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ARTICLE · 09 FEBRUARY 2024

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A Closer Look At The Pharmaceutical Patent Term Compensation System In China

Purplevine IP Group
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With the implementation of the 2023 Detailed Rules for the Implementation of the Patent Law (the "Rules") and the Guidelines for Patent Examination (the "Guidelines") in line with new Chinese...

ChinaIntellectual Property
Ming Liu
Ming Liu
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With the implementation of the 2023 Detailed Rules for the Implementation of the Patent Law (the "Rules") and the Guidelines for Patent Examination (the "Guidelines") in line with new Chinese Patent Law on January 20, 2024, several substantive amendments to the patent law will take effect. One notable advancement is the introduction of the pharmaceutical patent term compensation system, marking a substantial stride in the evolution of Chinese patent system. This change holds significant and widespread implications, particularly for stakeholders in the pharmaceutical sector.

Historically, the patent term extension (PTE) was originated from the Hatch-Waxman Act of the United States in 1984. It aimed to compensate for the time spent in clinical trials and marketing approval of drugs.

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