Washington International Law Journal


Yūsuke Satō is the original author of the article. Jiameng Kathy Liu translated the article into English.


The following is a translation of “Patent Protection of Medical Methods—Focusing on Ethical Issues,” an article written by Professor Yūsuke Satō in the June 2007 issue of the Japanese periodical Annual of Industrial Property Law. In Japan, despite the lack of an explicit statutory prohibition, methods of medical treatment have never been patentable. The Japan Patent Office (“JPO”) has rejected patenting medical processes on ethical grounds, interpreting that they do not fulfill the statutory requirement of “industrial applicability” in the main sentence of Article 29, Section 1 of the Patent Act, and courts have been confirming this practice. In light of recent developments in biotechnology, this prohibition is now in question. Reforms are being discussed from the perspective that Japan’s patent system should encourage the development of new medical technology. In this article, Professor Satō examines the underlying ethical reasons for excluding medical methods from patent protection and discusses whether they are appropriate. He compares the treatment of medical methods under the Japanese patent system to that of the European Patent Convention (“EPC”), where Article 52, Section 4 explicitly provides that medical processes do not have “industrial applicability.” He also compares the same to the United States Patent Act (“U.S. Patent Act”), 35 U.S.C. § 1 et seq. where, while medical processes are patentable, Section 287(c) immunizes medical practitioners from liability from medical process patent infringements. After reviewing a wide range of theories, Professor Satō argues that the ethical issues surrounding Japan’s patent system should be viewed from the standpoint of whether the patent system could be socially justified and whether it would lead to industrial development. To do so, the elements of “industry,” as well as limitations of patent rights enforcement, should be kept in mind when considering patentability requirements.

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