اليابان

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.