Docket Nos. 2017-2557, -2559, -2560
NEWMAN, O’MALLEY, CHEN
Nov. 20, 2018 (Non-precedential)
Brief summary: DC decision finding Tris’s claims invalid for obviousness vacated and remanded because of “gaps in the [DC’s] opinion and remanding it for further fact-findings”.
Summary: Tris sued Actavis with respect to its ANDA seeking approval of a generic version of Quillivant XR (extended release methylphenidate (MPH) formulation for treatment of Attention Deficit Hyperactive Disorder (ADHD); NDA 202100). After a bench trial, the DC found all the asserted claims of Orange Book-listed US 8,465,765; 8,563,033; 8,778,390; 8,956,649; and 9,040,083 invalid for obviousness (§ 103). It is noted that OB-listed US 8,062,667 and 8,287,903 are not mentioned in this opinion. The opinion explains that Quillivant XR includes immediate release (IR) and sustained release (SR) components (“achieves a 45-minute therapeutic onset and 12 hours of therapeutic effect” (the claimed pharmacodynamic (PD) profile). Tris appealed the DC’s judgment as to claims 4 and 10 of the ‘033 patent; claims 6 and 20 of the ‘765 patent; and claims 15, 16 and 20 of the ‘390 patent that all “recite, among other properties, a single mean PK profile” (“single mean peak and early Tmax) and the PD profile. The DC found the claims obvious in view of Concerta (extended release MPH tablet), Daytrana (MPH patch which the DC found to “clearly exhibit a single mean peak PK profile”), Focalin XR (extended release MPH capsule), Metadate CD (capsule version of MPH), Ritalin A (capsule version of MPH), scientific articles, and a US patent publication (Scicinski which the DC found describes a “hypothetical product” (“prophetic example”) that exhibits “a long duration of action, rapid onset, and a single mean PK profile”). Tris argued the prior art formulations “were designed to mimic the peaks and valleys of multiple immediate release dosings” and “have a late Tmax to achieve the sustained duration of action” (e.g., “Concerta…achieves the 12-hour duration of effect but has a later Tmax that is outside the claimed range of about 4 to 5.25.”) The DC considered “Tris’[s] evidence regarding the second generation product persuasive” but found “it [wa]s not dispositive on the obviousness inquiry” (e.g., the single mean peak PK profile of Daytrana, Scicinski’s “hypothetical product”, and Actavis’s expert testimony). The DC found Tris’s proferred evidence of unexpected results “irrelevant because Tris has not performed the proper comparison to the closest prior art” (Proctor & Gamble, FC 2009; Kao, FC 2006), and was not persuaded by Tris’s long-felt need and commercial success arguments. The FC panel reviewed the DC’s conclusions of obviousness de novo (Eli Lilly, FC 2017) and its factual findings for clear error (Par Pharm., FC 2014). Tris argued there was no reasonable expectation of success of combining the claimed PK and PD characteristics “because the PK-PD relationship was unknown”, the DC “failed to address why the combination…would have been obvious”, and “mistakenly disregarded Tris’s evidence of unexpected results” (FN3 distinguishing this case from In re Cyclobenzaprine, FC 2012 because, here, “the prior art disclosed numerous” ER formulations with one or more of the claimed profiles). The FC panel agreed with Tris, finding “gaps in the [DC’s] opinion and remanding it for further fact-findings” (e.g., “it is unclear if these statements amount to actual fact-findings as opposed to mere recounting of Actavis’s arguments” (Golden Blount, FC 2004), did not explain “why a skilled artisan would have been motivated to use a single mean peak PK profile”, “analysis with respect to Tmax is very cursory”, Kao does not “require Tris to identify and focus on just one prior art product”, DC did “not adequately address Tris’s specific theory as to a long-felt need”). Thus, the DC decision was vacated and remanded.