This case addresses the legal framework for determining whether prior art anticipates a claimed range. The appropriate legal framework applies a different test depending on whether the prior art discloses a point within the claimed range vs. a range overlapping the claimed range.

Background

UCB, Inc. (“UCB”) holds patents (the “Muller” patents, priority date in 1999) covering the active ingredient rotigotine in Neupro, a Parkinson’s medication administered via a patch on the skin. The effectiveness of patch administered rotigotine dips significantly if the rotigotine crystalizes, preventing its passage out of the patch and through the skin. Neupro’s original formula contains a mixture of an additive polyvinlpyrrolidone (“PVP”) to prevent crystallization of Neupro. The Muller patents disclose ratios of rotigotine to PVP ranging from 9:1.5 to 9:5. Neupro’s original formulation has a rotigotine to PVP ratio of 9:2.

Actavis Laboratories UT, Inc. (“Actavis”) submitted an ANDA application for approval of a generic version of Neupro’s original formulation in 2013. In 2014, UCB sued Actavis for infringement of the Muller patents. UCB prevailed in the lawsuit, and was awarded an injunction against Actavis until March 2021, when one of the Muller patents expires.

In 2018, UCB filed a new patent application (the “’589 patent”, priority date 2009) covering a reformulation of Neupro. The reformulated Neupro has a rotigotine to PVP ratio of 9:4, and the ‘589 patent claims a range of rotigotine to PVP ratios from 9:4 to 9:6.

In 2019, UCB again sued Actavis, this time asserting Actavis’ 2013 ANDA application infringed the ‘589 patent. The District Court applied Kennametal’s “at once envisage” test to find the ‘589 patent invalid as anticipated by the Muller patents. The District Court also found the ‘589 patent invalid as obvious in view of multiple prior art references, including the Muller patents.

UCB appealed the District Court’s invalidity findings. Judge Stoll writes the opinion for the Federal Circuit.

Issue(s)

Did The District Court err in applying Kennametal’s “at once envisage” test when analyzing anticipation of a claimed range by a prior art disclosure of an overlapping range?

Holding(s)

The District Court’s application of Kennametal’s “at once envisage” test to analyze anticipation of the ‘589’s claimed range by the Muller patents’ disclosure of an overlapping range was erroneous.

While the District Court’s finding of invalidity based on anticipation was erroneous, it’s finding of invalidity based on obviousness was not clearly erroneous. As such, the District Court’s finding of invalidity was affirmed.

Reasoning

The correct legal framework (referred to herein as the Ineos legal framework) to analyze anticipation of a claimed range is as follows:

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

2. If the prior art discloses a range overlapping a claimed range, the prior art only anticipates the claimed range 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 USA LLC v. Berry Plastics Corp., 783 F.3d 865, 869 (Fed. Cir. 2015) (citing Atofina, 441 F.3d at 999; ClearValue, Inc. v. Pearl River Polymers, Inc., 668 F.3d 1340, 1345 (Fed. Cir. 2012)). Once a patent challenger has established, through overlapping ranges, its prima facie case of anticipation, the court must evaluate whether the patentee has established 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).

The Federal Circuit opinion included the figure below to illustrate how the claimed range overlaps with the Muller patents’ disclosed range:

Figure 1: Asserted patent ‘589’s claimed range vs. prior art Muller Patents disclosed range.

The Federal Circuit found the District Court’s application of Kennametal’s “at once envisage” test to analyze anticipation of the ‘589’s claimed range by the Muller patents’ disclosure of an overlapping range, erroneous. Under Kennametal’s “at once envisage” test, a 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.” 780 F.3d at 1381.

The Federal Circuit held the District Court should have instead applied the Ineos legal framework (above) to first find a prima facia case of anticipation established by the undisputed ranges, and then looked for a showing of criticality of the ‘589 patent’s claimed range to the invention in the ‘589 patent.

The Federal Circuit declined to rule on the criticality of the claimed range, as the ‘589 patent was still found to be invalid based on the District Court’s finding of obviousness.