Chinas Hatch-Waxman Act: Patent Linkage System Implemented in the 4th Amendment to the Chinese Patent Law – JD Supra

The Standing Committee of the 13th National Peoples Congress, Chinas top legislature, adopted the Fourth Amendment to the 1984 Chinese Patent Law on October 17, 2020. The Fourth Amendment follows a series of amendments that were last adopted in 2008 and will become effective on June 1, 2021. Among the provisions is Article 76, establishing a new pharmaceutical patent linkage system modeled after the U.S. Hatch-Waxman Act. Article 76 of the Fourth Amendment was implemented in accordance with Article 1.11 of the Economic and Trade Agreement Between the Government of the United States of America and the Government of the Peoples Republic of China.[1]

Key provisions of Article 76 of the Fourth Amendment include:

There are several key differences between the U.S. Hatch-Waxman system and the new Chinese law. Chinas patent linkage system is not limited to small molecules and also includes biologics and traditional Chinese medicine. Further, China provides a much shorter stay period of only 9 months. This 9-month stay period only applies to small molecules and excludes biologics or traditional Chinese medicine. The market exclusivity period for first generic entrants (12 months), however, is far longer than that of the United States (180 days).

The patent linkage system for pharmaceutical patents in China is just developing, and the resolution mechanism for patent disputes under Article 76 of the Fourth Amendment currently lacks detail for both generic market entrants and patentees. One notable piece of information missing in the current legislation is whether there is an obligation for the generic market entrants to notify the patentee of the non-infringement statement. In this regard, stay tuned for updates on finalized draft rules, which are expected to provide further guidance on Chinas new patent linkage system.

[1]The text of the Phase One Trade Agreement with China (2020) is available at: https://ustr.gov/sites/default/files/files/agreements/phase%20one%20agreement/Economic_And_Trade_Agreement_Between_The_United_States_And_China_Text.pdf. Article 1.11 begins on page 1-6 on Chapter 1 (page 7 of the PDF).

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Chinas Hatch-Waxman Act: Patent Linkage System Implemented in the 4th Amendment to the Chinese Patent Law - JD Supra