Date of
Judgment: April
28, 2011
Issuing
Authority: Supreme Court
Level of
the Issuing Authority: Final Instance
Type of
Procedure: Judicial (Administrative)
Subject
Matter: Patent (Inventions)
Summary
of the judgment (decision):
Even in
the case where, prior to the approval for manufacturing and sale under Article
14, paragraph (1) of the Pharmaceutical Affairs Act because of which an
application for registration of extension of the duration of a patent right has
been filed, another approval for manufacturing and sale under said paragraph
had been issued with regard to a pharmaceutical product which has the same
active ingredient as well as effect and efficacy as those of the pharmaceutical
product covered by the approval pertaining to said application, if the
pharmaceutical product covered by the earlier approval is not included in the
technical scope of the patented invention specified by any of the claims for
the patent right pertaining to the application for registration of extension,
it is unreasonable to deny that it was necessary to obtain the approval, which
gave rise to the necessity to file said application for registration of
extension, for the working of the patented invention based on said patent
right, on the grounds of the existence of the earlier approval.