Japan

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)

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 final appeal argued by the representatives designated for final appeal

1. In this case, the appellee of final appeal, who holds a patent right based on Patent No. 3398382 (hereinafter this patent and patent right are respectively referred to as the "Patent" and the "Patent Right"), 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 of refusal of the application for registration of extension of the duration of the Patent Right. The point in dispute in this case is, in a case where, prior to the approval of manufacturing and sale of a pharmaceutical product under the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, etc. (its name prior to the amendment by Act No. 84 of 2013 was the "Pharmaceutical Affairs Act"; hereinafter referred to as the "Pharmaceuticals and Medical Devices Act" throughout the period before and after said amendment), for which an application for registration of extension of the duration of a patent right was filed (hereinafter such application is referred to as an "application for registration of extension" and such approval is hereinafter referred to as a "disposition stated as the reason for the application"), another approval of manufacturing and sale of the pharmaceutical product had been granted under the Pharmaceuticals and Medical Devices Act with regard to the same patented invention (such approval is hereinafter referred to as a "prior disposition"), whether or not, due to the existence of the prior disposition, such case is deemed to fall under Article 67-3, paragraph (1), item (i) of the Patent Act (hereinafter referred to as the "Act") on the grounds that the disposition 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 pertained.

2. The outline of the facts legally determined by the court of prior instance is as follows.

(1) The Patent (number of claims: 11) was granted for the invention titled "vascular endothelial growth factor antagonist" for which the patent application was filed on October 28, 1992. The establishment of the Patent Right was registered on February 14, 2003.

The invention covered by the Patent relates to a composition for treating cancer, comprising a therapeutically effective amount of vascular endothelial growth factor antagonist.

(2) On September 18, 2009, with regard to the pharmaceutical product with the product name "AVASTIN 100 mg/4ml for intravenous infusion" and the generic name "bevacizumab (genetically modified)," the appellee obtained approval for partial change to the matters approved for manufacturing and sale of the pharmaceutical product under Article 14, paragraph (9) of the Pharmaceuticals and Medical Devices Act (hereinafter this approval is referred to as the "Disposition" and the pharmaceutical product subject to the Disposition is referred to as the "Pharmaceutical Product"). The active ingredient of the Pharmaceutical Product is "bevacizumab (genetically modified)," which falls within the category of "hVEGF antagonist, which is an anti-VEGF antibody" as referred to in Claim 1 of the Patent. Its effectiveness or effect is described as being "unresectable advanced or recurrent colorectal cancer," and its dosage and administration are described as follows: "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." The manufacturing and sale of the Pharmaceutical Product constitutes the working of the patented invention covered by the Patent Right.

(3) Prior to the Disposition, another approval of manufacturing and sale had been granted under Article 14, paragraph (1) of the Pharmaceuticals and Medical Devices Act with regard to the pharmaceutical product that is identical with the Pharmaceutical Product in terms of characteristics except for the dosage and administration (hereinafter this approval is referred to as the "Prior Disposition" and the pharmaceutical product subject to the Prior Disposition is referred to as the "Prior Pharmaceutical Product"). The dosage and administration of the Prior Pharmaceutical Product are described as follows: "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." The manufacturing and sale of the Prior Pharmaceutical Product constitutes the working of the patented invention covered by the Patent Right.

(4) The Prior Disposition did not permit the manufacturing and sale of the Pharmaceutical Product 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. The Disposition made it possible to manufacture and sell that product for this purpose for the first time.

(5) On December 17, 2009, the appellee filed an application for registration of extension with regard to the Patent Right, on the grounds that the appellee had been unable to work the patented invention covered by the Patent Right for a certain period of time because of the necessity to obtain the Disposition, but the JPO examiner rendered a decision to refuse this application. Dissatisfied with this, the appellee filed a request for a trial against the examiner's decision of refusal.

(6) On March 5, 2013, the JPO rendered a decision (hereinafter referred to as the "JPO Decision") to dismiss the appellee's request for a trial, holding as follows. The working of the patented invention referred to in Article 67-3, paragraph (1), item (i) of the Act should be interpreted as referring to an act of manufacturing and selling the pharmaceutical product that is defined by all the matters that correspond to the matters necessary for defining the patented invention (the matters the applicant deems necessary to define the invention for which a patent is sought) among the matters stated in the written approval of the pharmaceutical product which was subject to a disposition designated by Cabinet Order referred to in Article 67, paragraph (2) of the Act (hereinafter referred to as a "Cabinet Order disposition"). The Prior Disposition already made it possible to work the patented invention covered by the Patent Right to the extent defined by all the matters that correspond to the matters necessary for defining the invention in relation to the Pharmaceutical Product, and therefore the Disposition is not deemed to have been necessary to obtain for the working of the patented invention covered by the Patent Right.

3. The purpose of the system for registration of extension of the duration of a patent right is to allow the patentee to reclaim a period of time during which the patentee has been unable to work the patented invention because of the necessity to obtain a Cabinet Order disposition. In view of the wording of Article 67-3, paragraph (1), item (i) of the Act, the case where the Cabinet Order disposition is not deemed to have been necessary to obtain for the working of the patented invention is clearly stipulated as a requirement for the examiner to refuse the application for registration of extension. Given the above, where there are a prior disposition and a disposition stated as the reason for the application, both of which were issued with regard to the manufacturing and sale of a pharmaceutical product, and if, as a result of the comparison between these dispositions, the scope of the manufacturing and sale of the pharmaceutical product subject to the prior disposition is deemed to include the manufacturing and sale of the pharmaceutical product subject to the disposition stated as the reason for the application, it should be concluded that the disposition 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. Determination as to whether or not the disposition stated as the reason for the application was necessary for the working of the patented invention should be made exclusively by comparing the prior disposition and the disposition stated as the reason for the application, and it should not be made by making reference to all the matters that correspond to the matters necessary for defining the patented invention.

It is construed that approval of manufacturing and sale of a pharmaceutical product under the provisions of the Pharmaceuticals and Medical Devices Act makes it possible to manufacture and sell the pharmaceutical product defined for each approval with regard to all the matters to be examined in relation to the pharmaceutical product, namely, its "name, ingredients, quantity, dosage, administration, effectiveness, effect, side effects and other matters relating to the quality, efficacy and safety" (the main body of Article 14, paragraph (2), item (iii) of the Pharmaceuticals and Medical Devices Act). However, according to the purpose of the system for registration of the extension of the duration of a patent right as mentioned above, if a comparison is made between the prior disposition and the disposition stated as the reason for the application by taking into account the matters to be examined that would not 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, this approach could lead to comparing these dispositions by taking into account the matters to be examined that would hardly be a hindrance to the working of the patented invention in relation to the pharmaceutical product, and thus finally allowing registration of an extension of the duration of the patent right, therefore it cannot be deemed to be appropriate. If so, determination as to whether or not the scope of manufacturing and sale of the pharmaceutical product subject to the prior disposition includes the manufacturing and sale of the pharmaceutical product subject to the disposition stated as the reason for the application should be made not by comparing these dispositions in form with regard to all those matters to be examined, but by comparing them with regard to the matters to be examined that would directly affect the substantial identity of the relevant products as pharmaceutical products in light of the type or subject of the patent to which the application for registration of extension pertains.

According to the above, it is appropriate to construe that where there is a disposition stated as the reason for the application and a prior disposition, 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 pharmaceutical products 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 disposition is deemed to include the manufacturing and sale of the pharmaceutical product subject to the disposition stated as the reason for the application, the disposition 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.

4. This reasoning can be applied in this case as follows. 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. In the case of an invention of a product for which the subject matter is an ingredient of a pharmaceutical product, the matters to be examined when issuing said two dispositions, which would directly affect the substantial identity of the relevant products as pharmaceutical products, are the ingredients, quantity, dosage, administration, effectiveness, and effect of the pharmaceutical product. In this case, comparing the Disposition and the Prior Disposition that had been issued prior to the Disposition, the dosage and administration of the Prior Pharmaceutical Product 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 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." The Prior Disposition did not permit the manufacturing and sale of the Pharmaceutical Product for the purpose of conducting the combination treatment of XELOX treatment and bevacizumab treatment, but the Disposition made it possible to manufacture and sell that product for this purpose for the first time.

Given the circumstances mentioned above, in the present case, the scope of the manufacturing and sale of the pharmaceutical product subject to the prior disposition is not deemed to include the manufacturing and sale of the pharmaceutical product subject to the disposition stated as the reason for the application.

5. The court of prior instance determined the JPO Decision to be illegal because the JPO held that the Disposition was not deemed to have been necessary to obtain for the working of the patented invention to which the application for registration of extension with regard to the Patent Right pertains. According to the above, this determination by the court of prior instance can be affirmed as justifiable. The arguments by the representatives designated for final appeal cannot be accepted.

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.)