IPR2013-00365
Hospira Inc v. Janssen Pharmaceuticals Inc
1. Case Identification
- Case #: IPR2013-00365
- Patent #: 6,747,002
- Filed: June 19, 2013
- Petitioner(s): Hospira, Inc.
- Patent Owner(s): Ortho-McNeil Pharmaceutical, Inc. (Assignee); Johnson & Johnson (Served as Patent Owner)
- Challenged Claims: 1-7, 12, 14-28
2. Patent Overview
- Title: Pharmacokinetic and Pharmacodynamic Modeling of Erythropoietin Administration
- Brief Description: The ’002 patent discloses methods of treating anemia by administering erythropoietin (EPO) according to a dosage regimen that maintains serum EPO concentration above a predose level for about 5 to 30 days between doses. The invention purports to be an improvement over standard, more frequent (e.g., three times weekly) EPO administration schedules.
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 et al., “Pharmacokinetics and Pharmacodynamics of Recombinant Human Erythropoietin after Single and Multiple Subcutaneous Doses to Healthy Subjects,” Clinical Pharmacology & Therapeutics (Oct. 1998) (“Cheung”).
- Core Argument for this Ground:
- Prior Art Mapping: Petitioner argued that Cheung discloses every limitation of the challenged claims. Specifically, Cheung described a clinical study involving a once-per-week (q.w.) subcutaneous administration of 600 IU/kg of epoetin alfa for four weeks. Petitioner asserted that data from this study, particularly Figure 2, demonstrated that this regimen maintained serum EPO levels above the predose level for 5 to 8 days, which falls squarely within the claimed range of "about 5 to about 30 days." Dependent claims were allegedly met by Cheung’s express disclosures of treating various forms of anemia, using specific EPO dosages (600 IU/kg), administering epoetin alfa, and using subcutaneous administration.
Ground 2: Anticipation over Goldberg - Claims 1-4, 12, 14-20, 22, 25, 27, and 28 are anticipated under 35 U.S.C. §102(b) by Goldberg.
- Prior Art Relied Upon: Goldberg M.A., “Erythropoiesis, Erythropoietin, and Iron Metabolism in Elective Surgery,” Am. J. Surgery (1995) (“Goldberg”).
- Core Argument for this Ground:
- Prior Art Mapping: Petitioner contended that Goldberg inherently anticipated the claims. Goldberg disclosed a dosing regimen of 600 U/kg of epoetin alfa on days 1 and 10 to stimulate red blood cell (RBC) production before surgery. While Goldberg did not directly report serum EPO levels, it showed that hematocrit, hemoglobin, and reticulocyte counts remained elevated above predose levels for over 20 days. Petitioner argued, supported by expert testimony, that since EPO is known to stimulate RBC production, a sustained increase in these biomarkers for over 20 days necessarily means that serum EPO concentration was also maintained above the predose level for a duration within the claimed 5 to 30 day range. Goldberg also disclosed treating anemia and patients with rheumatoid arthritis, meeting limitations of dependent claims.
Ground 3: Obviousness over Cheung, Goldberg, and/or Hayashi 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, Goldberg, and/or Hayashi (a 1994 journal article) in view of Levine et al., “Hematologic Response to Epoetin Alfa in Anemic HIV-Positive Patients,” Blood (Nov. 1999) (“Levine”).
Core Argument for this Ground:
- Prior Art Mapping: Petitioner asserted that the primary references (Cheung, Goldberg, Hayashi) each teach the core concept of a less frequent EPO dosing regimen that maintains elevated EPO levels or RBC production. To the extent these references might not explicitly teach every detail of certain dependent claims, Levine supplied the missing elements. Levine described a 16-week study evaluating once-weekly (q.w.) epoetin alfa dosing (40,000 IU) in anemic, HIV-positive patients being treated with zidovudine (AZT). This disclosure directly taught the once-weekly administration of claim 5, the specific dosage range of claim 7, and the treatment of AIDS drug therapy-related anemia of claim 21 where the drug is zidovudine (claim 24).
- Motivation to Combine: A POSITA would combine Levine's teachings with any of the primary references because they all address the same technical problem: effective EPO administration for treating anemia. Combining them would have been a matter of applying a known dosing strategy (from the primary references) to a known patient population with a known dosage range (from Levine) to achieve the predictable result of increased RBC production.
- Expectation of Success: Success was predictable because EPO's effects on erythropoiesis were well-understood, and applying a known effective drug to a patient population known to benefit from it would have been routine for a POSITA.
Additional Grounds: Petitioner asserted additional obviousness challenges based on combining Cheung, Goldberg, and/or Hayashi with other references, including Zappacosta (for treating renal failure), Tsukuda (for chemotherapy-induced anemia), Mitus (for bone marrow transplant recipients), and Murphy (for rheumatoid arthritis), all relying on similar motivations to apply known dosing regimens to specific patient populations. A final ground alleged obviousness over the primary references in view of the general knowledge of a POSITA.
4. Key Claim Construction Positions
- "EPO dosing regimen": Petitioner argued this term, central to independent claim 1, should be construed as "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 based on the claim language requiring maintenance of serum EPO levels for "about 5 to about 30 days between EPO doses," which Petitioner argued necessitates that the doses themselves must be separated by at least 5 days. This interpretation was supported by the patent's examples (e.g., once-weekly dosing) and the prosecution history, where the examiner amended the duration from 4 to 5 days to overcome prior art.
5. Key Technical Contentions (Beyond Claim Construction)
- Denial of Priority Date: Petitioner argued the ’002 patent was not entitled to the May 11, 1999 filing date of its provisional application (’418 application).
- The ’418 application was alleged to lack written description support for the key limitation of maintaining serum EPO levels for 5 to 30 days between doses. The provisional only disclosed a three-times-a-week regimen with doses separated by at least 2 days. Therefore, Petitioner contended the effective filing date of the challenged claims is the patent’s actual filing date of May 10, 2000, making references published between the provisional and actual filing dates, such as Levine, available as prior art.
6. Relief Requested
- Petitioner requested institution of an inter partes review and cancellation of claims 1-7, 12, and 14-28 of the ’002 patent as unpatentable.