Federal Circuit Says Teva's Planned Parkinson's Patch Infringes UCB Patent Under Doctrine Of Equivalents

In UCB Inc. v. Watson Laboratories, Inc., Nos. 2018-1397, -1453 (Fed. Cir. June 24, 2019), the Federal Circuit affirmed the district court's decision holding UCB's '434 patent not invalid and infringed under the doctrine of equivalents (DOE) and holding UCB's later-expiring '414 patent anticipated by prior public use.

UCB markets Neupro®, a rotigotine transdermal patch for Parkinson's disease. UCB's '434 patent claims patches comprising rotigotine in "an acrylate-based or silicone-based" polymer matrix, and UCB's '414 patent claims a rotigotine polymorph (Form II rotigotine). Watson filed an ANDA seeking to market generic patches comprising rotigotine in a polyisobutylene (PIB) matrix.

Addressing infringement of the '434 patent, the Federal Circuit found that the district court did not clearly error in concluding that PIB was insubstantially different from acrylate- and silicone-based polymers. The Court also agreed with the district court that (i) UCB's election in response to a restriction requirement did not invoke prosecution history estoppel because the requirement was unrelated to the patentability of PIB; (ii) there was insufficient record evidence to conclude UCB surrendered PIB as an equivalent by intentional narrow claiming; (iii) finding PIB equivalent did not vitiate the "acrylate-based or silicone-based" polymer limitation; and (iv) the equivalence theory did not ensnare the prior art.

As to the '414 patent, the Federal Circuit held that the district court did not clearly error in finding a patient in the United States used Neupro® patches containing Form II rotigotine before the '414 patent's critical date, and thus affirmed the district court's finding that the asserted claims were anticipated.

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