IPR2016-01582 (US 8,882,438 B2)
Decision Instituting IPR
January 17, 2017
Brief Summary: IPR instituted as Wockhardt showed a reasonable likelihood of prevailing, Amerigan did not need to be named, and no “second bite at the apple by an identical petitioner”.
Summary: Wockhardt filed a Petition for IPR of Jannsen’s US 8,882,438B2 related to methods for treating prostate cancer using the CYP17 enzyme (involved in testosterone synthesis) inhibitor abiraterone (ZYTIGA®) and prednisone, alleging the claims (“method…comprising administering…a therapeutically effective amount of abiraterone…and a therapeutically effective amount of prednisone”) would have been obvious in view of three prior art references and two declarations. Four litigations and two IPRs related to the ‘438 patent are described as pending. Under the broadest reasonable interpretation (Cuozzo, US 2016), the Board applied its constructions of “treat”, “treating,”, “treatment,” and “therapeutically effective amount of prednisone,” as previously determined in IPR2016-00286 (instituted and joined with IPR2016-01337 on Sept. 19, 2016) using the ‘438 specification (“treat”, “treating,”, “treatment,” “includes 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” means “an amount of prednisone effective for treating prostate cancer”). The Gerber reference was found to teach that PSA levels in patients with rising PSA are decreased following treatment with ketoconazole and prednisone. The O’Donnell reference was found to teach “that the need for concomitant therapy of abiraterone with a glucocorticoid needs to be further investigated.” And the Board explained that the Sartor reference showed prednisone can decrease PSA in one-third of patients “and hypothesizes ‘a dose-responsive relationship between glucocorticoid dose and PSA decline.” The Board concluded that based on these disclosures, “a person of ordinary skill in the art ‘would have reasonably expected each of abiraterone acetate and prednisone to treat prostate cancer when co-administered” (i.e., Wockhardt showed a reasonable likelihood of prevailing). Wockhardt argued Jannsen would not be able to rely on secondary considerations but since no such evidence was presented, the Board did not address this issue. Jannsen argued Amerigan should have been named as a real party in interest (§ 312(a)(2); e.g., the companies are co-defendants in a lawsuit) but the Board disagreed (e.g., “the focus of our real-party-in-interest inquiry is the relationship between a party and a proceeding” (Aruze Gaming, IPR2014-01288 (Paper 13) and the submitted “email exchange…[is] not supportive of Patent Owner’s allegations”). Jannsen also argued the Board should use its discretion under § 325(d) to decline initiation of this IPR because “the same prior art and substantially the same arguments” have been presented in the co-pending IPRs, but the Board disagreed (e.g., same prior art but different declarants, “it appears this case will involved arguments concerning objective indicia of non-obviousness, which involves a fact-specific analysis that often turns on evidence presented during trial”, “we do not perceive that either Patent Owner or the Board will be overwhelmed”, “we are not presented with a second bite at the apple by an identical petitioner”). Thus, this IPR was instituted.