Docket No. 2015-1902
PROST, MOORE, TARANTO
May 16, 2016
Brief Summary: DC finding that Glenmark’s proposed generic (ANDA) version of Fincaea® Gel for treatment of rosacea infringed claims 1-12 of US 6,534,070 under the doctrine of equivalents (DOE) and were not invalid affirmed.
Summary: Glenmark appealed DC finding that its proposed generic (ANDA) version of Fincaea® Gel for treatment of rosacea infringed claims 1-12 of US 6,534,070 under the doctrine of equivalents (DOE) and were not invalid. The infringement question centered on whether Glenmark’s product met the triglyceride and lecithin limitations under the DOE (function-way-result (FWR) (Crown Pckg., FC 2009)), the DC finding that it did and rejecting Glenmark’s arguments that infringement under the DOE would encompass prior art and was barred by prosecution history estoppel (PHE). Glenmark’s appeal was directed to whether its “isopropyl myristate performed essentially the same function as the claimed triglyceride and lecithin” (“penetration enhancers” for azelaic acid). Glenmark argued the ‘070 patent described triglyceride and lecithin not as penetration enhancers but only “as an emulsifier and an emollient, respectively” and that “not a single literature reference in evidence” identified those as penetration enhancers. The FC panel explained, however, that the lack of disclosure in the ‘070 patent was not fatal as it has “never held that a patent must spell out a claim element’s [FWR] in order for the [DOE] to apply as to that element” and that, where it does not, “we should turn to the ordinary skilled artisan” (Stumbo, FC 2007) and “a fact finder may rely on extrinsic evidence in making this factual determination” (Zenith Labs., FC 1994). It found no clear error in the DC’s finding of DOE, in part because Glenmark represented to the FDA that triglyceride and lecithin, as well as its isopropyl myristate, were penetration enhancers (which it argued in the appeal should not have any weight since it “was a ‘guess’ and ‘wrong’”). Regarding whether that “scope of equivalency would encompass, or ensnare, the prior art”, the FC reviewed the DC’s two-step “hypothetical claim analysis” process ((1) construct a hypothetical claim that literally covers the accused device; and 2) determine whether the patentee has persuaded the court that the hypothetical claim is patentable over the prior art (DuPuy, FC 2009)) for clear error and did not find such an error. The FC panel also found no clear error with the DC determination “that the ‘070 patent applicants surrendered a lecithin-free composition…as an equivalent during prosecution” (Conoco, FC 2006; Festo, US 2002). Glenmark’s argument was the the examiner noted that two dependent claims “could include zero lecithin” (claim 1 is to “[a] composition that comprises…lecithin”) and the applicants responded that the claims “clearly did not include zero” and amended dependent claims to recite a “concentration of from more than 0 to 1%” (or “to 3%”) but the DC determined “the amendments were for clarification purposes, ‘not to disclaim formulations with zero lecithin’”. But the FC panel found no error with this analysis because the amendment “was not a narrowing amendment made to obtain the patent” but was only a “clarifying amendment” (no “clear and unmistakable surrender of subject matter” (Deering, FC 2003)).
The DC also found that the prior art did not disclose “every element of independent claim 1”, a motivation to combine the art was not shown, and unexpected results/commercial success “weighed in favor of nonobviousness”; it therefore rejected Glenmark’s obviousness arguments. The DC “noted that Glenmark’s only support to combine [the prior art]…was the testimony by [its] expert that a skilled artisan ‘could have put…information together from another two publications’ to render claim 1 obvious’” and that, even if it had more, “Glenmark failed to carry its burden to demonstrate a reasonable expectation of success”. The FC found no clear error in the DC’s finding of no motivation to combine or its conclusions regarding unexpected results/commercial success.