KOREA: LIFE-CYCLE INSIGHTS 

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IPD’s Korean subscription brings transparency to this highly complex and unique market, offering:

  • Easy-to-use Korean brand,

       biosimilar, and generic drug

       launch tracking schedules

  • Korean litigation tracking and

       in-the-courtroom coverage with 

       real-time updates

  • Personalized consults with local Korean intellectual property analysts​

  • Weekly updates including trending Korean drug topics, recent publications, and​

       loss-of-exclusivity information 

  • Comprehensive Korean clinical development tracking in every major disease class
     

  • Complete drug information with locally reviewed Korean indications

  • Korean API (DMF) information

Our International Legal Analysts discuss the Korean patent and regulatory system, including:

  • Unique features of the Korean regulatory and patent system

    • Patent linkage system and Green List​

    • Scope confirmation actions

    • Patent term extensions

  • 9-month generic exclusivity​

    • Forfeiture ​

    • Extension

    • First challenger

  • Scope confirmation actions​

  • Validity challenges​ under the bifurcated system

    • Invalidation actions

    • Cancellation actions

  • Preliminary injunctions​

  • Trial length​

  • Court document and information availability

  • Post-market surveillance period

  • Alternative pathways to approval

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

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

 

First, Korea has a patent approval linkage system like the U.S., but the details are quite different. We have a Green List akin to the Orange Book in the U.S., but the Green List covers biologics as well as the small molecule drugs. The Korean linked system provides a 9-month stay in place of a 3-month stay in the U.S., and we have 9 months for generic exclusivity, which is different from 180 days in the U.S. On the legal side, the fundamental difference is that Korean IP litigation system is bifurcated, like Germany or Japan. So, invalidity proceedings and infringement proceedings can go in parallel. And sometimes, those two proceedings give conflicting outcomes on the validity issue. In such a case, a higher-level court such as a patent court or the Supreme Court resolves the validity issue on appeal.
 

Another unique feature in the Korean litigation [system] is scope confirmation action. In such an action, the petitioner, which may be the patent owner or a threatened or likely-to-be-threatened competitor, seeks a decision on whether or not a certain product falls within the scope of the patent.


Another thing is the patent term extension system is somewhat different from other jurisdictions. Multiple patents can receive PTE, but only once in Korea. On the regulatory side, there is no data exclusivity in Korea, but de facto protection is available via PMS, which is short for post-marketing surveillance. The purpose of the PMS system is to monitor the safety and efficacy of reviewed drugs by imposing PMS duties on the first developer. The thing is, during the PMS period, competitors cannot obtain generic approval unless they submit independent clinical data. So, due to the general difficulty in generating such clinical data, the PMS system in Korea effectively operates to give de facto data protection."