Sandoz Files IPR Petition Against Humira Psoriasis Patent

On July 20, 2017, Sandoz filed an IPR Petition (IPR2017-01824) against Abbvie’s U.S. Patent No.: 9,512,216, which just issued on Dec. 6, 2016.  The ‘216 Patent covers a method of treating chronic plaque psoriasis by administering Humira (adalimumab) starting with an initial dose of 80 mg of adalimumab, followed by 40 mg of adalimumab every other week.  The claims of the ’216 Patent also have a wherein clause requiring that “the patient achieves at least Psoriasis Area and Severity Index (PASI) 75 response at week 12 of the treatment.”

US Patent 9,512,216
1. A method for treating moderate to severe chronic plaque psoriasis, comprising subcutaneously administering to an adult patient having moderate to severe chronic plaque psoriasis an initial dose of 80 mg of adalimumab, followed by 40 mg of adalimumab every other week starting one week after said first dosing, wherein the patient achieves at least Psoriasis Area and Severity Index (PASI) 75 response at week 12 of the treatment.

Sandoz does not have an anticipatory position.  Rather, Sandoz mainly argues that the claimed method for treating psoriasis is obvious in view of prior art for treating rheumatoid arthritis since the two diseases “are closely related conditions, mediated by TNF-α, that could be treated with the same drugs using the same dosing regimens.”  Sandoz further argues that “it was obvious to administer an 80 mg induction dose of adalimumab one week before beginning the PsO (psoriasis) adalimumab treatment dose because a POSA would have known that (i) an induction dose would provide more rapid relief to patients suffering severe physical and psychological symptoms associated with diseases like PsO; (ii) the first-in-class TNF-α inhibitor infliximab was administered with an induction dose to treat PsO; (iii) an appropriate induction dose for a drug like adalimumab, which has linear (i.e., “first order”) pharmacokinetics and is dosed approximately on its two-week half-life, would be double the 40 mg treatment dose; (iv) 80 mg was shown to be effective in treating RA when dosed weekly;(v) an interval of one week instead of two weeks between administering an induction dose and beginning treatment dosing would have achieved the goal of more rapid relief; and (v) it would be most convenient to use an induction dose (such as 80 mg) that was a multiple of AbbVie’s already approved 40 mg pre-filled syringe.”

Sandoz further argues “that the ‘wherein’ clause of claim 1 merely ‘characterizes the result’ of the claimed method while failing to inform ‘how’ the method is performed, the clause does not limit the scope of the claim.  See Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir. 2003).”  

Sandoz provides the following claim chart in its petition.  Sandoz cites to the ‘216 Patent in the prior art section since the ’216 Patent “demonstrates the result is inherent for some portion of treated patient.”  

Claims 1 and 9
9,512,216	Prior Art
A method for treating moderate to severe chronic plaque psoriasis,
comprising subcutaneously administering	“HUMIRA is supplied in single-use, 1 mL pre-filled syringes, and also 2 mL glass vials as a sterile, preservative-free solution for subcutaneous injection.”  “The recommended dose of HUMIRA for adult patients with rheumatoid arthritis is 40 mg administered every other week as a subcutaneous injection.”
to an adult patient having moderate to severe chronic plaque psoriasis	“[T]reatment was efficacious and safe in PsA and psoriasis.”  “Adult patients who had moderate to severe plaque psoriasis involving at least 5% of the body surface area and who were in good general health were referred to us . . . or were identified through general advertisements” to participate in the study.  Ex. 1036  at 1843; see also Ex. 1003 at 250, 316. “Psoriasis . . .  [is an] autoimmune disorder[] in which . . . tumor necrosis factor-alpha . . . has been suggested to play a role.”  Clinical data “suggest[s] . . . treatments that inhibit TNF-alpha may be effective in these disease states.” “HUMIRA . . . works by specifically blocking TNF-alpha.” Abbott sought to “assess safety and efficacy [of adalimumab] in adult patients with moderate to severe chronic-plaque psoriasis.”  Ex. 1052 at 2. “[I]nfliximab at a dose of 3 mg/kg with methotrexate has proven effective in rheumatoid arthritis.  We therefore aimed to assess the efficacy of infliximab at a dose of 3 mg/kg in combination with methotrexate in the treatment of patients with PsA and skin psoriasis.”  Ex. 1060 at 1.
an initial dose of 80 mg of adalimumab	An induction dose “may be administered initially in order to achieve a peak plasma concentration that lies within the therapeutic range of the drug” and “[t]o reduce the time required for onset of the full therapeutic effect.”  Ex. 1051 at 284-285. “As a general rule, the loading dose should be twice the size of the maintenance dose if the selected dosage time interval corresponds to the biological half-life of the drug.” Ex. 1051 at 28
followed by 40 mg of adalimumab	“Each syringe delivers 0.8 mL (40 mg) of drug product. . . . Each 0.8 mL HUMIRA contains 40 mg adalimumab . . . .”  Ex. 1026 at 1.
every other week	“The recommended dose of HUMIRA for adult patients with rheumatoid arthritis is 40 mg administered every other week as a subcutaneous injection.”  Ex. 1026 at 14.
starting one week after said first dosing,	An induction dose “may be administered initially in order to achieve a peak plasma concentration that lies within the therapeutic range of the drug” and “[t]o reduce the time required for onset of the full therapeutic effect.”  Ex. 1051 at 284-285.
[claim 1 only:] wherein the patient achieves at least Psoriasis Area and Severity Index (PASI) 75 response at week 12 of the treatment.	“[A]t Week 12, statistically significantly greater percentages of patients achieved a PASI 75 response or better on D2E7 than those on a placebo treatment.”  Ex. 1001 at 42:5-8  [The ’216 patent is not prior art but its disclosure demonstrates the result is inherent for some portion of treated patient].