CRA consultants supported Plaintiff in a patent litigation regarding an extended-release formulation of an anti-pain medication. CRA assessed the commercial success of the product and the nexus between the success and the patents-in-suit, which covered extended-release technology. Marketing and promotional materials indicated the importance of the long-lasting controlled release formulation of the painkiller in terms of efficacy and patient compliance. The District Court relied on secondary considerations of nonobviousness, including CRA expert’s testimony demonstrating the commercial success the product and the nexus of the patent claims and market success.
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,...