Merck Sharp & Dohme B.V. v. Warner Chilcott Company, LLC et al.

Docket No. 2016-2583

October 19, 2017


Brief summary: DC decision that Merck’s claims relating to NuvaRing® reversed and remanded (e.g., “the only way to arrive at the hypothetical ring is by using the ‘581 patent as the roadmap” which “represents an improper reliance on hindsight.”)

Summary: Merck appealed DC finding that claims 4 and 11 of US 5,989,581 relating to NuvaRing® (a contraceptive vaginal ring) are invalid for obviousness in view of “PCT ‘015” application (WO 97/02015). Both “claims 4 and 11…require at least a single-compartment that includes a progestogenic steroidal compound” (e.g., etonogestrel (ETO)) “and an estrogenic steroidal compound” (e.g., ethinyl estradiol (EE)). “Claim 4…requires direct release of ‘physiologically required amounts ‘of both compounds from one compartment” and claim 11 “requires ‘at least one compartment’ to include a ‘mixture of a progestonic steroidal compound and an estrogenic steroidal compound’ in specific ratios and concentrations.” The DC concluded “a person of ordinary skill would have been motivated to optimize PCT ‘015” to reach the ‘581 invention, and “it would have been obvious for a person of skill to derive the claimed ratios of progestin and estrogen’ from the target release rates”. The FC panel explained that obviousness is a question of law reviewed de novo and facts underlying that conclusion (including the Graham factors, US 1966) are reviewed for clear error (Honeywell, FC 2010). “[A] patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was independently known in the art” (KSR, US 2007) and “it is improper to combine references ‘like separate pieces of a simple jigsaw puzzle’ without ‘explain[ing] what reason or motivation one of ordinary skill in the art at the time of the invention would have had to place the pieces together” (InTouch, FC 2014). In addition, “[t]he inventor’s own path itself never leads to a conclusion of obviousness; that is hindsight” (Otsuka, FC 2012). The FC panel explained that “PCT ‘015…relies on a two-compartment design” and “criticizes one-compartment vaginal rings”. It found flaws in the DC’s reasoning that the skilled artisan “would have optimized the second compartment to release physiologically required amounts of ETO and EE” (which was also alleged to “comprise[] 97% of the ring”) and, therefore, “there would have been “little reason to keep the first compartment in place”. This is because, e.g., “PCT ‘015 does not actually disclose a ring with a second compartment that comprises 97% of the ring”, which is “outside of the usual or preferred range disclosed in PCT ‘015”. In that “hypothetical ring”, that person would also need to “pick a concentration of ETO from the high end of the disclosed range, but conversely select a concentration of EE from the low end of the range” and “[n]othing in PCT ‘015 suggests picking these values out of the innumerable possible combinations” (also noting the above-mentioned criticism). “[T]he only way to arrive at the hypothetical ring is by using the ‘581 patent as the roadmap” which “represents an improper reliance on hindsight.” Thus, the DC decision was reversed and remanded.

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