The newly revised "Patent Examination Guidelines" shall come into force on January 15, 2021 (December 2020)

On December 14, 2020, the CNIPA issued a notice to amend the Patent Examination Guidelines (hereinafter referred to as the "Guidelines"), and the amended Guidelines shall come into effect from January 15, 2021.

This revision involves Part II, Chapter 10 of the Guide, and major revisions include complementary experimental data, novelty and inventiveness of compounds, claims of monoclonal antibodies, claims of compositions, and creativity in the biological field.  Among them, the Guidelines give examples of examination involving pharmaceutical patent applications for supplemental experimental data of pharmaceutical patent applications. It also provides examples of inventive judgment for the inventiveness of compounds.

Regarding the inventiveness of inventions in the field of biotechnology, the Guidelines stipulate that in the judgment process, it is necessary to determine the distinguishing features of the invention from the closest prior art based on the specific limited contents of different protected subjects. Then, one evaluates whether technical problems are actually addressed by the invention based on the technical effects that the distinguishing features can achieve in the invention, followed by a judgement as to whether the prior art as a whole gives technical motivation. The Guidelines point out that given inventions in the field of biotechnology involve different levels of protection topics such as biological macromolecules, cells, individual microorganisms, etc., the inventive judgment also needs to consider the structural differences between the invention and the prior art, the proximity of affinities and the predictability of technical effects. In addition, the Guidelines provide the criteria for judging the inventiveness in specific situations such as genes, recombinant vectors, transformants and monoclonal antibodies.

Adapted from the website of the CNIPA