PTAB

IPR2013-00365

Hospira Inc v. JansSen PharmaceuTicals Inc

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1. Case Identification

  • Patent #: 6,747,002
  • Filed: June 19, 2013
  • Petitioner(s): Hospira, Inc.
  • Patent Owner(s): Johnson & Johnson
  • Challenged Claims: 1-7, 12, and 14-28

2. Patent Overview

  • Title: Pharmacokinetic and Pharmacodynamic Modeling of Erythropoietin Administration
  • Brief Description: The ’002 patent describes methods for treating anemia by administering erythropoietin (EPO) according to specific dosing regimens. The invention purports to improve upon standard, more frequent dosing by using less frequent administration (e.g., once-weekly) that maintains serum EPO concentration above a pre-dose level for about 5 to 30 days between doses.

3. Grounds for Unpatentability

Ground 1: Anticipation over Cheung - Claims 1-7, 12, 14-22, 24, and 28 are anticipated under 35 U.S.C. §102(b) by Cheung.

  • Prior Art Relied Upon: Cheung (Clinical Pharmacology & Therapeutics, Oct. 1998).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Cheung explicitly taught every limitation of the challenged claims. Cheung disclosed a study involving a once-weekly (q.w.) subcutaneous dosing regimen of 600 IU/kg of epoetin alfa for four weeks. This regimen was shown to maintain serum EPO levels above the pre-dose level for 5 to 8 days, directly anticipating the "about 5 to about 30 days" limitation of independent claim 1. Cheung also reported that this regimen sustained an increased percentage of reticulocytes (a measure of red blood cell production) for over 21 days, anticipating dependent claims requiring increased red blood cell production for at least one or two weeks.

Ground 2: Anticipation over Goldberg - Claims 1-4, 12, 14-20, 22, 25, 27, and 28 are anticipated under §102(b) by Goldberg.

  • Prior Art Relied Upon: Goldberg (Am. J. Surgery, 1995).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner contended that Goldberg inherently anticipated the claims. Goldberg disclosed administering epoetin alfa at 600 U/kg on days 1 and 10 (a 9-day interval), which falls within the claimed 5-30 day window. While Goldberg did not directly report serum EPO levels, it showed that this regimen increased hemoglobin and reticulocyte counts for over 20 days.
    • Key Aspects: The core of this ground rested on an inherency argument, supported by an expert declaration. Petitioner asserted that a sustained increase in reticulocyte and hemoglobin levels for over 20 days, as taught by Goldberg, would necessarily and inevitably result from a serum EPO concentration that was maintained above the pre-dose level for the same period, thus inherently disclosing the primary limitation of claim 1.

Ground 3: Anticipation over Hayashi - Claims 1-6, 14-19, 25, and 28 are anticipated under §102(b) by Hayashi.

  • Prior Art Relied Upon: Hayashi (Transfusion, 1994).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Hayashi disclosed a dosing regimen that met all limitations of claim 1. Hayashi described administering recombinant human EPO (rHuEPO) subcutaneously on days 21, 14, and 7 prior to surgery, establishing a once-weekly dosing schedule. Data from Hayashi's figures demonstrated that this regimen caused serum EPO levels to increase and remain elevated above pre-dose levels for the entire two-week period between the first and last doses. This two-week (14-day) period of elevated EPO levels falls squarely within the claimed range of "about 5 to about 30 days," thereby anticipating the claim.

Ground 4: Obviousness over Core References in view of Levine - Claims 5, 7, 21, and 24 are obvious over Cheung, Goldberg, and/or Hayashi in view of Levine.

  • Prior Art Relied Upon: Cheung (Clinical Pharmacology & Therapeutics, Oct. 1998), Goldberg (Am. J. Surgery, 1995), and/or Hayashi (Transfusion, 1994) in view of Levine (Blood, Nov. 1999).

  • Core Argument for this Ground:

    • Prior Art Mapping: The base references (Cheung, Goldberg, Hayashi) established the fundamental elements of claim 1. Levine was introduced to provide additional, specific disclosures relevant to dependent claims. For example, Levine taught administering a 40,000 U once-weekly dose of epoetin alfa to anemic, HIV-positive patients treated with zidovudine. This specific dosage and patient population directly mapped onto limitations in dependent claims 7, 21, and 24.
    • Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) would combine the teachings. All references were in the same field of using EPO to stimulate red blood cell production. A POSITA would have looked to a reference like Levine, which studied a specific once-weekly dosing regimen, to supplement the general methods taught in the base references to develop additional, convenient, and effective dosing options for specific patient populations.
    • Expectation of Success: Success would have been expected because the combination merely applied a known drug (EPO) in a known manner (less frequent, higher-dose administration) to a known patient population (anemic patients) to achieve a predictable result (increased red blood cell production).

  • Additional Grounds: Petitioner asserted additional obviousness challenges, including combinations of the primary references (Cheung, Goldberg, Hayashi) with Zappacosta (for renal failure patients), Tsukuda (for chemotherapy patients), Mitus (for bone marrow transplant recipients), and Murphy (for rheumatoid arthritis patients). A final ground argued obviousness over the primary references in view of the general knowledge of a POSITA.

4. Key Claim Construction Positions

  • Petitioner argued that the term "EPO dosing regimen" from claim 1 required construction. Based on the specification, examples, and prosecution history, Petitioner proposed the construction: "a predetermined treatment plan, wherein each successive individual EPO dose is separated by at least 5 days, but can be separated by up to 30 days."
  • This construction was critical to the invalidity arguments, as it established the minimum 5-day interval between doses—a feature added during prosecution to overcome prior art. Petitioner asserted this construction was necessary because the claim language requires the elevated EPO concentration to be maintained between doses for at least 5 days, logically requiring the doses themselves to be separated by at least that long.

5. Key Technical Contentions

  • Petitioner dedicated a significant portion of its argument to invalidating the ’002 patent’s claim to the May 11, 1999 priority date of its provisional application. Petitioner argued that the provisional application only disclosed a three-times-a-week dosing regimen with doses separated by at least 2 days and failed to provide written description support for the claimed regimen requiring a 5-to-30 day interval between doses.
  • Consequently, Petitioner argued the claims were only entitled to the non-provisional filing date of May 10, 2000. This contention was crucial, as it established that references published between May 1999 and May 2000, such as Levine (Nov. 1999), qualified as prior art under §102(a).

6. Relief Requested

  • Petitioner requested institution of an inter partes review and cancellation of claims 1-7, 12, and 14-28 of Patent 6,747,002 as unpatentable.