Docket No. 2017-1017, -1018 (IPR2015-00561, -00562)
MOORE, LINN, CHEN
April 18, 2018
Brief summary: PTAB findings of invalidity for obviousness of the claims of ICOS’ Orange Book-listed patents for tadalafil (Eli Lilly’s Cialis®) affirmed.
Summary: ICOS appealed PTAB IPR decisions that claims 1-32 of US 7,182,958 and claims 1-11 of US 6,821,975 directed to formulations comprising micronized tadalafil (both Orange Book-listed for Eli Lilly’s Cialis®) or a free particulate form of the compound, respectively, would have been obvious in view of combinations of four references (“Daugan”, “Butler”, “Seth”, and “Wadke”). The FC panel explained that the PTAB found “Daugan discloses a compound having the structural formula in the claims, i.e., tadalafil, and the excipients included in claim 1 of the ‘958 patent”, and a motivation to combine Butler’s teaching that the drug has poor solubility, Seth’s teaching that “compounds with low solubility generally also have a slow dissolution rate”, and both Seth’s and Wadke’s teaching “that reducing particle size through micronization can increase dissolution rate.” The PTAB also found that even though “Seth recognizes disadvantages to micronization, those disadvantages would not have stopped ordinarily skill artisans from using the technique” and “a reasonable expectation of success in combining the teaching of those references, and rejected ICOS’ claim of unexpected results.” ICOS argued the PTAB “improperly substituted its own obviousness arguments for those in the petition and improperly shifted the burden to ICOS to show nonobviousness” (§ 316(e)) and that “the references do not provide a motivation to combine or a reasonable likelihood of success.” The FC panel reviewed the PTAB’s determination of obviousness de novo and its underlying factual findings for substantial evidence” (Belden, FC 2015), noting decisions “must be set aside if they are ‘arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law” (5 USC § 706). The FC decided that “[s]ubstantial evidence supports the Board’s findings” (e.g., “Wadke teaches the micronization of drug particles”, “Butler teaches tadalafil is poorly water soluble”, and “Seth and Wadke…disclose that micronization solves dissolution problems”). The FC panel also found that substantial evidence supported the PTAB’s conclusion “that a skilled artisan would have had a reasonable expectation of success in combining these teachings”, based in part on Acetlion’s expert witness testimony. The FC panel also found that substantial evidence supported the PTAB’s conclusion that athe prior art did not teach away from micronization, based on Acetlion’s (and ICOS’) expert witness testimony. The FC panel also agreed with the PTAB that each of the claimed limitations were disclosed by Daugan’s examples. The FC panel also found no § 316(e) violation since the PTAB “did not use” new art “to teach elements of the claim or to supply the motivation to combine”, limiting its “findings…to its rejection of ICOS’ arguments regarding” the same or “responding to ICOS’ late-raised interpretation of Wadke” (“[u]nlike in Honeywell”, FC 2017). Thus, the PTAB’s decision was affirmed.