Fourth amendments of the Chinese patent law has taken effect on June 1, 2021, wherein, as for Patent Term Adjustment (PTA) for pharmaceutical patents, Paragraph 3 of Article 42 stipulates that, in order to compensate for the time taken for the review and approval of new drugs, for new drug-related invention patents that have been approved for marketing in China, the Patent Administration Department of the State Council shall, at the request of the patentee, grant compensation for the duration of the patent right. The compensation period shall not exceed 5 years, and the total effective patent right period after the new drug is approved for marketing shall not exceed 14 years. 

Before Fourth amendments of Chinese patent law comes into effect, the State Intellectual Property Office (SIPO) provided the corresponding proposed revision of Implementing Regulations of Patent Law (draft for comment) on November 27, 2020.  On December 21, 2023, the SIPO issued final version of the Implementing Regulations of Patent Law, which will enter into force on January 20, 2024.

What are the differences for the regulations as for PTA of pharmaceutical patents between the proposed revision and final revision of Implementing Regulations of Patent Law?

According to our comparison, we found, in addition to some formal adjustments in expressions, the main substantive adjustment is that one of the requirements for requesting PTA of pharmaceutical patent is revised from “The remaining period of protection of the patent for which compensation for the duration of drug patent is requested shall not be less than 6 months” into “The patent is within the valid term.”, which means, only if the patent is within the valid period, then the request for compensation for the duration of the patent right of a new drug-related invention patent can be filed to the SIPO.

Now, we provide the related parts for PTA of pharmaceutical patent in the final version of Implementing Regulations of Patent Law as follows:

Rule 80
The term “new drug-related invention patents” as mentioned in Paragraph 3 of Article 42 of the Patent Law refers to new drug product patents, preparation method patents, and medical use patents that comply with regulations.

Rule 81
A request for compensation for the duration of a patent right of an invention relating to a new drug in accordance with the provisions of Paragraph 3 of Article 42 of the Patent Law shall meet the following requirements and shall be submitted to the Patent Administration Department of the State Council within 3 months from the date when the new drug obtains marketing authorization in China:
(1) Where there are multiple patents for a new drug at the same time, the patentee can only request compensation for the duration of the patent right for one of the patents;
(2) Where one patent involves multiple new drugs at the same time, only the patent in terms of one new drug can be requested for compensation for the duration of the patent right;
(3) The patent is within the valid period and has not yet received compensation for the duration of the patent right of the new drug-related invention.

Rule 82
If compensation is granted for the duration of the patent right in accordance with the provisions of Paragraph 3 of Article 42 of the Patent Law, the compensation period shall be based on the number of days between the application date of this patent and the date when the new drug obtains marketing authorization in China minus 5 years, and determined on the basis of compliance with the provisions of Article 42, Paragraph 3 of the Patent Law.

Rule 83 
During the compensation period of the patent right for new drug-related invention patents, the protection scope of the patent is limited to the related technical solutions for the new drug and its approved indications; within the protection scope, the rights and obligations of the patentee shall be same as that before the compensation period of the patent right.

Rule 84
After reviewing the request for compensation for the duration of the patent right submitted in accordance with the provisions of Paragraph 2 and Paragraph 3 of Article 42 of the Patent Law, the Patent Administration Department of the State Council shall make a decision to grant the compensation for the duration if it deems that the conditions for compensation are met, and register and announce for said compensation; if the compensation conditions are not met, the Patent Administration Department of the State Council shall make decision not to grant the compensation for the duration, and notify the patentee who made the request.