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Q73. Pharmacological Data

Q73. 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”?

A73. No. 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.