Chinese Life-Cycle Insights Report, Patent Linkage: Insights From Five Years of Operation—Scope Confirmation and Patent Challenges in Practice

IPD Analytics has released a new report, "Chinese Insights: Patent Linkage: Insights From Five Years of Operation — Scope Confirmation and Patent Challenges in Practice."

Since China's drug patent linkage system took effect in July 2021, generic and biosimilar competitors have been required to make one of four certifications when filing a generic drug application. This report analyzes five years of scope confirmation action (SCA) activity at China's National Intellectual Property Administration (CNIPA), examining 181 distinct SCA disputes to assess how certifications lead to subsequent disputes and how those disputes are resolved.

Key findings include: CNIPA's annual SCA caseload has remained relatively stable at 60—70 proceedings per year, though 2026 activity may exceed this range. Type 4 certification activity has expanded substantially, driven by Type 4.2 certifications, without a comparable increase in SCAs. Among disputes reaching a substantive determination, outside-scope findings were more common than within-scope determinations. Follow-on activity differed materially between Type 4.1 and Type 4.2 certifications, with Type 4.1 frequently paired with direct invalidity challenges.

Taken together, the five-year record suggests that China's patent linkage system operates as a strategic framework rather than a linear clearance process, with outcomes depending not only on the certification itself, but on the strategy pursued after the certification.

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