Pharmaceutical Innovation, Competition and Patent Law
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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.
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Chapter 8: Patent term extension in Japan: focusing on the Pacif Capsule decision

Toshiaki Imura

Extract

In 2009, the Intellectual Property High Court (the Court) ruled that the Board of Appeal at Japanese Patent Office erred in refusing the application for patent term extension, on the grounds that there was a prior approval for a drug with the identical active ingredients and efficacy and effectiveness. This chapter comments and assesses this decision of the IP High Court. The decision in Pacif Capsule significantly changes the practices of the Japanese Patent Office in the following two points. First, the Court held that it was erroneous to refuse patent term extension based on the Japanese Patent Act Article 67ter(1)(i), on the grounds that there is a prior disposition of which the subject was a drug with ‘active ingredients’ and ‘efficacy and effectiveness (usage)’ in common with the drug concerning the drug which is subject to the approval (second disposition), for manufacturing/selling as a drug under Article 14 of the Pharmaceutical Affairs Act (hereinafter ‘PAA’). Secondly, the Court also held that the scope of protection for a patent right whose term has been extended pursuant to the Patent Act Article 68 shall be decided by ‘the product’ identified by ‘ingredients’, ‘volume’ and ‘structure’ of the drug approved under the PAA Article 14. The system for patent term extension was introduced in Japan by the 1987 revision of Patent Act. In principle, the term of a patent right is 20 years from the filing date (Article 67(1)). Through the 1987 revision, a new subsection was added to allow the term to be extended.

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