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)
Main
text of the judgment (decision):
1.The
final appeal is dismissed.
2.The
appellant of final appeal shall bear the cost of the final appeal.
Reasons:
Concerning the reasons for acceptance of
final appeal argued by the agents appointed for final appeal, SUDO Noriaki, et
al.
1. In this case, the appellee of final appeal, who holds a patent right for
Patent No. 3134187 (this patent and patent right shall hereinafter be referred
to as the "Patent" and "Patent Right," respectively), seeks
revocation of the trial decision issued by the Japan Patent Office (JPO)
dismissing the appellee's request for a trial against the examiner's decision
to refuse the appellee's application for registration of extension of the
duration of the Patent Right.
2. The outline of the facts legally determined by the court of prior instance
is as follows.
(1) The Patent (containing 22 claims) was based on the patent application filed
on March 6, 1997, for the invention entitled "controlled release
composition," and was registered on December 1, 2000.
The invention claimed in the Patent relates to a controlled release composition
wherein the core containing medicinal substances is coated by a coating agent
that contains a water-insoluble substance, a certain hydrophilic substance, and
a certain cross-linked acrylic polymer.
(2) On September 30, 2005, the appellee obtained approval for manufacturing and
sale under Article 14, paragraph (1) of the Pharmaceutical Affairs Act
(hereinafter referred to as the "Disposition") with regard to the
pharmaceutical product called "Pacif Capsules 30mg" (hereinafter
referred to as the "Pharmaceutical Product"). The Pharmaceutical
Product contains morphine hydrochloride as its active ingredient, and has the
effect and efficacy of a painkiller for various types of cancers that cause a
medium to high level of pain.
(3) Prior to the Disposition, another approval for manufacturing and sale under
Article 14, paragraph (1) of the Pharmaceutical Affairs Act had been issued to
another pharmaceutical product called "OPSO (oral solution) 5mg/10mg"
which has the same active ingredient as well as effect and efficacy as those of
the Pharmaceutical Product (this approval and pharmaceutical product shall
hereinafter be referred to as the "Earlier Disposition" and
"Earlier Pharmaceutical Product," respectively). The Earlier
Pharmaceutical Product is not included in the technical scope of the patented
invention specified by any of the claims for the Patent Right.
(4) On December 16, 2005, the appellee filed an application for registration of
extension of the duration of the Patent Right, on the grounds that the appellee
had been unable to work the patented invention based on the Patent Right during
a certain period of time due to the necessity to obtain the Disposition, but
the JPO examiner issued a decision to refuse this application. Dissatisfied
with this decision, the appellee filed a request for a trial against the
examiner's decision of refusal.
(5) On October 21, 2008, the JPO issued a trial decision dismissing the
appellee's request for a trial, holding that since the Earlier Disposition had
been issued, prior to the Disposition, with regard to the Earlier
Pharmaceutical Disposition which has the same active ingredient as well as
effect and efficacy as those of the Pharmaceutical Product, it is not found
that it was necessary to obtain the Disposition for the working of the patented
invention based on the Patent Right (this trial decision by the JPO shall
hereinafter be referred to as the "JPO Decision").
3. Even in the case where, prior to the approval for manufacturing and sale
under Article 14, paragraph (1) of the Pharmaceutical Affairs Act, which gave
rise to the necessity to file an application for registration of extension of
the duration of a patent right (this approval shall hereinafter be referred to
as the "later disposition"), another approval for manufacturing and
sale under said paragraph (hereinafter referred to as the "earlier
disposition") had been issued with regard to the pharmaceutical product
which has the same active ingredient as well as effect and efficacy as those of
the pharmaceutical product covered by the later disposition (the pharmaceutical
product covered by the earlier disposition and that covered by the later disposition
shall hereinafter be referred to as the "earlier pharmaceutical
product" and "later pharmaceutical product," respectively), if
the earlier pharmaceutical product 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 later disposition for the working
of the patented invention based on said patent right, on the grounds of the
existence of the earlier disposition. The purpose of the system of extension of
the duration of a patent right is to reclaim the period of time during which
the patentee has been unable to work the patented invention due to the
necessity to obtain the disposition designated by Cabinet Order as set forth in
Article 67, paragraph (2) of the Patent Act. Just because the earlier
disposition had been issued with regard to the earlier pharmaceutical product
which has the same active ingredient as well as effect and efficacy as those of
the later pharmaceutical product, inasmuch as the earlier pharmaceutical
product 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, the existence of the earlier disposition does
not mean that the patentee must have been able to work the patented invention
based on the patent right pertaining to the application for registration of
extension where the later pharmaceutical product constitutes the working of
said patented invention, nor does it meant that the patentee must have been
able to work the patented invention specified by any of the claims for said
patent right. If the earlier pharmaceutical product 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,
this conclusion is not affected irrespective of how the scope of the effect of
the patent right (Article 68-2 of the Patent Act) is defined in the case where
the duration could have been extended because of the existence of the earlier
disposition.
Since the Earlier Pharmaceutical Product is not included in the technical scope
of the patented invention specified by any of the claims for the Patent Right,
it is unreasonable to deny, in this case, that it was necessary to obtain the
Disposition for the working of the patented invention, on the grounds of the
existence of the Earlier Disposition.
4. For the reasons stated above, the ruling by the court of prior instance can
be affirmed as justifiable in that the court found the JPO Decision to be
illegal, holding that the existence of the Earlier Disposition cannot be the
grounds for denying that it was necessary to obtain approval for manufacturing
and sale under Article 14, paragraph (1) of the Pharmaceutical Affairs Act for
the working of the patented invention based on the Patent Right. We cannot
accept the arguments for the final appeal.
Therefore, the judgment has been rendered in the form of the main text by the
unanimous consent of the Justices.
(This translation is
provisional and subject to revision.)