UCB, Inc. et al. v. Actavis Laboratories UT, Inc. / Mylan Technologies, Inc.
Docket No. 2021-1924, -2336 (https://cafc.uscourts.gov/opinions-orders/21-1924.OPINION.4-12-2023_2109643.pdf)
MOORE, CHEN, STOLL
April 12, 2023
Brief Summary: DC finding UCB’s ‘589 patent invalid for anticipation and obviousness affirmed.
Summary: UCB appealed DC finding US 10,130,589 directed to transdermal rotigone patches (TTSs) for treating Parkinson’s disease (UCB’s product being Neupro®) invalid for anticipation and obviousness. The FC panel affirmed the DC’s decision as its “fact findings on overlapping ranges, teaching away, unexpected results, and commercial success are not clearly erroneous”. The FC panel opinion explains that UCB’s “original” Neupro® patch, covered by UCB’s US 6,884,434 and 7,413,747 (the Muller patents), “contains a dispersion of amorphous rotigotine and polyvinylpyrrolidone (PVP)” at a ratio of 9:2, where the “PVP stabilizes amorphous rotigotine by increasing the Tg and preventing hydrogen bonding between rotigotine molecules, which prevents a clumping of sorts that creates crystallization” (which “can reduce the amount of drug leaving the patch and hence reduce a patient’s dose”). This opinion explains that “[t]he ’434 patent teaches a TTS having rotigotine in an amount effective for treating Parkinson’s disease, with PVP in the range of 1.5% to 5% (w/w)”, the ‘747 patent “teaches a TTS with a ratio of 9% rotigotine to 1.5% to 5% PVP by weight”, and “an exemplary process for making a TTS with a rotigotine to PVP weight ratio of 9:3 rotigotine to PVP.” After finding storage of the original Neupro® patches at room temperature led to the development of a Form II crystal, UCB recalled those, which was followed by FDA approval of a new version. UCB sued Actavis in 2013 for infringement of the ‘434 patent and US 8,232,414 with its ANDA (UCB I), and the DC upheld the validity of the ‘434 patent, some of the ‘414 claims invalid, and granted UCB an injunction which expired with the ‘434 patent in 2021. While UCB I was on appeal, the ‘589 patent issued, claiming priority to a 2009 provisional application, with claims to “[a] method for stabilizing rotigotine” using a “weight ratio of rotigotine free base to polyvinylpyrrolidone is in a range from about 9:4 to about 9:6.” The FC panel explained that “the ranges of rotigotine to PVP ratios disclosed in the Muller patents and the ’589 patent overlap from about 9:4 to 9:5 and include the ratio in reformulated Neupro®” which extends to “about 9.6”. In 2019, UCB sued Actavis and Mylan (separately) for infringement of the ‘589 patent. The DC made its ‘589 invalidity determination under the “‘at once envisage’ framework for anticipation articulated in Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381 (Fed. Cir. 2015)” (Nidec Motor, FC 2017) and obviousness “in view of multiple prior art references”. UCB argued the DC “(1) impermissibly relied on hindsight in its analysis; and (2) improperly disregarded evidence of objective indicia of nonobviousness.” The FC panel found no error with the DC’s analyses, citing, e.g., Ineos (FC 2015), Titanium Metals (FC 1985) (for anticipation, e.g., “no reasonable difference in how the invention operates over the ranges”, “claimed range is critical to the operability” (Genentech, FC 2020); for obviousness, Ormco, FC 2006 (“presumption of obviousness applies “[w]here a claimed range overlaps with a range disclosed in the prior art”), Almirall, FC 2022 (“absent a reason to conclude otherwise, a factfinder is justified in concluding that a disclosed range does just that—discloses the entire range”); “pre-Form II prior art” relevant; no teaching away (Galderma (FC 2013), DuPuy Spine (FC 2009) (“a reference does not teach away if it ‘merely expresses a general preference for an alternative invention but does not ‘criticize, discredit or otherwise discourage’ investigation into the invention claimed’”), no unexpected results (Bristol-Myers, FC 2014 (range must produce “a new property dissimilar to the known property”)), Hoffman-La Roche, FC 2014 (“evidence of superior efficacy does not undercut a reasonable expectation of success”); Fox Factory, FC 2019 (“evidence of commercial success must have a nexus to the claims to be given weight in an obviousness analysis”) (here, e.g., “Muller patents have operated as blocking patents dissuading competitors” (citing Merck (FC 2017) and Galderma)). The DC decision was therefore affirmed.