PTAB

IPR2017-02036

Sandoz Inc v. Genentech Inc

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Therapy of Autoimmune Disease in a Patient with an Inadequate Response to a TNF-α Inhibitor
  • Brief Description: The ’838 patent claims methods of treating rheumatoid arthritis (RA) in a human patient who has experienced an inadequate response to a tumor necrosis factor-alpha (TNF-α) inhibitor. The method involves administering an anti-CD20 antibody, such as rituximab, according to a specific dosing regimen.

3. Grounds for Unpatentability

Ground 1: Claims 1-14 are obvious over Edwards in view of DeVita and Curd.

  • Prior Art Relied Upon: Edwards (a 2001 article in RHEUMATOLOGY), DeVita (a 2001 article in REUMATISMO), and Curd (International Publication No. WO 00/67796).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the prior art collectively disclosed all elements of the challenged claims. Edwards taught treating refractory RA patients with rituximab, demonstrating its efficacy and establishing a baseline dosing protocol (four infusions totaling 2100 mg). DeVita explicitly taught treating patients who had an inadequate response to TNF-α inhibitors (TNFIRs) with rituximab, demonstrating a clinical response in this specific patient subset. Curd disclosed a broad dose range for rituximab in RA treatment (20 mg/m² to 1000 mg/m²) that encompasses the claimed "two intravenous doses of 1000 mg," and explicitly taught that the antibody could be given in one or more doses and that the dosing schedule was subject to therapeutic discretion. Dependent claims adding concomitant methotrexate and/or corticosteroids were also rendered obvious, as Curd expressly teaches combining rituximab with these standard RA therapies.
    • Motivation to Combine: A person of ordinary skill in the art (POSITA) would have been motivated to treat TNFIRs with rituximab because it was a known problem that a significant percentage of patients failed TNF-α therapy, and rituximab offered a promising alternative with a different mechanism of action (B-cell depletion vs. TNF-α inhibition). The failure of one therapy would not predict the failure of the other. Furthermore, a POSITA would have been motivated to optimize the dosing regimen taught by Edwards (four infusions) to one with fewer administrations (two infusions) to improve patient compliance and convenience, a common goal in clinical practice. The claimed regimen of two 1000 mg doses was a predictable modification, as it represented a therapeutically equivalent total dose to the known effective regimens in Edwards and DeVita, and fell within the range disclosed by Curd. The long half-life of rituximab (weeks) provided a scientific rationale for less frequent dosing.
    • Expectation of Success: A POSITA would have had a reasonable expectation of success. The distinct mechanisms of action meant there was no reason to believe a TNFIR would not respond to rituximab. DeVita confirmed this by reporting positive clinical results in TNFIRs treated with rituximab. The pharmacokinetic data available at the time would have assured a POSITA that administering two 1000 mg doses would produce an equivalent blood plasma profile to the known effective weekly dosing regimens, leading to an expectation of similar clinical outcomes. Toxicity was not a concern, as prior art showed that single doses exceeding 1000 mg were well-tolerated.
    • Key Aspects: The petition asserted that the claimed invention is merely the application of a known drug (rituximab) to a known subset of patients (TNFIRs) using a dosing regimen that is an obvious optimization of prior art protocols. The specification of the ’838 patent itself provides no clinical data and treats the claimed 2x1000 mg regimen as interchangeable with the prior art 4x375 mg/m² regimen, undermining any argument of non-obviousness.

4. Key Claim Construction Positions

  • Petitioner argued that claim elements reciting specific clinical outcomes (e.g., "in an amount that is effective to provide an ACR50 response at week 24," "no erosive progression at weeks 24 and beyond") are not entitled to patentable weight.
  • The petition contended these clauses merely recite the intended or aspirational result of the administration step, rather than imposing any additional limitations on the method itself. The method remains the same—administering two 1000 mg doses—regardless of whether the clinical outcome is achieved.
  • Petitioner cited Federal Circuit and PTAB precedent holding that such "intended result" clauses do not add to the patentability of a claim, especially where, as here, the specification provides no experimental data to demonstrate that the recited outcomes are actually achieved by the claimed method steps.

5. Relief Requested

  • Petitioner requested institution of an inter partes review and cancellation of claims 1-14 of the ’838 patent as unpatentable under 35 U.S.C. §103.