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16/12/2021: Update on the Chinese Patent Terms

China’s patent system has been under a lot of reform during the past year. The most recent reform was made on the 1st of June 2021, known as the fourth amendment to the Chinese Patent Law. This amendment consists of four parts, part one, the patent application, part two the patent exploitation and commercialization, part 3, patent protection, and part 4, other general changes.

Patent Term Adjustment

Part one concentrates on the patent application which in turn focuses on the patent term. A term compensation mechanism for invention patents was created which allows patentees to claim patent term loss, caused by unreasonable delay in the granting of the patent application. This relates to patents issued after 4 years from filing or 3 years date request of the substantive examination, the new mechanism applies to patents issued after the 1st of June 2021.

For this to be pursued the patentee must submit a request via a form within 3 months of the patent grant date. The patent term adjustment period will be determined by the CNIPA delay in granting the application minus the client's delay. CNIPA delay primarily looks at the number of unreasonable days that caused delay during the examination period. To calculate these days, the grant date will be deducted from the later of the 4 years from the application date or 3 years from the substantive examination request.

A patentee is said to have caused unreasonable delay by failing to respond to CNIPA before the deadlines, deferred examination, the restoration of right, and delays in entering the PCT application in China.

Patent Term Extensions

As well as the Patent Term Adjustment, the new Chinese patent law explicitly outlines the prospects of attaining a Patent Term Extensions for pharmaceutical patents. This can be requested 3 months from the new drug marketing authorization approval by the National Medical Products Administration (“NMPA”).

The extension time is calculated by the date of market authorization minus the filing date. The number of years for extension is capped to a maximum of 5 years, and there is a limit of 14 years patent time for when the drug receives market authorisation.

Drugs, that will be applicable for an extension are limited to esters or salts of a known active ingredients, vaccines, traditional Chinese medicine with new indication, and chemical drugs with new indication.