Revised Japanese Examination Guidelines for Medical Inventions

By Toyomi Ohara, Patent Agent & Technical Adviser

The Japanese Patent Office (“JPO”) introduced a revised version of the “Examination Guidelines for Medical Inventions,” in October of 2009. The revised guidelines are applicable to all patent applications being examined after November 1, 2009 including pharmaceutical products and medical devices.

1. Methods for Collecting data from the human body

In Japan, the examination guidelines stipulate that patentable inventions must be “industrially applicable inventions.” Prior to the revision, a method to gather data from the human body for diagnostic purposes was not eligible for patent rights since it was not considered an industrially applicable subject matter.Under the current examination guidelines, the above can be granted patent rights as long as it does not include a diagnostic step or process in the claims.For example, the following claims are patentable according to the revised guidelines:

(Claim A) A method of collecting oral mucous membrane for diagnosing influenza.

(Claim B) A method for taking X-ray images of lung.

(Claim C) A method for measuring body temperature by inserting an ear thermometer into the external ear.

2. Medicaments with a new dosage regimen

Under the revised guidelines, medicinal inventions with new dosages, dosage intervals, administration routes (e.g. intravenous vs. sublingual) or administration sites of known compounds are treated as medicinal uses which  impart novelty to a claim over the prior art and are patentable so long as the claimed invention is not obvious over the prior art.According to the revised guidelines, the following examples are considered inventive since changing the dosage and mode of administration of the medicine shows “a remarkable effect beyond that which is expected by a person skilled in the art.”: Under the revised guidelines, the inventions presented below are considered “inventive” since they would impact a consumer’s quality of life:(Example A)Prior Art: It has been known that asthma is treated with 1 µg/kg body weight per day of compound A and is frequently accompanied by side effect B.Present Invention: It was found that asthma symptoms improved over a long period of time by orally administering 30-40?g/kg of compound A once every 3 months while reducing the incidence of side effect B.(Example B)Prior Art: It has been known that compound A shows growth-inhibitory effects against ovarian cancer when given intravenously, while giving rise to hepatotoxicity as a side effect.Present Invention: It was found in this invention that the blood level of hormone Y secreted from the pituitary gland changed when administering compound A to a particular site Z in the human brain, which had the effect of significantly diminishing ovarian cancer compared to the conventional treatment of  intravenous administration.This revision broadens the scope of patentable subject matter and stimulates research and development in the pharmaceutical industry. Furthermore, the revision encourages research and development of medical products with minimized side effects and enhanced patient compliance.

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