• Jun 24 2019
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  • Category: CAFC Updates

UCB owns U.S. Patent Nos. 6,884,434 and 8,232,414, claiming a transdermal therapeutic system comprising rotigotine, a drug used for the treatment of Parkinson’s disease, and a polymorph of rotigotine. The FDA approved UCB’s rotigotine transdermal patches, and UCB has been selling the product under the brand name Neupro. Actavis filed an Abbreviated New Drug Application (ANDA) for generic versions of transdermal rotigotine patches, and UCB filed suit for infringement.  Actavis appeals the district court’s finding that the generic products of Watson and Actavis infringe the ’434 patent under the doctrine of equivalents. The only infringement issue is whether the use a polyisobutylene adhesive in the accused products is the equivalent of the claimed “matrix . . . based on an acrylate-based or silicone-based polymer adhesive system.” In response to Actavis’ various arguments, the CAFC finds that: 1) UCB’s election in response to a restriction requirement, does not indicate a surrender of polyisobutylene as an equivalent; 2) despite the fact that UCB chose to draft narrow claims, there is not enough indication from the patent specification, claims, or the record evidence of the inventor’s knowledge here to conclude that UCB surrendered polyisobutylene as a possible equivalent; 3) finding polyisobutylene to be an equivalent does not gives the element “an acrylate-based or silicone-based polymer adhesive system” such broad play as to vitiate that limitation; 4) Actavis has not shown that a hypothetical claim including polyisobutylene-based polymers would ensnare the prior art. Thus, the CAFC affirms the district court’s conclusion that the accused products infringe the claims under the doctrine of equivalents. With respect to UCB’s cross-appeal regarding the district court’s invalidation of the ’414 patent, the CAFC finds no clear error in the district court’s finding that Actavis presented clear and convincing evidence of public use before the date of invention under § 102(a), andaffirms the district court’s invalidation of the asserted ’414 patent claims.

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