Pharmaceutical Innovation, Competition and Patent Law

Pharmaceutical Innovation, Competition and Patent Law

A Trilateral Perspective

Edited by Josef Drexl and Nari Lee

Considering the arguments from the perspectives of innovation, competition law and patent law, this book explores the difficult question of balancing protection with access, highlighting the difficulties in harmonization and coordination. The contributors to this book, including academics, judges and practitioners from Europe, the US and Japan, explore to what extent patent strategies and life-cycle management practices take advantage of patent laws and health-care regulation and disrupt the necessary balance between incentives for innovation and access to affordable medicine and health care.

Chapter 6: Patent term extension in Japan: an academic and comparative perspective

Ryoko Iseki

Subjects: law - academic, biotechnology and pharmaceutical law, competition and antitrust law, intellectual property law


International issues of intellectual property law always seem to be taking steps toward the harmonization of legal systems internationally. There is a history of many arrangements of international treaties in this field, and endeavors to harmonize legal interpretations of administration. However, is a uniform system for all countries really preferable? The issue of patent term extension systems might be an illustration of ‘one system is not good for everyone’. This article shows the trilateral comparison of legislative intents of patent term extension systems. All three systems seem to be the same in granting protection to a patent holder, because the patent term will be eroded in order to obtain marketing approval for a drug. However, it is clear that these systems are very different in their legislative intent. The differences are drawn from industrial policies and what each patent law regards as being the nature of patent rights. This chapter will explore the recent conflict in Japan concerning the requirement for a patent term extension, and the scope of a patent right after the extension of a patent term. The issue arises when multiple marketing approvals are provided for similar drugs, as to whether each application on the approval may enjoy an extension of patent term. There is an epoch-making IP High Court judgment of 2009 on this issue, which has overturned all precedents. This chapter will offer some academic and legal comments about this judgment, as this issue illustrates the wide differences among the administration of these trilateral systems.

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