The Japan Patent Office (JPO) announced revision of the Examination Guidelines for inventions relating to medical treatment on October 23, 2009 on its website. The revised Examination Guidelines are applicable to applications examined on or after November 1, 2009.

　This revision expands the scope of patentable inventions. More particularly, the following inventions are newly included in the scope of patentable inventions:

1. “Medicine producing remarkable effects such as reduction of side effects by specifying dosage and/or administration” and;
2. “Methods for collecting various data from a human body (methods for measuring a human body) excluding diagnostic processes.”

　As a result of the expanded scope of patentable inventions, patents may be obtained for i. “Medicine producing remarkable effects such as reduction of side effects by specifying dosage and/or administration” in Japan, but not in the U.S. and Europe. Also, patents may be obtained for ii. “Methods for measuring a human body excluding diagnostic processes” not only in the U.S. and Europe but also in Japan.

　The following table compares the scope of patentable inventions relating to medical treatment, including the content of the revised Examination Guidelines, between Japan, the U.S., and Europe.

　“Medicine producing remarkable effects such as reduction of side effects by specifying dosage and/or administration,” for which patents may be obtained in Japan, includes the following example as given in the revised Examination Guidelines.

　It was found in this invention that the symptom of asthma is improved for a long term and the incidence of side effect B is reduced compared to before, by orally administering 30-40 μg/kg of compound A to asthma patients once per 3 months. As shown by the above example, medicine could be patentable by redesigning dosage and/or administration of compound A to reduce the incidence of side effect B.

(By Masaru MATSUMOTO)