JAPAN Law and Practice Contributed by: Hirofumi Tada, Ohno & Partners
divisions. Japanese courts have divisions high - ly specialised in IP, but they are not specific to pharma/life sciences patent litigation. There is little room for forum selection in Japan. Tokyo and Osaka District Courts have exclusive jurisdiction over first-instance patent-related cases. In some circumstances, patent owners may have options between these two courts, but there is no significant difference between these two courts. Tokyo District Court has more cases.
(i) there is an agreement between a patent owner (or an entity substantially identical to the pat - ent owner) and an original buyer which excludes Japan from the sales area, and (ii) the agree - ment is displayed on products. Depending on the facts, this exception may apply to drugs and the parallel importation may constitute patent infringement, although there is no case law and it is not clear. 2.2 Regulatory Data and Market Exclusivity The typical data exclusivity periods in Japan are as follows: • new substance drug – eight years; • orphan drug – ten years; • paediatric drug – ten years; • new administration route – six years; and • new indications, combinations, reclassifica - tions – four years. Challenges to data exclusivity is not common in Japan. (To be more accurate, Japan does not have offi - cial data exclusivity periods. There are periods for post-grant re-evaluation of effect/efficacy and safety. The government agency, MHLW, substantially utilises these re-evaluation periods as data exclusivity periods.) 2.3 Acceptable Pre-Launch Preparations Experimental use exception applies to generics, and activities necessary for clinical trial do not constitute infringement. 2.4 Publicly Available Drug and Patent Information Japan does not have a publicly available list of new drug patents such as the Orange Book. New drug applicants voluntarily report sub -
2. Generic Market Entry 2.1 Infringing Acts Infringement Acts
Japan does not have infringing activities specific to pharmaceutical products. Thus, just like gen - eral patent infringement, selling, making, using, exporting, importing, and offering to sell generic drugs constitutes infringement. Other acts such as a marketing approval application or grant; an application for reimbursement, pricing or list - ing; a submission or award of tender; or offer to supply after patent term expiry usually does not constitute infringement. Skinny Labelling In Japan, an invention for a new use of a known substance is allowed as a product patent. This means that a product patent can be granted for a second medical use. But the scope of such a patent is not clear. The government agency (Ministry of Health, Labour and Welfare of Japan (MHLW)) grants approval for skinny labelling generics. However, it is not clear whether and to what extent skinny labelling avoids infringement. Parallel Importation Generally speaking, parallel importation usually does not constitute patent infringement unless
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