Innovative drug companies can obtain patent rights and exclusive rights for drug trial data for new drugs, their initial uses and new uses developed in the future. Both rights are exclusive rights, which are designed to protect innovative drug companies in their predominant position in the market. The initial exclusivity and subsequent exclusivity of innovative drugs constitute institutional barriers to the marketing of generic drugs. However, in the practice of the United States, once the initial exclusivity expires, generic drugs will be encouraged to enter the market. Actually, subsequent exclusivity cannot prevent the process of the replacement of innovative drugs by generic drugs. This article analyzes the practical measures of American society to break through institutional barriers from three aspects of administrative supervision, medical practice and judicial relief, and finds that the evasion of subsequent exclusive rights by stakeholders in administrative supervision. Furthermore, medical practice is the main reason for the breakthrough of institutional barriers. The difficulty of asserting the subsequent exclusivity is the secondary reason for the breakthrough of institutional barriers.

method patent  /  drug patent  /  patent linkage  /  innovative drug  /  generic drug