Sandoz Files IPR Petition Against Humira Formulation Patent

On July 20, 2017, Sandoz filed an IPR Petition (IPR2017-01824) against Abbvie’s U.S. Patent No. 8,802,100, which covers a stable liquid formulation of Humira.  The ‘100 Patent is similar to Abbvie’s U.S. Patent  8916157, for which the PTAB denied Amgen’s IPR petition:

8,802,100	8916157 (Amgen’s IPR Petition was not instituted)	9085619 (Coherus has filed multiple IPR petitions for this “bufferless patent”)
1. A stable liquid aqueous pharmaceutical formulation comprising	1. A stable liquid aqueous pharmaceutical formulation comprising	1. An aqueous pharmaceutical formulation consisting essentially of:
a) a human IgG1 anti-human Tumor Necrosis Factor alpha (TNF-alpha) antibody, or an antigen-binding portion thereof, at a concentration of 45 to 150 mg/ml,	a) a human IgG1 anti-human Tumor Necrosis Factor alpha (TNF-alpha) antibody, or an antigen-binding portion thereof, at a concentration of 20 to 150 mg/ml,	(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) a polyol,	b) a tonicity agent,	(b) water.
(c) a polysorbate at a concentration of 0.1 to 10 mg/ml, and	(c) a surfactant, and
(d) a buffer system having a pH of 4.5 to 7.0, wherein the antibody comprises the light chain variable region and the heavy chain variable region of D2E	(d) a buffer system having a pH of 4.0 to 8.0, wherein the antibody comprises the light chain variable region and the heavy chain variable region of D2E7

Sandoz argues obviousness based on multiple references (over Salfeld in combination with van de Putte, Barrera, Remington and Lam).  According to Sandoz, “a POSA seeking to formulate D2E7 [Humira] would (1) determine the concentration of D2E7 to use based upon AbbVie’s own van de Putte disclosure of clinical data demonstrating the safety and efficacy of 20, 40 and 80 mg doses, which are readily converted to concentrations; (2) use Salfeld’s teaching that D2E7 should be combined with a tonicity agent like mannitol, a surfactant and a buffer; (3) determine the amount of mannitol based upon Remington’s teaching of how to use tonicity agents and AbbVie’s own Barrera disclosure of a D2E7 formulation having 12 mg/ml mannitol; and (4) identify the type and amount of surfactant based on Remington’s teaching that polysorbate is the most widely used surfactant and Lam’s teaching of a 0.01% to about 0.1% concentration of polysorbate, which is readily converted into mg/ml.” 

The PTAB’s denial of Amgen’s petition over a similar patent and Sandoz’s reliance on so many references does not bode well for Sandoz.