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 3: Patentability of medical methods in Japan

A Trilateral Perspective

Nari Lee


Patent law is a part of the system of incentives for innovation. It is shaped by the interplay of the objective as a legal institution to provide the neutral rule of law, and the subjective need to implement innovative policies. While the history of modern patent laws attests that the patent law has often been used as a policy instrument to foster industrial development in particular technological sectors, the contemporary patent laws seem to be firmly established as a system of intangible property, based on neutrally applicable norms, with the principle of non- discrimination among industry sectors. In most countries, the procedure of patent granting is based on objective administrative examination of subjective claims by the patent applicant, applying an objective set of rules of patentability. Substantively, norms of patent have become more technology neutral and the standard of patentability applies in a non-discriminating manner, regardless of the field of technology, and regardless of the identity of the inventor and the location of the invention. The neutrality of substantive aspects of patent law, among others, now extends to the subject matter and the principle of non-discrimination that the availability of patent protection should not be tied to the technological field of invention. This technological neutrality is enshrined in international convention such as the TRIPs Agreement, where multilateral obligation is imposed on the member states not to discriminate inventions, based on the field of technology. In sum, international intellectual property norms prohibit the use of so called macro-exceptionalism in patent law, as a matter of principle.

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