Recently, Chemical Group of TANI & ABE handled 6 applications of patent term extension. We found that the important thing is to define "hydrate thereof" as well as "pharmaceutically acceptable salt thereof" in claims because in the preparation of pharmaceutical products, essential chemical compounds of the product are usually used in the form of hydrate. Therefore, in the Approval rendered by the Ministry of Welfare, Health and Labor, the chemical compounds are described in the form of hydrate. In view of the above, the compound in claims should be identical to the compound described in the Approval.

In such special type of application, the documents of the Approval rendered by the Ministry of Welfare, Health and Labor and the Notice of plans for clinical tests (which shows a period during which the patented invention could not be worked) are needed. A masking is necessary for descriptions in these documents which are important information but not necessary for the patent term extension application. We think that we should have time enough to prepare the application because the application is of a special type, thus requiring special documents and a meeting with a client in many cases.

We must handle this kind of application with full attention because it is said that sales of pharmaceutical products possibly reach 100 billion-yen or more.