JAPAN Law and Practice Contributed by: Hirofumi Tada, Ohno & Partners
1.18 Court Arbiter All patent litigation cases in Japan are decided by a panel of three judges from IP-specialised divisions. Japanese courts have divisions highly 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. Japan does not have infringing activities specific to pharmaceutical products. Thus, just like general pat ‑ ent infringement, selling, making, using, exporting, importing, and offering to sell generic drugs consti ‑ tutes infringement. Other acts such as a marketing approval application or grant; an application for reim ‑ bursement, pricing or listing; 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 sub ‑ stance 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 (i) there is an agreement between a patent owner (or an entity substantially identical to the patent owner) and an original buyer which excludes Japan from the sales area, and (ii) the agreement is displayed on products. Depending on the facts, this exception may apply to 2. Generic Market Entry 2.1 Infringing Acts Infringement Acts
drugs and the parallel importation may constitute pat ‑ ent 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, reclassifications – four years. Challenges to data exclusivity are not common in Japan. (To be more accurate, Japan does not have official 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 peri ‑ ods.) 2.3 Acceptable Pre-Launch Preparations Experimental use exception applies to generics, and activities necessary for clinical trial do not constitute infringement. On the other hand, the manufacturing of drugs during the patent period for sale after the patent’s expiry constitutes 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 substance and use pat ‑ ents covering their new drugs to the government agency, MHLW, so MHLW has a non-public list of patents. MHLW does not grant marketing approval if a generic drug is covered by substance or use patents of new drug applicants. 2.5 Reimbursement and Pricing/Linkage Markets Japan does not have an official patent linkage scheme but has an informal process based on rules set by
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