"Let's get started with some of the biggest differences between the Japanese patent and regulatory landscape, as compared to the United States...

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Well, in terms of the regulation, the timing of the generic launches is completely different. In Japan, Japan's Ministry of Health, Labor and Welfare, JMHLW, which corresponds to the FDA in the United States, approves generic products only twice a year. Also, at-risk launches are not so frequent, because the JMHLW controls generic approvals and the competitors have limited ability to launch their products. In terms of patent, Japanese patent term extensions are unique and they’re different from those of the United States because the Japanese Patent Law allows multiple patent term extensions on the same patent. Also, unlike the United States, the Japanese courts cannot revoke or invalidate the patents, or the accused infringers can assert invalidity defenses at the court’s trials. So, in order to remove patents, competitors need to file invalidity challenges at the Japan Patent Office."