Claims for Patent: 9,085,619

Summary for Patent: 9,085,619

Title:	Anti-TNF antibody formulations
Abstract:	The invention provides an aqueous formulation comprising water and a protein, and methods of making the same. The aqueous formulation of the invention may be a high protein formulation and/or may have low levels of conductity resulting from the low levels of ionic excipients. Also included in the invention are formulations comprising water and proteins having low osmolality.
Inventor(s):	Fraunhofer; Wolfgang (Gurnee, IL), Bartl; Annika (Ludwigshafen, DE), Krause; Hans-Juergen (Biblis, DE), Tschoepe; Markus (Hessheim, DE)
Assignee:	AbbVie Biotechnology LTD. (Hamilton, BM)
Application Number:	14/506,576
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,085,619
Patent Claims:	1. An aqueous pharmaceutical formulation consisting essentially of: (a) an anti-tumor necrosis factor alpha antibody comprising a light chain variable region (LCVR) having a CDR3 domain comprising the amino acid sequence of SEQ ID NO:3, a CDR2 domain comprising the amino acid sequence of SEQ ID NO:5, and a CDR1 domain comprising the amino acid sequence of SEQ ID NO: 7, and a heavy chain variable region (HCVR) having a CDR3 domain comprising the amino acid sequence of SEQ ID NO:4, a CDR2 domain comprising the amino acid sequence of SEQ ID NO: 6, and a CDR1 domain comprising the amino acid sequence of SEQ ID NO:8, wherein the concentration of the antibody is 50 to 200 mg/ml; and (b) water. 2. The formulation of claim 1, wherein the antibody comprises a LCVR comprising the amino acid sequence set forth in SEQ ID NO: 1, and a HCVR comprising the amino acid sequence set forth in SEQ ID NO: 2. 3. The formulation of claim 2, wherein the antibody is adalimumab. 4. The formulation of claim 1, wherein the pH of the formulation is from 4 to 8. 5. The formulation of claim 3, wherein the pH of the formulation is from 4 to 8. 6. An aqueous pharmaceutical formulation comprising: (a) an anti-tumor necrosis factor alpha antibody comprising a light chain variable region (LCVR) having a CDR3 domain comprising the amino acid sequence of SEQ ID NO:3, a CDR2 domain comprising the amino acid sequence of SEQ ID NO:5, and a CDR1 domain comprising the amino acid sequence of SEQ ID NO: 7, and a heavy chain variable region (HCVR) having a CDR3 domain comprising the amino acid sequence of SEQ ID NO:4, a CDR2 domain comprising the amino acid sequence of SEQ ID NO: 6, and a CDR1 domain comprising the amino acid sequence of SEQ ID NO:8, wherein the concentration of the antibody is 50 to 200 mg/ml; and (b) water; wherein the formulation does not comprise a tonicity modifier. 7. The formulation of claim 6, wherein the antibody comprises a LCVR comprising the amino acid sequence set forth in SEQ ID NO: 1, and a HCVR comprising the amino acid sequence set forth in SEQ ID NO: 2. 8. The formulation of claim 7, wherein the antibody is adalimumab. 9. The formulation of claim 6, wherein the pH of the formulation is from 4 to 8. 10. The formulation of claim 6, wherein the pH of the formulation is from 4 to 6. 11. The formulation of claim 6, wherein the pH of the formulation is from 5 to 6. 12. The formulation of claim 8, wherein the pH of the formulation is from 4 to 8. 13. The formulation of claim 8, wherein the pH of the formulation is from 4 to 6. 14. The formulation of claim 8, wherein the pH of the formulation is from 5 to 6. 15. The formulation of claim 8, wherein the pH of the formulation is 5.2. 16. An aqueous pharmaceutical formulation comprising: (a) an anti-tumor necrosis factor alpha antibody comprising a light chain variable region (LCVR) having a CDR3 domain comprising the amino acid sequence of SEQ ID NO:3, a CDR2 domain comprising the amino acid sequence of SEQ ID NO:5, and a CDR1 domain comprising the amino acid sequence of SEQ ID NO: 7, and a heavy chain variable region (HCVR) having a CDR3 domain comprising the amino acid sequence of SEQ ID NO:4, a CDR2 domain comprising the amino acid sequence of SEQ ID NO: 6, and a CDR1 domain comprising the amino acid sequence of SEQ ID NO:8, wherein the concentration of the antibody is 50 to 200 mg/ml; and (b) water; wherein the formulation does not comprise a buffering system. 17. The formulation of claim 16, wherein the antibody comprises a LCVR comprising the amino acid sequence set forth in SEQ ID NO: 1, and a HCVR comprising the amino acid sequence set forth in SEQ ID NO: 2. 18. The formulation of claim 17, wherein the antibody is adalimumab. 19. The formulation of claim 16, wherein the formulation further comprises a non-ionizable excipient. 20. The formulation of claim 16, wherein the formulation further comprises a polyol. 21. The formulation of claim 20, wherein the polyol is selected from the group consisting of mannitol, sorbitol, and sucrose. 22. The formulation of claim 16, wherein the formulation further comprises a surfactant. 23. The formulation of claim 22, wherein the surfactant is selected from the group consisting of polysorbate 80 and polysorbate 20. 24. The formulation of claim 16, wherein the pH of the formulation is from 4 to 8. 25. The formulation of claim 16, wherein the pH of the formulation is from 4 to 6. 26. The formulation of claim 16, wherein the pH of the formulation is from 5 to 6. 27. The formulation of claim 18, wherein the pH of the formulation is from 4 to 8. 28. The formulation of claim 18, wherein the pH of the formulation is from 4 to 6. 29. The formulation of claim 18, wherein the pH of the formulation is from 5 to 6. 30. The formulation of claim 18, wherein the pH of the formulation is 5.2.

Details for Patent 9,085,619

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	December 31, 2002		2034-10-03
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	February 21, 2008		2034-10-03
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	April 24, 2013		2034-10-03
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	September 23, 2014		2034-10-03
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	November 23, 2015		2034-10-03
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	March 09, 2016		2034-10-03

International Patent Family for US Patent 9,085,619

Country	Patent Number	Estimated Expiration
South Africa	201205433
World Intellectual Property Organization (WIPO)	2014130064
World Intellectual Property Organization (WIPO)	2009073569
United States of America	8883146
United States of America	8420081
United States of America	2023007847