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Overlapping Ranges in Anticipation and Obviousness Overlapping Ranges in Anticipation and Obviousness

Overlapping Ranges in Anticipation and Obviousness

Federal Circuit precedent has set forth an established framework for analyzing whether a prior art reference anticipates a claimed range. If the prior art discloses a point (such as a specific example or a range) within the claimed range, the prior art anticipates the claim. On the other hand, if the prior art discloses an overlapping range, the prior art anticipates the claimed range “only if it describes the claimed range with sufficient specificity such that a reasonable fact finder could conclude that there is no reasonable difference in how the invention operates over the ranges.” Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006); see also Clear Value, Inc. v. Pearl River Polymers, Inc., 668 F.3d 1340, 1345 (Fed. Cir. 2012).

In a recent opinion, UCB, Inc. v. Actavis Laboratories UT, Inc., 2023 WL 2904757, — F.4th — (Fed. Cir. Apr. 12, 2023), the Federal Circuit elaborated the standards for analyzing the anticipation and obviousness of overlapping ranges. The patent at issue in this case, U.S. Patent No. 10,130,589, is directed to transdermal therapeutic systems (TTSs) for rotigotine, a drug used to treat Parkinson’s disease. This patent claims a TTS having a range of rotigotine to polyvinylpyrrolidone (PVP) ratios by weight of about 9:4 to about 9:6. A prior art reference disclosed combinations of rotigotine and PVP present at a range of weight ratios from 9:1.5 to 9.5.

On appeal, the Federal Circuit reversed the district court’s anticipation ruling, but affirmed on the basis of obviousness. In this case, the prior art disclosed a range (9:1.5 to 9.5) that overlaps with claimed range (9:4 to 9:6). The Federal Circuit held it was legal error for the district court to have found that the entire range claimed in the patent-in-suit was anticipated based on a specific example. The prior art did not literally disclose any point within the claimed range, but the district court had concluded, based on expert testimony, that the range disclosed in the prior art would implicitly teach a person of skill “a few examples” of specific weight ratios, including 9:4 and 9:5 weight ratios of rotigotine to PVP. 

However, the Federal Circuit held that a presumption of obviousness applies when a claimed range overlaps with a range disclosed in the prior art. This presumption can be overcome if the prior art teaches away from the claimed range, or the claimed range produces new and unexpected results, or other evidence demonstrates the non-obviousness of the claimed range. Because it was undisputed that the claimed 9:4 to 9:6 range overlaps with the 9:1.5 to 9.5 range taught in the prior art, the Federal Circuit held that there was a prima facie case of obviousness. 

Furthermore, the Federal Circuit agreed with the district court that the patentee had failed to present evidence to rebut the presumption of obviousness. For example, the district court held that 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.” Here, while another prior art reference expresses a preference for a higher PVP percentage (a 9:18 rotigotine to PVP weight ratio), “it does not teach away from the claimed range.” In addition, the district court had found the patentee had blocking patents that dissuaded competitors from developing a rotigotine TTS patch, which weakened the patentee’s evidence of commercial success. 

This publication is intended for general information purposes only and does not and is not intended to constitute legal advice. The reader should consult with legal counsel to determine how laws or decisions discussed herein apply to the reader's specific circumstances.
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