Background

Article 67(2) of the Patent Law allows for the filing of an application for extension of the duration of a patent right by not more than 5 years for pharmaceutical products, pharmaceutical apparatus and the like that require the approval of the relevant authorities.
 

Article 67(2)
Where there is a period during which the patented invention cannot be worked because approval as prescribed by laws intended to ensure safety or the like, or any other disposition designated by Cabinet Order as requiring considerable time for the proper execution of the disposition in light of the purpose, procedures, etc., of such a disposition, must be obtained for the working of the patented invention, the duration of the patent right may be extended, upon the filing of a request for the registration of extension of the duration, by a period not exceeding 5 years.

 
In this regard, Article 67ter of the Patent Law establishes reasons for rejection of an application for the registration of extension.
 

Article 67ter(1)
Where an application for the registration of extension of the duration of a patent right falls under any of the following items, the Examiner shall render an Examiner's decision to the effect that the application is to be refused:
(i)　where the disposition designated by Cabinet Order under Article 67(2) is not deemed to have been necessary to obtain for the working of the patented invention; ... .

 
In addition, Article 68bis of the Patent Law stipulates that the validity of the patent right for which the duration has been extended is limited to usage applications of the disposition that was the reason for extension.
 

Article 68bis
Where the duration of a patent right is extended ..., such patent right shall not be effective against any act other than the working of the patented invention for the product which was the subject of the disposition ... which constituted the reason for the registration of extension (where the specific usage of the product is prescribed by the disposition, the product used for that usage).

 
In the present case, the provision at issue was that of "where the disposition … is not deemed to have been necessary to obtain for the working of the patented invention" of Article 67ter(1)(i) of the Patent Law.

The Case

The plaintiff was the proprietor of Patent No. 3398382 (number of claims: 11).
 

Claim 1
A composition for treating cancer, comprising a therapeutically effective amount of hVEGF antagonist, which is an anti-VEGF antibody.

 
In 2009, the plaintiff obtained the following approval for change ("the present disposition") with regard to "AVASTIN 100 mg/4 ml for intravenous infusion". As a result of this approved change, XELOX treatment (giving internal treatment and administering a two-hour infusion in a three-week cycle) became possible for the first time. Manufacture and sale of this pharmaceutical product constitutes the working of the invention of the subject patent. Based on the present disposition, the plaintiff filed an application for registration of a five-year extension of the patent term.
 
The pharmaceutical product that received the present disposition
Active ingredient: "bevacizumab (genetically modified)"
Effectiveness or effect: "unresectable advanced or recurrent colorectal cancer"
Dosage and administration: "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"
 
However, the plaintiff had, prior to the present disposition, obtained approval ("the prior disposition") for a prior pharmaceutical product that was identical to the pharmaceutical product described above except for dosage and administration, and, based on the prior disposition, the application for registration of an extension was issued with a Decision of Refusal on the grounds that "the disposition … is not deemed to have been necessary to obtain for the working of the patented invention" and, further, an Appeal Trial filed against the Decision of Refusal was unsuccessful. Manufacture and sale of the prior pharmaceutical product constitutes the working of the invention of the subject patent.
 
The pharmaceutical product that received the prior disposition
Active ingredient: "bevacizumab (genetically modified)"
Effectiveness or effect: "unresectable advanced or recurrent colorectal cancer"
Dosage and administration: "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 plaintiff filed suit with the IP High Court against the Appeal Trial Decision.
 

IP High Court Decision

The IP High Court ruled as follows regarding the original decision.
 
(1) Regarding the pertinence of Article 67ter(1)(i) of the Patent Law
The "working of the patented invention" in Article 67ter(1)(i) of the Patent Law stipulates as to the act of manufacture, sale and the like of a pharmaceutical product defined by "ingredients, quantity, dosage, administration, effectiveness, and effect" from among the matters for examination in relation to a pharmaceutical product of "name, ingredients, quantity, dosage, administration, effectiveness, effect, side effects, and other matters relating to quality, efficacy and safety". In the present case, prohibition of the use, manufacture, sale or the like of the present pharmaceutical product, which is defined by the dosage and administration provisions of "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", was not lifted by the previous disposition, and was lifted for the first time by the present disposition. Therefore, the Appeal Trial Decision was overturned.
 
(2) Regarding the effectiveness of the extended patent right
A patent right having had the duration thereof extended under Article 68bis was held effective within the scope of the working of the invention of said patent as defined as a "product" in terms of "ingredients (not limited to active ingredients)" and as defined as a "usage application" in terms of "effectiveness, effect" and "dosage, administration".
 
Appealing this ruling, the JPO took the case to the Supreme Court.

Supreme Court Decision

The Supreme Court ruled that "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 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." In the present case, where the "matters to be examined that would directly affect the substantial identity of the relevant products as pharmaceutical products" are the "ingredients, quantity, dosage, administration, effectiveness, and effect of a pharmaceutical product", the JPO's appeal to the Supreme Court was overruled on the basis that prohibition of the manufacture, sale and the like of the present pharmaceutical product was first lifted by the present disposition. In other words, while contradicting the reasoning of the IP High Court, the decision of the IP High Court in the original trial was upheld.
 
It should be noted that since the Supreme Court ruling made no mention of the effectiveness of an extended patent right, this issue remains to be addressed.
 

Summary

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 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.
 
Overview of the Supreme Court Decision
http://www.courts.go.jp/app/hanrei_en/detail?id=1427