Correspondence: Sachiko Masuda, 4-6-1, Komaba, Meguro-ku, Tokyo 153-8904, Japan. Tel: +81 3 5452 5270; Fax: +81 3 5452 5280; E-mail: smasuda@ip.rcast.u-tokyo.ac.jp

¹is a visiting scientist at Harvard School of Public Health and a collaborative research fellow at University of Tokyo, Research Center for Advanced Science and Technology (RCAST).

Received 9 November 2007; Revised 9 November 2007; Published online 18 December 2007.

Abstract

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.