PTAB

IPR2017-01115

Pfizer Inc v. Genentech Inc

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Treatment of Autoimmune Disease
  • Brief Description: The ’161 patent is directed to methods of treating rheumatoid arthritis (RA) in humans by administering more than one intravenous dose of the anti-CD20 antibody rituximab in combination with methotrexate.

3. Grounds for Unpatentability

Ground 1: Obviousness over Edwards, the FDA Conversation, and the Rituxan Label - Claims 1-12 are obvious over Edwards in view of the FDA Conversation and the Rituxan Label.

  • Prior Art Relied Upon: Edwards (a 1998 journal article), the FDA Conversation (a 1995 publication on biologics), and the Rituxan Label (a 1997 FDA-approved product insert).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the prior art collectively disclosed every element of the challenged claims. Edwards explicitly proposed treating RA by killing B-cells with an anti-B-cell (CD20) antibody like rituximab. The FDA Conversation established that it was standard practice for clinicians to use methotrexate as "background therapy" with all new biologic agents being developed for RA. The Rituxan Label, approved for treating non-Hodgkin's lymphoma (NHL), provided a known safe and effective intravenous dosing regimen (375 mg/m² weekly for four doses) for depleting B-cells, the same therapeutic goal as treating RA.
    • Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) would combine these teachings because methotrexate was the "cornerstone" of RA therapy. The FDA Conversation showed it was ethically and practically necessary to keep RA patients on methotrexate while introducing a new biologic agent. Therefore, a POSITA seeking to implement Edwards’s proposal to treat RA with rituximab would have been motivated to do so in combination with the standard of care, methotrexate, as guided by the FDA.
    • Expectation of Success: A POSITA would have had a reasonable expectation of success. The Rituxan Label confirmed that a multi-dose intravenous regimen of rituximab was safe and effective at depleting B-cells. Since methotrexate and rituximab operate via different mechanisms, a POSITA would expect an additive effect without interference. Petitioner asserted that real-world evidence, such as contemporaneous proposals by researchers to study rituximab for RA, confirmed this expectation.

Ground 2: Obviousness over Edwards and O'Dell, in view of the Rituxan Label - Claims 1-12 are obvious over Edwards in view of O'Dell and the Rituxan Label.

  • Prior Art Relied Upon: Edwards (a 1998 journal article), O'Dell (a 1997 journal article), and the Rituxan Label (a 1997 product insert).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground presented a similar argument to Ground 1, substituting the O'Dell reference for the FDA Conversation to establish the central role of methotrexate. Edwards proposed using rituximab for RA. O'Dell described methotrexate as the "gold standard" and the "most commonly used" disease-modifying antirheumatic drug (DMARD) for treating RA, noting its "therapeutic dominance." The Rituxan Label again provided the known effective dosing regimen for B-cell depletion.
    • Motivation to Combine: A POSITA would combine Edwards’s suggestion with O'Dell's teaching because O'Dell established methotrexate as the foundational therapy against which new combination treatments should be measured. O'Dell explicitly discussed the common practice of adding other DMARDs to methotrexate for patients with partial responses. A POSITA would have been motivated to add a promising new biologic agent, rituximab, to the established gold-standard therapy to improve outcomes.
    • Expectation of Success: The expectation of success was based on the same reasoning as in Ground 1: rituximab was known to be effective at B-cell depletion, and its combination with the standard RA therapy, methotrexate, was a predictable and logical step to achieve an additive therapeutic benefit.

Ground 3: Obviousness over Edwards and Kalden, in view of the Rituxan Label - Claims 1-12 are obvious over Edwards in view of Kalden and the Rituxan Label.

  • Prior Art Relied Upon: Edwards (a 1998 journal article), Kalden (a 1997 journal article), and the Rituxan Label (a 1997 product insert).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground was substantively similar to Grounds 1 and 2, using Kalden to reinforce the rationale for combination therapy. Edwards proposed rituximab for RA. Kalden taught that, as of 1997, new biologic agents were already being successfully used in combination therapy with methotrexate and that this approach was important for RA patients not fully controlled by methotrexate alone. Kalden concluded that biologic agents hold "special value" when used in combination with methotrexate. The Rituxan Label provided the dosing framework.
    • Motivation to Combine: A POSITA reading Edwards and Kalden would be directly motivated to combine rituximab with methotrexate. Kalden explicitly taught that combination therapies using monoclonal antibodies (like rituximab) and methotrexate were already being tested and demonstrated promise. This provided an express motivation to apply this known successful strategy to the specific biologic agent suggested by Edwards.
    • Expectation of Success: Kalden's report on the success of other biologic-methotrexate combinations provided a strong basis for a POSITA to expect that combining rituximab with methotrexate would also be successful in treating RA.

4. Relief Requested

  • Petitioner requested the institution of an inter partes review (IPR) and the cancellation of claims 1-12 of the ’161 patent as unpatentable.