The China National Intellectual Property Administration ("CNIPA") recently issued the Draft Revision of the Guidelines for Patent Examination (First Batch of Draft for Comment) (the "Draft for Comment") for public comments by November 15, 2020.

The content of the Draft for Comment relates to Chapter 10, Part II of the Guidelines for Patent Examination, and mainly covers the supplement of experimental data, inventive step of compounds, and other five aspects of revisions. Among others, the Draft for Comment adds Section 3.5.2 "Supplement of Experimental Data for Drug Patent Applications”, specifying the examination criteria for experimental data on effects submitted after the date of filing through two typical cases. Meanwhile, the Draft for Comment clarifies the relationship and the boundary between "reference is disclosure" and "presumption is of no novelty" in terms of the novelty of compounds, and defines the relevant burden of proof. In addition, the Draft for Comment revises the over-absolute expression of "unexpected technical effects", clarifies the basic principles and methods for the examination of inventive step of an invention in the field of biotechnology, and standardizes the examination ideas for inventive step for each protection subject in Section 9.4.2.