Claims for Patent: 9,056,915

Summary for Patent: 9,056,915

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:	14/459,768
Patent Claims:	1. A monoclonal antibody that binds to an epitope on PCSK9, wherein the epitope comprises at least one 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, and wherein said monoclonal antibody comprises: a heavy chain variable region; and a light chain variable region; wherein the monoclonal antibody blocks binding interaction between PCSK9 and EGFa domain of LDLR. 2. The monoclonal antibody of claim 1, wherein the light chain variable region comprises at least one selected from the group consisting of L48, S51, Y93, and S98 of SEQ ID NO:12. 3. The monoclonal antibody of claim 1, wherein said monoclonal antibody is a human or a humanized monoclonal antibody. 4. The monoclonal antibody of claim 1, wherein said monoclonal antibody binds to a D374Y variant of a PCSK9 protein comprising SEQ ID NO: 1. 5. The monoclonal antibody of claim 1, wherein said monoclonal antibody is an IgG. 6. The monoclonal antibody of claim 1, wherein said light chain variable region is connected to a human kappa amino acid sequence. 7. The monoclonal antibody of claim 1, wherein the monoclonal antibody comprises an intact immunoglobulin. 8. The monoclonal antibody of claim 1, wherein the monoclonal antibody comprises a fragment of an intact immunoglobulin. 9. The monoclonal antibody of claim 1, wherein the monoclonal antibody comprises the amino acid sequence of SEQ ID NO: 157. 10. A pharmaceutical composition comprising: a pharmaceutically acceptable carrier; and a monoclonal antibody that binds to an epitope on PCSK9, wherein the epitope comprises at least one 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, and wherein said monoclonal antibody comprises a heavy chain variable region and a light chain variable region; wherein the monoclonal antibody blocks binding interaction between PCSK9 and EGFa domain of LDLR. 11. The monoclonal antibody of claim 1, wherein the heavy chain variable region comprises at least one amino acid in the specified position selected from the group consisting of T28, S30, S31, Y32, S54, S55, S56, Y57, I58, S59, Y60, N74, A75, R98, Y100, F102, W103, S104, A105, Y106, Y107, D108, A109, and D111 of SEQ ID NO: 67. 12. The monoclonal antibody of claim 11, wherein the light chain variable region comprises at least one selected from the group consisting of L48, S51, Y93, and S98 of SEQ ID NO: 12. 13. The monoclonal antibody of claim 12, wherein said monoclonal antibody is a human or a humanized monoclonal antibody. 14. The monoclonal antibody of claim 12, wherein said monoclonal antibody binds to a D374Y variant of a PCSK9 protein comprising SEQ ID NO: 1. 15. The monoclonal antibody of claim 12, wherein said monoclonal antibody is an IgG. 16. The monoclonal antibody of claim 12, wherein said light chain variable region is connected to a human kappa amino acid sequence. 17. The monoclonal antibody of claim 12, wherein the monoclonal antibody comprises an intact immunoglobulin. 18. The monoclonal antibody of claim 12, wherein the monoclonal antibody comprises a fragment of an intact immunoglobulin. 19. The monoclonal antibody of claim 12, wherein the monoclonal antibody comprises the amino acid sequence of SEQ ID NO: 157. 20. The monoclonal antibody of claim 12, further comprising a HCDR1 that is a HCDR1 in SEQ ID NO:60 according to the definition of Chothia. 21. The pharmaceutical composition of claim 10, wherein the heavy chain variable region comprises at least one amino acid in the specified position selected from the group consisting of T28, S30, S31, Y32, S54, S55, S56, Y57, I58, S59, Y60, N74, A75, R98, Y100, F102, W103, S104, A105, Y106, Y107, D108, A109, and D111 of SEQ ID NO: 67. 22. The pharmaceutical composition of claim 10, wherein the light chain variable region comprises at least one amino acid in the specified position selected from the group consisting of L48, S51, Y93, and S98 of SEQ ID NO: 12. 23. The pharmaceutical composition of claim 21, wherein the light chain variable region comprises at least one amino acid in the specified position selected from the group consisting of L48, S51, Y93, and S98 of SEQ ID NO: 12.

Details for Patent 9,056,915

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Amgen, Inc.	REPATHA	evolocumab	Injection	125522	08/27/2015		2027-08-23
Amgen, Inc.	REPATHA	evolocumab	Injection	125522	07/08/2016		2027-08-23

International Patent Family for US Patent 9,056,915

Country	Patent Number	Estimated Expiration
Argentina	068011
Argentina	110799
Australia	2008288791