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.)