PTAB

IPR2017-02106

Sandoz Inc v. AbbVie Biotechnology Ltd

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Use of TNFα Inhibitor for Treatment of Psoriatic Arthritis
  • Brief Description: The ’992 patent claims methods of treating psoriatic arthritis (PsA) by subcutaneously administering the anti-TNF-α antibody adalimumab at a dose of 40mg every other week (eow).

3. Grounds for Unpatentability

Ground 1: Anticipation by Mease 2004 - Claims 1, 5, and 6 are anticipated by Mease 2004

  • Prior Art Relied Upon: Mease 2004 (a 2004 clinical study publication).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Mease 2004, published more than one year before the asserted May 16, 2006 priority date for these claims, explicitly disclosed every limitation. The publication described a 24-week clinical study treating adult patients with moderate to severe active PsA (defined as ≥3 swollen and ≥3 tender joints) who had failed NSAID therapy. The study administered the claimed dosing regimen of 40mg adalimumab subcutaneously eow. The results reported that 39% of patients achieved an ACR50 response and 23% achieved an ACR70 response at week 24, directly mapping to the clinical endpoint limitations of claims 1, 5, and 6.

Ground 2: Obviousness over RA Treatment Art - Claims 1, 2, and 5-7 are obvious over Keystone in view of Lorenz and Mease 2000

  • Prior Art Relied Upon: Keystone (a 2001 clinical trial publication), Lorenz (a 2002 review article), and Mease 2000 (a 2000 clinical trial publication).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted that the only difference between the claimed method and the primary reference, Keystone, was the disease treated. Keystone taught the exact claimed dosing regimen—subcutaneous administration of 40mg adalimumab eow—and demonstrated its effectiveness for treating Rheumatoid Arthritis (RA). Lorenz was cited to establish that PsA and RA were understood to be closely related, TNF-α-mediated diseases, and that it was common practice to treat PsA with drugs and dosages proven effective for RA. Mease 2000 was cited to show that the claimed patient enrollment criteria (moderate to severe PsA, ≥3 swollen/tender joints, failed NSAID therapy) were standard for PsA clinical trials at the time.
    • Motivation to Combine: A POSITA would combine these references because the prior art established a clear pathway for repurposing successful RA therapies for PsA. Given that other TNF-α inhibitors like infliximab and etanercept were successfully used to treat PsA with the same regimens used for RA, it would have been an obvious and predictable step to apply Keystone’s established RA regimen for adalimumab to treat the analogous condition of PsA.
    • Expectation of Success: A POSITA would have a reasonable expectation of success because of the known shared pathology between RA and PsA. The documented success of other drugs in the same class (TNF-α inhibitors) in treating both conditions with identical or similar dosing regimens provided strong evidence that adalimumab would follow the same predictable pattern.

Ground 3: Obviousness over Alternative Combination - Claims 1, 2, and 5-7 are obvious over Keystone in view of Mease 2000, Dechant 2000, and Rau

  • Prior Art Relied Upon: Keystone (a 2001 clinical trial publication), Mease 2000 (a 2000 clinical trial publication), Dechant 2000 (a 2000 clinical study publication), and Rau (a 2000 clinical study publication).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground was presented as an alternative based on an earlier potential priority date of July 19, 2002. The core argument remained the same: Keystone disclosed the 40mg eow adalimumab dosing regimen for RA. Mease 2000 (studying etanercept) and Dechant 2000 (studying infliximab) provided further evidence that TNF-α inhibitors were effective in treating PsA using the same dosing regimens that were successful for RA. For claim 7, which recites inhibition of structural damage, Petitioner cited Rau, which taught that adalimumab treatment inhibited the progression of structural damage in RA patients as assessed by radiograph.
    • Motivation to Combine: The motivation was identical to Ground 2. The collective teachings of Mease 2000 and Dechant 2000 confirmed the principle that effective RA therapies were prime candidates for treating PsA. A POSITA would thus be motivated to apply the specific adalimumab regimen from Keystone to treat PsA.
    • Expectation of Success: The expectation of success was similarly rooted in the known biological relationship between RA and PsA and the established pattern of successful treatment crossover for TNF-α inhibitors. Since Rau showed adalimumab inhibited joint damage in RA, a POSITA would reasonably expect a similar effect in the closely related inflammatory arthritis of PsA.

4. Key Claim Construction Positions

  • Petitioner argued that the preambles of independent claims 1 ("A method of treatment of moderate to severe active [PsA]") and 2 ("A method for reducing or inhibiting symptoms in a patient with [PsA]") are non-limiting statements of intended use.
  • In the alternative, should the Board construe the preambles, Petitioner proposed that "treatment" in claim 1 be given its broadest reasonable interpretation of "reducing the signs, symptoms and/or progression" of PsA.
  • No other special claim constructions were asserted.

5. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1, 2, and 5-7 of the ’992 patent as unpatentable.