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Japan: IP High Court gives new ruling on patent term extension




Genentech, the plaintiff, is the patentee of a patent for an invention titled "vascular endothelial cell growth factor antagonists". Genentech filed an application for the registration of patent term extension in relation to the patent asserting that Genentech obtained an approval of partial changes in manufacturing approval (the disposition), which added a new dosage and administration of its medicine Avastin, whose general name is bevacizumab (the medicine). Regarding the medicine, there was a prior disposition that differs only in dosage and administration (see figure for the differences between the prior disposition and the disposition).

The JPO rejected the application and dismissed an appeal based on the revised Examination Guidelines because the prior disposition already existed for a medicine which had the same general name, effectiveness and efficacy as the medicine. Genentech appealed to the IP High Court seeking to revoke the decision of the JPO.

Judgment of May 30 2014, IP High Court

The Grand Panel of the IP High Court set out two requirements regarding the requirements of Japanese Patent Act Article 67-3(1)(i) which is the same as in the Pacif case judgment of IP High Court. It held that in order to refuse an application, it is necessary for an examiner (trial examiner) to selectively demonstrate either [1] "that it cannot be said that a ban was lifted through obtainment of the disposition designated by Cabinet Order" (first requirement) or [2] that "the 'act on which the ban was lifted through obtainment of the disposition designated by Cabinet Order' is not included in the 'acts that fall under the practising of the patented invention'" (second requirement).

The Court provided a new criterion regarding the determination concerning whether the application fulfils the first requirement and held that the scope of the "practising of a patented invention" on which the ban is lifted covers the act of manufacturing, selling, etc a medicine that is identified by ingredient, quantity, dosage, administration, effectiveness and efficacy.

Regarding this case, the Court held that the prior disposition did not lift the ban on the act of using the medicine by the use method that is identified by the dosage and administration which is newly added by the disposition and on the act of manufacturing, selling, etc the medicine on the premise of its use by the aforementioned use method, that said ban was lifted by the disposition, and that it is obvious that the disposition does not fulfil the first requirement. For this reason, the Court revoked the JPO decision.

Furthermore, the Court clearly mentioned in dicta regarding the scope of the extended patent right, especially the meaning of a "product" and a "usage" provided in Article 68-2 of the Patent Act. The Court stated that the patent right whose duration was extended is effective for the scope of the practising of the patented invention that is identified by an "ingredient (not limited to active ingredient)" as an invention pertaining to a "product" and is also identified by "effectiveness and efficacy" and "dosage and administration" as an invention pertaining to a "usage" (it can originally be said to be natural in light of the legislative purpose of the extension registration system that equivalents and products that are evaluated as substantially identical are included).

In addition, the Court stated that the scope of the practising of the patented invention on which the ban is lifted through obtaining a disposition designated by Cabinet Order and the scope of the practising of the patented invention for which the patent right is effective in the cases where the duration of the patent right was extended are not always the same. Where the practising of a patented invention on which the ban was lifted through obtaining a disposition designated by Cabinet Order is included in the scope of the practising of the patented invention for which the relevant patent right whose duration was extended based on a prior disposition is effective, the effect of the extension can become redundant.

The medicine which is the subject of the prior disposition The medicine which is the subject of the disposition

General: bevacizumab

Effectiveness and efficacy: unresectable advanced or recurrent colorectal cancer

Dosage and administration: in combination with other anticancer drugs, adults 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.


General: bevacizumab

Effectiveness and efficacy: unresectable advanced or recurrent colorectal cancer

Dosage and administration: in combination with other anticancer drugs, adults ordinarily intravenously infused with bevacizumab at a dose of 7.5 mg/kg (weight) at administration intervals of at least three weeks.





Can patent term extension be granted for this new dosage and administration ?

Significance of the judgment

This judgment approves the granting of registration of patent term extension where an applicant obtains a disposition which differs in dosage and administration from a prior disposition even if its effectiveness and efficacy are the same as that of a prior disposition. For brand-name pharmaceutical companies, it seems to be favourable because the number of cases where patent term extension would be granted for a drug which has characteristics in dosage and administration will be larger than the one judged by the revised Examination Guidelines. However, according to Professor Kato, the scope of the extended patent right could be interpreted more narrowly than before. Therefore it is difficult to conclude whether this judgment is favourable or not to them.

Furthermore, this judgment separates the scope of being granted registration of extension from the scope of extended patent right and approves that the effect of the extension can be redundant. Professor Iseki points out that it may impair foreseeability of the expiration date for generic drug manufacturers.

Takanori Abe Michiko Kinoshita

ABE & Partners

Matsushita IMP Building, 1-3-7, Shiromi, Chuo-ku, Osaka, 540-0001,
Japan
Tel: +81 6 6949 1496
Fax: +81 6 6949 1487
abe@abe-law.com
www.abe-law.com


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