اليابان

Date of Judgment: October 22, 1999

Issuing Authority: Supreme Court

Level of the Issuing Authority: Final Instance

Type of Procedure: Judicial (Administrative)

Subject Matter: Patent (Inventions)

Main text of the judgment (decision):

1. The judgment of the original instance court shall be quashed.

2. The award of the Patent Agency of October 31, 1996 on the adjudication case No.5909 of 1993 shall be revoked.

2. The cost of litigation shall be borne by the appellee.

Reasons:

On Item 1 of the grounds of appeal by the representative of the appellant, Tamotsu Aoyama and

Shoji Nakajima

1. Facts lawfully ascertained by the original instance court are as follows:

P holds a patent on an invention called 'new group of polypeptides, its method of production, pharmaceutical product containing this group of polypeptide and its means of use' (registered on June 28, 1989, patent No.1501778, hereinafter, 'the Patented Invention' and 'the Patent' respectively).

Joint Stock Company Q Pharmaceutical, which was licensed by P to work the Patented Invention, obtained approval of partial alteration of the matters subject to import approval as provided by the Law on Pharmaceutical Business on June 28, 1991 (approval (01AMYu) No.0040 (partial alteration), hereinafter, 'the Approval'). P applied for the registration of the extension of the period of subsistence for the Patent for 2 years and 12 days on the ground that the company received the certificate of Approval on June 28, 1991, and therefore, the period in which the Patented Invention could not be worked was between the date of registration and the day before the date of the receiving of the certificate, but the application was rejected. Upon the request of P, the Patent Agency considered the case as adjudication case No.5509 and rejected this application on the ground that this the period for which the extension is applied exceeds the period in which the patent could not be worked as provided by subpara.4, para.1 of Article 67-3 of the Patent Law before the amendment by Law No.26, 1993 on October 31, 1996 (hereinafter, 'the Adjudication').

The appellant succeeded the rights of P in December 20, 1996 by merger.

2. The present case involves a claim by the appellant for the revocation of the Adjudication on the ground that the calculation of the period in which the patent could not be worked was wrong.

The original instance court dismissed the claim of the appellant on the ground that:

1 'the period in which the patented invention could not be worked' as provided by Art.67-3, para.1, subpara.4 of the Patent Law before the amendment is the period the between the date of the beginning of the test which is required for the approval as provided by the cabinet order on the basis of Art.67, para.3, or the date of patent registration, whichever is later, and the day before the date when the above approval as provided by the above cabinet order was given 1 in the present case, this period shall be calculated from the date of patent registration, which is

June 28, 1989 1 the day before the date of the approval as provided by the above cabinet order is June 27, 1991, and thus, the period in which the Patented Invention could not be worked was one year 364 days. Therefore, the present Application for the extension of two years 12 days coincides with Art.67-3, para.1, subpara.4 of the Patent Law before the amendment.

Thus, the court found the ruling of the Adjudication to be justifiable and dismissed the claim of the appellant.

3. However, within the judgment of the original instance court, item (3) cannot be upheld on the following grounds:

1) While the system of patent acknowledges the exclusive right to work the patented invention as a business to the patent holder and provides for the period of subsistence of patents, Art.67, para.3 of the previous Patent Law provides that the period of subsistence of a patent can be extended up to five years by application for the registration of extension, if the patent could not be worked due to the necessity of obtaining an approval based upon a provision of a law the purpose of which is to ensure safety in relation to the working of the patented invention. Decisions which serve as a ground for application for extension as provided in the said paragraph are limited to those determined by a cabinet order. Approval and partial alteration of matters subject to approval of production and importation of pharmaceutical products as provided by the Law on Pharmaceutical Business (hereinafter, 'Approvals') fall within the category of these decisions (Art.1-3, Enforcement Order of Patent Law).

1) In order to produce or import pharmaceutical products as a business, a licence based on the Law on Pharmaceutical Business is required (arts.11 and 12, Law on Pharmaceutical Business); this licence is not available, if the applicant for the approval has not obtained approval for the product which he intends to produce or import (arts.13, para.1, 23, Law on Pharmaceutical Business). Approvals are acts of an administrative agency to publicly confirm the effectiveness and safety of pharmaceutical products; by these Approvals, the applicant is granted a status to obtain licence of producing the products as a business and therefore, the Approvals can be regarded as administrative acts in relation to the applicant. Thus, the effect of Approvals emerges when they reach the applicant, i.e. when the applicant actually becomes aware of the approval or is in a situation where he should be aware of the approval unless there is a special provision to the contrary.

By examining relevant legislation, there is no provision which provides for the means of notification of Approvals, but in the light of the wording of arts.14, para.1, 13, para.1 of the Law on Pharmaceutical Business, the absence of the provision on notification cannot be interpreted as denying the necessity of notification to the applicant; there is no provision from which it can be surmised that the Approvals take effect without reaching the applicant.

Furthermore, provisions of the Patent Law on the extension of the period of subsistence (arts.67, para.3, 67-2, para.3 etc.) are understood to presuppose that decisions which serve as the basis of registration of extension take effect when they reach the relevant party.

Therefore, Approvals which serve as the basis of registration of extension should be understood to take effect when they reach the applicant.

1) Since, as mentioned above, the situation of being unable to work the patented invention ceases when the approval as provided by the Law on Pharmaceutical Business which serves as the basis of registration of extension takes effect when it reaches the applicant and thus takes effect, the date when the approval has taken effect is not included in the period in which the patented invention could not be worked because of the necessity of obtaining the decision as provided by arts.67, para.3, 67-3, para.1, subpara.4 of the Patent Law before the amendment, and the end of the above period is the day before the approval reached the applicant.

1) Thus, 'the period in which the patented invention could not be worked' due to the necessity of obtaining approval of production etc. as provided by Art.67-3, para.1, subpara.4 of the Law on Pharmaceutical Business before the amendment should be understood as the period between the date of the beginning of the test which is required for the approval, or the date of patent registration, whichever is later, and the day before the date when the above approval took effect by reaching the applicant.

1) Therefore, the award of adjudication which found the day before June 28, 1991, the date as indicated in the Certificate, to be the end of the period in which the Patented Invention could not be worked without ascertaining the date of the arrival of the Approval to Joint Stock Company Q Pharmaceutical and rejected the Application on the ground that it coincides with Art.67-3, para.1, subpara.4 of the Law before the amendment, is against the law and should be revoked. 1 The judgment of the original instance court which dismissed the claim of the appellant for the revocation of the Award of Adjudication based upon a view different from the above contains a breach of law which evidently affects the judgment. The argument of the appellant coincides with the above and therefore, has a ground, and the judgment of the original instance court cannot but be quashed. Based upon the above, the claim for the revocation of the Adjudication Award should be acknowledged. Therefore, the justices unanimously rule as the main text of the judgment.

(This translation is provisional and subject to revision.)