CRA consultants supported Endo International plc (Endo) in its successful challenge of products that infringed on its patents covering Opana® Extended Release (ER). Dr. Gregory K. Bell assessed the commercial success of Opana ER. He testified with respect to the issue of non-obviousness regarding the patents-in-suit, as the patents-in-suit enabled a long-lasting controlled release formulation of the painkiller. The District Court relied on secondary considerations of nonobviousness, including Dr. Bell’s testimony demonstrating the commercial success of Opana ER and the nexus of the patent claims and market success. Dr. Bell was supported by a team including Dr. Andrew Tepperman and Dr. Justin Ho.
Anticompetitive conduct and patents listed in the Orange Book
Branded pharmaceutical manufacturers are required by law to list all patents in the Orange Book that cover an approved drug product. However,...