-mediated disorder such as rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), systemic JIA (sJIA), polyarticular course JIA (pcJIA), systemic sclerosis, or giant cell arteritis (GCA), with subcutaneously administered antibody that binds interleukin-6 receptor (anti-IL-6R antibody). In particular, it relates to identification of a fixed dose of anti-IL-6R antibody, e.g. tocilizumab, which is safe and effective for subcutaneous administration in patients with IL-6-mediated disorders. In addition, formulations and devices useful for subcutaneous administration of an anti-IL-6R antibody are disclosed.
Inventor(s):	Zhang; Xiaoping (Wayne, NJ), Bao; Min (San Mateo, CA), Jahreis; Angelika M. (Menlo Park, CA), Terao; Kimio (Funabashi, JP)
Assignee:	Genentech, Inc. (South San Francisco, CA) Hoffmann-La Roche Inc. (Nutley, NJ)
Application Number:	13/290,366
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,580,264
Patent Claims:	1. A method of treating rheumatoid arthritis (RA) in a patient comprising subcutaneously administering an anti-IL-6 receptor (IL-6R) antibody to the patient, wherein the anti-IL-6R antibody is administered as a fixed dose of 162 mg per dose every week or every two weeks, and wherein the anti-IL-6R antibody comprises the light chain and heavy chain amino acid sequences of SEQ ID NOs. 1 and 2, respectively. 2. The method of claim 1 wherein the fixed dose is administered every week. 3. The method of claim 1 wherein the RA patient is a DMARD-inadequate responder. 4. The method of claim 1 which further comprises administering to the RA patient one or more additional drug which treats the RA. 5. The method of claim 4 wherein the additional drug is selected from the group consisting of: immunosuppressive agents, non-steroidal anti-inflammatory drugs (NSAIDs), disease modifying anti-rheumatic drugs (DMARDs), methotrexate (MTX), anti-B-cell surface marker antibodies, anti-CD20 antibodies, rituximab, TNF-inhibitors, corticosteroids, and co-stimulatory modifiers. 6. The method of claim 5 wherein the additional drug is selected from the group consisting of non-biological DMARDS, NSAIDs, and corticosteroids. 7. The method of claim 1 wherein the fixed dose is administered every two weeks. 8. A method of treating rheumatoid arthritis in a patient comprising subcutaneously administering tocilizumab to the patient, wherein the tocilizumab is administered as a fixed dose of 162 mg per dose every week or every two weeks. 9. The method of claim 8 further comprising administering one or more additional drug which treats the rheumatoid arthritis, wherein the additional drug is selected from the group consisting of non-biological DMARDS, NSAIDs, and corticosteroids.

Details for Patent 8,580,264

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2030-11-08
Idec Pharmaceuticals Corp.	RITUXAN	rituximab	Injection	103737	02/19/2002		2030-11-08
Genentech, Inc.	ACTEMRA	tocilizumab	Injection	125276	01/08/2010		2030-11-08
Genentech, Inc.	ACTEMRA	tocilizumab	Injection	125472	10/21/2013		2030-11-08
Genentech, Inc.	ACTEMRA	tocilizumab	Injection	125472	11/19/2018		2030-11-08