JAPAN: LIFE-CYCLE INSIGHTS 

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IPD’s Japanese subscription brings transparency to this highly complex

market, offering:

  • Easy-to-use Japanese brand,
    biosimilar, and generic drug launch 
    tracking schedules 

     

  • Japanese litigation tracking and
    in-the-courtroom coverage with
    real-time email updates

     

  • ƒPersonalized consults with local Japanese intellectual property analysts 
     

  • ƒWeekly updates including Japanese trending drug topics, recent publications, and
    loss-of-exclusivity information

     

  • Complete drug information with locally reviewed Japanese indications
     

  • Comprehensive Japanese clinical development tracking in every

       major disease class

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

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, JMHW, 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 JMHW 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."

Our International Legal Analysts discuss the ins and outs of the Japanese patent and regulatory system in comparison to the United States system, including:

  • Unique features of Japanese patent and regulatory system

    • Generic approvals

    • At-risk launches

    • Patent term extensions

  • Drug launches

    • JMHW approval timing

    • NHI price listing

  • Patent term extensions

  • Skinny labels

  • Regulatory exclusivity

    • ​Novel drugs

    • Combination products

    • Orphan drug exclusivity

    • Regulatory exclusivities

  • Litigation 

    • Bifurcated system

    • Post-grant oppositions

    • Trials for invalidation

    • Patent infringement

  • At-risk launches​​

Listen to our podcast to learn more about the Japanese patent and regulatory system