CHINA: LIFE-CYCLE INSIGHTS 

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IPD’s Chinese subscription brings transparency to this large, complex, and highly opaque market, offering:

  • Easy-to-use Chinese brand, biosimilar,

       and generic drug launch 

       tracking schedules
 

  • Chinese litigation tracking and

       in-the-courtroom coverage with 

       real-time email updates

  • ƒPersonalized consults with local Chinese intellectual property analysts 
     

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

  • Complete drug information with locally Chinese reviewed indications
     

  • Comprehensive Chinese clinical development tracking in every major disease class
     

  • Chinese API (DMF) information

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

  • Unique features of the Chinese patent and regulatory system

  • Bifurcated system

  • Patent validity challenges

  • Changes coming June 1, 2021

    • Future patent linkage system

    • Scope confirmation actions

    • Patent term extensions

    • Monetary damages

  • Generic market exclusivity period

  • Regulatory exclusivities

  • Class 3 generics

  • Class 2 improved new drugs

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

"Could you discuss the patent linkage system that's coming into effect in June? 

So, for China's patent linkage system, the NMPA will first establish a drug patent information platform, which is attuned to the Orange Book in the United States. But the Chinese platform covers small molecule drafts, biologics, and traditional Chinese medicine. When competitors seek market approvals for generic drugs, biosimilars, and generic traditional Chinese medicines, they shall make a declaration under status of patents related to the reference product. Chinese patent linkage system provides a 9-month stay, in place of the 30-month stay in the U.S. And they also provide a 12-month first generic market exclusivity, not 180 days. 

However, the stay and the first generic exclusivity do not apply to biosimilars and generic Chinese medicine. In China, competitors are not obligated to notify the brand about the filing of a Paragraph IV challenge. The NMPA will publish the submission with Paragraph IV challenges aligned. The brand or competitors have to initiate a scope confirmation proceeding within 45 days. Otherwise, the NMPA would not stay the approval process. Another unique feature in China is that the parties can bring the scope confirmation proceeding in two venues. They can do it in front of the Beijing IP Court, by filing a civil lawsuit, or before CNIPA for an administrative adjudication."