PTAB

IPR2016-01582

Wockhardt Bio AG v. Janssen Oncology, Inc.

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1. Case Identification

  • Case #: Unassigned
  • Patent #: 8,822,438
  • Filed: August 10, 2016
  • Petitioner(s): Wockhardt Bio AG
  • Patent Owner(s): Janssen Oncology, Inc.
  • Challenged Claims: 1-20

2. Patent Overview

  • Title: Method of Treating Prostate Cancer
  • Brief Description: The ’438 patent is directed to methods of treating prostate cancer in a human by co-administering a therapeutically effective amount of abiraterone acetate (or a salt thereof) and a therapeutically effective amount of prednisone.

3. Grounds for Unpatentability

Ground 1: Claims 1-20 are obvious over Gerber, O’Donnell, and Sartor.

  • Prior Art Relied Upon: Gerber (a 1990 journal article), O’Donnell (a 2004 journal article), and Sartor (a 1998 journal article).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the combination of references taught every element of the challenged claims. Independent claim 1 requires a method of treating prostate cancer by administering abiraterone acetate and prednisone. Petitioner asserted that Gerber taught treating metastatic castration-resistant prostate cancer (mCRPC) by co-administering ketoconazole (a known CYP17 enzyme inhibitor) with prednisone. O’Donnell taught that abiraterone acetate is a more potent and specific CYP17 inhibitor than ketoconazole and is effective at suppressing testosterone in prostate cancer patients. Sartor taught that prednisone administered as a monotherapy is effective for treating hormone-refractory prostate cancer, demonstrating a significant decline in prostate-specific antigen (PSA) levels. Thus, Petitioner contended that substituting the superior CYP17 inhibitor (abiraterone acetate) from O’Donnell for the older one (ketoconazole) in Gerber’s established combination therapy was an obvious modification. The continued use of prednisone was justified by its known standalone efficacy (Sartor) and its necessity in mitigating side effects from CYP17 inhibition (taught by Gerber and suggested by O'Donnell). Dependent claims reciting specific dosage ranges were argued to be obvious as mere routine optimization of known therapeutic agents.
    • Motivation to Combine: A Person of Ordinary Skill in the Art (POSA) would combine the references to improve upon an existing therapy. The primary motivation was to replace the known, non-selective CYP17 inhibitor in Gerber’s regimen (ketoconazole) with the more potent and specific CYP17 inhibitor disclosed in O’Donnell (abiraterone acetate) to achieve a more effective treatment with potentially fewer side effects. A POSA would have been further motivated to maintain the co-administration of prednisone for two reasons: (1) it was already part of the standard of care with CYP17 inhibitors like ketoconazole to manage side effects, and O’Donnell’s data on abiraterone acetate suggested it would also cause adrenocortical suppression requiring a replacement glucocorticoid; and (2) Sartor confirmed prednisone’s own therapeutic benefit in treating prostate cancer.
    • Expectation of Success: Petitioner argued a POSA would have had a reasonable expectation of success. Gerber demonstrated that combining a CYP17 inhibitor with prednisone was a safe and effective treatment paradigm for prostate cancer. O’Donnell showed abiraterone acetate was a superior drug working by the same mechanism (CYP17 inhibition). Therefore, a POSA would reasonably expect that substituting a better drug into an established, successful treatment framework would yield predictable, successful results. The known anti-cancer effects of both abiraterone acetate and prednisone individually would lead a POSA to reasonably expect that their combination would be effective.

4. Key Claim Construction Positions

  • Petitioner stated it would analyze the claims under the Board’s constructions from a related proceeding, Amerigen Pharms., Ltd. v. Janssen Oncology, Inc., IPR2016-00286.
  • The term “treat,” “treating,” and “treatment” was construed to "include the eradication, removal, modification, management or control of a tumor or primary, regional, or metastatic cancer cells or tissue and the minimization or delay of the spread of cancer."
  • The term “therapeutically effective amount of prednisone” was construed to mean "an amount of prednisone effective for treating prostate cancer." Petitioner argued the addition of Sartor specifically addresses this construction by teaching that prednisone treats prostate cancer.

5. Arguments Regarding Discretionary Denial

  • Petitioner argued that the Board should not exercise its discretion to deny institution under §325(d), despite a previously filed petition on the ’438 patent (Amerigen Pharms.).
  • The key reasons provided were: (1) the instant petition relies on a different combination of prior art, notably including Sartor, which was not of record in the Amerigen IPR nor considered during the original prosecution; (2) the petition relies on new testimonial evidence from new experts (Dr. Godley and Dr. Stoner); and (3) Petitioner Wockhardt was not a party to the prior IPR proceeding.

6. Relief Requested

  • Petitioner requested the institution of an inter partes review and the cancellation of claims 1-20 of the ’438 patent as unpatentable under 35 U.S.C. §103.