Claims for Patent: 9,809,652

Summary for Patent: 9,809,652

Title:	Methods of treating progressive forms of multiple sclerosis comprising subcutaneously administering daclizumab
Abstract:	The present disclosure relates to methods of treating individuals suffering from progressive forms of multiple sclerosis.
Inventor(s):	Greenberg; Steven Jay (Pawleys Island, SC), Elkins; Jacob Stephen Broomall (Brookline, MA)
Assignee:	AbbVie Biotherapeutics Inc. (Redwood City, CA) Biogen MA Inc. (Cambridge, MA)
Application Number:	14/236,374
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,809,652
Patent Claims:	1. A method of treating a human subject suffering from a progressive form of multiple sclerosis, comprising subcutaneously administering to the subject about 150 mg to about 300 mg of a daclizumab once every four weeks for a period of at least one year, wherein the daclizumab has one or both of the following: (a) an N-terminal isoform with one glutamine residue and one valine residue that comprises 3%-12% of the total daclizumab; (b) an N-linked oligosaccharide profile comprising two main peaks and a minor peak, wherein one of the two main peaks is G0-GlcNAc glycoform present in 7% to 15% of the AUC, the other main peak is G0 glycoform present in 81% to 88% of the AUC, and the minor peak is G1 glycoform present in 1% to 4% of the AUC when determined according to the method described in Section 7.6.14. 2. The method of claim 1 in which the progressive form of multiple sclerosis is secondary progressive multiple sclerosis. 3. The method of claim 1 wherein the daclizumab has an N-terminal isoform with one glutamine residue and one valine residue that comprises 3%-12% of the total daclizumab. 4. The method of claim 1 wherein the daclizumab has an N-linked oligosaccharide profile comprising two main peaks and a minor peak, wherein one of the two main peaks is G0-GlcNAc glycoform present in 7% to 15% of the AUC, the other main peak is G0 glycoform present in 81% to 88% of the AUC, and the minor peak is G1 glycoform present in 1% to 4% of the AUC when determined according to the method described in Section 7.6.14. 5. The method of claim 1 wherein the daclizumab has (a) an N-terminal isoform with one glutamine residue and one valine residue that comprises 3%-12% of the total daclizumab, and (b) an N-linked oligosaccharide profile comprising two main peaks and a minor peak, wherein one of the two main peaks is G0-GlcNAc glycoform present in 7% to 15% of the AUC, the other main peak is G0 glycoform present in 81% to 88% of the AUC, and the minor peak is G1 glycoform present in 1% to 4% of the AUC when determined according to the method described in Section 7.6.14.

Details for Patent 9,809,652

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029	05/27/2016		2031-08-08
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029	05/26/2017		2031-08-08