Abstract:
Translator’s note: 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.
