Japan Supreme Court Decision on Application for Patent Term Extension dated November 17, 2015 (2014 (Gyo-Hi) No. 356)

Japan Patent Information Committee

On November 17, 2015, the third petty bench of the Supreme Court rendered a decision in a case where, prior to an approval for manufacture and sales that was required for the purpose of regulations in pharmaceutical affairs, and which was a reason for filing an application for patent term extension (the approval is hereunder referred to as “the disposition as a reason for application”), an approval for manufacture and sales had already been made in connection with the same patented invention (this approval is hereunder referred to as “the prior disposition”), and the matter at issue was whether the application for patent term extension involving the disposition as a reason for application should be rejected by reason of the existence of the prior disposition (Article 67-3, Par. 1, item 1 of the Japanese patent law).  The decision may be summarized as follows.

In the case where both the disposition as a reason for application and the prior disposition have been effected, if, as a result of comparing the two dispositions with regard to the matters under examination that will directly concern the substantial identicalness as a pharmaceutical product in light of the type and subject of the patented invention under application for patent term extension, the manufacture and sales of the pharmaceutical product under the prior disposition are recognized to include the manufacture and sales of the pharmaceutical product under the disposition as a reason for application, it is reasonable to hold that having the disposition as a reason for application is not considered necessary for working of the patented invention under application for the registration of extension.

In the case at issue, it was concluded, “in the case of a product directed to the ingredients of a pharmaceutical, the matters of examination of the two dispositions that will directly concern the substantial identicalness as a pharmaceutical product are the ingredients of the pharmaceutical product and their amounts, as well as the administration, dosage, effectiveness and efficacy of the pharmaceutical product.”

According to the interpretation the Japan Patent Office has so far adopted in applying the current Examination Guidelines, the scope over which the ban on the working of a patented invention was lifted by the prior disposition shall be determined by all matters that are indicated in a written approval for the pharmaceutical product that fall under the category of an invention’s essential constituents (invention specifying matters).
(N.B.: If the Claims do not specify any pharmaceutical use, the effectiveness and efficacy indicated in the written approval shall also be used to determine the scope over which the ban was lifted.)

Based on this interpretation, the examination standards have heretofore been operated not to approve the registration of extension even if the disposition as a reason for application is effected at a later time.

Receiving this Supreme Court Decision that contravenes its traditional policy, the Patent Office has announced that a revision of Examination Guidelines will be made by spring in 2016.