Case No. IPR2016-00712 (U.S. Pat. No. 8,927,592 B2)
Final Written Decision
September 21, 2017
Brief summary: FWD concludes Mylan showed the ‘592 claims are invalid for obviousness.
Summary: The ‘592 patent is one of three patents listed on the FDA Orange Book for Aventis’ Jevtana® (cabazitaxel) approved for treatment of prostate cancer. The PTO previously denied institution of IPR against US 5,847,170 (IPR2016-00627) which expires in 2021. The other listed patent is US 7,241,907, and litigation regarding the all three patents is pending in NJ. This FWD relates to Mylan’s IPR alleging claims 1-5 and 7-30 of the ‘592 patent are invalid for obviousness over four combinations of prior art references (Winquist and the TROPIC listing (both disclosing “the same ongoing phase III clinical trial”) with Attard and Beardsley, Didier, Mita, or Tannock, respectively). The PTAB construed “A method for treating a patient” and “A method of increasing the survival of a patient” as non-limiting preamble language (statements of use (Bristol-Myers, FC 2001)). After reviewing the prosecution history, the PTAB explained the independent ‘592 claims “are limited to the step(s) of: administering a 20-25 mg/m2 dose…in combination with a corticoid…to a docetaxel-refractory prostate cancer…or mCRPC patient” and that, “[a]s indicated by the patent applicant’s final claim language”, these steps “are performed without regard to whether the claimed method results in a clinically effective treatment” (Bristol-Myers, FC 2001; “in contrast to In re Cyclobenzprine and Amgen, the ‘592 patent does not recite a comparable ‘therapeutically effective’ limitation”). It also explained that it considered the obviousness issue under KSR (US 2007 (the Graham factors) and Proctor & Gamble (FC 2009) (motivation to combine and reasonable expectation of success). It found that Mylan “established by a preponderance of the evidence that Winquist and the TROPIC listing disclose all of the method steps” and “that a POSA would have had good reason to combine the teachings…and would have read the two references together” (which “Patent Owner implicitly acknowledge[d]”). “The fundamental dispute” turned on the “reasonable expectation of ‘success’ in achieving the claimed method” which the PTAB explained “devolves into a claim construction dispute.” Here, since the claims do not recite a “therapeutically effective amount”, Mylan did not need to “establish a POA reasonably would have expected successful phase III clinical trial results, FDA approval…, or an actual increase in patient survival, to demonstrate obviousness” but only a “reasonable expectation of success in developing the claimed invention” (Allergan, FC 2013) which it determined was shown (based in large part on expert testimony). It also reviewed Aventis’ evidence of secondary considerations (Prometheus, FC 2015), which is the Patent Owner’s burden and must have a nexus to the claims In re Huai-Hung Kao, FC 2011), and found that evidence not to “outweigh Petitioner’s strong evidence of obviousness” (“This is not a case where isolated claim limitations are disclosed individually in different prior art references and the claimed combination itself provides the nexus to the merits of the invention” (WBIP, FC 2016)). Aventis’ contingent motion to amend the claims was denied (“Patent Owner bears the burden of proving patentability of each proposed substitute claim.” 37 CFR § 42.20(c)); Nike, FC 2016)).