The Market Exclusivity Period for New Drugs in Japan: Overview of Intellectual Property Protection and Related Regulations

This paper reviews the institutional factors in Japan that affect the market exclusivity period for new drugs. The factors which directly affect the period are (1) statutory subject matter of patent protection, (2) patent term extension, and (3) restriction of the entry of generic drugs (market exclusivity right or data protection system). Other factors include (4) the experimental use exception (the so-called Bolar provision) and (5) compulsory license. In addition, the impacts of these factors on both brand-named manufacturers and generic drug manufacturers under the specific circumstances of the Japanese pharmaceutical market, such as the influence of the healthcare insurance system or the drug price control system, are discussed.