Wockhardt Bio AG v. Janssen Oncology Inc

1. Case Identification

• Case #: IPR2016-01582
• 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 for the Treatment of 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 and a therapeutically effective amount of prednisone.

3. Grounds for Unpatentability

Ground 1: Obviousness over Gerber, O'Donnell, and Sartor - Claims 1-20 are obvious over Gerber in view of O'Donnell and Sartor.

• Prior Art Relied Upon: Gerber (a 1990 journal article on ketoconazole and prednisone for prostate cancer), O'Donnell (a 2004 journal article on abiraterone acetate for prostate cancer), and Sartor (a 1998 journal article on prednisone for prostate cancer).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that the prior art disclosed all elements of the challenged claims. Independent claim 1 requires treating prostate cancer by co-administering abiraterone acetate and prednisone. Gerber taught co-administering prednisone with ketoconazole, a known CYP17 enzyme inhibitor, to effectively treat hormone-refractory metastatic prostate cancer and reduce prostate-specific antigen (PSA) levels. O’Donnell taught that abiraterone acetate is a more potent and specific CYP17 inhibitor than ketoconazole, effectively suppressing testosterone in prostate cancer patients. O’Donnell also disclosed that abiraterone acetate's inhibition of CYP17 can cause adrenocortical suppression, suggesting that concomitant administration of a replacement glucocorticoid, such as prednisone, may be necessary to manage side effects. Finally, Sartor established that prednisone as a monotherapy was an effective treatment for hormone-refractory prostate cancer, causing a significant decline in PSA levels in patients. Together, these references disclosed both claimed active agents and their use in treating the same condition.
  • Motivation to Combine (for §103 grounds): Petitioner asserted that a Person of Ordinary Skill in the Art (POSA) would combine the prior art teachings for two primary reasons. First, a POSA would modify the established therapy in Gerber by substituting the superior CYP17 inhibitor, abiraterone acetate (taught by O'Donnell), for the less specific ketoconazole to achieve a more effective treatment. Second, a POSA would be motivated to maintain the co-administration of prednisone for a dual purpose: 1) as an effective anti-cancer agent in its own right, as shown by Sartor and its established use in standard-of-care combination therapies, and 2) to mitigate the known side effects of CYP17 inhibition (mineralocorticoid excess) caused by abiraterone acetate, a need suggested by O'Donnell and a practice already established by Gerber for ketoconazole.
  • Expectation of Success (for §103 grounds): A POSA would have had a reasonable expectation of success because the combination involved substituting a known, superior compound (abiraterone acetate) for an older one (ketoconazole) in an established therapeutic combination (CYP17 inhibitor + prednisone) to treat the same disease, where the second agent (prednisone) was independently effective and also managed the known side effects of the first.
  • Key Aspects: Petitioner argued that the specific dosage ranges recited in dependent claims 2-4, 6-8, 10-11, and 18-20 represented nothing more than routine optimization of known therapeutic agents. For example, O'Donnell taught abiraterone acetate doses of 500 mg/day and 800 mg/day, and Gerber taught a prednisone dose of 10 mg/day, all falling within or rendering obvious the claimed ranges. Petitioner also preemptively argued that any claims of secondary nonobviousness, such as commercial success of the product Zytiga, lack a nexus to the patented invention because the individual components and the rationale for their combination were already well-established in the prior art.

4. Key Claim Construction Positions

• Petitioner noted that the Board had previously construed key terms in a related proceeding (IPR2016-00286) and adopted those constructions for the purposes of the petition.
• "treat," "treating," and "treatment": 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."
• "therapeutically effective amount of prednisone": Construed to mean "an amount of prednisone effective for treating prostate cancer."

5. Arguments Regarding Discretionary Denial

• Petitioner argued that the Board should not exercise its discretion to deny institution under 35 U.S.C. § 325(d) based on a previously filed petition (IPR2016-00286) by a different party.
• The core reasons asserted were that this petition presented a new combination of prior art, specifically by including the Sartor reference, which was not of record in the prior IPR or considered during prosecution. Furthermore, Petitioner Wockhardt was not a party to the earlier proceeding and presented new testimonial evidence from its own experts.

6. Relief Requested

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