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Q72. Enablement Requirement for Medicine

Q72. Enablement Requirement for Medicine
 Explain enable requirement for medicine.

A72. According to the Examination Guideline, normally one or more representative embodiments or working examples are necessary which enable a person skilled in the art to work the invention, except the case where a person skilled in the art can manufacture the compounds etc. and can use the compounds etc. for medicinal use, in the light of common general technical knowledge as of the filing. As for working examples supporting the medicinal use, a description of the result of the pharmacological test is usually required.
In order to confirm the pharmacological effect of compounds etc. of the claimed medicinal invention, all of the followings should be made sufficiently clear, in principle; (i) which compounds etc. are (ii) applied to what sort of the pharmacological test system, (iii) what sort of result is obtained, and (iv) what sort of relationship the pharmacological test system has with the medicinal use of the claimed medicinal invention. It should be noted that the result of the pharmacological test should be described with numerical data as a general rule, but when the result cannot be described with the numerical data due to the nature of the pharmacological test system, an objective description equivalent to the numerical data for example, a description of the objective observation result by a medical doctor may be accepted. Furthermore, a clinical test, an animal experiment, and in-vitro test are employed as the pharmacological test system.