The framework for analyzing whether a prior art reference anticipates a claimed range varies depending on whether the prior art discloses a point within the claimed range or discloses its own range that overlaps with the claimed range.

If the prior art discloses a point within the claimed range, then the prior art anticipates the claim. Ineos USA LLC v. Berry Plastics Corp., 783 F.3d 865, 869 (Fed. Cir. 2015); Titanium Metals Corp. v. Banner, 778 F.2d 775, 782 (Fed. Cir. 1985).

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.” Ineos, 783 F.3d at 869; Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006); ClearValue, Inc. v. Pearl River Polymers, Inc., 668 F.3d 1340, 1345 (Fed. Cir. 2012)). “Once the patent challenger has established, through overlapping ranges, its prima facie case of anticipation, ‘the court must evaluate whether the patentee has established that the claimed range is critical to the operability of the claimed invention.'” Genentech, Inc. v. Hospira, Inc., 946 F.3d 1333, 1338 (Fed. Cir. 2020) (quoting Ineos, 783 F.3d at 871).

Rotigotine Patch

In UCB, Inc. v. Actavis Lab'ys UT, Inc., No. 21-1924, 2023 WL 2904757, — 4th — (Fed. Cir. Apr. 12, 2023), the technology at issue was directed to transdermal therapeutic systems (TTSs) for rotigotine, a drug used to treat Parkinson's disease. TTSs are usually implemented as skin patches that deliver drugs across the patient's skin barrier to enter the patient's bloodstream. These patches contain drugs in an “amorphous,” i.e., non-crystalline, form because drugs in crystalline form cannot cross the skin barrier.

The prior art disclosed a weight ratio of 9% amorphous rotigotine to 1.5% to 5% polyvinylpyrrolidone (PVP). And a prior product (original Neupro®) had a weight ratio of rotigotine to PVP of 9:2 which had to be kept in “cold-chain conditions” (refrigerated), and a later reformulated product (reformulated Neupro®) having a weight ratio of rotigotine to PVP of 9:4 which had long-term stability at room temperature.

The patent-in-suit discloses and claims a TTS having a range of rotigotine to PVP ratios by weight of about 9:4 to about 9:6.

Anticipation

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.

Specifically, the Federal Circuit held that the district court had misapplied Kennametal and the “immediately envisage” line of cases to convert an overlapping-range case into a point-within-a-range case. Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381 (Fed. Cir. 2015) (a prior art reference can anticipate a claim “even if it ‘does not expressly spell out' all the limitations arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage' the claimed arrangement or combination” (cleaned up) (citation omitted)); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 851 F.3d 1270, 1274 (Fed. Cir. 2017) (“Kennametal addresses whether the disclosure of a limited number of combination possibilities discloses one of the possible combinations”).

Obviousness

A presumption of obviousness, however, applies “[w]here a claimed range overlaps with a range disclosed in the prior art.” Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299, 1311 (Fed. Cir. 2006) (citation omitted).

This presumption can be overcome if the “prior art teaches away from the claimed range, . . . the claimed range produces new and unexpected results,” or other evidence demonstrates non-obviousness of the claimed range. Id. (citation omitted). “A presumption of obviousness does not shift the burden of persuasion to the patentee to prove nonobviousness, but a presumption establishes that, ‘absent a reason to conclude otherwise, a factfinder is justified in concluding that a disclosed range does just that—discloses the entire range.'” Almirall, LLC v. Amneal Pharms. LLC, 28 F.4th 265, 272 (Fed. Cir. 2022) (quoting E.I. duPont de Nemours & Co. v. Synvina C.V., 904 F.3d 996, 1008 (Fed. Cir. 2018)).

Because it was undisputed that the 9:4 to 9:6 range claimed in the patent in suit 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.

Teaching Away

The district court had found that other prior art, namely the Tang reference, did not criticize, discredit, or otherwise dissuade a
skilled artisan from investigating the claimed range of ratios. A reference teaches away “when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken.” Galderma Lab'ys., L.P. v. Tolmar, Inc., 737 F.3d 731, 738 (Fed. Cir. 2013) (quoting DePuy Spine,
Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009)). By contrast, 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.” DePuy, 567 F.3d at 1327 (quoting In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004)). Here, while the Tang 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.”

Unexpected Results

The district court had found there was no unexpected results from the 9:4 to 9:6 range claimed in the patent. The patentee had argued that given the “failure” of the original product at 9:2, it was expected that the only slightly larger claimed range of “about 9:4 to about 9:6” would exhibit the same stability failure. But the Federal Circuit “read the district court's finding of similar levels of stability as a finding that any differences in stability between the claimed range and prior art is one of degree.” (emphasis in original). While adding more PVP increased stability to a degree, “there would be no new properties.” Prior art and expert testimony showed that PVP was “the most effective crystallization inhibitor” tested, so “a person of ordinary skill would expect the claimed rotigotine to PVP weight ratio range and the range disclosed in the prior art to provide stability in a similar way.”

Commercial Success

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. See Galderma Lab'ys., L.P. v. Tolmar, Inc., 737 F.3d 731, 738 (Fed. Cir. 2013). And the Federal Circuit declined to “reweigh” the evidence. See Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc., 25 F.4th 1354, 1364 (Fed. Cir. 2022) (whether prior art teaches away from the claimed invention, whether the claimed invention is new and unexpected, and “the existence of and weight assigned to any objective indicia of nonobviousness,” like commercial success, “are underlying factual questions we review for clear error”).

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