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19 Biotechnology L. Rep. 1 (2000)

handle is hein.journals/bothnl19 and id is 1 raw text is: 19 Biotechnology Law Report 1
Number 1 (February 2000)
Mary Ann Liebert, Inc.
{BLR 3035} Doctrine of Equivalents - Enablement - Japanese Patent Office
Maximizing the Value of Biotechnology Patents in Japan
HATSUSHI SHIMIZU and STEPHEN B. MAEBIUS

INTRODUCTION
C hanges in Japanese patent practice over the past
decade have made it possible to obtain broader
patents in Japan. These changes may already have
encouraged U.S. entities to file more patent appli-
cations in Japan, especially in the field of biotech-
nology. In the genetic engineering field (IPC =
C12N15), only about 510 Japanese patent applica-
tions by U.S. entities were published in 1993. In
1997, however, this number grew to 720. This arti-
cle examines the impact of recent changes in Japan-
ese patent practice on biotechnology inventions and
ways to maximize the value of biotechnology
patents in Japan. Section II of the article discusses
the general impact on claim scope of the revised Ex-
amination Guidelines of the Japanese Patent Office
(JPO). Section III discusses the impact of the Japan-
ese examination standards on the requirement of en-
ablement, again with particular emphasis on the
scope of allowable claims. Section IV provides a
brief discussion of the permissibility of claims to
methods of treatment or medical uses of biotech-
nology inventions. Section V examines the differ-
ing attitudes of Japanese companies and U.S. or Eu-
ropean companies toward the scope of allowable
Dr. Shimizu is the founder of the Shimizu Patent Office and a
Visiting Professor at Tokyo University's RCAST intellectual
property department, as well as a former Patent Examiner of
the Japanese Patent Office. Mr. Maebius is a patent attorney in
the Biotechnology & Pharmaceutical Group of Foley & Lard-
ner. He is currently serving as a Visiting Associate Professor
at Tokyo University's RCAST intellectual property department.
This article is based on a presentation given by Dr. Shimizu at
California Western School of Law entitled Patenting Biotech-
nology Inventions in Japan (March 4, 1999).

claims for early-stage biotechnology inventions.
Section VI looks at the problem of literal claim
scope and the recent, somewhat limited, introduc-
tion of the doctrine of equivalents into Japanese
patent law. The article concludes that the much
broader scope of claims now granted in Japan, to-
gether with the introduction of the doctrine of equiv-
alents, provides a significant opportunity for foreign
companies seeking to patent biotechnology inven-
tions in Japan and should be of great strategic value
in licensing biotechnology to a Japanese company.
II. THE REVISED JAPANESE
EXAMINATION STANDARD OF
CLAIM DESCRIPTION FOR
BIOTECHNOLOGY INVENTIONS
Like the U.S. Patent and Trademark Office, the
JPO has a requirement that each claim must be sup-
ported by the Detailed Description of the Invention
so that one of ordinary skill in the art can carry out
the inventions (Article 36, Section 4). This is known
as the enablement requirement and is discussed in
Section III of this article. Separate and apart from
the enablement requirement, Japanese patent law
stipulates how claims should be described. Under
prior Japanese Patent Law (Article 36, Section 5(2)),
only items essential to the constitution of an in-
vention should be included in a patent claim. The
examination standard also prescribed the claim for-
mat in detail, which limited the breadth of claims.
Recently, such restrictions on claim format were
lifted to permit an applicant to include a patent claim
all items which the applicant deems necessary to
identify his or her invention to which he or she

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