Mylan Laboratories Limited v. Aventis Pharma S.A.
Docket No. 2020-1302 (IPR2016-00712) (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-1302.RULE_36_JUDGMENT.1-15-2021_1718184.pdf)
NEWMAN, O’MALLEY, WALLACH
January 15, 2020
Brief Summary: FC panel affirmed Board IPR FWD finding Sanofi’s amended claims not to be unpatentable for obviousness, public use and section 101. Summary: FC panel affirmed Board final written decision (FWD) on remand that was entered on Oct. 22, 2019 (Sanofi Mature IP v. Mylan Labs., FC 2019 (vacating denial of Sanofi’s Motion to Amend (MTA) by introducing new replacement claims 31-34 and remanding)). The FWD relates to US 8,927,592 directed to “[a] method of increasing survival comprising administering” (new claim 31) a cabazitaxel formulation to a patient having “castration resistant or hormone refractory, metastatic prostate cancer that has progressed during or after treatment with docetaxel.” The Board construed the ‘592 claims according to their broadest reasonable construction in light of the specification…‘to the extent necessary to resolve the controversy’” (37 CFR 42.100(b), Cuozzo Speed Techs., US 2016; Wellman, FC 2011). On remand, the Board was “instructed to treat the preamble of claim 31 ‘as an additional limitation of’ the claim that ‘require[s] ‘increasing survival’ as the ‘intentional purpose…for which the [recited] method must be performed’” and found the MTA to meet the requirements of section 316(d). The Board explained that “[a]n invention is not obvious ‘just because all of the elements that comprise the invention were known in the prior art’” and that finding obviousness “requires a ‘plausible rational[e] as to why the prior art references would have worked together” as well as “a reasonable expectation of achieving what is claimed in the patent-at-issue” (Broadcom, FC 2013; Intelligent Bio-Systems, FC 2016). The reasonable expectation of success arguments regarded the “intentional purpose” of claim 31, which the Board found “would be shown only if the evidence of record proves that a person of ordinary skill in the art [POSA] would have expected carrying out the recited method steps to result in increased survival” (agreeing with Sanofi, citing Sanofi v. Glenmark (D. Del. 2016); Sanofi v. Watson, FC 2017 (“reasonable expectation” is not “known certainty”)). The Board explained that “the mere fact that the” phase III cabazitaxel TROPIC study “investigating overall survival” “does not prove that a POSA would have expected…increase[d] survival.” Expert testimony, the Board determined, showed that a POSA “would have hoped” for increased survival but did not “support a conclusion that the person would have expected such a result” (OSI, FC 2019; Coalition, PTAB 2015). The Board also wrote that “[t]he existence of a phase III study to determine whether the claimed treatment method would achieve the intended purpose is strong evidence that the inventor had not yet determined that the invention would work for its intended purpose” (In re Omeprazole, FC 2008), and concluded the TROPIC study is not constitute a public-use bar under section 102(b). The Board also concluded that the claims (the “intentional purpose” limitation, “performed in the human mind”) are patent eligible under section 101 because it “integrates a mental process into a method of treatment” (Vanda, FC 2018). The Board therefore found new claims 31-34 not to be unpatentable and granted Sanofi’s MTA.