Date of
Judgment: November
17, 2015
Issuing
Authority:
Supreme Court
Level of
the Issuing Authority: Final Instance
Type of
Procedure: Judicial
(Administrative)
Subject Matter: Patent (Inventions) (Extension of Duration)
Summary
of the judgment (decision):
1. Where,
prior to the approval of manufacturing and sale of a pharmaceutical product
under the Pharmaceuticals and Medical Devices Act for which an application for
registration of extension of the duration of a patent right was filed, another
approval of manufacturing and sale of the pharmaceutical product had been
granted under said Act with regard to the same patented invention, and if, as a
result of the comparison between them with regard to the matters to be examined
that would directly affect the substantial identity of the relevant products as
a pharmaceutical product in light of the type or subject of the patent to which
the application for registration of extension pertains, the scope of the
manufacturing and sale of the pharmaceutical product subject to the prior
approval is deemed to include the manufacturing and sale of the pharmaceutical
product subject to the approval stated as the reason for the application, the
approval stated as the reason for the application is not deemed to have been
necessary to obtain for the working of the patented invention to which the
application for registration of extension pertains.
2. Where, prior to the approval of manufacturing
and sale of a pharmaceutical product under the Pharmaceuticals and Medical
Devices Act for which an application for registration of extension of the
duration of a patent right was filed, another approval of manufacturing and
sale of the pharmaceutical product had been granted under said Act with regard
to the same patented invention, and given the following circumstances (1) to
(3) as explained in the judgment, the scope of the manufacturing and sale of
the pharmaceutical product subject to the prior approval is not deemed to
include the manufacturing and sale of the pharmaceutical product subject to the
approval stated as the reason for the application:
(1) The patented invention covered by the patent
right relates to a composition for treating cancer, comprising a
therapeutically effective amount of vascular endothelial growth factor antagonist,
and thus it is an invention of a product for which the subject matter is the
ingredient of a pharmaceutical product; and the matters to be examined when
issuing said two approvals, which would directly affect the substantial
identity of the relevant products as a pharmaceutical product, are the
ingredients, quantity, dosage, administration, effectiveness, and effect of the
pharmaceutical product;
(2) The dosage and administration of the
pharmaceutical product subject to the prior approval are described as "in
combination with other anticancer drugs, adults are ordinarily intravenously
infused with bevacizumab at a dose of 5 mg/kg (weight) or 10 mg/kg (weight) at
administration intervals of at least two weeks," whereas the dosage and
administration of the pharmaceutical product subject to the approval stated as
the reason for the application for registration of extension are described as
"in combination with other anticancer drugs, adults are ordinarily
intravenously infused with bevacizumab at a dose of 7.5 mg/kg (weight) at
administration intervals of at least three weeks"; and
(3) The prior approval did not permit the
manufacturing and sale of the pharmaceutical product, which is subject to the
approval stated as the reason for the application for registration of
extension, for the purpose of conducting the combination treatment of XELOX
treatment (giving internal medicine and administering a two-hour infusion in a
three-week treatment cycle) and bevacizumab treatment; but the approval stated
as the reason for the application for registration of extension made it
possible to manufacture and sell that product for this purpose for the first
time.