In response to the Supreme Court’s judgment in relation to the application for registration of extension of the duration of a patent right in 2015, the Japanese Patent Office has published the revised versions of Examination Guidelines and Examination Handbook and commenced examining based on them. The new judgment standards are applied as regards the correlation with prior disposition. The contents of the judgment are summarized as follows:

(1) History of the revision of the Examination Guidelines and Examination Handbook

On November 17, 2015, the Third Petty Bench of the Supreme Court (2014 (Gyo-Hi) 356) 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 Patent Law). (Japan Supreme Court Decision on Application for Patent Term Extension dated November 17, 2015 (2014 (Gyo-Hi) No. 356))

In view of this Supreme Court’s judgment, the Examination Guidelines and Examination Handbook for Patent and Utility Model in Japan were revised in regard to the application for registration of extension of the duration of the patent right, which have been applied to examination on or after April 1, 2016.

Part IX Extension of Patent Term

9. Case Examples Relating to Extension of Patent Term (Article 67ter(1) (i) of Patent Act)

(2) “The details of a disposition designated by Cabinet Order” to be stated in the request of the application

The request of the application for registration of extension should state the details of a disposition designated by Cabinet Order, including the present disposition (disposition stated as the reason for the application), the number for identifying the disposition, a product that became the subject of the disposition, and in a case where a particular use in which the product is used in the disposition, said particular use. For example, in the case of a pharmaceutical product, the name (product name etc.), active ingredients, efficacy, effect, etc. which are stated in the written approval should be included. Where there are more than one disposition corresponding to an act of working of the patented invention pertaining to the application for registration of extension and where the difference between the dispositions needs to be clarified, for example, in the case of a pharmaceutical product, an applicant can clarify the difference by stating dosage and administration in a column of use in the application.

(3) The concept of the correlation with prior disposition in the new Examination Guidelines

Regarding the correlation with prior disposition, the new Examination Guidelines state that “in a case an act of manufacturing and distribution of drug products or an act of manufacturing and import of agricultural chemicals subject to both the present disposition and the prior disposition falls under an act of working of the patented invention pertaining to an application for registration of extension, when manufacturing and distribution of drug products or manufacturing and import of agricultural chemicals subject to the prior disposition include those subject to the present disposition,” such disposition designated by Cabinet Order is not deemed to have been necessary.

In a case where a prior disposition and a present disposition have been made, the two dispositions are compared with respect to the examination matters related directly to substantial identity as drug products or agricultural chemicals in the light of the type and subject of the patented invention pertaining to an application for registration of extension. As a result of this, when manufacturing and distribution of drug products or manufacturing and import of agricultural chemicals subject to the prior disposition include those subject to the present disposition, such disposition designated by Cabinet Order is not deemed to have been necessary to obtain for the working of the patented invention pertaining to an application for registration of extension. Where the disposition designated by Cabinet Order is an approval for manufacturing and distributing pharmaceuticals and the patented invention claimed in an application for registration of extension is an invention of a product, “examination matters related directly to substantial identity” include “ingredient, dose, dosage, administration, efficacy, and effect.” The term “include” includes partial overlapping.

(4) In a case where multiple dispositions correspond to the same patent right

Where multiple dispositions were issued for a single patent right, patent term extensions based on those different dispositions will be registered for the single patent right on a disposition-by-disposition basis, provided that those respective dispositions are deem to be required for the working of the patented invention. Where manufacturing and distribution, etc. of drug products, etc. subjected to the present disposition are partially overlapped with manufacturing and distribution, etc. of drug products, etc. subject to the prior disposition, it is deemed that the present disposition has been necessary to obtain for the working of the patented invention except the part overlapped in the two dispositions. For example, this applies to a case where the efficacy and effect of a pharmaceutical product subject to the present disposition is a generic concept, while the efficacy and effect of a pharmaceutical product subject to the prior disposition is a more specific concept.

(5) Reviews on filing an application for registration for the extension of the duration for each disposition

The original judgment of the above-noted Supreme Court’s judgment, Heisei 25 (2013) “Gyo-Ke” NO.10195, states that “it is reasonable to understand that (dosage and administration) are also included in the “use” recited in (Article 68-2 of the Patent Law) and become elements that limit the effect of an extended patent right”; on the other hand, the above-noted Supreme’s Court judgment does not refer to this issue at all.

In view of the foregoing, it is construed that “dosage and administration” are one of the most important examination matters among those required for approval in accordance with the Law for Ensuring the Quality, Efficacy, and Safety of Drugs and Medical Device, which are included in the “use” recited in Article 68-2 of the Patent Law and the elements that limit the effect of an extended patent right. If different dispositions that differ not only in “dosage and administration” but also in “examination matters directly related to substantial identity” have been granted, it is required to consider filing an application for registration of extension of the duration of a patent right for each disposition, considering the possibility that the effect of the extended patent right may be limited.