On December 21, 2023, the China National Intellectual Property Administration (CNIPA) issued the final version of the revised Implementing Rules for the Patent Law and the Guidelines for Patent Examination, which will become effective on January 20, 2024. These Regulations complete legislative efforts on changes to the Chinese patent system introduced by the 4th amendment to the Patent Law that was promulgated in June 2021. They also provide details on the much-anticipated Chinese patent term extension introduced by Art. 42(3) of the Patent Law back in 2021. The patent term extension (PTE) is to compensate for the loss of the effective patent term due to time spent on seeking marketing approval of new drugs.
PTEs are available for patents in China on certain new drugs and improved new drugs. Eligible patents are compound patents, formulation patents, crystal patents, method of manufacture patents and medical use patents (both first and second medical uses) but do not include intermediate patents. “New drug” refers to innovative drugs and specified improved new drugs according to the definition provisions of the related Laws and Regulations and in accordance with the National Medical Products Administration (NMPA) provisions. However, according to the Work Plan for the Reform of Chemical Drug Registration Classification and its official interpretation implemented by the NMPA, “innovative drugs” refers to new drugs that have not been marketed in China or abroad. Therefore, according to the position of CNIPA, “innovative drugs” means Class 1 new drugs, which are “new globally,” not just “new in China.” Despite this, neither the Patent Law nor the Implementing Rules gives a specific definition for “new drugs.” There is therefore the possibility that CNIPA’s position on the interpretation of new drugs will be challenged in future litigation. Read more