Claims for Patent: 6,939,539

Summary for Patent: 6,939,539

Title:	Copolymer-1 improvements in compositions of copolymers
Abstract:	The present invention relates to an improved composition of copolymer-1 comprising copolymer-1 substantially free of species having a molecular weight of over 40 kilodaltons.
Inventor(s):	Konfino; Eliezer (Ramat Gan, IL), Sela; Michael (Rehovot, IL), Teitelbaum; Dvora (Rehovot, IL), Arnon; Ruth (Rehovot, IL)
Assignee:	Yeda Research & Development (Rehovot, IL)
Application Number:	10/615,865
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 6,939,539
Patent Claims:	1. A copolymer-1 composition comprising a mixture of polypeptides composed of glutamic acid, lysine, alanine and tyrosine, wherein the mixture has an average molecular weight of about 4 to about 9 kilodaltons, wherein the mixture of polypeptides is non-uniform with respect to molecular weight and sequence, and wherein the composition is suitable for treating multiple sclerosis. 2. The composition of claim 1, wherein over 75% of the polypeptides of the mixture, on a molar fraction basis, have a molecular weight in a range of about 2 kilodaltons to about 20 kilodaltons. 3. The composition of claim 1, wherein less than 5% of the polypeptides of the mixture, on a molar fraction basis, have a molecular weight of over 40 kilodaltons. 4. The composition of claim 3, wherein over 75% of the polypeptides of the mixture, on a molar fraction basis, have a molecular weight in a range of about 2 kilodaltons to about 20 kilodaltons. 5. The composition of claim 4, wherein the mixture has an average molecular weight of 6.25 to 8.4 kilodaltons. 6. The composition of claim 1, wherein the mixture has an average molecular weight of about 4 to about 8.6 kilodaltons. 7. The composition of claim 1, wherein the mixture has an average molecular weight of about 5 to about 9 kilodaltons. 8. The composition of claim 1, wherein less than 2.5% of the polypeptides of the mixture, on a molar fraction basis, have a molecular weight of over 40 kilodaltons. 9. The composition of claim 8, wherein over 75% of the polypeptides of the mixture, on a molar fraction basis, have a molecular weight in a range of about 2 kilodaltons to about 20 kilodaltons. 10. The composition of claim 9, wherein the mixture has an average molecular weight of 6.25 to 8.4 kilodaltons. 11. The composition of claim 1, wherein the mixture has a molecular weight distribution substantially as depicted in the curves of FIG. 1 or FIG. 2 in which the average molecular weight is about 7.7 kDa. 12. A pharmaceutical composition comprising: a dose therapeutically effective to treat multiple sclerosis of a copolymer-1 composition, wherein the copolymer-1 composition comprises a mixture of polypeptides composed of glutamic acid, lysine, alanine and tyrosine, wherein the mixture has an average molecular weight of about 4 to about 9 kilodaltons, wherein the mixture of polypeptides is non-uniform with respect to molecular weight and sequence; and a pharmaceutically acceptable excipient. 13. The pharmaceutical composition of claim 12, wherein over 75% of the polypeptides of the mixture, on a molar fraction basis, have a molecular weight in a range of about 2 kilodaltons to about 20 kilodaltons. 14. The pharmaceutical composition of claim 12, wherein less than 5% of the polypeptides of the mixture, on a molar fraction basis, have a molecular weight of over 40 kilodaltons. 15. The pharmaceutical composition of claim 14, wherein over 75% of the polypeptides of the mixture, on a molar fraction basis, have a molecular weight in a range of about 2 kilodaltons to about 20 kilodaltons. 16. The pharmaceutical composition of claim 15, wherein the mixture has an average molecular weight of 6.25 to 8.4 kilodaltons. 17. The pharmaceutical composition of claim 12, wherein the mixture has an average molecular weight of about 4 to about 8.6 kilodaltons. 18. The pharmaceutical composition of claim 12, wherein the mixture has an average molecular weight of about 5 to about 9 kilodaltons. 19. The pharmaceutical composition of claim 12, wherein less than 2.5% of the polypeptides of the mixture, on a molar fraction basis, have a molecular weight of over 40 kilodaltons. 20. The pharmaceutical composition of claim 19, wherein over 75% of the polypeptides of the mixture, on a molar fraction basis, have a molecular weight in a range of about 2 kilodaltons to about 20 kilodaltons. 21. The pharmaceutical composition of claim 20, wherein the mixture has an average molecular weight of 6.25 to 8 4 kilodaltons. 22. The pharmaceutical composition of claim 12, wherein the mixture has a molecular weight distribution substantially as depicted in the curves of FIG. 1 or FIG. 2 in which the average molecular weight is about 7.7 kDa. 23. A method for treating a patient suffering from multiple sclerosis comprising administering to a patient in need thereof the pharmaceutical composition of claim 12. 24. A method for treating a patient suffering from multiple sclerosis comprising administering to a patient in need thereof the pharmaceutical composition of claim 13. 25. A method for treating a patient suffering from multiple sclerosis comprising administering to a patient in need thereof the pharmaceutical composition of claim 14. 26. A method for treating a patient suffering from multiple sclerosis comprising administering to a patient in need thereof the pharmaceutical composition of claim 15. 27. A method for treating a patient suffering from multiple sclerosis comprising administering to a patient in need thereof the pharmaceutical composition of claim 16. 28. A method for treating a patient suffering from multiple sclerosis comprising administering to a patient in need thereof the pharmaceutical composition of claim 17. 29. A method for treating a patient suffering from multiple sclerosis comprising administering to a patient in need thereof the pharmaceutical composition of claim 18. 30. A method for treating a patient suffering from multiple sclerosis comprising administering to a patient in need thereof the pharmaceutical composition of claim 19. 31. A method for treating a patient suffering from multiple sclerosis comprising administering to a patient in need thereof the pharmaceutical composition of claim 20. 32. A method for treating a patient suffering from multiple sclerosis comprising administering to a patient in need thereof the pharmaceutical composition of claim 21. 33. A method for treating a patient suffering from multiple sclerosis comprising administering to a patient in need thereof the pharmaceutical composition of claim 22.