PTAB

IPR2017-02042

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 for treating rheumatoid arthritis (RA) in patients who have an inadequate response to a tumor necrosis factor alpha (TNF-α) inhibitor. The claimed method involves administering two intravenous doses of 1,000 mg of an anti-CD20 antibody, such as rituximab.

3. Grounds for Unpatentability

Ground 1: Claims 1-14 are obvious over Edwards 2002 in view of Patel and Curd.

  • Prior Art Relied Upon: Edwards 2002 (a 2002 clinical trial abstract published in Arthritis & Rheumatism), Patel (a 2002 review article in Arthritis & Rheumatism), and Curd (WO 00/67796).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Edwards 2002 disclosed the core therapeutic regimen: treating RA patients with two intravenous 1,000 mg doses of rituximab, optionally combined with methotrexate and corticosteroids (addressing dependent claims 4-6). However, Edwards 2002 studied a general population of refractory RA patients. Patel explicitly taught that RA patients refractory to conventional therapy, specifically including TNF inhibitors (TNFIRs), were candidates for and "may respond" to B-cell ablative therapies like rituximab. Curd disclosed a broad dosage range for rituximab in treating RA, including fixed doses of 1,000 mg, and taught its combination with agents like methotrexate and corticosteroids.
    • Motivation to Combine: Petitioner contended a person of ordinary skill in the art (POSITA) would combine the teachings to treat the specific TNFIR patient population from Patel with the exact dosing regimen from Edwards 2002. The motivation stemmed from several factors: (1) rituximab offered a different mechanism of action (B-cell depletion) than TNF-α inhibitors, making it a logical next step for non-responders; (2) Patel explicitly identified TNFIRs as a patient group that could benefit from rituximab; and (3) the Edwards 2002 two-dose regimen was simpler and improved patient compliance compared to other known four-dose regimens.
    • Expectation of Success: A POSITA would have a reasonable expectation of success because the prior art, including studies referenced in Patel, already demonstrated rituximab's effectiveness in treating refractory RA patients. Since TNFIRs are a subset of this population and rituximab's mechanism is distinct from TNF-α inhibitors, it was predictable that a known effective regimen would work for them. The success shown in Edwards 2002 with refractory RA patients generally would translate to the specific TNFIR sub-population.

Ground 2: Claims 1-14 are obvious over Edwards 2002 in view of Tuscano and Curd.

  • Prior Art Relied Upon: Edwards 2002 (a 2002 clinical trial abstract), Tuscano (a 2002 abstract in Arthritis & Rheumatism), and Curd (WO 00/67796).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground is substantially similar to Ground 1, with Tuscano serving the same primary purpose as Patel. Edwards 2002 and Curd are applied for the same reasons as above. Tuscano provided even more direct evidence than Patel, as its title is "Successful Treatment of Infliximab-Refractory Rheumatoid Arthritis with Rituximab." Tuscano reported on a clinical trial treating patients who failed the TNF-α inhibitor infliximab, concluding that rituximab is a "promising agent" for this specific patient group.
    • Motivation to Combine: The motivation to combine Edwards 2002 with Tuscano was even stronger than with Patel. Tuscano not only suggested treating TNFIRs with rituximab but reported actual successful clinical data for that specific patient group. A POSITA seeing Tuscano's successful results would be highly motivated to apply a well-tolerated and effective regimen, like the two 1,000 mg doses from Edwards 2002, to this population to achieve a positive clinical outcome. The desire for a simplified, compliance-enhancing regimen provided further motivation to select the Edwards 2002 protocol.
    • Expectation of Success: Tuscano's direct report of success in treating infliximab-refractory patients provided a strong basis for expecting success. A POSITA would expect that applying the optimized, two-dose regimen from the larger Edwards 2002 study to the patient population successfully treated in Tuscano would yield predictable and beneficial results, including the clinical outcomes recited in the dependent claims.

4. Key Claim Construction Positions

  • Clinical Outcomes as Intended Results: Petitioner argued that claim elements reciting specific clinical outcomes (e.g., "effective to provide an ACR50 response at week 24" in claims 2 and 10-14) are not entitled to patentable weight.
  • Rationale: Petitioner asserted these clauses merely state the intended or aspirational result of administering the claimed dosage. The patent’s specification contains no experimental data demonstrating these outcomes are achieved but instead describes them in a prophetic example as what "will result" from the administration. Therefore, these clauses do not add a further limitation to the method steps and should be disregarded for patentability analysis.

5. Relief Requested

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