Medical product

  • 3. Enablement Requirement for Medicine

    (See details in JPAA homepage)

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.

Pharmacological Data
If the specification includes an example which exactly describes how to test the claimed chemical composition, can the data associated with the example later be added, if it is proven that the example is actual, rather than paper or prophetic?

The written requirement (support and enablement) concerning the pharmaceutical invention is very strict in recent practice. If the pharmacological efficacy data of the pharmaceutical composition of the example (or the description which is considered equivalent to the pharmacological efficacy data) were not disclosed in the specification at the filing date of the patent application, it is almost impossible to obtain a patent for the pharmaceutical composition. The addition of the data to the specification after the filing date of the present application is considered as new matter. “Paper or prophetic examples are not considered as the working examples.

Physical-Chemical Data
What physical-chemical data are required in Japanese applications to support an invention of a composition which is a mixture of known ingredients?

The physical-chemical data should be usually required in the specification for an invention of a composition. The chemical field is the technical field where the effect of a composition cannot be readily expected based on the components constituting the composition. A composition invention is usually invented for providing a new and useful composition for some intended purpose. Such usefulness is usually proved by the physical-chemical property of the composition relating to such intended purpose. The kind of the physical-chemical property of the composition should vary depending on the kind of the composition. For example, please assume that an adhesive composition has been invented, which provides a stronger adhesive property than the conventional adhesive composition. In order to confirm that the claimed adhesive composition is indeed useful as an adhesive composition, it is natural that the specification should contain physical-chemical data based on which the adhesive strength of the claimed invention can be evaluated.

It is usually necessary for supporting the utility of an invention of a chemical compound. Physical data or test data are useful for proving that the compound was actually prepared and for proving that the compound would be useful for the intended purpose (such as the use of an effective component for a pharmaceutical composition).

As stated above, the chemical field is the technical field where the effect of a composition cannot be readily expected based on the components constituting the composition. It is usually impossible to expect the property or usefulness of the compound. Therefore, test data concerning the herbicidal effect should be usually necessary for proving an invention of a herbicidal composition.

The disclosure of the specification has to enable one skilled in the art to practice the claimed invention. The chemical field is the technical field where the effect of a compound cannot be readily expected from its chemical structure or chemical name. Further, the support requirement is recently strictly evaluated. The support requirement is to evaluate how broadly the working example justifies or generalizes the scope of the claimed invention. Therefore, it should be necessary to provide as many examples as possible at the filing date of the application. Generally, of course, at least one representative working example is required to support the chemical compound. If the chemical compound claimed is defined by the general formula covering a generic concept of a compound, which can broadly cover various distinct types of chemical structures from each other (such as an aliphatic group and aromatic group), it should be reasonably necessary to provide working examples for each one of the distinct chemical groups.

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