UCB, Inc. v. Actavis Labs. UT, Inc. Neupro® (Rotigotine)

Robins Kaplan LLP

Robins Kaplan LLP

Case Name: UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679 (Fed. Cir. Apr. 12, 2023) (Circuit Judges Moore, Chen, and Stoll presiding; Opinion by Stoll, J.) (Appeal from D. Del., Jordan, J.) (Th

Drug Product and Patent(s)-in-Suit: Neupro® (rotigotine); U.S. Patent No. 10,130,589 (“the ’589 patent”)

Nature of the Case and Issue(s) Presented: The ’589 patent is directed to transdermal rotigotine patches. In particular, the ’589 patent claims a formulation including PVP, to stabilize the amorphous (non-crystalline) form of rotigotine. The ’589 patent claims methods for stabilizing rotigotine, including particular weight ratios of rotigotine:PVP. The ’589 patent—in addition to older, now-expired patents—covers reformulated Neupro.

In an earlier case, UCB had secured an injunction against Actavis’s ANDA product (preventing approval), asserting the older patents. That injunction expired with the older patents. But before losing its injunction, UCB initiated suit asserting the ’589 patent. Following two suits against the first (Actavis) and second ANDA filers, respectively, UCB appealed the district court judgment that the asserted patent was invalid as anticipated and obvious. The district court determined that UCB’s older Neupro patents anticipated the asserted ’589 claims, and that that multiple prior art references, including the older UCB patents, rendered the asserted ’589 claims obvious. On appeal, the Federal Circuit determined that the district court erred in its anticipation analysis, but its fact findings on overlapping ranges, teaching away, unexpected results, and commercial success were not clearly erroneous.

Why Actavis Prevailed: The district court erred in its anticipation analysis, applying an incorrect standard in handling the claimed ranges. If the prior art discloses a point within the claimed range, the prior art anticipates the claim. And 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.” Here, the older UCB patents disclosed an overlapping range. But the district court did not apply the established “overlapping range” framework—it applied the “immediately envisage” line of cases to identify discrete points in the prior art patent’s range and analyzed those discrete points as a point-within-a-range case. Thus, the district court did not consider the criticality of the claimed range, and the Court reversed the anticipation holding.

With respect to the issue of obviousness, the district court held the asserted claims obvious based on two separate grounds: (i) the claimed range of weight ratios of rotigotine to PVP overlaps with that disclosed in the older UCB patents, and UCB failed to rebut this prima facie case of obviousness; and (i) the prior art’s 9:2 and 9:3 TTS examples as modified by Muller's teachings of a range of 1.5% to 5% PVP render the claims obvious. The Federal Circuit determined that the district court did not clearly err in rejecting UCB’s argument that the new form of Neupro “changed the state of the art” and, thus, did not render all earlier prior art—including the older UCB patents—irrelevant. The Federal Circuit also found that the district court did not clearly err when it determined that no prior art taught away from the asserted claims—the prior art simply taught an alternative invention. The prior art did not “criticize, discredit, or otherwise dissuade a skilled artisan from investigating the claimed range of ratios.” The Federal Circuit further held that the district court did not clearly err when it determined that the claimed range did not produce new and unexpected results—rather, results were similar to those expressed in the older UCB patents. Finally, the district court did not clearly err when it determined that UCB’s evidence of commercial success was weak.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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