Authored by: Tai Hong (Tina) , Shudan ZHU and Jiaqi GAO
The technical effect is a crucial factor in determination of inventiveness for pharmaceutical patents, and it relies heavily on experimental data. The presence and quality of experimental data can directly affect the grant or reject of a patent. Therefore, the acceptance of post-filing data has always been a matter of great concern.
In accordance with the first-to-file principle under China’s Patent Law, experimental data should be disclosed in the original patent application documents. However, due to factors such as the unpredictability of the prior art references cited by examiners and invalidation petitioners, the specific drafting of claims under the Markush system, and the diversity of experimental parameters, applicants often find it necessary to supplement experimental data after the application date to address challenges related to inventiveness and insufficient disclosure during prosecution and invalidation proceedings.