In an American Arbitration Association (AAA) dispute over early-stage drug candidates in a development agreement between two pharmaceutical companies, CRA consultants were retained to assist in expert reports regarding industry practices regarding exclusivity of drug product candidates. A key issue was whether exclusivity was limited to individual antibodies and who had the right to select the antibodies for development. The reports addressed the scope and breadth of exclusivity in the industry and whether the payments in the contract were consistent with broad or narrow exclusivity.
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,...

