JAPAN

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Patent Term
20 years from date of filing

Pharmaceutical Patent Extension?
Yes. Article 67(2) Patents Act.

An extension of the patent term by up to 5 years may be granted for pharmaceutical, veterinary and agrochemical patents if regulatory delay exceed 2 years. The application for patent extension must be filed within 3 months of approval and at least 6 months before expiry. An application for extension will not be accepted after the expiration of the original patent term.

Bolar Provision
Yes.

Article 69(1) of the Japanese Patent Law provides that “the effects of the patent right shall not extend to the working of the patent right for the purposes of experiment or research”.
This provision was interpreted by Japanese Supreme Court in its decision of Ono Pharmaceutical v. Malco Pharmaceutical K.K (1999) as allowing generic drug manufacturers to experiment with a patented drug to obtain regulatory approval.

That is the Supreme Court held that the use of a patented invention for the purpose of obtaining a licence to market the generic equivalent of a patented medicine will fall within the scope of the statutory exemption provided for under Article 69(1).

It is also important to realize that unlike the US exemption, the Japanese exemption is not limited to drugs and medical devices but applies to all patented products.

References
http://www.derwent.com/patentguides/gpe/jp_aug.htm
http://www.jpo.go.jp
http://www.ladas.com/BULLETINS/1999/0899Bulletin/Japan_ExperimentalUse.html

Prepared for IP Organisers by Dr Grace Chan, David Tadgell and Virginia Beniac-Brooks, Phillips Ormonde & Fitzpatrick - November 2007.