Claims for Patent: 9,493,576

Summary for Patent: 9,493,576

Title:	Antigen binding proteins to proprotein convertase subtilisin kexin type 9 (PCSK9)
Abstract:	Antigen binding proteins that interact with Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) are described. Methods of treating hypercholesterolemia and other disorders by administering a pharmaceutically effective amount of an antigen binding protein to PCSK9 are described. Methods of detecting the amount of PCSK9 in a sample using an antigen binding protein to PCSK9 are described.
Inventor(s):	Jackson; Simon Mark (San Carlos, CA), Walker; Nigel Pelham Clinton (Burlingame, CA), Piper; Derek Evan (Santa Clara, CA), Shan; Bei (Redwood City, CA), Shen; Wenyan (Palo Alto, CA), King; Chadwick Terence (North Vancouver, CA), Ketchem; Randal Robert (Snohomish, WA), Mehlin; Christopher (Seattle, WA), Carabeo; Teresa Arazas (New York, NY)
Assignee:	AMGEN INC. (Thousand Oaks, CA)
Application Number:	14/459,787
Patent Claims:	1. A monoclonal antibody that recognizes a conformational epitope on human PCSK9 comprising amino acid residues: S153, R194, D238, D374, T377, and F379 of SEQ ID NO: 3, wherein the monoclonal antibody reduces binding between PCSK9 and EGFa domain of LDLR. 2. The monoclonal antibody of claim 1, wherein the monoclonal antibody is a neutralizing antibody. 3. The monoclonal antibody of claim 1 wherein the monoclonal antibody is a human antibody. 4. The monoclonal antibody of claim 1, wherein the monoclonal antibody is a humanized antibody. 5. The monoclonal antibody of claim 1, wherein the monoclonal antibody was produced by a mammalian cell. 6. The monoclonal antibody of claim 1, wherein the monoclonal antibody was produced by a CHO cell. 7. The monoclonal antibody of claim 1, wherein the monoclonal antibody binds to PCSK9 with a K.sub.D of less than or equal to 5.times.10.sup.-9 M. 8. The monoclonal antibody of claim 1, wherein the monoclonal antibody comprises a light chain region that comprises an amino acid sequence of SEQ ID NO: 157. 9. The monoclonal antibody of claim 1, wherein the monoclonal antibody comprises a heavy chain region that comprises an amino acid sequence of SEQ ID NO: 154. 10. The monoclonal antibody of claim 9, wherein the monoclonal antibody comprises a light chain region that comprises an amino acid sequence of SEQ ID NO: 157. 11. The monoclonal antibody of claim 10, further comprising a HCDR1 that is a HCDR1 in SEQ ID NO: 60 according to the definition of Chothia. 12. The monoclonal antibody of claim 1, further comprising a HCDR1 that is a HCDR1 in SEQ ID NO: 60 according to the definition of Chothia. 13. A monoclonal antibody that binds to amino acids in human PCSK9 of SEQ ID NO:1, wherein the amino acids comprise S153, R194, D238, D374, T377, and F379 of SEQ ID NO: 3, and wherein the monoclonal antibody reduces binding between PCSK9 and EGFa domain of LDLR. 14. The monoclonal antibody of claim 13, wherein the monoclonal antibody is a neutralizing antibody. 15. The monoclonal antibody of claim 13, wherein the monoclonal antibody is a humanized antibody. 16. The monoclonal antibody of claim 13, wherein the monoclonal antibody was produced by a mammalian cell. 17. The monoclonal antibody of claim 13, wherein the monoclonal antibody was produced by a CHO cell. 18. The monoclonal antibody of claim 13, wherein the monoclonal antibody comprises a light chain region that comprises an amino acid sequence of SEQ ID NO: 157. 19. The monoclonal antibody of claim 13, wherein the monoclonal antibody comprises a heavy chain region that comprises an amino acid sequence of SEQ ID NO: 154. 20. The monoclonal antibody of claim 19, wherein the monoclonal antibody comprises a light chain region that comprises an amino acid sequence of SEQ ID NO: 157. 21. The monoclonal antibody of claim 20, further comprising a HCDR1 that is a HCDR1 in SEQ ID NO: 60 according to the definition of Chothia. 22. The monoclonal antibody of claim 13, further comprising a HCDR1 that is a HCDR1 in SEQ ID NO: 60 according to the definition of Chothia. 23. A monoclonal antibody that recognizes a conformational epitope on human PCSK9, wherein the conformational epitope comprises at least ten of the following residues: S153, 1154, P155, R194, D238, A239, 1369, S372, D374, C375, T377, C378, F379, V380, or S381 of SEQ ID NO: 3, wherein the monoclonal antibody reduces binding between PCSK9 and EGFa domain of LDLR. 24. The monoclonal antibody of claim 23, wherein the conformational epitope comprises at least thirteen of the following residues: S153, I154, P155, R194, D238, A239, I369, S372, D374, C375, T377, C378, F379, V380, or S381 of SEQ ID NO: 3. 25. The monoclonal antibody of claim 23, wherein the monoclonal antibody binds to at least S381. 26. The monoclonal antibody of claim 23, wherein the monoclonal antibody is a humanized antibody. 27. The monoclonal antibody of claim 23, wherein the monoclonal antibody was produced by a mammalian cell. 28. The monoclonal antibody of claim 23, wherein the monoclonal antibody was produced by a CHO cell. 29. The monoclonal antibody of claim 23, wherein the monoclonal antibody is a neutralizing antibody. 30. The monoclonal antibody of claim 23, wherein the monoclonal antibody comprises a light chain region that comprises an amino acid sequence of SEQ ID NO: 157. 31. The monoclonal antibody of claim 23, wherein the monoclonal antibody comprises a heavy chain region that comprises an amino acid sequence of SEQ ID NO: 154. 32. The monoclonal antibody of claim 31, wherein the monoclonal antibody comprises a light chain region that comprises an amino acid sequence of SEQ ID NO: 157. 33. A monoclonal antibody that binds to amino acids in human PCSK9, wherein the amino acids comprise ten or more of the following amino acids: S153, I154, P155, R194, D238, A239, I369, S372, D374, C375, T377, C378, F379, V380, or S381 of SEQ ID NO: 3, and wherein the monoclonal antibody reduces binding between PCSK9 and EGFa domain of LDLR. 34. The monoclonal antibody of claim 33, wherein the monoclonal antibody binds thirteen or more of the following amino acids: S153, I154, P155, R194, D238, A239, I369, S372, D374, C375, T377, C378, F379, V380, or S381 of SEQ ID NO: 3. 35. The monoclonal antibody of claim 33, wherein the monoclonal antibody binds to at least S381. 36. The monoclonal antibody of claim 33 wherein the monoclonal antibody is a humanized antibody. 37. The monoclonal antibody of claim 33, wherein the monoclonal antibody was produced by a mammalian cell. 38. The monoclonal antibody of claim 33, wherein the monoclonal antibody was produced by a CHO cell. 39. The monoclonal antibody of claim 33, wherein the monoclonal antibody is a neutralizing antibody. 40. The monoclonal antibody of claim 33, wherein the monoclonal antibody comprises a light chain region that comprises an amino acid sequence of SEQ ID NO: 157. 41. The monoclonal antibody of claim 33, wherein the monoclonal antibody comprises a heavy chain region that comprises an amino acid sequence of SEQ ID NO: 154. 42. The monoclonal antibody of claim 41, wherein the monoclonal antibody comprises a light chain region that comprises an amino acid sequence of SEQ ID NO: 157. 43. A pharmaceutical composition comprising: a pharmaceutically acceptable carrier; and the monoclonal antibody of any one of claims 1-42.

Details for Patent 9,493,576

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Amgen Inc.	REPATHA	evolocumab	Injection	125522	August 27, 2015	9,493,576	2027-08-23
Amgen Inc.	REPATHA	evolocumab	Injection	125522	July 08, 2016	9,493,576	2027-08-23

International Patent Family for US Patent 9,493,576

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2009026558
United States of America	9920134
United States of America	9056915